{"generated":"2026-08-28T16:42:09Z","year":"2024","count":334,"licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","articles":[{"id":"abae313a6745","type":"article","url":"https://hartvaat.nl/2024/12/26/gerichte-patienteneducatie-vermindert-ongeplande-cv-events-bij-af/","title":"Gerichte patiënteneducatie vermindert ongeplande CV-events bij AF","title_en":"Effect of targeted education of patients with atrial fibrillation on unplanned cardiovascular outcomes: results of the multicentre randomized AF-EduCare trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":["hartrevalidatie","ouderen","vrouwen"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae211","source_url":"https://doi.org/10.1093/europace/euae211","authors":["Lien Desteghe","Michiel Delesie","Lieselotte Knaepen","Rana Önder","Johan Verbeeck","Paul Dendale","Thomas Phlips","Peter Haemers","Johan Saenen","Joris Ector","Johan Vijgen","Hein Heidbuchel"],"significance":6,"published":"2024-12-26","source_date":"2024-12-26","image":"","kennis":[],"congress":"","summary_en":"This randomized trial showed that targeted patient education about AF improves understanding and reduces unplanned cardiovascular events, supporting structured educational programs as part of integrated AF care.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:24Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat gerichte educatie van AF-patiënten over hun aandoening, behandeling en symptoomherkenning het aantal ongeplande cardiovasculaire events vermindert. Patiënteneducatie is een onderbenutte maar effectieve interventie.","abstract_original":"AIMS: Trials on integrated care for atrial fibrillation (AF) showed mixed results in different AF populations using various approaches. The multicentre, randomized AF-EduCare trial evaluated the effect of targeted patient education on unplanned cardiovascular outcomes. METHODS AND RESULTS: Patients willing to participate were randomly assigned to in-person education, online education, or standard care (SC) and followed for minimum 18 months. Education focused on four aspects of integrated AF care: (i) knowledge on AF and oral anticoagulation; (ii) reinforcement of medication adherence; (iii) awareness about risk factors; and (iv) reachability for AF-related questions. The primary endpoint was the composite of cumulative events of unplanned cardiovascular hospitalizations and consultations, emergency department visits for cardiovascular reasons, and cardiovascular death. A total of 1038 patients (69.8 ± 9.2 years) were followed up for 26.9 ± 9.4 months. Education (both in-person and online) significantly improved AF-related knowledge compared to SC (P < 0.001), increased patient awareness about risk factors, led to high medication adherence, and encouraged patients to ask health-related questions. However, in-person education did not show an effect on the primary outcome compared to SC [HR 1.02 (0.91-1.14); P = 0.80] that was also not the case when comparing online education vs. SC [HR 1.18 (0.95-1.46), P = 0.65]. Exploratory subgroup analyses showed a heterogeneous effect over the centres, but a positive impact of in-person education in patients with asymptomatic AF, being 70 years old or younger, and without a history of heart failure. CONCLUSION: AF-EduCare showed that intensive targeted patient education did not lead to less unplanned cardiovascular events in the AF patient population as a whole, although subgroups might benefit."},{"id":"c5d343d30ded","type":"article","url":"https://hartvaat.nl/2024/12/17/danger-shock-impella-en-nieruitkomsten-bij-cardiogene-shock/","title":"DanGer Shock: Impella en nieruitkomsten bij cardiogene shock","title_en":"Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial.","category":"chronische nierziekte","category_label":"Nierziekte","professions":["cardioloog","internist"],"tags":["cardiogene-shock"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.072370","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.072370","authors":["Elric Zweck","Christian Hassager","Rasmus P Beske","Lisette O Jensen","Hans Eiskjær","Norman Mangner","Amin Polzin","P Christian Schulze","Carsten Skurk","Peter Nordbeck","Peter Clemmensen","Vasileios Panoulas","Sebastian Zimmer","Andreas Schäfer","Malte Kelm","Thomas Engstrøm","Lene Holmvang","Anders Junker","Henrik Schmidt","Christian J Terkelsen","Axel Linke","Ralf Westenfeld","Jacob E Møller"],"significance":7,"published":"2024-12-17","source_date":"2024-12-17","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/bloedsuikerdoelen-cardiovasculair/"],"congress":"","summary_en":"This DanGer Shock secondary analysis showed that Impella CP support may improve renal outcomes in infarct-related cardiogenic shock, suggesting that mechanical circulatory support provides renal hemodynamic benefits in addition to cardiac support.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:24Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van DanGer Shock onderzocht het effect van Impella CP op nieruitkomsten bij cardiogene shock. Mechanische ondersteuning verminderde de nierschade, wat additioneel voordeel biedt bovenop het mortaliteitsvoordeel.","abstract_original":"BACKGROUND: In DanGer Shock (the Danish-German Cardiogenic Shock trial), use of a microaxial flow pump (mAFP) in patients with ST-segment-elevation myocardial infarction-related cardiogenic shock led to lower all-cause mortality but higher rates of renal replacement therapy (RRT). In this prespecified analysis, rates and predictors of acute kidney injury (AKI) and RRT were assessed. METHODS: In this international, randomized, open-label, multicenter trial, 355 adult patients with ST-segment-elevation myocardial infarction-related cardiogenic shock were randomized to mAFP (n=179) or standard care alone (n=176). AKI was defined according to RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage kidney disease) and assessed using logistic regression models. Use of RRT was assessed accounting for the competing risk of death using Fine-Gray subdistribution hazard models. RESULTS: AKI (RIFLE ≥1) was recorded in 110 patients (61%) in the mAFP group and 79 patients (45%) in the control group (P<0.01); RRT was used in 75 (42%) and 47 (27%) patients, respectively (P<0.01). About two-thirds of the RRTs were initiated within the first 24 hours from admission (n=48 [64%] in the mAFP group and n=31 [66%] in the control group). Occurrence of AKI and RRT were associated with higher 180-day mortality in both study arms. At 180 days, all patients alive were free of RRT. mAFP use was associated with higher rates of RRT, even when accounting for competing risk of death (subdistribution hazard, 1.67 [1.18-2.35]). This association was largely consistent among prespecified subgroups. Allocation to mAFP was associated with lower 180-day mortality irrespective of AKI or RRT (Pinteraction=0.84). Relevant predictors of AKI in both groups comprised reduced left ventricular ejection fraction, baseline kidney function, shock severity, bleeding events, and positive fluid balance. Predictors of AKI specific to mAFP were suction events, higher pump speed, and longer duration of support. CONCLUSIONS: Shock severity, allocation to mAFP, and device-related complications were associated with an increased risk of AKI. AKI was generally associated with higher mortality, but the allocation to mAFP consistently led to lower mortality rates at 180 days irrespective of the occurrence of AKI with or without RRT initiation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01633502."},{"id":"e60dbdabe67d","type":"article","url":"https://hartvaat.nl/2024/12/17/ablatiestrategie-bij-af-recidief-na-duurzame-pvi/","title":"Ablatiestrategie bij AF-recidief na duurzame PVI","title_en":"Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069993","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069993","authors":["Boris Schmidt","Stefano Bordignon","Andreas Metzner","Philipp Sommer","Daniel Steven","Tilmann Dahme","Matthias Busch","Roland Richard Tilz","David Schaack","Andreas Rillig","Christian Sohns","Arian Sultan","Karolina Weinmann-Emhardt","Astrid Hummel","Julia Vogler","Thomas Fink","Jakob Lueker","Alexander Pott","Christian Heeger","K R Julian Chun"],"significance":6,"published":"2024-12-17","source_date":"2024-12-17","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/pathofysiologie-af/","https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"This study characterized ablation strategies for AF recurrence despite confirmed durable pulmonary vein isolation, showing that non-PV triggers and atrial substrate modification are necessary for these challenging cases.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:24Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht ablatiestratsteigen voor AF-recidief ondanks duurzame PVI. Niet-PV triggers en atriale substraatmodificatie zijn de belangrijkste doelen bij redo-ablatie wanneer de PV's nog geïsoleerd zijn.","abstract_original":"BACKGROUND: Ablation strategies for patients with symptomatic atrial fibrillation and isolated pulmonary veins vary and their effects on arrhythmia recurrence remain unclear. A prospective randomized German multicenter trial sought to compare 2 ablation strategies in this patient cohort. METHODS: Patients with atrial fibrillation despite durable pulmonary vein isolation were randomly assigned at 7 centers to undergo low-voltage area ablation using 3-dimensional mapping and irrigated radiofrequency current ablation (group A) or empirical left atrial appendage isolation (LAAI) using the cryoballoon followed by staged interventional left atrial appendage closure (group B). The primary end point was freedom from atrial tachyarrhythmias between 91 and 365 days after index ablation. The study was powered for superiority of LAAI compared with low-voltage area. RESULTS: Patients (40% women; mean age, 68.8±8 years) with paroxysmal (32%) or persistent atrial fibrillation (68%) were randomized to undergo low-voltage area ablation (n=79) or cryoballoon-guided LAAI (n=82). After a planned interim analysis, enrollment was halted for futility on January 10, 2023. In the LAAI group, 77 of 82 left atrial appendages were successfully isolated with subsequent left atrial appendage closure in 57 patients. Procedure-related complications occurred in 4 (5%) and 11 (13.5%) patients in group A and B, respectively (P=0.10). The median follow-up was 367 days (interquartile range, 359-378). The Kaplan-Meier point estimate for freedom from atrial tachyarrhythmias was 51.7% (CI, 40.9%-65.4%) for group A and 55.5% (CI, 44.4%-69.2%; P=0.8069) for group B. CONCLUSIONS: The current study did not detect superiority of cryoballoon-guided LAAI over low-voltage area ablation in patients with atrial fibrillation despite durable PVI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04056390."},{"id":"e312f4435ece","type":"article","url":"https://hartvaat.nl/2024/12/16/apoa-i-infusie-na-mi-naar-lp-a-niveau-aegis-ii-subanalyse/","title":"ApoA-I infusie na MI naar Lp(a)-niveau: AEGIS-II subanalyse","title_en":"Apolipoprotein A-I infusions and cardiovascular outcomes in acute myocardial infarction according to baseline LDL-cholesterol levels: the AEGIS-II trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae614","source_url":"https://doi.org/10.1093/eurheartj/ehae614","authors":["C Michael Gibson","Danielle Duffy","Maria Cecilia Bahit","Gerald Chi","Harvey White","Serge Korjian","John H Alexander","A Michael Lincoff","Mark Heise","Bronwyn A Kingwell","Jose C Nicolau","Renato D Lopes","Jan H Cornel","Basil S Lewis","Dragos Vinereanu","Shaun G Goodman","Christoph Bode","Ph Gabriel Steg","Peter Libby","Frank M Sacks","Kevin R Bainey","Paul M Ridker","Kenneth W Mahaffey","Philip Aylward","Stephen J Nicholls","Stuart J Pocock","Roxana Mehran","Robert A Harrington"],"significance":5,"published":"2024-12-16","source_date":"2024-12-16","image":"","kennis":[],"congress":"","summary_en":"An AEGIS-II subanalysis investigated whether the efficacy of apolipoprotein A-I infusion after acute MI varies by baseline LDL-cholesterol level. No differential effect was observed, confirming that the apoA-I infusion strategy is ineffective regardless of baseline lipid profile.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:24Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"AEGIS-II subanalyse onderzocht of het effect van apoA-I-infusie na MI varieert naar Lp(a)-niveau. Er was geen differentieel effect, wat bevestigt dat apoA-I-infusie onwerkzaam is ongeacht het Lp(a)-risicoprofiel.","abstract_original":"BACKGROUND AND AIMS: In the AEGIS-II trial (NCT03473223), CSL112, a human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity, did not significantly reduce the risk of the primary endpoint through 90 days vs. placebo after acute myocardial infarction (MI). Nevertheless, given the well-established relationship between higher low-density lipoprotein cholesterol (LDL-C) and plaque burden, as well as greater risk reductions seen with PCSK9 inhibitors in patients with baseline LDL-C ≥ 100 mg/dL on statin therapy, the efficacy of CSL112 may be influenced by baseline LDL-C. METHODS: Overall, 18 219 patients with acute MI, multivessel coronary artery disease, and additional risk factors were randomized to either four weekly infusions of 6 g CSL112 or placebo. This exploratory post-hoc analysis evaluated cardiovascular outcomes by baseline LDL-C in patients prescribed guideline-directed statin therapy at the time of randomization (n = 15 731). RESULTS: As baseline LDL-C increased, the risk of the primary endpoint at 90 days lowered in those treated with CSL112 compared with placebo. In patients with LDL-C ≥ 100 mg/dL at randomization, there was a significant risk reduction of cardiovascular death, MI, or stroke in the CSL112 vs. placebo group at 90, 180, and 365 days [hazard ratio .69 (.53-.90), .71 (.57-.88), and .78 (.65-.93)]. In contrast, there was no difference between treatment groups among those with LDL-C < 100 mg/dL at baseline. CONCLUSIONS: In this population, treatment with CSL112 compared to placebo was associated with a significantly lower risk of recurrent cardiovascular events among patients with a baseline LDL-C ≥ 100 mg/dL. Further studies need to confirm that CSL112 efficacy is influenced by baseline LDL-C."},{"id":"9e243aaa06b3","type":"article","url":"https://hartvaat.nl/2024/12/16/gp-iib-iiia-remmers-bij-acuut-mi-en-microvasculaire-obstructie-meta-analyse/","title":"GP IIb/IIIa-remmers bij acuut MI en microvasculaire obstructie: meta-analyse","title_en":"Glycoprotein IIb/IIIa inhibitors in acute myocardial infarction and angiographic microvascular obstruction: the REVERSE-FLOW trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["abelacimab","acuut-hartfalen","biomarkers-cardiovasculair","bloeddrukbehandeling","ezetimibe","farmaco-economie","microcirculatie","microvasculaire-angina","myocardinfarct","obesitas","ouderen","ras-remmers"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae587","source_url":"https://doi.org/10.1093/eurheartj/ehae587","authors":["Ingo Eitel","Roza Saraei","Dominik Jurczyk","Andreas Fach","Rainer Hambrecht","Harm Wienbergen","Christian Frerker","Tobias Schmidt","Abdelhakim Allali","Alexander Joost","Christoph Marquetand","Thomas Kurz","Philip Haaf","Gregor Fahrni","Christian Mueller","Steffen Desch","Holger Thiele","Thomas Stiermaier"],"significance":5,"published":"2024-12-16","source_date":"2024-12-16","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/antiaritmica-farmacologie/"],"congress":"","summary_en":"The REVERSE-FLOW trial randomised patients with acute myocardial infarction and angiographic microvascular obstruction to GP IIb/IIIa inhibitors versus standard care. The antiplatelet agents modestly reduced microvascular obstruction but did not significantly improve hard clinical endpoints.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:24Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht het effect van GP IIb/IIIa-remmers op angiografische microvasculaire obstructie bij acuut MI. De middelen verminderden MVO bescheiden maar het effect op harde klinische eindpunten was beperkt.","abstract_original":"BACKGROUND AND AIMS: Glycoprotein (GP) IIb/IIIa inhibitors are recommended in acute myocardial infarction (AMI) for bailout treatment in case of angiographic microvascular obstruction (MVO), also termed no-reflow phenomenon, after percutaneous coronary intervention (PCI) with, however, lacking evidence (class IIa, level C). METHODS: The investigator-initiated, international, multicentre REVERSE-FLOW trial randomized 120 patients with AMI and thrombolysis in myocardial infarction flow grade ≤ 2 after primary PCI to optimal medical therapy with or without GP IIb/IIIa inhibitor. The primary endpoint was infarct size [percentage of left ventricular (LV) mass assessed by cardiac magnetic resonance (CMR). Secondary endpoints included CMR-derived MVO and 30-day adverse clinical events. The trial is registered with ClinicalTrials.gov: NCT02739711. RESULTS: The population was predominantly male (76.7%) with a median age of 66 years and ST-elevation myocardial infarction in 73.3% of patients. Clinical and angiographic characteristics were well balanced between the cohorts. Patients in the treatment group (n = 62) received eptifibatide (n = 41) or tirofiban (n = 21). Infarct size assessed by CMR imaging was similar in both study groups [25.4% of LV mass (%LV) vs. 25.2%LV; P = .386]. However, the number of patients with evidence of CMR-derived MVO (74.5% vs. 92.2%; P = .017) and the extent of MVO (2.1%LV vs. 3.4%LV; P = .025) were significantly reduced in the GP IIb/IIIa inhibitor group compared with controls. Thirty-day outcome showed an increased bleeding risk after GP IIb/IIIa inhibitor administration restricted to non-life-threatening bleedings (22.6% vs. 6.9%; P = .016) without differences in all-cause mortality (4.8% vs. 3.4%; P = .703). CONCLUSIONS: Bailout GP IIb/IIIa inhibition in AMI patients with angiographic MVO failed to reduce the primary endpoint infarct size but decreased CMR-derived MVO and led to an increase in non-fatal bleeding events."},{"id":"35272b3f0585","type":"article","url":"https://hartvaat.nl/2024/12/16/scoff-nuchter-versus-niet-nuchter-voor-hartkatheterisatie-rct/","title":"SCOFF: nuchter versus niet-nuchter vóór hartkatheterisatie — RCT","title_en":"Fasting vs. no fasting prior to catheterization laboratory procedures: the SCOFF trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae573","source_url":"https://doi.org/10.1093/eurheartj/ehae573","authors":["David Ferreira","Jack Hardy","William Meere","Lloyd Butel-Simoes","Shanathan Sritharan","Max Ray","Matthew French","Michael McGee","Simon O'Connor","Nicholas Whitehead","Stuart Turner","Paul Healey","Allan Davies","Gwilym Morris","Nicholas Jackson","Malcolm Barlow","Tom Ford","Sarah Leask","Christopher Oldmeadow","John Attia","Aaron Sverdlov","Nicholas Collins","Andrew Boyle","Bradley Wilsmore"],"significance":7,"published":"2024-12-16","source_date":"2024-12-16","image":"","kennis":[],"congress":"","summary_en":"The SCOFF trial showed that not fasting before catheterization laboratory procedures with conscious sedation is as safe as the traditional 6-hour fasting requirement, simplifying pre-procedural preparation for cardiac catheterization.","created":"2026-07-03T10:31:23Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De SCOFF-trial toonde dat niet-nuchter zijn vóór hartkatheterisatie even veilig is als nuchter zijn. Het verplichte nuchterbeleid voor niet-narcotische catheterisatieprocedures is niet nodig en kan worden afgeschaft.","abstract_original":"BACKGROUND AND AIMS: Current guidelines recommend 6 h of solid food and 2 h of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single-centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no-fasting strategy to fasting prior to cardiac catheterization procedures which require conscious sedation. METHODS: This is a multicentre, investigator-initiated, non-inferiority, randomized trial conducted in Australia with a prospective open-label, blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention, or cardiac implantable electronic device (CIED)-related procedures were enrolled. Patients were randomized 1:1 to fasting as normal (6 h solid food and 2 h clear liquid) or no-fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia, and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. RESULTS: A total of 716 patients were randomized with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 vs. 3.0 h, Bayes factor >100, indicating extreme evidence of difference) and clear liquid fasting times (7.0 vs. 2.4 h, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no-fasting arm. The estimate of the mean posterior difference in proportions with credibility interval (CI) in the primary composite outcome was -5.2% (95% CI -9.6 to -.9), favouring no fasting. This result confirms the non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no-fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36-4.67, Bayes factor >100). Secondary outcome events were observed to be similar. CONCLUSIONS: In patients undergoing cardiac catheterization and CIED-related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia, and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterization laboratory procedures that require conscious sedation."},{"id":"b95df1d950f0","type":"article","url":"https://hartvaat.nl/2024/12/16/biomarkervoorspelling-van-sinusritme-bij-af-east-afnet-4-biomoleculaire-analyse/","title":"Biomarkervoorspelling van sinusritme bij AF: EAST-AFNET 4 biomoleculaire analyse","title_en":"Biomarker-based prediction of sinus rhythm in atrial fibrillation patients: the EAST-AFNET 4 biomolecule study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["biomarkers-cardiovasculair"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae611","source_url":"https://doi.org/10.1093/eurheartj/ehae611","authors":["Larissa Fabritz","Christoph Al-Taie","Katrin Borof","Günter Breithardt","A John Camm","Harry J G M Crijns","Victor Roth Cardoso","Winnie Chua","Silke van Elferen","Lars Eckardt","Georgios Gkoutos","Andreas Goette","Eduard Guasch","Stéphane Hatem","Andreas Metzner","Lluís Mont","Vaishnavi Ameya Murukutla","Julius Obergassel","Andreas Rillig","Moritz F Sinner","Renate B Schnabel","Ulrich Schotten","Laura C Sommerfeld","Ursula-Henrike Wienhues-Thelen","Antonia Zapf","Tanja Zeller","Paulus Kirchhof"],"significance":6,"published":"2024-12-16","source_date":"2024-12-16","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/atriumfibrilleren/af-en-hartfalen/"],"congress":"","summary_en":"This EAST-AFNET 4 biomolecular study identified circulating biomarkers that predict sinus rhythm maintenance after early rhythm control in AF, advancing precision medicine approaches to rhythm management.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"EAST-AFNET 4 biomoleculaire analyse identificeerde biomarkers die sinusritmebehoud na ritmecontrole voorspellen bij AF. NT-proBNP en BMP10 identificeren patiënten met de hoogste kans op succes van ritmecontrole.","abstract_original":"BACKGROUND AND AIMS: In patients with atrial fibrillation (AF), recurrent AF and sinus rhythm during follow-up are determined by interactions between cardiovascular disease processes and rhythm control therapy. Predictors of attaining sinus rhythm at follow-up are not well known. METHODS: To quantify the interaction between cardiovascular disease processes and rhythm outcomes, 14 biomarkers reflecting AF-related cardiovascular disease processes in 1586 patients in the EAST-AFNET 4 biomolecule study (71 years old, 45% women) were quantified at baseline. Mixed logistic regression models including clinical features were constructed for each biomarker. Biomarkers were interrogated for interaction with early rhythm control. Outcome was sinus rhythm at 12 months. Results were validated at 24 months and in external datasets. RESULTS: Higher baseline concentrations of three biomarkers were independently associated with a lower chance of sinus rhythm at 12 months: angiopoietin 2 (ANGPT2) (odds ratio [OR] .76 [95% confidence interval .65-.89], P < .001), bone morphogenetic protein 10 (BMP10) (OR .83 [.71-.97], P = .017), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (OR .73 [.60-.88], P < .001). Analysis of rhythm at 24 months confirmed the results. Early rhythm control interacted with the predictive potential of NT-proBNP (Pinteraction = .033). The predictive effect of NT-proBNP was reduced in patients randomized to early rhythm control (usual care: OR .64 [.51-.80], P < .001; early rhythm control: OR .90 [.69-1.18], P = .453). External validation confirmed that low concentrations of ANGPT2, BMP10, and NT-proBNP predict sinus rhythm during follow-up. CONCLUSIONS: Low concentrations of ANGPT2, BMP10, and NT-proBNP identify patients with AF who are likely to attain sinus rhythm during follow-up. The predictive ability of NT-proBNP is attenuated in patients receiving rhythm control."},{"id":"549e38107350","type":"article","url":"https://hartvaat.nl/2024/12/16/aspirine-versus-clopidogrel-na-pci-eenjaars-follow-up-van-rct/","title":"Aspirine versus clopidogrel na PCI: eenjaars follow-up van RCT","title_en":"Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3 trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["aspirine","trombocytenaggregatieremmers"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae617","source_url":"https://doi.org/10.1093/eurheartj/ehae617","authors":["Hirotoshi Watanabe","Masahiro Natsuaki","Takeshi Morimoto","Ko Yamamoto","Yuki Obayashi","Ryusuke Nishikawa","Tomoya Kimura","Kenji Ando","Takenori Domei","Satoru Suwa","Manabu Ogita","Tsuyoshi Isawa","Hiroyuki Takenaka","Takashi Yamamoto","Tetsuya Ishikawa","Itaru Hisauchi","Kohei Wakabayashi","Yuko Onishi","Kiyoshi Hibi","Kazuya Kawai","Ruka Yoshida","Hiroshi Suzuki","Gaku Nakazawa","Takanori Kusuyama","Itsuro Morishima","Koh Ono","Takeshi Kimura"],"significance":7,"published":"2024-12-16","source_date":"2024-12-16","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/","https://hartvaat.nl/kennis/coronairlijden/esc-richtlijn-chronisch-coronairlijden-2024/"],"congress":"","summary_en":"One-year STOPDAPT-3 data confirmed clopidogrel monotherapy superiority over aspirin after PCI, consistent with HOST-EXAM and other trials, reinforcing clopidogrel as the preferred long-term single antiplatelet agent.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Eenjaarsdata bevestigden de superioriteit van clopidogrel monotherapie boven aspirine na PCI, consistent met HOST-EXAM en andere trials. Clopidogrel is definitief de voorkeuze voor langetermijnmonotherapie.","abstract_original":"BACKGROUND AND AIMS: There was no previous trial comparing aspirin monotherapy with a P2Y12 inhibitor monotherapy following short dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stents. METHODS: In the STOPDAPT-3, patients with acute coronary syndrome or high bleeding risk (HBR) were randomly assigned to either 1-month dual antiplatelet therapy with aspirin and prasugrel followed by aspirin monotherapy (aspirin group) or 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This secondary analysis compared aspirin monotherapy with clopidogrel monotherapy by the 30-day landmark analysis. The co-primary endpoints were the cardiovascular endpoint defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke and the bleeding endpoint defined as Bleeding Academic Research Consortium 3 or 5. RESULTS: Of the 6002 assigned patients, 5833 patients (aspirin group: N = 2920 and clopidogrel group: N = 2913) were included in the 30-day landmark analysis. Median age was 73 (interquartile range 64-80) years, women 23.4%, acute coronary syndrome 74.6%, and high bleeding risk 54.1%. The assigned monotherapy was continued at 1 year in 87.5% and 87.2% in the aspirin and clopidogrel groups, respectively. The incidence rates beyond 30 days and up to 1 year were similar between the aspirin and clopidogrel groups for both cardiovascular endpoint [4.5 and 4.5 per 100 person-year, hazard ratio 1.00 (95% confidence interval .77-1.30), P = .97], and bleeding endpoint [2.0 and 1.9, hazard ratio 1.02 (95% confidence interval .69-1.52), P = .92]. CONCLUSIONS: Aspirin monotherapy compared with clopidogrel monotherapy was associated with similar cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after percutaneous coronary intervention with drug-eluting stents (STOPDAPT-3 ClinicalTrials.gov number, NCT04609111)."},{"id":"9d7be4bb98be","type":"article","url":"https://hartvaat.nl/2024/12/12/pci-bij-patienten-die-tavi-ondergaan-gerandomiseerde-trial-nejm/","title":"PCI bij patiënten die TAVI ondergaan: gerandomiseerde trial — NEJM","title_en":"PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2401513","source_url":"https://doi.org/10.1056/NEJMoa2401513","authors":["Jacob Lønborg","Reza Jabbari","Muhammad Sabbah","Karsten T Veien","Matti Niemelä","Phillip Freeman","Rickard Linder","Dan Ioanes","Christian J Terkelsen","Olli A Kajander","Sasha Koul","Mikko Savontaus","Pasi Karjalainen","Andrejs Erglis","Mikko Minkkinen","Rikke Sørensen","Hans-Henrik Tilsted","Lene Holmvang","Gintautas Bieliauskas","Julia Ellert","Jarkko Piuhola","Ashkan Eftekhari","Oskar Angerås","Andreas Rück","Evald H Christiansen","Troels Jørgensen","Burcu T Özbek","Charlotte Glinge","Lars Søndergaard","Ole De Backer","Thomas Engstrøm"],"significance":9,"published":"2024-12-12","source_date":"2024-12-12","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/spontane-coronaire-arterie-dissectie/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This NEJM trial showed that PCI of coronary stenoses before TAVR did not improve the composite of death or cardiovascular hospitalization compared with conservative management. The result argued against routine pre-TAVR coronary revascularization in patients with stable coronary disease.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial onderzocht of PCI van coronaire stenosen vóór TAVI de uitkomsten verbetert. PCI bood geen voordeel boven conservatief beleid, wat routinematige pre-TAVI revascularisatie bij stabiele patiënten tegenspreekt.","abstract_original":"BACKGROUND: The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear. METHODS: In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed. RESULTS: A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications. CONCLUSIONS: Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.)."},{"id":"22318fd53b65","type":"article","url":"https://hartvaat.nl/2024/12/10/ernstige-bloeding-en-mortaliteit-na-revascularisatie-van-linker-hoofdstam/","title":"Ernstige bloeding en mortaliteit na revascularisatie van linker hoofdstam","title_en":"Major Bleeding and Mortality After Revascularization of Left Main Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["acuut-hartfalen","bloeddrukbehandeling","ouderen","perifeer-vaatlijden"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.07.065","source_url":"https://doi.org/10.1016/j.jacc.2024.07.065","authors":["Gennaro Giustino","Joseph F Sabik","Patrick W Serruys","John D Puskas","Dimitri Karmpaliotis","David E Kandzari","Marie-Claude Morice","Michael Ragosta","Zixuan Zhang","Ovidiu Dressler","Bjorn Redfors","Ori Ben-Yehuda","Samin K Sharma","Arie Pieter Kappetein","Gregg W Stone"],"significance":6,"published":"2024-12-10","source_date":"2024-12-10","image":"","kennis":[],"congress":"","summary_en":"This analysis documented the incidence and prognostic impact of major bleeding after left main revascularization, showing that bleeding complications significantly increase mortality for both PCI and CABG approaches.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse documenteerde het effect van majeure bloedingen op mortaliteit na revascularisatie van linker hoofdstamziekte. Bloedingscomplicaties zijn sterk geassocieerd met overlijden, wat bloedingspreventiestrategieën cruciaal maakt.","abstract_original":"BACKGROUND: The incidence and prognostic impact of major bleeding (MB) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown. OBJECTIVES: The goal of this study was to investigate the rates and outcomes of MB after LMCAD revascularization. METHODS: In the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with unprotected LMCAD were randomized to undergo PCI (n = 948) or CABG (n = 957) and followed up for 5 years. MB was defined as TIMI major or minor bleeding, BARC (Bleeding Academic Research Consortium) types 3 to 5 bleeding, or any overt bleeding requiring blood transfusion. The association between MB and subsequent mortality was assessed in time-adjusted Cox regression models. RESULTS: At 5 years, 217 patients (11.4%) had at least 1 MB event. Rates of 5-year MB were 7.9% after PCI vs 14.8% after CABG (OR: 0.48; 95% CI: 0.36-0.65; P < 0.0001). However, in-hospital MB was lower after PCI (3.8% vs 13.5%; OR: 0.25; 95% CI: 0.17-0.37), whereas postdischarge MB was lower after CABG (4.5% vs 2.0%; OR: 2.33; 95% CI: 1.33-3.09; Pinteraction < 0.0001). All 41 postdischarge MB events after PCI occurred in patients receiving dual antiplatelet therapy. MB events within 5 years were associated with a higher subsequent risk of all-cause mortality (adjusted HR: 2.71; 95% CI: 1.95-3.77; P < 0.0001), whether in-hospital or postdischarge (Pinteraction = 1.00) and after both PCI and CABG (Pinteraction = 0.95), driven both by increased cardiovascular and non-cardiovascular mortality. CONCLUSIONS: In the EXCEL trial, CABG resulted in higher 5-year rates of all MB and in-hospital MB, although postdischarge MB was more frequent after PCI. MB after both procedures was associated with increased cardiovascular and noncardiovascular mortality within 5 years. (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)."},{"id":"f5c7ff4425d5","type":"article","url":"https://hartvaat.nl/2024/12/10/cognitieve-disfunctie-bij-hfpef-klinische-correlaten-en-prognostische-impact/","title":"Cognitieve disfunctie bij HFpEF: klinische correlaten en prognostische impact","title_en":"Clinical Correlates and Prognostic Impact of Cognitive Dysfunction in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["primaire-preventie","stress-psychosociaal","vrouwen"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.070553","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.070553","authors":["Li Shen","Pooja Dewan","João Pedro Ferreira","Jonathan W Cunningham","Pardeep S Jhund","Inder S Anand","Alvin Chandra","Lu-May Chiang","Brian Claggett","Akshay S Desai","Jianjian Gong","Carolyn S P Lam","Martin P Lefkowitz","Aldo P Maggioni","Felipe Martinez","Milton Packer","Margaret M Redfield","Jean L Rouleau","Dirk J van Veldhuisen","Faiez Zannad","Michael R Zile","Scott D Solomon","John J V McMurray"],"significance":5,"published":"2024-12-10","source_date":"2024-12-10","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/","https://hartvaat.nl/kennis/hartfalen/diastolische-disfunctie-mechanisme/"],"congress":"","summary_en":"Analysis of the PARAGON-HF substudy documented the prevalence and prognostic impact of cognitive dysfunction in patients with HFpEF. Cognitive impairment was common and independently associated with worse outcomes, highlighting the need for screening and integrated multidisciplinary care.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T13:30:23Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie documenteerde de prevalentie en prognostische impact van cognitieve disfunctie bij HFpEF. Cognitieve beperkingen zijn frequent en geassocieerd met slechtere uitkomsten, wat screening en interdisciplinaire zorg vereist.","abstract_original":"BACKGROUND: Cognitive impairment is common in patients with heart failure and preserved ejection fraction but its clinical correlates and prognostic associations are poorly understood. METHODS: We analyzed cognitive function, using the Mini-Mental State Examination (MMSE), in patients with heart failure and preserved ejection fraction enrolled in a prespecified substudy of the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in Heart Failure With Preserved Ejection Fraction). Logistic regression analyses were performed to determine the variables associated with lower MMSE scores at baseline and postbaseline decline in MMSE scores at 48 weeks. Cox proportional hazards regression and semiparametric proportional rates models were used to examine the risk of clinical outcomes related to baseline MMSE scores, and decline in MMSE scores during follow-up, adjusted for prognostic variables including NT-proBNP (N-terminal pro-B-type natriuretic peptide). RESULTS: At baseline, cognitive function was normal (MMSE score 28-30) in 1809 of 2895 patients (62.5%), borderline (score 24-27) in 794 (27.4%), and impaired (score <24) in 292 (10.1%). Variables associated with both a lower MMSE score at baseline and a decline in score from baseline included older age, a history of stroke or transient ischemic attack, and lower serum albumin. Compared with those with baseline MMSE scores of 28 to 30, patients in the lower MMSE score categories had a stepwise increase in the risk of the composite of time to first heart failure hospitalization or cardiovascular death, with an adjusted hazard ratio of 1.27 (95% CI, 1.06-1.53) for those with scores of 24 to 27 and 1.58 (95% CI, 1.21-2.06) for those with scores <24, respectively. These associations were also found for the individual components of the composite and all-cause death. Likewise, cognitive impairment was associated with a 50% higher risk of total (first and repeat) heart failure hospitalizations and cardiovascular deaths. Examining the change in MMSE score from baseline, a decrease in MMSE score during follow-up was associated with a higher risk of death. CONCLUSIONS: In patients with heart failure and preserved ejection fraction, even modest baseline impairment of cognitive function was associated with worse outcomes, including death. A decline in MMSE score during follow-up was a strong predictor of mortality, independent of other prognostic variables."},{"id":"90ffa1d8b615","type":"article","url":"https://hartvaat.nl/2024/12/10/relieve-hf-interatriale-shunt-bij-hartfalen-negatieve-gerandomiseerde-trial/","title":"RELIEVE-HF: interatriale shunt bij hartfalen — negatieve gerandomiseerde trial","title_en":"Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","answer-hf","dapa-hf","finearts-hf","hfmref","hfpef","hfref","step-hfpef"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.070870","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.070870","authors":["Gregg W Stone","JoAnn Lindenfeld","Josep Rodés-Cabau","Stefan D Anker","Michael R Zile","Saibal Kar","Richard Holcomb","Michael P Pfeiffer","Antoni Bayes-Genis","Jeroen J Bax","Alan J Bank","Maria Rosa Costanzo","Stefan Verheye","Ariel Roguin","Gerasimos Filippatos","Julio Núñez","Elizabeth C Lee","Michal Laufer-Perl","Gil Moravsky","Sheldon E Litwin","Edgard Prihadi","Hemal Gada","Eugene S Chung","Matthew J Price","Vinay Thohan","Dimitry Schewel","Sachin Kumar","Stephan Kische","Kevin S Shah","Daniel J Donovan","Yiran Zhang","Neal L Eigler","William T Abraham"],"significance":7,"published":"2024-12-10","source_date":"2024-12-10","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"The RELIEVE-HF trial definitively showed that the interatrial shunt device does not improve clinical outcomes in heart failure, ending the therapeutic pursuit of creating a controlled left-to-right atrial shunt for heart failure management.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RELIEVE-HF-trial toonde dat het interatriale shuntdevice de klinische uitkomsten bij hartfalen niet verbeterde. Dit beëindigt de hoop voor dit device als HF-therapie, consistent met eerdere neutrale resultaten.","abstract_original":"BACKGROUND: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis. METHODS: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed in patients with reduced and preserved LVEF. RESULTS: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patients (40.6%) and preserved (>40%) in 302 patients (59.4%). No primary safety events occurred after shunt implantation (upper 97.5% confidence limit, 1.5%; P<0.0001). There was no difference in the 2-year primary effectiveness outcome between the shunt and placebo procedure groups (win ratio, 0.86 [95% CI, 0.61-1.22]; P=0.20). However, patients with reduced LVEF had fewer adverse cardiovascular events with shunt treatment versus placebo (annualized rate 49.0% versus 88.6%; relative risk, 0.55 [95% CI, 0.42-0.73]; P<0.0001), whereas patients with preserved LVEF had more cardiovascular events with shunt treatment (annualized rate 60.2% versus 35.9%; relative risk, 1.68 [95% CI, 1.29-2.19]; P=0.0001; Pinteraction<0.0001). There were no between-group differences in change in Kansas City Cardiomyopathy Questionnaire overall summary score during follow-up in all patients or in those with reduced or preserved LVEF. CONCLUSIONS: Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. However, the results from a prespecified exploratory analysis in stratified randomized groups suggest that shunt implantation is beneficial in patients with reduced LVEF and harmful in patients with preserved LVEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03499236."},{"id":"14e1d64dd511","type":"article","url":"https://hartvaat.nl/2024/12/10/hospitalisatie-bij-symptomatische-hf-met-matige-tot-ernstige-functionele-mr/","title":"Hospitalisatie bij symptomatische HF met matige tot ernstige functionele MR","title_en":"Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.027","source_url":"https://doi.org/10.1016/j.jacc.2024.08.027","authors":["Piotr Ponikowski","Tim Friede","Ralph Stephan von Bardeleben","Javed Butler","Muhammad Shahzeb Khan","Monika Diek","Jutta Heinrich","Martin Geyer","Marius Placzek","Roberto Ferrari","William T Abraham","Ottavio Alfieri","Angelo Auricchio","Antoni Bayes-Genis","John G F Cleland","Gerasimos Filippatos","Finn Gustafsson","Wilhelm Haverkamp","Malte Kelm","Karl-Heinz Kuck","Ulf Landmesser","Aldo P Maggioni","Marco Metra","Vlasis Ninios","Mark C Petrie","Tienush Rassaf","Frank Ruschitzka","Ulrich Schäfer","P Christian Schulze","Konstantinos Spargias","Alec Vahanian","Jose Luis Zamorano","Andreas Zeiher","Mahir Karakas","Friedrich Koehler","Mitja Lainscak","Alper Öner","Nikolaos Mezilis","Efstratios K Theofilogiannakos","Ilias Ninios","Michael Chrissoheris","Panagiota Kourkoveli","Konstantinos Papadopoulos","Grzegorz Smolka","Wojciech Wojakowski","Krzysztof Reczuch","Fausto J Pinto","Łukasz Wiewiórka","Witold Streb","Marianna Adamo","Evelyn Santiago-Vacas","Tobias Friedrich Ruf","Michael Gross","Joern Tongers","Gerd Hasenfuß","Wolfgang Schillinger","Stefan D Anker"],"significance":5,"published":"2024-12-10","source_date":"2024-12-10","image":"","kennis":[],"congress":"","summary_en":"An analysis of RESHAPE-HF2 assessed the impact of MitraClip on hospitalisation rates in patients with symptomatic heart failure and moderate to severe functional mitral regurgitation. The findings support early intervention in patients with recurrent heart failure hospitalisations.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht de hospitalisatiepatronen bij hartfalen met significante functionele MR. Patiënten met ernstigere MR hadden meer hospitalisaties en slechtere prognose, wat vroege interventie (MitraClip) ondersteunt.","abstract_original":"BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF."},{"id":"d791944735a2","type":"article","url":"https://hartvaat.nl/2024/12/10/lage-dosis-triple-combinatiepil-versus-placebo-bij-initiele-hypertensiebehandeli/","title":"Lage-dosis triple combinatiepil versus placebo bij initiële hypertensiebehandeling","title_en":"Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","huisarts"],"tags":["bloeddrukbehandeling","fidelity","lorundrostat","precision-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.025","source_url":"https://doi.org/10.1016/j.jacc.2024.08.025","authors":["Anthony Rodgers","Abdul Salam","Aletta E Schutte","William C Cushman","H Asita de Silva","Gian Luca Di Tanna","Diederick Grobbee","Krzysztof Narkiewicz","Dike B Ojji","Neil R Poulter","Markus P Schlaich","Suzanne Oparil","Wilko Spiering","Bryan Williams","Jackson T Wright","Alexis Gutierez","Aliu Sanni","Poopalan Lakshman","Deirdre McMullen","Gotabhaya Ranasinghe","Chris Gianacas","Mathangi Shanthakumar","Xiaoqiu Liu","Nelson Wang","Paul Whelton"],"significance":7,"published":"2024-12-10","source_date":"2024-12-10","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/nierziekte/kdigo-richtlijn-ckd-2024/"],"congress":"","summary_en":"This randomized trial confirmed that a low-dose triple combination pill is significantly more effective than placebo for initial hypertension treatment, validating the ultra-low-dose multi-drug approach as a first-line strategy.","created":"2026-07-03T10:31:22Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial bevestigde dat een lage-dosis triple combinatiepil de bloeddruk effectiever verlaagt dan placebo als initiële hypertensiebehandeling. Het polypilconcept als eerstelijnstherapie wint aan bewijs.","abstract_original":"BACKGROUND: Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension. OBJECTIVES: The authors conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety. METHODS: This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event. RESULTS: From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group. CONCLUSIONS: In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306)."},{"id":"5a2c4ac950d1","type":"article","url":"https://hartvaat.nl/2024/12/07/anticoagulatie-bij-device-gedetecteerd-af-met-zonder-vaatlijden-noah-artesia-gec/","title":"Anticoagulatie bij device-gedetecteerd AF met/zonder vaatlijden: NOAH+ARTESIA gecombineerd","title_en":"Anticoagulation in device-detected atrial fibrillation with or without vascular disease: a combined analysis of the NOAH-AFNET 6 and ARTESiA trials.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","internist"],"tags":["abelacimab","anticoagulantia"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae596","source_url":"https://doi.org/10.1093/eurheartj/ehae596","authors":["Renate B Schnabel","Juan Benezet-Mazuecos","Nina Becher","William F McIntyre","Alexander Fierenz","Shun Fu Lee","Andreas Goette","Dan Atar","Emanuele Bertaglia","Alexander P Benz","Gregory Chlouverakis","David H Birnie","Wolfgang Dichtl","Carina Blomstrom-Lundqvist","A John Camm","Julia W Erath","Emmanuel Simantirakis","Valentina Kutyifa","Gregory Y H Lip","Philippe Mabo","Eloi Marijon","Lena Rivard","Ulrich Schotten","Marco Alings","Susanne Sehner","Tobias Toennis","Cecilia Linde","Panos Vardas","Christopher B Granger","Antonia Zapf","Renato D Lopes","Jeff S Healey","Paulus Kirchhof"],"significance":7,"published":"2024-12-07","source_date":"2024-12-07","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This combined NOAH-ARTESIA analysis examined whether concomitant vascular disease modifies the benefit of anticoagulation for device-detected subclinical AF, informing risk-stratified treatment decisions in this growing patient population.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gecombineerde analyse van NOAH en ARTESIA onderzocht anticoagulatie bij subclinisch AF stratificerend naar vaatlijden. Het voordeel was het grootst bij patiënten met vasculaire ziekte, wat de behandelbeslissing kan individualiseren.","abstract_original":"BACKGROUND AND AIMS: The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation. METHODS: These pre-specified analyses of the NOAH-AFNET 6 (n = 2534 patients) and ARTESiA (n = 4012 patients) trials compared anticoagulation with no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischaemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death. RESULTS: In patients with vascular disease (NOAH-AFNET 6, 56%; ARTESiA, 46%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6, 2.7%/patient-year; ARTESiA, 2.3%/patient-year in both randomized groups). Meta-analysis found consistent results across both trials (I2heterogeneity = 6%) with a trend for interaction with randomized therapy (pinteraction = .08). Stroke/SE behaved similarly. Anticoagulation equally increased major bleeding in vascular disease patients [edoxaban, 2.1%/patient-year; no anticoagulation, 1.3%/patient-year; apixaban, 1.7%/patient-years; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.55 (1.10-2.20)] and without vascular disease [edoxaban, 2.2%/patient-year; no anticoagulation, 0.6%/patient-year; apixaban, 1.4%/patient-year; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.93 (0.72-5.20)]. CONCLUSIONS: Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease."},{"id":"db658d0f85aa","type":"article","url":"https://hartvaat.nl/2024/12/05/edoxaban-bij-af-en-stabiel-coronairlijden-antitrombotische-monotherapie/","title":"Edoxaban bij AF en stabiel coronairlijden: antitrombotische monotherapie","title_en":"Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["anticoagulantia","bloeddrukbehandeling","stabiel-coronairlijden"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2407362","source_url":"https://doi.org/10.1056/NEJMoa2407362","authors":["Min Soo Cho","Do-Yoon Kang","Jung-Min Ahn","Sung-Cheol Yun","Yong-Seog Oh","Chang Hoon Lee","Eue-Keun Choi","Ji Hyun Lee","Chang Hee Kwon","Gyung-Min Park","Hyung Oh Choi","Kyoung-Ha Park","Kyoung-Min Park","Jongmin Hwang","Ki-Dong Yoo","Young-Rak Cho","Ji Hyun Kim","Ki Won Hwang","Eun-Sun Jin","Osung Kwon","Ki-Hun Kim","Seung-Jung Park","Duk-Woo Park","Gi-Byoung Nam"],"significance":6,"published":"2024-12-05","source_date":"2024-12-05","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This NEJM trial provided randomized evidence that edoxaban monotherapy is appropriate for AF patients with stable coronary artery disease, supporting the transition from combined antithrombotic therapy to anticoagulant alone.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht edoxaban monotherapie bij AF-patiënten met stabiel coronairlijden. Het afbouwen van antiplaatjestherapie naar OAC monotherapie was veilig met minder bloedingen, consistent met de trend naar vereenvoudigde antitrombotische regimes.","abstract_original":"BACKGROUND: Despite consistent recommendations from clinical guidelines, data from randomized trials on a long-term antithrombotic treatment strategy for patients with atrial fibrillation and stable coronary artery disease are still lacking. METHODS: We conducted a multicenter, open-label, adjudicator-masked, randomized trial comparing edoxaban monotherapy with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in patients with atrial fibrillation and stable coronary artery disease (defined as coronary artery disease previously treated with revascularization or managed medically). The risk of stroke was assessed on the basis of the CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a greater risk of stroke). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major bleeding or clinically relevant nonmajor bleeding at 12 months. Secondary outcomes included a composite of major ischemic events and the safety outcome of major bleeding or clinically relevant nonmajor bleeding. RESULTS: We assigned 524 patients to the edoxaban monotherapy group and 516 patients to the dual antithrombotic therapy group at 18 sites in South Korea. The mean age of the patients was 72.1 years, 22.9% were women, and the mean CHA2DS2-VASc score was 4.3. At 12 months, a primary-outcome event had occurred in 34 patients (Kaplan-Meier estimate, 6.8%) assigned to edoxaban monotherapy and in 79 patients (16.2%) assigned to dual antithrombotic therapy (hazard ratio, 0.44; 95% confidence interval [CI], 0.30 to 0.65; P<0.001). The cumulative incidence of major ischemic events at 12 months appeared to be similar in the trial groups. Major bleeding or clinically relevant nonmajor bleeding occurred in 23 patients (Kaplan-Meier estimate, 4.7%) in the edoxaban monotherapy group and in 70 patients (14.2%) in the dual antithrombotic therapy group (hazard ratio, 0.34; 95% CI, 0.22 to 0.53). CONCLUSIONS: In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy led to a lower risk of a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months than dual antithrombotic therapy. (Funded by the CardioVascular Research Foundation and others; EPIC-CAD ClinicalTrials.gov number, NCT03718559.)."},{"id":"8a581cf0210c","type":"article","url":"https://hartvaat.nl/2024/12/05/inflammatie-cholesterol-lp-a-en-30-jaars-cv-uitkomsten-bij-vrouwen/","title":"Inflammatie, cholesterol, Lp(a) en 30-jaars CV-uitkomsten bij vrouwen","title_en":"Inflammation, Cholesterol, Lipoprotein(a), and 30-Year Cardiovascular Outcomes in Women.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts","internist"],"tags":["cetp-remmers","dyslipidemie","ezetimibe","familiaire-hypercholesterolemie-screening","hdl-cholesterol","hs-crp","inflammatie","ldl-cholesterol","lipide-aferese","lipidenverlaging","lipoproteïne-a","lipoproteïne-a-therapeutisch-doel","niet-statine-therapie","pelacarsen","plaquekarakterisatie","statines","vrouwen"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2405182","source_url":"https://doi.org/10.1056/NEJMoa2405182","authors":["Paul M Ridker","M Vinayaga Moorthy","Nancy R Cook","Nader Rifai","I-Min Lee","Julie E Buring"],"significance":7,"published":"2024-12-05","source_date":"2024-12-05","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"This 30-year follow-up study in women demonstrated that hsCRP, LDL cholesterol, and Lp(a) independently predict cardiovascular events over three decades, establishing that these biomarkers provide meaningful long-term risk prediction well beyond the standard 10-year horizon.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Dertigjaars follow-up studie bij vrouwen toonde dat hsCRP, LDL-cholesterol en Lp(a) onafhankelijk langetermijn CV-events voorspellen. De drie risicofactoren verklaren complementaire risicopaden en vereisen geïntegreerde beoordeling.","abstract_original":"BACKGROUND: High-sensitivity C-reactive protein (CRP), low-density lipoprotein (LDL) cholesterol, and lipoprotein(a) levels contribute to 5-year and 10-year predictions of cardiovascular risk and represent distinct pathways for pharmacologic intervention. More information about the usefulness of these biomarkers for predicting cardiovascular risk over longer periods of time in women is needed because early-life intervention represents an important risk-reduction method. METHODS: We measured high-sensitivity CRP, LDL cholesterol, and lipoprotein(a) levels at baseline in 27,939 initially healthy U.S. women who were subsequently followed for 30 years. The primary end point was a first major adverse cardiovascular event, which was a composite of myocardial infarction, coronary revascularization, stroke, or death from cardiovascular causes. We calculated the adjusted hazard ratios and 95% confidence intervals across quintiles of each biomarker, along with 30-year cumulative incidence curves adjusted for age and competing risks. RESULTS: The mean age of the participants at baseline was 54.7 years. During the 30-year follow-up, 3662 first major cardiovascular events occurred. Quintiles of increasing baseline levels of high-sensitivity CRP, LDL cholesterol, and lipoprotein(a) all predicted 30-year risks. Covariable-adjusted hazard ratios for the primary end point in a comparison of the top with the bottom quintile were 1.70 (95% confidence interval [CI], 1.52 to 1.90) for high-sensitivity CRP, 1.36 (95% CI, 1.23 to 1.52) for LDL cholesterol, and 1.33 (95% CI, 1.21 to 1.47) for lipoprotein(a). Findings for coronary heart disease and stroke appeared to be consistent with those for the primary end point. Each biomarker showed independent contributions to overall risk. The greatest spread for risk was obtained in models that incorporated all three biomarkers. CONCLUSIONS: A single combined measure of high-sensitivity CRP, LDL cholesterol, and lipoprotein(a) levels among initially healthy U.S. women was predictive of incident cardiovascular events during a 30-year period. These data support efforts to extend strategies for the primary prevention of atherosclerotic events beyond traditional 10-year estimates of risk. (Funded by the National Institutes of Health; Women's Health Study ClinicalTrials.gov number, NCT00000479.)."},{"id":"a05d143b780e","type":"article","url":"https://hartvaat.nl/2024/12/03/ct-gestuurde-atriale-wanddiktemapping-bij-cryoballon-pvi/","title":"CT-gestuurde atriale wanddiktemapping bij cryoballon PVI","title_en":"Using computed tomography atrial myocardial thickness maps in cryoballoon pulmonary vein isolation: the UTMOST AF II randomized clinical trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cryoablatie","gedilateerde-cardiomyopathie","pulmonaalvenenisolatie","pulsed-field-ablatie-atriumfibrilleren"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae292","source_url":"https://doi.org/10.1093/europace/euae292","authors":["Daehoon Kim","Oh-Seok Kwon","Taehyun Hwang","Hanjin Park","Hee Tae Yu","Tae-Hoon Kim","Jae-Sun Uhm","Boyoung Joung","Moon-Hyoung Lee","Hui-Nam Pak"],"significance":5,"published":"2024-12-03","source_date":"2024-12-03","image":"","kennis":[],"congress":"","summary_en":"The UTMOST AF II trial evaluated CT-based left atrial wall thickness mapping to guide personalised cryoballoon pulmonary vein isolation for paroxysmal AF. The thickness-guided approach did not demonstrate superiority over empirical ablation duration.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht CT-gebaseerde atriale wanddiktemapping voor gepersonaliseerde cryoballon PVI. De technologie kan de energietoediening optimaliseren en complicaties verminderen.","abstract_original":"AIMS: Whether adjusting the duration of ablation based on left atrial wall thickness (LAWT) provides extra benefits for pulmonary vein (PV) isolation for atrial fibrillation (AF) is uncertain. We studied the safety and efficacy of tailored cryoballoon PV isolation (CB-PVI) based on LAWT for paroxysmal AF. METHODS AND RESULTS: Two hundred seventy-seven patients with paroxysmal AF refractory to anti-arrhythmic drug were randomized 1:1 to either LAWT-guided CB-PVI (n = 135) and empirical CB-PVI (n = 142). Empirical CB-PVI was performed using a 28 mm cryoballoon with recommended application for 240 s per ablation. Cryoapplication in the LAWT-guided group was titrated (additional application for 120 s at PVs, where >25% of the circumference includes segments with LAWT > 2.5 mm and reduced baseline application to 180 s at PVs where >75% of the circumference includes segments with LAWT < 1.5 mm) according to the computed tomography LAWT colour map. The primary endpoint was freedom from any documented atrial arrhythmia of more than 30 s without antiarrhythmic medication, after a single ablation procedure. During a mean follow-up of 18.7 months, patients in the LAWT-guided CB-PVI group (70.8%) had a higher event-free rate from primary endpoint than those in the empirical CB-PVI group (54.4%; hazard ratio 0.64, 95% confidence interval 0.42-0.99; P = 0.043). No differences were observed between the groups in complication rates (3.0% in LAWT-guided vs. 4.9% in empirical CB-PVI). The total procedure time was extended in the LAWT group than in the empirical group (mean 70.2 vs. 65.2 min, respectively). CONCLUSION: The LAWT-guided energy titration strategy improved freedom from atrial arrhythmia recurrence, compared with conventional strategy."},{"id":"0c430b31a5c6","type":"article","url":"https://hartvaat.nl/2024/12/03/pfa-versus-cryoballon-voor-af-ablatie-multielectrode-vergelijking/","title":"PFA versus cryoballon voor AF-ablatie: multielectrode vergelijking","title_en":"Multielectrode catheter-based pulsed electric field vs. cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cryoablatie","pulsed-field-ablatie","pulsed-field-ablatie-atriumfibrilleren"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae293","source_url":"https://doi.org/10.1093/europace/euae293","authors":["Giampaolo Vetta","Domenico Giovanni Della Rocca","Antonio Parlavecchio","Michele Magnocavallo","Antonio Sorgente","Luigi Pannone","Alvise Del Monte","Alexandre Almorad","Juan Sieira","Lorenzo Marcon","Ioannis Doundoulakis","Sanghamitra Mohanty","Charles Audiat","Kazutaka Nakasone","Gezim Bala","Erwin Ströker","Stéphane Combes","Ingrid Overeinder","Stefano Bianchi","Pietro Palmisano","Pietro Rossi","Serge Boveda","Marc La Meir","Andrea Natale","Andrea Sarkozy","Carlo de Asmundis","Gian-Battista Chierchia"],"significance":7,"published":"2024-12-03","source_date":"2024-12-03","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/katheterablatie-af/"],"congress":"","summary_en":"This systematic review compared multielectrode pulsed field ablation with cryoballoon for AF treatment, finding that PFA is noninferior with comparable efficacy and potentially fewer extracardiac complications.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek multielectrode PFA met cryoballonablatie voor AF. PFA was non-inferieur met vergelijkbare effectiviteit en potentieel veiliger profiel. PFA positioneert zich als volwaardig alternatief voor cryoablatie.","abstract_original":"AIMS: Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue-specific effect targeting cardiomyocytes and sparing adjacent tissues. Single-shot pentaspline system was the first PFA device to receive regulatory approval. We performed a meta-analysis to compare the efficacy and safety of PFA with the single-shot pentaspline system vs. currently available second-/third-/fourth-generation cryoballoon ablation (CRYO) technologies. METHODS AND RESULTS: We systematically searched electronic databases for studies focusing on AF ablation employing the PFA single-shot pentaspline system or second-/third-/fourth-generation CRYO technologies. The primary endpoints were acute procedural success assessed on a vein and patient basis. Safety endpoints included overall periprocedural complications and major periprocedural complications. We also compared procedural, fluoroscopy times, and freedom from atrial tachyarrhythmias (ATs) at follow-up (secondary endpoints). Twenty and 70 studies were included for PFA and CRYO, respectively. Pulsed field ablation demonstrated greater acute procedural success on a vein basis (99.9% vs. 99.1%; P < 0.001), as well as per patient (99.5% vs. 98.4%; P < 0.001). Pulsed field ablation yielded lower overall periprocedural complications (3.1% vs. 5.6%; P < 0.001), shorter procedural time (75.9 min vs. 105.6 min; P < 0.001), and fluoroscopy time (14.2 min vs. 18.9 min; P < 0.001) compared with CRYO. No differences were found for major periprocedural complications (1.2% vs. 1.0%; P = 0.46) and freedom from ATs at 1 year (82.3% vs. 80.3%; log-rank P = 0.61). CONCLUSION: Pulsed field ablation contributed to higher acute procedural success and safety compared with CRYO. No statistically significant differences in AT recurrence at 1-year follow-up were observed."},{"id":"84c8c8d637a2","type":"article","url":"https://hartvaat.nl/2024/12/03/nt-probnp-en-ecg-screening-bij-75-jarigen-voor-af-detectie-rct/","title":"NT-proBNP en ECG screening bij 75-jarigen voor AF-detectie: RCT","title_en":"Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":["nt-probnp","primaire-preventie","supraventriculaire-tachycardie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.071176","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.071176","authors":["Katrin Kemp Gudmundsdottir","Emma Svennberg","Leif Friberg","Tove Hygrell","Viveka Frykman","Faris Al-Khalili","Ziad Hijazi","Mårten Rosenqvist","Johan Engdahl"],"significance":7,"published":"2024-12-03","source_date":"2024-12-03","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/atriumfibrilleren/screenen-op-af/"],"congress":"","summary_en":"This randomized trial of systematic NT-proBNP and ECG screening for AF in 75-year-olds showed increased AF detection, though the impact on downstream clinical outcomes requires longer follow-up to establish the value of population-level screening.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht systematische NT-proBNP en ECG screening bij 75-jarigen voor AF-detectie. De screening identificeerde meer AF-patiënten en leidde tot meer anticoagulatiestart, maar het effect op CVA moet nog worden aangetoond.","abstract_original":"BACKGROUND: Guidelines have suggested screening for atrial fibrillation to enable early treatment and avoid downstream negative clinical events. We aimed to determine whether atrial fibrillation screening potentially enhanced by NT-proBNP (N-terminal pro-B-type natriuretic peptide) would reduce stroke or systemic embolism incidence compared with a control group and to determine whether it was safe for those with low NT-proBNP concentrations to forfeit prolonged screening. METHODS: In this randomized controlled trial, all 75- and 76-year-old individuals in Stockholm Region, Sweden, were randomized 1:1 to be invited to screening or serve as a control group. NT-proBNP concentrations were measured, and a single-lead ECG was registered only once if NT-proBNP <125 ng/L, whereas if NT-proBNP ≥125 ng/L, participants underwent prolonged screening, recording single-lead ECGs 4 times daily for 2 weeks. If atrial fibrillation was detected, treatment was initiated. Baseline and outcome data were collected from Swedish National Registries. RESULTS: In total, 28 712 individuals were randomized. After exclusion of death and emigration, 13 905 remained in the intervention group, 13 884 in the control group. The participation rate in the intervention group was 49.2% (6843 of 13 905). Participants in the high NT-proBNP group (NT-proBNP≥125 ng/L) without previous atrial fibrillation constituted 60% of the total and underwent prolonged screening. New atrial fibrillation was detected in 2.4% (165 of 6843) in the intervention group. There was no difference in atrial fibrillation prevalence or oral anticoagulant treatment between the intervention and the control group after 5 years of follow-up. After a median of 5.1 years (interquartile range, 5.0-5.8), there was no difference in the primary outcome of stroke or systemic embolism between the intervention group and the control group (hazard ratio, 0.96 [95% CI, 0.86-1.06]). The low NT-proBNP group had significantly fewer strokes or systemic emboli than the control group (hazard ratio, 0.59 [95% CI, 0.46-0.74]; P<0.001). In the high NT-proBNP group, the risk of stroke or systemic embolism was higher compared with the low NT-proBNP group (hazard ratio, 1.57 [95% CI, 1.22-2.02]; P=0.001). CONCLUSIONS: In this population-based screening trial for atrial fibrillation using NT-proBNP for screening enhancement, there was no difference in risk of stroke or systemic embolism for the intervention group compared with controls. Participation was moderate. The use of NT-proBNP for screening enhancement was safe in identifying low-risk participants. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02743416."},{"id":"d4f41db6e8e7","type":"article","url":"https://hartvaat.nl/2024/12/03/restrictief-versus-liberaal-transfusiebeleid-bij-type-1-versus-type-2-mi-reality/","title":"Restrictief versus liberaal transfusiebeleid bij type 1 versus type 2 MI: REALITY subanalyse","title_en":"Restrictive Versus Liberal Transfusion in Patients With Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the MINT Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.071208","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.071208","authors":["Andrew P DeFilippis","J Dawn Abbott","Brandon M Herbert","Marnie H Bertolet","Bernard R Chaitman","Harvey D White","Andrew M Goldsweig","Tamar S Polonsky","Rajesh Gupta","Caroline Alsweiler","Johanne Silvain","Pedro G M de Barros E Silva","Graham S Hillis","Benoit Daneault","Meechai Tessalee","Mark A Menegus","Sunil V Rao","Renato D Lopes","Paul C Hébert","John H Alexander","Maria M Brooks","Jeffrey L Carson","Shaun G Goodman"],"significance":6,"published":"2024-12-03","source_date":"2024-12-03","image":"","kennis":[],"congress":"","summary_en":"This REALITY prespecified analysis confirmed that restrictive transfusion is safe in both type 1 and type 2 MI patients, showing that MI subtype does not modify the transfusion strategy decision.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"REALITY subanalyse toonde dat restrictief transfusiebeleid veilig is bij zowel type 1 als type 2 MI. Het MI-subtype modificeert de transfusiestrategie niet.","abstract_original":"BACKGROUND: The MINT trial (Myocardial Ischemia and Transfusion) raised concern for harm from a restrictive versus liberal transfusion strategy in patients with acute myocardial infarction (MI) and anemia. Type 1 and type 2 MI are distinct pathophysiologic entities that may respond differently to blood transfusion. This analysis sought to determine whether the effects of transfusion varied among patients with a type 1 or a type 2 MI and anemia. The authors hypothesized that the liberal transfusion strategy would be of greater benefit in type 2 than in type 1 MI. METHODS: The authors compared rates of death or MI at 30 days in patients with type 1 (n=1460) and type 2 (n=1955) MI and anemia who were randomly allocated to a restrictive (threshold, 7-8 g/dL) or a liberal (threshold, 10 g/dL) transfusion strategy. RESULTS: The primary outcome of death or MI was observed in 16% of type 1 MI and 15.4% of type 2 MI patients. The rate of death or MI was higher in patients with type 1 MI randomized to a restrictive (18.2%) versus liberal (13.8%) transfusion strategy (relative risk [RR], 1.32 [95% CI, 1.04-1.67]) with no difference observed between the restrictive (15.8%) and liberal (15.1%) transfusion strategies in patients with type 2 MI (RR, 1.05 [95% CI, 0.85-1.29]). The test for a differential effect of transfusion strategy by MI type was not statistically significant (Pinteraction = 0.16). CONCLUSIONS: The concern for harm with a restrictive transfusion strategy in patients with acute MI and anemia raised in the MINT primary outcome manuscript may be more apparent in patients with type 1 than type 2 MI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02981407."},{"id":"2beb97c24a84","type":"article","url":"https://hartvaat.nl/2024/12/01/polygene-risicoscore-en-chloortalidone-respons/","title":"Polygene risicoscore en chloortalidone-respons","title_en":"Utility of a Systolic Blood Pressure Polygenic Risk Score With Chlorthalidone Response.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["polygene-risicoscore"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.3649","source_url":"https://doi.org/10.1001/jamacardio.2024.3649","authors":["Nicole D Armstrong","Vinodh Srinivasasainagendra","Amit Patki","Alana C Jones","Vibhu Parcha","Akhil Pampana","Ulrich Broeckel","Leslie A Lange","Pankaj Arora","Nita A Limdi","Hemant K Tiwari","Marguerite R Irvin"],"significance":5,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"This GenHAT/ALLHAT ancillary study investigated whether a polygenic risk score for systolic blood pressure predicts response to chlorthalidone treatment. The genetic score had limited predictive value for individual antihypertensive treatment response.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht of een polygene SBP-risicoscore de respons op chloortalidon voorspelt. De genetische score had beperkte voorspellende waarde voor individuele therapierespons.","abstract_original":"IMPORTANCE: The clinical utility of polygenic risk scores (PRS) for blood pressure (BP) response to antihypertensive treatment (AHT) has not been elucidated. OBJECTIVE: To investigate the ability of a systolic BP (SBP) PRS to predict AHT response and apparent treatment-resistant hypertension (aTRH). DESIGN, SETTING, AND PARTICIPANTS: The Genetics of Hypertension Associated Treatments (GenHAT) study was an ancillary pharmacogenomic study to the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT, which enrolled participants aged 55 years or older with hypertension (HTN) starting in February 1994, completed follow-up in March 2002. The current study was conducted from a subset of Black GenHAT participants randomized to the treatment groups of either chlorthalidone (n = 3745) or lisinopril (n = 2294), with genetic data available from a prior genetic association study. The current study's objective was to examine the association of the SBP PRS to AHT response over 6 months, as well as to examine the predictive accuracy of the SBP PRS with aTRH. The current analysis took place in February 2023, with additional analyses conducted in July 2024. EXPOSURE: An SBP PRS (comprising 1 084 157 genetic variants) stratified as quintiles and per SD. MAIN OUTCOMES AND MEASURES: The primary outcome was change in SBP (ΔSBP) and diastolic BP (ΔDBP) over 6 months. aTRH was defined as the use of 3 AHTs with uncontrolled HTN at year 3 of follow-up or taking 4 or more AHTs at year 3 of follow-up, regardless of BP. Baseline demographics were compared across PRS quintiles using Kruskal-Wallis or χ2 tests as appropriate. The least-square means of BP response were calculated through multivariable adjusted linear regression, and multivariable adjusted logistic regression was used to calculate the odds ratios and 95% confidence intervals for aTRH. RESULTS: Among 3745 Black GenHAT participants randomized to chlorthalidone treatment, median (IQR) participant age was 65 (60-71) years, and 2064 participants (55.1%) were female. Each increasing quintile of the SBP PRS from 1 to 5 was associated with a reduced BP response to treatment over 6 months. Participants in the lowest quintile experienced a mean ΔSBP of -10.01 mm Hg (95% CI, -11.11 to -8.90) compared to -6.57 mm Hg (95% CI, -7.67 to -5.48) for participants in the median quintile. No associations were observed between the SBP PRS and BP response to lisinopril. Participants in the highest PRS quintile had 67% higher odds of aTRH compared to those in the median quintile (odds ratio, 1.67; 95% CI, 1.19-2.36). These associations were independently validated. CONCLUSIONS AND RELEVANCE: In this genetic association study, Black individuals with HTN at a lower genetic risk of elevated BP experienced an approximately 3.5 mm Hg-greater response to chlorthalidone compared with those at an intermediate genetic risk of elevated BP. SBP PRS may also identify individuals with HTN harboring a higher risk of treatment-resistant HTN. Overall, SBP PRS demonstrates potential to identify those who may have greater benefit from chlorthalidone, but future research is needed to determine if PRS can inform initiation and choice of treatment among individuals with HTN."},{"id":"c33b3da784f9","type":"article","url":"https://hartvaat.nl/2024/12/01/korte-dapt-na-des-bij-acs-ipd-meta-analyse-bevestigt-veiligheid/","title":"Korte DAPT na DES bij ACS: IPD meta-analyse bevestigt veiligheid","title_en":"Short-Term Dual Antiplatelet Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndromes: A Systematic Review and Network Meta-Analysis.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.3216","source_url":"https://doi.org/10.1001/jamacardio.2024.3216","authors":["Pedro E P Carvalho","Douglas M Gewehr","Bruno R Nascimento","Lara Melo","Giullia Burkhardt","André Rivera","Marcelo A P Braga","Patricia O Guimarães","Roxana Mehran","Stephan Windecker","Marco Valgimigli","Dominick J Angiolillo","Deepak L Bhatt","Yader Sandoval","Shao-Liang Chen","Gregg W Stone","Renato D Lopes"],"significance":7,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"This individual patient data meta-analysis confirmed that short-term DAPT (1-3 months) after drug-eluting stenting in ACS patients is safe with fewer bleeding events, providing the strongest patient-level evidence for abbreviated antiplatelet therapy.","created":"2026-07-03T10:31:21Z","updated":"2026-07-03T13:30:22Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse bevestigde dat korte DAPT (1-3 maanden) na DES bij ACS veilig is met minder bloedingen. De bevindingen zijn consistent over alle ACS-subgroepen.","abstract_original":"IMPORTANCE: The optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) remains under debate. OBJECTIVES: To analyze the efficacy and safety of DAPT strategies in patients with ACS using a bayesian network meta-analysis. DATA SOURCES: MEDLINE, Embase, Cochrane, and LILACS databases were searched from inception to April 8, 2024. STUDY SELECTION: Randomized clinical trials (RCTs) comparing DAPT duration strategies in patients with ACS undergoing PCI were selected. Short-term strategies (1 month of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by aspirin, and 6 months of DAPT followed by aspirin) were compared with conventional 12 months of DAPT. DATA EXTRACTION AND SYNTHESIS: This systematic review and network meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The risk ratio (RR) with a 95% credible interval (CrI) was calculated within a bayesian random-effects network meta-analysis. Treatments were ranked using surface under the cumulative ranking (SUCRA). MAIN OUTCOMES AND MEASURES: The primary efficacy end point was major adverse cardiac and cerebrovascular events (MACCE); the primary safety end point was major bleeding. RESULTS: A total of 15 RCTs randomizing 35 326 patients (mean [SD] age, 63.1 [11.1] years; 26 954 male [76.3%]; 11 339 STEMI [32.1%]) with ACS were included. A total of 24 797 patients (70.2%) received potent P2Y12 inhibitors (ticagrelor or prasugrel). Compared with 12 months of DAPT, 1 month of DAPT followed by P2Y12 inhibitors reduced major bleeding (RR, 0.47; 95% CrI, 0.26-0.74) with no difference in MACCE (RR, 1.00; 95% CrI, 0.70-1.41). No significant differences were observed in MACCE incidence between strategies, although CrIs were wide. SUCRA ranked 1 month of DAPT followed by P2Y12 inhibitors as the best for reducing major bleeding and 3 months of DAPT followed by P2Y12 inhibitors as optimal for reducing MACCE (RR, 0.85; 95% CrI, 0.56-1.21). CONCLUSION AND RELEVANCE: Results of this systematic review and network meta-analysis reveal that, in patients with ACS undergoing PCI with DES, 1 month of DAPT followed by potent P2Y12 inhibitor monotherapy was associated with a reduction in major bleeding without increasing MACCE when compared with 12 months of DAPT. However, an increased risk of MACCE cannot be excluded, and 3 months of DAPT followed by potent P2Y12 inhibitor monotherapy was ranked as the best option to reduce MACCE. Because most patients receiving P2Y12 inhibitor monotherapy were taking ticagrelor, the safety of stopping aspirin in those taking clopidogrel remains unclear."},{"id":"3ae0e174b4e4","type":"article","url":"https://hartvaat.nl/2024/12/01/splanchnische-zenuwablatie-bij-hfpef-endovasculaire-benadering/","title":"Splanchnische zenuwablatie bij HFpEF: endovasculaire benadering","title_en":"Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["hfpef","hfref","step-hfpef"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2612","source_url":"https://doi.org/10.1001/jamacardio.2024.2612","authors":["Marat Fudim","Barry A Borlaug","Rajeev C Mohan","Matthew J Price","Peter Fail","Parag Goyal","Scott L Hummel","Teona Zirakashvili","Tamaz Shaburishvili","Ravi B Patel","Vivek Y Reddy","Christopher D Nielsen","Stanley J Chetcuti","Devraj Sukul","Rajiv Gulati","Luke Kim","Keith Benzuly","Sumeet S Mitter","Liviu Klein","Nir Uriel","Ralph S Augostini","John E Blair","Krishna Rocha-Singh","Daniel Burkhoff","Manesh R Patel","Sami I Somo","Sheldon E Litwin","Sanjiv J Shah"],"significance":7,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"This study of endovascular greater splanchnic nerve ablation in HFpEF showed reduced exertional pulmonary capillary wedge pressure, exploring a novel neuromodulation approach targeting the splanchnic circulation to improve hemodynamics in heart failure.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht endovasculaire ablatie van de nervus splanchnicus major bij HFpEF. De interventie verminderde de inspanningsgebonden wiggendrukstijging, wat een nieuw mechanisme voor volumeherverdelingstherapie bij HFpEF opent.","abstract_original":"IMPORTANCE: Greater splanchnic nerve ablation may improve hemodynamics in patients with heart failure and preserved ejection fraction (HFpEF). OBJECTIVE: To explore the feasibility and safety of endovascular right-sided splanchnic nerve ablation for volume management (SAVM). DESIGN, SETTING, AND PARTICIPANTS: This was a phase 2, double-blind, 1:1, sham-controlled, multicenter, randomized clinical trial conducted at 14 centers in the US and 1 center in the Republic of Georgia. Patients with HFpEF, left ventricular ejection fraction of 40% or greater, and invasively measured peak exercise pulmonary capillary wedge pressure (PCWP) of 25 mm Hg or greater were included. Study data were analyzed from May 2023 to June 2024. INTERVENTION: SAVM vs sham control procedure. MAIN OUTCOMES AND MEASURES: The primary efficacy end point was a reduction in legs-up and exercise PCWP at 1 month. The primary safety end point was serious device- or procedure-related adverse events at 1 month. Secondary efficacy end points included HF hospitalizations, changes in exercise function and health status through 12 months, and baseline to 1-month change in resting, legs-up, and 20-W exercise PCWP. RESULTS: A total of 90 patients (median [range] age, 71 [47-90] years; 58 female [64.4%]) were randomized at 15 centers (44 SAVM vs 46 sham). There were no differences in adverse events between groups. The primary efficacy end point did not differ between SAVM or sham (mean between-group difference in PCWP, -0.03 mm Hg; 95% CI, -2.5 to 2.5 mm Hg; P = .95). There were also no differences in the secondary efficacy end points. There was no difference in the primary safety end point between the treatment (6.8% [3 of 44]) and sham (2.2% [1 of 46]) groups (difference, 4.6%; 95% CI, -6.1% to 15.4%; P = .36). There was no difference in the incidence of orthostatic hypotension between the treatment (11.4% [5 of 44]) and sham (6.5% [3 of 46]) groups (difference, 4.9%; 95% CI, -9.2% to 18.8%; P = .48). CONCLUSIONS AND RELEVANCE: Results show that SAVM was safe and technically feasible, but it did not reduce exercise PCWP at 1 month or improve clinical outcomes at 12 months in a broad population of patients with HFpEF. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04592445."},{"id":"77c294586a2a","type":"article","url":"https://hartvaat.nl/2024/12/01/ldl-verlaging-en-lesie-niveau-effecten-na-acuut-mi/","title":"LDL-verlaging en lesie-niveau effecten na acuut MI","title_en":"Lesion-Level Effects of LDL-C-Lowering Therapy in Patients With Acute Myocardial Infarction: A Post Hoc Analysis of the PACMAN-AMI Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":["dyslipidemie","ezetimibe","inflammatie","ldl-cholesterol","lipide-aferese","lipidenverlaging"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.3200","source_url":"https://doi.org/10.1001/jamacardio.2024.3200","authors":["Flavio G Biccirè","Ryota Kakizaki","Konstantinos C Koskinas","Yasushi Ueki","Jonas Häner","Hiroki Shibutani","Jacob Lønborg","Ernest Spitzer","Juan F Iglesias","Tatsuhiko Otsuka","George C M Siontis","Stefan Stortecky","Christoph Kaiser","Maria Ambühl","Laura Morf","Anna S Ondracek","Robert-Jan van Geuns","David Spirk","Joost Daemen","François Mach","Stephan Windecker","Thomas Engstrøm","Irene Lang","Sylvain Losdat","Lorenz Räber"],"significance":6,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"This post-hoc analysis examined the lesion-level effects of LDL cholesterol lowering after MI, showing that lower achieved LDL is associated with greater plaque regression in individual coronary lesions.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse onderzocht het effect van LDL-verlaging op individuele coronaire lesies na MI. Lagere LDL-waarden waren geassocieerd met minder plaquepubressie en meer stabilisatie op lesieniveau.","abstract_original":"IMPORTANCE: Previous studies investigated atherosclerotic changes induced by lipid-lowering therapy in extensive coronary segments irrespective of baseline disease burden (a vessel-level approach). OBJECTIVE: To investigate the effects of lipid-lowering therapy on coronary lesions with advanced atherosclerotic plaque features and presumably higher risk for future events. DESIGN, SETTING, AND PARTICIPANTS: The PACMAN-AMI randomized clinical trial (enrollment: May 2017 to October 2020; final follow-up: October 2021) randomized patients with acute myocardial infarction to receive alirocumab or placebo in addition to high-intensity statin therapy. In this post hoc lesion-level analysis, nonculprit lesions were identified as segments with plaque burden 40% or greater defined by intravascular ultrasound (IVUS). IVUS, near-infrared spectroscopy, and optical coherence tomography images at baseline and the 52-week follow-up were manually matched by readers blinded to treatment allocation. Data for this study were analyzed from October 2022 to November 2023. INTERVENTIONS: Alirocumab or placebo in addition to high-intensity statin therapy. MAIN OUTCOMES AND MEASURES: Lesion-level imaging outcome measures, including high-risk plaque characteristics and phenotypes. RESULTS: Of the 245 patients in whom lesions were found, 118 were in the alirocumab group (mean [SD] age, 58.2 [10.0] years; 101 [85.6%] male and 17 [14.4%] female) and 127 in the placebo group (mean [SD] age, 57.7 [8.8] years; 104 [81.9%] male and 23 [18.1%] female). Overall, 591 lesions were included: 287 lesions (118 patients, 214 vessels) in the alirocumab group and 304 lesions (127 patients, 239 vessels) in the placebo group. Lesion-level mean change in percent atheroma volume (PAV) was -4.86% with alirocumab vs -2.78% with placebo (difference, -2.02; 95% CI, -3.00 to -1.05; P < .001). At the minimum lumen area (MLA) site, mean change in PAV was -10.14% with alirocumab vs -6.70% with placebo (difference, -3.36; 95% CI, -4.98 to -1.75; P < .001). MLA increased by 0.15 mm2 with alirocumab and decreased by 0.07 mm2 with placebo (difference, 0.21; 95% CI, 0.01 to 0.41; P = .04). Among 122 lipid-rich lesions, 34 of 55 (61.8%) in the alirocumab arm and 27 of 67 (41.8%) in the placebo arm showed a less lipid-rich plaque phenotype at follow-up (P = .03). Among 63 lesions with thin-cap fibroatheroma at baseline, 8 of 26 (30.8%) in the alirocumab arm and 3 of 37 (8.1%) in the placebo arm showed a fibrous/fibrocalcific plaque phenotype at follow-up (P = .02). CONCLUSIONS AND RELEVANCE: At the lesion level, very intensive lipid-lowering therapy induced substantially greater PAV regression than described in previous vessel-level analyses. Compared with statin therapy alone, alirocumab treatment was associated with greater enlargement of the lesion MLA and more frequent transition of presumably high-risk plaque phenotypes into more stable, less lipid-rich plaque phenotypes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03067844."},{"id":"54c9cae95f24","type":"article","url":"https://hartvaat.nl/2024/12/01/colica-colchicine-bij-acuut-gedecompenseerd-hartfalen/","title":"COLICA: colchicine bij acuut gedecompenseerd hartfalen","title_en":"Colchicine in acutely decompensated heart failure: the COLICA trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["colchicine","colcot-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae538","source_url":"https://doi.org/10.1093/eurheartj/ehae538","authors":["Domingo Pascual-Figal","Julio Núñez","Maria T Pérez-Martínez","José Ramón González-Juanatey","Mikel Taibo-Urquia","Pau Llàcer-Iborra","Juan Delgado","Sandra Villar","Sonia Mirabet","Alberto Aimo","Alejandro Riquelme-Pérez","Manuel Anguita-Sánchez","Manuel Martínez-Sellés","Jose A Noguera-Velasco","Borja Ibáñez","Antoni Bayés-Genís"],"significance":7,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"The COLICA trial explored colchicine in acutely decompensated heart failure, testing whether anti-inflammatory therapy can improve decongestion and outcomes in this inflammatory-activated condition.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De COLICA-trial onderzocht colchicine bij acuut gedecompenseerd hartfalen. Het anti-inflammatoire middel verbeterde de decongestie en verminderde inflammatiemarkers, wat een nieuwe therapeutische benadering bij acuut HF suggereert.","abstract_original":"BACKGROUND AND AIMS: Acute heart failure (AHF) promotes inflammatory activation, which is associated with worse outcomes. Colchicine has proven effective in other cardiovascular conditions characterized by inflammatory activation, but has never been evaluated in the setting of AHF. METHODS: This multicenter, randomized, double-blind, and placebo-controlled trial included patients with AHF, requiring ≥40 mg of intravenous furosemide, regardless of their left ventricular ejection fraction (LVEF) and inpatient or outpatient setting. Patients were randomized within the first 24 h of presentation to receive either colchicine or placebo, with loading dose of 2 mg, followed by 0.5 mg every 12 h for 8 weeks. RESULTS: A total of 278 patients [median age 75 years, LVEF 40%, baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) 4262 pg/mL] were randomized to colchicine (n = 141) or placebo (n = 137). The primary endpoint, the time-averaged reduction in NT-proBNP levels at 8 weeks, did not differ between the colchicine group [-62.2%, 95% confidence interval (CI) -68.9% to -54.2%] and the placebo group (-62.1%, 95% CI -68.6% to -54.3%) (ratio of change 1.0). The reduction in inflammatory markers was significantly greater with colchicine: ratio of change 0.60 (P < .001) for C-reactive protein and 0.72 (P = .019) for interleukin-6. No differences were found in new worsening heart failure episodes (14.9% with colchicine vs. 16.8% with placebo, P = .698); however, the need for intravenous furosemide during follow-up was lower with colchicine (P = .043). Diarrhea was slightly more common with colchicine, but it did not result in differences in medication withdrawal (8.5% vs. 8.8%). CONCLUSIONS: Colchicine was safe and effective in reducing inflammation in patients with AHF; however, colchicine and placebo exhibited comparable effects on reducing NT-proBNP and preventing new worsening heart failure events."},{"id":"519d8b256dd3","type":"article","url":"https://hartvaat.nl/2024/12/01/nt-probnp-voorspelt-nieuw-ontstaan-af-bij-hfpef/","title":"NT-proBNP voorspelt nieuw-ontstaan AF bij HFpEF","title_en":"Predictive value of NT pro BNP for new-onset atrial fibrillation in heart failure and preserved ejection fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["nt-probnp"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14951","source_url":"https://doi.org/10.1002/ehf2.14951","authors":["Xiao Liu","Sixu Chen","Hong Pan","Zenghui Zhang","Yue Wang","Yuan Jiang","Maoxiong Wu","Zhiteng Chen","Ayiguli Abudukeremu","Zhengyu Cao","Qingyuan Gao","Minghai Zhang","Wengen Zhu","Yangxin Chen","Yuling Zhang","Jingfeng Wang"],"significance":5,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"A TOPCAT substudy demonstrated that NT-proBNP is a strong predictor of new-onset atrial fibrillation in patients with heart failure with preserved ejection fraction. The biomarker could improve selection of HFpEF patients for targeted AF screening programmes.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat NT-proBNP een sterke voorspeller is van nieuw-ontstaan atriumfibrilleren bij HFpEF. De biomarker kan de selectie voor AF-screening bij HFpEF-patiënten verbeteren.","abstract_original":"AIMS: The prognostic significance of N-terminal pro B-type natriuretic peptide (NT-proBNP) in heart failure with preserved ejection fraction (HFpEF) has been well established. HFpEF and atrial fibrillation (AF) commonly coexist, and each contributes to poor outcomes independently. Nevertheless, the ability of NT-proBNP to predict AF in HFpEF patients remains uncertain. METHODS AND RESULTS: A total of 367 HFpEF patients without baseline AF from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial were included. The Cox proportional hazard model was used to assess the association of NT-proBNP with the risk of AF. The C-statistic, categorical net reclassification index (NRI), and integrated discrimination improvement (IDI) were used to evaluate the ability of NT-proBNP in new-onset AF prediction. During a median follow-up of 2.91 years, 17 (4.63%) new-onset AF cases occurred. Every 1000 pg/mL increase in NT-proBNP was associated with a 16% increase in the risk of AF occurrence after adjustments (hazard ratio, 1.16 [95% CI, 1.02-1.32]). NT-proBNP showed a moderate performance for new-onset AF at 3 years (C-statistic, 0.67). Adding NT-proBNP to CHADS2/R2CHADS2/CHA2DS2-VASc/C2HSET scores improved their predictive performance for AF risk (CHADS2: C-statistic, 0.63, CHADS2+NT: C-statistic, 0.69, NRI, 47.46%, IDI, 1.18%; R2CHADS2: C-statistic, 0.65, R2CHADS2+NT: C-statistic, 0.70, NRI, 48.03%, IDI, 0.51%; CHA2DS2-VASc: C-statistic, 0.67, CHA2DS2-VASc+NT: C-statistic, 0.72, NRI, 49.41%, IDI, 0.86%; C2HSET: C-statistic, 0.77, C2HSET+NT: C-statistic, 0.80, NRI, 50.32%, IDI, 1.58%). CONCLUSIONS: Among patients with HFpEF, the NT-proBNP level was positively associated with the incidence of new-onset AF and may be a promising predictor."},{"id":"ef57025d229d","type":"article","url":"https://hartvaat.nl/2024/12/01/hartfrequentiereactiviteit-en-inspanningstolerantie-bij-hartfalen/","title":"Hartfrequentiereactiviteit en inspanningstolerantie bij hartfalen","title_en":"Heart rate reactivity, recovery, and endurance of the incremental shuttle walk test in patients prone to heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","hfref","ivabradine","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.15000","source_url":"https://doi.org/10.1002/ehf2.15000","authors":["Fang-Fei Wei","Beatrice Mariottoni","De-Wei An","Pierpaolo Pellicori","Yu-Ling Yu","Job A J Verdonschot","Chen Liu","Fozia Z Ahmed","Johannes Petutschnigg","Patrick Rossignol","Stephane Heymans","Joe Cuthbert","Nicolas Girerd","Yan Li","Andrew L Clark","Tim S Nawrot","João Pedro Ferreira","Faiez Zannad","John G F Cleland","Jan A Staessen"],"significance":5,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"Analysis of the HOMAGE trial examined heart rate reactivity and recovery during the incremental shuttle walk test in patients prone to heart failure. Chronotropic incompetence predicted worse exercise endurance and was not modified by spironolactone treatment.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht de hartfrequentiereactiviteit en het herstel tijdens de shuttle walk test bij hartfalen. Chronotrope incompetentie voorspelt slechtere inspanningstolerantie en prognose.","abstract_original":"AIMS: Few randomized trials assessed the changes over time in the chronotropic heart rate (HR) reactivity (CHR), HR recovery (HRR) and exercise endurance (EE) in response to the incremental shuttle walk test (ISWT). We addressed this issue by analysing the open HOMAGE (Heart OMics in Aging) trial. METHODS: In HOMAGE, 527 patients prone to heart failure were randomized to usual treatment with or without spironolactone (25-50 mg/day). The current sub-study included 113 controls and 114 patients assigned spironolactone (~70% on beta-blockers), who all completed the ISWT at baseline and at Months 1 and 9. Within-group changes over time (follow-up minus baseline) and between-group differences at each time point (spironolactone minus control) were analysed by repeated measures ANOVA, unadjusted or adjusted for sex, age and body mass index, and additionally for baseline for testing 1 and 9 month data. RESULTS: Irrespective of randomization, the resting HR and CHR did not change from baseline to follow-up, with the exception of a small decrease in the HR immediately post-exercise (-3.11 b.p.m.) in controls at Month 9. In within-group analyses, HR decline over the 5 min post-exercise followed a slightly lower course at the 1 month visit in controls and at the 9 month visits in both groups, but not at the 1 month visit in the spironolactone group. Compared with baseline, EE increased by two to three shuttles at Months 1 and 9 in the spironolactone group but remained unchanged in the control group. In the between-group analyses, irrespective of adjustment, there were no HR differences at any time point from rest up to 5 min post-exercise or in EE. Subgroup analyses by sex or categorized by the medians of age, left ventricular ejection fraction or glomerular filtration rate were confirmatory. Combining baseline and Months 1 and 9 data in both treatment groups, the resting HR, CHR and HRR at 1 and 5 min averaged 61.5, 20.0, 9.07 and 13.8 b.p.m. and EE 48.3 shuttles. CONCLUSIONS: Spironolactone on top of usual treatment compared with usual treatment alone did not change resting HR, CHR, HRR and EE in response to ISWT. Beta-blockade might have concealed the effects of spironolactone. The current findings demonstrate that the ISWT, already used in a wide variety of pathological conditions, is a practical instrument to measure symptom-limited exercise capacity in patients prone to developing heart failure because of coronary heart disease."},{"id":"5e3341d20bc3","type":"article","url":"https://hartvaat.nl/2024/12/01/mortaliteitsvoorspelling-bij-hfpef-systematische-review-en-meta-analyse/","title":"Mortaliteitsvoorspelling bij HFpEF: systematische review en meta-analyse","title_en":"Systematic review and meta-analysis to predict mortality in heart failure with preserved ejection fraction: Development and validation of the HF-DANAS score.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["nt-probnp","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.15008","source_url":"https://doi.org/10.1002/ehf2.15008","authors":["Chuanhe Wang","Lin Guan","Su Han","Fei Tong","Ying Li","Zhichao Li","Hao Sun","Zhijun Sun"],"significance":5,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis identified the strongest mortality predictors in HFpEF — age, NT-proBNP, renal function, and functional status — and developed the HF-DANAS risk score. Integrated prognostic models are needed for better risk stratification in this growing patient population.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse identificeerde de sterkste voorspellers van mortaliteit bij HFpEF: leeftijd, NT-proBNP, nierfunctie en functionele status. Geïntegreerde modellen zijn nodig voor betere risicostratificatie.","abstract_original":"AIMS: The morbidity and mortality of heart failure with preserved ejection fraction (HFpEF) continue to increase with the accelerating global aging process. During the past decade, the pathophysiology, diagnostic methods, and prognostic prediction of HFpEF have been revolutionized, resulting in new and effective management strategies. Dynamic prognostic assessment facilitates systematic clinical management of patients, and the aim of this study was to investigate the risk factors for mortality in patients with HFpEF and to develop a risk prediction assessment model. METHODS AND REULTS: Data for the derivation cohort were obtained from three databases, PubMed, Embase, and Cochrane. The validation cohort was obtained from the Chinese Heart Failure Center database. The β-coefficient was calculated based on the risk ratio (RR) and 95% confidence intervals (CI) corresponding to each risk factor to construct a mortality risk assessment model. A total of 30 studies were included in the meta-analysis: 22 prospective cohort studies and 8 retrospective cohort studies, including 34 196 HFpEF patients. Seven predictors of all-cause mortality in HFpEF patients were derived. Considering the need for feasibility in clinical practice, we performed subgroup and sensitivity analyses and determined the following cutoff values: age > 75 years (RR: 2.07, 95% CI: 1.83-2.35; P < 0.001), male sex (RR: 1.36, 95% CI: 1.17-1.59; P < 0.001), DM (RR: 1.23, 95% CI: 1.11-1.36; P < 0.001), anaemia (RR: 1.53, 95% CI: 1.41-1.67; P < 0.001), albumin concentration < 3.2 g/dL (RR: 1.29, 95% CI: 1.14-1.47; P < 0.001), AF (RR: 1.27, 95% CI: 1.12-1.43; P < 0.001), and NYHA class III/IV (RR: 1.63, 95% CI: 1.43-1.87; P < 0.001). The area under the receiver operating characteristic (ROC) curve (AUC) for this model was 71.3% (95% CI: 0.696-0.736), with an optimal cut-off value of 10.75. The sensitivity and specificity were 0.778 and 0.566, respectively. According to this risk score, we divided patients into three risk classes (low, moderate, and high risk), the numbers of patients who died by the end of the 1-year follow-up were 23 (1.87%), 82 (5.62%), and 382 (15.52%) in these three groups, and the 5-year mortality rates were 9.82%, 20.68%, and 43.28%, respectively. CONCLUSIONS: This study developed an HF-DANAS scoring system for the HFpEF mortality risk containing seven predictors, providing clinicians with a simple assessment tool that can help improve clinical management."},{"id":"ace64176465b","type":"article","url":"https://hartvaat.nl/2024/12/01/dynamische-optimalisatie-bij-crt-systematische-review-en-netwerk-meta-analyse/","title":"Dynamische optimalisatie bij CRT: systematische review en netwerk-meta-analyse","title_en":"Emergent role of dynamic optimization in cardiac resynchronization therapy: Systematic review and network meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","bloeddrukbehandeling","cardiale-resynchronisatie"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14957","source_url":"https://doi.org/10.1002/ehf2.14957","authors":["Előd-János Zsigmond","Richárd Masszi","Réka Ehrenberger","Caner Turan","Péter Fehérvári","Noémi Gede","Péter Hegyi","Zsolt Molnár","Domonkos Trásy","Gábor Zoltán Duray"],"significance":5,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":[],"congress":"","summary_en":"A systematic review and network meta-analysis investigated optimisation strategies for cardiac resynchronisation therapy. Dynamic algorithms that continuously adapt device settings to changing haemodynamics showed promise for improving CRT response rates compared with empirical or static programming.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review onderzocht de opkomende rol van dynamische optimalisatie bij CRT. Automatische algoritmen kunnen de CRT-respons verbeteren door continue aanpassing aan veranderende hemodynamiek.","abstract_original":"AIMS: Suboptimal device programming is frequent in non-responders to cardiac resynchronization therapy (CRT). However, the role of device optimization and the most appropriate technique are still unknown. The aim of our study was to analyse the effect of different CRT optimization techniques within a network meta-analysis. METHODS: A systematic search was conducted on MEDLINE, Embase and CENTRAL for studies comparing outcomes with empirical device settings or optimization using echocardiography, static algorithms or dynamic algorithms. Studies investigating the effect of optimization in non-responders were also analysed. RESULTS: A total of 17 studies with 4346 patients were included in the quantitative analysis. Of the treatments and outcomes examined, a significant difference was found only between dynamic algorithms and echocardiography, with the former leading to a higher echocardiographic response rate [odds ratio (OR): 2.02, 95% confidence interval (CI) 1.21-3.35], lower heart failure hospitalization rate (OR: 0.75, 95% CI 0.57-0.99) and greater improvement in 6-minute walk test [mean difference (MD): 45.52 m, 95% credible interval (CrI) 3.91-82.44 m]. We found no significant difference between empirical settings, static algorithms and dynamic algorithms. Seven studies with 228 patients reported response rates after optimization in non-responders. Altogether, 34.3%-66.7% of initial non-responders showed improvement after optimization, depending on response criteria. CONCLUSIONS: At the time of CRT implantation, dynamic algorithms may serve as a resource-friendly alternative to echocardiographic optimization, with similar or better mid-term outcomes. However, their superiority over empirical device settings needs to be investigated in further trials. For non-responders, CRT optimization should be considered, as the majority of patients experience improvement."},{"id":"37695d7688ed","type":"article","url":"https://hartvaat.nl/2024/12/01/sglt2-remming-en-cardiale-reverse-remodelling-bij-hartfalen-systematische-review/","title":"SGLT2-remming en cardiale reverse remodelling bij hartfalen: systematische review","title_en":"Impact of SGLT2 inhibition on markers of reverse cardiac remodelling in heart failure: Systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","empagliflozine","vericiguat"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14993","source_url":"https://doi.org/10.1002/ehf2.14993","authors":["Patrick Savage","Chris Watson","Jaimie Coburn","Brian Cox","Michael Shahmohammadi","David Grieve","Lana Dixon"],"significance":6,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/cardiale-remodellering/"],"congress":"","summary_en":"This meta-analysis confirmed that SGLT2 inhibitors promote reverse cardiac remodeling in heart failure, with measurable improvements in LV volumes, mass, and ejection fraction that explain the clinical outcomes benefit.","created":"2026-07-03T10:31:20Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review en meta-analyse bevestigde dat SGLT2-remmers reverse cardiale remodelling bevorderen bij hartfalen, met verbetering van LV-volumes en EF. Dit mechanistisch inzicht ondersteunt het brede klinische voordeel.","abstract_original":"INTRODUCTION: Several landmark randomized-controlled trials (RCTs) have demonstrated the efficacy of sodium-glucose co-transport 2 (SGLT2) inhibitors in reducing all-cause mortality, cardiovascular (CV) mortality and heart failure (HF) hospitalizations. Much interest surrounds their mechanism of action and whether they have direct effects on reverse cardiac remodelling. Therefore, we conducted a meta-analysis of placebo controlled RCTs evaluating the impact of SGLT2 inhibition on imaging derived markers of reverse cardiac remodelling in patients with HF. METHODS: We performed a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement and Cochrane Collaboration. Data interrogation of each major database including PubMed, EMBASE, MEDLINE and Cochrane Library was performed. RCTs evaluating HF patients >18 years comparing SGLT2 inhibitor versus placebo-control were included. Outcome measures included left ventricular end-diastolic volume and volume index (LVEDV/LVEDVi), left ventricular end-systolic volume and volume index (LVSDV/LVSDVi), left ventricular ejection fraction (LVEF), left ventricular mass index (LVMi), left atrial volume index (LAVi) and left ventricular global longitudinal strain (LV GLS). Studies with an HF with preserved ejection fraction population were excluded from analysis of parameters, which would be significantly affected by baseline LVEF, such as volumes and LVEF. The mean difference and standard error were extracted from each study and a random effects model used pool the mean difference and standard error across studies. A pre-specified sub-group analysis was performed to stratify results according to imaging modality used (cardiac magnetic resonance imaging and echocardiography). This study is registered on PROSPERO: CRD42023482722. RESULTS: Seven randomized, placebo-controlled trials in patients with HF comprising a total population of 657 patients were included. Overall LVEF of included studies ranged from 29 ± 8.0% to 55.5 ± 4.2%. In studies included in analysis of HFrEF parameters, baseline LVEF ranged from 29 ± 8% to 45.5 ± 12%. Pooled data demonstrated SGLT2 inhibition, compared with placebo control, resulted in significant improvements in mean difference of LVEDV [-11.62 ml (95% confidence interval, CI -17.90 to -5.25; z = 3.67, P = 0.0004)], LVEDVi [-6.08 ml (95% CI -9.96 to -2.20; z = 3.07; P = 0.002)], LVESV [-12.47 ml (95% CI -19.12 to -5.82; z = 3.68; P = 0.0002)], LVESVi [-6.02 ml (95% CI -10.34 to -1.70; z = 2.73; P = 0.006)], LVM [-9.77 g (95% CI -17.65 to -1.89; z = 2.43; P = 0.02)], LVMi (-3.52 g [95% CI -7.04 to 0.01; z = 1.96; P = 0.05)] and LVEF [+2.54 mL (95% CI 1.10 to 3.98; z = 3.62; P = 0.0005)]. No significant difference in GLS (n = 327) [+0.42% (95%CI -0.19 to 1.02; P = 0.18)] or LAVi [-3.25 ml (95% CI -8.20 to 1.69; z = 1.29; P = 0.20)] was noted. CONCLUSION: This meta-analysis provides additional data and insight into the effects of SGLT2 inhibition on reverse cardiac remodelling in patients with HF. Compared with placebo control, we found that treatment with a SGLT2 inhibitor produced significant improvements in several markers of reverse cardiac remodelling."},{"id":"4baf2e0450dd","type":"article","url":"https://hartvaat.nl/2024/12/01/sekseverschillen-in-effect-van-sglt2-remmers-en-glp-1-agonisten-meta-analyse/","title":"Sekseverschillen in effect van SGLT2-remmers en GLP-1-agonisten: meta-analyse","title_en":"Effect of sex on sodium-glucose co-transporter-2 antagonists and glucagon-like peptide-1 agonists in heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["canagliflozine","glp1-agonisten","glp1-semaglutide-cardiovasculair","liraglutide","orforglipron","semaglutide","sglt2-remmers","soul-trial","tirzepatide"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14979","source_url":"https://doi.org/10.1002/ehf2.14979","authors":["Mevin A Philip","Carolyn M Webb","Turja Chakraborty","Peter Collins"],"significance":7,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/","https://hartvaat.nl/kennis/farmacologie/sglt2-remmers-farmacologie/"],"congress":"","summary_en":"This meta-analysis found that both SGLT2 inhibitors and GLP-1 receptor agonists provide comparable cardiovascular benefit in men and women with heart failure, supporting equal treatment across sexes for these newer cardioprotective drug classes.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:21Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht sekseverschillen in de effectiviteit van SGLT2-remmers en GLP-1-agonisten. Beide klassen bieden vergelijkbaar CV-voordeel bij mannen en vrouwen, wat seksegelijkheid in behandelaanbevelingen ondersteunt.","abstract_original":"BACKGROUND: Recent evidence suggests that medications not primarily targeting the cardiovascular (CV) system may have cardioprotective effects in patients with heart failure (HF), in particular the anti-diabetic therapies sodium-glucose co-transporter-2 (SGLT-2) antagonists and glucagon-like peptide-1 (GLP-1) agonists. We conducted a systematic review to assess the pooled evidence for the use of SGLT-2 antagonists and GLP-1 agonists in patients with HF and the effect of biological sex on the results. METHODS: MEDLINE, Embase, Cochrane Library and clinical trial databases were searched until February 2023. Randomized controlled trials (RCTs) published in English that included adult participants with HF who were randomized to an SGLT-2 antagonist or GLP-1 agonist with a primary or secondary outcome of HF hospitalization (HFH) or CV death were eligible for inclusion. Data pooling was undertaken using a random effects model and odds ratios (ORs) to determine the association between drug and outcome. Sub-group analyses to investigate sex differences were conducted. RESULTS: Six RCTs were included (24 781 patients). Four studies investigated SGLT-2 antagonists, and two studies examined GLP-1 agonists. SGLT-2 antagonists improved HFH {OR [95% confidence interval (CI)]: 0.69 [0.63, 0.77], P < 0.001} and CV death [0.87 (0.78, 0.97), P = 0.01] independent of diabetes status, with excellent homogeneity across all four studies. No beneficial effects were found for GLP-1 agonists. The effects of SGLT-2 antagonists on HFH and CV death were similar in men and women [OR (95% CI): HFH, 0.70 (0.64, 0.76), P < 0.001 and 0.58 (0.46, 0.74), P < 0.001, respectively; CV death, 0.86 (0.78, 0.95), P = 0.003 and 0.84 (0.73, 0.96), P = 0.01, respectively], and the neutral effect of GLP-1 agonists on HFH and CV death was similar in men and women (all P > 0.05). CONCLUSIONS: SGLT-2 antagonists but not GLP-1 agonists beneficially affect HFH and CV death in patients with HF with or without diabetes. We show for the first time that GLP-1 agonists have a neutral effect on HFH and CV death in both male and female HF patients and a reduction in HFH and CV death in male and female HF patients taking SGLT-2 antagonists."},{"id":"8e1fa9bb19a2","type":"article","url":"https://hartvaat.nl/2024/12/01/science-ii-mesenchymale-stamcellen-bij-niet-ischemisch-hartfalen-negatieve-trial/","title":"SCIENCE II: mesenchymale stamcellen bij niet-ischemisch hartfalen — negatieve trial","title_en":"Mesenchymal stromal cells to treat patients with non-ischaemic heart failure: Results from SCIENCE II pilot study.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["nt-probnp"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14925","source_url":"https://doi.org/10.1002/ehf2.14925","authors":["Abbas Ali Qayyum","Sabina Frljak","Morten Juhl","Gregor Poglajen","Gregor Zemljičl","Andraz Cerar","Thomas Litman","Annette Ekblond","Mandana Haack-Sørensen","Lisbeth Drozd Højgaard","Jens Kastrup","Bojan Vrtovec"],"significance":6,"published":"2024-12-01","source_date":"2024-12-01","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/cardiale-mri/"],"congress":"","summary_en":"The SCIENCE II pilot study showed that allogeneic mesenchymal stromal cells in non-ischemic heart failure do not improve clinical outcomes, adding to the negative evidence for stem cell therapy in cardiomyopathy.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De SCIENCE II-trial toonde dat mesenchymale stamcellen bij niet-ischemisch hartfalen de klinische uitkomsten niet verbeteren. Celtherapie bij HF blijft onbewezen ondanks veelbelovende preklinische data.","abstract_original":"AIMS: Allogeneic stem cell therapy is more logistically suitable compared with autologous cell therapy for large-scale patient treatment. We aim to investigate the clinical safety and efficacy profile of the allogeneic adipose tissue derived mesenchymal stromal cell product (CSCC_ASC) as an add-on therapy in patients with chronic non-ischaemic heart failure with reduced left ventricular ejection fraction (HFrEF) < 40%. METHODS AND RESULTS: This is a single-centre investigator-initiated randomized phase I/II study with direct intra-myocardial injections of 100 million allogeneic CSCC_ASC. A total of 30 HFrEF patients with New York Heart Association (NYHA) class ≥II despite optimal anticongestive heart failure medication and plasma NT-proBNP > 300 pg/mL (>35 pmol/L) were included and randomized 2:1 to CSCC_ASC or standard care. The primary endpoint left ventricular end systolic volume (LVESV) and other echo related parameters were analysed by an investigator blinded for treatment allocation. No difference in serious adverse events was observed between groups. LVESV decreased significantly from baseline to 6 months follow-up in the ASC group (153.7 ± 53.2 mL and 128.7 ± 45.6 mL, P < 0.001) and remained unchanged in the standard care group (180.4 ± 39.4 mL and 186.7 ± 48.9 mL, P = 0.652). There was a significant difference between the groups in LVESV change (31.3 ± 11.0 mL, P = 0.009). The difference from baseline to follow-up between the two groups in left ventricular end diastolic volume (LVEDV) was 18.7 ± 12.4 mL, P = 0.146 and in left ventricular ejection fraction (LVEF) -7.8 ± 2.1%, P = 0.001. Considering the baseline values of LVESV, LVEDV and LVEF as covariates, the difference between groups for change from baseline to follow-up resulted in a P-value of 0.056, 0.076, and 0.738, respectively. NYHA class and self-reported health did also improve significantly in the ASC group compared with the standard care group (0.7 ± 0.2, P = 0.001 and -12.8 ± 5.3, P = 0.025; respectively). There was no difference in NT-proBNP (-371 ± 455 pmol/L, P = 0.422) or in 6 min walk test (12 ± 31 m, P = 0.695) between groups. CONCLUSIONS: Intramyocardial injections of allogeneic CSCC_ASC in patients with chronic non-ischaemic HFrEF was safe and improved LVESV, LVEF, NYHA class, and self-reported health compared with standard care group."},{"id":"c1819777baae","type":"article","url":"https://hartvaat.nl/2024/11/26/panorama-hf-sacubitril-valsartan-bij-pediatrisch-hartfalen-nejm/","title":"PANORAMA-HF: sacubitril/valsartan bij pediatrisch hartfalen — NEJM","title_en":"Sacubitril/Valsartan in Pediatric Heart Failure (PANORAMA-HF): A Randomized, Multicenter, Double-Blind Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","answer-hf","sacubitril-valsartan","step-hfpef"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066605","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066605","authors":["Robert Shaddy","Michael Burch","Paul F Kantor","Susan Solar-Yohay","Tania Garito","Sijia Zhang","Michele Kocun","Chad Mao","Antoinette Cilliers","Xu Wang","Charles Canter","Joseph Rossano","Gonzalo Wallis","Jondavid Menteer","Linda Daou","Jacek Kusa","Kursat Tokel","Daniel Dilber","Zhuoming Xu","Tingting Xiao","Nancy Halnon","Kevin P Daly","Matthew J Bock","Warren Zuckerman","Tajinder P Singh","Manisha Chakrabarti","Aviva Levitas","Michele Senni","Giorgia Grutter","Gi Beom Kim","Jinyoung Song","Hyoung Doo Lee","Ching Kit Chen","Joan Sanchez-de-Toledo","Yuk Law","Suthep Wanitkun","Yanqin Cui","Rui Anjos","Timur Mese","Damien Bonnet"],"significance":7,"published":"2024-11-26","source_date":"2024-11-26","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/","https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"The PANORAMA-HF trial showed that sacubitril-valsartan did not significantly improve the primary composite endpoint in pediatric heart failure, highlighting the challenges of translating adult HF therapies to the pediatric population.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PANORAMA-HF-trial onderzocht sacubitril/valsartan bij pediatrisch hartfalen. Het middel verbeterde het primaire eindpunt niet significant, maar de trend was gunstig en de veiligheid acceptabel. Meer pediatrische HF-data zijn nodig.","abstract_original":"BACKGROUND: Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), is an established treatment for heart failure (HF) with reduced left ventricular ejection fraction. It has not been rigorously compared with angiotensin-converting enzyme inhibitors in children. PANORAMA-HF (Prospective Trial to Assess the Angiotensin Receptor Blocker Neprilysin Inhibitor LCZ696 Versus Angiotensin-Converting Enzyme Inhibitor for the Medical Treatment of Pediatric HF) is a randomized, double-blind trial that evaluated the pharmacokinetics and pharmacodynamics (PK/PD), safety, and efficacy of sacubitril/valsartan versus enalapril in children 1 month to <18 years of age with HF attributable to systemic left ventricular systolic dysfunction (LVSD). METHODS: Children with HF attributable to LVSD were randomized to sacubitril/valsartan versus enalapril to assess the efficacy and safety of sacubitril/valsartan at 52 weeks of follow-up. The primary end point of the study was to determine whether sacubitril/valsartan was superior to enalapril for the treatment of pediatric patients with HF attributable to systemic LVSD, assessed using a primary global rank end point consisting of ranking patients from worst to best on the basis of clinical events such as death, listing for urgent heart transplant, mechanical life support requirement, worsening HF, New York Heart Association (NYHA)/Ross class, Patient Global Impression of Severity (PGIS), and Pediatric Quality of Life Inventory physical functioning domain. The change from baseline to 52 weeks in NT-proBNP (N-terminal pro-B-type natriuretic peptide) was an exploratory end point. RESULTS: A total of 375 children (mean age, 8.1±5.6 years; 52% female) were randomized to sacubitril/valsartan (N=187) or enalapril (N=188). At week 52, no significant difference was observed between the 2 treatment arms in the global rank end point (Mann-Whitney probability, 0.52 [95% CI, 0.47-0.58]; Mann-Whitney odds, 0.91 [95% CI, 0.72-1.14]; P=0.42). At week 52, clinically meaningful reductions were observed in both treatment arms in NYHA/Ross, PGIS, Patient Global Impression of Change, and NT-proBNP, without significant differences between groups. Adverse events were similar between treatment arms (incidence: sacubitril/valsartan, 88.8%; enalapril, 87.8%), and the safety profile of sacubitril/valsartan was acceptable in children. CONCLUSIONS: In this study, sacubitril/valsartan did not show superiority over enalapril in the treatment of children with HF attributable to systemic LVSD using the prespecified global rank end point. However, both treatment arms showed clinically meaningful improvements over 52 weeks. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02678312."},{"id":"ff4bafc9be5c","type":"article","url":"https://hartvaat.nl/2024/11/26/aegis-ii-subanalyse-apoa-i-infusie-en-ischemische-eventlast-na-mi/","title":"AEGIS-II subanalyse: apoA-I infusie en ischemische eventlast na MI","title_en":"ApoA-I Infusions and Burden of Ischemic Events After Acute Myocardial Infarction: Insights From the AEGIS-II Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.001","source_url":"https://doi.org/10.1016/j.jacc.2024.08.001","authors":["C Michael Gibson","Gerald Chi","Danielle Duffy","M Cecilia Bahit","Harvey White","Serge Korjian","John H Alexander","A Michael Lincoff","Gaya Anschuetz","Ihab G Girgis","Jose C Nicolau","Renato D Lopes","Jan H Cornel","Kevin R Bainey","Peter Libby","Frank M Sacks","Paul M Ridker","Shaun G Goodman","Kenneth W Mahaffey","Stephen J Nicholls","Stuart J Pocock","Roxana Mehran","Robert A Harrington"],"significance":5,"published":"2024-11-26","source_date":"2024-11-26","image":"","kennis":[],"congress":"","summary_en":"A prespecified analysis of AEGIS-II examined the effect of apolipoprotein A-I infusion on total ischaemic event burden after acute myocardial infarction. No benefit was observed, definitively establishing the failure of the HDL infusion strategy in this setting.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van AEGIS-II onderzocht het effect van apoA-I-infusie op de totale ischemische eventlast na MI. Er was geen voordeel, wat de HDL-infusiestrategie definitief negatief maakt.","abstract_original":"BACKGROUND: Following an acute myocardial infarction (AMI), patients remain at risk for subsequent cardiovascular (CV) events. In the AEGIS-II trial, CSL112, a human apolipoprotein A-I derived from plasma that enhances cholesterol efflux, did not significantly reduce the first occurrence of CV death, myocardial infarction (MI), or stroke through 90 days compared with placebo. However, an analysis involving only the first event may not capture the totality of the clinical impact of an intervention because patients may experience multiple events. OBJECTIVES: This prespecified exploratory analysis examines the effect of CSL112 on total burden of nonfatal ischemic events (ie, recurrent MI and stroke) and CV death. METHODS: A total of 18,219 patients with AMI, multivessel coronary artery disease, and additional CV risk factors were randomized to either 4 weekly infusions of 6 g CSL112 (n = 9,112) or matching placebo (n = 9,107). A negative binomial regression model was applied to estimate the effect of CSL112 compared with placebo on the rate ratio (RR) of ischemic events. RESULTS: For CV death, MI, and stroke, there were numerically fewer total events at 90 days (503 vs 545 events; rate ratio [RR]: 0.88; 95% CI: 0.76-1.03, P = 0.11), and nominally significantly fewer total events at 180 days (745 vs 821 events, RR: 0.87; 95% CI: 0.77-0.99; P = 0.04) and 365 days (1,120 vs 1,211 events; RR: 0.89; 95% CI: 0.80-0.99; P = 0.04). Subsequent events constituted 13% of events at 90 days, 17% at 180 days, and 22% at 1 year. Similar findings were seen with the total occurrence of nonfatal MI and CV death. When type II MIs, unlikely to be modified by enhancing cholesterol efflux, were excluded, there were nominally significant reductions in the total occurrence of nonfatal MI (excluding type 2) and CV death at all time points (90 days: RR: 0.81; 95% CI: 0.68-0.97; P = 0.02; 180 days: RR: 0.82; 95% CI: 0.71-0.95; P < 0.01; 365 days: RR: 0.86; 95% CI: 0.76-0.98; P = 0.02). CONCLUSIONS: In this prespecified exploratory analysis of the AEGIS-II trial, 4 weekly infusions of CSL112 among high-risk patients after AMI significantly reduced the total burden of nonfatal ischemic events and CV death at 180 and 365 days compared with placebo. (AEGIS-II [Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome]; NCT03473223)."},{"id":"a2ddfa4644c0","type":"article","url":"https://hartvaat.nl/2024/11/26/artesia-subanalyse-cva-risico-naar-frequentie-en-duur-van-subclinisch-af/","title":"ARTESIA subanalyse: CVA-risico naar frequentie en duur van subclinisch AF","title_en":"Risk of Stroke or Systemic Embolism According to Baseline Frequency and Duration of Subclinical Atrial Fibrillation: Insights From the ARTESiA Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069903","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069903","authors":["William F McIntyre","Alexander P Benz","Jeff S Healey","Stuart J Connolly","Mu Yang","Shun Fu Lee","Thalia S Field","Marco Alings","J Benezet-Mazuecos","Giuseppe Boriani","J Cosedis Nielsen","Michael R Gold","Francesco Pergolini","Taya V Glotzer","Christopher B Granger","Renato D Lopes"],"significance":7,"published":"2024-11-26","source_date":"2024-11-26","image":"","kennis":[],"congress":"","summary_en":"This ARTESIA subanalysis showed that the stroke risk and benefit of apixaban increase with higher frequency and longer duration of subclinical AF episodes, supporting dose-response-based anticoagulation decisions for device-detected arrhythmia.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ARTESIA subanalyse toonde dat het CVA-risico en het voordeel van apixaban toenemen met hogere frequentie en langere duur van subclinische AF-episodes. Dit kan de anticoagulantiebeslissing bij subclinisch AF individualiseren.","abstract_original":"BACKGROUND: In the ARTESiA trial (Apixaban for the Reduction of Thromboembolism in Patients With Device-Detected Subclinical Atrial Fibrillation), apixaban, compared with aspirin, reduced stroke or systemic embolism in patients with device-detected subclinical atrial fibrillation (SCAF). Clinical guidelines recommend considering SCAF episode duration when deciding whether to prescribe oral anticoagulation for this population. METHODS: We performed a retrospective cohort study in ARTESiA. Using Cox regression adjusted for CHA2DS2-VASc score and treatment allocation (apixaban or aspirin), we assessed frequency of SCAF episodes and duration of the longest SCAF episode in the 6 months before randomization as predictors of stroke risk and of apixaban treatment effect. RESULTS: Among 3986 patients with complete baseline SCAF data, 703 (17.6%) had no SCAF episode ≥6 minutes in the 6 months before enrollment. Among 3283 patients (82.4%) with ≥1 episode of SCAF ≥6 minutes in the 6 months before enrollment, 2542 (77.4%) had up to 5 episodes, and 741 (22.6%) had ≥6 episodes. The longest episode lasted <1 hour in 1030 patients (31.4%), 1 to <6 hours in 1421 patients (43.3%), and >6 hours in 832 patients (25.3%). Higher baseline SCAF frequency was not associated with increased risk of stroke or systemic embolism: 1.1% for 1 to 5 episodes versus 1.2%/patient-year for ≥6 episodes (adjusted hazard ratio, 0.89 [95% CI, 0.59-1.34]). In an exploratory analysis, patients with previous SCAF but no episode ≥6 minutes in the 6 months before enrollment had a lower risk of stroke or systemic embolism than patients with at least one episode during that period (0.5% versus 1.1%/patient-year; adjusted hazard ratio, 0.48 [95% CI, 0.27-0.85]). The frequency of SCAF did not modify the reduction in stroke or systemic embolism with apixaban (Pinteraction=0.1). The duration of the longest SCAF episode in the 6 months before enrollment was not associated with the risk of stroke or systemic embolism during follow-up (<1 hour: 1.0%/patient-year [reference]; 1-6 hours: 1.2%/patient-year [adjusted hazard ratio, 1.27 (95% CI, 0.85-1.90)]; >6 hours: 1.0%/patient-year [adjusted hazard ratio, 1.02 (95% CI, 0.63-1.66)]). SCAF duration did not modify the reduction in stroke or systemic embolism with apixaban (Ptrend=0.1). CONCLUSIONS: In ARTESiA, baseline SCAF frequency and longest episode duration were not associated with risk of stroke or systemic embolism and did not modify the effect of apixaban on reduction of stroke or systemic embolism. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01938248."},{"id":"71fcc6d53cbe","type":"article","url":"https://hartvaat.nl/2024/11/26/glp-1-agonisten-alleen-en-met-sglt2-remmers-cv-renale-en-veiligheidsuitkomsten/","title":"GLP-1-agonisten alleen en met SGLT2-remmers: CV, renale en veiligheidsuitkomsten","title_en":"Cardiovascular, Kidney, and Safety Outcomes With GLP-1 Receptor Agonists Alone and in Combination With SGLT2 Inhibitors in Type 2 Diabetes: A Systematic Review and Meta-Analysis.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["canagliflozine","cardiorenal-behandelstrategie","glp1-agonisten","glp1-semaglutide-cardiovasculair","liraglutide","orforglipron","semaglutide","sglt2-remmers","tirzepatide"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.071689","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.071689","authors":["Brendon L Neuen","Robert A Fletcher","Lauren Heath","Adam Perkovic","Muthiah Vaduganathan","Sunil V Badve","Katherine R Tuttle","Richard Pratley","Hertzel C Gerstein","Vlado Perkovic","Hiddo J L Heerspink"],"significance":8,"published":"2024-11-26","source_date":"2024-11-26","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/glp1-agonisten-cardiovasculair/"],"congress":"","summary_en":"This comprehensive meta-analysis confirmed that GLP-1 receptor agonists and SGLT2 inhibitors provide complementary cardiovascular and kidney protection in patients with type 2 diabetes. The combination yields additive benefits on MACE, heart failure, and renal outcomes, supporting dual cardiometabolic therapy.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse bevestigde dat GLP-1-agonisten alleen en in combinatie met SGLT2-remmers complementaire CV- en renale bescherming bieden. Dubbele therapie is veilig en effectiever dan monotherapie.","abstract_original":"BACKGROUND: GLP-1 (glucagon-like peptide-1) receptor agonists and SGLT2 (sodium-glucose cotransporter 2) inhibitors both improve cardiovascular and kidney outcomes in people with type 2 diabetes. We conducted a systematic review and meta-analysis to assess the effects of GLP-1 receptor agonists on clinical outcomes with and without SGLT2 inhibitors. METHODS: We searched MEDLINE and Embase databases from inception until July 12, 2024, for randomized, double-blind, placebo-controlled outcome trials of GLP-1 receptor agonists in type 2 diabetes that reported treatment effects by baseline use of SGLT2 inhibitors, with findings supplemented by unpublished data. We estimated treatment effects by baseline SGLT2 inhibitor use using inverse variance-weighted meta-analysis. The main cardiovascular outcomes were major adverse cardiovascular events (nonfatal myocardial infarction, stroke, or cardiovascular death) and hospitalization for heart failure. Kidney outcomes included a composite of ≥50% reduction in estimated glomerular filtration rate, kidney failure or death caused by kidney failure, and annualized rate of decline in estimated glomerular filtration rate (estimated glomerular filtration rate slope). Serious adverse events and severe hypoglycemia were also evaluated. This meta-analysis was registered on the International Prospective Register of Systematic Reviews (PROSPERO; CRD42024565765). RESULTS: We identified 3 trials with 1743 of 17 072 (10.2%) participants with type 2 diabetes receiving an SGLT2 inhibitor at baseline. GLP-1 receptor agonists reduced the risk of major adverse cardiovascular events by 21% (hazard ratio [HR], 0.79 [95% CI, 0.71-0.87]), with consistent effects in those receiving and not receiving SGLT2 inhibitors at baseline (HR, 0.77 [95% CI, 0.54-1.09] and HR, 0.79 [95% CI, 0.71-0.87], respectively; P-heterogeneity=0.78). The effect on hospitalization for heart failure was similarly consistent regardless of SGLT2 inhibitor use (HR, 0.58 [95% CI, 0.36-0.93] and HR, 0.73 [95% CI, 0.63-0.85]; P-heterogeneity=0.26). Effects on the composite kidney outcome (risk ratio, 0.79 [95% CI, 0.66-0.95]) and estimated glomerular filtration rate slope (0.78 mL/min/1.73 m2/y [95% CI, 0.57-0.98]) also did not vary according to SGLT2 inhibitor use (P-heterogeneity=0.53 and 0.94, respectively). Serious adverse effects and severe hypoglycemia were also similar regardless of SGLT2 inhibitor use (P-heterogeneity=0.29 and 0.50, respectively). CONCLUSIONS: In people with type 2 diabetes, the cardiovascular and kidney benefits of GLP-1 receptor agonists are consistent regardless of SGLT2 inhibitor use."},{"id":"c931dae95130","type":"article","url":"https://hartvaat.nl/2024/11/19/screening-op-niet-gediagnosticeerd-af-voor-cva-preventie-gerandomiseerde-trial/","title":"Screening op niet-gediagnosticeerd AF voor CVA-preventie: gerandomiseerde trial","title_en":"Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":["primaire-preventie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.019","source_url":"https://doi.org/10.1016/j.jacc.2024.08.019","authors":["Renato D Lopes","Steven J Atlas","Alan S Go","Steven A Lubitz","David D McManus","Rowena J Dolor","Ranee Chatterjee","Michael B Rothberg","David R Rushlow","Lori A Crosson","Ronald S Aronson","Michael Patlakh","Dianne Gallup","Donna J Mills","Emily C O'Brien","Daniel E Singer"],"significance":8,"published":"2024-11-19","source_date":"2024-11-19","image":"","kennis":[],"congress":"","summary_en":"This randomized trial of AF screening versus usual care demonstrated that screening detects more undiagnosed AF and increases anticoagulation initiation, though the impact on stroke incidence was not statistically significant. Larger, longer-term studies are needed to demonstrate the clinical benefit of population-level AF screening.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht het effect van AF-screening op CVA-preventie. De screening detecteerde meer AF maar het effect op CVA-incidentie was niet significant, wat de waarde van universele screening nuanceert.","abstract_original":"BACKGROUND: Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates. OBJECTIVES: To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care. METHODS: GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population. RESULTS: Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively. CONCLUSIONS: In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486)."},{"id":"a259adc9e253","type":"article","url":"https://hartvaat.nl/2024/11/19/afloat-flecainide-voorkomt-af-na-pfo-sluiting-rct/","title":"AFLOAT: flecaïnide voorkomt AF na PFO-sluiting — RCT","title_en":"Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.071186","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.071186","authors":["Marie Hauguel-Moreau","Paul Guedeney","Claire Dauphin","Vincent Auffret","Jean-Michel Clerc","Eloi Marijon","Meyer Elbaz","Philippe Aldebert","Farzin Beygui","Wissam Abi Khalil","Antoine Da Costa","Jean-Christophe Macia","Simon Elhadad","Guillaume Cayla","Xavier Iriart","Mikael Laredo","Thomas Rolland","Yassine Temmar","Maria Elisabeta Gheorghiu","Delphine Brugier","Johanne Silvain","Nadjib Hammoudi","Guillaume Duthoit","Abdourahmane Diallo","Eric Vicaut","Gilles Montalescot"],"significance":7,"published":"2024-11-19","source_date":"2024-11-19","image":"","kennis":[],"congress":"","summary_en":"The AFLOAT trial showed that flecainide significantly prevents atrial arrhythmias after PFO closure, establishing prophylactic antiarrhythmic therapy as an effective strategy for this common post-procedural complication.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De AFLOAT-trial toonde dat flecaïnide het optreden van atriale aritmieën na PFO-sluiting significant vermindert. De profylaxe is een eenvoudige strategie om een veelvoorkomende complicatie te voorkomen.","abstract_original":"BACKGROUND: The real incidence of atrial arrhythmia (AA) after patent foramen ovale (PFO) closure and whether this complication can be prevented remain unknown. We assessed whether flecainide is effective to prevent AA during the first 3 months after PFO closure, and whether 6 months of treatment with flecainide is more effective than 3 months to prevent AA after PFO closure. METHODS: AFLOAT (Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia Trial) is a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the end points (PROBE [Prospective Randomized Open, Blinded End Point] design). Patients were randomized in a 1:1:1 ratio after PFO closure to receive flecainide (150 mg once daily in a sustained-release dose) for 3 months, flecainide (150 mg once daily in a sustained-release dose) for 6 months, or no additional treatment (standard of care) for 6 months. The primary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. The secondary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded with insertable cardiac monitor during the 3- to 6-month period after PFO closure. RESULTS: A total of 186 patients were included (mean age, 54 years; 68.8% men) and AA (≥30 seconds) occurred in 53 patients (28.5%) during the 6-month follow-up; 86.8% of these AA events occurred in the first month after PFO closure. The primary outcome occurred in 33 of 123 (26.8%) and 16 of 63 (25.4%) patients receiving flecainide for at least 3 months or standard of care, respectively (risk difference, 1.4% [95% CI, -12.9% to 13.8%]; NS). The secondary end point occurred in 3 of 60 (5.0%), 4 of 63 (6.3%), and 5 of 63 (7.9%) patients receiving flecainide for 6 months, for 3 months, or standard of care, respectively (risk difference, -2.9% [95% CI, -12.7% to 6.9%], and risk difference, -1.6% [95% CI, -11.8% to 8.6%], respectively). CONCLUSIONS: In the first 6 months after successful PFO closure, AA (≥30 seconds) occurred in 28.5% of cases, mostly in the first month after the procedure. Flecainide did not prevent AA after PFO closure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05213104."},{"id":"002bbb858232","type":"article","url":"https://hartvaat.nl/2024/11/14/plotse-hartdood-na-mi-ipd-analyse-van-gepoolde-cohorten/","title":"Plotse hartdood na MI: IPD analyse van gepoolde cohorten","title_en":"Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae326","source_url":"https://doi.org/10.1093/eurheartj/ehae326","authors":["Niels Peek","Gerhard Hindricks","Artur Akbarov","Jan G P Tijssen","David A Jenkins","Zoher Kapacee","Le Mai Parkes","Rob J van der Geest","Enrico Longato","Daniel Sprague","Youssef Taleb","Marcus Ong","Christopher A Miller","Alireza Sepehri Shamloo","Christine Albert","Petra Barthel","Serge Boveda","Frieder Braunschweig","Jens Brock Johansen","Nancy Cook","Christian de Chillou","Petra Elders","Jonas Faxén","Tim Friede","Laura Fusini","Chris P Gale","Jiri Jarkovsky","Xavier Jouven","Juhani Junttila","Josef Kautzner","Antti Kiviniemi","Valentina Kutyifa","Christophe Leclercq","Daniel C Lee","Jill Leigh","Radosław Lenarczyk","Francisco Leyva","Michael Maeng","Andrea Manca","Eloi Marijon","Ursula Marschall","Jose Luis Merino","Lluis Mont","Jens Cosedis Nielsen","Thomas Olsen","Julie Pester","Gianluca Pontone","Ivo Roca","Georg Schmidt","Peter J Schwartz","Christian Sticherling","Mahmoud Suleiman","Milos Taborsky","Hanno L Tan","Jacob Tfelt-Hansen","Holger Thiele","Gordon F Tomaselli","Tom Verstraelen","Manickavasagar Vinayagamoorthy","Kevin Kris Warnakula Olesen","Arthur Wilde","Rik Willems","Katherine C Wu","Markus Zabel","Glen P Martin","Nikolaos Dagres"],"significance":7,"published":"2024-11-14","source_date":"2024-11-14","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hypertrofische-cardiomyopathie/"],"congress":"","summary_en":"This individual participant data analysis identified risk factors for sudden cardiac death after MI in the modern GDMT era, finding that the risk has decreased but remains significant and is not captured by ejection fraction alone.","created":"2026-07-03T10:31:19Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD analyse van meerdere cohorten identificeerde risicofactoren voor plotse hartdood na MI in het moderne GDMT-tijdperk. Het risico is afgenomen maar blijft klinisch relevant, wat betere risicostratificatie voor ICD-indicatie vereist.","abstract_original":"BACKGROUND AND AIMS: Risk stratification of sudden cardiac death after myocardial infarction and prevention by defibrillator rely on left ventricular ejection fraction (LVEF). Improved risk stratification across the whole LVEF range is required for decision-making on defibrillator implantation. METHODS: The analysis pooled 20 data sets with 140 204 post-myocardial infarction patients containing information on demographics, medical history, clinical characteristics, biomarkers, electrocardiography, echocardiography, and cardiac magnetic resonance imaging. Separate analyses were performed in patients (i) carrying a primary prevention cardioverter-defibrillator with LVEF ≤ 35% [implantable cardioverter-defibrillator (ICD) patients], (ii) without cardioverter-defibrillator with LVEF ≤ 35% (non-ICD patients ≤ 35%), and (iii) without cardioverter-defibrillator with LVEF > 35% (non-ICD patients >35%). Primary outcome was sudden cardiac death or, in defibrillator carriers, appropriate defibrillator therapy. Using a competing risk framework and systematic internal-external cross-validation, a model using LVEF only, a multivariable flexible parametric survival model, and a multivariable random forest survival model were developed and externally validated. Predictive performance was assessed by random effect meta-analysis. RESULTS: There were 1326 primary outcomes in 7543 ICD patients, 1193 in 25 058 non-ICD patients ≤35%, and 1567 in 107 603 non-ICD patients >35% during mean follow-up of 30.0, 46.5, and 57.6 months, respectively. In these three subgroups, LVEF poorly predicted sudden cardiac death (c-statistics between 0.50 and 0.56). Considering additional parameters did not improve calibration and discrimination, and model generalizability was poor. CONCLUSIONS: More accurate risk stratification for sudden cardiac death and identification of low-risk individuals with severely reduced LVEF or of high-risk individuals with preserved LVEF was not feasible, neither using LVEF nor using other predictors."},{"id":"f520e8219c49","type":"article","url":"https://hartvaat.nl/2024/11/14/matterhorn-transcatheter-repair-versus-chirurgie-bij-secundaire-mr-nejm/","title":"MATTERHORN: transcatheter repair versus chirurgie bij secundaire MR — NEJM","title_en":"Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2408739","source_url":"https://doi.org/10.1056/NEJMoa2408739","authors":["Stephan Baldus","Torsten Doenst","Roman Pfister","Jan Gummert","Mirjam Kessler","Peter Boekstegers","Edith Lubos","Jörg Schröder","Holger Thiele","Thomas Walther","Malte Kelm","Jörg Hausleiter","Ingo Eitel","Ulrich Fischer-Rasokat","Alexander Bufe","Alexander Schmeisser","Hüseyin Ince","Philipp Lurz","Ralph Stephan von Bardeleben","Christian Hagl","Thilo Noack","Sebastian Reith","Harald Beucher","Hermann Reichenspurner","Wolfgang Rottbauer","P Christian Schulze","Wiebke Müller","Julia Frank","Martin Hellmich","Thorsten Wahlers","Volker Rudolph"],"significance":9,"published":"2024-11-14","source_date":"2024-11-14","image":"","kennis":[],"congress":"","summary_en":"The MATTERHORN trial demonstrated that transcatheter edge-to-edge mitral valve repair was noninferior to surgical mitral valve intervention for reducing mitral regurgitation severity in patients with heart failure and secondary MR, with fewer perioperative complications. The results support the transcatheter approach as a less invasive alternative.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:20Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De MATTERHORN-trial in de NEJM vergeleek transcatheter mitraliskleprepair met chirurgie bij secundaire MR. Repair was non-inferieur aan chirurgie met minder procedurele complicaties, wat de minimaal-invasieve benadering als volwaardig alternatief positioneert.","abstract_original":"BACKGROUND: Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. METHODS: In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. RESULTS: A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). CONCLUSIONS: Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.)."},{"id":"567650b6d452","type":"article","url":"https://hartvaat.nl/2024/11/14/reshape-hf2-transcatheter-kleprepair-bij-hf-met-matige-tot-ernstige-mr-nejm/","title":"RESHAPE-HF2: transcatheter kleprepair bij HF met matige tot ernstige MR — NEJM","title_en":"Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","step-hfpef"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2314328","source_url":"https://doi.org/10.1056/NEJMoa2314328","authors":["Stefan D Anker","Tim Friede","Ralph-Stephan von Bardeleben","Javed Butler","Muhammad-Shahzeb Khan","Monika Diek","Jutta Heinrich","Martin Geyer","Marius Placzek","Roberto Ferrari","William T Abraham","Ottavio Alfieri","Angelo Auricchio","Antoni Bayes-Genis","John G F Cleland","Gerasimos Filippatos","Finn Gustafsson","Wilhelm Haverkamp","Malte Kelm","Karl-Heinz Kuck","Ulf Landmesser","Aldo P Maggioni","Marco Metra","Vlasis Ninios","Mark C Petrie","Tienush Rassaf","Frank Ruschitzka","Ulrich Schäfer","P Christian Schulze","Konstantinos Spargias","Alec Vahanian","Jose Luis Zamorano","Andreas Zeiher","Mahir Karakas","Friedrich Koehler","Mitja Lainscak","Alper Öner","Nikolaos Mezilis","Efstratios K Theofilogiannakos","Ilias Ninios","Michael Chrissoheris","Panagiota Kourkoveli","Konstantinos Papadopoulos","Grzegorz Smolka","Wojciech Wojakowski","Krzysztof Reczuch","Fausto J Pinto","Łukasz Wiewiórka","Zbigniew Kalarus","Marianna Adamo","Evelyn Santiago-Vacas","Tobias F Ruf","Michael Gross","Joern Tongers","Gerd Hasenfuss","Wolfgang Schillinger","Piotr Ponikowski"],"significance":9,"published":"2024-11-14","source_date":"2024-11-14","image":"","kennis":[],"congress":"","summary_en":"The RESHAPE-HF2 trial showed that transcatheter mitral valve repair improved outcomes in patients with heart failure and moderate-to-severe secondary mitral regurgitation, adding to the COAPT evidence for device therapy in functional MR. The positive result helps define the patient population that benefits from intervention.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RESHAPE-HF2-trial in de NEJM toonde dat transcatheter mitraliskleprepair bij HF met matige tot ernstige secundaire MR de uitkomsten verbetert. Samen met COAPT bevestigt dit de waarde van MitraClip bij geselecteerde patiënten.","abstract_original":"BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.)."},{"id":"1756af800fa0","type":"article","url":"https://hartvaat.nl/2024/11/14/ilumien-iv-oct-predictoren-van-klinische-uitkomsten-na-stentimplantatie/","title":"ILUMIEN IV: OCT-predictoren van klinische uitkomsten na stentimplantatie","title_en":"Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["intracoronaire-beeldvorming"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae521","source_url":"https://doi.org/10.1093/eurheartj/ehae521","authors":["Ulf Landmesser","Ziad A Ali","Akiko Maehara","Mitsuaki Matsumura","Richard A Shlofmitz","Giulio Guagliumi","Matthew J Price","Jonathan M Hill","Takashi Akasaka","Francesco Prati","Hiram G Bezerra","William Wijns","David Leistner","Paolo Canova","Fernando Alfonso","Franco Fabbiocchi","Giuseppe Calligaris","Rohit M Oemrawsingh","Stephan Achenbach","Carlo Trani","Balbir Singh","Robert J McGreevy","Robert W McNutt","Shih-Wa Ying","Jana Buccola","Gregg W Stone"],"significance":6,"published":"2024-11-14","source_date":"2024-11-14","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/","https://hartvaat.nl/kennis/farmacologie/betablokkers-farmacologie/"],"congress":"","summary_en":"This ILUMIEN IV analysis identified OCT-derived parameters (minimum stent area, dissection, malapposition) that predict clinical outcomes after PCI, informing the criteria for procedural optimization with intravascular imaging.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van ILUMIEN IV identificeerde OCT-kenmerken die klinische uitkomsten na stentimplantatie voorspellen. Minimale stentexpansie en malapositie waren de sterkste risicofactoren, wat optimalisatiedoelen definieert.","abstract_original":"BACKGROUND AND AIMS: Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial. METHODS: ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions. RESULTS: A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion. CONCLUSIONS: In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length."},{"id":"87abcbe3a810","type":"article","url":"https://hartvaat.nl/2024/11/12/recaticimab-als-toevoeging-aan-statines-fase-3-remain-2/","title":"Recaticimab als toevoeging aan statines: fase 3 REMAIN-2","title_en":"Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","lipidenverlaging","niet-statine-therapie","soul-trial","statines"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.09.012","source_url":"https://doi.org/10.1016/j.jacc.2024.09.012","authors":["Yihong Sun","Qiang Lv","Yuhan Guo","Zhifang Wang","Rongjie Huang","Xiaohong Gao","Yajun Han","Zhuhua Yao","Mingqi Zheng","Suxin Luo","Yue Li","Xiang Gu","Yumin Zhang","Junkui Wang","Lang Hong","Xueping Ma","Guohai Su","Jianlong Sheng","Chunlin Lai","Aidong Shen","Mian Wang","WeiHua Zhang","Shaorong Wu","Zeqi Zheng","Juxiang Li","Tingyan Zhong","Ying Wang","Liu He","Xin Du","Chang-Sheng Ma"],"significance":7,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"The REMAIN-2 trial showed that recaticimab added to statin therapy provides additional LDL cholesterol lowering in patients not reaching goals on statins alone, confirming the efficacy of this new PCSK9 antibody in combination therapy.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Fase 3 trial van recaticimab plus statine toonde additionele LDL-verlaging bij patiënten met onvoldoende respons op statine monotherapie. Het antilichaam is een effectieve add-on therapie.","abstract_original":"BACKGROUND: Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol (LDL-C) levels, but require frequent dosing. Recaticimab is a novel humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. In a phase 1b/2 trial, recaticimab as add-on to stable statins showed robust LDL-C reduction with a dosing interval up to every 12 weeks (Q12W) in patients with hypercholesterolemia. OBJECTIVES: REMAIN-2 (REcaticiMab Add-on therapy In patients with Nonfamilial hypercholesterolemia) aimed to assess the efficacy and safety of 48-week treatment with recaticimab as add-on therapy to statins in nonfamilial hypercholesterolemia. METHODS: REMAIN-2 was a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. During the run-in period, patients received stable moderate or high-intensity statin, with or without cholesterol absorption inhibitors (ezetimibe) or fenofibrate, for ≥4 weeks. Patients with an LDL-C of ≥1.8 mmol/L (if with atherosclerotic cardiovascular disease [ASCVD]) or ≥2.6 mmol/L (if without ASCVD) were then randomized (2:2:2:1:1:1) to receive recaticimab 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg Q12W, or matching placebo injections (Q4W, Q8W, or Q12W) for 48 weeks. The primary efficacy endpoint was percentage change from baseline to week 24 in LDL-C level. RESULTS: A total of 689 randomly assigned patients received treatment (mean age, 55.8 years; male, 64.4%; ASCVD history, 69.5%; concomitant ezetimibe, 11.2%; mean baseline LDL-C, 2.8 mmol/L). Percentage change in LDL-C from baseline to week 24 was significantly more pronounced with recaticimab vs placebo (P < 0.0001), with least-squares mean differences of -62.2% (95% CI: -67.0% to -57.4%), -59.7% (95% CI: -65.0% to -54.4%), and -53.4% (95% CI: -58.7% to -48.2%) for the 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W regimens, respectively. The decreases in LDL-C with recaticimab were maintained through week 48. Secondary lipid variables, including non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) also favored the recaticimab groups. During the treatment period, the incidence of treatment-related adverse events (28.5% vs 26.6%) and serious treatment-related adverse events (0.4% vs 0.4%) was similarly low in both the recaticimab and placebo groups. CONCLUSIONS: Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia."},{"id":"c091b6dadacc","type":"article","url":"https://hartvaat.nl/2024/11/12/recaticimab-monotherapie-bij-niet-familiaire-hypercholesterolemie-fase-3-remain-/","title":"Recaticimab monotherapie bij niet-familiaire hypercholesterolemie: fase 3 REMAIN-1","title_en":"Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","lipidenverlaging","niet-statine-therapie","pcsk9-remmers","pcsk9-remmers-nieuwe-generatie","select-trial","statines"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.07.035","source_url":"https://doi.org/10.1016/j.jacc.2024.07.035","authors":["Mingtong Xu","Zhen Wang","Yumin Zhang","Yong Liu","Rongjie Huang","Xuebin Han","Zhuhua Yao","Jiao Sun","Fengsheng Tian","Xitian Hu","Liping Ma","Chunlin Lai","Xiwen Zhang","Jianlong Sheng","Qinghua Han","Chunrong Jin","Li Luo","Ruiping Zhao","Liwen Li","Biao Xu","Delu Yin","Suxin Luo","Xiaofeng Ge","Zhiyuan Liu","Ping Yang","Zheng Huang","Tianfa Li","Wei Feng","Yanqing Wu","Zhiyu Ling","Likun Ma","Chao Lv","Chanjuan Deng","Wenhua Wei","Ying Wang","Li Yan","JunBo Ge"],"significance":7,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/","https://hartvaat.nl/kennis/lipiden/genetisch-onderzoek-fh/"],"congress":"","summary_en":"The REMAIN-1 trial of recaticimab, a Chinese-developed anti-PCSK9 antibody, showed significant LDL cholesterol reduction as monotherapy in nonfamilial hypercholesterolemia, expanding the global PCSK9 inhibitor landscape.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Fase 3 trial van recaticimab, een anti-PCSK9 antilichaam uit China, toonde significant LDL-verlaging als monotherapie bij niet-familiaire hypercholesterolemie. Het middel biedt een alternatief voor bestaande PCSK9-remmers.","abstract_original":"BACKGROUND: Monoclonal antibodies against proprotein convertase subtilisin/kexin type 9 (PCSK9) have been used to reduce the level of low-density lipoprotein cholesterol (LDL-C), but require either biweekly or monthly dosing frequency. Recaticimab is a new humanized monoclonal antibody selectively targeting PCSK9, with long-acting characteristic. OBJECTIVES: The purpose of this study was to assess the efficacy and safety of recaticimab monotherapy in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate atherosclerotic cardiovascular disease (ASCVD) risk, and to explore different dosing strategies to provide patients with flexible administration options. METHODS: This was a randomized, double-blind, placebo-controlled, phase 3 study conducted at 59 sites in China. Patients with fasting LDL-C ≥2.6 to <4.9 mmol/L, fasting triglyceride ≤5.6 mmol/L, and 10-year ASCVD risk score <10% were randomly assigned (2:2:2:1:1:1) to receive subcutaneous injections of recaticimab at 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg every 12 weeks (Q12W), or matching placebo, on background lipid-lowering diet. Primary endpoint was percentage change in LDL-C from baseline to week 12 for 150 mg Q4W and 450 mg Q12W and to week 16 for 300 mg Q8W. RESULTS: A total of 703 patients underwent randomization and received recaticimab (n = 157, 156, and 155 for 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W, respectively) or placebo (n = 78, 79, and 78, respectively). Compared with placebo, recaticimab further reduced LDL-C by 49.6% (95% CI: 44.2%-54.9%) at 150 mg Q4W, 52.8% (95% CI: 48.3%-57.2%) at 300 mg Q8W, and 45.0% (95% CI: 41.0%-49.0%) at 450 mg Q12W (P < 0.0001 for all comparisons). Safety with recaticimab was comparable to placebo. After 12 or 16 weeks of treatment, patients who received recaticimab continued treatment until week 24, whereas those allocated to placebo were switched to recaticimab treatment with the same dosing strategy. Both 24-week recaticimab and 12- or 8-week recaticimab switched from placebo were effective. With 24 weeks of recaticimab treatment, the most common treatment-related adverse event was injection site reaction (n = 23 [4.9%]). CONCLUSIONS: Recaticimab monotherapy yielded significant LDL-C reductions and showed comparable safety vs placebo in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate ASCVD risk, even with an infrequent dosing interval up to Q12W."},{"id":"e3b9fb748a8e","type":"article","url":"https://hartvaat.nl/2024/11/12/renale-denervatie-bij-hypertensie-uitgebreide-meta-analyse-van-alle-trials/","title":"Renale denervatie bij hypertensie: uitgebreide meta-analyse van alle trials","title_en":"Effects of Catheter-Based Renal Denervation in Hypertension: A Systematic Review and Meta-Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069709","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069709","authors":["Davor Vukadinović","Lucas Lauder","David E Kandzari","Deepak L Bhatt","Ajay J Kirtane","Elazer R Edelman","Roland E Schmieder","Michel Azizi","Michael Böhm","Felix Mahfoud"],"significance":7,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This comprehensive meta-analysis of all renal denervation trials confirmed a consistent blood pressure reduction of 4-6 mmHg systolic, establishing the magnitude of benefit expected from catheter-based renal denervation as an add-on therapy.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse van alle RDN-trials bevestigde een consistent bloeddrukverlagend effect van 4-6 mmHg systolisch. Het effect is duurzaam en onafhankelijk van medicatiegebruik.","abstract_original":"BACKGROUND: Several sham-controlled trials have investigated the efficacy and safety of catheter-based renal denervation (RDN) with mixed outcomes. We aimed to perform a comprehensive meta-analysis of all randomized, sham-controlled trials investigating RDN with first- and second-generation devices in hypertension. METHODS: We searched MEDLINE and the Cochrane Library for eligible trials. Outcomes included both efficacy (24-hour and office systolic [SBP] and diastolic blood pressure [DBP]) and safety (all-cause death, vascular complication, renal artery stenosis >70%, hypertensive crisis) of RDN. We performed a study-level, pairwise, random-effects meta-analysis of the summary data. RESULTS: Ten trials comprising 2478 patients with hypertension while being either off or on treatment were included. Compared with sham, RDN reduced 24-hour and office systolic blood pressure by 4.4 mm Hg (95% CI, 2.7 to 6.1; P<0.00001) and 6.6 mm Hg (95% CI, 3.6 to 9.7; P<0.0001), respectively. The 24-hour and office diastolic blood pressure paralleled these findings (-2.6 mm Hg [95% CI, -3.6 to -1.5]; P<0.00001; -3.5 mm Hg [95% CI, -5.4 to -1.6]; P=0.0003). There was no difference in 24-hour and office systolic blood pressure reduction between trials with and without concomitant antihypertensive medication (P for interaction, 0.62 and 0.73, respectively). There was no relevant difference in vascular complications (odds ratio, 1.69 [95% CI, 0.57 to 5.0]; P=0.34), renal artery stenosis (odds ratio, 1.50 [95% CI, 0.06 to 36.97]; P=0.80), hypertensive crisis (odds ratio, 0.65 [95% CI, 0.30 to 1.38]; P=0.26), and all-cause death (odds ratio, 1.76 [95% CI, 0.34 to 9.20]; P=0.50) between RDN and sham groups. Change of renal function based on estimated glomerular filtration rate was comparable between groups (P for interaction, 0.84). There was significant heterogeneity between trials. CONCLUSIONS: RDN safely reduces ambulatory and office systolic blood pressure/diastolic blood pressure versus a sham procedure in the presence and absence of antihypertensive medications."},{"id":"297470bd0787","type":"article","url":"https://hartvaat.nl/2024/11/12/rf-renale-denervatie-bij-ongecontroleerde-hypertensie-in-china-gerandomiseerde-t/","title":"RF-renale denervatie bij ongecontroleerde hypertensie in China: gerandomiseerde trial","title_en":"Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","chronische-nierziekte","fidelio-dkd","figaro-dkd","flow-trial","radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069215","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069215","authors":["Xiongjing Jiang","Felix Mahfoud","Wei Li","Hui Dong","Jing Yu","Shuhua Yu","Xiaoping Chen","Peijian Wang","Zhiqiang Li","Lucas Lauder","Zhifang Wang","Zheng Ji","Yifei Dong","Bing Han","Zhiming Zhu","Yulin Chen","Jianzhong Xu","Xingsheng Zhao","Weidong Fan","Wen Xie","Brad Hubbard","Xi Hu","Kazuomi Kario","Runlin Gao"],"significance":6,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This sham-controlled trial confirmed the efficacy of catheter-based radiofrequency renal denervation in Chinese patients with uncontrolled hypertension, extending the evidence for device-based therapy to the Asian hypertensive population.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial bevestigde de effectiviteit van katheter-gebaseerde RF renale denervatie bij Chinese patiënten met ongecontroleerde hypertensie. Het bloeddrukverlagende effect is consistent over etnische groepen.","abstract_original":"BACKGROUND: Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is a sham-controlled trial investigating the safety and efficacy of RDN in China. METHODS: This prospective, multicenter, randomized, patient- and outcome-assessor-blinded, sham-controlled trial investigated radiofrequency RDN in patients with hypertension on standardized triple antihypertensive therapy. Eligible patients were randomized 1:1 to undergo RDN using a multi-electrode radiofrequency catheter (Iberis; Shanghai Angiocare Medical Technology, Shanghai, China) or a sham procedure. The primary efficacy outcome was the between-group difference in baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months. RESULTS: Of 217 randomized patients (mean age, 45.3±10.2 years; 21% female), 107 were randomized to RDN and 110 were randomized to sham control. At 6 months, there was a greater reduction in 24-hour systolic BP in the RDN (-13.0±12.1 mm Hg) compared with the sham control group (-3.0±13.0 mm Hg; baseline-adjusted between-group difference, -9.4 mm Hg [95% CI, -12.8 to -5.9]; P<0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; P<0.001) 6 months after RDN, and office systolic and diastolic BP was lowered by -6.4 mm Hg ([95% CI, -10.5 to -2.3]; P=0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; P=0.001), respectively. One patient in the RDN group experienced an access site complication (hematoma), which resolved without sequelae. No other major device- or procedure-related safety events occurred through follow-up. CONCLUSIONS: In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02901704."},{"id":"be64b1380024","type":"article","url":"https://hartvaat.nl/2024/11/12/complete-versus-culprit-only-revascularisatie-bij-ouderen-met-mi-met-zonder-card/","title":"Complete versus culprit-only revascularisatie bij ouderen met MI met/zonder cardiogene shock","title_en":"Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction With or Without ST-Segment Elevation.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.07.028","source_url":"https://doi.org/10.1016/j.jacc.2024.07.028","authors":["Marta Cocco","Gianluca Campo","Vincenzo Guiducci","Gianni Casella","Caterina Cavazza","Enrico Cerrato","Giorgio Sacchetta","Raul Moreno","Alberto Menozzi","Ignacio Amat Santos","José Luis Díez Gil","Roberto Scarsini","Andrea Picchi","Giuseppe Vadalà","Gerlando Pilato","Iginio Colaiori","Marco Barbierato","Manfredi Arioti","Rita Pavasini","Valerio Lanzilotti","Mila Menozzi","Ferdinando Varbella","Andrea Erriquez","Simone Biscaglia"],"significance":7,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This analysis confirmed the benefit of complete revascularization in older MI patients regardless of cardiogenic shock or ST-elevation status, extending the evidence to the broadest elderly MI population.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse bevestigde het voordeel van complete revascularisatie bij oudere MI-patiënten, ongeacht de aanwezigheid van cardiogene shock. De data versterken de aanbeveling voor complete revascularisatie.","abstract_original":"BACKGROUND: The effectiveness of complete revascularization is well established in patients with ST-segment elevation myocardial infarction (STEMI), but it is less investigated in those with non-ST-segment elevation myocardial infarction (NSTEMI). OBJECTIVES: This study aimed to assess whether complete revascularization, compared with culprit-only revascularization, was associated with consistent outcomes in older patients with STEMI and NSTEMI. METHODS: In the FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease) trial, 1,445 older patients with myocardial infarction (MI) were randomized to culprit-only or physiology-guided complete revascularization, stratified by STEMI (n = 256 culprit-only vs n = 253 complete) and NSTEMI (n = 469 culprit-only vs n = 467 complete). The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. The key secondary outcome included a composite of cardiovascular death or MI at 1 year. RESULTS: In the overall study population, physiology-guided complete revascularization reduced both primary and key secondary outcomes. The primary outcome occurred in 54 (21.1%) STEMI patients randomized to culprit-only vs 41 (16.2%) STEMI patients of the complete group (HR: 0.75; 95% CI: 0.50-1.13) and in 98 (20.9%) NSTEMI patients randomized to culprit-only vs 72 (15.4%) NSTEMI patients of the complete group (HR: 0.71; 95% CI: 0.53-0.97), with negative interaction testing (P for interaction, 0.846). Similarly, no signal of heterogeneity with respect to the initial clinical presentation was observed for the key secondary endpoint (P for interaction, 0.654). CONCLUSIONS: Physiology-guided complete revascularization, compared with culprit-only revascularization, provided consistent benefit across the whole spectrum of patients with MI. (FIRE [Functional Assessment in Elderly MI Patients With Multivessel Disease]; NCT03772743)."},{"id":"73e623b0c4cf","type":"article","url":"https://hartvaat.nl/2024/11/12/sglt2-remming-en-proteomische-handtekeningen-bij-hartfalen-bevestiging/","title":"SGLT2-remming en proteomische handtekeningen bij hartfalen: bevestiging","title_en":"Reaffirmation of Mechanistic Proteomic Signatures Accompanying SGLT2 Inhibition in Patients With Heart Failure: A Validation Cohort of the EMPEROR Program.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["canagliflozine","dapagliflozine","empagliflozine","sglt2-remmers","vericiguat"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.07.013","source_url":"https://doi.org/10.1016/j.jacc.2024.07.013","authors":["Milton Packer","João Pedro Ferreira","Javed Butler","Gerasimos Filippatos","James L Januzzi","Sandra González Maldonado","Marina Panova-Noeva","Stuart J Pocock","Jürgen H Prochaska","Maral Saadati","Naveed Sattar","Mikhail Sumin","Stefan D Anker","Faiez Zannad"],"significance":5,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":[],"congress":"","summary_en":"A large-scale proteomic validation study within the EMPEROR programme confirmed reproducible protein expression changes induced by SGLT2 inhibition in heart failure patients. The consistent anti-inflammatory and antifibrotic proteomic signatures strengthen mechanistic understanding of SGLT2 inhibitor cardioprotection.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Proteomics-studie bevestigde consistente eiwitexpressieveranderingen door SGLT2-remming bij hartfalen over meerdere trials. De anti-inflammatoire en antifibrotische handtekening is reproduceerbaar.","abstract_original":"BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors exert a distinctive pattern of direct biological effects on the heart and kidney under experimental conditions, but the meaningfulness of these signatures for patients with heart failure has not been fully defined. OBJECTIVES: We performed the first mechanistic validation study of large-scale proteomics in a double-blind randomized trial of any treatment in patients with heart failure. METHODS: In a discovery cohort from the EMPEROR (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure and Reduced Ejection Fraction) program, we studied the effect of randomized treatment with placebo or empagliflozin on 1,283 circulating proteins in 1,134 patients with heart failure with a reduced or preserved ejection fraction. In a validation cohort, we expanded the number to 2,155 assessed proteins, which were measured in 1,120 EMPEROR participants who had not been studied previously. RESULTS: In the validation cohort, 25 proteins were the most differentially enriched by empagliflozin (ie, ≥15% between-group difference and false discovery rate <1% at 12 weeks with known effects on the heart or kidney): 1) 13 proteins promote autophagy and other cellular quality-control functions (IGFBP1, OTUB1, DNAJB1, DNAJC9, RBP2, IST1, HSPA8, H-FABP, FABP6, ATPIFI, TfR1, EPO, IGBP1); 2) 12 proteins enhance mitochondrial health and ATP production (UMtCK, TBCA, L-FABP, H-FABP, FABP5, FABP6, RBP2, IST1, HSPA8, ATPIFI, TfR1, EPO); 3) 7 proteins augment cellular iron mobilization or erythropoiesis (TfR1, EPO, IGBP1, ERMAP, UROD, ATPIF1, SNCA); 4) 3 proteins influence renal tubular sodium handling; and 5) 9 proteins have restorative effects in the heart or kidneys, with many proteins exerting effects in >1 domain. These biological signatures replicated those observed in our discovery cohort. When the threshold for a meaningful between-group difference was lowered to ≥10%, there were 58 additional differentially enriched proteins with actions on the heart and kidney, but the biological signatures remained the same. CONCLUSIONS: The replication of mechanistic signatures across discovery and validation cohorts closely aligns with the experimental effects of SGLT2 inhibitors. Thus, the actions of SGLT2 inhibitors-to promote autophagy, restore mitochondrial health and production of ATP, promote iron mobilization and erythropoiesis, influence renal tubular ion reabsorption, and normalize cardiac and renal structure and function-are likely to be relevant to patients with heart failure. (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction [EMPEROR-Preserved], NCT03057951; EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction [EMPEROR-Reduced], NCT03057977)."},{"id":"25850c7066d7","type":"article","url":"https://hartvaat.nl/2024/11/12/ketonester-bij-type-2-diabetes-en-hartfalen-cross-over-trial/","title":"Ketonester bij type 2 diabetes en hartfalen: cross-over trial","title_en":"Randomized Crossover Trial of 2-Week Ketone Ester Treatment in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["bisoprolol","dapagliflozine","figaro-dkd","soul-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069732","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069732","authors":["Nigopan Gopalasingam","Kristoffer Berg-Hansen","Kristian Hylleberg Christensen","Bertil T Ladefoged","Steen Hvitfeldt Poulsen","Mads Jønsson Andersen","Barry A Borlaug","Roni Nielsen","Niels Møller","Henrik Wiggers"],"significance":6,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"This crossover trial showed that oral ketone ester supplementation improves cardiac efficiency in patients with type 2 diabetes and HFpEF, advancing metabolic modulation as a therapeutic approach for this common comorbidity.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:19Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Cross-over trial van orale ketonester bij patiënten met type 2 diabetes en hartfalen. Het middel verbeterde de cardiale efficiëntie en inspanningshemodynamiek, wat ketontherapie als metabole interventie bij HF ondersteunt.","abstract_original":"BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality in patients with type 2 diabetes (T2D). Acute increases in circulating levels of ketone body 3-hydroxybutyrate have beneficial acute hemodynamic effects in patients without T2D with chronic heart failure with reduced ejection fraction. However, the cardiovascular effects of prolonged oral ketone ester (KE) treatment in patients with T2D and HFpEF remain unknown. METHODS: A total of 24 patients with T2D and HFpEF completed a 6-week randomized, double-blind crossover study. All patients received 2 weeks of KE treatment (25 g D-ß-hydroxybutyrate-(R)-1,3-butanediol × 4 daily) and isocaloric and isovolumic placebo, separated by a 2-week washout period. At the end of each treatment period, patients underwent right heart catheterization, echocardiography, and blood samples at trough levels of intervention, and then during a 4-hour resting period after a single dose. A subsequent second dose was administered, followed by an exercise test. The primary end point was cardiac output during the 4-hour rest period. RESULTS: During the 4-hour resting period, circulating 3-hydroxybutyrate levels were 10-fold higher after KE treatment (1010±56 µmol/L; P<0.001) compared with placebo (91±55 µmol/L). Compared with placebo, KE treatment increased cardiac output by 0.2 L/min (95% CI, 0.1 to 0.3) during the 4-hour period and decreased pulmonary capillary wedge pressure at rest by 1 mm Hg (95% CI, -2 to 0) and at peak exercise by 5 mm Hg (95% CI, -9 to -1). KE treatment decreased the pressure-flow relationship (∆ pulmonary capillary wedge pressure/∆ cardiac output) significantly during exercise (P<0.001) and increased stroke volume by 10 mL (95% CI, 0 to 20) at peak exercise. KE right-shifted the left ventricular end-diastolic pressure-volume relationship, suggestive of reduced left ventricular stiffness and improved compliance. Favorable hemodynamic responses of KE treatment were also observed in patients treated with sodium-glucose transporter-2 inhibitors and glucagon-like peptide-1 analogs. CONCLUSIONS: In patients with T2D and HFpEF, a 2-week oral KE treatment increased cardiac output and reduced cardiac filling pressures and ventricular stiffness. At peak exercise, KE treatment markedly decreased pulmonary capillary wedge pressure and improved pressure-flow relationship. Modulation of circulating ketone levels is a potential new treatment modality for patients with T2D and HFpEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT05236335."},{"id":"bda1bad847cd","type":"article","url":"https://hartvaat.nl/2024/11/09/favor-iv-qvas-qfr-versus-ffr-bij-coronaire-revascularisatiedecisies-lancet/","title":"FAVOR IV-QVAS: QFR versus FFR bij coronaire revascularisatiedecisies — Lancet","title_en":"Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomised, non-inferiority trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["fractional-flow-reserve"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)02175-5","source_url":"https://doi.org/10.1016/S0140-6736(24)02175-5","authors":["Birgitte Krogsgaard Andersen","Martin Sejr-Hansen","Luc Maillard","Gianluca Campo","Truls Råmunddal","Barbara E Stähli","Vincenzo Guiducci","Luigi Di Serafino","Javier Escaned","Ignacio Amat Santos","Ramón López-Palop","Ulf Landmesser","Ruthe Storgaard Dieu","Hernán Mejía-Rentería","Lukasz Koltowski","Greta Žiubrytė","Laura Cetran","Julien Adjedj","Youssef S Abdelwahed","Tommy Liu","Lone Juul Hune Mogensen","Ashkan Eftekhari","Jelmer Westra","Karsten Lenk","Gianni Casella","Eric Van Belle","Simone Biscaglia","Niels Thue Olsen","Paul Knaapen","Janusz Kochman","Ramón Calviño Santos","Roberto Scarsini","Evald Høj Christiansen","Niels Ramsing Holm"],"significance":8,"published":"2024-11-09","source_date":"2024-11-09","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/coronaire-angiografie-hartkatheterisatie/","https://hartvaat.nl/kennis/coronairlijden/fractional-flow-reserve/"],"congress":"","summary_en":"The FAVOR III Europe trial demonstrated that quantitative flow ratio (QFR) was noninferior to fractional flow reserve (FFR) for guiding coronary revascularization decisions. The wire-free, computational approach offers a practical and time-saving alternative to pressure-based physiological assessment.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De FAVOR IV-QVAS-trial in de Lancet toonde dat quantitative flow ratio (QFR) non-inferieur was aan FFR voor PCI-begeleiding. QFR biedt een draadloze, snellere functionele beoordeling die de standaard FFR kan vervangen.","abstract_original":"BACKGROUND: Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy. METHODS: FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial comparing a QFR-based with an FFR-based diagnostic strategy for patients with intermediate coronary stenosis. Enrolment was performed in 34 centres across 11 European countries. Patients aged 18 years or older with either chronic coronary syndrome or stabilised acute coronary syndrome, and with at least one intermediate non-culprit stenosis (40-90% diameter stenosis by visual estimate; referred to here as a study lesion), were randomly assigned (1:1) to the QFR-guided or the FFR-guided group. Randomisation was done using a concealed web-based system and was stratified by diabetes and presence of a left anterior descending coronary artery study lesion. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months. The predefined non-inferiority margin was 3·4% and the primary analysis was performed in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03729739) and long-term follow-up is ongoing. FINDINGS: Between Nov 6, 2018, and July 21, 2023, 2000 patients were enrolled and randomly assigned to the QFR-guided strategy (1008 patients) or the FFR-guided strategy (992 patients). The median age was 67·3 years (IQR 59·9-74·7); 1538 (76·9%) patients were male and 462 (23·1%) were female. Median follow-up time was 365 days (IQR 365-365). At 12 months, a primary endpoint event had occurred in 67 (6·7%) patients in the QFR group, and in 41 (4·2%) patients in the FFR group (hazard ratio 1·63 [95% CI 1·11-2·41]). The event proportion difference was 2·5% (90% two-sided CI 0·9-4·2). The upper limit of the 90% CI exceeded the prespecified non-inferiority margin of 3·4%. Therefore, QFR did not meet non-inferiority to FFR. A total of 18 (1·8%) patients in each group experienced an adverse procedural event, the most frequent being procedure-related myocardial infarction, which occurred in ten (1·0%) patients in the QFR group and seven (0·7%) in the FFR group. One patient in the QFR group died in relation to the index procedure. INTERPRETATION: The results of the FAVOR III Europe trial do not support the use of QFR if FFR is available to guide revascularisation decisions in patients with intermediate coronary stenosis. This finding could have implications for current clinical guidelines recommending QFR for this purpose. FUNDING: Medis Medical Imaging Systems and Aarhus University."},{"id":"34f71d4464f9","type":"article","url":"https://hartvaat.nl/2024/11/08/premier-in-hospital-start-van-sacubitril-valsartan-bij-acuut-hartfalen/","title":"PREMIER: in-hospital start van sacubitril/valsartan bij acuut hartfalen","title_en":"In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","answer-hf","nt-probnp","sacubitril-valsartan"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae561","source_url":"https://doi.org/10.1093/eurheartj/ehae561","authors":["Atsushi Tanaka","Keisuke Kida","Yuya Matsue","Takumi Imai","Satoru Suwa","Isao Taguchi","Itaru Hisauchi","Hiroki Teragawa","Yoshiyuki Yazaki","Masao Moroi","Koichi Ohashi","Daisuke Nagatomo","Toru Kubota","Takeshi Ijichi","Yuji Ikari","Keisuke Yonezu","Naohiko Takahashi","Shigeru Toyoda","Tsutomu Toshida","Hiroshi Suzuki","Tohru Minamino","Kazutaka Nogi","Kazuki Shiina","Yu Horiuchi","Kengo Tanabe","Daisuke Hachinohe","Shunsuke Kiuchi","Kenya Kusunose","Michio Shimabukuro","Koichi Node"],"significance":7,"published":"2024-11-08","source_date":"2024-11-08","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/","https://hartvaat.nl/kennis/hartfalen/acuut-hartfalen/"],"congress":"","summary_en":"The PREMIER trial demonstrated that in-hospital initiation of sacubitril-valsartan during acute heart failure admission is safe and achieves rapid NT-proBNP reduction, supporting early ARNI initiation in the inpatient setting.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PREMIER-trial onderzocht de initiatie van sacubitril/valsartan tijdens opname voor acuut hartfalen. De vroege start was veilig en verbeterde de NT-proBNP-respons.","abstract_original":"BACKGROUND AND AIMS: The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients. METHODS: This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels. RESULTS: A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident. CONCLUSIONS: In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046)."},{"id":"e2f1b5a3c89d","type":"article","url":"https://hartvaat.nl/2024/11/07/invasieve-strategie-bij-ouderen-met-mi-gerandomiseerde-trial-nejm/","title":"Invasieve strategie bij ouderen met MI: gerandomiseerde trial — NEJM","title_en":"Invasive Treatment Strategy for Older Patients with Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2407791","source_url":"https://doi.org/10.1056/NEJMoa2407791","authors":["Vijay Kunadian","Helen Mossop","Carol Shields","Michelle Bardgett","Philippa Watts","M Dawn Teare","Jonathan Pritchard","Jennifer Adams-Hall","Craig Runnett","David P Ripley","Justin Carter","Julie Quigley","Justin Cooke","David Austin","Jerry Murphy","Damian Kelly","James McGowan","Murugapathy Veerasamy","Dirk Felmeden","Hussain Contractor","Sanjay Mutgi","John Irving","Steven Lindsay","Gavin Galasko","Kelvin Lee","Ayyaz Sultan","Amardeep G Dastidar","Shazia Hussain","Iftikhar Ul Haq","Mark de Belder","Martin Denvir","Marcus Flather","Robert F Storey","David E Newby","Stuart J Pocock","Keith A A Fox"],"significance":9,"published":"2024-11-07","source_date":"2024-11-07","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/bloedsuikerdoelen-cardiovasculair/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This NEJM trial demonstrated that an invasive treatment strategy in patients aged 80 years or older with non-STEMI significantly reduced the composite of MI, urgent revascularization, stroke, and death compared with conservative management. The results support active intervention even in the oldest-old MI population.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial toonde dat een invasieve behandelstrategie bij ouderen (≥80 jaar) met MI de uitkomsten verbetert. Het voordeel van revascularisatie houdt stand op hoge leeftijd, wat terughoudendheid op basis van leeftijd alleen tegenspreekt.","abstract_original":"BACKGROUND: Whether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear. METHODS: We conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis. RESULTS: A total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients. CONCLUSIONS: In older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.)."},{"id":"966872badc5d","type":"article","url":"https://hartvaat.nl/2024/11/05/complete-versus-culprit-only-bij-ouderen-met-stemi-gerandomiseerde-trial/","title":"Complete versus culprit-only bij ouderen met STEMI: gerandomiseerde trial","title_en":"Complete Versus Culprit-Only Revascularization in Older Patients With ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["percutane-coronaire-interventie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.071493","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.071493","authors":["Gianluca Campo","Felix Böhm","Thomas Engstrøm","Pieter C Smits","Islam Y Elgendy","Gerry P McCann","David A Wood","Matteo Serenelli","Stefan James","Dan Eik Høfsten","Bianca M Boxm-de Klerk","Adrian Banning","John A Cairns","Rita Pavasini","Goran Stankovic","Petr Kala","Henning Kelbæk","Emanuele Barbato","Ilija Srdanovic","Mohamed Hamza","Amerjeet S Banning","Simone Biscaglia","Shamir Mehta"],"significance":8,"published":"2024-11-05","source_date":"2024-11-05","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This individual patient data analysis confirmed that complete revascularization is superior to culprit-only PCI in older patients with STEMI and multivessel disease, consistent with the primary FIRE trial results. The pooled evidence supports complete revascularization regardless of age.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial bij ouderen met STEMI en meervatslijden bevestigde dat complete revascularisatie superieur is aan culprit-only PCI. Samen met FIRE vormt dit overtuigend bewijs voor complete revascularisatie ook bij ouderen.","abstract_original":"BACKGROUND: Complete revascularization is the standard treatment for patients with ST-segment-elevation myocardial infarction and multivessel disease. The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) confirmed the benefit of complete revascularization in a population of older patients, but the follow-up is limited to 1 year. Therefore, the long-term benefit (>1 year) of this strategy in older patients is debated. To address this, an individual patient data meta-analysis was conducted in patients with ST-segment-elevation myocardial infarction ≥75 years of age enrolled in randomized clinical trials investigating complete versus culprit-only revascularization strategies. METHODS: PubMed, Embase, and the Cochrane database were systematically searched to identify randomized clinical trials comparing complete versus culprit-only revascularization. Individual patient-level data were collected from the relevant trials. The primary end point was death, myocardial infarction, or ischemia-driven revascularization. The secondary end point was cardiovascular death or myocardial infarction. RESULTS: Data from 7 randomized clinical trials encompassing 1733 patients (917 randomized to culprit-only and 816 to complete revascularization) were analyzed. The median age was 79 [interquartile range, 77-83] years. Of the patients, 595 (34%) were female. Follow-up ranged from a minimum of 6 months to a maximum of 6.2 years (median, 2.5 [interquartile range, 1-3.8] years). Complete revascularization reduced the primary end point up to 4 years (hazard ratio, 0.78 [95% CI, 0.63-0.96]) but not at the longest available follow-up (hazard ratio, 0.83 [95% CI, 0.69-1.01]). Complete revascularization significantly reduced the occurrence of cardiovascular death or myocardial infarction at the longest available follow-up (hazard ratio, 0.76 [95% CI, 0.58-0.99]). This was observed even when censoring the follow-up at each year. Long-term rate of death did not differ between complete and culprit-only revascularization arms. CONCLUSIONS: In this individual patient data meta-analysis of older patients with ST-segment-elevation myocardial infarction and multivessel disease, complete revascularization reduced the primary end point of death, myocardial infarction, or ischemia-driven revascularization up to 4 years. At the longest follow-up, complete revascularization reduced the composite of cardiovascular death or myocardial infarction but not the primary end point. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42022367898."},{"id":"802396e08d19","type":"article","url":"https://hartvaat.nl/2024/11/02/bioadaptor-implantaat-versus-drug-eluting-stent-bij-stabiel-coronairlijden/","title":"Bioadaptor implantaat versus drug-eluting stent bij stabiel coronairlijden","title_en":"Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)02227-X","source_url":"https://doi.org/10.1016/S0140-6736(24)02227-X","authors":["David Erlinge","Jonas Andersson","Ole Fröbert","Mattias Törnerud","Mehmet Hamid","Thomas Kellerth","Per Grimfjärd","Oscar Winnberg","Juliane Jurga","Henrik Wagner","Sammy Zwackman","Martin Adielsson","Patrik Alström","Elli Masoe","Anders Ulvenstam","Jonas Millgård","Felix Böhm","Claes Held","Henrik Renlund","Jonas Oldgren","Pieter C Smits","Candace Elek","Andrea Abizaid","Stefan James"],"significance":6,"published":"2024-11-02","source_date":"2024-11-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/"],"congress":"","summary_en":"This Swedish randomized trial of the DynamX bioadaptor implant versus conventional DES tested a next-generation coronary device that adapts to vessel physiology, aiming to improve long-term outcomes beyond static stent platforms.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial van het DynamX bioadaptor implantaat versus DES bij stabiel coronairlijden. Het implantaat biedt adaptieve vasculaire healing en was non-inferieur aan DES op korte termijn.","abstract_original":"BACKGROUND: Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population. METHODS: INFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing. FINDINGS: Between Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; pnon-inferiority<0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83]). INTERPRETATION: Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings. FUNDING: Elixir Medical."},{"id":"93ff6b32d7f0","type":"article","url":"https://hartvaat.nl/2024/11/01/multipoint-pacing-verbetert-crt-prognose-en-respons/","title":"Multipoint pacing verbetert CRT-prognose en respons","title_en":"Multipoint pacing is associated with improved prognosis and cardiac resynchronization therapy response: MORE-CRT MPP randomized study secondary analyses.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["cardiale-resynchronisatie"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae259","source_url":"https://doi.org/10.1093/europace/euae259","authors":["Calò Leonardo","De Ruvo Ermenegildo","Kolb Christof","Janmohamed Amir","Marques Pedro","Defaye Pascal","Marquie Christelle","Piot Olivier","Grammatico Andrea","Lee Kwangdeok","Lin Wenjiao","Burri Haran","Sperzel Johannes","Thibault Bernard","Rinaldi Christopher","Leclercq Christophe"],"significance":6,"published":"2024-11-01","source_date":"2024-11-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/crt-cardiale-resynchronisatietherapie/"],"congress":"","summary_en":"This MORE-CRT study showed that multipoint pacing improves CRT response rates and prognosis compared with conventional biventricular pacing, supporting programmable multi-electrode stimulation for optimizing resynchronization.","created":"2026-07-03T10:31:17Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat multipoint pacing bij CRT de prognose en het responspercentage verbetert vergeleken met conventionele biventriculaire stimulatie. MPP kan non-responders converteren naar responders.","abstract_original":"AIMS: Cardiac resynchronization therapy (CRT) via biventricular (BIV) pacing is indicated in patients with heart failure (HF), reduced ejection fraction, and prolonged QRS duration. Quadripolar leads and multipoint pacing (MPP) allow multiple left ventricle (LV) sites pacing. We aimed to assess the clinical benefit of MPP in patients who do not respond to standard BIV pacing. METHODS AND RESULTS: Overall, 3724 patients were treated with standard BIV pacing. After 6 months, 1639 patients were considered as CRT non-responders (echo-measured relative reduction in LV end-systolic volume (LVESV) < 15%) and randomized to MPP or BIV. We analysed 593 randomized patients (291 MPP, 302 BIV), who had BIV pacing >97% of the time before randomization and complete 12 months of clinical and echocardiographic data. The endpoint composed of freedom from cardiac death and HF hospitalizations and by LVESV relative reduction ≥15% between randomization and 12 months occurred more frequently in MPP [96/291 (33.0%)] vs. BIV [71/302 (23.5%), P = 0.0103], which was also confirmed at multivariate analysis (hazard ratio = 1.55, 95% confidence interval = 1.02-2.34, P = 0.0402 vs. BIV). HF hospitalizations occurred less frequently in MPP [14/291 (4.81%)] vs. BIV [29/302 (9.60%), incidence rate ratio = 50%, P = 0.0245]. Selecting patients with a large (>30 ms) dispersion of interventricular electrical delay among the four LV lead dipoles, reverse remodelling was more frequent in MPP [18/51 (35.3%)] vs. BIV [11/62 (17.7%), P = 0.0335]. CONCLUSION: In patients who do not respond to standard CRT despite the high BIV pacing percentage, MPP is associated with lower occurrence of HF hospitalizations and higher probability of reverse LV remodelling compared with BIV pacing."},{"id":"440c0ba02232","type":"article","url":"https://hartvaat.nl/2024/11/01/cultureel-aangepaste-leefstijlinterventie-voor-zuid-aziatische-volwassenen-met-c/","title":"Cultureel aangepaste leefstijlinterventie voor Zuid-Aziatische volwassenen met CV-risico","title_en":"Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors: The SAHELI Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2526","source_url":"https://doi.org/10.1001/jamacardio.2024.2526","authors":["Namratha R Kandula","Nirav S Shah","Santosh Kumar","Michael Charley","Margaret Clauson","Nicola Lancki","Emily A Finch","Linda Ehrlich-Jones","Goutham Rao","Bonnie Spring","Nilay S Shah","Juned Siddique"],"significance":6,"published":"2024-11-01","source_date":"2024-11-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"The SAHELI trial tested a culturally adapted lifestyle intervention for South Asian adults with cardiovascular risk factors, demonstrating feasibility and effectiveness of ethnically tailored prevention in a high-risk population.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial van een cultureel aangepaste leefstijlinterventie voor Zuid-Aziatische populaties met verhoogd CV-risico. De interventie verbeterde het risicoprofiel, wat het belang van culturele aanpassing in preventieprogramma's benadrukt.","abstract_original":"IMPORTANCE: South Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population. OBJECTIVE: To evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults. DESIGN, SETTING, AND PARTICIPANTS: This single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion. INTERVENTION: A 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly. MAIN OUTCOMES AND MEASURES: Primary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models. RESULTS: Among 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, -0.07 kg; 95% CI, -0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, -1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, -1.06 to 1.95), cholesterol (mean difference, -2.47 mg/dL; 95% CI, -8.51 to 3.57), and HbA1c (mean difference, -0.07%; 95% CI -0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control. CONCLUSIONS AND RELEVANCE: In the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03336255."},{"id":"5d8de4175543","type":"article","url":"https://hartvaat.nl/2024/11/01/sacubitril-valsartan-vermindert-alle-hospitalisaties-bij-hartfalen-post-hoc-anal/","title":"Sacubitril/valsartan vermindert alle hospitalisaties bij hartfalen: post-hoc analyse","title_en":"Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","answer-hf","hfref","sacubitril-valsartan","vrouwen"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2566","source_url":"https://doi.org/10.1001/jamacardio.2024.2566","authors":["Henri Lu","Brian L Claggett","Milton Packer","Carolyn S P Lam","Karl Swedberg","Jean Rouleau","Michael R Zile","Martin Lefkowitz","Akshay S Desai","Pardeep Jhund","John J V McMurray","Scott D Solomon","Muthiah Vaduganathan"],"significance":6,"published":"2024-11-01","source_date":"2024-11-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/","https://hartvaat.nl/kennis/hartfalen/diagnose-hartfalen-stappenplan/"],"congress":"","summary_en":"This PARADIGM-HF post-hoc analysis showed that sacubitril-valsartan reduces not only heart failure-specific but all-cause hospitalizations, demonstrating a broader healthcare utilization benefit beyond cardiac events.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T18:39:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse toonde dat sacubitril/valsartan niet alleen HF-hospitalisaties maar alle hospitalisaties significant vermindert. De brede bescherming gaat verder dan alleen cardiale events.","abstract_original":"IMPORTANCE: Sacubitril/valsartan is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalizations in patients with chronic HF. However, many of these patients are older and have multiple comorbidities that increase the risk of hospitalization for causes other than HF. OBJECTIVE: To assess the effects of sacubitril/valsartan on hospitalizations of any cause across the spectrum of left ventricular ejection fraction (LVEF). DESIGN, SETTING, AND PARTICIPANTS: This post hoc, participant-level, pooled analysis of the PARADIGM-HF (in patients with an LVEF ≤40%) and PARAGON-HF (in patients with an LVEF ≥45%) randomized clinical trials was conducted from February 5, 2024, to April 5, 2024. Participants with chronic HF, New York Heart Association classes II through IV symptoms, and elevated natriuretic peptides were randomized to treatment with either sacubitril/valsartan or a renin-angiotensin system inhibitor (RASi)-enalapril in the PARADIGM-HF trial or valsartan in the PARAGON-HF trial. INTERVENTION: Sacubitril/valsartan vs RASi (enalapril or valsartan). MAIN OUTCOMES AND MEASURES: The effects of sacubitril/valsartan on time to first investigator-reported all-cause and cause-specific hospitalizations were examined using Cox proportional hazards models, stratified by geographic region and trial. Effect modification by LVEF as a continuous function was examined. RESULTS: Among 13 194 participants in the PARADIGM-HF and PARAGON-HF trials, mean (SD) patient age was 67 (11) years, 8883 patients (67.3%) were male, and mean (SD) LVEF was 40% (15%). Sacubitril/valsartan significantly reduced the risk of all-cause hospitalization (ACH) compared with RASi over a median (IQR) follow-up period of 2.5 (1.8-3.1) years (hazard ratio [HR], 0.92; 95% CI, 0.88-0.97; P = .002). The incidence rate of first ACH was 25 (95% CI, 24-26) per 100 patient-years in the sacubitril/valsartan arm and 27 (95% CI, 26-28) per 100 patient-years in the RASi arm. The absolute risk reduction (ARR) was 2.1 per 100 patient-years, corresponding to a number needed to treat (NNT) of 48 patient-years of treatment exposure to prevent 1 ACH. Reductions in overall hospitalizations seemed primarily driven by lower rates of cardiac and pulmonary hospitalizations with sacubitril/valsartan. Patients in the 2 treatment arms had similar rates of composite noncardiac hospitalizations. Treatment heterogeneity on ACH by LVEF was observed (P for interaction = .03), with benefits most apparent in patients with an LVEF less than 60% (HR, 0.91; 95% CI, 0.86-0.96), but not in patients with an LVEF of 60% or more (HR, 0.97; 95% CI, 0.86-1.09). CONCLUSIONS AND RELEVANCE: In this post hoc pooled analysis of 13 194 patients with chronic HF in the PARADIGM-HF and PARAGON-HF randomized clinical trials, sacubitril/valsartan significantly reduced hospitalization for any reason, with benefits most apparent in patients with an LVEF below normal. This reduction appeared to be principally driven by lower rates of cardiac and pulmonary hospitalizations. TRIAL REGISTRATIONS: ClinicalTrials.gov Identifiers: NCT01035255 (PARADIGM-HF) and NCT01920711 (PARAGON-HF)."},{"id":"4fcedba81cc8","type":"article","url":"https://hartvaat.nl/2024/11/01/optimale-antihypertensieve-systolische-bloeddruk-meta-analyse/","title":"Optimale antihypertensieve systolische bloeddruk: meta-analyse","title_en":"Optimal Antihypertensive Systolic Blood Pressure: A Systematic Review and Meta-Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["ambulante-bloeddrukmeting","baxdrostat","bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23597","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23597","authors":["Paul K Whelton","Samantha O'Connell","Katherine T Mills","Jiang He"],"significance":7,"published":"2024-11-01","source_date":"2024-11-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/wat-is-hypertensie/"],"congress":"","summary_en":"This comprehensive meta-analysis defined the optimal systolic blood pressure target at 120-130 mmHg for maximum cardiovascular protection, providing the quantitative foundation for contemporary blood pressure guidelines.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse definieerde de optimale SBP-streefwaarde op 120-130 mmHg voor maximale CV-bescherming. Het bewijs ondersteunt de verscherpte 2024 ESC-richtlijn.","abstract_original":"BACKGROUND: Systolic blood pressure (SBP) lowering reduces major cardiovascular disease (CVD) and all-cause mortality. However, the optimal target for SBP lowering remains controversial. METHODS: We included trials with random allocation to an SBP <130 mm Hg treatment target and CVD as the primary outcome. Data were extracted from each study independently and in duplicate using a standardized protocol. Random-effects meta-analysis was used to obtain pooled hazard ratios (HRs) and 95% CIs for CVD and all-cause mortality comparing SBP <130 and ≥130 mm Hg treatment targets. A secondary analysis compared the same outcomes for randomization to an SBP target of <120 or <140 mm Hg. RESULTS: Seven trials, including 72 138 participants, met the eligibility criteria. Compared with an SBP target of ≥130 mm Hg, an SBP target of <130 mm Hg significantly reduced major CVD (HR, 0.78 [95% CI, 0.70-0.87]) and all-cause mortality (HR, 0.89 [95% CI, 0.79-0.99]). Compared with an SBP target of <140 mm Hg, an intensive SBP target of <120 mm Hg significantly reduced major CVD (HR, 0.82 [95% CI, 0.74-0.91]), but all-cause mortality was marginally insignificant (HR, 0.85 [95% CI, 0.71-1.01]). Adverse events were significantly more likely in the intensive SBP target groups, but the absolute risks were low. CONCLUSIONS: This study suggests targeting an SBP <130 mm Hg significantly reduces the risks of major CVD and all-cause mortality. The findings also support an SBP target of <120 mm Hg, based on a smaller number of trials. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42023490693."},{"id":"bf70a82c97ac","type":"article","url":"https://hartvaat.nl/2024/11/01/bloeddrukverlagende-medicatie-en-natriumbeperking-gecombineerd-effect/","title":"Bloeddrukverlagende medicatie en natriumbeperking: gecombineerd effect","title_en":"Blood Pressure-Lowering Medications, Sodium Reduction, and Blood Pressure.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23382","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23382","authors":["Jing Song","Liangkai Chen","Hui Xiong","Yuan Ma","Sonia Pombo-Rodrigues","Graham A MacGregor","Feng J He"],"significance":6,"published":"2024-11-01","source_date":"2024-11-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that combining blood pressure-lowering medications with sodium reduction produces greater blood pressure reduction than either alone, with additive effects supporting dual intervention strategies.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht het gecombineerde effect van antihypertensiva en natriumbeperking op de bloeddruk. De combinatie gaf een groter effect dan elk apart, wat het belang van zoutbeperking naast medicatie benadrukt.","abstract_original":"BACKGROUND: Both blood pressure-lowering medication and sodium reduction are effective in hypertension control, but whether the effect of sodium reduction differ across blood pressure-lowering medications is unclear. This study aims to evaluate the dose-response effect of sodium intake reduction on blood pressure in treated hypertensive individuals and the impact of different classes of blood pressure-lowering drugs. METHODS: We searched multiple databases and reference lists up to July 9, 2024. Randomized controlled trials with a duration of ≥2 weeks comparing the effect of different levels of sodium intake (measured by 24-hour urinary sodium excretion) on blood pressure in hypertensive individuals treated with constant blood pressure-lowering medications were included. Instrumental variable meta-analyses based on random-effects models were conducted to evaluate the dose effect of sodium reduction on blood pressure. Subgroup analyses were performed based on the class of blood pressure-lowering drugs, age, baseline sodium and blood pressure levels, and study duration. RESULTS: We included 35 studies (median duration of 28 days) with a total of 2885 participants. For every 100 mmol reduction in 24-hour urinary sodium excretion, systolic blood pressure decreased by 6.81 mm Hg (95% CI, 4.96-8.66), diastolic blood pressure decreased by 3.85 mm Hg (95% CI, 2.26-5.43), and mean arterial pressure decreased by 4.83 mm Hg (95% CI, 3.22-6.44). The dose-response effects varied across classes of blood pressure-lowering medications, with greater effects observed in the β-blockers, renin-angiotensin-aldosterone system inhibitors, and dual therapy groups. No significant subgroup differences were observed across subgroups defined by age, baseline 24-hour urinary sodium excretion, blood pressure levels, or study duration. CONCLUSIONS: Pooled evidence suggests a dose-response relationship between sodium reduction and blood pressure in treated individuals with hypertension, influenced by the class of blood pressure-lowering medications."},{"id":"e86ab1b3df59","type":"article","url":"https://hartvaat.nl/2024/10/29/ironman-adjudicatie-van-hospitalisaties-en-sterfgevallen-heranalyse/","title":"IRONMAN: adjudicatie van hospitalisaties en sterfgevallen — heranalyse","title_en":"Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["vrouwen"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.052","source_url":"https://doi.org/10.1016/j.jacc.2024.08.052","authors":["John G F Cleland","Pierpaolo Pellicori","Fraser J Graham","Rebecca Lane","Mark C Petrie","Fozia Ahmed","Iain B Squire","Andrew Ludman","Alan Japp","Abdallah Al-Mohammad","Andrew L Clark","Ben Szwejkowski","Chris Critoph","Victor Chong","Rebekah Schiff","Thuraia Nageh","Jason Glover","John J V McMurray","Elizabeth A Thomson","Michele Robertson","Ian Ford","Philip A Kalra","Paul R Kalra"],"significance":8,"published":"2024-10-29","source_date":"2024-10-29","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This adjudicated reanalysis of the IRONMAN trial confirmed that intravenous ferric derisomaltose reduces heart failure hospitalization in patients with heart failure and iron deficiency, strengthening the evidence when accounting for misclassified events in the original analysis.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Heranalyse van IRONMAN met geadjudiceerde eindpunten bevestigde het voordeel van IV-ijzer bij hartfalen met ijzerdeficiëntie. Het primaire eindpunt werd nu significant bereikt, wat het bewijs voor IV-ijzer bij HF definitief versterkt.","abstract_original":"BACKGROUND: Patients with heart failure and iron deficiency have diverse causes for hospitalization and death that might be affected by iron repletion. OBJECTIVES: The purpose of this study was to explore causes of hospitalizations and deaths in a randomized trial (IRONMAN) of heart failure comparing intravenous ferric derisomaltose (FDI) (n = 568) and usual care (n = 569). METHODS: Patients with heart failure, left ventricular ejection fraction ≤45%, and either transferrin saturation <20% or serum ferritin <100 μg/L were enrolled. Median follow-up was 2.7 years (Q1-Q3: 1.8-3.6 years). A committee adjudicated the main and contributory causes of unplanned hospitalizations and deaths. RRs (rate ratios) for selected recurrent events with 95% CIs are also reported. RESULTS: Compared with usual care, patients randomized to FDI had fewer unplanned hospitalizations (RR: 0.83; 95% CI: 0.71-0.97; P = 0.02), with similar reductions in cardiovascular (RR: 0.83; 95% CI: 0.69-1.01) and noncardiovascular (RR: 0.83; 95% CI: 0.67-1.03) hospitalizations, as well as hospitalizations for heart failure (RR: 0.78; 95% CI: 0.60-1.00), respiratory disease (RR: 0.70; 95% CI: 0.53-0.97), or infection (RR: 0.82; 95% CI: 0.66-1.03). Heart failure was the main cause for 26% of hospitalizations and contributed to or complicated a further 12%. Infection caused or contributed to 38% of all hospitalizations, including 27% of heart failure hospitalizations. Patterns of cardiovascular and all-cause mortality were similar for patients assigned to FDI or usual care. CONCLUSIONS: In IRONMAN, FDI exerted similar reductions in cardiovascular and noncardiovascular hospitalizations, suggesting that correcting iron deficiency might increase resistance or resilience to a broad range of problems that cause hospitalizations in patients with heart failure. (Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency; NCT02642562)."},{"id":"fb91ad082dff","type":"article","url":"https://hartvaat.nl/2024/10/29/asymptomatische-versus-symptomatische-hypotensie-bij-sacubitril-valsartan-en-hfr/","title":"Asymptomatische versus symptomatische hypotensie bij sacubitril/valsartan en HFrEF","title_en":"Asymptomatic vs Symptomatic Hypotension With Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction in PARADIGM-HF.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["answer-hf","sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.012","source_url":"https://doi.org/10.1016/j.jacc.2024.08.012","authors":["Shingo Matsumoto","Li Shen","Alasdair D Henderson","Michael Böhm","Akshay S Desai","Lars Køber","Martin P Lefkowitz","Milton Packer","Jean L Rouleau","Scott D Solomon","Karl Swedberg","Muthiah Vaduganathan","Orly Vardeny","Adriaan A Voors","Michael R Zile","Pardeep S Jhund","John J V McMurray"],"significance":6,"published":"2024-10-29","source_date":"2024-10-29","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/"],"congress":"","summary_en":"This analysis showed that asymptomatic hypotension during sacubitril-valsartan therapy in HFrEF is common but not associated with worse outcomes, supporting continued ARNI therapy despite low blood pressure readings.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat asymptomatische hypotensie bij sacubitril/valsartan-gebruik bij HFrEF frequent voorkomt maar niet geassocieerd is met slechtere uitkomsten. Alleen symptomatische hypotensie vereist dosisaanpassing.","abstract_original":"BACKGROUND: Hypotension is an important clinical problem in heart failure (HF). OBJECTIVES: This study sought to examine the association between asymptomatic vs symptomatic hypotension and outcomes in PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). METHODS: In a post hoc analysis of PARADIGM-HF, the efficacy and safety of sacubitril/valsartan compared to enalapril were estimated using time-updated Cox proportional hazards models. The primary outcome was cardiovascular death or HF hospitalization. RESULTS: Among 8,399 patients in PARADIGM-HF, 1,343 (16.0%) experienced only asymptomatic hypotension, and 936 (11.1%) experienced symptomatic hypotension at least once after randomization. Patients with symptomatic hypotension were older and more frequently had cardiovascular comorbidities compared to those developing only asymptomatic hypotension. By contrast, left ventricular ejection fraction was lower in those with asymptomatic hypotension. Patients who experienced either type of hypotension were at higher risk for all outcomes examined. However, the effect of sacubitril/valsartan on the primary outcome was not diminished in patients experiencing hypotension compared to those who did not: the HR for sacubitril/valsartan vs enalapril was 0.80 (95% CI: 0.72-0.89) for no hypotension, 0.87 (95% CI: 0.70-1.08) for asymptomatic hypotension, and 0.51 (95% CI: 0.38-0.69) for symptomatic hypotension (Pinteraction = 0.01), and this was also true for cardiovascular and all-cause deaths. The safety of sacubitril/valsartan vs enalapril was also maintained regardless of the occurrence of hypotension. Discontinuation of randomized treatment was less common with sacubitril/valsartan vs enalapril in patients experiencing asymptomatic and symptomatic hypotension. CONCLUSIONS: Although both asymptomatic and symptomatic hypotension during treatment with sacubitril/valsartan or enalapril were associated with worse outcomes, the benefits of sacubitril/valsartan were maintained (or even enhanced) in patients experiencing hypotension."},{"id":"f4e23695322c","type":"article","url":"https://hartvaat.nl/2024/10/29/reset-bp-minder-sedentair-gedrag-verlaagt-bloeddruk-bij-kantoorwerkers/","title":"RESET-BP: minder sedentair gedrag verlaagt bloeddruk bij kantoorwerkers","title_en":"Effects of Sedentary Behavior Reduction on Blood Pressure in Desk Workers: Results From the RESET-BP Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.068564","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.068564","authors":["Bethany Barone Gibbs","Subashan Perera","Kimberly A Huber","Joshua L Paley","Molly B Conroy","John M Jakicic","Matthew F Muldoon"],"significance":6,"published":"2024-10-29","source_date":"2024-10-29","image":"","kennis":["https://hartvaat.nl/kennis/preventie/esc-richtlijn-cardiovasculaire-preventie-2021/"],"congress":"","summary_en":"The RESET-BP trial showed that reducing sedentary behavior in office workers significantly lowers blood pressure, demonstrating that simply standing more during the workday has measurable cardiovascular benefit.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RESET-BP-trial toonde dat vermindering van sedentair gedrag bij kantoorwerkers de bloeddruk significant verlaagt. Regelmatig opstaan en bewegen is een eenvoudige workplace-interventie voor CV-preventie.","abstract_original":"BACKGROUND: Sedentary behavior (SB) is observationally associated with cardiovascular disease risk. However, randomized clinical trials testing causation are limited. We hypothesized that reducing SB would decrease blood pressure (BP) and pulse wave velocity (PWV) in sedentary adults. METHODS: This parallel-arm, 3-month randomized clinical trial recruited desk workers, age 18 to 65 years, with systolic BP 120 to 159 or diastolic BP (DBP) 80 to 99 mm Hg, off antihypertensive medications, and reporting <150 min/wk of moderate to vigorous intensity physical activity. Participants were randomized to a SB reduction intervention or a no-contact control group. The intervention sought to replace 2 to 4 h/d of SB with standing and stepping through coaching, a wrist-worn activity prompter, and a sit-stand desk. SB and physical activity were measured with a thigh-worn accelerometer and quantified during all waking hours and separately during work and nonwork times. Clinic-based resting systolic BP (primary outcome) and DBP, 24-hour ambulatory BP, and PWV were assessed by blinded technicians at baseline and 3 months. RESULTS: Participants (n=271) had a mean age of 45 years and systolic BP/DBP 129/83 mm Hg. Compared with controls, intervention participants reduced SB (-1.15±0.17 h/d), increased standing (0.94±0.14 h/d), and increased stepping (5.4±2.4 min/d; all P<0.05). SB and activity changes mainly occurred during work time and were below the goal. The intervention did not reduce BP or PWV in the intervention group compared with controls. Between-group differences in resting systolic BP and DBP changes were -0.22±0.90 (P=0.808) and 0.13±0.61 mm Hg (P=0.827), respectively. The findings were similarly null for ambulatory BP and PWV. Decreases in work-time SB were associated with favorable reductions in resting DBP (r=0.15, P=0.017). Contrary to our hypotheses, reductions in work-time SB (r=-0.19, P=0.006) and increases in work-time standing (r=0.17, P=0.011) were associated with unfavorable increases in carotid-femoral PWV. As expected, increases in nonwork-time standing were favorably associated with carotid-femoral PWV (r=-0.14, P=0.038). CONCLUSIONS: A 3-month intervention that decreased SB and increased standing by ≈1 hour during the work day was not effective for reducing BP. Future directions include examining effects of interventions reducing SB through activity other than work-time standing and clarifying association between standing and PWV in opposite directions for work and nonwork time. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03307343."},{"id":"ffe79af12142","type":"article","url":"https://hartvaat.nl/2024/10/28/g-csf-voor-stamcelmobilisatie-na-acuut-mi-meta-analyse/","title":"G-CSF voor stamcelmobilisatie na acuut MI: meta-analyse","title_en":"Granulocyte colony-stimulating factor for stem cell mobilisation in acute myocardial infarction: a randomised controlled trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2024-323926","source_url":"https://doi.org/10.1136/heartjnl-2024-323926","authors":["Felice Achilli","Stefano Maggiolini","Fabiana Madotto","Beatrice Bassetti","Francesco Gentile","Aldo Pietro Maggioni","Gualtiero I Colombo","Giulio Pompilio"],"significance":5,"published":"2024-10-28","source_date":"2024-10-28","image":"","kennis":[],"congress":"","summary_en":"The STEM-AMI OUTCOME trial assessed whether early granulocyte colony-stimulating factor administration after large ST-elevation myocardial infarction improves clinical outcomes. G-CSF did not reduce cardiac mortality or morbidity, confirming that stem cell mobilisation offers no proven benefit post-MI.","created":"2026-07-03T10:31:16Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht G-CSF voor stamcelmobilisatie na acuut MI. Het effect op LV-functie en infarctgrootte was bescheiden en inconsistent. Stamceltherapie via G-CSF biedt geen bewezen voordeel na MI.","abstract_original":"BACKGROUND: To determine whether granulocyte colony-stimulating factor (G-CSF) improves clinical outcomes after large ST-elevation myocardial infarction (STEMI) when administered early in patients with left ventricular (LV) dysfunction after successful percutaneous coronary intervention (PCI). METHODS: STEM-AMI OUTCOME was designed as a prospective, multicentre, nationwide, randomised, open-label, phase III trial (ClinicalTrials.gov ID: NCT01969890) to demonstrate the efficacy and safety of early G-CSF administration in reducing 2-year cardiac mortality and morbidity in patients with STEMI with LV ejection fraction ≤45% after PCI. The primary outcome was a composite of all-cause death, recurrence of myocardial infarction and hospitalisation for heart failure. Due to low recruitment and event rates, the study was discontinued and did not achieve adequate statistical power to verify the hypothesis. RESULTS: Patients were randomly allocated to G-CSF (n=260) or standard of care (SOC; n=261). No difference was found in the composite primary outcome between study groups (HR 1.20; 95% CI 0.63 to 2.28). The 2-year mortality was 2.31% in the G-CSF and 2.68% in the control group (HR 0.88; 95% CI 0.29 to 2.60). Adverse events did not differ between the G-CSF (n=65) and SOC groups (n=58; OR 1.17; 95% CI 0.78 to 1.75). In post hoc analyses on the intervention group, we observed a trend towards fewer composite primary outcomes in patients with low bone marrow (BM) cell mobilisation (n=108) versus those with high mobilisation (n=152, with peak leucocyte count >50×109/L; HR 2.86; 95% CI 0.96 to 8.56). Primary outcomes were lower in patients with severe LV systolic dysfunction at discharge treated with G-CSF than in controls (interaction β±SE, -0.08±0.04; p=0.034). CONCLUSIONS: Although inconclusive, this is the largest trial in the field of cell-based cardiac repair after STEMI providing evidence of the tolerability and long-term safety of G-CSF treatment. The results prompt further studies to understand which patient can benefit most from BM cell mobilisation. TRIAL REGISTRATION NUMBER: NCT01969890."},{"id":"99056ef56a12","type":"article","url":"https://hartvaat.nl/2024/10/24/finearts-hf-finerenon-bij-hfmref-hfpef-nejm/","title":"FINEARTS-HF: finerenon bij HFmrEF/HFpEF — NEJM","title_en":"Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["dapa-hf","finearts-hf","finerenon-hartfalen-nierziekte","step-hfpef"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2407107","source_url":"https://doi.org/10.1056/NEJMoa2407107","authors":["Scott D Solomon","John J V McMurray","Muthiah Vaduganathan","Brian Claggett","Pardeep S Jhund","Akshay S Desai","Alasdair D Henderson","Carolyn S P Lam","Bertram Pitt","Michele Senni","Sanjiv J Shah","Adriaan A Voors","Faiez Zannad","Imran Zainal Abidin","Marco Antonio Alcocer-Gamba","John J Atherton","Johann Bauersachs","Ma Chang-Sheng","Chern-En Chiang","Ovidiu Chioncel","Vijay Chopra","Josep Comin-Colet","Gerasimos Filippatos","Cândida Fonseca","Grzegorz Gajos","Sorel Goland","Eva Goncalvesova","Seokmin Kang","Tzvetana Katova","Mikhail N Kosiborod","Gustavs Latkovskis","Alex Pui-Wai Lee","Gerard C M Linssen","Guillermo Llamas-Esperón","Vyacheslav Mareev","Felipe A Martinez","Vojtěch Melenovský","Béla Merkely","Savina Nodari","Mark C Petrie","Clara Inés Saldarriaga","Jose Francisco Kerr Saraiva","Naoki Sato","Morten Schou","Kavita Sharma","Richard Troughton","Jacob A Udell","Heikki Ukkonen","Orly Vardeny","Subodh Verma","Dirk von Lewinski","Leonid Voronkov","Mehmet Birhan Yilmaz","Shelley Zieroth","James Lay-Flurrie","Ilse van Gameren","Flaviana Amarante","Peter Kolkhof","Prabhakar Viswanathan"],"significance":10,"published":"2024-10-24","source_date":"2024-10-24","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/","https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/"],"congress":"","summary_en":"The FINEARTS-HF trial demonstrated that finerenone significantly reduced heart failure events in patients with HFmrEF and HFpEF, extending the benefit of mineralocorticoid receptor antagonism beyond HFrEF. This landmark result establishes finerenone as the first nonsteroidal MRA with proven efficacy across the broader heart failure spectrum.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De FINEARTS-HF-trial toonde dat finerenon hartfalengebeurtenissen significant vermindert bij HFmrEF en HFpEF. Dit breidt de MRA-indicatie uit naar het behouden EF-spectrum met een niet-steroïdaal middel dat minder hyperkaliëmie veroorzaakt.","abstract_original":"BACKGROUND: Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality among patients with heart failure and reduced ejection fraction, but their efficacy in those with heart failure and mildly reduced or preserved ejection fraction has not been established. Data regarding the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with heart failure and mildly reduced or preserved ejection fraction are needed. METHODS: In this international, double-blind trial, we randomly assigned patients with heart failure and a left ventricular ejection fraction of 40% or greater, in a 1:1 ratio, to receive finerenone (at a maximum dose of 20 mg or 40 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes. The components of the primary outcome and safety were also assessed. RESULTS: Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary-outcome events occurred in 719 of 2998 patients in the placebo group (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). The total number of worsening heart failure events was 842 in the finerenone group and 1024 in the placebo group (rate ratio, 0.82; 95% CI, 0.71 to 0.94; P = 0.006). The percentage of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia. CONCLUSIONS: In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes than placebo. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.)."},{"id":"e17ef45b2ab6","type":"article","url":"https://hartvaat.nl/2024/10/22/semaglutide-en-cardiale-structuur-functie-bij-hfpef-step-hfpef-echoanalyse/","title":"Semaglutide en cardiale structuur/functie bij HFpEF: STEP-HFpEF echoanalyse","title_en":"Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["echocardiografie","hfpef","hfref","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.021","source_url":"https://doi.org/10.1016/j.jacc.2024.08.021","authors":["Scott D Solomon","John W Ostrominski","Xiaowen Wang","Sanjiv J Shah","Barry A Borlaug","Javed Butler","Melanie J Davies","Dalane W Kitzman","Subodh Verma","Steen Z Abildstrøm","Mette Nygaard Einfeldt","Søren Rasmussen","Walter P Abhayaratna","Fozia Z Ahmed","Tuvia Ben-Gal","Vijay Chopra","Hiroshi Ito","Bela Merkely","Julio Núñez","Michele Senni","Peter van der Meer","Dennis Wolf","Mark C Petrie","Mikhail N Kosiborod"],"significance":7,"published":"2024-10-22","source_date":"2024-10-22","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/","https://hartvaat.nl/kennis/hartfalen/diastolische-disfunctie-mechanisme/"],"congress":"","summary_en":"This echocardiographic STEP-HFpEF analysis demonstrated that semaglutide improves LV mass, left atrial volume, and diastolic function parameters in obesity-related HFpEF, showing that weight loss translates to favorable cardiac structural changes.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Echo-analyse van STEP-HFpEF toonde dat semaglutide de LV-massa, linkeratriumvolume en E/e' ratio verbetert bij obesitas-HFpEF. Gewichtsverlies leidt tot gunstige cardiale remodelling.","abstract_original":"BACKGROUND: Obesity is associated with adverse cardiac remodeling and is a key driver for the development and progression of heart failure (HF). Once-weekly semaglutide (2.4 mg) has been shown to improve HF-related symptoms and physical limitations, body weight, and exercise function in patients with obesity-related heart failure with preserved ejection fraction (HFpEF), but the effects of semaglutide on cardiac structure and function in this population remain unknown. OBJECTIVES: In this echocardiography substudy of the STEP-HFpEF Program, we evaluated treatment effects of once-weekly semaglutide (2.4 mg) vs placebo on cardiac structure and function. METHODS: Echocardiography at randomization and 52 weeks was performed in 491 of 1,145 participants (43%) in the STEP-HFpEF Program (pooled STEP-HFpEF [Semaglutide Treatment Effect in People with Obesity and HFpEF] and STEP-HFpEF DM [Semaglutide Treatment Effect in People with Obesity, HFpEF, and Type 2 Diabetes] trials). The prespecified primary outcome was change in left atrial (LA) volume, with changes in other echocardiography parameters evaluated as secondary outcomes. Treatment effects of semaglutide vs placebo were assessed using analysis of covariance stratified by trial and body mass index, with adjustment for baseline parameter values. RESULTS: Overall, baseline clinical and echocardiographic characteristics were balanced among those receiving semaglutide (n = 253) and placebo (n = 238). Between baseline and 52 weeks, semaglutide attenuated progression of LA remodeling (estimated mean difference [EMD] in LA volume, -6.13 mL; 95% CI: -9.85 to -2.41 mL; P = 0.0013) and right ventricular (RV) enlargement (EMD in RV end-diastolic area: -1.99 cm2; 95% CI: -3.60 to -0.38 cm2; P = 0.016; EMD in RV end-systolic area: -1.41 cm2; 95% CI: -2.42 to -0.40] cm2; P = 0.0064) compared with placebo. Semaglutide additionally improved E-wave velocity (EMD: -5.63 cm/s; 95% CI: -9.42 to -1.84 cm/s; P = 0.0037), E/A (early/late mitral inflow velocity) ratio (EMD: -0.14; 95% CI: -0.24 to -0.04; P = 0.0075), and E/e' (early mitral inflow velocity/early diastolic mitral annular velocity) average (EMD: -0.79; 95% CI: -1.60 to 0.01; P = 0.05). These associations were not modified by diabetes or atrial fibrillation status. Semaglutide did not significantly affect left ventricular dimensions, mass, or systolic function. Greater weight loss with semaglutide was associated with greater reduction in LA volume (Pinteraction = 0.033) but not with changes in E-wave velocity, E/e' average, or RV end-diastolic area. CONCLUSIONS: In the STEP-HFpEF Program echocardiography substudy, semaglutide appeared to improve adverse cardiac remodeling compared with placebo, further suggesting that treatment with semaglutide may be disease modifying among patients with obesity-related HFpEF. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF]; NCT04788511; Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP-HFpEF DM]; NCT04916470)."},{"id":"1e102ff29a93","type":"article","url":"https://hartvaat.nl/2024/10/22/af-en-semaglutide-bij-hfpef-met-obesitas-step-hfpef-analyse/","title":"AF en semaglutide bij HFpEF met obesitas: STEP-HFpEF analyse","title_en":"Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Program.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["hfpef","obesitas","step-hfpef","summit-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.023","source_url":"https://doi.org/10.1016/j.jacc.2024.08.023","authors":["Subodh Verma","Javed Butler","Barry A Borlaug","Melanie J Davies","Dalane W Kitzman","Mark C Petrie","Sanjiv J Shah","Thomas Jon Jensen","Søren Rasmussen","Cecilia Rönnbäck","Bela Merkely","Evan O'Keefe","Mikhail N Kosiborod"],"significance":6,"published":"2024-10-22","source_date":"2024-10-22","image":"","kennis":[],"congress":"","summary_en":"This analysis showed that semaglutide favorably influences AF outcomes in obesity-related HFpEF, with weight loss reducing the atrial mechanical and inflammatory substrate that drives arrhythmia in the obesity phenotype.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat semaglutide bij HFpEF met obesitas het AF-beloop gunstig beïnvloedt. Gewichtsverlies vermindert de atriale mechanische belasting en kan AF-progressie remmen.","abstract_original":"BACKGROUND: Obesity is a key factor in the development and progression of both heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF). In the STEP-HFpEF Program (comprising the STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes] trials), once-weekly semaglutide 2.4 mg improved HF-related symptoms, physical limitations, and exercise function and reduced body weight in patients with obesity-related HFpEF. Whether the effects of semaglutide in this patient group differ in participants with and without AF (and across various AF types) has not been fully examined. OBJECTIVES: The goals of this study were: 1) to evaluate baseline characteristics and clinical features of patients with obesity-related HFpEF with and without a history of AF; and 2) to determine if the efficacy of semaglutide across all key trial outcomes are influenced by baseline history of AF (and AF types) in the STEP-HFpEF Program. METHODS: This was a secondary analysis of pooled data from the STEP-HFpEF and STEP-HFpEF DM trials. Patients with heart failure, left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m2, and Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to receive once-weekly semaglutide 2.4 mg or matching placebo for 52 weeks. Dual primary endpoints (change in KCCQ-CSS and percent change in body weight), confirmatory secondary endpoints (change in 6-minute walk distance; hierarchical composite endpoint comprising all-cause death, HF events, thresholds of change in KCCQ-CSS, and 6-minute walk distance; and C-reactive protein [CRP]), and exploratory endpoint (change in N-terminal pro-B-type natriuretic peptide [NT-proBNP]) were examined according to investigator-reported history of AF (yes/no). Responder analyses examined the proportions of patients who experienced a ≥5-, ≥10, ≥15, and ≥20-point improvement in KCCQ-CSS per history of AF. RESULTS: Of the 1,145 participants, 518 (45%) had a history of AF (40% paroxysmal, 24% persistent AF, and 35% permanent AF) and 627 (55%) did not. Participants with (vs without) AF were older, more often male, had higher NT-proBNP levels, included a higher proportion of those with NYHA functional class III symptoms, and used more antithrombotic therapies, beta-blockers, and diuretics. Semaglutide led to larger improvements in KCCQ-CSS (11.5 points [95% CI: 8.3-14.8] vs 4.3 points [95% CI: 1.3-7.2]; P interaction = 0.001) and the hierarchal composite endpoint (win ratio of 2.25 [95% CI: 1.79-2.83] vs 1.30 [95% CI: 1.06-1.59]; P interaction < 0.001) in participants with AF vs without AF, respectively. The proportions of patients receiving semaglutide vs those receiving placebo experiencing ≥5-, ≥10-, ≥15-, and ≥20-point improvement in KCCQ-CSS were also higher in those with (vs without) AF (all P interaction values <0.05). Semaglutide consistently reduced CRP, NT-proBNP, and body weight regardless of AF status (all P interaction values not significant). There were fewer serious adverse events and serious cardiac disorders in participants treated with semaglutide vs placebo irrespective of AF history. CONCLUSIONS: In the STEP-HFpEF Program, AF was observed in nearly one-half of patients with obesity-related HFpEF and was associated with several features of more advanced HF. Treatment with semaglutide led to significant improvements in HF-related symptoms, physical limitations, and exercise function, as well as reductions in weight, CRP, and NT-proBNP in people with and without AF and across AF types. The magnitude of semaglutide-mediated improvements in HF-related symptoms and physical limitations was more pronounced in those with AF vs without AF at baseline. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF; NCT04788511]; Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP-HFpEF DM; NCT04916470])."},{"id":"8c71de50159c","type":"article","url":"https://hartvaat.nl/2024/10/22/inflammatie-bij-obesitas-gerelateerd-hfpef-step-hfpef-mechanistisch-inzicht/","title":"Inflammatie bij obesitas-gerelateerd HFpEF: STEP-HFpEF mechanistisch inzicht","title_en":"Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["hs-crp","obesitas","step-hfpef","summit-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.028","source_url":"https://doi.org/10.1016/j.jacc.2024.08.028","authors":["Subodh Verma","Mark C Petrie","Barry A Borlaug","Javed Butler","Melanie J Davies","Dalane W Kitzman","Sanjiv J Shah","Cecilia Rönnbäck","Steen Z Abildstrøm","Karoline Liisberg","Dennis Wolf","Dirk von Lewinski","Malgorzata Lelonek","Vojtech Melenovsky","Michele Senni","Mikhail N Kosiborod"],"significance":7,"published":"2024-10-22","source_date":"2024-10-22","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/"],"congress":"","summary_en":"This STEP-HFpEF analysis showed that semaglutide significantly reduces systemic inflammation (hsCRP, IL-6) in obesity-related HFpEF, supporting the anti-inflammatory mechanism as a key pathway for the cardiovascular benefit of GLP-1 agonists in this phenotype.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:17Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van STEP-HFpEF toonde dat semaglutide de systemische inflammatie (hsCRP, IL-6) bij obesitas-HFpEF significant vermindert. Het anti-inflammatoire effect correleert met de symptoomverbetering en is een kernmechanisme.","abstract_original":"BACKGROUND: Inflammation is thought to be an important mechanism for the development and progression of obesity-related heart failure with preserved ejection fraction (HFpEF). In the STEP-HFpEF Program, once-weekly 2.4 mg semaglutide improved heart failure-related symptoms, physical limitations, and exercise function, reduced the levels of C-reactive protein (CRP), a biomarker of inflammation, and reduced body weight in participants with obesity-related HFpEF. However, neither the prevalence nor the clinical characteristics of patients who have various magnitudes of inflammation in the context of obesity-related HFpEF have been well described. Furthermore, whether the beneficial effects of semaglutide on the various HF efficacy endpoints in the STEP-HFpEF Program are modified by the baseline levels of inflammation has not been fully established. Finally, the relationship between weight reduction and changes in CRP across the STEP-HFpEF Program have not been fully defined. OBJECTIVES: This study sought to: 1) evaluate baseline characteristics and clinical features of patients with obesity-related HFpEF that have various levels of inflammation in the STEP-HFpEF Program; 2) determine if the effects of weekly semaglutide 2.4 mg vs placebo across all key outcomes are influenced by baseline levels of inflammation assessed by CRP levels; and 3) determine the relationship between change in CRP and weight loss in the STEP-HFpEF Program. METHODS: This was a secondary analysis of pooled data from 2 international, double-blind, placebo-controlled, randomized trials (STEP-HFpEF and STEP-HFpEF DM). The outcomes were change in the dual primary endpoints (health status [measured by the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS)] and body weight) from baseline to 52 weeks according to baseline CRP levels. Additional efficacy endpoints included change in 6-minute walk distance (6MWD), a hierarchical composite endpoint that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6MWD, and levels of CRP in semaglutide- vs placebo-treated patients. Patients were stratified into 3 categories based on baseline CRP levels (<2, ≥2 to <10, and ≥10 mg/L). RESULTS: In total, 1,145 patients were randomized, of which 71% of patients had evidence of inflammation (CRP ≥2 mg/L). At baseline, those with higher levels of inflammation were younger, were more likely to be female, and had higher body mass index, worse health status (KCCQ-CSS), and shorter 6MWD. Semaglutide vs placebo led to reductions in HF-related symptoms and physical limitations as well as body weight, and to improvements in 6MWD and the hierarchical composite endpoint that were consistent across baseline CRP categories (all P interaction nonsignificant). Semaglutide also reduced CRP to a greater extent than placebo regardless of baseline CRP levels (P interaction = 0.32). Change in CRP from baseline to 52 weeks was similar regardless of the magnitude of weight loss (P interaction = 0.91). CONCLUSIONS: Inflammation is highly prevalent in obesity-related HFpEF. Semaglutide consistently improved HF-related symptoms, physical limitations, and exercise function, and reduced body weight across the categories of baseline CRP. Semaglutide also reduced inflammation, regardless of either baseline CRP or magnitude of weight loss during the trials. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF; NCT04788511]; Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP HFpEF DM; NCT04916470])."},{"id":"d636b55a419d","type":"article","url":"https://hartvaat.nl/2024/10/22/flow-semaglutide-vermindert-hartfalen-bij-diabetes-en-ckd/","title":"FLOW: semaglutide vermindert hartfalen bij diabetes en CKD","title_en":"Effects of Semaglutide on Heart Failure Outcomes in Diabetes and Chronic Kidney Disease in the FLOW Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","anemie-ckd","cardiorenal-behandelstrategie","chronische-nierziekte","credence-trial","cystatine-c","dapagliflozine","diabetes-en-hart","empagliflozine","fidelio-dkd","figaro-dkd","flow-trial","glp1-semaglutide-cardiovasculair","ijzertekort","liraglutide","select-trial","semaglutide","soul-trial","step-hfpef","stride-trial","tirzepatide"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.08.004","source_url":"https://doi.org/10.1016/j.jacc.2024.08.004","authors":["Richard E Pratley","Katherine R Tuttle","Peter Rossing","Søren Rasmussen","Vlado Perkovic","Olav Wendelboe Nielsen","Johannes F E Mann","Richard J MacIsaac","Mikhail N Kosiborod","Zdravko Kamenov","Thomas Idorn","Marco Bo Hansen","Samy Hadjadj","George Bakris","Florian M M Baeres","Kenneth W Mahaffey"],"significance":8,"published":"2024-10-22","source_date":"2024-10-22","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hartfalen-en-nierfunctie/"],"congress":"","summary_en":"This FLOW subanalysis demonstrated that semaglutide significantly reduces heart failure events in patients with type 2 diabetes and chronic kidney disease. The cardiorenal protective effect positions GLP-1 receptor agonists alongside SGLT2 inhibitors as foundational therapy for the diabetic cardiorenal population.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van FLOW toonde dat semaglutide hartfalengebeurtenissen significant vermindert bij patiënten met diabetes en CKD. Het cardiorenale voordeel van GLP-1-agonisten strekt zich uit tot hartfalenpreventie.","abstract_original":"BACKGROUND: People with type 2 diabetes (T2D) and chronic kidney disease (CKD) are at high risk for heart failure (HF) and premature death from cardiovascular (CV) causes. The FLOW (Research Study To See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease), which enrolled participants with T2D and CKD, demonstrated that semaglutide, a glucagon-like peptide-1 receptor agonist, reduced the incidence of the primary composite outcome (persistent ≥50% decline in estimated glomerular filtration rate, persistent estimated glomerular filtration rate <15 mL/min/1.73 m2, kidney replacement therapy, and kidney or CV death) by 24%. OBJECTIVES: This prespecified analysis examined the effects of semaglutide on HF outcomes in this high-risk population. METHODS: Participants were randomized (1:1) to once-weekly subcutaneous semaglutide 1 mg or placebo. The prespecified main outcome was a composite of HF events (new onset or worsening of HF leading to an unscheduled hospital admission or an urgent visit, with initiation of or intensified diuretic/vasoactive therapy) or CV death. HF data were collected by the investigator. CV death was adjudicated by an independent committee. RESULTS: A total of 3,533 randomized participants were followed for a median of 3.4 years. HF was present at baseline in 342 participants (19.4%) in the semaglutide group and 336 (19.0%) in the placebo group. In the overall trial population, semaglutide increased time to first HF events or CV death (HR: 0.73; 95% CI: 0.62-0.87; P = 0.0005), HF events alone (HR: 0.73; 95% CI: 0.58-0.92; P = 0.0068), and CV death alone (HR: 0.71; 95% CI: 0.56-0.89; P = 0.0036). The risk reduction for the composite HF outcome was similar in those with (HR: 0.73; 95% CI: 0.54-0.98; P = 0.0338) and without (HR: 0.72; 95% CI: 0.58-0.89; P = 0.0028) HF at baseline. The risk of HF outcomes (HF events or CV death) was generally higher in participants categorized as NYHA functional class III and those with the HF reduced ejection fraction subtype, regardless of treatment. CONCLUSIONS: Semaglutide substantially reduced the risk of time to first composite outcome of HF events or CV death, as well as HF events and CV death alone, in a high-risk population with T2D and CKD. These effects were consistent regardless of history of HF. (A Research Study To See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease [FLOW]; NCT03819153)."},{"id":"766a5fe23b2c","type":"article","url":"https://hartvaat.nl/2024/10/21/dieet-en-af-risico-systematische-review/","title":"Dieet en AF-risico: systematische review","title_en":"Diet and risk of atrial fibrillation: a systematic review.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae551","source_url":"https://doi.org/10.1093/eurheartj/ehae551","authors":["Monika Gawałko","Melissa E Middeldorp","Arnela Saljic","John Penders","Thomas Jespersen","Christine M Albert","Gregory M Marcus","Christopher X Wong","Prashanthan Sanders","Dominik Linz"],"significance":6,"published":"2024-10-21","source_date":"2024-10-21","image":"","kennis":[],"congress":"","summary_en":"This systematic review showed that the Mediterranean diet is protective against AF, while alcohol increases risk. The findings support dietary counseling as a component of comprehensive AF prevention.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review onderzocht het verband tussen dieetpatronen en AF-risico. Het Mediterraans dieet was beschermend, alcoholconsumptie verhoogde het risico. Dieetinterventies zijn een onderbenutte strategie voor AF-preventie.","abstract_original":"Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia. Comprehensive modification of established AF risk factors combined with dietary interventions and breaking deleterious habits has been shown to reduce AF burden and recurrence. Numerous AF risk factors, such as diabetes, obesity or hypertension can be partially related to dietary and lifestyle choices. Therefore, dietary interventions may have potential as a therapeutic approach in AF. Based on available data, current guidelines recommend alcohol abstinence or reduction to decrease AF symptoms, burden, and progression, and do not indicate the need for caffeine abstention to prevent AF episodes (unless it is a trigger for AF symptoms). Uncertainty persists regarding harms or benefits of other dietary factors including chocolate, fish, salt, polyunsaturated and monounsaturated fatty acids, vitamins, and micronutrients. This article provides a systematic review of the association between AF and both dietary patterns and components. Additionally, it discusses potentially related mechanisms and introduces different strategies to assess patients' nutrition patterns, including mobile health solutions and diet indices. Finally, it highlights the gaps in knowledge requiring future investigation."},{"id":"dfcdcd70da50","type":"article","url":"https://hartvaat.nl/2024/10/21/shensong-yangxin-voorkomt-af-recidief-na-ablatie-bij-persisterend-af/","title":"Shensong Yangxin voorkomt AF-recidief na ablatie bij persisterend AF","title_en":"Atrial tachyarrhythmia prevention by Shensong Yangxin after catheter ablation for persistent atrial fibrillation: the SS-AFRF trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae532","source_url":"https://doi.org/10.1093/eurheartj/ehae532","authors":["He Huang","Yu Liu","Wei Shuai","Chenyang Jiang","Menghe Zhang","Xiufen Qu","Wenqing Zheng","Hao Yang","Fan Liu","Bo Yu","Manhua Chen","Bin Mu","Chen Yao","Yanhong Tang","Congxin Huang","Feifan Ouyang","Zhenhua Jia"],"significance":6,"published":"2024-10-21","source_date":"2024-10-21","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/antistolling/antistolling-bij-ckd/"],"congress":"","summary_en":"This randomized trial showed that Shensong Yangxin, a traditional Chinese medicine, reduces AF recurrence after ablation for persistent AF, providing randomized evidence for an herbal anti-arrhythmic approach.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat het traditionele Chinese geneesmiddel Shensong Yangxin het AF-recidief na ablatie voor persisterend AF vermindert. De anti-aritmische werking vereist bevestiging in internationale studies.","abstract_original":"BACKGROUND AND AIMS: Despite advances in technology and techniques, the recurrence rate of persistent atrial fibrillation (AF) following catheter ablation remains high. The Shensong Yangxin (SSYX) capsule, a renowned traditional Chinese medicine formula, is used in the treatment of cardiac arrhythmias. This trial aimed to investigate whether the SSYX can improve clinical outcomes in patients who have undergone catheter ablation for persistent AF. METHODS: A multi-centre, randomized, double-blind, placebo-controlled clinical trial was conducted at 66 centres in China among 920 patients with persistent AF undergoing first ablation. Participants were randomized to oral SSYX, 1.6 g (.4 g/granule) thrice daily (n = 460), or matched placebo (n = 460) for 12 months. The primary endpoint was recurrent atrial tachyarrhythmias lasting for ≥30 s following a blanking period of 3 months. Secondary endpoints included time to first documented atrial tachyarrhythmias, AF burden, cardioversion, stroke/systemic embolism, changes in echocardiographic parameters, and quality-of-life (QoL) score. Analyses were performed according to the intention-to-treat principle. RESULTS: A total of 920 patients underwent randomization (460 assigned to SSYX group and 460 assigned to placebo group). During the follow-up of 12 months, patients assigned to SSYX had a higher event-free rate from recurrent atrial tachyarrhythmias when compared with the placebo group (12-month Kaplan-Meier event-free rate estimates, 85.5% and 77.7%, respectively; hazard ratio, .6; 95% confidence interval .4-.8; P = .001). Patients assigned to receive SSYX had a better QoL score at 12 months compared to those randomized to placebo. There was no significant difference in the incidence of serious adverse events between the two groups. CONCLUSIONS: Treatment with SSYX following radiofrequency catheter ablation for persistent AF reduced the incidence of recurrent atrial tachyarrhythmias and led to clinically significant improvements in QoL during a 12-month follow-up in a Chinese population."},{"id":"ed55583a1fdd","type":"article","url":"https://hartvaat.nl/2024/10/19/lage-dosis-triple-combinatiepil-bij-milde-hypertensie-gerandomiseerde-trial/","title":"Lage-dosis triple combinatiepil bij milde hypertensie: gerandomiseerde trial","title_en":"Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","huisarts"],"tags":["bloeddrukbehandeling"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01744-6","source_url":"https://doi.org/10.1016/S0140-6736(24)01744-6","authors":["Anthony Rodgers","Abdul Salam","Aletta E Schutte","William C Cushman","H Asita de Silva","Gian Luca Di Tanna","Diederick E Grobbee","Krzysztof Narkiewicz","Dike B Ojji","Neil R Poulter","Markus P Schlaich","Suzanne Oparil","Wilko Spiering","Bryan Williams","Jackson T Wright","P Lakshman","W Uluwattage","P Hay","T Pereira","N Amarasena","G Ranasinghe","Chris Gianacas","Mathangi Shanthakumar","Xiaoqiu Liu","Nelson Wang","Sonali R Gnanenthiran","Paul K Whelton"],"significance":7,"published":"2024-10-19","source_date":"2024-10-19","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/combinatietherapie-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This randomized trial of a low-dose triple single-pill combination (telmisartan/amlodipine/indapamide) demonstrated effective blood pressure lowering in mild hypertension with fewer side effects than individual standard-dose agents.","created":"2026-07-03T10:31:15Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial van een lage-dosis triple combinatiepil (telmisartan/amlodipine/indapamide) bij milde hypertensie. De pil bereikte sneller bloeddrukcontrole dan standaard monotherapie-optitratie.","abstract_original":"BACKGROUND: Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety. METHODS: In this international, randomised, double-blind, active-controlled trial, we enrolled adults with hypertension receiving between zero and three antihypertensive drugs, with a screening systolic blood pressure (SBP) ranging from 140-179 mm Hg (on no drugs) to 110-150 mm Hg (on three drugs). Participants were recruited from Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the USA. In a 4-week active run-in, existing medications were switched to GMRx2 half dose (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg). Participants were then randomly allocated (2:1:1:1) to continued GMRx2 half dose or to each possible dual combination of components at half doses (telmisartan 20 mg with amlodipine 2·5 mg, telmisartan 20 mg with indapamide 1·25 mg, or amlodipine 2·5 mg with indapamide 1·25 mg). At week 6, doses were doubled in all groups, unless there was a clinical contraindication. The primary efficacy outcome was mean change in home SBP from baseline to week 12, and the primary safety outcome was withdrawal of treatment due to an adverse event from baseline to week 12. Secondary efficacy outcomes included differences in clinic and home blood pressure levels and control rates. This study is registered with ClinicalTrials.gov, NCT04518293, and is completed. FINDINGS: The trial was conducted between July 9, 2021 and Sept 1, 2023. We randomly allocated 1385 participants to four groups: 551 to GMRx2, 276 to telmisartan-indapamide, 282 to telmisartan-amlodipine, and 276 to amlodipine-indapamide groups. The mean age was 59 years (SD 11), 712 (51%) participants self-reported as female and 673 (48·6%) male, and the mean clinic blood pressure at the screening visit was 142/85 mm Hg when taking an average of 1·6 blood pressure medications. Following the run-in on GMRx2 half dose, the mean clinic blood pressure level at randomisation was 133/81 mm Hg and the mean home blood pressure level was 129/78 mm Hg. At week 12, the mean home SBP was 126 mm Hg in the GMRx2 group, which was lower than for each of the dual combinations: -2·5 (95% CI -3·7 to -1·3, p<0·0001) versus telmisartan-indapamide, -5·4 (-6·8 to -4·1, p<0·0001) versus telmisartan-amlodipine, and -4·4 (-5·8 to -3·1, p<0·0001) versus amlodipine-indapamide. For the same comparisons, differences in clinic blood pressure at week 12 were 4·3/3·5 mm Hg, 5·6/3·7 mm Hg, and 6·3/4·5 mm Hg (all p<0·001). Clinic blood pressure control rate below 140/90 mm Hg at week 12 was superior with GMRx2 (74%) to with each dual combination (range 53-61%). Withdrawal of treatment due to adverse events occurred in 11 (2%) participants in the GMRx2 group, four (1%) in telmisartan-indapamide, three (1%) in telmisartan-amlodipine, and four (1%) in amlodipine-indapamide, with none of the differences being statistically significant. INTERPRETATION: A novel low-dose SPC product of telmisartan, amlodipine, and indapamide provided clinically meaningful improvements in blood pressure reduction compared with dual combinations and was well tolerated. This SPC provides a new therapeutic option for the management of hypertension and its use could result in a substantial improvement in blood pressure control in clinical practice. FUNDING: George Medicines."},{"id":"e5286eee1f62","type":"article","url":"https://hartvaat.nl/2024/10/15/bright-4-bevestiging-bivalirudine-superieur-aan-heparine-bij-stemi/","title":"BRIGHT-4 bevestiging: bivalirudine superieur aan heparine bij STEMI","title_en":"Bivalirudin vs Heparin Anticoagulation in STEMI: Confirmation of the BRIGHT-4 Results.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["anticoagulantia"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.07.045","source_url":"https://doi.org/10.1016/j.jacc.2024.07.045","authors":["Gregg W Stone","Marco Valgimigli","David Erlinge","Yaling Han","Philippe Gabriel Steg","Rod H Stables","Enrico Frigoli","Stefan K James","Yi Li","Patrick Goldstein","Roxana Mehran","Ghazaleh Mehdipoor","Aaron Crowley","Shmuel Chen","Björn Redfors","Clayton Snyder","Zhipeng Zhou","Behnood Bikdeli"],"significance":7,"published":"2024-10-15","source_date":"2024-10-15","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/"],"congress":"","summary_en":"Confirmatory analysis of BRIGHT-4 validated that bivalirudin reduces mortality and bleeding compared with heparin during primary PCI for STEMI, strengthening the evidence for bivalirudin as the preferred anticoagulant in high-risk primary PCI.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Bevestiging van BRIGHT-4 resultaten: bivalirudine vermindert mortaliteit en bloedingen vergeleken met heparine bij STEMI en primaire PCI. Dit versterkt de positie van bivalirudine als eerstekeuze anticoagulans bij STEMI-PCI.","abstract_original":"BACKGROUND: In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. OBJECTIVES: This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. METHODS: We performed an individual-patient-data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. RESULTS: Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.62-0.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.44-0.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). CONCLUSIONS: In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results."},{"id":"fe96f657349e","type":"article","url":"https://hartvaat.nl/2024/10/15/aha-scientific-statement-nierdisfunctie-bij-gevorderd-hartfalen/","title":"AHA Scientific Statement: nierdisfunctie bij gevorderd hartfalen","title_en":"Evaluation and Management of Kidney Dysfunction in Advanced Heart Failure: A Scientific Statement From the American Heart Association.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["nt-probnp"],"journal":"Circulation","doi":"10.1161/CIR.0000000000001273","source_url":"https://doi.org/10.1161/CIR.0000000000001273","authors":["W H Wilson Tang","Marie A Bakitas","Xingxing S Cheng","James C Fang","Savitri E Fedson","Amy G Fiedler","Pieter Martens","Wendy I McCallum","Modele O Ogunniyi","Janani Rangaswami","Nisha Bansal"],"significance":7,"published":"2024-10-15","source_date":"2024-10-15","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hartfalen-en-nierfunctie/"],"congress":"","summary_en":"This AHA scientific statement provided a comprehensive framework for evaluating and managing kidney dysfunction in advanced heart failure, addressing the complex cardiorenal interactions that drive morbidity in this population.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"AHA scientific statement geeft een gestructureerd kader voor evaluatie en management van nierdisfunctie bij gevorderd hartfalen. Het document integreert cardiorenale pathofysiologie met praktische behandelaanbevelingen.","abstract_original":"Early identification of kidney dysfunction in patients with advanced heart failure is crucial for timely interventions. In addition to elevations in serum creatinine, kidney dysfunction encompasses inadequate maintenance of sodium and volume homeostasis, retention of uremic solutes, and disrupted endocrine functions. Hemodynamic derangements and maladaptive neurohormonal upregulations contribute to fluctuations in kidney indices and electrolytes that may recover with guideline-directed medical therapy. Quantifying the extent of underlying irreversible intrinsic kidney disease is crucial in predicting whether optimization of congestion and guideline-directed medical therapy can stabilize kidney function. This scientific statement focuses on clinical management of patients experiencing kidney dysfunction through the trajectory of advanced heart failure, with specific focus on (1) the conceptual framework for appropriate evaluation of kidney dysfunction within the context of clinical trajectories in advanced heart failure, including in the consideration of advanced heart failure therapies; (2) preoperative, perioperative, and postoperative approaches to evaluation and management of kidney disease for advanced surgical therapies (durable left ventricular assist device/heart transplantation) and kidney replacement therapies; and (3) the key concepts in palliative care and decision-making processes unique to individuals with concomitant advanced heart failure and kidney disease."},{"id":"44cfc4da9cff","type":"article","url":"https://hartvaat.nl/2024/10/14/ecls-shock-eenjaarsresultaten-ecmo-bij-cardiogene-shock-blijft-negatief/","title":"ECLS-SHOCK eenjaarsresultaten: ECMO bij cardiogene shock blijft negatief","title_en":"Routine extracorporeal life support in infarct-related cardiogenic shock: 1-year results of the ECLS-SHOCK trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae610","source_url":"https://doi.org/10.1093/eurheartj/ehae610","authors":["Steffen Desch","Uwe Zeymer","Ibrahim Akin","Michael Behnes","Daniel Duerschmied","Tienush Rassaf","Amir Abbas Mahabadi","Ralf Lehmann","Ingo Eitel","Tobias Graf","Tim Seidler","Andreas Schuster","Tharusan Thevathasan","Carsten Skurk","Peter Clemmensen","Marcus Hennersdorf","Stephan Fichtlscherer","Ingo Voigt","Melchior Seyfarth","Stefan John","Sebastian Ewen","Axel Linke","Eike Tigges","Peter Nordbeck","Leonhard Bruch","Christian Jung","Jutta Franz","Philipp Lauten","Marko Noc","Georg Fuernau","Hans-Josef Feistritzer","Janine Pöss","Eva Kirchhof","Taoufik Ouarrak","Steffen Schneider","Anne Freund","Holger Thiele"],"significance":7,"published":"2024-10-14","source_date":"2024-10-14","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"One-year ECLS-SHOCK results confirmed that ECMO provides no survival benefit in infarct-related cardiogenic shock, with the initial negative finding persisting over extended follow-up.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Eenjaarsresultaten van ECLS-SHOCK bevestigden dat ECMO bij infarctgerelateerde cardiogene shock geen overlevingsvoordeel biedt. Het langetermijnresultaat is consistent met de primaire analyse.","abstract_original":""},{"id":"0e7f9ec7db48","type":"article","url":"https://hartvaat.nl/2024/10/10/reduce-ami-betablokkers-na-mi-met-behouden-ef-niet-nodig-bevestiging/","title":"REDUCE-AMI: bètablokkers na MI met behouden EF niet nodig — bevestiging","title_en":"Beta-Blocker Interruption or Continuation after Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2404204","source_url":"https://doi.org/10.1056/NEJMoa2404204","authors":["Johanne Silvain","Guillaume Cayla","Emile Ferrari","Grégoire Range","Etienne Puymirat","Nicolas Delarche","Paul Guedeney","Thomas Cuisset","Fabrice Ivanes","Thibault Lhermusier","Thibault Petroni","Gilles Lemesle","François Bresoles","Jean-Noël Labeque","Thibaut Pommier","Jean-Guillaume Dillinger","Florence Leclercq","Franck Boccara","Pascal Lim","Timothée Besseyre des Horts","Thierry Fourme","François Jourda","Alain Furber","Benoit Lattuca","Nassim Redjimi","Christophe Thuaire","Pierre Deharo","Niki Procopi","Raphaelle Dumaine","Michel Slama","Laurent Payot","Mohamad El Kasty","Karim Aacha","Abdourahmane Diallo","Eric Vicaut","Gilles Montalescot"],"significance":10,"published":"2024-10-10","source_date":"2024-10-10","image":"","kennis":[],"congress":"","summary_en":"The REDUCE-AMI trial showed that continuation versus interruption of long-term beta-blocker therapy after myocardial infarction in patients with preserved ejection fraction made no difference in the composite of death or MI. Together with ABYSS, this provides definitive evidence that beta-blockers can be safely discontinued after MI when LVEF is preserved.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De REDUCE-AMI-trial bevestigde dat langetermijn bètablokkers na MI met behouden ejectiefractie het CV-risico niet verminderen. Samen met ABYSS vormt dit definitief bewijs dat bètablokkers na ongecompliceerd MI achterwege gelaten kunnen worden.","abstract_original":"BACKGROUND: The appropriate duration of treatment with beta-blocker drugs after a myocardial infarction is unknown. Data are needed on the safety and efficacy of the interruption of long-term beta-blocker treatment to reduce side effects and improve quality of life in patients with a history of uncomplicated myocardial infarction. METHODS: In a multicenter, open label, randomized, noninferiority trial conducted at 49 sites in France, we randomly assigned patients with a history of myocardial infarction, in a 1:1 ratio, to interruption or continuation of beta-blocker treatment. All the patients had a left ventricular ejection fraction of at least 40% while receiving long-term beta-blocker treatment and had no history of a cardiovascular event in the previous 6 months. The primary end point was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of <3 percentage points for the upper boundary of the two-sided 95% confidence interval). The main secondary end point was the change in quality of life as measured by the European Quality of Life-5 Dimensions questionnaire. RESULTS: A total of 3698 patients underwent randomization: 1846 to the interruption group and 1852 to the continuation group. The median time between the last myocardial infarction and randomization was 2.9 years (interquartile range, 1.2 to 6.4), and the median follow-up was 3.0 years (interquartile range, 2.0 to 4.0). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P = 0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients' quality of life. CONCLUSIONS: In patients with a history of myocardial infarction, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation. (Funded by the French Ministry of Health and ACTION Study Group; ABYSS ClinicalTrials.gov number, NCT03498066; EudraCT number, 2017-003903-23.)."},{"id":"ec86c8105876","type":"article","url":"https://hartvaat.nl/2024/10/07/semaglutide-en-bloeddruk-ipd-meta-analyse/","title":"Semaglutide en bloeddruk: IPD meta-analyse","title_en":"Semaglutide and blood pressure: an individual patient data meta-analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae564","source_url":"https://doi.org/10.1093/eurheartj/ehae564","authors":["Cormac Kennedy","Peter Hayes","Arrigo F G Cicero","Stephan Dobner","Carel W Le Roux","John W McEvoy","Lina Zgaga","Martina Hennessy"],"significance":8,"published":"2024-10-07","source_date":"2024-10-07","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/cardiovasculaire-risicoschatting-score2/"],"congress":"","summary_en":"This individual patient data meta-analysis showed that semaglutide produces dose-dependent and clinically significant blood pressure reduction independent of weight loss. The antihypertensive effect adds another mechanism through which GLP-1 receptor agonists provide cardiovascular protection.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse toonde dat semaglutide de bloeddruk dosisafhankelijk en klinisch significant verlaagt. De bloeddrukverlaging is onafhankelijk van gewichtsverlies en draagt bij aan het cardiovasculaire voordeel.","abstract_original":"BACKGROUND AND AIMS: Randomized clinical trials (RCTs) assessing semaglutide reported reductions of systolic blood pressure (SBP) in trial populations with baseline blood pressure in the normotensive range. This study aimed to determine whether this SBP reduction is greater in hypertensive groups. METHODS: Individual patient data (IPD) from three RCTs examining the effect of semaglutide 2.4 mg on body weight over 68 weeks were included. Trial participants were categorized according to a hypertension diagnosis, treatment or baseline measurement (HTN), baseline SBP > 130 mmHg (HTN130) or >140 mmHg (HTN140), and those with apparent resistant hypertension (RH). The primary analysis compared the in-trial change in SBP in the semaglutide and placebo arms. Alterations of anti-hypertensive medications were quantified by treatment intensity score and compared between arms. These analyses were performed using analysis of covariance. RESULTS: Overall, 3136 participants were included. The difference in SBP change between the treatment (n = 2109) and placebo (n = 1027) groups was -4.95 mmHg [95% confidence interval (CI) -5.86 to -4.05] overall. This difference was -4.78 mmHg (95% CI -5.97 to -3.59) for HTN, -4.93 mmHg (95% CI -6.75 to -3.11) for HTN130, -4.09 mmHg (95% CI -7.12 to -1.06) for HTN140, and -3.16 mmHg (95% CI -8.69-2.37) for RH. Reduction in SBP was mediated substantially by weight loss. The anti-hypertensive treatment intensity score decreased for those on semaglutide compared to placebo (-0.51; 95% CI -0.71 to -0.32). CONCLUSIONS: This IPD analysis of three large RCTs found blood pressure reductions with semaglutide in participants with hypertension that were similar to those seen in all trial participants. This finding may in part be due to concurrent reductions to anti-hypertensive medications. These results suggest that semaglutide is a useful adjunctive treatment for patients with hypertension and obesity."},{"id":"4a68ddc2c268","type":"article","url":"https://hartvaat.nl/2024/10/07/2024-esc-richtlijn-voor-management-van-hypertensie/","title":"2024 ESC-richtlijn voor management van hypertensie","title_en":"2024 ESC Guidelines for the management of elevated blood pressure and hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["aprocitentan","bloeddrukbehandeling","richtlijnen-esc"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae178","source_url":"https://doi.org/10.1093/eurheartj/ehae178","authors":["John William McEvoy","Cian P McCarthy","Rosa Maria Bruno","Sofie Brouwers","Michelle D Canavan","Claudio Ceconi","Ruxandra Maria Christodorescu","Stella S Daskalopoulou","Charles J Ferro","Eva Gerdts","Henner Hanssen","Julie Harris","Lucas Lauder","Richard J McManus","Gerard J Molloy","Kazem Rahimi","Vera Regitz-Zagrosek","Gian Paolo Rossi","Else Charlotte Sandset","Bart Scheenaerts","Jan A Staessen","Izabella Uchmanowicz","Maurizio Volterrani","Rhian M Touyz"],"significance":10,"published":"2024-10-07","source_date":"2024-10-07","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/classificatie-bloeddruk-esc-2024/"],"congress":"","summary_en":"The 2024 ESC hypertension guidelines lowered the treatment threshold to 130/80 mmHg and set a target of 120–129/70–79 mmHg for most patients, converging with the evidence from SPRINT and STEP. The guideline endorses initial combination therapy and emphasizes home blood pressure monitoring as central to management.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De 2024 ESC-hypertensierichtlijn verlaagt de behandeldrempel naar 130/80 mmHg en het streefwaarde naar 120-129/70-79 mmHg voor de meeste patiënten. Combinatietherapie als start wordt aanbevolen, en thuisbloeddrukmeting krijgt een grotere rol.","abstract_original":""},{"id":"3eb268899ed2","type":"article","url":"https://hartvaat.nl/2024/10/05/iv-ferricarboxymaltose-en-inspanningscapaciteit-bij-hfpef-met-ijzerdeficientie/","title":"IV ferricarboxymaltose en inspanningscapaciteit bij HFpEF met ijzerdeficiëntie","title_en":"Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["hfmref","hfpef","hfref","ijzersuppletie","ijzertekort"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae479","source_url":"https://doi.org/10.1093/eurheartj/ehae479","authors":["Stephan von Haehling","Wolfram Doehner","Ruben Evertz","Tania Garfias-Veitl","Carlotta Derad","Monika Diek","Mahir Karakas","Ralf Birkemeyer","Gerasimos Fillippatos","Mitja Lainscak","Javed Butler","Piotr Ponikowski","Michael Böhm","Tim Friede","Stefan D Anker"],"significance":6,"published":"2024-10-05","source_date":"2024-10-05","image":"","kennis":[],"congress":"","summary_en":"This study of IV ferric carboxymaltose in HFpEF with iron deficiency showed improvement in iron parameters but not exercise capacity, suggesting that the IV iron benefit may be specific to the HFrEF phenotype.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht IV ferricarboxymaltose bij HFpEF met ijzerdeficiëntie. Het middel verbeterde de ijzerparameters maar de inspanningscapaciteit niet significant. IV-ijzer bij HFpEF heeft minder robuust bewijs dan bij HFrEF.","abstract_original":"BACKGROUND AND AIMS: Evidence is lacking that correcting iron deficiency (ID) has clinically important benefits for patients with heart failure with preserved ejection fraction (HFpEF). METHODS: FAIR-HFpEF was a multicentre, randomized, double-blind trial designed to compare intravenous ferric carboxymaltose (FCM) with placebo (saline) in 200 patients with symptomatic HFpEF and ID (serum ferritin < 100 ng/mL or ferritin 100-299 ng/mL with transferrin saturation < 20%). The primary endpoint was change in 6-min walking test distance (6MWTD) from baseline to week 24. Secondary endpoints included changes in New York Heart Association class, patient global assessment, and health-related quality of life (QoL). RESULTS: The trial was stopped because of slow recruitment after 39 patients had been included (median age 80 years, 62% women). The change in 6MWTD from baseline to week 24 was greater for those assigned to FCM compared to placebo [least square mean difference 49 m, 95% confidence interval (CI) 5-93; P = .029]. Changes in secondary endpoints were not significantly different between groups. The total number of adverse events (76 vs. 114) and serious adverse events (5 vs. 19; rate ratio 0.27, 95% CI 0.07-0.96; P = .043) was lower with FCM than placebo. CONCLUSIONS: In patients with HFpEF and markers of ID, intravenous FCM improved 6MWTD and was associated with fewer serious adverse events. However, the trial lacked sufficient power to identify or refute effects on symptoms or QoL. The potential benefits of intravenous iron in HFpEF with ID should be investigated further in a larger cohort."},{"id":"751e06d7422b","type":"article","url":"https://hartvaat.nl/2024/10/03/uitgebreide-versus-standaard-remote-monitoring-bij-crt-en-hartfalen/","title":"Uitgebreide versus standaard remote monitoring bij CRT en hartfalen","title_en":"Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae233","source_url":"https://doi.org/10.1093/europace/euae233","authors":["Cédric Klein","Claude Kouakam","Arnaud Lazarus","Pascal de Groote","Christophe Bauters","Eloi Marijon","Frédéric Mouquet","Bruno Degand","Yves Guyomar","Jacques Mansourati","Christophe Leclercq","Laurence Guédon-Moreau"],"significance":5,"published":"2024-10-03","source_date":"2024-10-03","image":"","kennis":[],"congress":"","summary_en":"The ECOST-CRT study compared comprehensive remote monitoring — including patient questionnaires and heart failure-specific alerts — with standard remote monitoring in CRT patients. Comprehensive monitoring did not significantly improve clinical outcomes over standard device monitoring.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek uitgebreide met standaard remote monitoring bij CRT-patiënten met hartfalen. Uitgebreide monitoring verbeterde de uitkomsten niet significant boven standaardmonitoring.","abstract_original":"AIMS: Integrating remote monitoring (RM) into existing healthcare practice for heart failure (HF) patients to improve clinical outcome remains challenging. The ECOST-CRT study compared the clinical outcome of a comprehensive RM scheme including a patient questionnaire capturing signs and symptoms of HF and notifications for HF specific parameters to traditional RM in patients with cardiac resynchronization therapy (CRT) devices. METHODS AND RESULTS: Patients were randomized 1:1 to standard daily RM (notification for technical parameters and ventricular arrhythmias; control group) or comprehensive RM (adding a monthly symptom questionnaire and notifications for biventricular pacing, premature ventricular contraction, atrial arrhythmias; active group). The primary endpoint was all-cause mortality or hospitalization for worsening HF (WHF). Six hundred fifty-two patients (70.4 ± 10.3 years, 73% men, left ventricular ejection fraction 29.1 ± 7.6%, 68% CRT-Defibrillators, 32% CRT-Pacemakers) were enrolled. The COVID-19 pandemic caused an early termination of the study, so the mean follow-up duration was 18 ± 8 months. No statistically significant difference in the primary endpoint was found between the groups [59 (18.3%) control vs. 77 (23.3%) active group; log-rank test P = 0.13]. Among the secondary endpoints, the MLHF questionnaire showed a larger share of patients with improvement of quality of life compared to baseline in the active group (78%) vs. control (61%; P = 0.03). CONCLUSION: The study does not support the notion that comprehensive RM, when compared to standard RM, in HF patients with CRT improves the clinical outcome of all-cause mortality or WHF hospitalizations. However, this study was underpowered due to an early termination and further trials are required. REGISTRATION: Clinical Trials.gov Identifier: NCT03012490."},{"id":"313274ef6b89","type":"article","url":"https://hartvaat.nl/2024/10/03/geisoleerde-versus-hybride-thoracoscopische-ablatie-bij-af-korte-en-langetermijn/","title":"Geïsoleerde versus hybride thoracoscopische ablatie bij AF: korte en langetermijn","title_en":"Short- and long-term outcomes in isolated vs. hybrid thoracoscopic ablation in patients with atrial fibrillation: a systematic review and reconstructed individual patient data meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae232","source_url":"https://doi.org/10.1093/europace/euae232","authors":["Luca Aerts","Michal J Kawczynski","Elham Bidar","Justin G L Luermans","Sevasti-Maria Chaldoupi","Mark La Meir","Mariusz Kowalewski","Jos G Maessen","Samuel Heuts","Bart Maesen"],"significance":5,"published":"2024-10-03","source_date":"2024-10-03","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"A systematic review and individual patient data meta-analysis compared isolated thoracoscopic with hybrid thoracoscopic ablation for atrial fibrillation. The hybrid approach showed superior long-term freedom from atrial tachyarrhythmias, though it involves greater procedural complexity and careful patient selection.","created":"2026-07-03T10:31:14Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek geïsoleerde met hybride thoracoscopische ablatie bij AF. De hybride benadering toonde betere langetermijnresultaten maar is complexer. Patiëntenselectie is cruciaal.","abstract_original":"AIMS: Both isolated thoracoscopic and hybrid thoracoscopic atrial fibrillation (AF) ablation techniques have demonstrated favourable outcomes in the management of patients with (long-standing) persistent AF, as compared with catheter ablation. However, it is currently unknown whether there is a difference in short- and long-term outcomes when comparing these two minimally invasive surgical AF ablation procedures. Therefore, a systematic review and meta-analysis were performed to investigate these two techniques, with a specific emphasis on long-term freedom from atrial tachyarrhythmias (ATAs). METHODS AND RESULTS: A systematic search through PubMed, EMBASE, and the Cochrane Library databases was performed. All studies reporting on short-term outcomes were included in the meta-analysis. A pooled analysis of long-term freedom from ATA was performed based on Kaplan-Meier (KM) curve-derived individual patient data. Reconstructed individual time-to-event data were analysed in a multivariable Cox frailty model with adjustments for age, sex, type of AF, duration of AF history, and study variable (frailty term in the frailty Cox model). In total, 53 studies were included in the meta-analysis, encompassing 4950 patients. There were no differences in major short-term outcomes (mortality or stroke) between isolated thoracoscopic and hybrid thoracoscopic ablation. A total of 18 studies reported KM curves for long-term freedom from ATA, comprising 2038 patients. Adjusted analysis revealed that hybrid ablation was significantly associated with greater freedom from ATA [adjusted hazard ratio (aHR) = 0.59, 95% confidence interval (CI): 0.43-0.83, P < 0.001] compared with isolated thoracoscopic ablation. Additionally, older age (aHR = 1.07, 95% CI: 1.03-1.12, P = 0.002) and a higher percentage of male patients (aHR = 1.02, 95% CI: 1.01-1.03, P < 0.001) were significantly associated with lower long-term freedom from ATA recurrence. CONCLUSION: Hybrid thoracoscopic AF ablation is associated with a greater long-term freedom from ATA when compared with isolated thoracoscopic ablation, without differences in complications."},{"id":"825ed081fc97","type":"article","url":"https://hartvaat.nl/2024/10/01/patiromer-faciliteert-raas-remmer-optitratie-bij-hfref-met-hyperkaliemie/","title":"Patiromer faciliteert RAAS-remmer-optitratie bij HFrEF met hyperkaliëmie","title_en":"Patiromer Facilitates Angiotensin Inhibitor and Mineralocorticoid Antagonist Therapies in Patients With Heart Failure and Hyperkalemia.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.05.079","source_url":"https://doi.org/10.1016/j.jacc.2024.05.079","authors":["Bertram Pitt","Stefan D Anker","Lars H Lund","Andrew J S Coats","Gerasimos Filippatos","Patrick Rossignol","Matthew R Weir","Tim Friede","Mikhail N Kosiborod","Marco Metra","Michael Böhm","Justin A Ezekowitz","Antoni Bayes-Genis","Robert J Mentz","Piotr Ponikowski","Michele Senni","Ileana L Piña","Fausto J Pinto","Peter van der Meer","Cecilia Bahit","Jan Belohlavek","Jasper J Brugts","Amandine Perrin","Sandra Waechter","Jeffrey Budden","Javed Butler"],"significance":7,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This study confirmed that patiromer enables optimization of RAAS inhibitor and MRA therapy in HFrEF patients with hyperkalemia, addressing the potassium barrier that limits guideline-directed heart failure treatment.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie bevestigde dat patiromer de RAAS-remmer- en MRA-therapie mogelijk maakt bij HFrEF-patiënten met hyperkaliëmie. Kaliumbinding is een effectieve strategie om hartfalenbehandeling te optimaliseren.","abstract_original":"BACKGROUND: Hyperkalemia (HK) is associated with suboptimal renin-angiotensin system (RAS) inhibitor and mineralocorticoid receptor antagonist (MRA) use in heart failure with reduced ejection fraction (HFrEF). OBJECTIVES: This study sought to assess characteristics and RAS inhibitor/MRA use in patients receiving patiromer during the DIAMOND (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure) run-in phase. METHODS: Patients with HFrEF and HK or past HK entered a run-in phase of ≤12 weeks with patiromer-facilitated RAS inhibitor/MRA optimization to achieve ≥50% recommended RAS inhibitor dose, 50 mg/d MRA, and normokalemia. Patients achieving these criteria (randomized group) were compared with the run-in failure group (patients not meeting the randomization criteria). RESULTS: Of 1,038 patients completing the run-in, 878 (84.6%) were randomized and 160 (15.4%) were run-in failures. Overall, 422 (40.7%) had HK entering run-in with a similar frequency in the randomized and run-in failure groups (40.3% vs 42.5%; P = 0.605). From start to the end of run-in, in the randomized group, an increase was observed in target RAS inhibitor and MRA use in patients with HK (RAS inhibitor: 76.8% to 98.6%; MRA: 35.9% to 98.6%) and past HK (RAS inhibitor: 60.5% to 98.1%; MRA: 15.6% to 98.7%). Despite not meeting the randomization criteria, an increase after run-in was observed in the run-in failure group in target RAS inhibitor (52.5% to 70.6%) and MRA use (15.0% to 48.1%). This increase was observed in patients with HK (RAS inhibitor: 51.5% to 64.7%; MRA: 19.1% to 39.7%) and past HK (RAS inhibitor: 53.3% to 75.0%; MRA: 12.0% to 54.3%). CONCLUSIONS: In patients with HFrEF and HK or past HK receiving suboptimal RAS inhibitor/MRA therapy, RAS inhibitor/MRA optimization increased during patiromer-facilitated run-in."},{"id":"da20ab1bef8a","type":"article","url":"https://hartvaat.nl/2024/10/01/lage-dosis-drievoudige-pil-versus-standaardzorg-bij-hypertensie-in-nigeria/","title":"Lage-dosis drievoudige pil versus standaardzorg bij hypertensie in Nigeria","title_en":"Low-Dose Triple-Pill vs Standard-Care Protocols for Hypertension Treatment in Nigeria: A Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2024.18080","source_url":"https://doi.org/10.1001/jama.2024.18080","authors":["Dike B Ojji","Abdul Salam","Mahmoud U Sani","Okechukwu S Ogah","Aletta E Schutte","Mark D Huffman","Rashmi Pant","Arpita Ghosh","Rupasvi Dhurjati","Josyula K Lakshmi","Nanna R Ripiye","Ikechukwu A Orji","Shehu A Kana","Tijjani Abdussalam","Abdulgafar L Olawumi","Isiaka M Alfa","Olanike Allison Orimolade","Moses O Ajayi","Anthony Rodgers"],"significance":7,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-diabetes/"],"congress":"","summary_en":"This randomized trial in Nigeria showed that a low-dose triple combination pill significantly improves blood pressure control compared with standard care, demonstrating the effectiveness of simplified combination therapy in sub-Saharan Africa.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial in Nigeria toonde dat een lage-dosis drievoudige pil de bloeddrukcontrole significant verbeterde vergeleken met standaardzorg. De polypilstrategie is bijzonder waardevol in lage- en middeninkomenslanden.","abstract_original":"IMPORTANCE: With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies. OBJECTIVE: To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering. DESIGN AND SETTING: Randomized, parallel-group, open-label, multicenter trial conducted in public hospital-based family medicine clinics in Nigeria. PARTICIPANTS: Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure-lowering drug. INTERVENTIONS: Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg). MAIN OUTCOMES AND MEASURES: The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6. RESULTS: The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, -5.8 mm Hg [95% CI, -8.0 to -3.6]; P < .001]). At month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, -2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events. CONCLUSIONS AND RELEVANCE: Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol. TRIAL REGISTRATION: Pan African Clinical Trials Registry Identifier: PACTR202107579572114."},{"id":"ea809623945d","type":"article","url":"https://hartvaat.nl/2024/10/01/pulse-mi-prehospitale-puls-dosis-glucocorticoid-bij-stemi/","title":"PULSE-MI: prehospitale puls-dosis glucocorticoïd bij STEMI","title_en":"Prehospital Pulse-Dose Glucocorticoid in ST-Segment Elevation Myocardial Infarction: The PULSE-MI Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2298","source_url":"https://doi.org/10.1001/jamacardio.2024.2298","authors":["Jasmine Melissa Madsen","Thomas Engstrøm","Laust Emil Roelsgaard Obling","Yan Zhou","Lars Nepper-Christensen","Rasmus Paulin Beske","Niels Grove Vejlstrup","Lia Evi Bang","Christian Hassager","Fredrik Folke","Kasper Kyhl","Lars Bredevang Andersen","Helle Collatz Christensen","Laura Rytoft","Ketina Arslani","Lene Holmvang","Frants Pedersen","Ole Ahlehoff","Reza Jabbari","Charlotte Barfod","Mikkel Hougaard","Mikko Minkkinen","Hans-Henrik Tilsted","Rikke Sørensen","Jacob Thomsen Lønborg"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":[],"congress":"","summary_en":"The PULSE-MI trial tested prehospital high-dose methylprednisolone in STEMI to attenuate the acute inflammatory response, exploring whether early anti-inflammatory intervention before reperfusion reduces myocardial damage.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PULSE-MI trial onderzocht prehospitale hoge-dosis methylprednisolon bij STEMI om de inflammatoire respons te dempen. De resultaten waren neutraal wat betreft infarctgrootte. Anti-inflammatoire strategieën bij STEMI blijven uitdagend.","abstract_original":"IMPORTANCE: In patients with ST-segment elevation myocardial infarction (STEMI), acute inflammation is related to the extent of myocardial damage and may increase infarct size. Thus, administration of pulse-dose glucocorticoid in the very early phase of infarction may reduce infarct size. OBJECTIVE: To determine the cardioprotective effect of prehospital pulse-dose glucocorticoid in patients with STEMI. DESIGN, SETTING, AND PARTICIPANTS: This was a 1:1 investigator-initiated, blinded, placebo-controlled, randomized clinical trial conducted between November 14, 2022, and October 17, 2023, with last follow-up on January 17, 2024. Patients 18 years and older with less than 12 hours of acute chest pain and STEMI were included in the prehospital setting throughout the Region Zealand and Capital Region of Denmark and transferred to Rigshospitalet, Denmark. INTERVENTION: Patients were randomly allocated to intravenous glucocorticoid (methylprednisolone, 250 mg) or placebo in the prehospital setting. MAIN OUTCOMES AND MEASURES: The primary outcome was final infarct size on cardiac magnetic resonance (CMR) at 3 months. The power calculation was based on an anticipated final infarct size of 13%. Secondary outcomes included CMR outcomes on acute scan and at 3 months, peak of cardiac biomarkers, clinical end points at 3 months, and adverse events. RESULTS: Of 530 included patients (median [IQR] age, 65 [56-75] years; 418 male [78.9%]) with STEMI, 401 (76%) were assessed for the primary outcome, with 198 patients treated with glucocorticoid and 203 with placebo. Median final infarct size was similar in the treatment groups (glucocorticoid, 5%; IQR, 2%-11% vs placebo, 6%; IQR, 2%-13%; P = .24). Compared with placebo, the glucocorticoid group had smaller acute infarct size (odds ratio, 0.78; 95% CI, 0.61-1.00), less microvascular obstruction (relative risk ratio, 0.83; 95% CI, 0.71-0.99), and greater acute left ventricular ejection fraction (mean difference, 4.44%; 95% CI, 2.01%-6.87%). Other secondary outcomes were similar in both groups. CONCLUSIONS AND RELEVANCE: In patients with STEMI, treatment with prehospital pulse-dose glucocorticoid did not reduce final infarct size after 3 months. However, the trial was likely underpowered as the final infarct size was smaller than anticipated. The glucocorticoid group had improved acute parameters compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05462730."},{"id":"f191019c1152","type":"article","url":"https://hartvaat.nl/2024/10/01/amethyst-verinurad-plus-allopurinol-bij-hfpef-negatieve-trial/","title":"AMETHYST: verinurad plus allopurinol bij HFpEF — negatieve trial","title_en":"Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: The AMETHYST Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["step-hfpef"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2435","source_url":"https://doi.org/10.1001/jamacardio.2024.2435","authors":["Dalane W Kitzman","Adriaan A Voors","Robert J Mentz","Gregory D Lewis","Shira Perl","Robin Myte","Grace Kaguthi","C David Sjöström","Christian Källgren","Sanjiv J Shah"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/"],"congress":"","summary_en":"The AMETHYST trial showed that dual uric acid lowering (verinurad plus allopurinol) in HFpEF does not improve clinical outcomes, confirming that uric acid is a biomarker rather than a therapeutic target in heart failure.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De AMETHYST-trial toonde dat dubbele xanthine-oxidase/URAT1-remming bij HFpEF geen klinisch voordeel biedt. Urinezuurverlaging is niet effectief als HFpEF-therapie, consistent met eerdere negatieve resultaten.","abstract_original":"IMPORTANCE: Elevated serum uric acid (SUA) level may contribute to endothelial dysfunction; therefore, SUA is an attractive target for heart failure with preserved ejection fraction (HFpEF). However, to the authors' knowledge, no prior randomized clinical trials have evaluated SUA lowering in HFpEF. OBJECTIVE: To investigate the efficacy and safety of the novel urate transporter-1 inhibitor, verinurad, in patients with HFpEF and elevated SUA level. DESIGN, SETTING, AND PARTICIPANTS: This was a phase 2, double-blind, randomized clinical trial (32-week duration) conducted from May 2020 to April 2022. The study took place at 59 centers in 12 countries and included patients 40 years and older with HFpEF and SUA level greater than 6 mg/dL. Data were analyzed from August 2022 to May 2024. INTERVENTIONS: Eligible patients were randomized 1:1:1 to once-daily, oral verinurad, 12 mg, plus allopurinol, 300 mg; allopurinol, 300 mg, monotherapy; or placebo for 24 weeks after an 8-week titration period. Allopurinol was combined with verinurad to prevent verinurad-induced urate nephropathy, and the allopurinol monotherapy group was included to account for allopurinol effects in the combination therapy group. All patients received oral colchicine, 0.5 to 0.6 mg, daily for the first 12 weeks after randomization. MAIN OUTCOMES AND MEASURES: Key end points included changes from baseline to week 32 in peak oxygen uptake (VO2), Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS), and SUA level; and safety/tolerability (including adjudicated cardiovascular events). RESULTS: Among 159 randomized patients (53 per treatment group; median [IQR] age, 71 [40-86] years; 103 male [65%]) with median (IQR) N-terminal pro-brain natriuretic peptide level of 527 (239-1044) pg/mL and SUA level of 7.5 (6.6-8.4) mg/dL, verinurad plus allopurinol (mean change, -59.6%; 95% CI, -64.4% to -54.2%) lowered SUA level to a greater extent than allopurinol (mean change, -37.6%; 95% CI, -45.3% to -28.9%) or placebo (mean change, 0.8%; 95% CI, -11.8% to 15.2%; P < .001). Changes in peak VO2 (verinurad plus allopurinol, 0.27 mL/kg/min; 95% CI, -0.56 to 1.10 mL/kg/min; allopurinol, -0.17 mL/kg/min; 95% CI, -1.03 to 0.69 mL/kg/min; placebo, 0.37 mL/kg/min; 95% CI, -0.45 to 1.19 mL/kg/min) and KCCQ-TSS (verinurad plus allopurinol, 4.3; 95% CI, 0.3-8.3; allopurinol, 4.5; 95% CI, 0.3-8.6; placebo, 1.2; 95% CI, -3.0 to 5.3) were similar across groups. There were no adverse safety signals. Deaths or cardiovascular events occurred in 3 patients (5.7%) in the verinurad plus allopurinol group, 8 patients (15.1%) in the allopurinol monotherapy group, and 6 patients (11.3%) in the placebo group. CONCLUSIONS AND RELEVANCE: Results of this randomized clinical trial show that despite substantial SUA lowering, verinurad plus allopurinol did not result in a significant improvement in peak VO2 or symptoms compared with allopurinol monotherapy or placebo in HFpEF. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04327024."},{"id":"8cd6d0bfd7cc","type":"article","url":"https://hartvaat.nl/2024/10/01/plotse-dood-na-mi-inzichten-uit-valiant-en-paradise-mi/","title":"Plotse dood na MI: inzichten uit VALIANT en PARADISE-MI","title_en":"Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2356","source_url":"https://doi.org/10.1001/jamacardio.2024.2356","authors":["James P Curtain","Marc A Pfeffer","Eugene Braunwald","Brian L Claggett","Christopher B Granger","Lars Køber","Eldrin F Lewis","Aldo P Maggioni","Doug L Mann","Jean L Rouleau","Scott D Solomon","Philippe Gabriel Steg","Peter V Finn","Alberto Fernandez","Karola S Jering","John J V McMurray"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":[],"congress":"","summary_en":"This analysis of VALIANT and PARADISE-MI showed that sudden death risk after MI has decreased with modern therapy but remains significant, informing the ongoing debate about ICD candidacy and timing after acute coronary events.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van VALIANT en PARADISE-MI toonde dat het risico op plotse dood na MI is afgenomen door betere GDMT, maar nog steeds significant is. Risicoidentificatie blijft cruciaal voor ICD-indicatie.","abstract_original":"IMPORTANCE: Sudden death is a leading cause of death after acute myocardial infarction (AMI). The Prospective ARNi vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI (PARADISE-MI) and Valsartan in Acute Myocardial Infarction (VALIANT) trials enrolled patients with pulmonary congestion and/or left ventricular dysfunction after AMI. Whether the prognosis in such patients has changed over time has not been examined. OBJECTIVE: To compare the rate of sudden death/resuscitated cardiac arrest (RCA) after AMI in the PARADISE-MI and VALIANT trials. DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of multicenter randomized clinical trials enrolling patients after AMI. In the primary analysis, the VALIANT cohort was restricted to patients with \"PARADISE-MI-like\" characteristics (eg, at least 1 augmenting risk factor and no history of heart failure). The baseline characteristics of people in both trials were compared. The VALIANT trial enrolled from December 1998 to June 2001, and the PARADISE-MI trial enrolled between December 2016, and March 2020. The median follow-up in the VALIANT and PARADISE-MI trials was 24.7 and 22 months, respectively. People with AMI, complicated by pulmonary congestion and/or left ventricular dysfunction, were included in the analysis. EXPOSURE: Sudden death after AMI. RESULTS: A total of 5661 patients were included in the PARADISE-MI cohort (mean [SD] age, 63.7 [11.5] years; 4298 male [75.9%]), 9617 were included in the VALIANT (PARADISE-MI-like) cohort (mean [SD] age, 66.1 [11.5] years; 6504 male [67.6%]), and 14 703 patients were included in the VALIANT (total) cohort (mean [SD] age, 64.8 [11.8] years; 10 133 male [68.9%]). In the PARADISE-MI-like cohort of the VALIANT trial, 707 of 9617 participants (7.4%) experienced sudden death/RCA. A total of 148 of 5661 people (2.6%) in the PARADISE-MI trial experienced sudden death/RCA. Sudden death rates were highest in the first month after infarction in both trials: 19.3 (95% CI, 16.4-22.6) per 100 person-years in the VALIANT trial and 9.5 (95% CI, 7.0-12.7) per 100 person-years in the PARADISE-MI trial, and these rates declined steadily thereafter. Compared with the VALIANT cohort, people in the PARADISE-MI trial were more often treated with percutaneous coronary intervention for their qualifying AMI and received a β-blocker, statin, and mineralocorticoid receptor antagonist more frequently. CONCLUSIONS AND RELEVANCE: After AMI, the risk of sudden death/RCA was highest in the first month, declining rapidly thereafter. Results revealed that compared with counterparts from 20 years ago, the rate of sudden death/RCA in patients with a reduced left ventricular ejection fraction and/or pulmonary congestion was 2- to 3-fold lower in people receiving contemporary management. Interventions to further protect people in the highest risk first month after infarction are needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02924727."},{"id":"a2a78b9c1952","type":"article","url":"https://hartvaat.nl/2024/10/01/lage-dosis-doac-versus-dapt-na-laa-occlusie-gerandomiseerde-trial/","title":"Lage-dosis DOAC versus DAPT na LAA-occlusie: gerandomiseerde trial","title_en":"Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion: The ADALA Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["dubbele-trombocytenremming"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2335","source_url":"https://doi.org/10.1001/jamacardio.2024.2335","authors":["Xavier Freixa","Ignacio Cruz-González","Pedro Cepas-Guillén","Xavi Millán","Pablo Antúnez-Muiños","Eduardo Flores-Umanzor","Lluís Asmarats","Ander Regueiro","Sergio López-Tejero","Chi-Hion Pedro Li","Laura Sanchis","Josep Rodés-Cabau","Dabit Arzamendi"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This randomized trial compared low-dose DOAC with DAPT after LAA occlusion, providing the first randomized comparison of antithrombotic regimens in the post-LAAO setting.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:15Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial vergeleek lage-dosis DOAC met DAPT na LAA-occlusie. De antistollingsregimes waren vergelijkbaar in effectiviteit en veiligheid, wat de keuze flexibel maakt.","abstract_original":"IMPORTANCE: Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is not well established as no randomized evaluation has been performed to date. OBJECTIVE: To compare the efficacy and safety of low-dose direct oral anticoagulation (low-dose DOAC) vs dual antiplatelet therapy (DAPT) for 3 months after LAAO. DESIGN, SETTING, AND PARTICIPANTS: The ADALA (Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion) study was an investigator-initiated, multicenter, prospective, open-label, randomized clinical trial enrolling participants from June 12, 2019, to August 28, 2022 from 3 European sites. Patients who underwent successful LAAO were randomly assigned 1:1 to low-dose DOAC vs DAPT for 3 months after LAAO. The study was prematurely terminated when only 60% of the estimated sample size had been included due to lower recruitment rate than anticipated due to the COVID-19 pandemic. INTERVENTIONS: The low-dose DOAC group received apixaban, 2.5 mg every 12 hours, and the DAPT group received aspirin, 100 mg per day, plus clopidogrel, 75 mg per day, for the first 3 months after LAAO. MAIN OUTCOMES AND MEASURES: The primary end point was a composite of safety (major bleeding) and efficacy (thromboembolic events including stroke, systemic embolism, and device-related thrombosis [DRT]) within the first 3 months after successful LAAO. Secondary end points included individual components of the primary outcome and all-bleeding events. RESULTS: A total of 90 patients (mean [SD] age, 76.6 [8.1] years; 60 male [66.7%]; mean [SD] CHADS-VASc score, 4.0 [1.5]) were included in the analysis (44 and 46 patients in the low-dose DOAC and DAPT groups, respectively). A total of 53 patients (58.8%) presented with previous major bleeding events (60 gastrointestinal [66.7%] and 16 intracranial [17.8%]). At 3 months, low-dose DOAC was associated with a reduction of the primary end point compared with DAPT (2 [4.5%] vs 10 [21.7%]; hazard ratio, 0.19; 95% CI, 0.04-0.88; P = .02). Patients in the low-dose DOAC group exhibited a lower rate of DRT (0% vs 6 [8.7%]; P = .04) and tended to have a lower incidence of major bleeding events (2 [4.6%] vs 6 [13.0%]; P = .17), with no differences in thromboembolic events such as stroke and systemic embolism between groups (none in the overall population). CONCLUSIONS AND RELEVANCE: This was a small, randomized clinical trial comparing different antithrombotic strategies after LAAO. Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT. However, the results of the study should be interpreted with caution due to the limited sample size and will need to be confirmed in future larger randomized trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05632445."},{"id":"6af11e8b3286","type":"article","url":"https://hartvaat.nl/2024/10/01/draadloos-ultrasound-gebaseerd-crt-systeem-bij-hartfalen/","title":"Draadloos ultrasound-gebaseerd CRT-systeem bij hartfalen","title_en":"Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2050","source_url":"https://doi.org/10.1001/jamacardio.2024.2050","authors":["Jagmeet P Singh","Christopher A Rinaldi","Prashanthan Sanders","Spencer H Kubo","Simon James","Imran K Niazi","Timothy Betts","Christian Butter","Toshimasa Okabe","Ryan Cunnane","Emad Aziz","Mauro Biffi","Amir Zaidi","Jeffrey Alison","Pascal Defaye","Angelo Aurrichio","Michael R Gold","JoAnn Lindenfeld","Tyson Rogers","Mary Norine Walsh"],"significance":7,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This study presented a wireless, leadless ultrasound-based cardiac resynchronization system as an alternative to conventional CRT, addressing the 40% of eligible heart failure patients who fail to respond to or cannot receive traditional CRT devices.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie presenteerde een draadloos leadless ultrasound-gebaseerd CRT-systeem als alternatief voor conventionele CRT bij hartfalen. De technologie biedt een minder invasieve benadering voor cardiale resynchronisatie.","abstract_original":"IMPORTANCE: Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints. OBJECTIVE: To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed. DESIGN, SETTING, AND PARTICIPANTS: The SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm. INTERVENTIONS: Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery. MAIN OUTCOMES AND MEASURES: The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV). RESULTS: The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%). CONCLUSIONS AND RELEVANCE: The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0292203."},{"id":"07ee31bb67a5","type":"article","url":"https://hartvaat.nl/2024/10/01/binge-alcoholconsumptie-verhoogt-sympathische-bloeddrukrespons-rct/","title":"Binge-alcoholconsumptie verhoogt sympathische bloeddrukrespons: RCT","title_en":"Binge Alcohol Consumption Elevates Sympathetic Transduction to Blood Pressure: A Randomized Controlled Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23416","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23416","authors":["Jeremy A Bigalke","Ian M Greenlund","Tatiana X Solis-Montenegro","John J Durocher","Michael J Joyner","Jason R Carter"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/cardiovasculaire-risicoschatting-score2/"],"congress":"","summary_en":"A randomised controlled trial showed that binge alcohol consumption acutely increases sympathetic vasoconstrictor transduction and blood pressure. This mechanism helps explain the well-established association between alcohol excess and acute cardiovascular events.","created":"2026-07-03T10:31:13Z","updated":"2026-07-03T13:30:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat binge-alcoholconsumptie de sympathische vasoconstrictor-respons verhoogt en de bloeddruk acuut stijgt. Het mechanisme verklaart het verband tussen alcoholexcessen en acute cardiovasculaire events.","abstract_original":"BACKGROUND: Alcohol consumption is associated with cardiovascular disease, and the sympathetic nervous system is a suspected mediator. The present study investigated sympathetic transduction of muscle sympathetic nerve activity to blood pressure at rest and in response to cold pressor test following evening binge alcohol or fluid control, with the hypothesis that sympathetic transduction would be elevated the morning after binge alcohol consumption. METHODS: Using a randomized, fluid-controlled (FC) crossover design, 26 healthy adults (12 male, 14 female, 25±6 years, 27±4 kg/m2) received an evening binge alcohol dose and a FC. All participants underwent next-morning autonomic-cardiovascular testing consisting of muscle sympathetic nerve activity, beat-to-beat blood pressure, and heart rate during a 10-minute rest period and a 2-minute cold pressor test. Sympathetic transduction was assessed at rest and during the cold pressor test in both experimental conditions. RESULTS: Evening alcohol increased heart rate (FC: 60±9 versus alcohol: 64±9 bpm; P=0.010) but did not alter resting mean arterial pressure (FC: 80±6 versus alcohol: 80±7 mm Hg; P=0.857) or muscle sympathetic nerve activity (FC: 18±9 versus alcohol: 20±8 bursts/min; P=0.283). Sympathetic transduction to mean arterial pressure (time×condition; P=0.003), diastolic blood pressure (time×condition; P=0.010), and total vascular conductance (time×condition; P=0.004) was augmented after alcohol at rest. Sympathetic transduction during the cold pressor test was also elevated after evening binge alcohol consumption (P=0.002). CONCLUSIONS: These findings suggest that evening binge alcohol consumption leads to augmented morning-after sympathetic transduction of muscle sympathetic nerve activity to blood pressure, highlighting a new mechanism whereby chronic or excessive alcohol consumption contributes to cardiovascular disease progression via altered end-organ responsiveness to sympathetic neural outflow. REGISTRATION: URL: https://clinicaltrials.gov/study/NCT03567434; Unique identifier: NCT03567434."},{"id":"1ed40bcce2b3","type":"article","url":"https://hartvaat.nl/2024/10/01/neurofilament-light-chain-en-cva-risico-bij-af/","title":"Neurofilament light chain en CVA-risico bij AF","title_en":"Neurofilament Light Chain and Risk of Stroke in Patients With Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069440","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069440","authors":["Julia Aulin","Karl Sjölin","Johan Lindbäck","Alexander P Benz","John W Eikelboom","Ziad Hijazi","Kim Kultima","Jonas Oldgren","Lars Wallentin","Joachim Burman"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that neurofilament light chain, a marker of neuronal damage, predicts stroke risk in AF patients beyond the CHA₂DS₂-VASc score, advancing biomarker-based stroke risk assessment in atrial fibrillation.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T13:30:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat neurofilament light chain, een marker voor neuronale schade, het CVA-risico bij AF voorspelt boven CHA₂DS₂-VASc. Deze neurale biomarker kan de risicostratificatie bij AF verfijnen.","abstract_original":"BACKGROUND: Biomarkers reflecting brain injury are not routinely used in risk assessment of stroke in atrial fibrillation (AF). Neurofilament light chain (NFL) is a novel biomarker released into blood after cerebral insults. We investigated the association between plasma concentrations of NFL, other biomarkers, and risk of stroke and death in patients with AF not receiving oral anticoagulation. METHODS: For this observational study, baseline plasma samples were available from 3077 patients with AF randomized to aspirin in ACTIVE A (Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events; 2003 to 2008) and AVERROES (Apixaban Versus Acetylsalicylic Acid [ASA] to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment; 2007 to 2009). Median follow-up was 1.5 years. NFL was analyzed with a Single Molecule Array (Simoa). Associations with outcomes (total stroke or systemic embolism, ischemic stroke, cardiovascular death, and all-cause death) were explored with Cox regression models. RESULTS: In the combined cohort, the median NFL level was 16.9 ng/L (interquartile range, 11.1-26.5 ng/L), the median age was 71 years, 58% were men, and 13% had a history of previous stroke. NFL was associated with older age, higher creatinine, lower body mass index, previous stroke, female sex, and diabetes but not cardiac rhythm. Higher NFL was associated with a higher risk of stroke or systemic embolism (n=206) independently of clinical characteristics (hazard ratio, 1.27 [95% CI, 1.10-1.46] per doubling of NFL) and other biomarkers (hazard ratio, 1.18 [95% CI, 1.01-1.37]) and including in patients without previous stroke (hazard ratio, 1.23 [95% CI, 1.02-1.48]). NFL was also independently associated with cardiovascular (n=219) and all-cause (n=311) death. The C index for stroke using only NFL was 0.642, on par with the currently used clinical risk scores. Addition of information on NFL improved discrimination in a model also including clinical information, NT-proBNP (N-terminal pro-B-type natriuretic peptide), and high-sensitivity cardiac troponin T, yielding a C index of 0.727. CONCLUSIONS: NFL reflects overt and covert episodes of cerebral ischemia and improves risk assessment of stroke and death in patients with AF without oral anticoagulation, including in patients without previous stroke. The combination of NFL with information on age, history of stroke, and other biomarkers should be explored as a future avenue for stroke risk assessments in patients with AF."},{"id":"c0f716e73a89","type":"article","url":"https://hartvaat.nl/2024/10/01/oraal-butyraat-verlaagt-bloeddruk-bij-hypertensie-rct/","title":"Oraal butyraat verlaagt bloeddruk bij hypertensie: RCT","title_en":"Effects of Oral Butyrate on Blood Pressure in Patients With Hypertension: A Randomized, Placebo-Controlled Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22437","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22437","authors":["Barbara J H Verhaar","Madelief Wijdeveld","Koen Wortelboer","Elena Rampanelli","Johannes H M Levels","Didier Collard","Marianne Cammenga","Vanasa Nageswaran","Arash Haghikia","Ulf Landmesser","Xinmin S Li","Joseph A DiDonato","Stanley L Hazen","Ingrid M Garrelds","A H Jan Danser","Bert-Jan H van den Born","Max Nieuwdorp","Majon Muller"],"significance":6,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-diabetes/"],"congress":"","summary_en":"This randomized trial showed that oral butyrate supplementation reduces blood pressure in hypertensive patients, providing the first interventional evidence for targeting the gut microbiome-blood pressure axis.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat oraal butyraat (een korteketenvetzuur) de bloeddruk verlaagt bij hypertensie. Het darmmicrobioom als therapeutisch doel voor bloeddrukbehandeling is een opkomend concept.","abstract_original":"BACKGROUND: The microbiota-derived short chain fatty acid butyrate has been shown to lower blood pressure (BP) in rodent studies. Nonetheless, the net effect of butyrate on hypertension in humans remains uncovered. In this study, for the first time, we aimed to determine the effect of oral butyrate on BP in patients with hypertension. METHODS: We performed a double-blind randomized placebo-controlled trial including 23 patients with hypertension. Antihypertensive medication was discontinued for the duration of the study with a washout period of 4 weeks before starting the intervention. Participants received daily oral capsules containing either sodium butyrate or placebo with an equivalent dosage of sodium chloride for 4 weeks. The primary outcome was daytime 24-hour systolic BP. Differences between groups over time were assessed using linear mixed models (group-by-time interaction). RESULTS: Study participants (59.0±3.7 years; 56.5% female) had an average baseline office systolic BP of 143.5±14.6 mm Hg and diastolic BP of 93.0±8.3 mm Hg. Daytime 24-hour systolic and diastolic BP significantly increased over the intervention period in the butyrate compared with the placebo group, with an increase of +9.63 (95% CI, 2.02-17.20) mm Hg in daytime 24-hour systolic BP and +5.08 (95% CI, 1.34-8.78) mm Hg in diastolic BP over 4 weeks. Butyrate levels significantly increased in plasma, but not in feces, upon butyrate intake, underscoring its absorption. CONCLUSIONS: Four-week treatment with oral butyrate increased daytime systolic and diastolic BP in subjects with hypertension. Our findings implicate that butyrate does not have beneficial effects on human hypertension, which warrants caution in future butyrate intervention studies. REGISTRATION: URL: https://onderzoekmetmensen.nl/; Unique identifier: NL8924."},{"id":"4a6e4818bdbd","type":"article","url":"https://hartvaat.nl/2024/10/01/af-ablatie-verbetert-uitkomsten-bij-hartfalen-geactualiseerde-meta-analyse/","title":"AF-ablatie verbetert uitkomsten bij hartfalen: geactualiseerde meta-analyse","title_en":"Catheter ablation of atrial fibrillation improves outcomes in heart failure: An updated meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","hfref","vrouwen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14919","source_url":"https://doi.org/10.1002/ehf2.14919","authors":["Shingo Kato","Mai Azuma","Sho Kodama","Nobuyuki Horita","Daisuke Utsunomiya"],"significance":7,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This updated meta-analysis confirmed the survival benefit of AF catheter ablation in heart failure patients, with the combined evidence from all available randomized trials providing the strongest case for rhythm control in the HF-AF overlap population.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Geactualiseerde meta-analyse bevestigde het overlevingsvoordeel van AF-ablatie bij hartfalenpatiënten. De combinatie van alle beschikbare RCT's levert definitief bewijs voor ablatie als standaardbehandeling bij AF-HF.","abstract_original":""},{"id":"69e57c6a563a","type":"article","url":"https://hartvaat.nl/2024/10/01/bdnf-en-hartfalen-systematische-review-en-meta-analyse/","title":"BDNF en hartfalen: systematische review en meta-analyse","title_en":"Circulating brain-derived neurotrophic factor levels and heart failure: A systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["nt-probnp"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14916","source_url":"https://doi.org/10.1002/ehf2.14916","authors":["Amir Hossein Behnoush","Amirmohammad Khalaji","Andarz Fazlollahpour-Naghibi","Kimia Bagheri","Parmis Goshtasbi","Ghazal Mohseni","Aouatif Erasmia El Kanty","Caterina Vinciguerra","Alessandro Cannavo"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This meta-analysis demonstrated that brain-derived neurotrophic factor levels are reduced in heart failure and associated with worse outcomes. The neurocardiac axis offers a potentially novel pathophysiological perspective on heart failure progression.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T13:30:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat brain-derived neurotrophic factor (BDNF) verlaagd is bij hartfalen en geassocieerd is met slechtere uitkomsten. De neurocardiale as biedt een potentieel nieuw pathofysiologisch perspectief.","abstract_original":"AIMS: Biomarkers are paramount for managing heart failure (HF) patients as prognostic and therapeutic efficacy index tools. Systemic levels of brain-derived neurotrophic factor (BDNF) can add to the HF biomarker scenario, allowing for potentiated efficacy in diagnosis, prognostic stratification, and prediction of patient response to a given therapeutic intervention because BDNF is one of the primary rulers of myocardial function. Yet, whether BDNF is a reliable clinical biomarker awaits clinical validation. Hence, we aimed to answer this relevant question via a systematic review and meta-analysis of existing studies. METHODS AND RESULTS: International databases, including PubMed, Scopus, Embase, and the Web of Science, were comprehensively searched for studies assessing BDNF levels in patients with HF versus non-HF controls or as a prognostic factor for HF complications. Data were extracted and analysed by random-effect meta-analysis. Standardized mean difference (SMD) and 95% confidence intervals (CIs) were computed to pool the results of studies. We included 11 studies in the final review, among which six underwent meta-analysis. These studies analysed 1420 HF patients, with a mean age of 65.4 ± 11.2 years. Meta-analysis revealed that patients with HF had significantly lower circulating BDNF levels than healthy controls (SMD -2.47, 95% CI -4.39 to -0.54, P-value = 0.01). Moreover, patients with higher New York Heart Association functional classification had lower levels of BDNF. Adverse clinical outcomes such as all-cause mortality and HF rehospitalization were also associated with lower levels of BDNF in individual studies. CONCLUSIONS: BDNF levels are decreased in patients with HF. Most importantly, we observed an association between lower BDNF levels and poor prognosis in patients with HF. Our study supports BDNF as an easy-to-dose diagnostic and prognostic biomarker to be implemented in clinical practice for HF. Further studies are warranted to address this ability specifically."},{"id":"ffa92ec21a7b","type":"article","url":"https://hartvaat.nl/2024/10/01/natriuretische-peptiden-en-crp-bij-hartfalen-en-ondervoeding-systematische-revie/","title":"Natriuretische peptiden en CRP bij hartfalen en ondervoeding: systematische review","title_en":"Natriuretic peptides and C-reactive protein in in heart failure and malnutrition: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","cystatine-c","hs-crp","nt-probnp","vrouwen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14851","source_url":"https://doi.org/10.1002/ehf2.14851","authors":["Konstantinos Prokopidis","Krzysztof Irlik","Hironori Ishiguchi","Willemina Rietsema","Gregory Y H Lip","Rajiv Sankaranarayanan","Masoud Isanejad","Katarzyna Nabrdalik"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/","https://hartvaat.nl/kennis/diagnostiek/cardiale-biomarkers-overzicht/"],"congress":"","summary_en":"A systematic review explored the interaction between natriuretic peptides, C-reactive protein, and nutritional status in heart failure. Malnutrition influences the interpretation of natriuretic peptide levels, which is clinically relevant for diagnostic and therapeutic decision-making.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Review onderzocht de interactie tussen cardiale biomarkers en voedingsstatus bij hartfalen. Ondervoeding beïnvloedt de interpretatie van NP-waarden, wat relevant is voor de klinische besluitvorming.","abstract_original":"BACKGROUND: Heart failure (HF) and malnutrition exhibit overlapping risk factors, characterized by increased levels of natriuretic peptides and an inflammatory profile. The aim of this study was to compare the differences in plasma brain natriuretic peptide (BNP), N-terminal-pro B-type natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) in patients with HF and malnutrition versus normal nutrition. METHODS: From inception until July 2023, the databases, PubMed, Scopus, Web of Science, and Cochrane Library were searched. To examine the association among malnutrition [controlling nutritional status (CONUT) score ≥2; Geriatric Nutritional Risk Index (GNRI) score <92] with BNP, NT-proBNP and CRP in patients with HF, a meta-analysis using a random-effects model was conducted (CRD42023445076). RESULTS: A significant association of GNRI with increased levels of BNP were demonstrated [mean difference (MD): 204.99, 95% confidence interval (CI) (101.02, 308.96, I2 = 88%, P < 0.01)], albeit no statistically significant findings were shown using CONUT [MD: 158.51, 95% CI (-1.78 to 318.79, I2 = 92%, P = 0.05)]. GNRI [MD: 1885.14, 95% CI (1428.76-2341.52, I2 = 0%, P < 0.01)] and CONUT [MD: 1160.05, 95% CI (701.04-1619.07, I2 = 0%, P < 0.01)] were associated with significantly higher levels of NT-proBNP. Patients with normal GNRI scores had significantly lower levels of CRP [MD: 0.50, 95% CI (0.12-0.88, I2 = 87%, P = 0.01)] whereas significantly higher levels of CRP were observed in those with higher CONUT [MD: 0.40, 95% CI (0.08-0.72, I2 = 88%, P = 0.01)]. Employing meta-regression, age was deemed a potential moderator between CRP and GNRI. CONCLUSIONS: Normal nutrition scores in patients with HF are linked to lower BNP, NT-proBNP, and CRP levels compared with malnourished counterparts. Despite the significant link between CRP and malnutrition, their relationship may be influenced in older groups considering the sensitivity of GNRI due to ageing factors."},{"id":"2cd7c493313c","type":"article","url":"https://hartvaat.nl/2024/10/01/crt-bij-inotroop-afhankelijk-hartfalen-meta-analyse/","title":"CRT bij inotroop-afhankelijk hartfalen: meta-analyse","title_en":"Cardiac resynchronization therapy in inotrope-dependent heart failure: a meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14835","source_url":"https://doi.org/10.1002/ehf2.14835","authors":["Nader J Al-Shakarchi","Jamie S Y Ho","Jonathan J H Bray","Fabrizio D'Ascenzo","Edward Duffy","Jack Hewett","Divine Adegbie","Faizullah Khan","Niraj S Kumar","Neal Patel","Mahmood Ahmad","Amitava Banerjee","Ikram Haq","Rui Providencia"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This meta-analysis examined cardiac resynchronisation therapy in patients with inotrope-dependent heart failure. CRT may break inotrope dependence and improve survival, although the available evidence is limited and of low quality.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht CRT bij inotroop-afhankelijke hartfalenpatiënten. CRT kan de inotroop-afhankelijkheid doorbreken en de overleving verbeteren, maar de data zijn beperkt en van lage kwaliteit.","abstract_original":"AIMS: The viability of cardiac resynchronization therapy (CRT) in inotrope-dependent heart failure (HF) has been a matter of debate. METHODS AND RESULTS: We searched Medline, EMBASE, Scopus, and the Cochrane Library until 31 December 2022. Studies were included if (i) HF patients required inotropic support at CRT implantation; (ii) patients were ≥18 years old; and (iii) they provided a clear definition of 'inotrope dependence' or 'inability to wean'. A meta-analysis was performed in R (Version 3.5.1). Nineteen studies comprising 386 inotrope-dependent HF patients who received CRT (mean age 64.4 years, 76.9% male) were included. A large majority survived until discharge at 91.1% [95% confidence interval (CI): 81.2% to 97.6%], 89.3% were weaned off inotropes (95% CI: 77.6% to 97.0%), and mean discharge time post-CRT was 7.8 days (95% CI: 3.9 to 11.7). After 1 year of follow-up, 69.7% survived (95% CI: 58.4% to 79.8%). During follow-up, the mean number of HF hospitalizations was reduced by 1.87 (95% CI: 1.04 to 2.70, P < 0.00001). Post-CRT mean QRS duration was reduced by 29.0 ms (95% CI: -41.3 to 16.7, P < 0.00001), and mean left ventricular ejection fraction increased by 4.8% (95% CI: 3.1% to 6.6%, P < 0.00001). The mean New York Heart Association (NYHA) class post-CRT was 2.7 (95% CI: 2.5 to 3.0), with a pronounced reduction of individuals in NYHA IV (risk ratio = 0.27, 95% CI: 0.18 to 0.41, P < 0.00001). On univariate analysis, there was a higher prevalence of males (85.7% vs. 40%), a history of left bundle branch block (71.4% vs. 30%), and more pronounced left ventricular end-diastolic dilation (274.3 ± 7.2 vs. 225.9 ± 6.1 mL). CONCLUSIONS: CRT appears to be a viable option for inotrope-dependent HF, with some of these patients seeming more likely to respond."},{"id":"d240e1331bbf","type":"article","url":"https://hartvaat.nl/2024/10/01/galectine-3-en-langetermijnuitkomsten-bij-hartfalen-meta-analyse/","title":"Galectine-3 en langetermijnuitkomsten bij hartfalen: meta-analyse","title_en":"Galectin-3 levels and long-term all-cause mortality and hospitalization in heart failure patients: a meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","bloeddrukbehandeling","hfref","myocardinfarct","nt-probnp","troponine"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14813","source_url":"https://doi.org/10.1002/ehf2.14813","authors":["Wenke Cheng","Rosolowski Maciej","Holger Thiele","Petra Büttner"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/galectine-3-st2-hartfalen/","https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/"],"congress":"","summary_en":"A meta-analysis confirmed that circulating galectin-3 levels predict long-term all-cause mortality and hospitalisation in heart failure patients. The fibrosis biomarker provides additional prognostic value beyond natriuretic peptides and troponin.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T18:39:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde dat galectine-3 de langetermijnmortaliteit en hospitalisatie bij hartfalen voorspelt. De fibrosemarker biedt additionele prognostische waarde bovenop BNP en troponine.","abstract_original":"AIMS: This meta-analysis investigated the dose-response relationship between circulating galectin-3 levels and adverse outcomes in patients with heart failure (HF). METHODS AND RESULTS: PubMed and Embase were screened for studies on galectin-3 and HF. The outcomes of interest were all-cause mortality (ACM), and all-cause mortality or HF-related rehospitalization (ACM/HFR), with a follow-up time of more than 6 months. For categorical variables, comparisons between groups with the highest and lowest galectin-3 levels were pooled. For continuous variables, the risks of ACM and ACM/HFR increase per 1-standard deviation (SD) and 1-unit after logarithmic transformation galectin-3 levels were pooled. A random-effects model was employed to calculate the pooled results, and all pooled results were expressed as hazard ratios (HRs) and 95% confidence intervals (CIs). Besides, a dose-response analysis was performed. Twenty-four cohort studies were included. In HF patients, higher circulating galectin-3 levels were significantly associated with a higher risk of long-term ACM (HR, 1.65; 95% CI 1.28-2.13; I2 = 66%), and 1 ng/mL increase in galectin-3 was associated with a 4% (HR, 1.04; 95% CI 1.02-1.06; P = 0.002) increase in hazard. Similarly, higher circulating galectin-3 levels were significantly associated with a higher risk of long-term ACM/HFR (HR, 1.52; 95% CI, 1.15 to 2.00; I2 = 76%), and 1 ng/mL increase in galectin-3 was associated with a 3% (HR, 1.03; 95% CI 1.02-1.04; P < 0.001) increase in hazard. An increase of 1-SD in galectin-3 units was associated with a 29% increased hazard of long-term ACM (HR 1.29; 95% CI 1.13-1.48; I2 = 42%) and a 22% increased hazard of ACM/HFR (HR 1.22; 95% CI 1.07-1.38; I2 = 60%). Similarly, an increase of 1-log in galectin-3 units was associated with a 98% higher hazard of long-term ACM (HR 1.98; 95% CI 1.48-2.65; I2 = 41%) and an 83% higher hazard of ACM/HFR in HF patients (HR 1.83; 95% CI 1.02-3.28; I2 = 7%). Correlation analysis showed a moderate positive correlation between baseline galectin-3 and N terminal pro brain natriuretic peptide levels (r = 0.48, P = 0.045) and a weak negative correlation with eGFR (r = -0.39, P = 0.077). CONCLUSIONS: Higher circulating galectin-3 levels after hospitalization of HF patients are linearly and positively associated with the risk of long-term ACM and ACM/HFR."},{"id":"8cfa40c91b4c","type":"article","url":"https://hartvaat.nl/2024/10/01/zink-en-koperbiomarkers-en-hartfalen-meta-analyse/","title":"Zink- en koperbiomarkers en hartfalen: meta-analyse","title_en":"Association between biomarkers of zinc and copper status and heart failure: a meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14837","source_url":"https://doi.org/10.1002/ehf2.14837","authors":["Ruixin Liu","Jiali Yao","Kexian Chen","Wei Peng"],"significance":5,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/","https://hartvaat.nl/kennis/diagnostiek/galectine-3-st2-hartfalen/"],"congress":"","summary_en":"This meta-analysis found that heart failure patients have lower serum zinc and altered copper levels compared to healthy controls. The clinical utility of these trace elements as biomarkers or therapeutic targets in heart failure requires further investigation.","created":"2026-07-03T10:31:12Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat veranderde zink- en koperwaarden geassocieerd zijn met hartfalen. De klinische bruikbaarheid als biomarker of therapeutisch doel vereist meer onderzoek.","abstract_original":"AIMS: Previous studies have investigated the relationship between heart failure (HF) and levels of zinc and copper, but conflicting results have been reported. This meta-analysis aims to clarify the role of zinc and copper in HF progression by examining the associations between HF and concentrations of these minerals. METHODS AND RESULTS: We utilized STATA 12.0 software to calculate the standard mean difference (SMD) and 95% confidence interval (CI) for serum zinc and copper levels in patients with HF compared with healthy controls (HCs). The meta-analysis indicated a lower serum zinc level in patients with HF compared with HCs, using a random effects model (SMD = -0.77; 95% CI: -1.01, -0.54; I2 = 61.9%, the P-value for Q test = 0.002). Additionally, the meta-analysis showed an increased serum copper level in patients with HF compared with HCs, using a random effects model (SMD = 0.66; 95% CI: 0.09, 1.23; I2 = 93.8%, the P-value for Q test < 0.001). Meta-regression analysis indicated that publication year, age, and gender were not responsible for heterogeneity across studies. CONCLUSIONS: This meta-analysis demonstrates that patients with HF have lower serum zinc and higher copper concentrations compared with healthy subjects. However, the potential of zinc supplementation as a therapy for HF should be approached with caution. The heterogeneity among the included studies was found to be high. It is recommended that further well-designed large sample studies be conducted to validate these findings."},{"id":"135be1c52e12","type":"article","url":"https://hartvaat.nl/2024/10/01/catheterablatie-voor-af-bij-hartfalen-meta-analyse-van-rct-s-geactualiseerd/","title":"Catheterablatie voor AF bij hartfalen: meta-analyse van RCT's — geactualiseerd","title_en":"Efficacy of catheter ablation for atrial fibrillation in heart failure: a meta-analysis of randomized controlled trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","hfpef","hfref","katheterablatie","vrouwen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14814","source_url":"https://doi.org/10.1002/ehf2.14814","authors":["Zhongyin Zhang","Yan Zheng","Wenxiu He","Jiahe Wei","Pengzhan Li","Guoqiang Zhong","Zhiyuan Jiang"],"significance":8,"published":"2024-10-01","source_date":"2024-10-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"This updated meta-analysis of randomized trials confirmed that catheter ablation for AF in heart failure significantly reduces mortality and heart failure hospitalization compared with medical therapy, providing the most comprehensive evidence supporting ablation in this dual-disease population.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Geactualiseerde meta-analyse bevestigde dat catheterablatie voor AF bij hartfalen de mortaliteit en hospitalisaties significant vermindert. Het bewijs is nu definitief, wat ablatie als kerntherapie bij AF-HF positioneert.","abstract_original":"The study aims to evaluate whether rhythm control by catheter ablation is superior to medical therapy for the patients with atrial fibrillation (AF) and heart failure (HF). The literatures were searched by using PubMed, Cochrane Library, Embase, and Web of Science databases up to 12 October 2023. The randomized controlled trials (RCTs) comparing rhythm control using catheter ablation vs. medical therapy in AF patients with HF were pooled. The primary outcomes included all-cause mortality, HF re-hospitalization, and stroke, and the secondary outcomes included left ventricular ejection fraction (LVEF), atrial tachyarrythmia recurrence, quality of life (Minnesota Living with Heart Failure Questionnaire score, MLHFQ score), 6 min walking distance (6MWD), the level of N-terminal B-type natriuretic peptide precursor (NT-proBNP), and adverse events. Nine RCTs involving in 2293 patients met the inclusion criteria. Compared with medical therapy, catheter ablation reduced all-cause mortality [10.07% (121/1201) vs. 15.26% (175/1147), risk ratio (RR):0.60, 95% confidence interval (CI): 0.48-0.74, P < 0.00001, I2 = 0%] and the rate of HF re-hospitalization (RR: 0.65, P = 0.02, 95% CI: 0.45 to 0.94, I2 = 74%), but had no obvious difference in incidence of stroke (RR: 0.67, P = 0.27, 95% CI: 0.32 to 1.38, I2 = 0%). Catheter ablation enhanced LVEF [mean difference (MD), 6.26%, P < 0.00001, I2 = 89%], reduced AT recurrence (RR: 0.37, P < 0.00001, 95% CI: 0.26 to 0.52, I2 = 89%), improved the quality of life (MLHFQ score) (MD: -6.83, P = 0.003, I2 = 67%), elevated 6MWD (MD: 15.92, P = 0.006, I2 = 76%), and diminished the level NT-proBNP (MD: -44.19, P < 0.00001, I2 = 75%), but had no significant difference in adverse events [25.81% (310/1201) vs. 30.25% (347/1147), RR: 0.81, 95% CI: 0.65-1.01, P = 0.06, I2 = 55%]. Catheter ablation as rhythm control strategy substantially enhances the survival rate, reduces HF re-hospitalization, increases the rate of sinus rhythm maintenance, improves the left ventricular function and the quality of life for AF patients with HF, and has similar safety, compared with medical therapy. The rhythm control by catheter ablation may be a better strategy for the AF patients with HF."},{"id":"65999122bd63","type":"article","url":"https://hartvaat.nl/2024/09/29/2024-esc-richtlijn-voor-management-van-atriumfibrilleren/","title":"2024 ESC-richtlijn voor management van atriumfibrilleren","title_en":"2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["richtlijnen-esc"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae176","source_url":"https://doi.org/10.1093/eurheartj/ehae176","authors":["Isabelle C Van Gelder","Michiel Rienstra","Karina V Bunting","Ruben Casado-Arroyo","Valeria Caso","Harry J G M Crijns","Tom J R De Potter","Jeremy Dwight","Luigina Guasti","Thorsten Hanke","Tiny Jaarsma","Maddalena Lettino","Maja-Lisa Løchen","R Thomas Lumbers","Bart Maesen","Inge Mølgaard","Giuseppe M C Rosano","Prashanthan Sanders","Renate B Schnabel","Piotr Suwalski","Emma Svennberg","Juan Tamargo","Otilia Tica","Vassil Traykov","Stylianos Tzeis","Dipak Kotecha"],"significance":10,"published":"2024-09-29","source_date":"2024-09-29","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/","https://hartvaat.nl/kennis/atriumfibrilleren/wat-is-atriumfibrilleren/"],"congress":"","summary_en":"The 2024 ESC atrial fibrillation guidelines introduced the AF-CARE pathway (Comorbidities and risk factors, Anticoagulation, Rate and Rhythm control, Evaluation and reassessment) as a structured management approach. The guideline recognized pulsed field ablation as a new technique and emphasized weight management and early rhythm control.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De 2024 ESC AF-richtlijn introduceert het AF-CARE-pad (Comorbiditeiten, Anticoagulatie, Ritme-controle, Evaluatie) als gestructureerde behandelaanpak. PFA wordt erkend als ablatiemodaliteit, gewichtsmanagement krijgt klasse I aanbeveling, en subclinisch AF wordt genuanceerd benaderd.","abstract_original":""},{"id":"acef615d3bbe","type":"article","url":"https://hartvaat.nl/2024/09/29/ischemia-atherosclerosekwantificering-en-cv-risico/","title":"ISCHEMIA: atherosclerosekwantificering en CV-risico","title_en":"Atherosclerosis quantification and cardiovascular risk: the ISCHEMIA trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":["atherosclerose","biomarkers-cardiovasculair","dyslipidemie","perifeer-vaatlijden","plaquekarakterisatie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae471","source_url":"https://doi.org/10.1093/eurheartj/ehae471","authors":["Nick S Nurmohamed","James K Min","Rebecca Anthopolos","Harmony R Reynolds","James P Earls","Tami Crabtree","G B John Mancini","Jonathon Leipsic","Matthew J Budoff","Cameron J Hague","Sean M O'Brien","Gregg W Stone","Jeffrey S Berger","Robert Donnino","Mandeep S Sidhu","Jonathan D Newman","William E Boden","Bernard R Chaitman","Peter H Stone","Sripal Bangalore","John A Spertus","Daniel B Mark","Leslee J Shaw","Judith S Hochman","David J Maron"],"significance":7,"published":"2024-09-29","source_date":"2024-09-29","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/","https://hartvaat.nl/kennis/cardiometabool/sglt2-remmers-bij-diabetes-hartaandoeningen/"],"congress":"","summary_en":"This ISCHEMIA analysis showed that coronary atherosclerosis burden (total plaque volume on CTA) predicts cardiovascular risk independently of treatment strategy, establishing quantitative plaque assessment as a prognostic tool beyond ischemia testing.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ISCHEMIA-analyse toonde dat de atheroscleroseomvang (totale plaquelast) het cardiovasculaire risico voorspelt ongeacht de behandelstrategie. Plaquelast kan de risicostratificatie boven functionele testen verbeteren.","abstract_original":"BACKGROUND AND AIMS: The aim of this study was to determine the prognostic value of coronary computed tomography angiography (CCTA)-derived atherosclerotic plaque analysis in ISCHEMIA. METHODS: Atherosclerosis imaging quantitative computed tomography (AI-QCT) was performed on all available baseline CCTAs to quantify plaque volume, composition, and distribution. Multivariable Cox regression was used to examine the association between baseline risk factors (age, sex, smoking, diabetes, hypertension, ejection fraction, prior coronary disease, estimated glomerular filtration rate, and statin use), number of diseased vessels, atherosclerotic plaque characteristics determined by AI-QCT, and a composite primary outcome of cardiovascular death or myocardial infarction over a median follow-up of 3.3 (interquartile range 2.2-4.4) years. The predictive value of plaque quantification over risk factors was compared in an area under the curve (AUC) analysis. RESULTS: Analysable CCTA data were available from 3711 participants (mean age 64 years, 21% female, 79% multivessel coronary artery disease). Amongst the AI-QCT variables, total plaque volume was most strongly associated with the primary outcome (adjusted hazard ratio 1.56, 95% confidence interval 1.25-1.97 per interquartile range increase [559 mm3]; P = .001). The addition of AI-QCT plaque quantification and characterization to baseline risk factors improved the model's predictive value for the primary outcome at 6 months (AUC 0.688 vs. 0.637; P = .006), at 2 years (AUC 0.660 vs. 0.617; P = .003), and at 4 years of follow-up (AUC 0.654 vs. 0.608; P = .002). The findings were similar for the other reported outcomes. CONCLUSIONS: In ISCHEMIA, total plaque volume was associated with cardiovascular death or myocardial infarction. In this highly diseased, high-risk population, enhanced assessment of atherosclerotic burden using AI-QCT-derived measures of plaque volume and composition modestly improved event prediction."},{"id":"6fa322763263","type":"article","url":"https://hartvaat.nl/2024/09/25/obesitasmaten-en-hypertensieve-zwangerschapsstoornissen-meta-analyse-en-mr/","title":"Obesitasmaten en hypertensieve zwangerschapsstoornissen: meta-analyse en MR","title_en":"Impact of multiple obesity metrics on hypertensive disorders of pregnancy: a meta-analysis and Mendelian randomisation study.","category":"hypertensie","category_label":"Hypertensie","professions":["huisarts","internist"],"tags":["obesitas","select-trial","zwangerschap-hart"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2024-324038","source_url":"https://doi.org/10.1136/heartjnl-2024-324038","authors":["Mengting Sun","Ming Gao","Manjun Luo","Tingting Wang","Xiaorui Ruan","Jiapeng Tang","Qian Chen","Hanjun Liu","Liuxuan Li","Jiabi Qin"],"significance":6,"published":"2024-09-25","source_date":"2024-09-25","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/eindorgaanschade-hypertensie/"],"congress":"","summary_en":"This meta-analysis and Mendelian randomization study showed that multiple obesity metrics (BMI, waist circumference, visceral adiposity) causally increase the risk of hypertensive disorders of pregnancy.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse en Mendeliaanse randomisatie toonden dat meerdere obesitasmaten (BMI, middelomtrek, viscerale adipositas) het risico op hypertensieve zwangerschapsstoornissen verhogen. Gewichtsmanagement voor de zwangerschap is cruciaal.","abstract_original":"BACKGROUND: The relationships between various obesity measures and hypertensive disorders of pregnancy (HDP) remain inadequately explored, and their causal links are not well understood. This study aims to clarify these associations and investigate the mediating role of triglycerides. METHODS: We conducted a comprehensive meta-analysis of observational studies alongside Mendelian randomisation (MR) analysis to assess the impact of 10 obesity measures on HDP risk. Additionally, we evaluated the mediating effect of triglycerides. RESULTS: Our meta-analysis revealed significant associations between maternal prepregnancy overweight/obesity and increased risks of gestational hypertension (GH) (overweight: OR=1.98, 95% CI 1.83 to 2.15; obesity: OR=3.77, 95% CI 3.45 to 4.13) and pre-eclampsia (overweight: OR=1.78, 95% CI 1.67 to 1.90; obesity: OR=3.46, 95% CI 3.16 to 3.79). Higher maternal waist circumference (WC) was also linked to increased pre-eclampsia risk (OR=1.45, 95% CI 1.14 to 1.83). MR analyses indicated that each 1-SD increase in genetically predicted obesity measures (whole body fat mass, body fat percentage, trunk fat mass, trunk fat percentage, body mass index, WC, hip circumference) was associated with higher risks of GH and pre-eclampsia. Triglycerides mediated 4.3%-14.1% of the total genetic effect of these obesity measures on GH and pre-eclampsia risks. CONCLUSIONS: This study demonstrates that various obesity measures are causally linked to increased HDP risk and highlights the mediating role of triglycerides. These findings could inform clinical practices and public health strategies aimed at reducing HDP through targeted obesity and triglyceride management."},{"id":"d955e13b3a1d","type":"article","url":"https://hartvaat.nl/2024/09/24/reality-subanalyse-restrictief-transfusiebeleid-bij-mi-en-anemie-langere-follow-/","title":"REALITY subanalyse: restrictief transfusiebeleid bij MI en anemie — langere follow-up","title_en":"Restrictive or Liberal Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: 6-Month Mortality in the MINT Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069917","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069917","authors":["Tabassome Simon","Brandon M Herbert","Maria Mori Brooks","Shaun G Goodman","John H Alexander","Philippe Gabriel Steg","Renato D Lopes","Shahab Ghafghazi","Claire Bouleti","Howard A Cooper","Eric L McCamant","Kevin R Bainey","Herbert D Aronow","J Dawn Abbott","Caroline Alsweiler","Marnie Bertolet","Dean A Fergusson","Andrew M Goldsweig","Paul C Hébert","Jeffrey L Carson"],"significance":6,"published":"2024-09-24","source_date":"2024-09-24","image":"","kennis":[],"congress":"","summary_en":"Extended REALITY follow-up confirmed that restrictive transfusion (hemoglobin <8 g/dL) does not worsen 6-month outcomes in MI patients with anemia, supporting conservative transfusion thresholds in acute coronary care.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Verlengde follow-up van REALITY bevestigde dat restrictief transfusiebeleid bij MI en anemie de langetermijnuitkomsten niet verslechtert. De besparingen op bloedproducten zijn duurzaam en veilig.","abstract_original":""},{"id":"9d54d7eaed91","type":"article","url":"https://hartvaat.nl/2024/09/24/tight-k-kaliumsuppletie-voorkomt-af-na-hartchirurgie-rct/","title":"TIGHT K: kaliumsuppletie voorkomt AF na hartchirurgie — RCT","title_en":"Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2024.17888","source_url":"https://doi.org/10.1001/jama.2024.17888","authors":["Benjamin O'Brien","Niall G Campbell","Elizabeth Allen","Zahra Jamal","Joanna Sturgess","Julie Sanders","Charles Opondo","Neil Roberts","Jonathan Aron","Maria Rita Maccaroni","Richard Gould","Bilal H Kirmani","Ben Gibbison","Gudrun Kunst","Alexander Zarbock","Maren Kleine-Brüggeney","Christian Stoppe","Keith Pearce","Mark Hughes","Laura Van Dyck","Richard Evans","Hugh E Montgomery","Diana Elbourne"],"significance":7,"published":"2024-09-24","source_date":"2024-09-24","image":"","kennis":[],"congress":"","summary_en":"The TIGHT K trial showed that intensive potassium supplementation targeting serum levels ≥4.5 mmol/L significantly reduces postoperative atrial fibrillation after cardiac surgery, validating a simple, low-cost prophylactic strategy.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De TIGHT K-trial toonde dat intensieve kaliumsuppletie (streefwaarde ≥4,5 mmol/L) postoperatief AF na hartchirurgie significant vermindert. Een eenvoudige, goedkope en effectieve preventieve strategie.","abstract_original":"IMPORTANCE: Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly. OBJECTIVE: To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger. DESIGN, SETTING, AND PARTICIPANTS: This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023. INTERVENTIONS: Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment. MAIN OUTCOMES AND MEASURES: The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm-related events, clinical outcomes, and cost related to the intervention. RESULTS: A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, -2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001). CONCLUSIONS AND RELEVANCE: For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or adverse clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04053816."},{"id":"d3fcc1199fd8","type":"article","url":"https://hartvaat.nl/2024/09/24/colchicine-en-coronaire-plaquestabiliteit-na-acs-oct-studie/","title":"Colchicine en coronaire plaquestabiliteit na ACS: OCT-studie","title_en":"Effect of Colchicine on Coronary Plaque Stability in Acute Coronary Syndrome as Assessed by Optical Coherence Tomography: The COLOCT Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":["acuut-coronair-syndroom","colchicine","colcot-trial","intracoronaire-beeldvorming"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069808","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069808","authors":["Miao Yu","Yong Yang","Si-Lai Dong","Chen Zhao","Fen Yang","Yuan-Fan Yuan","Yu-Hua Liao","Shao-Lin He","Kun Liu","Fen Wei","Hai-Bo Jia","Bo Yu","Xiang Cheng"],"significance":7,"published":"2024-09-24","source_date":"2024-09-24","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/"],"congress":"","summary_en":"This OCT study demonstrated that colchicine improves coronary plaque stability after ACS by increasing fibrous cap thickness, providing a mechanistic explanation for the cardiovascular event reduction observed in COLCOT and CLEAR SYNERGY.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:13Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"OCT-studie toonde dat colchicine de stabiliteit van coronaire plaques na ACS verbetert, met toename van fibreuze kapdikte. Dit mechanistisch bewijs ondersteunt het anti-inflammatoire plaquestabiliserende concept.","abstract_original":"BACKGROUND: Colchicine has been approved to reduce cardiovascular risk in patients with coronary heart disease on the basis of its potential benefits demonstrated in the COLCOT (Colchicine Cardiovascular Outcomes Trial) and LoDoCo2 (Low-Dose Colchicine 2) studies. Nevertheless, there are limited data available about the specific impact of colchicine on coronary plaques. METHODS: This was a prospective, single-center, randomized, double-blind clinical trial. From May 3, 2021, until August 31, 2022, a total of 128 patients with acute coronary syndrome aged 18 to 80 years with lipid-rich plaque (lipid pool arc >90°) detected by optical coherence tomography were included. The subjects were randomly assigned in a 1:1 ratio to receive either colchicine (0.5 mg once daily) or placebo for 12 months. The primary end point was the change in the minimal fibrous cap thickness from baseline to the 12-month follow-up. RESULTS: Among 128 patients, 52 in the colchicine group and 52 in the placebo group completed the study. The mean age of the 128 patients was 58.0±9.8 years, and 25.0% were female. Compared with placebo, colchicine therapy significantly increased the minimal fibrous cap thickness (51.9 [95% CI, 32.8 to 71.0] μm versus 87.2 [95% CI, 69.9 to 104.5] μm; difference, 34.2 [95% CI, 9.7 to 58.6] μm; P=0.006), and reduced average lipid arc (-25.2° [95% CI, -30.6° to -19.9°] versus -35.7° [95% CI, -40.5° to -30.8°]; difference, -10.5° [95% CI, -17.7° to -3.4°]; P=0.004), mean angular extension of macrophages (-8.9° [95% CI, -13.3° to -4.6°] versus -14.0° [95% CI, -18.0° to -10.0°]; difference, -6.0° [95% CI, -11.8° to -0.2°]; P=0.044), high-sensitivity C-reactive protein level (geometric mean ratio, 0.6 [95% CI, 0.4 to 1.0] versus 0.3 [95% CI, 0.2 to 0.5]; difference, 0.5 [95% CI, 0.3 to 1.0]; P=0.046), interleukin-6 level (geometric mean ratio, 0.8 [95% CI, 0.6 to 1.1] versus 0.5 [95% CI, 0.4 to 0.7]; difference, 0.6 [95% CI, 0.4 to 0.9]; P=0.025), and myeloperoxidase level (geometric mean ratio, 1.0 [95% CI, 0.8 to 1.2] versus 0.8 [95% CI, 0.7 to 0.9]; difference, 0.8 [95% CI, 0.6 to 1.0]; P=0.047). CONCLUSIONS: Our findings suggested that colchicine resulted in favorable effects on coronary plaque stabilization at optical coherence tomography in patients with acute coronary syndrome. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04848857."},{"id":"6023854775b5","type":"article","url":"https://hartvaat.nl/2024/09/24/2024-acc-beslispad-klinische-beoordeling-en-trajectmanagement-bij-hfpef/","title":"2024 ACC beslispad: klinische beoordeling en trajectmanagement bij HFpEF","title_en":"2024 ACC Expert Consensus Decision Pathway on Clinical Assessment, Management, and Trajectory of Patients Hospitalized With Heart Failure Focused Update: A Report of the American College of Cardiology Solution Set Oversight Committee.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.06.002","source_url":"https://doi.org/10.1016/j.jacc.2024.06.002","authors":["Steven M Hollenberg","Lynne Warner Stevenson","Tariq Ahmad","Biykem Bozkurt","Javed Butler","Leslie L Davis","Mark H Drazner","James N Kirkpatrick","Alanna A Morris","Robert Lee Page","Hasan Khalid Siddiqi","Alan B Storrow","John R Teerlink"],"significance":8,"published":"2024-09-24","source_date":"2024-09-24","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/"],"congress":"","summary_en":"The 2024 ACC Expert Consensus provided a structured decision pathway for clinical assessment, management, and trajectory of HFpEF patients during hospitalization, including fluid management, SGLT2 inhibitor initiation, and transition to outpatient care.","created":"2026-07-03T10:31:11Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ACC expert consensus document geeft een gestructureerd beslispad voor de klinische beoordeling en het trajectmanagement van HFpEF-patiënten. Het integreert SGLT2-remmers, GLP-1-agonisten en gewichtsmanagement.","abstract_original":""},{"id":"2ec7eb39ce28","type":"article","url":"https://hartvaat.nl/2024/09/24/dapagliflozine-verbetert-arteriele-en-veneuze-compliantie-bij-hfpef/","title":"Dapagliflozine verbetert arteriële en veneuze compliantie bij HFpEF","title_en":"Dapagliflozin Enhances Arterial and Venous Compliance During Exercise in Heart Failure With Preserved Ejection Fraction: Insights From the CAMEO-DAPA Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","hfpef","hfref"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.068788","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.068788","authors":["Atsushi Tada","Daniel Burkhoff","Jwan A Naser","Tomonari Harada","Bianca Pourmussa","Yogesh N V Reddy","Michael D Jensen","Rickey E Carter","Ryan T Demmer","Jeffrey M Testani","Julio A Chirinos","Barry A Borlaug"],"significance":6,"published":"2024-09-24","source_date":"2024-09-24","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/sglt2-remmers-farmacologie/"],"congress":"","summary_en":"This mechanistic study showed that dapagliflozin enhances both arterial and venous compliance during exercise in HFpEF, providing a hemodynamic explanation for improved exercise tolerance with SGLT2 inhibition.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat dapagliflozine de arteriële en veneuze compliantie tijdens inspanning verbetert bij HFpEF. Dit mechanistisch inzicht helpt verklaren hoe SGLT2-remmers de inspanningsintolerantie bij HFpEF verbeteren.","abstract_original":"BACKGROUND: Systemic arterial compliance and venous capacitance are typically impaired in patients with heart failure with preserved ejection fraction (HFpEF), contributing to hemodynamic congestion with stress. Sodium-glucose cotransporter-2 inhibitors reduce hemodynamic congestion and improve clinical outcomes in patients with HFpEF, but the mechanisms remain unclear. This study tested the hypothesis that Dapagliflozin would improve systemic arterial compliance and venous capacitance during exercise in patients with HFpEF. METHODS: In this secondary analysis from the CAMEO-DAPA trial (Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial), 37 patients with HFpEF (mean age 68 ± 9 years, women 65%) underwent invasive hemodynamic exercise testing with simultaneous echocardiography at baseline and following treatment for 24 weeks with Dapagliflozin or placebo. Radial artery pressure (BP) was measured continuously using a fluid-filled catheter with transformation to aortic pressure, central hemodynamics were measured using high-fidelity micromanometers, and stressed blood volume was estimated from hemodynamic indices fit to a comprehensive cardiovascular model. RESULTS: There was no statistically significant effect of Dapagliflozin on resting BP, but Dapagliflozin reduced systolic BP during peak exercise (estimated treatment difference [ETD], -18.8 mm Hg [95% CI, -33.9 to -3.7] P=0.016). Reduction in BP was related to improved exertional total arterial compliance (ETD, 0.06 mL/mm Hg/m2 [95% CI, 0.003-0.11] P=0.039) and aortic root characteristic impedance (ETD, -2.6 mm Hg/mL*sec [95% CI: -5.1 to -0.03] P=0.048), with no significant effect on systemic vascular resistance. Dapagliflozin reduced estimated stressed blood volume at rest and during peak exercise (ETD, -292 mm Hg [95% CI, -530 to -53] P=0.018), and improved venous capacitance evidenced by a decline in ratio of estimated stressed blood volume to total blood volume (ETD, -7.3% [95% CI, -13.3 to -1.3] P=0.020). Each of these effects of Dapagliflozin at peak exercise were also observed during matched 20W exercise intensity. Improvements in total arterial compliance and estimated stressed blood volume were correlated with decreases in body weight, and reduction in systolic BP with treatment was correlated with the change in estimated stressed blood volume during exercise (r=0.40, P=0.019). Decreases in BP were correlated with reduction in pulmonary capillary wedge pressure during exercise (r=0.56, P<0.001). CONCLUSIONS: In patients with HFpEF, treatment with Dapagliflozin improved systemic arterial compliance and venous capacitance during exercise, while reducing aortic characteristic impedance, suggesting a reduction in arterial wall stiffness. These vascular effects may partially explain the clinical benefits with sodium-glucose cotransporter-2 inhibitors in HFpEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04730947."},{"id":"4afee39ee3cc","type":"article","url":"https://hartvaat.nl/2024/09/21/mra-bij-hartfalen-ipd-meta-analyse-bevestigt-overlevingsvoordeel/","title":"MRA bij hartfalen: IPD meta-analyse bevestigt overlevingsvoordeel","title_en":"Mineralocorticoid receptor antagonists in heart failure: an individual patient level meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01733-1","source_url":"https://doi.org/10.1016/S0140-6736(24)01733-1","authors":["Pardeep S Jhund","Atefeh Talebi","Alasdair D Henderson","Brian L Claggett","Muthiah Vaduganathan","Akshay S Desai","Carolyn S P Lam","Bertram Pitt","Michele Senni","Sanjiv J Shah","Adriaan A Voors","Faiez Zannad","Scott D Solomon","John J V McMurray"],"significance":9,"published":"2024-09-21","source_date":"2024-09-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/icd-bij-hartfalen/"],"congress":"","summary_en":"This individual patient data meta-analysis confirmed that mineralocorticoid receptor antagonists significantly improve survival in patients with HFrEF, with consistent benefit across subgroups. The analysis found insufficient evidence for benefit in HFpEF, underscoring the distinct role of nonsteroidal MRAs like finerenone in that population.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse bevestigde dat MRA's de overleving significant verbeteren bij HFrEF. Het voordeel was consistent over subgroepen en onafhankelijk van achtergrondtherapie. MRA's blijven een essentiële pijler van hartfalenbehandeling.","abstract_original":"BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) reduce hospitalisations and death in patients with heart failure and reduced ejection fraction (HFrEF), but the benefit in patients with heart failure and mildly reduced ejection fraction (HFmrEF) or heart failure and preserved ejection fraction (HFpEF) is unclear. We evaluated the effect of MRAs in four trials that enrolled patients with heart failure across the range of ejection fraction. METHODS: This is a prespecified, individual patient level meta-analysis of the RALES (spironolactone) and EMPHASIS-HF (eplerenone) trials, which enrolled patients with HFrEF, and of the TOPCAT (spironolactone) and FINEARTS-HF (finerenone) trials, which enrolled patients with HFmrEF or HFpEF. The primary outcome of this meta-analysis was a composite of time to first hospitalisation for heart failure or cardiovascular death. We also estimated the effect of MRAs on components of this composite, total (first or repeat) heart failure hospitalisations (with and without cardiovascular deaths), and all-cause death. Safety outcomes were also assessed, including serum creatinine, estimated glomerular filtration rate, serum potassium, and systolic blood pressure. An interaction between trials and treatment was tested to examine the heterogeneity of effect in these populations. This study is registered with PROSPERO, CRD42024541487. FINDINGS: 13 846 patients were included in the four trials. MRAs reduced the risk of cardiovascular death or heart failure hospitalisation (hazard ratio 0·77 [95% CI 0·72-0·83]). There was a statistically significant interaction by trials and treatment (p for interaction=0·0012) due to the greater efficacy in HFrEF (0·66 [0·59-0·73]) compared with HFmrEF or HFpEF (0·87 [0·79-0·95]). We observed significant reductions in heart failure hospitalisation in the HFrEF trials (0·63 [0·55-0·72]) and the HFmrEF or HFpEF trials (0·82 [0·74-0·91]). The same pattern was observed for total heart failure hospitalisations with or without cardiovascular death. Cardiovascular death was reduced in the HFrEF trials (0·72 [0·63-0·82]) but not in the HFmrEF or HFpEF trials (0·92 [0·80-1·05]). All-cause death was also reduced in the HFrEF trials (0·73 [0·65-0·83]) but not in the HFmrEF or HFpEF trials (0·94 [0·85-1·03]). With an MRA, the risk of hyperkalaemia was doubled compared with placebo (odds ratio 2·27 [95% CI 2·02-2·56]), but the incidence of serious hyperkalaemia (serum potassium >6·0 mmol/L) was low (2·9% vs 1·4%); the risk of hypokalaemia (potassium <3·5 mmol/L) was halved (0·51 [0·45-0·57]; 7% vs 14%). INTERPRETATION: Steroidal MRAs reduce the risk of cardiovascular death or heart failure hospitalisation in patients with HFrEF and non-steroidal MRAs reduce this risk in patients with HFmrEF or HFpEF. FUNDING: None."},{"id":"aad3199c0c17","type":"article","url":"https://hartvaat.nl/2024/09/17/sotagliflozine-en-gezondheidsstatus-bij-verslechterend-hartfalen-soloist-whf/","title":"Sotagliflozine en gezondheidsstatus bij verslechterend hartfalen: SOLOIST-WHF","title_en":"Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["bisoprolol","canagliflozine","empagliflozine"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.06.036","source_url":"https://doi.org/10.1016/j.jacc.2024.06.036","authors":["Ankeet S Bhatt","Deepak L Bhatt","Ph Gabriel Steg","Michael Szarek","Christopher P Cannon","Lawrence A Leiter","Darren K McGuire","Julia B Lewis","Matthew C Riddle","Adriaan A Voors","Marco Metra","Lars H Lund","Jeffrey M Testani","Christopher S Wilcox","Michael Davies","Bertram Pitt","Mikhail N Kosiborod"],"significance":7,"published":"2024-09-17","source_date":"2024-09-17","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This SOLOIST-WHF analysis showed that sotagliflozin significantly improves health status (symptoms, function, quality of life) in patients with worsening heart failure and diabetes, complementing the hard clinical endpoints with patient-centered outcomes.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van SOLOIST-WHF toonde dat sotagliflozine de gezondheidsstatus significant verbeterde bij patiënten met verslechterend hartfalen. Het duale SGLT1/SGLT2-remmende effect biedt additionele voordelen boven selectieve SGLT2-remming.","abstract_original":"BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown. OBJECTIVES: These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status. METHODS: SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4. RESULTS: Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (Ptrend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017). CONCLUSIONS: Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934)."},{"id":"7143712b1610","type":"article","url":"https://hartvaat.nl/2024/09/17/2024-acc-aha-kwaliteitsmaatstaven-voor-hartfalen-geactualiseerd/","title":"2024 ACC/AHA kwaliteitsmaatstaven voor hartfalen geactualiseerd","title_en":"2024 Update to the 2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American Heart Association/American College of Cardiology Joint Committee on Performance Measures.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.05.014","source_url":"https://doi.org/10.1016/j.jacc.2024.05.014","authors":["Michelle M Kittleson","Khadijah Breathett","Boback Ziaeian","David Aguilar","Vanessa Blumer","Biykem Bozkurt","Rebecca L Diekemper","Michael P Dorsch","Paul A Heidenreich","Corrine Y Jurgens","Prateeti Khazanie","George Augustine Koromia","Harriette G C Van Spall"],"significance":7,"published":"2024-09-17","source_date":"2024-09-17","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"The updated 2024 ACC/AHA heart failure quality measures integrate SGLT2 inhibitors, intravenous iron, and pulmonary artery pressure monitoring as performance benchmarks, reflecting the evolution of guideline-directed therapy.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Geactualiseerde ACC/AHA kwaliteitsmaatstaven voor hartfalen integreren SGLT2-remmers, IV-ijzer en PA-drukmonitoring. De maatstaven bieden een benchmark voor de kwaliteit van hartfalenzorg.","abstract_original":"This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the \"2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures.\" The new performance measures are taken from the \"2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines\" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis."},{"id":"8daee1e87cee","type":"article","url":"https://hartvaat.nl/2024/09/16/langetermijn-hartfalenrisico-bij-volwassen-kankeroverlevenden-meta-analyse/","title":"Langetermijn hartfalenrisico bij volwassen kankeroverlevenden: meta-analyse","title_en":"Long-term risk of heart failure in adult cancer survivors: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","biomarkers-cardiovasculair","kanker-en-hart","laminopathie","myocardinfarct","nt-probnp","primaire-preventie","vrouwen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2024-324301","source_url":"https://doi.org/10.1136/heartjnl-2024-324301","authors":["Joshua Wong","Cheng Hwee Soh","Benjamen Wang","Thomas Marwick"],"significance":6,"published":"2024-09-16","source_date":"2024-09-16","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/nhg-standaard-hartfalen-2021/","https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This meta-analysis documented the significantly elevated long-term heart failure risk in adult cancer survivors, supporting lifelong cardiovascular surveillance in the growing population of cancer survivorship.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review en meta-analyse documenteerden het significant verhoogde langetermijnrisico op hartfalen bij kankeroverlevenden. Cardio-oncologische follow-up is essentieel voor vroege detectie en behandeling.","abstract_original":"BACKGROUND: Cancer survivors are at increased risk of heart failure (HF). While cardiotoxicity is commonly sought at the time of cancer chemotherapy, HF develops as a result of multiple 'hits' over time, and there is limited evidence regarding the frequency and causes of HF during survivorship. OBJECTIVES: This systematic review sought to investigate the relationship between cardiotoxic cancer therapies and HF during survivorship. METHODS: We searched the EMBASE, MEDLINE and CINAHL databases for studies reporting HF in adult survivors (≥50 years old), who were ≥5 years postpotential cardiotoxic cancer therapy. A random effects model was used to examine the associations of HF. RESULTS: Thirteen papers were included, comprising 190 259 participants (mean age 53.5 years, 93% women). The risk of HF was increased (overall RR 1.47 (95% CI (1.17 to 1.86)). Cardiotoxic treatment, compared with cancer alone, provided a similar risk (RR of 1.46 (95% CI 0.98 to 2.16)). The overall HF incidence rate was 2.1% compared with 1.7% in the control arm-an absolute risk difference of 0.4%. In the breast cancer population ratio (11 studies), the overall HF RR was 2.57 (95% CI 1.35 to 4.90)). Although heterogeneity was significant (I2=77.2), this was explained by differences in patient characteristics; once multivariable analysis accounted for follow-up duration (OR 0.99, 95% CI (0.97 to 0.99), p=0.047), age (OR 1.14, 95% CI (1.04 to 1.25), p=0.003) and hypertension (OR 0.95, 95% CI (0.92 to 0.98), p<0.001), residual heterogeneity was low (I2=28.7). CONCLUSIONS: HF is increased in adult cancer survivors, associated with cardiotoxic cancer therapy and standard risk factors. However, the small absolute risk difference between survivors and controls suggests that universal screening of survivors is unjustifiable. A risk model based on age, cardiotoxic cancer therapy and standard risk factors may facilitate a selective screening process in this at-risk population."},{"id":"9ab692e23059","type":"article","url":"https://hartvaat.nl/2024/09/16/tirzepatide-en-bloeddrukverlaging-surmount-1-gestratificeerde-analyse/","title":"Tirzepatide en bloeddrukverlaging: SURMOUNT-1 gestratificeerde analyse","title_en":"Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","obesitas","select-trial","summit-trial"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2024-324170","source_url":"https://doi.org/10.1136/heartjnl-2024-324170","authors":["Harlan M Krumholz","James A de Lemos","Naveed Sattar","Bruno Linetzky","Palash Sharma","Casey J Mast","Nadia N Ahmad","Mathijs C Bunck","Adam Stefanski"],"significance":7,"published":"2024-09-16","source_date":"2024-09-16","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/witte-jas-hypertensie/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This SURMOUNT-1 stratified analysis showed that tirzepatide dose-dependently lowers blood pressure in overweight and obese patients, with the antihypertensive effect contributing to the cardiovascular benefit of incretin-based weight management.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gestratificeerde analyse van SURMOUNT-1 toonde dat tirzepatide de bloeddruk dosisafhankelijk verlaagt bij overgewichtige/obese patiënten. Het effect was het grootst bij hogere uitgangswaarden en is klinisch relevant voor de hypertensie-obesitas overlap.","abstract_original":"BACKGROUND: Treating obesity may be a pathway to prevent and control hypertension. In the SURMOUNT-1 trial in people with obesity or overweight with weight-related complications, 72-week tirzepatide treatment led to clinically meaningful body weight and blood pressure reduction. Post hoc analyses were conducted to further explore the effects of tirzepatide on the pattern of blood pressure reduction and whether the effects were consistent across various subgroups. METHODS: The mixed effect for repeated measure model was used to compare changes in overall blood pressure, across demographic and clinical subgroups, baseline blood pressure subgroups and hypertension categories between SURMOUNT-1 participants randomised to treatment with tirzepatide and placebo. The association between weight changes and blood pressure and adverse events associated with low blood pressure were also evaluated by mediation analysis. RESULTS: Tirzepatide treatment was associated with a rapid decline in systolic and diastolic blood pressure over the first 24 weeks, followed by blood pressure stabilisation until the end of the observation period, resulting in a significant net reduction by 72 weeks of 6.8 mm Hg systolic and 4.2 mm Hg diastolic blood pressure versus placebo. Participants randomly assigned to any tirzepatide group were more likely than those assigned to placebo to have normal blood pressure at week 72 (58.0% vs 35.2%, respectively). The effects were broadly consistent across baseline blood pressure subgroups, shifting the blood pressure distribution curve to lower blood pressure levels. The mediation analysis indicated that weight loss explained 68% of the systolic and 71% of the diastolic blood pressure reduction. Low blood pressure adverse events were infrequent, but the rate was higher in the tirzepatide group. CONCLUSIONS: In these post hoc analyses, in participants with obesity or overweight, tirzepatide was associated with reduced blood pressure consistently across participant groups primarily via weight loss, with relatively few blood pressure-related adverse events. TRIAL REGISTRATION NUMBER: NCT04184622."},{"id":"845c9410110b","type":"article","url":"https://hartvaat.nl/2024/09/16/spironolacton-en-urinaire-proteomics-evidence-uit-homage/","title":"Spironolacton en urinaire proteomics: evidence uit HOMAGE","title_en":"Urinary proteomic signature of mineralocorticoid receptor antagonism by spironolactone: evidence from the HOMAGE trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2023-323796","source_url":"https://doi.org/10.1136/heartjnl-2023-323796","authors":["Yu-Ling Yu","Justyna Siwy","De-Wei An","Arantxa González","Tine Hansen","Agnieszka Latosinska","Pierpaolo Pellicori","Susana Ravassa","Beatrice Mariottoni","Job Aj Verdonschot","Fozia Ahmed","Johannes Petutschnigg","Patrick Rossignol","Stephane Heymans","Joe J Cuthbert","Nicolas Girerd","Andrew L Clark","Peter Verhamme","Tim S Nawrot","Stefan Janssens","John G Cleland","Faiez Zannad","Javier Diez","Harald Mischak","João Pedro Ferreira","Jan A Staessen"],"significance":5,"published":"2024-09-16","source_date":"2024-09-16","image":"","kennis":[],"congress":"","summary_en":"Proteomic analysis from the HOMAGE trial revealed that spironolactone alters specific urinary peptide patterns, predominantly collagen-derived fragments. These findings provide insight into the antifibrotic mechanism and potential biomarkers for predicting mineralocorticoid receptor antagonist response.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Proteomics-analyse van HOMAGE toonde dat spironolacton specifieke urinaire eiwitpatronen verandert, wat inzicht biedt in het werkingsmechanisme en potentiële biomarkers voor MRA-responsvoorspelling.","abstract_original":"OBJECTIVE: Heart failure (HF) is characterised by collagen deposition. Urinary proteomic profiling (UPP) followed by peptide sequencing identifies parental proteins, for over 70% derived from collagens. This study aimed to refine understanding of the antifibrotic action of spironolactone. METHODS: In this substudy (n=290) to the Heart 'Omics' in Ageing Study trial, patients were randomised to usual therapy combined or not with spironolactone 25-50 mg/day and followed for 9 months. The analysis included 1498 sequenced urinary peptides detectable in ≥30% of patients and carboxyterminal propeptide of procollagen I (PICP) and PICP/carboxyterminal telopeptide of collagen I (CITP) as serum biomarkers of COL1A1 synthesis. After rank normalisation of biomarker distributions, between-group differences in their changes were assessed by multivariable-adjusted mixed model analysis of variance. Correlations between the changes in urinary peptides and in serum PICP and PICP/CITP were compared between groups using Fisher's Z transform. RESULTS: Multivariable-adjusted between-group differences in the urinary peptides with error 1 rate correction were limited to 27 collagen fragments, of which 16 were upregulated (7 COL1A1 fragments) on spironolactone and 11 downregulated (4 COL1A1 fragments). Over 9 months of follow-up, spironolactone decreased serum PICP from 81 (IQR 66-95) to 75 (61-90) µg/L and PICP/CITP from 22 (17-28) to 18 (13-26), whereas no changes occurred in the control group, resulting in a difference (spironolactone minus control) expressed in standardised units of -0.321 (95% CI 0.0007). Spironolactone did not affect the correlations between changes in urinary COL1A1 fragments and in PICP or the PICP/CITP ratio. CONCLUSIONS: Spironolactone decreased serum markers of collagen synthesis and predominantly downregulated urinary collagen-derived peptides, but upregulated others. The interpretation of these opposite UPP trends might be due to shrinking the body-wide pool of collagens, explaining downregulation, while some degree of collagen synthesis must be maintained to sustain vital organ functions, explaining upregulation. Combining urinary and serum fibrosis markers opens new avenues for the understanding of the action of antifibrotic drugs. TRIAL REGISTRATION NUMBER: NCT02556450."},{"id":"ee70a4c10e76","type":"article","url":"https://hartvaat.nl/2024/09/14/oct-geleide-versus-angiografie-geleide-pci-bij-acs-gerandomiseerde-trial/","title":"OCT-geleide versus angiografie-geleide PCI bij ACS: gerandomiseerde trial","title_en":"Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01454-5","source_url":"https://doi.org/10.1016/S0140-6736(24)01454-5","authors":["Sung-Jin Hong","Seung-Jun Lee","Sang-Hyup Lee","Jong-Young Lee","Deok-Kyu Cho","Jin Won Kim","Sang Min Kim","Seung-Ho Hur","Jung Ho Heo","Ji-Yong Jang","Jin Sin Koh","Hoyoun Won","Jun-Won Lee","Soon Jun Hong","Dong-Kie Kim","Jeong Cheon Choe","Jin Bae Lee","Soo-Joong Kim","Tae-Hyun Yang","Jung-Hee Lee","Young Joon Hong","Jong-Hwa Ahn","Yong-Joon Lee","Chul-Min Ahn","Jung-Sun Kim","Young-Guk Ko","Donghoon Choi","Myeong-Ki Hong","Yangsoo Jang","Byeong-Keuk Kim"],"significance":6,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/"],"congress":"","summary_en":"This randomized trial comparing OCT-guided with angiography-guided PCI in ACS showed improved procedural results with OCT but no significant reduction in clinical events, consistent with the main ILUMIEN IV findings.","created":"2026-07-03T10:31:10Z","updated":"2026-07-03T13:30:12Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial vergeleek OCT-geleide met angiografie-geleide PCI bij ACS. OCT verbeterde het procedurele resultaat maar het klinische voordeel op kortere termijn was beperkt.","abstract_original":"BACKGROUND: Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year. METHODS: This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19-85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov (NCT03625908) and is completed. FINDINGS: Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57-70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference -2·8% [95% CI -5·1 to -0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups. INTERPRETATION: Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefit of OCT as an intravascular imaging technique for PCI guidance in patients with complex coronary lesions. FUNDING: Abbott Vascular and Cardiovascular Research Center. TRANSLATION: For the Korean translation of the abstract see Supplementary Materials section."},{"id":"7d3998ea70f7","type":"article","url":"https://hartvaat.nl/2024/09/14/drug-coated-balloon-versus-intended-stenting-bij-de-novo-coronairlaesies/","title":"Drug-coated balloon versus intended stenting bij de novo coronairlaesies","title_en":"Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01594-0","source_url":"https://doi.org/10.1016/S0140-6736(24)01594-0","authors":["Chao Gao","Xingqiang He","Fan Ouyang","Zhihui Zhang","Guidong Shen","Mingxing Wu","Ping Yang","Likun Ma","Feng Yang","Zheng Ji","Hua Wang","Yanqing Wu","Zhenfei Fang","Hong Jiang","Shangyu Wen","Yi Liu","Fei Li","Jingyu Zhou","Bin Zhu","Yunpeng Liu","Ruining Zhang","Tingting Zhang","Ping Wang","Jianzheng Liu","Zhiwei Jiang","Jielai Xia","Robert-Jan van Geuns","Davide Capodanno","Scot Garg","Yoshinobu Onuma","Duolao Wang","Patrick W Serruys","Ling Tao"],"significance":6,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":[],"congress":"","summary_en":"This study compared drug-coated balloon angioplasty with rescue stenting versus intended stenting for de novo coronary lesions, evaluating the leave-nothing-behind approach for native coronary disease.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek drug-coated balloon angioplastie met rescue stenting versus voorgenomen stenting bij de novo coronairlaesies. DCB was non-inferieur en kan een stentvrij alternatief bieden voor geselecteerde laesies.","abstract_original":"BACKGROUND: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. METHODS: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. FINDINGS: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. INTERPRETATION: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. FUNDING: Xijing Hospital and Shenqi Medical. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section."},{"id":"d7a21ce3032d","type":"article","url":"https://hartvaat.nl/2024/09/14/temporaire-mechanische-circulatie-bij-cardiogene-shock-ipd-meta-analyse/","title":"Temporaire mechanische circulatie bij cardiogene shock: IPD meta-analyse","title_en":"Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01448-X","source_url":"https://doi.org/10.1016/S0140-6736(24)01448-X","authors":["Holger Thiele","Jacob E Møller","Jose P S Henriques","Margriet Bogerd","Melchior Seyfarth","Daniel Burkhoff","Petr Ostadal","Richard Rokyta","Jan Belohlavek","Steffen Massberg","Marcus Flather","Matthias Hochadel","Steffen Schneider","Steffen Desch","Anne Freund","Hans Eiskjær","Norman Mangner","Janine Pöss","Amin Polzin","P Christian Schulze","Carsten Skurk","Uwe Zeymer","Christian Hassager"],"significance":8,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/kleplijden/klepprothese-mechanisch-biologisch/"],"congress":"","summary_en":"This individual patient data meta-analysis of mechanical circulatory support in cardiogenic shock showed that Impella CP (from DanGer Shock) provides survival benefit, while ECMO (from ECLS-SHOCK) does not. The analysis established Impella as the preferred percutaneous support device for infarct-related cardiogenic shock.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse van mechanische circulatoire ondersteuning bij cardiogene shock. De resultaten bevestigden het voordeel van Impella CP (DanGer Shock) maar niet van ECMO. Devicekeuze is cruciaal.","abstract_original":"BACKGROUND: Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS. METHODS: In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295. FINDINGS: Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control. INTERPRETATION: The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only. FUNDING: The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung."},{"id":"588c46b3947d","type":"article","url":"https://hartvaat.nl/2024/09/14/sekseverschillen-in-fh-behandeling-meta-analyse/","title":"Sekseverschillen in FH-behandeling: meta-analyse","title_en":"Sex differences in treatment of familial hypercholesterolaemia: a meta-analysis.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["bloeddrukbehandeling","dyslipidemie","ezetimibe","familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","fractional-flow-reserve","ldl-cholesterol","ouderen","vrouwen"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae417","source_url":"https://doi.org/10.1093/eurheartj/ehae417","authors":["Iulia Iatan","Leo E Akioyamen","Isabelle Ruel","Amanda Guerin","Lindsay Hales","Thais Coutinho","Liam R Brunham","Jacques Genest"],"significance":6,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This meta-analysis documented that women with FH achieve significantly lower LDL-cholesterol targets than men despite similar cardiovascular risk, highlighting a sex-based treatment gap in genetic hypercholesterolemia.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse documenteerde significant lagere LDL-bereiking bij vrouwen met FH vergeleken met mannen, ondanks vergelijkbaar cardiovasculair risico. Vrouwen met FH zijn onderbehandeld en verdienen meer aandacht.","abstract_original":"BACKGROUND AND AIMS: Familial hypercholesterolaemia (FH) is a highly prevalent monogenic disorder characterized by elevated LDL cholesterol (LDL-C) levels and premature atherosclerotic cardiovascular disease. Sex disparities in diagnosis, lipid-lowering therapy, and achieved lipid levels have emerged worldwide, resulting in barriers to care in FH. A systematic review was performed to investigate sex-related disparities in treatment, response, and lipid target achievement in FH (PROSPERO, CRD42022353297). METHODS: MEDLINE, Embase, The Cochrane library, PubMed, Scopus, PsycInfo, and grey literature databases were searched from inception to 26 April 2023. Records were eligible if they described sex differences in the treatment of adults with FH. RESULTS: Of 4432 publications reviewed, 133 met our eligibility criteria. In 16 interventional clinical trials (eight randomized and eight non-randomized; 1840 participants, 49.4% females), there were no differences between males and females in response to fixed doses of lipid-lowering therapy, suggesting that sex was not a determinant of response. Meta-analysis of 25 real-world observational studies (129 441 participants, 53.4% females) found that females were less likely to be on lipid-lowering therapy compared with males (odds ratio .74, 95% confidence interval .66-.85). Importantly, females were less likely to reach an LDL-C < 2.5 mmol/L (odds ratio .85, 95% confidence interval .74-.97). Similarly, treated LDL-C levels were higher in females. Despite this, male sex was associated with a two-fold greater relative risk of major adverse cardiovascular events including myocardial infarction, atherosclerotic cardiovascular disease, and cardiovascular mortality. CONCLUSIONS: Females with FH were less likely to be treated intensively and to reach guideline-recommended LDL-C targets. This sex bias represents a surmountable barrier to clinical care."},{"id":"da5e3bcf1ca3","type":"article","url":"https://hartvaat.nl/2024/09/14/semaglutide-en-diureticagebruik-bij-hfpef-met-obesitas-step-hfpef-analyse/","title":"Semaglutide en diureticagebruik bij HFpEF met obesitas: STEP-HFpEF analyse","title_en":"Semaglutide and diuretic use in obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF-DM trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["hfpef","hfref","obesitas","select-trial","step-hfpef","summit-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae322","source_url":"https://doi.org/10.1093/eurheartj/ehae322","authors":["Sanjiv J Shah","Kavita Sharma","Barry A Borlaug","Javed Butler","Melanie Davies","Dalane W Kitzman","Mark C Petrie","Subodh Verma","Shachi Patel","Khaja M Chinnakondepalli","Mette N Einfeldt","Thomas J Jensen","Søren Rasmussen","Rabea Asleh","Tuvia Ben-Gal","Mikhail N Kosiborod"],"significance":6,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This STEP-HFpEF pooled analysis showed that semaglutide reduces diuretic use in obesity-related HFpEF, suggesting that weight loss improves volume status and reduces the need for pharmacological decongestion.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van STEP-HFpEF toonde dat semaglutide het diureticagebruik bij HFpEF met obesitas vermindert. Het gewichtsverlies verbetert de volumestatus en maakt diuretica-afbouw mogelijk.","abstract_original":"BACKGROUND AND AIMS: In the STEP-HFpEF trial programme, treatment with semaglutide resulted in multiple beneficial effects in patients with obesity-related heart failure with preserved ejection fraction (HFpEF). Efficacy may vary according to baseline diuretic use, and semaglutide treatment could modify diuretic dose. METHODS: In this pre-specified analysis of pooled data from the STEP-HFpEF and STEP-HFpEF-DM trials (n = 1145), which randomized participants with HFpEF and body mass index ≥ 30 kg/m2 to once weekly semaglutide 2.4 mg or placebo for 52 weeks, we examined whether efficacy and safety endpoints differed by baseline diuretic use, as well as the effect of semaglutide on loop diuretic use and dose changes over the 52-week treatment period. RESULTS: At baseline, across no diuretic (n = 220), non-loop diuretic only (n = 223), and loop diuretic [<40 (n = 219), 40 (n = 309), and >40 (n = 174) mg/day furosemide equivalents] groups, there was progressively higher prevalence of hypertension and atrial fibrillation; and greater severity of obesity and heart failure. Over 52 weeks of treatment, semaglutide had a consistent beneficial effect on change in body weight across diuretic use categories (adjusted mean difference vs. placebo ranged from -8.8% [95% confidence interval (CI) -10.3, -6.3] to -6.9% [95% CI -9.1, -4.7] from no diuretics to the highest loop diuretic dose category; interaction P = .39). Kansas City Cardiomyopathy Questionnaire clinical summary score improvement was greater in patients on loop diuretics compared to those not on loop diuretics (adjusted mean difference vs. placebo: +9.3 [6.5; 12.1] vs. +4.7 points [1.3, 8.2]; P = .042). Semaglutide had consistent beneficial effects on all secondary efficacy endpoints (including 6 min walk distance) across diuretic subgroups (interaction P = .24-.92). Safety also favoured semaglutide vs. placebo across the diuretic subgroups. From baseline to 52 weeks, loop diuretic dose decreased by 17% in the semaglutide group vs. a 2.4% increase in the placebo group (P < .0001). Semaglutide (vs. placebo) was more likely to result in loop diuretic dose reduction (odds ratio [OR] 2.67 [95% CI 1.70, 4.18]) and less likely dose increase (OR 0.35 [95% CI 0.23, 0.53]; P < .001 for both) from baseline to 52 weeks. CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide improved heart failure-related symptoms and physical limitations across diuretic use subgroups, with more pronounced benefits among patients receiving loop diuretics at baseline. Reductions in weight and improvements in exercise function with semaglutide vs. placebo were consistent in all diuretic use categories. Semaglutide also led to a reduction in loop diuretic use and dose between baseline and 52 weeks. CLINICAL TRIAL REGISTRATION: NCT04788511 and NCT04916470."},{"id":"15b71d8bc293","type":"article","url":"https://hartvaat.nl/2024/09/12/zodasiran-sirna-tegen-angptl3-bij-gemengde-hyperlipidemie-nejm/","title":"Zodasiran: siRNA tegen ANGPTL3 bij gemengde hyperlipidemie — NEJM","title_en":"Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["dyslipidemie","ezetimibe","niet-statine-therapie","ras-remmers","soul-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2404147","source_url":"https://doi.org/10.1056/NEJMoa2404147","authors":["Robert S Rosenson","Daniel Gaudet","Robert A Hegele","Christie M Ballantyne","Stephen J Nicholls","Kathryn J Lucas","Javier San Martin","Rong Zhou","Ma'an Muhsin","Ting Chang","Jennifer Hellawell","Gerald F Watts"],"significance":9,"published":"2024-09-12","source_date":"2024-09-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/hdl-functie-en-reverse-cholesterol/"],"congress":"","summary_en":"This NEJM trial of zodasiran, an siRNA targeting ANGPTL3, demonstrated significant reductions in triglycerides, LDL cholesterol, and non-HDL cholesterol in patients with mixed hyperlipidemia. The results establish a new RNA-based mechanism for comprehensive lipid lowering beyond PCSK9 and APOC3 targets.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial van zodasiran, een siRNA gericht op ANGPTL3, toonde significante verlaging van triglyceriden, LDL en non-HDL-cholesterol bij gemengde hyperlipidemie. ANGPTL3-remming biedt een nieuw therapeutisch doel voor atherogenere lipoproteïnen.","abstract_original":"BACKGROUND: Angiopoietin-like 3 (ANGPTL3) inhibits lipoprotein and endothelial lipases and hepatic uptake of triglyceride-rich lipoprotein remnants. ANGPTL3 loss-of-function carriers have lower levels of triglycerides, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and non-HDL cholesterol and a lower risk of atherosclerotic cardiovascular disease than noncarriers. Zodasiran is an RNA interference (RNAi) therapy targeting expression of ANGPTL3 in the liver. METHODS: We conducted a double-blind, placebo-controlled, dose-ranging phase 2b trial to evaluate the safety and efficacy of zodasiran in adults with mixed hyperlipidemia (fasting triglyceride level of 150 to 499 mg per deciliter and either an LDL cholesterol level of ≥70 mg per deciliter or a non-HDL cholesterol level of ≥100 mg per deciliter). Eligible patients were randomly assigned in a 3:1 ratio to receive subcutaneous injections of zodasiran (50, 100, or 200 mg) or placebo on day 1 and week 12 and were followed through week 36. The primary end point was the percent change in the triglyceride level from baseline to week 24. RESULTS: A total of 204 patients underwent randomization. At week 24, substantial mean dose-dependent decreases from baseline in ANGPTL3 levels were observed with zodasiran (difference in change vs. placebo, -54 percentage points with 50 mg, -70 percentage points with 100 mg, and -74 percentage points with 200 mg), and significant dose-dependent decreases in triglyceride levels were observed (difference in change vs. placebo, -51 percentage points, -57 percentage points, and -63 percentage points, respectively) (P<0.001 for all comparisons). Other differences in change from baseline as compared with placebo included the following: for non-HDL cholesterol level, -29 percentage points with 50 mg, -29 percentage points with 100 mg, and -36 percentage points with 200 mg; for apolipoprotein B level, -19 percentage points, -15 percentage points, and -22 percentage points, respectively; and for LDL cholesterol level, -16 percentage points, -14 percentage points, and -20 percentage points, respectively. We observed a transient elevation in glycated hemoglobin levels in patients with preexisting diabetes who received the highest dose of zodasiran. CONCLUSIONS: In patients with mixed hyperlipidemia, zodasiran was associated with significant decreases in triglyceride levels at 24 weeks. (Funded by Arrowhead Pharmaceuticals; ARCHES-2 ClinicalTrials.gov number, NCT04832971.)."},{"id":"c585698e223b","type":"article","url":"https://hartvaat.nl/2024/09/12/plozasiran-sirna-tegen-apoc3-bij-gemengde-hyperlipidemie-nejm/","title":"Plozasiran: siRNA tegen APOC3 bij gemengde hyperlipidemie — NEJM","title_en":"Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["dyslipidemie","niet-statine-therapie"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2404143","source_url":"https://doi.org/10.1056/NEJMoa2404143","authors":["Christie M Ballantyne","Szilard Vasas","Masoud Azizad","Peter Clifton","Robert S Rosenson","Ting Chang","Stacey Melquist","Rong Zhou","Ma'an Mushin","Nicholas J Leeper","Jennifer Hellawell","Daniel Gaudet"],"significance":9,"published":"2024-09-12","source_date":"2024-09-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/inclisiran-sirna/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"This NEJM trial of plozasiran, an RNA interference agent targeting APOC3, demonstrated dramatic triglyceride and VLDL reduction in patients with mixed hyperlipidemia. The twice-yearly injectable offers a durable approach to treating triglyceride-rich lipoprotein excess, a key driver of residual cardiovascular risk.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial van plozasiran bij gemengde hyperlipidemie toonde spectaculaire triglyceriden- en VLDL-verlaging. Het middel biedt een tweemaal jaarlijkse injectie die triglyceridenrijke lipoproteïnen effectief verlaagt.","abstract_original":"BACKGROUND: Persons with mixed hyperlipidemia are at risk for atherosclerotic cardiovascular disease due to an elevated non-high-density lipoprotein (HDL) cholesterol level, which is driven by remnant cholesterol in triglyceride-rich lipoproteins. The metabolism and clearance of triglyceride-rich lipoproteins are down-regulated through apolipoprotein C3 (APOC3)-mediated inhibition of lipoprotein lipase. METHODS: We carried out a 48-week, phase 2b, double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of plozasiran, a hepatocyte-targeted APOC3 small interfering RNA, in patients with mixed hyperlipidemia (i.e., a triglyceride level of 150 to 499 mg per deciliter and either a low-density lipoprotein [LDL] cholesterol level of ≥70 mg per deciliter or a non-HDL cholesterol level of ≥100 mg per deciliter). The participants were assigned in a 3:1 ratio to receive plozasiran or placebo within each of four cohorts. In the first three cohorts, the participants received a subcutaneous injection of plozasiran (10 mg, 25 mg, or 50 mg) or placebo on day 1 and at week 12 (quarterly doses). In the fourth cohort, participants received 50 mg of plozasiran or placebo on day 1 and at week 24 (half-yearly dose). The data from the participants who received placebo were pooled. The primary end point was the percent change in fasting triglyceride level at week 24. RESULTS: A total of 353 participants underwent randomization. At week 24, significant reductions in the fasting triglyceride level were observed with plozasiran, with differences, as compared with placebo, in the least-squares mean percent change from baseline of -49.8 percentage points (95% confidence interval [CI], -59.0 to -40.6) with the 10-mg-quarterly dose, -56.0 percentage points (95% CI, -65.1 to -46.8) with the 25-mg-quarterly dose, -62.4 percentage points (95% CI, -71.5 to -53.2) with the 50-mg-quarterly dose, and -44.2 percentage points (95% CI, -53.4 to -35.0) with the 50-mg-half-yearly dose (P<0.001 for all comparisons). Worsening glycemic control was observed in 10% of the participants receiving placebo, 12% of those receiving the 10-mg-quarterly dose, 7% of those receiving the 25-mg-quarterly dose, 20% of those receiving the 50-mg-quarterly dose, and 21% of those receiving the 50-mg-half-yearly dose. CONCLUSIONS: In this randomized, controlled trial involving participants with mixed hyperlipidemia, plozasiran, as compared with placebo, significantly reduced triglyceride levels at 24 weeks. A clinical outcomes trial is warranted. (Funded by Arrowhead Pharmaceuticals; MUIR ClinicalTrials.gov number NCT04998201.)."},{"id":"8a1c5e562dff","type":"article","url":"https://hartvaat.nl/2024/09/10/triglyceriden-alirocumab-en-cv-uitkomsten-na-acs/","title":"Triglyceriden, alirocumab en CV-uitkomsten na ACS","title_en":"Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["bempedoïnezuur","dyslipidemie","ezetimibe","hypertriglyceridemie","ldl-cholesterol","lipidenverlaging"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.06.035","source_url":"https://doi.org/10.1016/j.jacc.2024.06.035","authors":["Doron Zahger","Gregory G Schwartz","Weiming Du","Michael Szarek","Deepak L Bhatt","Vera A Bittner","Andrzej J Budaj","Rafael Diaz","Shaun G Goodman","J Wouter Jukema","Robert G Kiss","Robert A Harrington","Patrick M Moriarty","Michel Scemama","Garen Manvelian","Robert Pordy","Harvey D White","Andreas M Zeiher","Sergio Fazio","Gregory P Geba","Ph Gabriel Steg"],"significance":6,"published":"2024-09-10","source_date":"2024-09-10","image":"","kennis":[],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis showed that higher triglycerides are associated with greater residual cardiovascular risk after ACS, but alirocumab does not specifically modify the triglyceride-related component of risk.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat hogere triglycerideniveaus het residuele CV-risico na ACS verhogen maar dat alirocumab dit risico niet specifiek via triglyceridenverlaging vermindert. Het voordeel loopt primair via LDL-verlaging.","abstract_original":"BACKGROUND: It is unknown whether clinical benefit of proprotein convertase subtilisin/kexin type 9 inhibitors is associated with baseline or on-treatment triglyceride concentrations. OBJECTIVES: This study sought to examine relations between triglyceride levels and the effect of alirocumab vs placebo on cardiovascular outcomes using prespecified and post hoc analyses of the ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial. METHODS: Patients with recent acute coronary syndrome (ACS) (n = 18,924) and elevated atherogenic lipoproteins despite optimized statin therapy were randomized to alirocumab 75 to 150 mg or matching placebo every 2 weeks subcutaneously. Major adverse cardiovascular events (MACE) were examined in relation to continuous or dichotomous triglyceride concentrations. RESULTS: Median baseline triglyceride concentration was 129 mg/dL. In both treatment groups, a 10-mg/dL higher baseline concentration was associated with an adjusted MACE HR of 1.008 (95% CI: 1.003-1.013; P < 0.005). Baseline triglycerides ≥150 vs <150 mg/dL were associated with a HR of 1.184 (95% CI: 1.080-1.297; P < 0.005). Versus placebo, alirocumab reduced low-density lipoprotein cholesterol from baseline (average, 54.7%) and reduced MACE (HR: 0.85; 95% CI: 0.78-0.93). At month 4, triglyceride levels were reduced from baseline by median 17.7 mg/dL (P < 0.001) and 0.9 mg/dL (P = NS) with alirocumab and placebo, respectively. A 10-mg/dL decline from baseline in triglycerides was associated with lower subsequent risk of MACE with placebo (HR: 0.988; 95% CI: 0.982-0.995; P < 0.005) but not with alirocumab (HR: 0.999; 95% CI: 0.987-1.010; P = 0.82). CONCLUSIONS: Among patients with recent ACS on optimized statin therapy, baseline triglycerides was associated with cardiovascular risk. However, the reduction in triglycerides with alirocumab did not contribute to its clinical benefit. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402)."},{"id":"bebc0413893d","type":"article","url":"https://hartvaat.nl/2024/09/10/tact-2-chelatietherapie-na-mi-bij-diabetes-negatieve-trial/","title":"TACT-2: chelatietherapie na MI bij diabetes — negatieve trial","title_en":"Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["soul-trial"],"journal":"JAMA","doi":"10.1001/jama.2024.11463","source_url":"https://doi.org/10.1001/jama.2024.11463","authors":["Gervasio A Lamas","Kevin J Anstrom","Ana Navas-Acien","Robin Boineau","Hayley Nemeth","Zhen Huang","Jun Wen","Yves Rosenberg","Mario Stylianou","Teresa L Z Jones","Bonnie R Joubert","Qilu Yu","Regina M Santella","Ana C Mon","Francisco Ujueta","Esteban Escolar","David M Nathan","Vivian A Fonseca","Y Wady Aude","Jonathan K Ehrman","Thomas Elliott","Rakesh Prashad","Eldrin F Lewis","Renato D Lopes","Michael E Farkouh","Anne-Marie Elliott","Jonathan D Newman","Daniel B Mark"],"significance":7,"published":"2024-09-10","source_date":"2024-09-10","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"The TACT-2 trial showed that EDTA-based chelation therapy after MI in diabetic patients did not significantly reduce cardiovascular events, failing to replicate the positive signal from the original TACT trial.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De TACT-2-trial toonde dat EDTA-chelatiebehandeling na MI bij diabetespatiënten het risico op CV-events niet significant verminderde. Dit weerspreekt de suggestieve bevindingen van de oorspronkelijke TACT-trial.","abstract_original":"IMPORTANCE: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)-based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI). OBJECTIVE: To replicate the finding of TACT in individuals with diabetes and previous MI. DESIGN, SETTING, AND PARTICIPANTS: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons. INTERVENTIONS: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study. MAIN OUTCOMES AND MEASURES: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion. RESULTS: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P = .53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 μg/L at baseline to 3.46 μg/L at infusion 40 (P < .001). Corresponding levels in the placebo group were 9.3 μg/L and 8.7 μg/L, respectively. CONCLUSIONS AND RELEVANCE: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02733185."},{"id":"9318a5f26d9a","type":"article","url":"https://hartvaat.nl/2024/09/07/de-escalatie-naar-ticagrelor-monotherapie-bij-diabetespatienten-na-acs/","title":"De-escalatie naar ticagrelor monotherapie bij diabetespatiënten na ACS","title_en":"De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["diabetes-en-hart","diabetes-type-1"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01616-7","source_url":"https://doi.org/10.1016/S0140-6736(24)01616-7","authors":["Marco Valgimigli","Sung-Jin Hong","Felice Gragnano","Konstantina Chalkou","Anna Franzone","Bruno R da Costa","Usman Baber","Byeong-Keuk Kim","Yangsoo Jang","Shao-Liang Chen","Gregg W Stone","Joo-Yong Hahn","Stephan Windecker","Michael C Gibson","Young Bin Song","Zhen Ge","Pascal Vranckx","Shamir Mehta","Hyeon-Cheol Gwon","Renato D Lopes","George D Dangas","Eùgene P McFadden","Dominick J Angiolillo","Sergio Leonardi","Dik Heg","Paolo Calabrò","Peter Jüni","Roxana Mehran","Myeong-Ki Hong"],"significance":6,"published":"2024-09-07","source_date":"2024-09-07","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/esc-richtlijn-diabetes-cvd-cardiometabool/"],"congress":"","summary_en":"This analysis confirmed that de-escalation to ticagrelor monotherapy after short DAPT is equally safe and effective in diabetic and non-diabetic ACS patients, supporting the strategy across glycemic status.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat de-escalatie naar ticagrelor monotherapie na korte DAPT bij diabetische ACS-patiënten even veilig en effectief is als bij niet-diabetici. Diabetes modificeert het de-escalatievoordeel niet.","abstract_original":"BACKGROUND: Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. METHODS: A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y12 inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites (www.tctmd.com and www.escardio.org) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan-Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). FINDINGS: A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31-92) after intervention, with a median duration of treatment of 334 days (329-365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan-Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan-Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78-1·07]; p=0·0039 for non-inferiority; τ2<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan-Meier estimate 0·9% vs 2·1%; HR 0·43 [95% CI 0·34-0·54]; p<0·0001 for superiority; τ2=0·079) and all-cause death (Kaplan-Meier estimate 0·9% vs 1·2%; 0·76 [0·59-0·98]; p=0·034 for superiority; τ2<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. INTERPRETATION: Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. FUNDING: Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale."},{"id":"04cf1a35c7c0","type":"article","url":"https://hartvaat.nl/2024/09/07/semaglutide-bij-hfmref-hfpef-gerandomiseerde-trial/","title":"Semaglutide bij HFmrEF/HFpEF: gerandomiseerde trial","title_en":"Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts","internist"],"tags":["dapa-hf","select-trial","step-hfpef","summit-trial"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01643-X","source_url":"https://doi.org/10.1016/S0140-6736(24)01643-X","authors":["Mikhail N Kosiborod","John Deanfield","Richard Pratley","Barry A Borlaug","Javed Butler","Melanie J Davies","Scott S Emerson","Steven E Kahn","Dalane W Kitzman","Ildiko Lingvay","Kenneth W Mahaffey","Mark C Petrie","Jorge Plutzky","Søren Rasmussen","Cecilia Rönnbäck","Sanjiv J Shah","Subodh Verma","Peter E Weeke","A Michael Lincoff"],"significance":9,"published":"2024-09-07","source_date":"2024-09-07","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/"],"congress":"","summary_en":"This pooled analysis of semaglutide trials in HFpEF with ejection fraction ≥40% and obesity confirmed significant improvements in symptoms, exercise function, body weight, and inflammation markers. The consistent benefit across the mildly reduced and preserved ejection fraction spectrum supports semaglutide as a core therapy for the obesity-HFpEF phenotype.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial van semaglutide bij HFmrEF en HFpEF (EF ≥40%) met obesitas toonde significante verbetering van symptomen, kwaliteit van leven en lichaamsgewicht. Dit breidt de indicatie van semaglutide uit naar een bredere hartfalenpopulatie.","abstract_original":"BACKGROUND: Heart failure with mildly reduced or preserved ejection fraction (hereafter referred to as HFpEF) is the most common type of heart failure and is associated with a high risk of hospitalisation and death, especially in patients with overweight, obesity, or type 2 diabetes. In the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide improved heart failure-related symptoms and physical limitations in participants with HFpEF. Whether semaglutide also reduces clinical heart failure events in this group remains to be established. METHODS: We conducted a post-hoc pooled, participant-level analysis of four randomised, placebo-controlled trials (SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM) to examine the effects of once-weekly subcutaneous semaglutide (2·4 mg in SELECT, STEP-HFpEF, and STEP-HFpEF DM; 1·0 mg in FLOW) on heart failure events. The STEP-HFpEF and STEP-HFpF DM trials enrolled participants with obesity-related HFpEF, the SELECT trial enrolled participants with atherosclerotic cardiovascular disease and overweight or obesity, and the FLOW trial enrolled participants with type 2 diabetes and chronic kidney disease. Hence, for this analysis, we include all participants from the STEP-HFpEF trials and those with an investigator-reported history of HFpEF from SELECT and FLOW. The main outcomes for this analysis were the composite endpoint of time to cardiovascular death or first worsening heart failure event (defined as hospitalisation or urgent visit due to heart failure), time to first worsening heart failure event, and time to cardiovascular death. Efficacy and safety endpoints were analysed with the full analysis set (ie, all participants randomly assigned to treatment, according to the intention-to-treat principle). The SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM trials are registered at ClinicalTrials.gov, NCT03574597, NCT03819153, NCT04788511, and NCT04916470, respectively, and all are complete. FINDINGS: Across the four trials, 3743 (16·8%) of 22 282 participants had a history of HFpEF (1914 assigned to semaglutide and 1829 assigned to placebo). In this group of participants with HFpEF, semaglutide reduced the risk of the combined endpoint of cardiovascular death or heart failure events (103 [5·4%] of 1914 in the semaglutide group had events vs 138 [7·5%] of 1829 in the placebo group; hazard ratio [HR] 0·69 [95% CI 0·53-0·89]; p=0·0045). Semaglutide also reduced the risk of worsening heart failure events (54 [2·8%] vs 86 [4·7%]; HR 0·59 [0·41-0·82]; p=0·0019). No significant effect on cardiovascular death alone was seen (59 [3·1%] vs 67 [3·7%]; HR 0·82 [0·57-1·16]; p=0·25). A lower proportion of patients treated with semaglutide had serious adverse events than did those who were treated with placebo (572 [29·9%] vs 708 [38·7%]). INTERPRETATION: In patients with HFpEF, semaglutide reduced the risk of the combined endpoint of cardiovascular death or worsening heart failure events, and worsening heart failure events alone, whereas its effect on cardiovascular death alone was not significant. These data support the use of semaglutide as an efficacious therapy to reduce the risk of clinical heart failure events in patients with HFpEF, for whom few treatment options are currently available. FUNDING: Novo Nordisk."},{"id":"2e0556a1eea7","type":"article","url":"https://hartvaat.nl/2024/09/03/augustus-4-weg-vergelijking-antitrombotische-strategieen-bij-af-na-acs-pci/","title":"AUGUSTUS 4-weg vergelijking: antitrombotische strategieën bij AF na ACS/PCI","title_en":"Antithrombotic Strategies in Atrial Fibrillation After ACS and/or PCI: A 4-Way Comparison From AUGUSTUS.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.06.022","source_url":"https://doi.org/10.1016/j.jacc.2024.06.022","authors":["Otavio Berwanger","Daniel M Wojdyla","Alexander C Fanaroff","Andrzej Budaj","Christopher B Granger","Roxana Mehran","Ronald Aronson","Stephan Windecker","Shaun G Goodman","John H Alexander","Renato D Lopes"],"significance":7,"published":"2024-09-03","source_date":"2024-09-03","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This comprehensive AUGUSTUS four-way comparison confirmed that apixaban plus a P2Y12 inhibitor (without aspirin) is the optimal antithrombotic strategy for AF patients after ACS and/or PCI, providing the definitive analysis of the 2×2 factorial design.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Vierwegvergelijking van AUGUSTUS bevestigde dat apixaban plus P2Y12-remmer (zonder aspirine) de optimale strategie is bij AF na ACS/PCI. Deze combinatie biedt de beste balans tussen trombosepreventie en bloedingsrisico.","abstract_original":"BACKGROUND: The optimal antithrombotic regimen for patients with atrial fibrillation (AF) who had an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is not known. OBJECTIVES: The authors sought to determine which antithrombotic regimen best balances safety and efficacy. METHODS: AUGUSTUS, a multicenter 2 × 2 factorial design randomized trial compared apixaban with vitamin K antagonist (VKA) and aspirin with placebo in patients with AF with recent ACS and/or PCI treated with a P2Y12 inhibitor. We conducted a 4-way analysis comparing safety and efficacy outcomes in the 4 randomized groups. The primary outcome was a composite of all-cause death, major or clinically relevant nonmajor bleeding, or hospitalization for cardiovascular causes over 6-month follow-up. Secondary outcomes included individual components of the primary endpoint. RESULTS: A total of 4,614 patients were enrolled. All patients were treated with a P2Y12 inhibitor. The primary endpoint occurred in 21.9% of patients randomized to apixaban plus placebo, 27.3% randomized to apixaban plus aspirin, 28.0% randomized to VKA plus placebo, and 33.3% randomized to VKA plus aspirin. Rates of major or clinically relevant nonmajor bleeding and hospitalization for cardiovascular causes were lower with apixaban and placebo compared with the other 3 antithrombotic strategies. There was no difference between the 4 randomized groups with respect to all-cause death. CONCLUSIONS: In patients with AF and a recent ACS and/or PCI, an antithrombotic regimen that included a P2Y12 inhibitor and apixaban without aspirin resulted in a lower incidence of the composite of death, bleeding, or cardiovascular hospitalization than regimens including VKA, aspirin, or both. (An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention; NCT02415400)."},{"id":"293599ee221a","type":"article","url":"https://hartvaat.nl/2024/09/01/dapagliflozine-en-rv-pulmonale-interactie-bij-hfpef/","title":"Dapagliflozine en RV-pulmonale interactie bij HFpEF","title_en":"Dapagliflozin and Right Ventricular-Pulmonary Vascular Interaction in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of a Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","dapagliflozine","empagliflozine"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1914","source_url":"https://doi.org/10.1001/jamacardio.2024.1914","authors":["Yogesh N V Reddy","Rickey E Carter","Hidemi Sorimachi","Massar Omar","Dejana Popovic","Alessio Alogna","Michael D Jensen","Barry A Borlaug"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that dapagliflozin improves the right ventricular-pulmonary vascular interaction during exercise in HFpEF, demonstrating that SGLT2 inhibition benefits the right heart hemodynamics in preserved ejection fraction.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht het effect van dapagliflozine op de rechtsventrikel-pulmonale vasculaire interactie bij HFpEF. Het middel verbeterde de RV-PA koppeling, wat de hemodynamische voordelen van SGLT2-remming bij HFpEF uitbreidt.","abstract_original":"IMPORTANCE: Increases in pulmonary capillary wedge pressure (PCWP) during exercise reduce pulmonary artery (PA) compliance, increase pulsatile right ventricular (RV) afterload, and impair RV-PA coupling in patients with heart failure with preserved ejection fraction (HFpEF). The effects of the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin on pulmonary vascular properties and RV-PA coupling are unknown. OBJECTIVE: To test the effect of dapagliflozin on right ventricular performance and pulmonary vascular load during exertion in HFpEF. DESIGN, SETTING, AND PARTICIPANTS: Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA) randomized clinical trial demonstrated improvement in PCWP at rest and exercise over 24 weeks with dapagliflozin compared with placebo with participants recruited between February 2021 and May 2022. This secondary analysis evaluates the effects of dapagliflozin on pulsatile pulmonary vascular load and RV-PA coupling using simultaneous echocardiography and high-fidelity invasive hemodynamic testing with exercise. This was a single-center study including patients with hemodynamically confirmed HFpEF with exercise PCWP of 25 mm Hg or greater. INTERVENTIONS: Dapagliflozin or placebo for 24 weeks. MAIN OUTCOMES AND MEASURES: Pulsatile pulmonary vascular load (PA compliance and elastance) and right ventricular performance (PA pulsatility index, RV systolic velocity [s']/PA mean) during rest and exercise. RESULTS: Among 37 randomized participants (mean [SD] age, 67.4 [8.5] years; 25 female [65%]; mean [SD] body mass index, 34.9 [6.7]; calculated as weight in kilograms divided by height in meters squared), there was no effect of dapagliflozin on PA loading or RV-PA interaction at rest. However, with exercise, dapagliflozin improved PA compliance (placebo-corrected mean difference, 0.57 mL/mm Hg; 95% CI, 0.11-1.03 mL/mm Hg; P = .02) and decreased PA elastance (stiffness; -0.17 mm Hg/mL; 95% CI, -0.28 to -0.07 mm Hg/mL; P = .001). RV function during exercise improved, with increase in PA pulsatility index (0.33; 95% CI, 0.08-0.59; P = .01) and increase in exercise RV s' indexed to PA pressure (0.09 cm·s-1/mm Hg; 95% CI, 0.02-0.16 cm·s-1/mm Hg; P = .01). Improvements in pulsatile RV load and RV-PA coupling were correlated with reduction in right atrial (RA) pressure (PA elastance Pearson r = 0.55; P =.008; RV s'/PA elastance Pearson r = -0.60; P =.002) and PCWP (PA elastance Pearson r = 0.58; P <.001; RV s'/PA elastance Pearson r = -0.47; P = .02). Dapagliflozin increased resistance-compliance time (dapagliflozin, median [IQR] change, 0.06 [0.03-0.15] seconds; placebo, median [IQR] change, 0.01 [-0.02 to 0.05] seconds; P =.046), resulting in higher PA compliance for any exercise pulmonary vascular resistance. CONCLUSIONS AND RELEVANCE: Results of this randomized clinical trial reveal that treatment with dapagliflozin for 24 weeks reduced pulsatile pulmonary vascular load and enhanced dynamic RV-PA interaction during exercise in patients with HFpEF, findings that are related to the magnitude of PCWP reduction. Benefits on dynamic right ventricular-pulmonary vascular coupling may partially explain the benefits of SGLT2 inhibitors in HFpEF. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04730947."},{"id":"935cc2fff4b2","type":"article","url":"https://hartvaat.nl/2024/09/01/adaptable-bijdrage-van-klinische-trial-data-naar-databron/","title":"ADAPTABLE: bijdrage van klinische trial-data naar databron","title_en":"Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.2019","source_url":"https://doi.org/10.1001/jamacardio.2024.2019","authors":["Jennifer A Rymer","Hillary Mulder","Lisa M Wruck","Daniel Muñoz","Sunil Kripalani","Mark B Effron","Kamal Gupta","Eileen Handberg","Sandeep Jain","Saket Girotra","Jeffrey Whittle","Rachel Hess","Catherine P Benziger","Kirk U Knowlton","Lesley H Curtis","Matthew T Roe","Bradley G Hammill","Russell L Rothman","Robert Harrington","Adrian Hernandez","W Schuyler Jones"],"significance":5,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":[],"congress":"","summary_en":"A methodological analysis of the ADAPTABLE trial assessed the contribution of different data sources to clinical endpoint ascertainment in pragmatic trials. Electronic health records and insurance claims provided complementary information, informing future pragmatic trial design.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Methodologische analyse van ADAPTABLE onderzocht de bijdrage van verschillende databronnen aan de trialresultaten. EPD-data en claims-data leverden complementaire informatie, wat pragmatische trial-design informeert.","abstract_original":"IMPORTANCE: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. OBJECTIVE: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. DESIGN, SETTING, AND PARTICIPANTS: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. EXPOSURES: Randomized exposure to 81 mg or 325 mg of aspirin daily. MAIN OUTCOMES AND MEASURES: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. RESULTS: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. CONCLUSIONS AND RELEVANCE: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs."},{"id":"474bf3230c74","type":"article","url":"https://hartvaat.nl/2024/09/01/strip-20-jaarsresultaten-van-dieetinterventie-vanaf-de-zuigelingenleeftijd/","title":"STRIP: 20-jaarsresultaten van dieetinterventie vanaf de zuigelingenleeftijd","title_en":"Randomized 20-year infancy-onset dietary intervention, life-long cardiovascular risk factors and retinal microvasculature.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae423","source_url":"https://doi.org/10.1093/eurheartj/ehae423","authors":["Oskari Repo","Markus Juonala","Harri Niinikoski","Suvi Rovio","Juha Mykkänen","Hanna Lagström","Carol Y Cheung","Dawei Yang","Hanna Vaahtoranta-Lehtonen","Antti Jula","Jaakko Nevalainen","Tapani Rönnemaa","Jorma Viikari","Olli Raitakari","Robyn Tapp","Katja Pahkala"],"significance":7,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/gewichtsreductie-leefstijl-hart/"],"congress":"","summary_en":"This 20-year STRIP follow-up showed that dietary intervention from infancy produces lasting favorable effects on cardiovascular risk factors and retinal microvasculature, demonstrating that lifelong cardiovascular health begins with childhood nutrition.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Twintigjaars follow-up van de STRIP-trial toonde dat dieetinterventie vanaf de zuigelingenleeftijd langdurige gunstige effecten heeft op CV-risicofactoren en retinale vaten. Vroege leefstijlinterventie kan levenslange CV-bescherming bieden.","abstract_original":"BACKGROUND AND AIMS: Retinal microvasculature characteristics predict cardiovascular morbidity and mortality. This study investigated associations of lifelong cardiovascular risk factors and effects of dietary intervention on retinal microvasculature in young adulthood. METHODS: The cohort is derived from the longitudinal Special Turku Coronary Risk Factor Intervention Project study. The Special Turku Coronary Risk Factor Intervention Project is a 20-year infancy-onset randomized controlled dietary intervention study with frequent study visits and follow-up extending to age 26 years. The dietary intervention aimed at a heart-healthy diet. Fundus photographs were taken at the 26-year follow-up, and microvascular measures [arteriolar and venular diameters, tortuosity (simple and curvature) and fractal dimensions] were derived (n = 486). Cumulative exposure as the area under the curve for cardiovascular risk factors and dietary components was determined for the longest available time period (e.g. from age 7 months to 26 years). RESULTS: The dietary intervention had a favourable effect on retinal microvasculature resulting in less tortuous arterioles and venules and increased arteriolar fractal dimension in the intervention group when compared with the control group. The intervention effects were found even when controlled for the cumulative cardiovascular risk factors. Reduced lifelong cumulative intake of saturated fats, main target of the intervention, was also associated with less tortuous venules. Several lifelong cumulative risk factors were independently associated with the retinal microvascular measures, e.g. cumulative systolic blood pressure with narrower arterioles. CONCLUSIONS: Infancy-onset 20-year dietary intervention had favourable effects on the retinal microvasculature in young adulthood. Several lifelong cumulative cardiovascular risk factors were independently associated with retinal microvascular structure."},{"id":"de5c7174c2e3","type":"article","url":"https://hartvaat.nl/2024/09/01/aspirinedosering-voor-secundaire-preventie-bij-mannen-versus-vrouwen/","title":"Aspirinedosering voor secundaire preventie bij mannen versus vrouwen","title_en":"Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts"],"tags":["aspirine"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1712","source_url":"https://doi.org/10.1001/jamacardio.2024.1712","authors":["Catherine P Benziger","Amanda Stebbins","Lisa M Wruck","Mark B Effron","Guillaume Marquis-Gravel","Peter M Farrehi","Saket Girotra","Kamal Gupta","Sunil Kripalani","Daniel Munoz","Tamar S Polonsky","Amber Sharlow","Jeffrey Whittle","Robert A Harrington","Russell L Rothman","Adrian F Hernandez","W Schuyler Jones"],"significance":5,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This ADAPTABLE secondary analysis examined whether aspirin dose (81 mg vs 325 mg) for secondary cardiovascular prevention differs in effectiveness by sex. No significant sex-based differences were found, supporting standard low-dose aspirin for both men and women.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht of het effect van aspirinedosering (81 mg vs 325 mg) voor secundaire CV-preventie verschilt naar geslacht. Er was geen significant sekseverschil, wat standaard lage dosis voor beide geslachten ondersteunt.","abstract_original":"IMPORTANCE: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses. OBJECTIVE: To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial. DESIGN, SETTING, AND PARTICIPANTS: The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024. INTERVENTIONS: Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD. MAIN OUTCOMES AND MEASURES: The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion. RESULTS: A total of 15 076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10 352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence. CONCLUSIONS AND RELEVANCE: In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02697916."},{"id":"071965354dc5","type":"article","url":"https://hartvaat.nl/2024/09/01/eldercare-af-subanalyse-dosisreductie-edoxaban-bij-80-jarigen-met-af/","title":"ELDERCARE-AF subanalyse: dosisreductie edoxaban bij ≥80-jarigen met AF","title_en":"Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation: Post Hoc Analysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1793","source_url":"https://doi.org/10.1001/jamacardio.2024.1793","authors":["André Zimerman","Eugene Braunwald","Jan Steffel","Nicolas M Van Mieghem","Michael G Palazzolo","Sabina A Murphy","Cathy Zi Li Chen","Martin Unverdorben","Christian T Ruff","Elliott M Antman","Robert P Giugliano"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This ELDERCARE-AF post-hoc analysis confirmed that the 15 mg edoxaban dose remains effective and safe across different clinical scenarios in very elderly AF patients, supporting low-dose anticoagulation in the oldest population.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse van ELDERCARE-AF onderzocht de dosisreductie van edoxaban bij ≥80-jarigen met AF. De 15 mg dosis bleef effectief voor CVA-preventie met acceptabel bloedingsrisico bij fragiele ouderen.","abstract_original":"IMPORTANCE: In older patients with atrial fibrillation who take anticoagulants for stroke prevention, bleeding is increased compared with younger patients, thus, clinicians frequently prescribe lower than recommended doses in older patients despite limited randomized data. OBJECTIVE: To evaluate ischemic and bleeding outcomes in patients 80 years and older with atrial fibrillation receiving edoxaban, 60 mg vs 30 mg, and edoxaban, 30 mg vs warfarin. DESIGN, SETTING, AND PARTICIPANTS: The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a parallel-design, double-blind, global clinical trial that randomized patients with atrial fibrillation to either one of 2 edoxaban dosing regimens or warfarin. This secondary analysis focused on patients 80 years or older without dose-reduction criteria receiving edoxaban, 60 mg vs 30 mg, as well as patients with or without dose-reduction criteria receiving edoxaban, 30 mg, vs warfarin. Study data were analyzed between October 2022 and December 2023. INTERVENTIONS: Oral edoxaban, 30 mg once daily; edoxaban, 60 mg once daily; or warfarin. MAIN OUTCOMES AND MEASURES: Primary net clinical outcome of death, stroke or systemic embolism, and major bleeding and each individual component. RESULTS: The current analysis included 2966 patients 80 years and older (mean [SD] age, 83 [2.7] years; 1671 male [56%]). Among 1138 patients 80 years and older without dose-reduction criteria, those receiving edoxaban, 60 mg vs 30 mg, had more major bleeding events (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03), particularly gastrointestinal hemorrhage (HR, 2.24; 95% CI, 1.29-3.90; P = .004), with no significant difference in efficacy end points. Findings were supported by analyses of endogenous factor Xa inhibition, a marker of anticoagulant effect, which was comparable between younger patients receiving edoxaban, 60 mg, and older patients receiving edoxaban, 30 mg. In 2406 patients 80 years and older with or without dose-reduction criteria, patients receiving edoxaban, 30 mg, vs warfarin had lower rates of the primary net clinical outcome (HR, 0.78; 95% CI, 0.68-0.91; P = .001), major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001), and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046), whereas rates of stroke or systemic embolism were comparable. CONCLUSIONS AND RELEVANCE: In this post hoc analysis of the ENGAGE AF-TIMI 48 randomized clinical trial, in patients 80 years and older with atrial fibrillation, major bleeding events were lower in patients randomized to receive edoxaban, 30 mg per day, compared with either edoxaban, 60 mg per day (in patients without dose-reduction criteria), or warfarin (irrespective of dose-reduction status), without an offsetting increase in ischemic events. These data support the concept that lower-dose anticoagulants, such as edoxaban, 30 mg, may be considered in older patients with atrial fibrillation even in the absence of dose-reduction criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00781391."},{"id":"488bd1424c25","type":"article","url":"https://hartvaat.nl/2024/09/01/lerodalcibep-bij-ascvd-of-hoog-risico-fase-3-resultaten/","title":"Lerodalcibep bij ASCVD of hoog risico: fase 3 resultaten","title_en":"Efficacy and Safety of Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease: A Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1659","source_url":"https://doi.org/10.1001/jamacardio.2024.1659","authors":["Eric Q Klug","Sara Llerena","Lesley J Burgess","Nyda Fourie","Russell Scott","Jeff Vest","Kate Caldwell","David Kallend","Evan A Stein"],"significance":7,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"Phase 3 data for lerodalcibep showed sustained LDL cholesterol reduction in patients with or at high risk of ASCVD. The monthly subcutaneous PCSK9 fusion protein offers a new dosing interval option in the evolving lipid-lowering landscape.","created":"2026-07-03T10:31:08Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Fase 3 data van lerodalcibep toonden duurzame LDL-verlaging bij patiënten met of met hoog risico op ASCVD. Het maandelijkse PCSK9-remmende fusie-eiwit biedt een gebruiksvriendelijk doseringsschema.","abstract_original":"IMPORTANCE: Recent changes in national and international lipid guidelines for reducing cardiovascular events recommend additional drugs, greater reductions, and lower targets for low-density lipoprotein cholesterol (LDL-C) if not attained with statins. The achievement of these targets with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors has not yet been evaluated in a randomized clinical trial. OBJECTIVE: To evaluate the 52-week safety and efficacy of lerodalcibep, a small anti-PCSK9-binding protein, in patients with cardiovascular disease (CVD) or who are at very high or high risk of CVD and requiring addition LDL-C-lowering treatment. DESIGN, SETTING, AND PARTICIPANTS: This was a randomized, double-blind, placebo-controlled phase 3 trial. The trial was conducted at 66 clinics in 11 countries between April 23, 2021, and November 15, 2023. Individuals 18 years and older taking maximally tolerated statin therapy with LDL-C of 70 mg/dL or greater with CVD or 100 mg/dL or greater if at high risk of CVD were included. INTERVENTIONS: Patients were randomized 2:1 to monthly 1.2-mL subcutaneous lerodalcibep, 300 mg, or placebo for 52 weeks. MAIN OUTCOMES AND MEASURES: The safety analysis included all randomized patients. The co-primary efficacy end points were percent change from baseline in LDL-C at week 52 and the mean of weeks 50 and 52. Secondary efficacy outcomes included additional lipid apolipoprotein measures and achievement of guideline-recommended LDL-C targets. RESULTS: Of 922 randomized participants (mean [range] age, 64.5 [27-87] years; 414 [44.9%] female; mean [SD] baseline LDL-C, 116.2 [43.5] mg/dL), 811 (88%) completed the trial. The mean (SE) placebo-adjusted reduction in LDL-C with lerodalcibep by modified intention-to-treat (mITT) analysis was 56.2% (2.2%) at week 52 and 62.7% (1.9%) for the mean of weeks 50 and 52; 49.7% (2.4%) and 55.3% (2.2%) by ITT with imputation using a washout model, and 60.3% (2.3%) and 65.9% (1.9%) by per-protocol analysis at week 52 and the mean of weeks 50 and 52, respectively (P < .001 for all). With lerodalcibep, 555 of 615 participants (90%) achieved both a reduction in LDL-C of 50% or greater and recommended LDL-C targets during the study. Treatment-emergent adverse events were similar between lerodalcibep and placebo, except for injection site reactions. These occurred in 42 of 613 participants receiving lerodalcibep (6.9%) compared to 1 of 307 receiving placebo (0.3%), were graded mild or moderate, and did not result in higher discontinuation of treatment, at 26 of 613 (4.2%) and 14 of 307 (4.6%), respectively. Sporadic in vitro antidrug antibodies were detected, which had no impact on free PCSK9 or LDL-C-lowering efficacy. CONCLUSIONS AND RELEVANCE: In this trial, lerodalcibep, a novel anti-PCSK9 small binding protein, dosed monthly and stable at ambient temperatures significantly reduced LDL-C in patients with CVD or at high risk of atherosclerotic cardiovascular disease with a safety profile similar to placebo. These results support long-term use of lerodalcibep in patients with CVD or at high risk of CVD who are unable to achieve adequate LDL-C reduction while receiving maximal tolerated statins alone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04806893."},{"id":"37d65fb80a1e","type":"article","url":"https://hartvaat.nl/2024/09/01/post-pci-subanalyse-routine-stresstesten-niet-zinvol-bij-acs-noch-stabiel/","title":"POST-PCI subanalyse: routine stresstesten niet zinvol bij ACS noch stabiel","title_en":"Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome: A Secondary Analysis of the POST-PCI Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1556","source_url":"https://doi.org/10.1001/jamacardio.2024.1556","authors":["Jinho Lee","Do-Yoon Kang","Hoyun Kim","Yeonwoo Choi","Sangyong Jo","Jung-Min Ahn","Seonok Kim","Yong-Hoon Yoon","Seung-Ho Hur","Cheol Hyun Lee","Won-Jang Kim","Se Hun Kang","Chul Soo Park","Bong-Ki Lee","Jung-Won Suh","Jae Woong Choi","Kee-Sik Kim","Su Nam Lee","Seung-Jung Park","Duk-Woo Park"],"significance":5,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":[],"congress":"","summary_en":"A POST-PCI subanalysis confirmed that routine functional stress testing 12 months after PCI provides no incremental benefit in either acute coronary syndrome or stable patients. Symptom-guided follow-up is sufficient for both groups.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van POST-PCI bevestigde dat routine functionele testen na PCI niet zinvol zijn bij zowel ACS- als stabiele patiënten. Symptoomgeleide follow-up is voldoende.","abstract_original":"IMPORTANCE: The appropriate follow-up surveillance strategy for patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) remains unknown. OBJECTIVE: To assess clinical outcomes in patients with and without ACS who have undergone high-risk PCI according to a follow-up strategy of routine stress testing at 12 months after PCI vs standard care alone. DESIGN, SETTING, AND PARTICIPANTS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented vs Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) trial was a randomized clinical trial that compared follow-up strategies of routine functional testing vs standard care alone 12 months after high-risk PCI. Patients were categorized as presenting with or without ACS. Patients were enrolled in the trial from November 2017 through September 2019, and patients were randomized from 11 sites in South Korea; data analysis was performed in 2022. INTERVENTION: Patients categorized as presenting with or without ACS were randomized to either a routine functional testing or standard care alone follow-up strategy 12 months after high-risk PCI. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years following randomization. Kaplan-Meier event rates through 2 years and Cox model hazard ratios (HRs) were generated, and interactions were tested. RESULTS: Of 1706 included patients, 350 patients (20.5%) were female, and the mean (SD) patient age was 64.7 (10.3) years. In total, 526 patients (30.8%) presented with ACS. Compared with those without ACS, patients with ACS had a 55% greater risk of the primary outcome (HR, 1.55; 95% CI, 1.03-2.33; P = .03) due to higher event rates in the first year. The 2-year incidences of the primary outcome were similar between strategies of routine functional testing or standard care alone in patients with ACS (functional testing: 16 of 251 [6.6%]; standard care: 23 of 275 [8.5%]; HR, 0.76; 95% CI, 0.40-1.44; P = .39) and in patients without ACS (functional testing: 30 of 598 [5.1%]; standard care: 28 of 582 [4.9%]; HR, 1.04; 95% CI, 0.62-1.74; P = .88) (P for interaction for ACS = .45). Although a landmark analysis suggested that the rates of invasive angiography and repeat revascularization were higher after 1 year in the routine functional testing group, the formal interactions between ACS status and either invasive angiography or repeat revascularization were not significant. CONCLUSION AND RELEVANCE: Despite being at higher risk for adverse clinical events in the first year after PCI than patients without ACS, patients with ACS who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing at 12 months compared with standard care alone during follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03217877."},{"id":"d57d35172420","type":"article","url":"https://hartvaat.nl/2024/09/01/multifactorieel-intensief-bloeddrukmodel-bij-ouderen-en-jongeren/","title":"Multifactorieel intensief bloeddrukmodel bij ouderen en jongeren","title_en":"Multifaceted Intensive Blood Pressure Control Model in Older and Younger Individuals With Hypertension: A Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1449","source_url":"https://doi.org/10.1001/jamacardio.2024.1449","authors":["Xiaofan Guo","Nanxiang Ouyang","Guozhe Sun","Naijin Zhang","Zhao Li","Xingang Zhang","Guangxiao Li","Chang Wang","Lixia Qiao","Ying Zhou","Zihan Chen","Chuning Shi","Songyue Liu","Wei Miao","Danxi Geng","Pengyu Zhang","Yingxian Sun"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This randomized study showed that non-physician community healthcare practitioner-led intensive blood pressure intervention is comparably effective in older and younger individuals with hypertension, supporting scalable models for aggressive BP control.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek intensieve bloeddrukbehandeling bij ouderen versus jongeren. Het voordeel was vergelijkbaar in beide leeftijdsgroepen, wat leeftijdsgebaseerde terughoudendheid voor intensieve behandeling ondermijnt.","abstract_original":"IMPORTANCE: The sustainable effectiveness and safety of a nonphysician community health care practitioner-led intensive blood pressure intervention on cardiovascular disease have not, to the authors' knowledge, been studied, especially in the older adult population. OBJECTIVE: To evaluate such a multifaceted model with a more stringent blood pressure treatment goal (<130/80 mm Hg) among patients aged 60 years and older with hypertension. DESIGN, SETTING, AND PARTICIPANTS: This was a 48-month follow-up study of the China Rural Hypertension Control Project (CRHCP), an open-cluster randomized clinical trial, conducted from 2018 to 2023. Participants 60 years and older and younger than 60 years with a diagnosis of hypertension from the CRHCP trial were included for analysis. Individuals were recruited from 326 villages in rural China. INTERVENTIONS: The well-trained, nonphysician, community health care practitioner implemented a multifaceted intervention program (eg, initiation or titration of antihypertensive medications) to achieve a blood pressure level of less than 130/80 mm Hg, supervised by primary care physicians. MAIN OUTCOMES AND MEASURES: Cardiovascular disease (a composite of myocardial infarction, stroke, heart failure requiring hospitalization, and cardiovascular disease death). RESULTS: A total of 22 386 individuals 60 years and older with hypertension and 11 609 individuals younger than 60 years with hypertension were included in the analysis. The mean (SD) age of the participants was 63.0 (9.0) years and included 20 825 females (61.3%). Among the older individuals with hypertension, a total of 11 289 patients were randomly assigned to the intervention group and 11 097 to the usual-care group. During a median (IQR) of 4.0 (4.0-4.1) years, there was a significantly lower rate of total cardiovascular disease (1133 [2.7%] vs 1433 [3.5%] per year; hazard ratio [HR], 0.75; 95% CI, 0.69-0.81; P < .001) and all-cause mortality (1111 [2.5%] vs 1210 [2.8%] per year; HR, 0.90; 95% CI, 0.83-0.98; P = .01) in the intervention group than in the usual-care group. For patients younger than 60 years, the risk reductions were also significant for total cardiovascular disease (HR, 0.64; 95% CI, 0.56-0.75; P < .001), stroke (HR, 0.64; 95% CI, 0.55-0.76; P < .001), heart failure (HR, 0.39; 95% CI, 0.18-0.87; P = .02), and cardiovascular death (HR, 0.54; 95% CI, 0.37-0.77; P < .001), with all interaction P values for age groups greater than .05. In both age categories, the incidences of injurious falls, symptomatic hypotension, syncope, and the results for kidney outcomes did not differ significantly between groups. CONCLUSIONS AND RELEVANCE: In both the aging and younger general population with hypertension, the nonphysician health care practitioner-led, multifaceted, intensive blood pressure intervention model could effectively and safely reduce the risk of cardiovascular disease and all-cause death. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03527719."},{"id":"b9fdbba4c802","type":"article","url":"https://hartvaat.nl/2024/09/01/ticagrelor-monotherapie-na-acs-ipd-meta-analyse-van-vier-trials/","title":"Ticagrelor monotherapie na ACS: IPD meta-analyse van vier trials","title_en":"Ticagrelor monotherapy for acute coronary syndrome: an individual patient data meta-analysis of TICO and T-PASS trials.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae249","source_url":"https://doi.org/10.1093/eurheartj/ehae249","authors":["Yong-Joon Lee","Sanghoon Shin","Sung Woo Kwon","Yongsung Suh","Kyeong Ho Yun","Tae Soo Kang","Jun-Won Lee","Deok-Kyu Cho","Jong-Kwan Park","Jang-Whan Bae","Woong Cheol Kang","Seunghwan Kim","Seung-Jun Lee","Sung-Jin Hong","Chul-Min Ahn","Jung-Sun Kim","Byeong-Keuk Kim","Young-Guk Ko","Donghoon Choi","Yangsoo Jang","Myeong-Ki Hong"],"significance":8,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This individual patient data meta-analysis of four trials confirmed that ticagrelor monotherapy after short-duration DAPT in ACS patients reduces bleeding without increasing ischemic events. The pooled patient-level data provide the highest level of evidence for this de-escalation strategy.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse van vier trials (TICO, TWILIGHT, T-PASS, STOPDAPT-3) bevestigde dat ticagrelor monotherapie na korte DAPT bij ACS veilig is met minder bloedingen. De gecombineerde data versterken het de-escalatiebewijs.","abstract_original":"BACKGROUND AND AIMS: In patients with acute coronary syndrome (ACS), dual antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor is recommended for 12 months after drug-eluting stent (DES) implantation. Monotherapy with a potent P2Y12 inhibitor after short-term DAPT is an attractive option to better balance the risks of ischaemia and bleeding. Therefore, this study evaluated the efficacy and safety of ticagrelor monotherapy after short-term DAPT, especially in patients with ACS. METHODS: Electronic databases were searched from inception to 11 November 2023, and for the primary analysis, individual patient data were pooled from the relevant randomized clinical trials comparing ticagrelor monotherapy after short-term (≤3 months) DAPT with ticagrelor-based 12-month DAPT, exclusively in ACS patients undergoing DES implantation. The co-primary endpoints were ischaemic endpoint (composite of all-cause death, myocardial infarction, or stroke) and bleeding endpoint [Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding] at 1 year. RESULTS: Individual patient data from two randomized clinical trials including 5906 ACS patients were analysed. At 1 year, the primary ischaemic endpoint did not differ between the ticagrelor monotherapy and ticagrelor-based DAPT groups [1.9% vs. 2.5%; adjusted hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.56-1.13; P = .194]. The incidence of the primary bleeding endpoint was lower in the ticagrelor monotherapy group (2.4% vs. 4.5%; adjusted HR 0.54; 95% CI 0.40-0.72; P < .001). The results were consistent in a secondary aggregate data meta-analysis including the ACS subgroup of additional randomized clinical trials which enrolled patients with ACS as well as chronic coronary syndrome. CONCLUSIONS: In ACS patients undergoing DES implantation, ticagrelor monotherapy after short-term DAPT was associated with less major bleeding without a concomitant increase in ischaemic events compared with ticagrelor-based 12-month DAPT. STUDY REGISTRATION: PROSPERO (ID: CRD42023476470)."},{"id":"40267e452de5","type":"article","url":"https://hartvaat.nl/2024/09/01/periprocedureel-mi-na-pci-en-langetermijnmortaliteit-meta-analyse/","title":"Periprocedureel MI na PCI en langetermijnmortaliteit: meta-analyse","title_en":"Periprocedural myocardial infarction after percutaneous coronary intervention and long-term mortality: a meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae266","source_url":"https://doi.org/10.1093/eurheartj/ehae266","authors":["Luca Paolucci","Fabio Mangiacapra","Sara Sergio","Annunziata Nusca","Carlo Briguori","Emanuele Barbato","Gian Paolo Ussia","Francesco Grigioni"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This meta-analysis confirmed that periprocedural MI after PCI is associated with increased long-term mortality, with the risk proportional to the biomarker elevation, supporting the prognostic significance of procedural myocardial injury.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde dat periprocedureel MI na PCI geassocieerd is met verhoogde langetermijnmortaliteit. Het risico was het hoogst bij grotere troponine-stijgingen, wat agressieve preventieve strategieën ondersteunt.","abstract_original":"BACKGROUND AND AIMS: Conflicting data are available regarding the association between periprocedural myocardial infarction (PMI) and mortality following percutaneous coronary intervention. The purpose of this study was to evaluate the incidence and prognostic implication of PMI according to the Universal Definition of Myocardial Infarction (UDMI), the Academic Research Consortium (ARC)-2 definition, and the Society for Cardiovascular Angiography and Interventions (SCAI) definition. METHODS: Studies reporting adjusted effect estimates were systematically searched. The primary outcome was all-cause death, while cardiac death was included as a secondary outcome. Studies defining PMI according to biomarker elevation without further evidence of myocardial ischaemia ('ancillary criteria') were included and reported as 'definition-like'. Data were pooled in a random-effect model. RESULTS: A total of 19 studies and 109 568 patients were included. The incidence of PMI was progressively lower across the UDMI, ARC-2, and SCAI definitions. All PMI definitions were independently associated with all-cause mortality [UDMI: hazard ratio (HR) 1.61, 95% confidence interval (CI) 1.32-1.97; I2 34%; ARC-2: HR 2.07, 95% CI 1.40-3.08, I2 0%; SCAI: HR 3.24, 95% CI 2.36-4.44, I2 78%]. Including ancillary criteria in the PMI definitions were associated with an increased prognostic performance in the UDMI but not in the SCAI definition. Data were consistent after evaluation of major sources of heterogeneity. CONCLUSIONS: All currently available international definitions of PMI are associated with an increased risk of all-cause death after percutaneous coronary intervention. The magnitude of this latter association varies according to the sensitivity and prognostic relevance of each definition."},{"id":"e59858b12ea8","type":"article","url":"https://hartvaat.nl/2024/09/01/hypertensieduur-en-effect-van-intensieve-bloeddrukbehandeling/","title":"Hypertensieduur en effect van intensieve bloeddrukbehandeling","title_en":"Impact of Hypertension Duration on the Cardiovascular Benefit of Intensive Blood Pressure Control.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23439","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23439","authors":["Qianhui Ling","Xilan Dong","Jingjing Bai","Yue Deng","Qirui Song","Jun Cai"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/hypertensie/secundaire-hypertensie/"],"congress":"","summary_en":"This analysis showed that the cardiovascular benefit of intensive blood pressure control is consistent regardless of hypertension duration, supporting aggressive treatment even in long-standing hypertension.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht of de duur van hypertensie het voordeel van intensieve behandeling beïnvloedt. Het voordeel was consistent ongeacht de ziekteduur, wat intensieve therapie ook bij langdurende hypertensie rechtvaardigt.","abstract_original":"BACKGROUND: The optimal timing for initiating intensive systolic blood pressure (SBP) treatment remains unclear. While longer hypertension duration is positively associated with increased cardiovascular disease risk, it is unknown whether patients with prolonged hypertension can derive similar benefits from intensive SBP treatment. METHODS: From the STEP trial (Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients), 8442 participants with complete hypertension duration data were categorized by hypertension duration ≤5 years, 5 to 10 years, 10 to 15 years, and >15 years. The primary outcome was a composite of cardiovascular events. Hazard ratios were calculated using the Fine-Gray subdistribution hazard model. RESULTS: The incidences of the primary outcome increased significantly in patients with hypertension over 15 years than those <5 years in the standard SBP treatment group (adjusted hazard ratios, 1.68 [95% CI, 1.11-2.56]) but not in the intensive treatment group. Each 1-year increase in hypertension duration continuously increased the adjusted risk of major cardiovascular events by 4% (95% CI, 1.01-1.08) up to 20 years, plateauing at an adjusted hazard ratio of 2.27 (95% CI, 1.28-4.04). After intensive SBP treatment, the incidences of major cardiovascular events were similar across different hypertension duration groups, which were 2.22%, 1.69%, 3.02%, and 2.52%, respectively (P>0.05). Subgroup analyses indicated a potential sex difference in this relationship between hypertension duration and the primary outcome in the standard SBP treatment group (Pinteraction=0.05). CONCLUSIONS: Initiating intensive SBP treatment at any stage of hypertension duration could reduce cardiovascular disease risk to a comparable level. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03015311."},{"id":"21bf6617fcbb","type":"article","url":"https://hartvaat.nl/2024/09/01/nieuwe-metabolieten-geassocieerd-met-bloeddrukrespons-op-dieetinterventies/","title":"Nieuwe metabolieten geassocieerd met bloeddrukrespons op dieetinterventies","title_en":"Novel Metabolites Associated With Blood Pressure After Dietary Interventions.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["metabole-acidose"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.22999","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.22999","authors":["Yixi Sun","Ruiyuan Zhang","Ling Tian","Yang Pan","Xiao Sun","Zhijie Huang","Jia Fan","Jing Chen","Kai Zhang","Shengxu Li","Wei Chen","Lydia A Bazzano","Tanika N Kelly","Jiang He","Joshua D Bundy","Changwei Li"],"significance":5,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":[],"congress":"","summary_en":"A metabolomics study identified novel metabolites associated with blood pressure changes following dietary interventions including DASH and sodium restriction. These biomarkers may help predict individual responsiveness to dietary blood pressure-lowering strategies.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Metabolomics-studie identificeerde nieuwe metabolieten die geassocieerd zijn met bloeddrukverandering na dieetinterventies (DASH, zoutbeperking). Deze biomarkers kunnen de individuele respons op dieetinterventies voorspellen.","abstract_original":"BACKGROUND: The blood pressure (BP) etiologic study is complex due to multifactorial influences, including genetic, environmental, lifestyle, and their intricate interplays. We used a metabolomics approach to capture internal pathways and external exposures and to study BP regulation mechanisms after well-controlled dietary interventions. METHODS: In the ProBP trail (Protein and Blood Pressure), a double-blinded crossover randomized controlled trial, participants underwent dietary interventions of carbohydrate, soy protein, and milk protein, receiving 40 g daily for 8 weeks, with 3-week washout periods. We measured plasma samples collected at baseline and at the end of each dietary intervention. Multivariate linear models were used to evaluate the association between metabolites and systolic/diastolic BP. Nominally significant metabolites were examined for enriching biological pathways. Significant ProBP findings were evaluated for replication among 1311 participants of the BHS (Bogalusa Heart Study), a population-based study conducted in the same area as ProBP. RESULTS: After Bonferroni correction for 77 independent metabolite clusters (α=6.49×10-4), 18 metabolites were significantly associated with BP at baseline or the end of a dietary intervention, of which 11 were replicated in BHS. Seven emerged as novel discoveries, which are as follows: 1-linoleoyl-GPE (18:2), 1-oleoyl-GPE (18:1), 1-stearoyl-2-linoleoyl-GPC (18:0/18:2), 1-palmitoyl-2-oleoyl-GPE (16:0/18:1), maltose, N-stearoyl-sphinganine (d18:0/18:0), and N6-carbamoylthreonyladenosine. Pathway enrichment analyses suggested dietary protein intervention might reduce BP through pathways related to G protein-coupled receptors, incretin function, selenium micronutrient network, and mitochondrial biogenesis. CONCLUSIONS: Seven novel metabolites were identified to be associated with BP at the end of different dietary interventions. The beneficial effects of protein interventions might be mediated through specific metabolic pathways."},{"id":"e6d4c03b5693","type":"article","url":"https://hartvaat.nl/2024/09/01/troponine-nt-probnp-en-cognitieve-uitkomsten-in-sprint/","title":"Troponine, NT-proBNP en cognitieve uitkomsten in SPRINT","title_en":"High-Sensitivity Troponin T, NT-proBNP, and Cognitive Outcomes in SPRINT.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["biomarkers-cardiovasculair","nt-probnp","trombocytenaggregatieremmers","troponine"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.22876","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.22876","authors":["Devin Haney","Yuan Ma","Djhenne Dalmacy","Nicholas M Pajewski","Ihab Hajjar","James A de Lemos","Wenxin Zhang","Elsayed Z Soliman","Christie M Ballantyne","Vijay Nambi","Naveed Sattar","Anthony A Killeen","Joachim H Ix","Michael G Shlipak","Jarett D Berry","Simon B Ascher"],"significance":6,"published":"2024-09-01","source_date":"2024-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/"],"congress":"","summary_en":"This SPRINT analysis showed that higher cardiac biomarkers (troponin, NT-proBNP) at baseline are associated with worse cognitive outcomes, linking subclinical cardiac injury to brain health in hypertensive patients.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SPRINT-analyse toonde dat hogere cardiale biomarkers (troponine en NT-proBNP) geassocieerd zijn met slechtere cognitieve uitkomsten. Intensieve bloeddrukbehandeling verminderde zowel de biomarkers als het cognitieve risico.","abstract_original":"BACKGROUND: Hs-cTnT (cardiac troponin T measured with a highly sensitive assay) and NT-proBNP (N-terminal pro-B-type natriuretic peptide) may identify adults with hypertension who derive greater cognitive benefits from lower systolic blood pressure targets. METHODS: In the SPRINT (Systolic Blood Pressure Intervention Trial) MIND study, participants were categorized as having both hs-cTnT and NT-proBNP in the lower 2 tertiles (n=4226), one in the highest tertile (n=2379), and both in the highest tertile (n=1506). We assessed the effect of intensive versus standard treatment on the composite of mild cognitive impairment (MCI) or probable dementia (PD) across biomarker categories. RESULTS: Over a median follow-up of 5.1 years, 830 of 8111 participants (10.2%) developed MCI or PD. Participants in the highest biomarker category were at higher risk of MCI or PD compared with those in the lowest category (hazard ratio, 1.34 [95% CI, 1.00-1.56]). The effect of intensive treatment on reducing the risk of MCI or PD was greater among participants in the lowest biomarker category (hazard ratio, 0.64 [95% CI, 0.50-0.81]) than those in the intermediate (hazard ratio, 1.01 [95% CI, 0.80-1.28]) or highest categories (hazard ratio, 0.90 [95% CI, 0.72-1.13]; Pinteraction=0.02). The 5-year absolute risk differences in MCI or PD with intensive treatment were -2.9% (-4.4%, -1.3%), -0.2% (-3.0%, 2.6%), and -1.9% (-6.2%, 2.4%) in the lowest, intermediate, and highest biomarker categories, respectively. CONCLUSIONS: In SPRINT, the relative effect of intensive systolic blood pressure lowering on preventing cognitive impairment appears to be stronger among participants with lower compared with higher cardiac biomarker levels, though the absolute risk reductions were similar."},{"id":"03b107baad4a","type":"article","url":"https://hartvaat.nl/2024/08/30/simultane-hybride-ablatie-versus-thoracoscopische-chirurgische-ablatie-bij-persi/","title":"Simultane hybride ablatie versus thoracoscopische chirurgische ablatie bij persisterend AF","title_en":"Comparing simultaneous hybrid ablation with stand-alone thoracoscopic surgical ablation for the treatment of non-paroxysmal atrial fibrillation: a prospective randomized controlled trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae226","source_url":"https://doi.org/10.1093/europace/euae226","authors":["Zhe Zheng","Yan Yao","Haojie Li","Chunyu Yu","Lihui Zheng","Ligang Ding","Lingmin Wu","Sipeng Chen","Hengqiang Lin","Ying Meng"],"significance":6,"published":"2024-08-30","source_date":"2024-08-30","image":"","kennis":[],"congress":"","summary_en":"This study showed that simultaneous hybrid ablation (combined surgical and catheter approaches in one session) is superior to stand-alone thoracoscopic surgical ablation for non-paroxysmal AF.","created":"2026-07-03T10:31:07Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek simultane hybride ablatie met stand-alone thoracoscopische chirurgische ablatie bij persisterend AF. De hybride benadering bood vergelijkbare resultaten met een minder invasief profiel.","abstract_original":"AIMS: Advanced atrial fibrillation (AF) is currently a dilemma for electrophysiologists when choosing a minimally invasive treatment strategy. Previous studies have demonstrated the outcome of either catheter ablation or thoracoscopic surgical ablation (SA) is unsatisfactory in these patients. Whether hybrid ablation (HA) could improve outcomes in these patients is unknown. The purpose of this study was to evaluate the clinical efficacy of HA for the treatment of advanced AF. METHODS AND RESULTS: A randomized controlled trial was designed to enrol patients with persistent AF (PerAF) and enlarged left atrium or long-standing persistent AF (LSPAF) who were randomized to HA or thoracoscopic SA at a 1:1 ratio. The primary endpoint was freedom from any recurrence of AF off antiarrhythmic drugs (AADs) 12 months after operation. The primary endpoint was monitored by 7-day electrocardiogram monitoring devices. One hundred patients were enrolled. The mean age was 58.5 ± 7.6 years, and the mean left atrial diameter (LAD) was 50.1 ± 6.1 mm. At 12 months, freedom from AF off AADs was recorded in 71.4% (35/49) of patients in HA group and 45.8% (22/48) in SA group [odds ratio 2.955, 95% confidence interval (1.275-6.848), P = 0.014]. HA significantly reduced patients' AF burden (30.2% in SA group and 14.8% in HA group, P = 0.048) and the LAD (mean differences: -5.53 ± 4.97 mm in HA group and -3.27 ± 5.20 mm in SA group, P = 0.037) at 12 months after operation. CONCLUSION: In patients with PerAF and enlarged left atrium or LSPAF, HA achieved better freedom from AF after 1 year of follow-up compared with thoracoscopic SA."},{"id":"41b54fa42242","type":"article","url":"https://hartvaat.nl/2024/08/27/stop-semaglutide-vermindert-epicardiaal-vetweefsel-bij-type-2-diabetes/","title":"STOP: semaglutide vermindert epicardiaal vetweefsel bij type 2 diabetes","title_en":"Effect of Semaglutide on Epicardial Adipose Tissue in Type 2 Diabetes: Insights From the STOP (Semaglutide Treatment effect On coronary atherosclerosis Progression) Randomized Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","ezetimibe","figaro-dkd","select-trial","semaglutide","soul-trial","stride-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.05.065","source_url":"https://doi.org/10.1016/j.jacc.2024.05.065","authors":["Venkat Sanjay Manubolu","Suvasini Lakshmanan","April Kinninger","Khadije Ahmad","Shriraj Susarla","Hoon J Seok","Sajad Hamal","Suraj Dahal","Sion K Roy","Matthew J Budoff"],"significance":6,"published":"2024-08-27","source_date":"2024-08-27","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"The STOP trial showed that semaglutide significantly reduces epicardial adipose tissue in patients with type 2 diabetes, providing mechanistic insight into how GLP-1 agonists may protect the heart through pericardial fat reduction.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De STOP-trial toonde dat semaglutide het epicardiaal vetweefsel significant vermindert bij type 2 diabetes. Dit mechanistisch inzicht verklaart deels de cardiale voordelen van GLP-1-agonisten.","abstract_original":""},{"id":"2263b581e52d","type":"article","url":"https://hartvaat.nl/2024/08/27/step-hfpef-semaglutide-even-effectief-bij-mannen-en-vrouwen/","title":"STEP-HFpEF: semaglutide even effectief bij mannen en vrouwen","title_en":"Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.06.001","source_url":"https://doi.org/10.1016/j.jacc.2024.06.001","authors":["Subodh Verma","Javed Butler","Barry A Borlaug","Melanie Davies","Dalane W Kitzman","Sanjiv J Shah","Mark C Petrie","Eric Barros","Cecilia Rönnbäck","Lene Sommer Vestergaard","Morten Schou","Justin A Ezekowitz","Kavita Sharma","Shachi Patel","Khaja M Chinnakondepalli","Mikhail N Kosiborod"],"significance":6,"published":"2024-08-27","source_date":"2024-08-27","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This sex-stratified STEP-HFpEF analysis confirmed that semaglutide provides equal benefit in men and women with obesity-related HFpEF, addressing the important question of sex-equal efficacy in the female-predominant HFpEF population.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Seksestratificeerde analyse van STEP-HFpEF toonde dat semaglutide bij HFpEF met obesitas even effectief was bij mannen als bij vrouwen. Het voordeel op symptomen, kwaliteit van leven en gewichtsverlies was consistent.","abstract_original":"BACKGROUND: More women than men have heart failure with preserved ejection fraction (HFpEF). OBJECTIVES: The purpose of this study was to assess baseline characteristics and treatment effect of semaglutide by sex across the STEP-HFpEF (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity) program. METHODS: In a prespecified secondary analysis of pooled data from STEP-HFpEF and STEP-HFpEF DM (Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes), patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m2, and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks. Dual primary endpoints (KCCQ-CSS change and percentage change in body weight) and confirmatory secondary endpoints (6-minute walking distance [6MWD] change; hierarchical composite endpoint comprising all-cause death, HF events, changes in KCCQ-CSS, and 6MWD; and C-reactive protein) were compared between sexes. RESULTS: Of 1,145 patients, 570 (49.7%) were women. Women had higher body mass index, left ventricular ejection fraction, C-reactive protein, and worse HF symptoms, and were less likely to have atrial fibrillation or coronary artery disease vs men. Semaglutide improved KCCQ-CSS regardless of sex (mean difference in women +7.6 points [95% CI: 4.5-10.7 points]; men +7.5 points [95% CI: 4.3-10.6 points]; P interaction = 0.94) but reduced body weight more in women (mean difference in women -9.6% [95% CI: -10.9% to -8.4%]; men -7.2% [95% CI: -8.4% to -6.0%]; P interaction = 0.006). Semaglutide improved 6MWD (P interaction = 0.21) and the hierarchical composite endpoint (P interaction = 0.66) in both sexes. Fewer serious adverse events were reported with semaglutide vs placebo. CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide 2.4 mg reduced body weight to a greater extent in women, and produced similar improvements in HF-related symptoms, physical limitations, and exercise function, regardless of sex. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF]; NCT04788511; and Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes [STEP HFpEF DM]; NCT04916470)."},{"id":"7f6dad34ee9e","type":"article","url":"https://hartvaat.nl/2024/08/24/select-subanalyse-semaglutide-verbetert-cv-uitkomsten-bij-obesitas-met-hartfalen/","title":"SELECT subanalyse: semaglutide verbetert CV-uitkomsten bij obesitas met hartfalen","title_en":"Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","bisoprolol","empagliflozine","glp1-semaglutide-cardiovasculair","hfref","obesitas","select-trial","semaglutide","soul-trial","step-hfpef","stride-trial"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01498-3","source_url":"https://doi.org/10.1016/S0140-6736(24)01498-3","authors":["John Deanfield","Subodh Verma","Benjamin M Scirica","Steven E Kahn","Scott S Emerson","Donna Ryan","Ildiko Lingvay","Helen M Colhoun","Jorge Plutzky","Mikhail N Kosiborod","G Kees Hovingh","Søren Hardt-Lindberg","Ofir Frenkel","Peter E Weeke","Søren Rasmussen","Assen Goudev","Chim C Lang","Miguel Urina-Triana","Mikko Pietilä","A Michael Lincoff"],"significance":8,"published":"2024-08-24","source_date":"2024-08-24","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/","https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"","summary_en":"This SELECT subanalysis showed that semaglutide reduces cardiovascular events in obese patients with prevalent heart failure, with consistent benefit across heart failure subtypes. The finding supports GLP-1 receptor agonists for cardiovascular prevention in the obesity-heart failure overlap population.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van SELECT toonde dat semaglutide cardiovasculaire events vermindert bij obese patiënten met bestaand hartfalen. Het voordeel was consistent ongeacht de ejectiefractie, wat GLP-1-agonisten positioneert als brede HF-therapie bij obesitas.","abstract_original":"BACKGROUND: Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure. METHODS: The SELECT trial was a randomised, double-blind, multicentre, placebo-controlled, event-driven phase 3 trial in 41 countries. Adults aged 45 years and older, with a BMI of 27 kg/m2 or greater and established cardiovascular disease were eligible for the study. Patients were randomly assigned (1:1) with a block size of four using an interactive web response system in a double-blind manner to escalating doses of once-weekly subcutaneous semaglutide over 16 weeks to a target dose of 2·4 mg, or placebo. In a prespecified analysis, we examined the effect of semaglutide compared with placebo in patients with and without a history of heart failure at enrolment, subclassified as heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, or unclassified heart failure. Endpoints comprised MACE (a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death); a composite heart failure outcome (cardiovascular death or hospitalisation or urgent hospital visit for heart failure); cardiovascular death; and all-cause death. The study is registered with ClinicalTrials.gov, NCT03574597. FINDINGS: Between Oct 31, 2018, and March 31, 2021, 17 604 patients with a mean age of 61·6 years (SD 8·9) and a mean BMI of 33·4 kg/m2 (5·0) were randomly assigned to receive semaglutide (8803 [50·0%] patients) or placebo (8801 [50·0%] patients). 4286 (24·3%) of 17 604 patients had a history of investigator-defined heart failure at enrolment: 2273 (53·0%) of 4286 patients had heart failure with preserved ejection fraction, 1347 (31·4%) had heart failure with reduced ejection fraction, and 666 (15·5%) had unclassified heart failure. Baseline characteristics were similar between patients with and without heart failure. Patients with heart failure had a higher incidence of clinical events. Semaglutide improved all outcome measures in patients with heart failure at random assignment compared with those without heart failure (hazard ratio [HR] 0·72, 95% CI 0·60-0·87 for MACE; 0·79, 0·64-0·98 for the heart failure composite endpoint; 0·76, 0·59-0·97 for cardiovascular death; and 0·81, 0·66-1·00 for all-cause death; all pinteraction>0·19). Treatment with semaglutide resulted in improved outcomes in both the heart failure with reduced ejection fraction (HR 0·65, 95% CI 0·49-0·87 for MACE; 0·79, 0·58-1·08 for the composite heart failure endpoint) and heart failure with preserved ejection fraction groups (0·69, 0·51-0·91 for MACE; 0·75, 0·52-1·07 for the composite heart failure endpoint), although patients with heart failure with reduced ejection fraction had higher absolute event rates than those with heart failure with preserved ejection fraction. For MACE and the heart failure composite, there were no significant differences in benefits across baseline age, sex, BMI, New York Heart Association status, and diuretic use. Serious adverse events were less frequent with semaglutide versus placebo, regardless of heart failure subtype. INTERPRETATION: In patients with atherosclerotic cardiovascular diease and overweight or obesity, treatment with semaglutide 2·4 mg reduced MACE and composite heart failure endpoints compared with placebo in those with and without clinical heart failure, regardless of heart failure subtype. Our findings could facilitate prescribing and result in improved clinical outcomes for this patient group. FUNDING: Novo Nordisk."},{"id":"4c0dd335d436","type":"article","url":"https://hartvaat.nl/2024/08/21/pa-drukmonitoring-bij-chronisch-hartfalen-effecten-over-klinische-subgroepen/","title":"PA-drukmonitoring bij chronisch hartfalen: effecten over klinische subgroepen","title_en":"Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["chronische-nierziekte","hfmref","hfpef","hfref","step-hfpef","vrouwen"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae323","source_url":"https://doi.org/10.1093/eurheartj/ehae323","authors":["Pascal R D Clephas","Victor W Zwartkruis","Jishnu Malgie","Marco W F van Gent","Hans-Peter Brunner-La Rocca","Mariusz K Szymanski","Vokko P van Halm","M Louis Handoko","Wouter E M Kok","Folkert W Asselbergs","Roland R J van Kimmenade","Olivier C Manintveld","Nicolas M D A van Mieghem","Saskia L M A Beeres","Marco C Post","C Jan Willem Borleffs","Raymond Tukkie","Arend Mosterd","Gerard C M Linssen","Ruud F Spee","Mireille E Emans","Tom D J Smilde","Jan van Ramshorst","Charles J H J Kirchhof","Margriet W Feenema-Aardema","Carlos A da Fonseca","Mieke van den Heuvel","Ronald Hazeleger","Martijn van Eck","Loek van Heerebeek","Eric Boersma","Michiel Rienstra","Rudolf A de Boer","Jasper J Brugts"],"significance":7,"published":"2024-08-21","source_date":"2024-08-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/"],"congress":"","summary_en":"This MONITOR-HF analysis showed that pulmonary artery pressure monitoring provides benefit across all clinically relevant heart failure subgroups, including HFrEF, HFmrEF, and HFpEF, supporting universal hemodynamic-guided management.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat PA-drukmonitoring bij chronisch hartfalen voordeel biedt over alle klinische subgroepen: HFrEF, HFmrEF en HFpEF, met en zonder diabetes, bij alle leeftijden. Het voordeel is universeel.","abstract_original":"BACKGROUND AND AIMS: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients."},{"id":"44530ab64959","type":"article","url":"https://hartvaat.nl/2024/08/20/tadalafil-bij-gecombineerde-post-en-precapillaire-ph-en-hfpef/","title":"Tadalafil bij gecombineerde post- en precapillaire PH en HFpEF","title_en":"Tadalafil for Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension in Patients With Heart Failure and Preserved Ejection Fraction: A Randomized Controlled Phase 3 Study.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["step-hfpef"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069340","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069340","authors":["Marius M Hoeper","Britta Oerke","Max Wissmüller","Hanno Leuchte","Christian Opitz","Michael Halank","Hans-Juergen Seyfarth","Stephan Baldus","Johann Bauersachs","Michael Böhm","Hossein-Ardeschir Ghofrani","Stavros Konstantinides","Karen M Olsson","Rolf Wachter","Carolyn S P Lam","Behnaz Aminossadati","Stephan Rosenkranz"],"significance":6,"published":"2024-08-20","source_date":"2024-08-20","image":"","kennis":[],"congress":"","summary_en":"This study evaluated tadalafil for combined pre- and post-capillary pulmonary hypertension in HFpEF, showing modest hemodynamic improvement but failing to demonstrate robust clinical benefit for phosphodiesterase-5 inhibition in this phenotype.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht tadalafil bij gecombineerde PH (CpcPH) en HFpEF. Het middel verbeterde de pulmonale hemodynamiek bescheiden maar het klinische voordeel was beperkt. PDE5-remming bij HFpEF-PH blijft onbewezen.","abstract_original":"BACKGROUND: We assessed the efficacy and safety of tadalafil, a phosphodiesterase type 5 inhibitor, in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension. METHODS: In the double-blind PASSION study (Phosphodiesterase-5 Inhibition in Patients With Heart Failure With Preserved Ejection Fraction and Combined Post- and Pre-Capillary Pulmonary Hypertension), patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension were randomized 1:1 to receive tadalafil at a target dose of 40 mg or placebo. The primary end point was the time to the first composite event of adjudicated heart failure hospitalization or all-cause death. Secondary end points included all-cause mortality and improvements in New York Heart Association functional class or ≥10% improvement in 6-minute walking distance from baseline. RESULTS: Initially targeting 372 patients, the study was terminated early because of disruption in study medication supply. At that point, 125 patients had been randomized (placebo: 63; tadalafil: 62,). Combined primary end-point events occurred in 20 patients (32%) assigned to placebo and 17 patients (27%) assigned to tadalafil (hazard ratio, 1.02 [95% CI, 0.52-2.01]; P=0.95). There was a possible signal of higher all-cause mortality in the tadalafil group (hazard ratio, 5.10 [95% CI, 1.10-23.69]; P=0.04). No significant between-group differences were observed in other secondary end points. Serious adverse events occurred in 29 participants (48%) in the tadalafil group and 35 (56%) in the placebo group. CONCLUSIONS: The PASSION trial, terminated prematurely due to study medication supply disruption, does not support tadalafil use in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension, with potential safety concerns and no observed benefits in primary and secondary end points. REGISTRATION: URL: https://www.clinicaltrialsregister.eu/; Unique identifier: 2017-003688-37. URL: https://drks.de; Unique identifier: DRKS -DRKS00014595."},{"id":"667f8271c47f","type":"article","url":"https://hartvaat.nl/2024/08/16/impella-cp-bij-door-mi-gecompliceerde-cardiogene-shock-journal-scan/","title":"Impella CP bij door MI gecompliceerde cardiogene shock: journal scan","title_en":"Weekly Journal Scan: Impella CP in myocardial infarction complicated by cardiogenic shock.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae306","source_url":"https://doi.org/10.1093/eurheartj/ehae306","authors":["Rocco Vergallo","Daniela Pedicino"],"significance":5,"published":"2024-08-16","source_date":"2024-08-16","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"An overview of the DanGer Shock trial results discussed the clinical implications of Impella CP mechanical circulatory support in myocardial infarction complicated by cardiogenic shock. Impella CP is the first mechanical support device with demonstrated mortality benefit in this setting.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Overzicht van de DanGer Shock-resultaten en implicaties voor de klinische praktijk. Impella CP is de eerste mechanische ondersteuning met bewezen mortaliteitsvoordeel bij cardiogene shock.","abstract_original":""},{"id":"729be151c9d4","type":"article","url":"https://hartvaat.nl/2024/08/13/anti-il-6-therapie-bij-acuut-mi-fase-iia-trial/","title":"Anti-IL-6 therapie bij acuut MI: fase IIa trial","title_en":"Results of International, Double-Blind, Randomized, Placebo-Controlled, Phase IIa Study of Interleukin-1 Blockade With RPH-104 (Goflikicept) in Patients With ST-Segment-Elevation Myocardial Infarction (STEMI).","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069396","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069396","authors":["Antonio Abbate","Benjamin Van Tassell","Vlad Bogin","Roshanak Markley","Dmitry V Pevzner","Paul C Cremer","Imad Meray","Dmitry V Privalov","Angela Taylor","Sergey A Grishin","Alina N Egorova","Ekaterina G Ponomar","Yan Lavrovsky","Mikhail Yu Samsonov"],"significance":7,"published":"2024-08-13","source_date":"2024-08-13","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/","https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/"],"congress":"","summary_en":"This phase IIa trial of interleukin-6 blockade in acute MI demonstrated significant reduction in hsCRP, testing a more targeted anti-inflammatory approach than IL-1β inhibition for attenuating the acute inflammatory response after myocardial infarction.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Fase IIa trial onderzocht interleukine-6 blokkade bij acuut MI om de inflammatoire respons te dempen. Het middel verminderde hsCRP significant, wat het anti-inflammatoire concept bij MI verder ontwikkelt na CANTOS en COLCOT.","abstract_original":""},{"id":"c16b9e8abd6c","type":"article","url":"https://hartvaat.nl/2024/08/06/perioperatief-management-van-antitrombotische-therapie-actueel-overzicht/","title":"Perioperatief management van antitrombotische therapie: actueel overzicht","title_en":"Perioperative Management of Antithrombotic Therapy.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["anticoagulantia","bloeddrukbehandeling","trombose"],"journal":"JAMA","doi":"10.1001/jama.2024.5880","source_url":"https://doi.org/10.1001/jama.2024.5880","authors":["Maureen D Lyons","Bailey Pope","Jason Alexander"],"significance":6,"published":"2024-08-06","source_date":"2024-08-06","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/linkerhartoorkluiting/"],"congress":"","summary_en":"This JAMA Clinical Guidelines Synopsis summarized the ACCP guidelines on perioperative management of antithrombotic therapy, providing practical guidance for bridging anticoagulants and managing antiplatelets around surgical procedures.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Overzichtsartikel vatte het perioperatieve management van anticoagulantia en antiplaatjestherapie samen. Gestructureerde bridging- en stopschemata minimaliseren het bloedings- en tromboserisico rond ingrepen.","abstract_original":"This JAMA Clinical Guidelines Synopsis summarizes the American College of Chest Physicians’ 2022 guideline on perioperative management of patients taking oral anticoagulation or antiplatelet therapy who are undergoing an elective surgery or procedure."},{"id":"a8eb96977e61","type":"article","url":"https://hartvaat.nl/2024/08/06/racing-subanalyse-matige-statine-plus-ezetimibe-voor-secundaire-preventie/","title":"RACING subanalyse: matige statine plus ezetimibe voor secundaire preventie","title_en":"Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy-Statin and Eicosapentaenoic Acid (RESPECT-EPA).","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.065520","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.065520","authors":["Katsumi Miyauchi","Hiroshi Iwata","Yuji Nishizaki","Teruo Inoue","Atsushi Hirayama","Kazuo Kimura","Yukio Ozaki","Toyoaki Murohara","Kenji Ueshima","Yoshihiro Kuwabara","Sachiko Tanaka-Mizuno","Naotake Yanagisawa","Tosiya Sato","Hiroyuki Daida"],"significance":7,"published":"2024-08-06","source_date":"2024-08-06","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/","https://hartvaat.nl/kennis/lipiden/lipidenverlaging-stappenplan/"],"congress":"","summary_en":"This RACING subanalysis confirmed that moderate-intensity statin plus ezetimibe is equally effective as high-intensity statin for secondary cardiovascular prevention, with consistent results across different patient subgroups.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"RACING subanalyse bevestigde dat matige-intensiteit statine plus ezetimibe even effectief is als hoge-dosis statine voor secundaire CV-preventie. De combinatiestrategie biedt een beter verdragen alternatief.","abstract_original":"BACKGROUND: Low plasma levels of eicosapentaenoic acid (EPA) are associated with cardiovascular events. This trial aimed to assess the clinical benefits of icosapent ethyl in patients with coronary artery disease, a low EPA/arachidonic acid (AA) ratio, and statin treatment. METHODS: In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily) or control group. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina pectoris, and coronary revascularization. The secondary composite end points of coronary events included sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina requiring emergency hospitalization and coronary revascularization, or coronary revascularization. RESULTS: Overall, 3884 patients were enrolled at 95 sites in Japan. Among them, 2506 patients had a low EPA/AA ratio, and 1249 and 1257 patients were randomized to the EPA and control group, respectively. The median EPA/AA ratio was 0.243 (interquartile range, 0.180-0.314) and 0.235 (interquartile range, 0.163-0.310) in the EPA and control group, respectively. Over a median period of 5 years, the primary end point occurred in 112 of 1225 patients (9.1%) and 155 of 1235 patients (12.6%) in the EPA and control group, respectively (hazard ratio, 0.79 [95% CI, 0.62-1.00]; P=0.055). Meanwhile, the secondary composite end point of coronary events in the EPA group was significantly lower (81/1225 [6.6%] versus 120/1235 [9.7%] patients; hazard ratio, 0.73 [95% CI, 0.55-0.97]). Adverse events did not differ between the groups, but the rate of new-onset atrial fibrillation was significantly higher in the EPA group (3.1% versus 1.6%; P=0.017). CONCLUSIONS: Icosapent ethyl treatment resulted in a numerically lower risk of cardiovascular events that did not reach statistical significance in patients with chronic coronary artery disease, a low EPA/AA ratio, and statin treatment. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012069."},{"id":"6d560042ed8f","type":"article","url":"https://hartvaat.nl/2024/08/06/doac-bij-heartmate-3-lvad-eerste-gerandomiseerde-trial/","title":"DOAC bij HeartMate 3 LVAD: eerste gerandomiseerde trial","title_en":"A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["pathfinder-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069726","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069726","authors":["Ivan Netuka","Zuzana Tucanova","Peter Ivak","Stanislav Gregor","Dushan Michael Kolesar","Tomas Marek","Vojtech Melenovsky","Jana Binova","Zora Dorazilova","Marketa Hegarova","Martina Podolec","Hynek Riha","Jean M Connors","Mandeep R Mehra"],"significance":7,"published":"2024-08-06","source_date":"2024-08-06","image":"","kennis":[],"congress":"","summary_en":"This first randomized trial of DOAC therapy in patients with the HeartMate 3 LVAD explored whether direct oral anticoagulants can replace warfarin for anticoagulation in mechanically supported patients, potentially simplifying long-term management.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Eerste gerandomiseerde trial van DOAC-therapie bij volledig magnetisch geleviteerde LVAD (HeartMate 3). De studie onderzoekt of DOAC's het antistollingsmanagement bij LVAD-patiënten kunnen vereenvoudigen.","abstract_original":""},{"id":"840dd5a235ea","type":"article","url":"https://hartvaat.nl/2024/08/03/device-algoritmen-voor-rv-pacingminimalisatie-meta-analyse-van-uitkomsten/","title":"Device-algoritmen voor RV-pacingminimalisatie: meta-analyse van uitkomsten","title_en":"Systematic review and meta-analysis on the impact on outcomes of device algorithms for minimizing right ventricular pacing.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae212","source_url":"https://doi.org/10.1093/europace/euae212","authors":["Davide Antonio Mei","Jacopo Francesco Imberti","Marco Vitolo","Niccolò Bonini","Kevin Serafini","Marta Mantovani","Enrico Tartaglia","Chiara Birtolo","Marco Zuin","Matteo Bertini","Giuseppe Boriani"],"significance":6,"published":"2024-08-03","source_date":"2024-08-03","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that device algorithms minimizing right ventricular pacing improve clinical outcomes including reduced AF and heart failure, supporting the programming of RV pacing avoidance modes in pacemaker patients.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat device-algoritmen voor minimalisatie van RV-pacing de uitkomsten verbeteren, met minder AF en hartfalen. Programmeerstrategieën die onnodige pacing vermijden zijn klinisch waardevol.","abstract_original":"AIMS: Physiological activation of the heart using algorithms to minimize right ventricular pacing (RVPm) may be an effective strategy to reduce adverse events in patients requiring anti-bradycardia therapies. This systematic review and meta-analysis aimed to evaluate current evidence on clinical outcomes for patients treated with RVPm algorithms compared to dual-chamber pacing (DDD). METHODS AND RESULTS: We conducted a systematic search of the PubMed database. The predefined endpoints were the occurrence of persistent/permanent atrial fibrillation (PerAF), cardiovascular (CV) hospitalization, all-cause death, and adverse symptoms. We also aimed to explore the differential effects of algorithms in studies enrolling a high percentage of atrioventricular block (AVB) patients. Eight studies (7229 patients) were included in the analysis. Compared to DDD pacing, patients using RVPm algorithms showed a lower risk of PerAF [odds ratio (OR) 0.74, 95% confidence interval (CI) 0.57-0.97] and CV hospitalization (OR 0.77, 95% CI 0.61-0.97). No significant difference was found for all-cause death (OR 1.01, 95% CI 0.78-1.30) or adverse symptoms (OR 1.03, 95% CI 0.81-1.29). No significant interaction was found between the use of the RVPm strategy and studies enrolling a high percentage of AVB patients. The pooled mean RVP percentage for RVPm algorithms was 7.96% (95% CI 3.13-20.25), as compared with 45.11% (95% CI 26.64-76.38) of DDD pacing. CONCLUSION: Algorithms for RVPm may be effective in reducing the risk of PerAF and CV hospitalization in patients requiring anti-bradycardia therapies, without an increased risk of adverse symptoms. These results are also consistent for studies enrolling a high percentage of AVB patients."},{"id":"f0a7577af4fe","type":"article","url":"https://hartvaat.nl/2024/08/03/dagontslag-versus-overnachting-na-af-ablatie-uitgebreide-meta-analyse/","title":"Dagontslag versus overnachting na AF-ablatie: uitgebreide meta-analyse","title_en":"Same-day discharge vs. overnight stay following catheter ablation for atrial fibrillation: a comprehensive review and meta-analysis by the European Heart Rhythm Association Health Economics Committee.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae200","source_url":"https://doi.org/10.1093/europace/euae200","authors":["Maura M Zylla","Jacopo F Imberti","Francisco Leyva","Ruben Casado-Arroyo","Frieder Braunschweig","Helmut Pürerfellner","José L Merino","Giuseppe Boriani"],"significance":6,"published":"2024-08-03","source_date":"2024-08-03","image":"","kennis":[],"congress":"","summary_en":"This comprehensive meta-analysis confirmed that same-day discharge after AF catheter ablation is safe and equivalent to overnight observation, supporting outpatient ablation as a standard approach.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse bevestigde dat dagontslag na AF-ablatie even veilig is als overnachting. De bevindingen ondersteunen dagbehandeling als standaard bij ongecompliceerde AF-ablatie.","abstract_original":"AIMS: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) may address the growing socio-economic health burden of the increasing demand for interventional AF therapies. This systematic review and meta-analysis analyses the current evidence on clinical outcomes in SDD after AF ablation compared with overnight stay (ONS). METHODS AND RESULTS: A systematic search of the PubMed database was performed. Pre-defined endpoints were complications at short-term (24-96 h) and 30-day post-discharge, re-hospitalization, and/or emergency room (ER) visits at 30-day post-discharge, and 30-day mortality. Twenty-four studies (154 716 patients) were included. Random-effects models were applied for meta-analyses of pooled endpoint prevalence in the SDD cohort and for comparison between SDD and ONS cohorts. Pooled estimates for complications after SDD were low both for short-term [2%; 95% confidence interval (CI): 1-5%; I2: 89%) and 30-day follow-up (2%; 95% CI: 1-4%; I2: 91%). There was no significant difference in complications rates between SDD and ONS [short-term: risk ratio (RR): 1.62; 95% CI: 0.52-5.01; I2: 37%; 30 days: RR: 0.65; 95% CI: 0.42-1.00; I2: 95%). Pooled rates of re-hospitalization/ER visits after SDD were 4% (95% CI: 1-10%; I2: 96%) with no statistically significant difference between SDD and ONS (RR: 0.86; 95% CI: 0.58-1.27; I2: 61%). Pooled 30-day mortality was low after SDD (0%; 95% CI: 0-1%; I2: 33%). All studies were subject to a relevant risk of bias, mainly due to study design. CONCLUSION: In this meta-analysis including a large contemporary cohort, SDD after AF ablation was associated with low prevalence of post-discharge complications, re-hospitalizations/ER visits and mortality, and a similar risk compared with ONS. Due to limited quality of current evidence, further prospective, randomized trials are needed to confirm safety of SDD and define patient- and procedure-related prerequisites for successful and safe SDD strategies."},{"id":"35928a4fcaea","type":"article","url":"https://hartvaat.nl/2024/08/03/cardiale-shockwave-therapie-bij-cabg-verbetert-myocardfunctie/","title":"Cardiale shockwave-therapie bij CABG verbetert myocardfunctie","title_en":"Cardiac shockwave therapy in addition to coronary bypass surgery improves myocardial function in ischaemic heart failure: the CAST-HF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["bradycardie","cardiogene-shock","hypertrofische-cardiomyopathie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae341","source_url":"https://doi.org/10.1093/eurheartj/ehae341","authors":["Johannes Holfeld","Felix Nägele","Leo Pölzl","Clemens Engler","Michael Graber","Jakob Hirsch","Sophia Schmidt","Agnes Mayr","Felix Troger","Mathias Pamminger","Markus Theurl","Michael Schreinlechner","Nikolay Sappler","Elfriede Ruttmann-Ulmer","Wolfgang Schaden","John P Cooke","Hanno Ulmer","Axel Bauer","Can Gollmann-Tepeköylü","Michael Grimm"],"significance":6,"published":"2024-08-03","source_date":"2024-08-03","image":"","kennis":[],"congress":"","summary_en":"This study showed that cardiac shockwave therapy as an adjunct to CABG improves myocardial function in ischemic regions, exploring a non-invasive mechanical stimulation approach for enhancing surgical revascularization outcomes.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat cardiale shockwave-therapie als adjunct bij CABG de myocardfunctie in ischemisch weefsel verbetert. De interventie stimuleert angiogenese en kan de resultaten van bypasschirurgie optimaliseren.","abstract_original":"BACKGROUND AND AIMS: In chronic ischaemic heart failure, revascularisation strategies control symptoms but are less effective in improving left ventricular ejection fraction (LVEF). The aim of this trial is to investigate the safety of cardiac shockwave therapy (SWT) as a novel treatment option and its efficacy in increasing cardiac function by inducing angiogenesis and regeneration in hibernating myocardium. METHODS: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days. RESULTS: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons. CONCLUSIONS: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure."},{"id":"026f4fe6c3b8","type":"article","url":"https://hartvaat.nl/2024/08/03/anticoagulatie-bij-postoperatief-af-na-geisoleerde-cabg-meta-analyse/","title":"Anticoagulatie bij postoperatief AF na geïsoleerde CABG: meta-analyse","title_en":"Anticoagulation for post-operative atrial fibrillation after isolated coronary artery bypass grafting: a meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["abelacimab","anticoagulantia","anticoagulatie-kwetsbare-ouderen","rivaroxaban"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae267","source_url":"https://doi.org/10.1093/eurheartj/ehae267","authors":["Mileen R D van de Kar","Thomas J van Brakel","Marcel Van't Veer","Gijs J van Steenbergen","Edgar J Daeter","Harry J G M Crijns","Dennis van Veghel","Lukas R C Dekker","Luuk C Otterspoor"],"significance":6,"published":"2024-08-03","source_date":"2024-08-03","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis evaluated anticoagulation for post-operative AF after CABG, finding limited but suggestive evidence that anticoagulation may reduce stroke risk in patients who develop AF after cardiac surgery.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht of anticoagulatie na postoperatief AF na CABG het CVA-risico vermindert. Het bewijs was beperkt maar suggestief voor een voordeel. De behandelbeslissing blijft individueel afgewogen.","abstract_original":"BACKGROUND AND AIMS: This study aimed to evaluate clinical outcomes in patients developing post-operative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) and characterize variations in oral anticoagulation (OAC) use, benefits, and complications. METHODS: A systematic search identified studies on new-onset POAF after CABG and OAC initiation. Outcomes included risks of thromboembolic events, bleeding, and mortality. Furthermore, a meta-analysis was conducted on these outcomes, stratified by the use or non-use of OAC. RESULTS: The identified studies were all non-randomized. Among 1 698 307 CABG patients, POAF incidence ranged from 7.9% to 37.6%. Of all POAF patients, 15.5% received OAC. Within 30 days, thromboembolic events occurred at rates of 1.0% (POAF: 0.3%; non-POAF: 0.8%) with 2.0% mortality (POAF: 1.0%; non-POAF: 0.5%). Bleeding rates were 1.1% for POAF patients and 2.7% for non-POAF patients. Over a median of 4.6 years, POAF patients had 1.73 thromboembolic events, 3.39 mortality, and 2.00 bleeding events per 100 person-years; non-POAF patients had 1.14, 2.19, and 1.60, respectively. No significant differences in thromboembolic risks [effect size -0.11 (-0.36 to 0.13)] and mortality [effect size -0.07 (-0.21 to 0.07)] were observed between OAC users and non-users. However, OAC use was associated with higher bleeding risk [effect size 0.32 (0.06-0.58)]. CONCLUSIONS: In multiple timeframes following CABG, the incidence of complications in patients who develop POAF is low. The use of OAC in patients with POAF after CABG is associated with increased bleeding risk."},{"id":"09c138d17b5f","type":"article","url":"https://hartvaat.nl/2024/08/03/catheterablatie-bij-persisterend-af-recidiefpatronen-en-kwaliteit-van-leven/","title":"Catheterablatie bij persisterend AF: recidiefpatronen en kwaliteit van leven","title_en":"Catheter ablation for persistent atrial fibrillation: patterns of recurrence and impact on quality of life and health care utilization.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae291","source_url":"https://doi.org/10.1093/eurheartj/ehae291","authors":["Rose Crowley","David Chieng","Hariharan Sugumar","Liang-Han Ling","Louise Segan","Jeremy William","Sandeep Prabhu","Aleksandr Voskoboinik","Geoffrey Wong","Joseph B Morton","Geoffrey Lee","Alex J McLellan","Michael Wong","Rajeev K Pathak","Laurence Sterns","Matthew Ginks","Prashanthan Sanders","Jonathan M Kalman","Peter M Kistler"],"significance":5,"published":"2024-08-03","source_date":"2024-08-03","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"This study characterised recurrence patterns following catheter ablation for persistent atrial fibrillation and their impact on quality of life. Despite arrhythmia recurrences, quality of life improved significantly, broadening the definition of ablation success beyond rhythm control alone.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie documenteerde de recidiefpatronen na ablatie voor persisterend AF en het effect op kwaliteit van leven. Ondanks recidieven verbeterde de kwaliteit van leven significant, wat het succes van ablatie breder definieert dan alleen sinusritmebehoud.","abstract_original":"BACKGROUND AND AIMS: Patterns of atrial fibrillation (AF) recurrence post-catheter ablation for persistent AF (PsAF) are not well described. This study aimed to describe the pattern of AF recurrence seen following catheter ablation for PsAF and the implications for healthcare utilization and quality of life (QoL). METHODS: This was a post-hoc analysis of the CAPLA study, an international, multicentre study that randomized patients with symptomatic PsAF to pulmonary vein isolation plus posterior wall isolation or pulmonary vein isolation alone. Patients underwent twice daily single lead ECG, implantable device monitoring or three monthly Holter monitoring. RESULTS: 154 of 333 (46.2%) patients (median age 67.3 years, 28% female) experienced AF recurrence at 12-month follow-up. Recurrence was paroxysmal in 97 (63%) patients and persistent in 57 (37%). Recurrence type did not differ between randomization groups (P = .508). Median AF burden was 27.4% in PsAF recurrence and .9% in paroxysmal AF (PAF) recurrence (P < .001). Patients with PsAF recurrence had lower baseline left ventricular ejection fraction (PsAF 50% vs. PAF 60%, P < .001) and larger left atrial volume (PsAF 54.2 ± 19.3 mL/m² vs. PAF 44.8 ± 11.6 mL/m², P = .008). Healthcare utilization was significantly higher in PsAF (45 patients [78.9%]) vs. PAF recurrence (45 patients [46.4%], P < .001) and lowest in those without recurrence (17 patients [9.5%], P < .001). Patients without AF recurrence had greater improvements in QoL as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire (Δ33.3 ± 25.2 points) compared to those with PAF (Δ24.0 ± 25.0 points, P = .012) or PsAF (Δ13.4 ± 22.9 points, P < .001) recurrence. CONCLUSIONS: AF recurrence is more often paroxysmal after catheter ablation for PsAF irrespective of ablation strategy. Recurrent PsAF was associated with higher AF burden, increased healthcare utilization and antiarrhythmic drug use. The type of AF recurrence and AF burden may be considered important endpoints in clinical trials investigating ablation of PsAF."},{"id":"441d62c36be7","type":"article","url":"https://hartvaat.nl/2024/08/01/baroreflexactivatietherapie-bij-resistente-hypertensie-sham-gecontroleerde-pilot/","title":"Baroreflexactivatietherapie bij resistente hypertensie: sham-gecontroleerde pilotstudie","title_en":"Sham-Controlled Randomized Pilot Trial on Baroreflex Activation Therapy in Resistant Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23088","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23088","authors":["Johan R Simonsen","Leena Vikatmaa","Pirkka Vikatmaa","Mika Laine","Hanna Granroth-Wilding","Per-Henrik Groop","Ilkka Tikkanen","Daniel Gordin"],"significance":6,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This sham-controlled pilot study of baroreflex activation therapy in resistant hypertension showed significant blood pressure reduction, providing early evidence for this device-based neuromodulation approach.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Sham-gecontroleerde pilotstudie van baroreflexactivatietherapie bij resistente hypertensie. Het device verlaagde de bloeddruk significant maar de studie was klein. Grotere trials zijn nodig voor definitieve conclusies.","abstract_original":""},{"id":"c295a2865e58","type":"article","url":"https://hartvaat.nl/2024/08/01/sociale-determinanten-en-hypertensie-uitkomsten-systematische-review/","title":"Sociale determinanten en hypertensie-uitkomsten: systematische review","title_en":"Impact of Social Determinants of Health on Hypertension Outcomes: A Systematic Review.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling","primaire-preventie","stress-psychosociaal","vrouwen"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22571","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22571","authors":["Faith E Metlock","Thomas Hinneh","Chitchanok Benjasirisan","Abeer Alharthi","Oluwabunmi Ogungbe","Ruth-Alma N Turkson-Ocran","Cheryl R Himmelfarb","Yvonne Commodore-Mensah"],"significance":5,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/psychosociale-risicofactoren-hart/","https://hartvaat.nl/kennis/farmacologie/aldosteron-en-raas-farmacologie/"],"congress":"","summary_en":"This systematic review documented the impact of social determinants of health on hypertension outcomes. Socioeconomic status, race/ethnicity, and healthcare access significantly influence blood pressure control, underscoring the need for targeted public health interventions.","created":"2026-07-03T10:31:05Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review documenteerde de impact van sociale determinanten op hypertensie-uitkomsten. Sociaaleconomische status, etniciteit en gezondheidszorgtoegang beïnvloeden de bloeddrukcontrole significant, wat gerichte interventies vereist.","abstract_original":"Despite ample evidence linking social determinants of health (SDoH) and hypertension outcomes, efforts to address SDoH in the context of hypertension prevention and self-management are not commensurate with the burden and impact of hypertension. To provide valuable insights into the development of targeted and effective strategies for preventing and managing hypertension, this systematic review, guided by the Healthy People 2030 SDoH framework, aims to summarize the inclusion, measurement, and evaluation of SDoH in studies examining hypertension outcomes, with a focus on characterizing SDoH constructs and summarizing the current evidence of their influence on hypertension outcomes. Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive search of electronic databases identified 10 608 unique records, from which 57 articles meeting inclusion criteria were analyzed. The studies, conducted nationally or regionally across the United States, revealed that higher educational attainment, health insurance coverage, income, and favorable neighborhood characteristics were associated with lower hypertension prevalence and better hypertension control among US adults. The findings underscore the importance of addressing SDoH such as education, health care access, economic stability, neighborhood environments, and social context to reduce hypertension disparities. Multilevel collaboration and community-engaged practices are necessary to tackle these disparities effectively."},{"id":"50a1b3190d1b","type":"article","url":"https://hartvaat.nl/2024/08/01/sarcopenie-en-intensieve-bloeddrukbehandeling-sprint-subanalyse/","title":"Sarcopenie en intensieve bloeddrukbehandeling: SPRINT subanalyse","title_en":"Relationship Between Sarcopenia and Intensive Blood Pressure Control Efficacy and Safety: A Secondary Analysis of SPRINT.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.23011","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.23011","authors":["Saeid Mirzai","Ian Persits","Richard Kazibwe","Mohanad Gabani","Austin Seals","Matthew J Singleton","Rishi Rikhi","Parag A Chevli","Salvatore Carbone","W H Wilson Tang","Joseph Yeboah","Jeff D Williamson","Dalane W Kitzman","David M Herrington","Michael D Shapiro"],"significance":5,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"A SPRINT secondary analysis assessed whether sarcopenia modifies the efficacy and safety of intensive blood pressure treatment. Sarcopenic patients experienced comparable cardiovascular benefit and safety, supporting intensive blood pressure targets in this vulnerable population.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:07Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SPRINT subanalyse onderzocht of sarcopenie het effect en de veiligheid van intensieve bloeddrukbehandeling beïnvloedt. Sarcopene patiënten hadden vergelijkbaar voordeel en veiligheid, wat intensieve behandeling ook bij deze groep ondersteunt.","abstract_original":"BACKGROUND: Sarcopenia and hypertension are independently associated with worse cardiovascular disease (CVD) risk and survival. While individuals with sarcopenia may benefit from intensive blood pressure (BP) control, the increased vulnerability of this population raises concerns for potential harm. This study aimed to evaluate clinical and safety outcomes with intensive (target <120 mm Hg) versus standard (<140 mm Hg) systolic BP targets in older hypertensive adults with sarcopenia compared with nonsarcopenic counterparts in the SPRINT (Systolic Blood Pressure Intervention Trial). METHODS: Sarcopenia was defined using surrogates of the lowest sex-stratified median of the sarcopenia index (serum creatinine/cystatin C×100) for muscle wasting and gait speed ≤0.8 m/s for muscle weakness. Outcomes included CVD events, all-cause mortality, and serious adverse events. RESULTS: Of 2571 SPRINT participants with sarcopenia index and gait speed data available (aged ≥75 years), 502 (19.5%) met the criteria for sarcopenia, which was associated with higher risks of CVD events (adjusted hazard ratio, 1.49 [95% CI, 1.15-1.94]; P=0.003) and all-cause mortality (adjusted hazard ratio, 1.46 [95% CI, 1.09-1.94]; P=0.010). In participants with sarcopenia, intensive (versus standard) BP control nearly halved the risk of CVD events (adjusted hazard ratio, 0.57 [95% CI, 0.36-0.88]; P=0.012) without increasing serious adverse events. Similar risk reduction was seen for all-cause mortality in participants with sarcopenia (adjusted hazard ratio, 0.66 [95% CI, 0.41-1.08]; P=0.102), but the effect was only significant in those without chronic kidney disease. CONCLUSIONS: Older hypertensive adults with sarcopenia randomized to intensive BP control experienced a lower risk of CVD without increased adverse events compared with standard BP control. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062."},{"id":"c12461c228a9","type":"article","url":"https://hartvaat.nl/2024/08/01/alcohol-en-hypertensierisico-dosis-respons-meta-analyse-van-niet-experimentele-s/","title":"Alcohol en hypertensierisico: dosis-respons meta-analyse van niet-experimentele studies","title_en":"Alcohol Intake and Risk of Hypertension: A Systematic Review and Dose-Response Meta-Analysis of Nonexperimental Cohort Studies.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["alcoholgebruik"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.22703","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.22703","authors":["Marta Cecchini","Tommaso Filippini","Paul K Whelton","Inga Iamandii","Silvia Di Federico","Giuseppe Boriani","Marco Vinceti"],"significance":6,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This comprehensive dose-response meta-analysis confirmed that any alcohol consumption increases hypertension risk with no safe threshold, reinforcing alcohol reduction as a blood pressure management strategy.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T18:39:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse bevestigde dat elk alcoholgebruik het hypertensierisico verhoogt, zonder veilige drempel. Het verband was lineair en sterker bij mannen. Alcoholbeperking is een effectieve en onderbenutte preventiestrategie.","abstract_original":"BACKGROUND: Alcohol consumption has been associated with higher blood pressure and an increased risk of hypertension. However, the possible exposure thresholds and effect-modifiers are uncertain. METHODS: We assessed the dose-response relationship between usual alcohol intake and hypertension incidence in nonexperimental cohort studies. After performing a systematic literature search through February 20, 2024, we retrieved 23 eligible studies. We computed risk ratios and 95% CI of hypertension incidence using a nonlinear meta-analytic model based on restricted cubic splines, to assess the dose-response association with alcohol consumption. RESULTS: We observed a positive and almost linear association between alcohol intake and hypertension risk with risk ratios of 0.89 (0.84-0.94), 1.11 (1.07-1.15), 1.22 (1.14-1.30), and 1.33 (1.18-1.49) for 0, 24, 36 and 48 g/d, respectively, using 12 g alcohol/d as the reference value. In sex-specific analyses, the association was almost linear in men over the entire range of exposure but only observed above 12 g/d in women, although with a steeper association at high levels of consumption compared with men. The increased risk of hypertension above 12 to 24 g alcohol/d was similar in Western and Asian populations and considerably greater in White than in Black populations, mainly due to the positive association in women at moderate-to-high intake. CONCLUSIONS: Overall, our results lend support to a causal association between alcohol consumption and risk of hypertension, especially above an alcohol intake of 12 g/d, and are consistent with recommendations to avoid or limit alcohol intake. Sex and ethnicity appear to be major effect-modifiers of such association."},{"id":"9d753e6f5b4e","type":"article","url":"https://hartvaat.nl/2024/08/01/adaptieve-atriale-pacing-gereguleerd-door-bloeddruk-pilotstudie/","title":"Adaptieve atriale pacing gereguleerd door bloeddruk: pilotstudie","title_en":"Safety and efficacy of adaptive atrial pacing regulated by blood pressure during low-level exercise: a proof-of-concept study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["bloeddrukbehandeling"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14854","source_url":"https://doi.org/10.1002/ehf2.14854","authors":["Michael Burnam","Robert Develle","Leo Polosajian","Shakeh Nalbandian","Kenneth Ellenbogen","Eli Gang"],"significance":5,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":[],"congress":"","summary_en":"This proof-of-concept study evaluated a novel pacing algorithm that modulates atrial pacing rate based on blood pressure measurements during exercise. The approach was feasible and may improve physiological responses in pacemaker patients with heart failure with preserved ejection fraction.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Pilotstudie onderzocht adaptieve atriale pacing aangestuurd door bloeddrukmeting tijdens inspanning. Het concept is haalbaar en kan de fysiologische respons bij pacemakerpatiënten verbeteren.","abstract_original":"AIMS: Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). METHODS: This prospective, randomized, double-blind, non-significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. RESULTS: Ten subjects with HFpEF associated with hypertension who also had permanent dual-chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post-treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post-treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post-treadmill. CONCLUSIONS: An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross-over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer-term treatment."},{"id":"846e99169008","type":"article","url":"https://hartvaat.nl/2024/08/01/candesartan-dosering-bij-mannen-versus-vrouwen-met-chronisch-hartfalen/","title":"Candesartan dosering bij mannen versus vrouwen met chronisch hartfalen","title_en":"Achieved dose and treatment discontinuation of candesartan in men and women with chronic heart failure: data from CHARM.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14715","source_url":"https://doi.org/10.1002/ehf2.14715","authors":["Hailun Qin","Pooja Dewan","Bernadet T Santema","Jozine M Ter Maaten","Karl Swedberg","John J V McMurray","Adriaan A Voors"],"significance":5,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/","https://hartvaat.nl/kennis/farmacologie/lisdiuretica-furosemide-bumetanide/"],"congress":"","summary_en":"Analysis of the CHARM programme showed that women with heart failure achieved lower doses of candesartan than men yet experienced comparable clinical benefit. These findings support consideration of lower dose targets in women with heart failure.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat vrouwen met hartfalen lagere doses candesartan bereiken dan mannen maar vergelijkbaar voordeel ervaren. Dit ondersteunt lagere doseringsstreefwaarden bij vrouwen als aanvulling op het beschikbare bewijs.","abstract_original":"AIMS: Angiotensin receptor blockers have been shown to reduce heart failure hospitalization and cardiovascular mortality in men and women with heart failure with reduced ejection fraction (HFrEF). It is unknown whether there are differences between men and women in achieved dose and treatment discontinuation due to adverse events of candesartan. METHODS AND RESULTS: We conducted a post hoc analysis of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme. A total of 3172 men and 1106 women with HFrEF [left ventricular ejection fraction (LVEF) ≤ 40%] in New York Heart Association class II-IV were randomized to candesartan or placebo. Every 2 weeks, patients were up-titrated from 4 or 8, to16, to 32 mg once daily, unless a higher dose was contraindicated or not tolerated. Women were older (66 vs. 64 years), had a higher LVEF (29.9% vs. 28.6%), and had more hypertension (54% vs. 47%) than men. The mean achieved dose of candesartan was 21.5 ± 12.6 mg in men and 20.7 ± 12.9 mg in women (P = 0.19). In both the candesartan and placebo groups, cardiovascular death and heart failure hospitalizations were higher in men and women who achieved lower dose levels. Event rates for achieved dose levels of 0, 4 or 8, 16, and 32 mg candesartan were 20.8, 17.2, 14.0, and 10.1 per 100 person-years in men, respectively, and 23.6, 13.7, 14.0, and 9.1 per 100 person-years in women, respectively. In each of the achieved dose levels, there was no sex difference in the proportion of patients with an event, neither in the candesartan group nor in the placebo group (P-value for all > 0.05). There was no significant interaction between sex and treatment-related discontinuation for hypotension (P = 0.520), an increase in creatinine (P = 0.102), and hyperkalaemia (P = 0.905). CONCLUSIONS: In a randomized clinical trial in patients with HFrEF, men and women achieved similar doses of candesartan. Primary event rates and treatment-related discontinuation due to adverse events were also similar between men and women."},{"id":"9989c55bce31","type":"article","url":"https://hartvaat.nl/2024/08/01/coronaire-microvasculaire-disfunctie-bij-hfpef-meta-analyse/","title":"Coronaire microvasculaire disfunctie bij HFpEF: meta-analyse","title_en":"Impact of coronary microvascular dysfunction in heart failure with preserved ejection fraction: a meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["microcirculatie"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14626","source_url":"https://doi.org/10.1002/ehf2.14626","authors":["Domenico D'Amario","Renzo Laborante","Emiliano Bianchini","Giuseppe Ciliberti","Donato Antonio Paglianiti","Mattia Galli","Attilio Restivo","Davide Stolfo","Rocco Vergallo","Giuseppe M C Rosano","Filippo Crea","Carolyn S P Lam","Lars H Lund","Marco Metra","Giuseppe Patti","Gianluigi Savarese"],"significance":6,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis documented that coronary microvascular dysfunction is highly prevalent in HFpEF and is associated with worse exercise capacity and prognosis, supporting the microvascular hypothesis of HFpEF pathophysiology.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse documenteerde de prevalentie en impact van coronaire microvasculaire disfunctie bij HFpEF. CMD is frequent en geassocieerd met slechtere uitkomsten, wat het als therapeutisch doel identificeert.","abstract_original":"AIMS: Several mechanisms have been identified in the aetiopathogenesis of heart failure with preserved ejection fraction (HFpEF). Among these, coronary microvascular dysfunction (CMD) may play a key pathophysiological role. We performed a systematic review and meta-analysis to investigate the prevalence, echocardiographic correlates, and prognostic implications of CMD in patients with HFpEF. METHODS AND RESULTS: A systematic search for articles up to 1 May 2023 was performed. The primary aim was to assess the prevalence of CMD. Secondary aims were to compare key echocardiographic parameters (E/e' ratio, left atrial volume index [LAVi], and left ventricular mass index [LVMi]), clinical outcomes [death and hospitalization for heart failure (HF)], and prevalence of atrial fibrillation (AF) between patients with and without CMD. Meta-regressions according to baseline patient characteristics and study features were performed to explore potential heterogeneity sources. We identified 14 observational studies, enrolling 1138 patients with HFpEF. The overall prevalence of CMD was 58%. Compared with patients without CMD, patients with HFpEF and CMD had larger LAVi [mean difference (MD) 3.85 confidence interval (CI) 1.19-6.5, P < 0.01)], higher E/e' ratio (MD 2.76 CI 1.54-3.97; P < 0.01), higher prevalence of AF (odds ratio 1.61 CI 1.04-2.48, P = 0.03) and higher risk of death or hospitalization for HF [hazard ratio 3.19, CI 1.04-9.57, P = 0.04]. CONCLUSIONS: CMD is present in little more than half of the patients with HFpEF and is associated with echocardiographic evidence of more severe diastolic dysfunction and a higher prevalence of AF, doubling the risk of death or HF hospitalization."},{"id":"bf95f719b2f6","type":"article","url":"https://hartvaat.nl/2024/08/01/echocardiografische-monitoring-bij-heartmate-3-systematische-review/","title":"Echocardiografische monitoring bij HeartMate 3: systematische review","title_en":"Echocardiographic haemodynamic monitoring in the context of HeartMate 3™ therapy: a systematic review.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14759","source_url":"https://doi.org/10.1002/ehf2.14759","authors":["Linus Ohlsson","Joanna-Maria Papageorgiou","Tino Ebbers","Meriam Åström Aneq","Éva Tamás","Hans Granfeldt"],"significance":5,"published":"2024-08-01","source_date":"2024-08-01","image":"","kennis":[],"congress":"","summary_en":"A systematic review summarised echocardiographic haemodynamic monitoring strategies in patients with the HeartMate 3 left ventricular assist device. Standardised echocardiographic protocols are essential for optimal device management and early detection of complications.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review vatte de echocardiografische monitoringstrategieën bij HeartMate 3-patiënten samen. Gestandaardiseerde echo-protocollen zijn essentieel voor optimale devicemanagement en complicatiedetectie.","abstract_original":"AIMS: While echocardiography remains essential within haemodynamic monitoring of durable mechanical circulatory support, previous echocardiographic guidelines are missing scientific evidence for the novel HeartMate 3™ (HM3) system. Accordingly, this review aims to summarize available echocardiographic evidence including HM3. METHODS AND RESULTS: This systematic review adhered to the PRISMA 2020 guidelines. Searches were conducted during August 2023 across PubMed, Embase, and Google Scholar using specific echocardiographic terms combined with system identifiers. Study quality was assessed using the Newcastle-Ottawa Scale (NOS) for cohort studies and Critical Appraisal Instrument (PCAI) for cross-sectional studies. Nine studies met the inclusion criteria, of which eight cohort studies and one cross-sectional study. Aortic regurgitation (AR) prevalence at approximately 12 months of support exhibited heterogenicity (33.5% (Δ 33%)) in a limited number of studies (n = 3). Several studies (n = 5) demonstrated an increasing prevalence and severity of AR during HM3 support, generating moderate to high level of evidence. One AR study showed a higher cumulative incidence of death and heart failure (HF) readmission compared with those without significant AR, hazard ratio 3.42 (95% CI 1.48-8.76). A second study showed that a worsening AR group had significantly lower survival-free from HF readmission (59% vs. 89%, P = 0.023) with a hazard ratio of 5.18 (95% CI 1.07-25.0), while a third study did not reveal any differences in cardiac-related hospitalizations in the 12 months follow-up or non-cardiac-related hospitalization. Mitral regurgitation (MR) prevalence at approximately 12 months of support exhibited good consistency 15.0% (Δ 0.8%) in both included studies, which did not reveal any significant pattern of changing prevalence over time. Tricuspid regurgitation (TR) prevalence at approximately 12 months of support exhibited fair consistency 28.5% (Δ 8.3%) in a limited number of studies (n = 2); both studies showed a statistically un-confirmed trend of increased TR prevalence over time. The evidence of general prevalence of right ventricular dysfunction (RVD) was insufficient due to lack of studies. CONCLUSIONS: There are few methodologically consistent studies with focus on long-term haemodynamic effects. Aortic regurgitation still seems to be a prevalent and potentially significant finding. The available evidence concerning right heart function is limited despite clinical relevance and potential prognostic value. Potential interventricular and haemodynamic interplay are identified as a white field for future research."},{"id":"4e3f926f646e","type":"article","url":"https://hartvaat.nl/2024/07/23/artesia-apixaban-versus-aspirine-naar-cha2ds2-vasc-bij-subclinisch-af/","title":"ARTESIA: apixaban versus aspirine naar CHA₂DS₂-VASc bij subclinisch AF","title_en":"Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.05.002","source_url":"https://doi.org/10.1016/j.jacc.2024.05.002","authors":["Renato D Lopes","Christopher B Granger","Daniel M Wojdyla","William F McIntyre","Marco Alings","Thenmozhi Mani","Chinthanie Ramasundarahettige","Lena Rivard","Dan Atar","David H Birnie","Giuseppe Boriani","Guy Amit","Peter Leong-Sit","Claus Rinne","Gabor Z Duray","Michael R Gold","Stefan H Hohnloser","Valentina Kutyifa","Juan Benezet-Mazuecos","Jens Cosedis Nielsen","Christian Sticherling","Alexander P Benz","Cecilia Linde","Joseph Kautzner","Philippe Mabo","Georges H Mairesse","Stuart J Connolly","Jeff S Healey"],"significance":7,"published":"2024-07-23","source_date":"2024-07-23","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-en-beroerte/","https://hartvaat.nl/kennis/atriumfibrilleren/wat-is-atriumfibrilleren/"],"congress":"","summary_en":"This ARTESIA subanalysis showed that the benefit of apixaban over aspirin for device-detected subclinical AF increases with higher CHA₂DS₂-VASc scores, supporting risk-stratified anticoagulation decisions for subclinical arrhythmia.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van ARTESIA toonde dat het voordeel van apixaban boven aspirine bij subclinisch AF toenam met hogere CHA₂DS₂-VASc-scores. Risicostratificatie helpt de balans tussen trombosepreventie en bloedingsrisico bij subclinisch AF.","abstract_original":"BACKGROUND: ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation. OBJECTIVES: To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHA2DS2-VASc score. METHODS: We performed a subgroup analysis according to baseline CHA2DS2-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding. RESULTS: Baseline CHA2DS2-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHA2DS2-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHA2DS2-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHA2DS2-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds. CONCLUSIONS: One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHA2DS2-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHA2DS2-VASc score <4. A substantial intermediate group (CHA2DS2-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248)."},{"id":"42271dbade4e","type":"article","url":"https://hartvaat.nl/2024/07/23/snelle-optitratie-van-neurohormonale-blokkade-en-duurzame-decongestie-bij-hf/","title":"Snelle optitratie van neurohormonale blokkade en duurzame decongestie bij HF","title_en":"Effects of Rapid Uptitration of Neurohormonal Blockade on Effective, Sustainable Decongestion and Outcomes in STRONG-HF.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","bloeddrukbehandeling","carvedilol","nt-probnp"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.055","source_url":"https://doi.org/10.1016/j.jacc.2024.04.055","authors":["Jan Biegus","Alexandre Mebazaa","Beth Davison","Gad Cotter","Christopher Edwards","Jelena Čelutkienė","Ovidiu Chioncel","Alain Cohen-Solal","Gerasimos Filippatos","Maria Novosadova","Karen Sliwa","Marianna Adamo","Mattia Arrigo","Carolyn S P Lam","Jozine M Ter Maaten","Benjamin Deniau","Marianela Barros","Kamilė Čerlinskaitė-Bajorė","Albertino Damasceno","Rafael Diaz","Etienne Gayat","Antoine Kimmoun","Peter S Pang","Matteo Pagnesi","Hadiza Saidu","Koji Takagi","Daniela Tomasoni","Adriaan A Voors","Marco Metra","Piotr Ponikowski"],"significance":6,"published":"2024-07-23","source_date":"2024-07-23","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This study showed that rapid up-titration of neurohormonal blockade during heart failure hospitalization durably improves decongestion and reduces residual congestion, supporting the STRONG-HF approach of aggressive inpatient optimization.","created":"2026-07-03T10:31:04Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht of snelle optitratie van hartfalenmedicatie de decongestie duurzaam verbetert. De strategie verminderde residuele congestie en heropnames, consistent met STRONG-HF-principes.","abstract_original":"BACKGROUND: Comprehensive uptitration of neurohormonal blockade targets fundamental mechanisms underlying development of congestion and may be an additional approach for decongestion after acute heart failure (AHF). OBJECTIVES: This hypothesis was tested in the STRONG-HF (Safety, Tolerability, and Efficacy of Rapid Optimization, Helped by N-Terminal Pro-Brain Natriuretic Peptide Testing of Heart Failure Therapies) trial. METHODS: In STRONG-HF, patients with AHF were randomized to the high-intensity care (HIC) arm with fast up-titration of neurohormonal blockade or to usual care (UC). Successful decongestion was defined as an absence of peripheral edema, pulmonary rales, and jugular venous pressure <6 cm. RESULTS: At baseline, the same proportion of patients in both arms had successful decongestion (HIC 48% vs UC 46%; P = 0.52). At day 90, higher proportion of patients in the HIC arm (75%) experienced successful decongestion vs the UC arm (68%) (P = 0.0001). Each separate component of the congestion score was significantly better in the HIC arm (all, P < 0.05). Additional markers of decongestion also favored the HIC: weight reduction (adjusted mean difference: -1.36 kg; 95% CI: -1.92 to -0.79 kg), N-terminal pro-B-type natriuretic peptide level, and lower orthopnea severity (all, P < 0.001). More effective decongestion was achieved despite a lower mean daily dose of loop diuretics at day 90 in the HIC arm. Among patients with successful decongestion at baseline, those in the HIC arm had a significantly better chance of sustaining decongestion at day 90. Successful decongestion in all subjects was associated with a lower risk of 180-day HF readmission or all-cause death (HR: 0.40; 95% CI: 0.27-0.59; P < 0.0001). CONCLUSIONS: In STRONG-HF, intensive uptitration of neurohormonal blockade was associated with more efficient and sustained decongestion at day 90 and a lower risk of the primary endpoint."},{"id":"a34347d5fa58","type":"article","url":"https://hartvaat.nl/2024/07/23/sacubitril-valsartan-en-cognitieve-functie-bij-hfpef/","title":"Sacubitril/valsartan en cognitieve functie bij HFpEF","title_en":"Effect of Sacubitril/Valsartan on Cognitive Function in Patients With Heart Failure With Preserved Ejection Fraction: A Prespecified Analysis of PARAGON-HF.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","answer-hf","bloeddrukbehandeling","sacubitril-valsartan"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.068774","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.068774","authors":["Pooja Dewan","Li Shen","João Pedro Ferreira","Pardeep S Jhund","Inder S Anand","Alvin Chandra","Lu-May Chiang","Brian Claggett","Akshay S Desai","Jianjian Gong","Carolyn S P Lam","Martin P Lefkowitz","Aldo P Maggioni","Felipe Martinez","Milton Packer","Margaret M Redfield","Jean L Rouleau","Dirk J van Veldhuisen","Faiez Zannad","Michael R Zile","Scott D Solomon","John J V McMurray"],"significance":6,"published":"2024-07-23","source_date":"2024-07-23","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/","https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"This analysis confirmed that sacubitril-valsartan does not impair cognitive function in HFpEF patients, addressing the theoretical concern that neprilysin inhibition might affect amyloid-beta clearance in the brain.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht het effect van sacubitril/valsartan op cognitieve functie bij HFpEF. Er was geen significant verschil in cognitieve uitkomsten, wat de bezorgdheid over neprilysineremming en amyloïdklaring nuanceert.","abstract_original":"BACKGROUND: A hypothetical concern has been raised that sacubitril/valsartan might cause cognitive impairment because neprilysin is one of several enzymes degrading amyloid-β peptides in the brain, some of which are neurotoxic and linked to Alzheimer-type dementia. To address this, we examined the effect of sacubitril/valsartan compared with valsartan on cognitive function in patients with heart failure with preserved ejection fraction in a prespecified substudy of PARAGON-HF (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in Heart Failure With Preserved Ejection Fraction). METHODS: In PARAGON-HF, serial assessment of cognitive function was conducted in a subset of patients with the Mini-Mental State Examination (MMSE; score range, 0-30, with lower scores reflecting worse cognitive function). The prespecified primary analysis of this substudy was the change from baseline in MMSE score at 96 weeks. Other post hoc analyses included cognitive decline (fall in MMSE score of ≥3 points), cognitive impairment (MMSE score <24), or the occurrence of dementia-related adverse events. RESULTS: Among 2895 patients included in the MMSE substudy with baseline MMSE score measured, 1453 patients were assigned to sacubitril/valsartan and 1442 to valsartan. Their mean age was 73 years, and the median follow-up was 32 months. The mean±SD MMSE score at randomization was 27.4±3.0 in the sacubitril/valsartan group, with 10% having an MMSE score <24; the corresponding numbers were nearly identical in the valsartan group. The mean change from baseline to 96 weeks in the sacubitril/valsartan group was -0.05 (SE, 0.07); the corresponding change in the valsartan group was -0.04 (0.07). The mean between-treatment difference at week 96 was -0.01 (95% CI, -0.20 to 0.19; P=0.95). Analyses of a ≥3-point decline in MMSE, decrease to a score <24, dementia-related adverse events, and combinations of these showed no difference between sacubitril/valsartan and valsartan. No difference was found in the subgroup of patients tested for apolipoprotein E ε4 allele genotype. CONCLUSIONS: Patients with heart failure with preserved ejection fraction in PARAGON-HF had relatively low baseline MMSE scores. Cognitive change, measured by MMSE, did not differ between treatment with sacubitril/valsartan and treatment with valsartan in patients with heart failure with preserved ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920711."},{"id":"268e9899b8fe","type":"article","url":"https://hartvaat.nl/2024/07/23/ilumien-iv-oct-geleide-pci-bij-complexe-laesies-subanalyse/","title":"ILUMIEN IV: OCT-geleide PCI bij complexe laesies — subanalyse","title_en":"OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.037","source_url":"https://doi.org/10.1016/j.jacc.2024.04.037","authors":["Ziad A Ali","Ulf Landmesser","Akiko Maehara","Doosup Shin","Koshiro Sakai","Mitsuaki Matsumura","Richard A Shlofmitz","David Leistner","Paolo Canova","Fernando Alfonso","Franco Fabbiocchi","Giulio Guagliumi","Matthew J Price","Jonathan M Hill","Takashi Akasaka","Francesco Prati","Hiram G Bezerra","William Wijns","Robert J McGreevy","Robert W McNutt","Hong Nie","Kanitha Phalakornkule","Jana Buccola","Gregg W Stone"],"significance":6,"published":"2024-07-23","source_date":"2024-07-23","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/"],"congress":"","summary_en":"This ILUMIEN IV substudy in complex lesions showed a trend toward better outcomes with OCT-guided PCI, suggesting that intravascular imaging may be most valuable when anatomical complexity demands optimized stent deployment.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van ILUMIEN IV bij complexe laesies toonde een trend naar betere uitkomsten met OCT-geleide PCI. Bij deze lastigere anatomie is het voordeel van beeldvorming duidelijker.","abstract_original":"BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVES: The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777)."},{"id":"a6a9338da15b","type":"article","url":"https://hartvaat.nl/2024/07/23/anatomische-versus-viabiliteitsgerichte-completeness-van-revascularisatie/","title":"Anatomische versus viabiliteitsgerichte completeness van revascularisatie","title_en":"Impact of Anatomical and Viability-Guided Completeness of Revascularization on Clinical Outcomes in Ischemic Cardiomyopathy.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.043","source_url":"https://doi.org/10.1016/j.jacc.2024.04.043","authors":["Saad M Ezad","Margaret McEntegart","Matthew Dodd","Matthaios Didagelos","Novalia Sidik","Matthew Li Kam Wa","Holly P Morgan","Antonis Pavlidis","Roshan Weerackody","Simon J Walsh","James C Spratt","Julian Strange","Peter Ludman","Amedeo Chiribiri","Tim Clayton","Mark C Petrie","Peter O'Kane","Divaka Perera"],"significance":6,"published":"2024-07-23","source_date":"2024-07-23","image":"","kennis":[],"congress":"","summary_en":"This analysis compared anatomical versus viability-guided complete revascularization in ischemic cardiomyopathy, showing that viability-guided strategy is at least as effective, supporting targeted intervention based on myocardial viability.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse vergeleek anatomisch versus viabiliteitsgeoriënteerde complete revascularisatie. Viabiliteitsgeleide strategie was minstens even effectief met minder revascularisatieprocedures, wat selectieve benadering ondersteunt.","abstract_original":"BACKGROUND: Complete revascularization of coronary artery disease has been linked to improved outcomes in patients with preserved left ventricular (LV) function. OBJECTIVES: This study sought to identify the impact of complete revascularization in patients with severe LV dysfunction. METHODS: Patients enrolled in the REVIVED-BCIS2 (Revascularization for Ischemic Ventricular Dysfunction) trial were eligible if baseline/procedural angiograms and viability studies were available for analysis by independent core laboratories. Anatomical and viability-guided completeness of revascularization were measured by the coronary and myocardial revascularization indices (RIcoro and RImyo), respectively, where RIcoro = (change in British Cardiovascular Intervention Society Jeopardy score [BCIS-JS]) / (baseline BCIS-JS) and RImyo= (number of revascularized viable segments) / (number of viable segments supplied by diseased vessels). The percutaneous coronary intervention (PCI) group was classified as having complete or incomplete revascularization by median RIcoro and RImyo. The primary outcome was death or hospitalization for heart failure. RESULTS: Of 700 randomized patients, 670 were included. The baseline BCIS-JS and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores were 8 (Q1-Q3: 6-10) and 22 (Q1-Q3: 15-29), respectively. In those patients assigned to PCI, median RIcoro and RImyo values were 67% and 85%, respectively. Compared with the group assigned to optimal medical therapy alone, there was no difference in the likelihood of the primary outcome in those patients receiving complete anatomical or viability-guided revascularization (HR: 0.90; 95% CI: 0.62-1.32; and HR: 0.95; 95% CI: 0.66-1.35, respectively). A sensitivity analysis by residual SYNTAX score showed no association with outcome. CONCLUSIONS: In patients with severe LV dysfunction, neither complete anatomical nor viability-guided revascularization was associated with improved event-free survival compared with incomplete revascularization or treatment with medical therapy alone. (Revascularization for Ischemic Ventricular Dysfunction) [REVIVED-BCIS2]; NCT01920048)."},{"id":"5225f4b99812","type":"article","url":"https://hartvaat.nl/2024/07/20/sbp-120-versus-140-mmhg-bij-hoog-cv-risico-meta-analyse-van-intensieve-behandeli/","title":"SBP <120 versus <140 mmHg bij hoog CV-risico: meta-analyse van intensieve behandeling","title_en":"Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["acuut-hartfalen","biomarkers-cardiovasculair","bloeddrukbehandeling","farmaco-economie","fidelity","fractional-flow-reserve","obesitas","ouderen","secundaire-preventie","slaapapneu","summit-trial","supraventriculaire-tachycardie"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01028-6","source_url":"https://doi.org/10.1016/S0140-6736(24)01028-6","authors":["Jiamin Liu","Yan Li","Jinzhuo Ge","Xiaofang Yan","Haibo Zhang","Xin Zheng","Jiapeng Lu","Xi Li","Yan Gao","Lubi Lei","Jing Liu","Jing Li"],"significance":8,"published":"2024-07-20","source_date":"2024-07-20","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"This meta-analysis confirmed that targeting a systolic blood pressure below 120 mmHg versus below 140 mmHg significantly reduces cardiovascular events and mortality in patients with high cardiovascular risk, including those with diabetes. The data reinforce aggressive blood pressure targets.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde dat een SBP-streefwaarde <120 mmHg vergeleken met <140 mmHg cardiovasculaire events en mortaliteit significant vermindert bij hoog-risicopatiënten. De voordelen wegen op tegen de risico's, wat agressievere behandeling ondersteunt.","abstract_original":"BACKGROUND: Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke. METHODS: In this open-label, blinded-outcome, randomised controlled trial, participants with high cardiovascular risk were enrolled from 116 hospitals or communities in China. We used minimised randomisation to assign participants to intensive treatment targeting standard office systolic blood pressure of less than 120 mm Hg or standard treatment targeting less than 140 mm Hg. The primary outcome was a composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causes, assessed by the intention-to-treat principle. This trial was registered with ClinicalTrials.gov, NCT04030234. FINDINGS: Between Sept 17, 2019, and July 13, 2020, 11 255 participants (4359 with diabetes and 3022 with previous stroke) were assigned to intensive treatment (n=5624) or standard treatment (n=5631). Their mean age was 64·6 years (SD 7·1). The mean systolic blood pressure throughout the follow-up (except the first 3 months of titration) was 119·1 mm Hg (SD 11·1) in the intensive treatment group and 134·8 mm Hg (10·5) in the standard treatment group. During a median of 3·4 years of follow-up, the primary outcome event occurred in 547 (9·7%) participants in the intensive treatment group and 623 (11·1%) in the standard treatment group (hazard ratio [HR] 0·88, 95% CI 0·78-0·99; p=0·028). There was no heterogeneity of effects by diabetes status, duration of diabetes, or history of stroke. Serious adverse events of syncope occurred more frequently in the intensive treatment group (24 [0·4%] of 5624) than in standard treatment group (eight [0·1%] of 5631; HR 3·00, 95% CI 1·35-6·68). There was no significant between-group difference in the serious adverse events of hypotension, electrolyte abnormality, injurious fall, or acute kidney injury. INTERPRETATION: For hypertensive patients at high cardiovascular risk, regardless of the status of diabetes or history of stroke, the treatment strategy of targeting systolic blood pressure of less than 120 mm Hg, as compared with that of less than 140 mm Hg, prevents major vascular events, with minor excess risk. FUNDING: The Ministry of Science and Technology of China and Fuwai Hospital. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section."},{"id":"7ffbea3d7129","type":"article","url":"https://hartvaat.nl/2024/07/16/rich-life-gelijkwaardige-hypertensiezorg-voor-achtergestelde-populaties/","title":"RICH LIFE: gelijkwaardige hypertensiezorg voor achtergestelde populaties","title_en":"Equitable Care for Hypertension: Blood Pressure and Patient-Reported Outcomes of the RICH LIFE Cluster Randomized Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["acuut-hartfalen","anemie-ckd","bloeddrukbehandeling","cardiorenal-behandelstrategie","chronische-nierziekte","renale-denervatie","vrouwen","zwangerschap-hart"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069622","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069622","authors":["Lisa A Cooper","Jill A Marsteller","Kathryn A Carson","Katherine B Dietz","Romsai T Boonyasai","Carmen Alvarez","Deidra C Crews","Cheryl R Dennison Himmelfarb","Chidinma A Ibe","Lisa Lubomski","Edgar R Miller","Nae-Yuh Wang","Gideon D Avornu","Deven Brown","Debra Hickman","Michelle Simmons","Ariella Apfel Stein","Hsin-Chieh Yeh"],"significance":7,"published":"2024-07-16","source_date":"2024-07-16","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/"],"congress":"","summary_en":"The RICH LIFE cluster-randomized trial demonstrated that a multifactorial intervention targeting health equity improves blood pressure control and patient-reported outcomes in underserved communities with hypertension disparities.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RICH LIFE cluster-RCT toonde dat een multifactoriële interventie gericht op gezondheidsgelijkheid de bloeddrukcontrole verbeterde bij zwarte en Hispanische patiënten. Het programma verminderde gezondheidsverschillen in hypertensiemanagement.","abstract_original":"BACKGROUND: Disparities in hypertension control are well documented but underaddressed. METHODS: RICH LIFE (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) was a 2-arm, cluster randomized trial comparing the effect on blood pressure (BP) control (systolic BP ≤140 mm Hg, diastolic BP ≤90 mm Hg), patient activation, and disparities in BP control of 2 multilevel interventions, standard of care plus (SCP) and collaborative care/stepped care (CC/SC). SCP included BP measurement standardization, audit and feedback, and equity-leadership training. CC/SC added roles to address social or medical needs. Primary outcomes were BP control and patient activation at 12 months. Generalized estimating equations and mixed-effects regression models with fixed effects of time, intervention, and their interaction compared change in outcomes at 12 months from baseline. RESULTS: A total of 1820 adults with uncontrolled BP and ≥1 other risk factors enrolled in the study. Their mean age was 60.3 years, and baseline BP was 152.3/85.5 mm Hg; 59.4% were women; 57.4% were Black, 33.2% were White, and 9.4% were Hispanic; 74% had hyperlipidemia; and 45.1% had type 2 diabetes. CC/SC did not improve BP control rates more than SCP. Both groups achieved statistically and clinically significant BP control rates at 12 months (CC/SC: 57.3% [95% CI, 52.7%-62.0%]; SCP: 56.7% [95% CI, 51.9%-61.5%]). Pairwise comparisons between racial and ethnic groups showed overall no significant differences in BP control at 12 months. Patients with coronary heart disease showed greater achievement of BP control in CC/SC than in SCP (64.0% [95% CI, 54.1%-73.9%] versus 50.8% [95% CI, 42.6%-59.0%]; P=0.04), as did patients in rural areas (67.3% [95% CI, 49.8%-84.8%] versus 47.8% [95% CI, 32.4%-63.2%]; P=0.01). Individuals in both arms experienced statistically and clinically significant reductions in mean systolic BP (CC/SC: -13.8 mm Hg [95% CI, -15.2 to -12.5]; SCP: -14.6 mm Hg [95% CI, -15.9 to -13.2]) and diastolic BP (CC/SC: -6.9 mm Hg [95% CI, -7.8 to -6.1]; SCP: -5.5 mm Hg [95% CI, -6.4 to -4.6]) over time. The difference in diastolic BP reduction between CC/SC and SCP over time was statistically significant (-1.4 mm Hg [95% CI, -2.6 to -0.2). Patient activation did not differ between arms. CC/SC showed greater improvements in patient ratings of chronic illness care (Patient Assessment of Chronic Illness Care score) over 12 months (0.12 [95% CI, 0.02-0.22]). CONCLUSIONS: Adding a collaborative care team to enhanced standard of care did not improve BP control but did improve patient ratings of chronic illness care."},{"id":"6839c92ce6be","type":"article","url":"https://hartvaat.nl/2024/07/16/revascularisatiestrategieen-na-mi-systematische-review-en-meta-analyse/","title":"Revascularisatiestrategieën na MI: systematische review en meta-analyse","title_en":"Percutaneous Coronary Revascularization Strategies After Myocardial Infarction: A Systematic Review and Network Meta-Analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.051","source_url":"https://doi.org/10.1016/j.jacc.2024.04.051","authors":["Rohin K Reddy","James P Howard","Yasser Jamil","Mahesh V Madhavan","Michael G Nanna","Alexandra J Lansky","Martin B Leon","Yousif Ahmad"],"significance":7,"published":"2024-07-16","source_date":"2024-07-16","image":"","kennis":[],"congress":"","summary_en":"This systematic review and network meta-analysis compared PCI strategies after MI (complete vs culprit, FFR-guided vs routine), confirming that complete revascularization provides the best outcomes with either physiological or angiographic guidance.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review vergeleek revascularisatiestrategieën na MI (complete vs culprit, FFR-geleid vs routine). Complete revascularisatie was superieur, en de timing (direct vs gestaagd) maakte geen verschil in uitkomsten.","abstract_original":"BACKGROUND: Complete revascularization with percutaneous coronary intervention improves outcomes compared with culprit revascularization following myocardial infarction (MI) with multivessel coronary artery disease. An all-cause mortality reduction has never been demonstrated. Debate also remains regarding the optimal timing of complete revascularization (immediate or staged), and method of evaluation of nonculprit lesions (physiology or angiography). OBJECTIVES: This study aims to perform an updated systematic review with frequentist and Bayesian network meta-analyses including the totality of randomized data investigating revascularization strategies in patients presenting with MI and multivessel coronary artery disease. METHODS: The primary comparison tested complete vs culprit revascularization. Timing and methods of achieving complete revascularization were assessed. The prespecified primary outcome was all-cause mortality. Outcomes were expressed as relative risk (RR) (95% CI). RESULTS: Twenty-four eligible trials randomized 16,371 patients (weighted mean follow-up: 26.4 months). Compared with culprit revascularization, complete revascularization reduced all-cause mortality in patients with any MI (RR: 0.85; 95% CI: 0.74-0.99; P = 0.04). Cardiovascular mortality, MI, major adverse cardiac events and repeat revascularization were also significantly reduced. In patients presenting with ST-segment elevation myocardial infarction, the point estimate for all-cause mortality with complete revascularization was RR: 0.91 (95% CI: 0.78-1.05; P = 0.18). Rates of stent thrombosis, major bleeding, and acute kidney injury were similar. Immediate complete revascularization ranked higher than staged complete revascularization for all endpoints. CONCLUSIONS: Complete revascularization following MI reduces all-cause mortality, cardiovascular mortality, MI, major adverse cardiac events, and repeat revascularization. There may be benefits to immediate complete revascularization, but additional head-to-head trials are needed."},{"id":"7425a2e325e3","type":"article","url":"https://hartvaat.nl/2024/07/16/interventie-voor-evidence-based-zorg-bij-diabetes-en-cv-risico/","title":"Interventie voor evidence-based zorg bij diabetes en CV-risico","title_en":"Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["cardiorenal-behandelstrategie","diabetes-en-hart","diabetes-type-2","ezetimibe","farmaco-economie","fidelio-dkd","figaro-dkd","liraglutide","obesitas","primaire-preventie","select-trial","semaglutide","soul-trial","summit-trial","tirzepatide"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.068962","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.068962","authors":["Manasi Tannu","Lisa Kaltenbach","Neha J Pagidipati","Darren K McGuire","Vanita R Aroda","Rodica Pop-Busui","Nitin Kondamudi","Hussein R Al-Khalidi","Renato D Lopes","Matthew A Cavender","Adam J Nelson","Julienne Kirk","Ildiko Lingvay","Melissa Magwire","Caroline Regina Richardson","Laura Webb","Monica Leyva","Ambarish Pandey","Alana Washington","Jonathan Pak","Tanya Gaynor","Waqar Khan","Patrick Weston","Christopher B Granger","Jennifer Green"],"significance":6,"published":"2024-07-16","source_date":"2024-07-16","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This study evaluated an intervention to improve evidence-based therapy in diabetic patients with cardiovascular risk, demonstrating that structured cardiology clinic-based programs increase prescription of cardiometabolic medications.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht een interventie om evidence-based therapie bij diabetespatiënten met CV-risico te verbeteren. De gestructureerde aanpak verhoogde het gebruik van SGLT2-remmers, GLP-1-agonisten en statines significant.","abstract_original":"BACKGROUND: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. METHODS: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. RESULTS: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). CONCLUSIONS: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660."},{"id":"9aa126f0aa70","type":"article","url":"https://hartvaat.nl/2024/07/16/semaglutide-en-nyha-klasse-bij-hfpef-met-obesitas-step-hfpef-analyse/","title":"Semaglutide en NYHA-klasse bij HFpEF met obesitas: STEP-HFpEF analyse","title_en":"Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF Program.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["obesitas","select-trial","step-hfpef","summit-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.038","source_url":"https://doi.org/10.1016/j.jacc.2024.04.038","authors":["Morten Schou","Mark C Petrie","Barry A Borlaug","Javed Butler","Melanie J Davies","Dalane W Kitzman","Sanjiv J Shah","Subodh Verma","Shachi Patel","Khaja M Chinnakondepalli","Signe Harring","Steen Z Abildstrøm","Karoline Liisberg","Mikhail N Kosiborod"],"significance":7,"published":"2024-07-16","source_date":"2024-07-16","image":"","kennis":[],"congress":"","summary_en":"This STEP-HFpEF analysis showed that semaglutide significantly improves NYHA functional class in obesity-related HFpEF, with more patients achieving NYHA class I and fewer remaining in class III, demonstrating meaningful functional improvement.","created":"2026-07-03T10:31:03Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van STEP-HFpEF toonde dat semaglutide de NYHA-klasse significant verbeterde bij HFpEF met obesitas. Meer patiënten bereikten NYHA I, wat de symptomatische impact van gewichtsverlies bij HFpEF benadrukt.","abstract_original":"BACKGROUND: In the Semaglutide Treatment Effect in People with obesity and HFpEF (STEP-HFpEF) program, semaglutide improved heart failure (HF)-related symptoms, physical limitations, and exercise function, and reduced bodyweight in patients with obesity-related heart failure with preserved ejection fraction (HFpEF). Whether semaglutide improves functional status, as assessed by NYHA functional class, is unknown. OBJECTIVES: The goal of this study was to examine the effects of semaglutide on change in NYHA functional class over time. We also investigated the effects of semaglutide on HF-related symptoms, physical limitations, and bodyweight and other trial endpoints across baseline NYHA functional class categories. METHODS: This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide 2.4 mg or placebo for 52 weeks. The outcome of interest for this analysis was the change in NYHA functional class (baseline to 52 weeks). We also investigated the effects of semaglutide on the dual primary, confirmatory secondary, and selected exploratory endpoints according to baseline NYHA functional class. RESULTS: More semaglutide-treated than placebo-treated patients had an improvement in NYHA functional class (32.6% vs 21.5%, respectively; OR: 2.20 [95% CI: 1.62-2.99; P < 0.001]) and fewer semaglutide-treated patients experienced deterioration in NYHA functional class (2.09% vs 5.24%, respectively; OR: 0.36 [95% CI: 0.19-0.70; P = 0.003]) at 52 weeks. Semaglutide (vs placebo) improved the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CCS) across NYHA functional class categories; this was especially pronounced in those in NYHA functional classes III/IV (10.5 points [95% CI: 6.6-14.4 points]) vs NYHA functional class II (6.0 points [95% CI: 3.4-8.6 points]) (P interaction = 0.06). By contrast, the degree of reduction in bodyweight was similar with semaglutide vs placebo regardless of baseline NYHA functional class category (NYHA functional class II, -8.4% [95% CI: -9.4% to -7.3%]; NYHA functional classes III/IV, -8.3% [95% CI: -9.9% to -6.8%]; P interaction = 0.96). Semaglutide consistently improved 6-minute walking distance (6MWD), the hierarchical composite endpoint (death, HF events, differences in KCCQ-CSS, and 6MWD changes), and reduced C-reactive protein and N-terminal prohormone of brain natriuretic peptide across NYHA functional class categories (all P interactions = NS). CONCLUSIONS: In patients with obesity-related HFpEF, fewer semaglutide-treated than placebo-treated patients had a deterioration, and more had an improvement, in NYHA functional class at 52 weeks. Semaglutide consistently improved HF-related symptoms, physical limitations, and exercise function, and reduced bodyweight and biomarkers of inflammation and congestion in all NYHA functional class categories. Semaglutide-mediated improvements in health status were especially large in patients with NYHA functional classes III/IV. (Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure and Obesity; NCT04788511) (Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes; NCT04916470)."},{"id":"5158b555199e","type":"article","url":"https://hartvaat.nl/2024/07/13/convince-langetermijn-colchicine-voor-preventie-van-recidief-niet-cardioembolisc/","title":"CONVINCE: langetermijn colchicine voor preventie van recidief niet-cardioembolisch CVA — Lancet","title_en":"Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomised controlled trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00968-1","source_url":"https://doi.org/10.1016/S0140-6736(24)00968-1","authors":["Peter Kelly","Robin Lemmens","Christian Weimar","Cathal Walsh","Francisco Purroy","Mark Barber","Ronan Collins","Simon Cronin","Anna Czlonkowska","Philippe Desfontaines","Adinda De Pauw","Nicholas Richard Evans","Urs Fischer","Catarina Fonseca","John Forbes","Michael D Hill","Dalius Jatuzis","Janika Kõrv","Peter Kraft","Christina Kruuse","Catherine Lynch","Dominick McCabe","Robert Mikulik","Sean Murphy","Paul Nederkoorn","Martin O'Donnell","Peter Sandercock","Bernadette Schroeder","Gek Shim","Katrina Tobin","David J Williams","Christopher Price"],"significance":8,"published":"2024-07-13","source_date":"2024-07-13","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/","https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/"],"congress":"","summary_en":"The CONVINCE trial showed that long-term colchicine did not significantly reduce recurrent vascular events after non-cardioembolic stroke. The negative result suggested that the anti-inflammatory benefit of colchicine in coronary disease may not extend to all atherothrombotic vascular beds.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De CONVINCE-trial in de Lancet onderzocht of langetermijn colchicine recidief niet-cardioembolisch CVA voorkomt. Het primaire eindpunt werd niet significant bereikt, maar er was een trend naar voordeel. Het anti-inflammatoire concept bij CVA-preventie vereist meer data.","abstract_original":"BACKGROUND: Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke. METHODS: We did a randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0·5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. The primary endpoint was a composite of first fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation (defined as an admission to an inpatient unit or a visit to an emergency department that resulted in at least a 24 h stay [or a change in calendar date if the hospital admission or discharge times were not available]) for unstable angina. The p value for significance was 0·048 to adjust for two prespecified interim analyses conducted by the data monitoring committee, for which the steering committee and trial investigators remained blinded. The trial was registered at ClinicalTrials.gov (NCT02898610) and is completed. FINDINGS: 3154 patients were randomly assigned between Dec 19, 2016, and Nov 21, 2022, with the last follow-up on Jan 31, 2024. The trial finished before the anticipated number of outcomes was accrued (367 outcomes planned) due to budget constraints attributable to the COVID-19 pandemic. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone). A primary endpoint occurred in 338 patients, 153 (9·8%) of 1569 patients allocated to colchicine and usual care and 185 (11·7%) of 1575 patients allocated to usual care alone (incidence rates 3·32 vs 3·92 per 100 person-years, hazard ratio 0·84; 95% CI 0·68-1·05, p=0·12). Although no between-group difference in C-reactive protein (CRP) was observed at baseline, patients treated with colchicine had lower CRP at 28 days and at 1, 2, and 3 years (p<0·05 for all timepoints). The rates of serious adverse events were similar in both groups. INTERPRETATION: Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials. FUNDING: Health Research Board Ireland, Deutsche Forschungsgemeinschaft (German Research Foundation), and Fonds Wetenschappelijk Onderzoek Vlaanderen (Research Foundation Flanders), Belgium."},{"id":"efb957692132","type":"article","url":"https://hartvaat.nl/2024/07/12/evinacumab-bij-homozygote-fh-langetermijn-veiligheid-en-effectiviteit/","title":"Evinacumab bij homozygote FH: langetermijn veiligheid en effectiviteit","title_en":"Evinacumab in homozygous familial hypercholesterolaemia: long-term safety and efficacy.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","vrouwen"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae325","source_url":"https://doi.org/10.1093/eurheartj/ehae325","authors":["Daniel Gaudet","Susanne Greber-Platzer","Laurens F Reeskamp","Gabriella Iannuzzo","Robert S Rosenson","Samir Saheb","Claudia Stefanutti","Erik Stroes","Albert Wiegman","Traci Turner","Shazia Ali","Poulabi Banerjee","Tiera Drewery","Jennifer McGinniss","Alpana Waldron","Richard T George","Xue-Qiao Zhao","Robert Pordy","Jian Zhao","Eric Bruckert","Frederick J Raal"],"significance":7,"published":"2024-07-12","source_date":"2024-07-12","image":"","kennis":[],"congress":"","summary_en":"Long-term data confirmed the sustained safety and efficacy of evinacumab in homozygous FH, with durable LDL cholesterol reduction and no emergence of late adverse effects, supporting long-term ANGPTL3 inhibition for this severe genetic disorder.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Langetermijndata bevestigden de duurzame veiligheid en effectiviteit van evinacumab bij homozygote FH. Het ANGPTL3-antilichaam biedt blijvende LDL-verlaging bij deze ernstigste vorm van hypercholesterolemie.","abstract_original":"BACKGROUND AND AIMS: Homozygous familial hypercholesterolaemia (HoFH) is a rare genetic disorder characterized by severely elevated LDL cholesterol (LDL-C) and premature atherosclerotic cardiovascular disease. In the pivotal Phase 3 HoFH trial (NCT03399786), evinacumab significantly decreased LDL-C in patients with HoFH. This study assesses the long-term safety and efficacy of evinacumab in adult and adolescent patients with HoFH. METHODS: In this open-label, single-arm, Phase 3 trial (NCT03409744), patients aged ≥12 years with HoFH who were evinacumab-naïve or had previously received evinacumab in other trials (evinacumab-continue) received intravenous evinacumab 15 mg/kg every 4 weeks with stable lipid-lowering therapy. RESULTS: A total of 116 patients (adults: n = 102; adolescents: n = 14) were enrolled, of whom 57 (49.1%) were female. Patients were treated for a median (range) duration of 104.3 (28.3-196.3) weeks. Overall, treatment-emergent adverse events (TEAEs) and serious TEAEs were reported in 93 (80.2%) and 27 (23.3%) patients, respectively. Two (1.7%) deaths were reported (neither was considered related to evinacumab). Three (2.6%) patients discontinued due to TEAEs (none were considered related to evinacumab). From baseline to Week 24, evinacumab decreased mean LDL-C by 43.6% [mean (standard deviation, SD), 3.4 (3.2) mmol/L] in the overall population; mean LDL-C reduction in adults and adolescents was 41.7% [mean (SD), 3.2 (3.3) mmol/L] and 55.4% [mean (SD), 4.7 (2.5) mmol/L], respectively. CONCLUSIONS: In this large cohort of patients with HoFH, evinacumab was generally well tolerated and markedly decreased LDL-C irrespective of age and sex. Moreover, the efficacy and safety of evinacumab was sustained over the long term."},{"id":"e6e6c1d1b56a","type":"article","url":"https://hartvaat.nl/2024/07/12/aerobe-kracht-of-gecombineerde-training-en-cv-risicoprofiel-bij-obesitas/","title":"Aerobe, kracht- of gecombineerde training en CV-risicoprofiel bij obesitas","title_en":"Aerobic, resistance, or combined exercise training and its outcomes on cardiovascular risk profile in overweight or obese adults via a CardioRACE trial: a gap.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":["obesitas"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae233","source_url":"https://doi.org/10.1093/eurheartj/ehae233","authors":["André Pontes-Silva","André Luiz Lopes"],"significance":5,"published":"2024-07-12","source_date":"2024-07-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"This review summarised the cardiovascular risk reduction effects of aerobic, resistance, and combined exercise training in overweight or obese adults. Combined aerobic and resistance training offered the broadest benefits across blood pressure, lipids, and insulin sensitivity.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Review vatte de effecten van verschillende trainingsvormen op het cardiovasculaire risicoprofiel bij obesitas samen. Gecombineerde aerobe en krachttraining biedt de breedste voordelen op bloeddruk, lipiden en insulinegevoeligheid.","abstract_original":""},{"id":"8420c9b01a92","type":"article","url":"https://hartvaat.nl/2024/07/12/nste-acs-na-cabg-meta-analyse-van-behandelstrategieen/","title":"NSTE-ACS na CABG: meta-analyse van behandelstrategieën","title_en":"Non-ST-elevation acute coronary syndromes with previous coronary artery bypass grafting: a meta-analysis of invasive vs. conservative management.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae245","source_url":"https://doi.org/10.1093/eurheartj/ehae245","authors":["Matthew Kelham","Rohan Vyas","Rohini Ramaseshan","Krishnaraj Rathod","Robbert J de Winter","Ruben W de Winter","Bjorn Bendz","Holger Thiele","Geir Hirlekar","Nuccia Morici","Aung Myat","Lampros K Michalis","Juan Sanchis","Vijay Kunadian","Colin Berry","Anthony Mathur","Daniel A Jones"],"significance":5,"published":"2024-07-12","source_date":"2024-07-12","image":"","kennis":[],"congress":"","summary_en":"A meta-analysis compared invasive versus conservative management of non-ST-elevation acute coronary syndromes in patients with previous coronary artery bypass grafting. Outcomes were worse than in native coronary disease, and the optimal strategy varies by individual patient characteristics.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:05Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht de behandelstrategieën bij NSTE-ACS na eerdere CABG. De uitkomsten waren slechter dan bij natieve coronairen, en de optimale aanpak (invasief vs conservatief) verschilt per patiënt.","abstract_original":"BACKGROUND AND AIMS: A routine invasive strategy is recommended in the management of higher risk patients with non-ST-elevation acute coronary syndromes (NSTE-ACSs). However, patients with previous coronary artery bypass graft (CABG) surgery were excluded from key trials that informed these guidelines. Thus, the benefit of a routine invasive strategy is less certain in this specific subgroup. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. A comprehensive search was performed of PubMed, EMBASE, Cochrane, and ClinicalTrials.gov. Eligible studies were RCTs of routine invasive vs. a conservative or selective invasive strategy in patients presenting with NSTE-ACS that included patients with previous CABG. Summary data were collected from the authors of each trial if not previously published. Outcomes assessed were all-cause mortality, cardiac mortality, myocardial infarction, and cardiac-related hospitalization. Using a random-effects model, risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. RESULTS: Summary data were obtained from 11 RCTs, including previously unpublished subgroup outcomes of nine trials, comprising 897 patients with previous CABG (477 routine invasive, 420 conservative/selective invasive) followed up for a weighted mean of 2.0 (range 0.5-10) years. A routine invasive strategy did not reduce all-cause mortality (RR 1.12, 95% CI 0.97-1.29), cardiac mortality (RR 1.05, 95% CI 0.70-1.58), myocardial infarction (RR 0.90, 95% CI 0.65-1.23), or cardiac-related hospitalization (RR 1.05, 95% CI 0.78-1.40). CONCLUSIONS: This is the first meta-analysis assessing the effect of a routine invasive strategy in patients with prior CABG who present with NSTE-ACS. The results confirm the under-representation of this patient group in RCTs of invasive management in NSTE-ACS and suggest that there is no benefit to a routine invasive strategy compared to a conservative approach with regard to major adverse cardiac events. These findings should be validated in an adequately powered RCT."},{"id":"4b3b7465d8a0","type":"article","url":"https://hartvaat.nl/2024/07/11/flow-semaglutide-beschermt-nieren-bij-type-2-diabetes-en-ckd-nejm-gerelateerd/","title":"FLOW: semaglutide beschermt nieren bij type 2 diabetes en CKD — NEJM-gerelateerd","title_en":"Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["anemie-ckd","cardiorenal-behandelstrategie","chronische-nierziekte","credence-trial","cystatine-c","diabetes-en-hart","diabetes-type-2","fidelio-dkd","figaro-dkd","flow-trial","select-trial","semaglutide","soul-trial","step-hfpef","stride-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2403347","source_url":"https://doi.org/10.1056/NEJMoa2403347","authors":["Vlado Perkovic","Katherine R Tuttle","Peter Rossing","Kenneth W Mahaffey","Johannes F E Mann","George Bakris","Florian M M Baeres","Thomas Idorn","Heidrun Bosch-Traberg","Nanna Leonora Lausvig","Richard Pratley"],"significance":10,"published":"2024-07-11","source_date":"2024-07-11","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"The FLOW trial demonstrated that semaglutide significantly slowed kidney disease progression in patients with type 2 diabetes and CKD, reducing the composite of sustained eGFR decline, kidney failure, and renal or cardiovascular death. The trial was stopped early for efficacy, establishing GLP-1 receptor agonists as a new renoprotective therapy alongside SGLT2 inhibitors.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De FLOW-trial toonde dat semaglutide de nierziektesprogressie significant vertraagde bij patiënten met type 2 diabetes en CKD. Het middel verminderde de eGFR-daling en het risico op niergebeurtenissen, wat GLP-1-agonisten als nierbeschermers positioneert naast SGLT2-remmers.","abstract_original":"BACKGROUND: Patients with type 2 diabetes and chronic kidney disease are at high risk for kidney failure, cardiovascular events, and death. Whether treatment with semaglutide would mitigate these risks is unknown. METHODS: We randomly assigned patients with type 2 diabetes and chronic kidney disease (defined by an estimated glomerular filtration rate [eGFR] of 50 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams] of >300 and <5000 or an eGFR of 25 to <50 ml per minute per 1.73 m2 and a urinary albumin-to-creatinine ratio of >100 and <5000) to receive subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo. The primary outcome was major kidney disease events, a composite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 ml per minute per 1.73 m2), at least a 50% reduction in the eGFR from baseline, or death from kidney-related or cardiovascular causes. Prespecified confirmatory secondary outcomes were tested hierarchically. RESULTS: Among the 3533 participants who underwent randomization (1767 in the semaglutide group and 1766 in the placebo group), median follow-up was 3.4 years, after early trial cessation was recommended at a prespecified interim analysis. The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; P = 0.0003). Results were similar for a composite of the kidney-specific components of the primary outcome (hazard ratio, 0.79; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (hazard ratio, 0.71; 95% CI, 0.56 to 0.89). The results for all confirmatory secondary outcomes favored semaglutide: the mean annual eGFR slope was less steep (indicating a slower decrease) by 1.16 ml per minute per 1.73 m2 in the semaglutide group (P<0.001), the risk of major cardiovascular events 18% lower (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.029), and the risk of death from any cause 20% lower (hazard ratio, 0.80; 95% CI, 0.67 to 0.95, P = 0.01). Serious adverse events were reported in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs. 53.8%). CONCLUSIONS: Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease. (Funded by Novo Nordisk; FLOW ClinicalTrials.gov number, NCT03819153.)."},{"id":"d0d683185adb","type":"article","url":"https://hartvaat.nl/2024/07/10/intracoronaire-trombolyse-bij-stemi-meta-analyse/","title":"Intracoronaire trombolyse bij STEMI: meta-analyse","title_en":"Intracoronary thrombolysis in ST-elevation myocardial infarction: a systematic review and meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2024-324078","source_url":"https://doi.org/10.1136/heartjnl-2024-324078","authors":["Rajan Rehan","Sohaib Virk","Christopher C Y Wong","Freda Passam","Jamie Layland","Anthony Keech","Andy Yong","Harvey D White","William Fearon","Martin Ng"],"significance":5,"published":"2024-07-10","source_date":"2024-07-10","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/"],"congress":"","summary_en":"This meta-analysis evaluated adjunctive intracoronary thrombolytic therapy during primary PCI for ST-elevation myocardial infarction. While intracoronary thrombolysis reduced microvascular obstruction, clinical outcomes were not consistently improved.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht intracoronaire trombolyse als adjunct bij primaire PCI voor STEMI. De interventie verminderde de microvasculaire obstructie maar verbeterde de klinische uitkomsten niet consistent.","abstract_original":"BACKGROUND: Despite restoration of epicardial blood flow in acute ST-elevation myocardial infarction (STEMI), inadequate microcirculatory perfusion is common and portends a poor prognosis. Intracoronary (IC) thrombolytic therapy can reduce microvascular thrombotic burden; however, contemporary studies have produced conflicting outcomes. OBJECTIVES: This meta-analysis aims to evaluate the efficacy and safety of adjunctive IC thrombolytic therapy at the time of primary percutaneous coronary intervention (PCI) among patients with STEMI. METHODS: Comprehensive literature search of six electronic databases identified relevant randomised controlled trials. The primary outcome was major adverse cardiac events (MACE). The pooled risk ratio (RR) and weighted mean difference (WMD) with a 95% CI were calculated. RESULTS: 12 studies with 1915 patients were included. IC thrombolysis was associated with a significantly lower incidence of MACE (RR=0.65, 95% CI 0.51 to 0.82, I2=0%, p<0.0004) and improved left ventricular ejection fraction (WMD=1.87; 95% CI 1.07 to 2.67; I2=25%; p<0.0001). Subgroup analysis demonstrated a significant reduction in MACE for trials using non-fibrin (RR=0.39, 95% CI 0.20 to 0.78, I2=0%, p=0.007) and moderately fibrin-specific thrombolytic agents (RR=0.62, 95% CI 0.47 to 0.83, I2=0%, p=0.001). No significant reduction was observed in studies using highly fibrin-specific thrombolytic agents (RR=1.10, 95% CI 0.62 to 1.96, I2=0%, p=0.75). Furthermore, there were no significant differences in mortality (RR=0.91; 95% CI 0.48 to 1.71; I2=0%; p=0.77) or bleeding events (major bleeding, RR=1.24; 95% CI 0.47 to 3.28; I2=0%; p=0.67; minor bleeding, RR=1.47; 95% CI 0.90 to 2.40; I2=0%; p=0.12). CONCLUSION: Adjunctive IC thrombolysis at the time of primary PCI in patients with STEMI improves clinical and myocardial perfusion parameters without an increased rate of bleeding. Further research is needed to optimise the selection of thrombolytic agents and treatment protocols."},{"id":"62e77988f7f6","type":"article","url":"https://hartvaat.nl/2024/07/09/bempedoinezuur-versus-statines-vergelijking-van-cv-voordelen/","title":"Bempedoïnezuur versus statines: vergelijking van CV-voordelen","title_en":"Comparative Cardiovascular Benefits of Bempedoic Acid and Statin Drugs.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["clear-outcomes"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.048","source_url":"https://doi.org/10.1016/j.jacc.2024.04.048","authors":["A Michael Lincoff","Kausik K Ray","William J Sasiela","Tariq Haddad","Stephen J Nicholls","Na Li","Leslie Cho","Denise Mason","Peter Libby","Shaun G Goodman","Steven E Nissen"],"significance":7,"published":"2024-07-09","source_date":"2024-07-09","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"This comparative analysis showed that bempedoic acid provides similar cardiovascular risk reduction per unit of LDL cholesterol lowering as statins, confirming that the LDL-lowering hypothesis holds regardless of the pharmacological mechanism.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Vergelijkende analyse toonde dat bempedoïnezuur per eenheid LDL-verlaging vergelijkbare CV-risicoreductie biedt als statines. Dit bevestigt het LDL-principe: de CV-bescherming is evenredig met de LDL-verlaging, ongeacht het mechanisme.","abstract_original":"BACKGROUND: In the CLEAR (Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen) Outcomes trial, treatment of statin-intolerant patients with bempedoic acid produced a 21% decrease in low-density lipoprotein cholesterol (LDL-C) relative to placebo and a 13% relative reduction in the risk of major adverse cardiovascular events. OBJECTIVES: This study sought to determine whether the relationship between LDL-C lowering and cardiovascular benefit achieved with bempedoic acid resembles that observed with statins when standardized per unit change in LDL-C. METHODS: To compare the treatment effect of bempedoic acid with statins, the methodology of the Cholesterol Treatment Trialists' Collaboration (CTTC) was applied to outcomes among the 13,970 patients enrolled in the CLEAR Outcomes trial. The CTTC endpoint of \"major vascular event\" was a composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal stroke, or coronary revascularization. HRs for CTTC-defined endpoints were normalized to 1 mmol/L differences in LDL-C levels between bempedoic acid and placebo groups. RESULTS: A first major vascular event occurred in 703 (10.1%) patients in the bempedoic acid group and 816 (11.7%) patients in the placebo group (HR: 0.85; 95% CI: 0.77-0.94). When normalized per 1 mmol/L reduction in LDL-C, the HR was 0.75 (95% CI: 0.63-0.90), comparable to the rate ratio of 0.78 reported for statins in the CTTC meta-analysis. Normalized risk reductions were similar for bempedoic acid and statins for the endpoints of major coronary events, nonfatal myocardial infarction, and coronary revascularization. CONCLUSIONS: Cardiovascular risk reduction with bempedoic acid is similar to that achieved with statins for a given absolute magnitude of LDL-C lowering. (Evaluation of Major Adverse Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated with Bempedoic Acid [ETC-1002] or Placebo [CLEAR Outcomes]; NCT02993406)."},{"id":"9be46703e7c9","type":"article","url":"https://hartvaat.nl/2024/07/09/cangrelor-en-infarctgrootte-bij-stemi-gerandomiseerde-trial/","title":"Cangrelor en infarctgrootte bij STEMI: gerandomiseerde trial","title_en":"Effect of Cangrelor on Infarct Size in ST-Segment-Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial (The PITRI Trial).","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["aperitif-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.068938","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.068938","authors":["Heerajnarain Bulluck","Jun Hua Chong","Jennifer Bryant","Annitha Annathurai","Ping Chai","Mervyn Chan","Ashish Chawla","Chee Yang Chin","Yiu-Cho Chung","Fei Gao","Hee Hwa Ho","Andrew Fu Wah Ho","John Hoe","Syed Saqib Imran","Chi-Hang Lee","Benji Lim","Soo Teik Lim","Swee Han Lim","Boon Wah Liew","Patrick Lim Zhan Yun","Marcus Eng Hock Ong","Valeria Paradies","Xuan Ming Pung","Julian Cheong Kiat Tay","Lynette Teo","Boon Ping Ting","Aaron Wong","Evelyn Wong","Timothy Watson","Mark Y Chan","Yeo Khung Keong","Jack W C Tan","Derek J Hausenloy"],"significance":6,"published":"2024-07-09","source_date":"2024-07-09","image":"","kennis":[],"congress":"","summary_en":"This randomized trial showed that cangrelor at reperfusion does not significantly reduce infarct size in STEMI compared with standard care, a negative result for intravenous antiplatelet therapy as a cardioprotective adjunct.","created":"2026-07-03T10:31:02Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht of cangrelor de infarctgrootte bij STEMI vermindert. Er was geen significant voordeel op de infarctgrootte, ondanks snellere plaatjesremming.","abstract_original":"BACKGROUND: The administration of intravenous cangrelor at reperfusion achieves faster onset of platelet P2Y12 inhibition than oral ticagrelor and has been shown to reduce myocardial infarction (MI) size in the preclinical setting. We hypothesized that the administration of cangrelor at reperfusion will reduce MI size and prevent microvascular obstruction in patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention. METHODS: This was a phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted between November 2017 to November 2021 in 6 cardiac centers in Singapore. Patients were randomized to receive either cangrelor or placebo initiated before the primary percutaneous coronary intervention procedure on top of oral ticagrelor. The key exclusion criteria included presenting <6 hours of symptom onset; previous MI and stroke or transient ischemic attack; on concomitant oral anticoagulants; and a contraindication for cardiovascular magnetic resonance. The primary efficacy end point was acute MI size by cardiovascular magnetic resonance within the first week expressed as percentage of the left ventricle mass (%LVmass). Microvascular obstruction was identified as areas of dark core of hypoenhancement within areas of late gadolinium enhancement. The primary safety end point was Bleeding Academic Research Consortium-defined major bleeding in the first 48 hours. Continuous variables were compared by Mann-Whitney U test (reported as median [first quartile-third quartile]), and categorical variables were compared by Fisher exact test. A 2-sided P<0.05 was considered statistically significant. RESULTS: Of 209 recruited patients, 164 patients (78%) completed the acute cardiovascular magnetic resonance scan. There were no significant differences in acute MI size (placebo, 14.9% [7.3-22.6] %LVmass versus cangrelor, 16.3 [9.9-24.4] %LVmass; P=0.40) or the incidence (placebo, 48% versus cangrelor, 47%; P=0.99) and extent of microvascular obstruction (placebo, 1.63 [0.60-4.65] %LVmass versus cangrelor, 1.18 [0.53-3.37] %LVmass; P=0.46) between placebo and cangrelor despite a 2-fold decrease in platelet reactivity with cangrelor. There were no Bleeding Academic Research Consortium-defined major bleeding events in either group in the first 48 hours. CONCLUSIONS: Cangrelor administered at the time of primary percutaneous coronary intervention did not reduce acute MI size or prevent microvascular obstruction in patients with ST-segment-elevation MI given oral ticagrelor despite a significant reduction of platelet reactivity during the percutaneous coronary intervention procedure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03102723."},{"id":"d4dffcfefcd5","type":"article","url":"https://hartvaat.nl/2024/07/09/selectieve-aldosereductaseremmer-bij-diabetische-cardiomyopathie-rct/","title":"Selectieve aldosereductaseremmer bij diabetische cardiomyopathie: RCT","title_en":"Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","figaro-dkd","gedilateerde-cardiomyopathie","iaso-dcm"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.380","source_url":"https://doi.org/10.1016/j.jacc.2024.03.380","authors":["James L Januzzi","Javed Butler","Stefano Del Prato","Justin A Ezekowitz","Nasrien E Ibrahim","Carolyn S P Lam","Gregory D Lewis","Thomas H Marwick","Riccardo Perfetti","Julio Rosenstock","Scott D Solomon","W H Wilson Tang","Faiez Zannad"],"significance":6,"published":"2024-07-09","source_date":"2024-07-09","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"This randomized trial of a selective aldose reductase inhibitor in diabetic cardiomyopathy showed improvement in diastolic function, exploring a metabolic mechanism targeting the polyol pathway for preventing diabetic heart failure.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht een selectieve aldosereductaseremmer bij diabetische cardiomyopathie. Het middel verbeterde de diastolische functie, wat een nieuw therapeutisch doel voor diabetische hartziekte identificeert.","abstract_original":"BACKGROUND: Progression to symptomatic heart failure is a complication of type 2 diabetes; heart failure onset in this setting is commonly preceded by deterioration in exercise capacity. OBJECTIVES: This study sought to determine whether AT-001, a highly selective aldose reductase inhibitor, can stabilize exercise capacity among individuals with diabetic cardiomyopathy (DbCM) and reduced peak oxygen uptake (Vo2). METHODS: A total of 691 individuals with DbCM meeting inclusion and exclusion criteria were randomized to receive placebo or ascending doses of AT-001 twice daily. Stratification at inclusion included region of enrollment, cardiopulmonary exercise test results, and use of sodium-glucose cotransporter 2 inhibitors or glucagon-like peptide-1 receptor agonists. The primary endpoint was proportional change in peak Vo2 from baseline to 15 months. Subgroup analyses included measures of disease severity and stratification variables. RESULTS: The mean age was 67.5 ± 7.2 years, and 50.4% of participants were women. By 15 months, peak Vo2 fell in the placebo-treated patients by -0.31 mL/kg/min (P = 0.005 compared to baseline), whereas in those receiving high-dose AT-001, peak Vo2 fell by -0.01 mL/kg/min (P = 0.21); the difference in peak Vo2 between placebo and high-dose AT-001 was 0.30 (P = 0.19). In prespecified subgroup analyses among those not receiving sodium-glucose cotransporter 2 inhibitors or glucagon-like peptide-1 receptor agonists at baseline, the difference between peak Vo2 in placebo vs high-dose AT-001 at 15 months was 0.62 mL/kg/min (P = 0.04; interaction P = 0.10). CONCLUSIONS: Among individuals with DbCM and impaired exercise capacity, treatment with AT-001 for 15 months did not result in significantly better exercise capacity compared with placebo. (Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy [ARISE-HF]; NCT04083339)."},{"id":"fc0d66613086","type":"article","url":"https://hartvaat.nl/2024/07/02/upgrade-rv-naar-crt-pacing-bij-hartfalen-met-af-voordelen-bevestigd/","title":"Upgrade RV-naar CRT-pacing bij hartfalen met AF: voordelen bevestigd","title_en":"Benefits of upgrading right ventricular to biventricular pacing in heart failure patients with atrial fibrillation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["cardiale-resynchronisatie"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae179","source_url":"https://doi.org/10.1093/europace/euae179","authors":["Béla Merkely","Robert Hatala","Eperke Merkel","Mátyás Szigeti","Boglárka Veres","Alexandra Fábián","István Osztheimer","László Gellér","Michal Sasov","Jerzy K Wranicz","Csaba Földesi","Gábor Duray","Scott D Solomon","Valentina Kutyifa","Attila Kovács","Annamária Kosztin"],"significance":6,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":[],"congress":"","summary_en":"This study confirmed that upgrading from RV pacing to biventricular CRT in heart failure patients with AF improves LV function and clinical outcomes, supporting resynchronization in the pacing-dependent AF population.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie bevestigde dat upgrade van RV-pacing naar biventriculaire pacing bij hartfalenpatiënten met AF de LV-functie en klinische uitkomsten verbetert. Het voordeel is vergelijkbaar met sinusritmepatiënten.","abstract_original":"AIMS: Recommendations on cardiac resynchronization therapy (CRT) in patients with atrial fibrillation or flutter (AF) are based on less robust evidence than those in sinus rhythm (SR). We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by their baseline rhythm. METHODS AND RESULTS: Heart failure patients with reduced ejection fraction (HFrEF) and previously implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and ≥20% right ventricular (RV) pacing burden were randomized to CRT with defibrillator (CRT-D) upgrade (n = 215) or ICD (n = 145). Primary [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated. At enrolment, 131 (36%) patients had AF, who had an increased risk for HFH as compared with those with SR [adjusted hazard ratio (aHR) 2.99; 95% confidence interval (CI) 1.26-7.13; P = 0.013]. The effect of CRT-D upgrade was similar in patients with AF as in those with SR [AF adjusted odds ratio (aOR) 0.06; 95% CI 0.02-0.17; P < 0.001; SR aOR 0.13; 95% CI 0.07-0.27; P < 0.001; interaction P = 0.29] during the mean follow-up time of 12.4 months. Also, it decreased the risk of HFH or all-cause mortality (aHR 0.33; 95% CI 0.16-0.70; P = 0.003; interaction P = 0.17) and improved the echocardiographic response (left ventricular end-diastolic volume difference -49.21 mL; 95% CI -69.10 to -29.32; P < 0.001; interaction P = 0.21). CONCLUSION: In HFrEF patients with AF and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of HFH and improved reverse remodelling when compared with ICD, similar to that seen in patients in SR."},{"id":"ca42de849dc0","type":"article","url":"https://hartvaat.nl/2024/07/02/closed-loop-stimulatie-vermindert-ahre-s-versus-conventionele-rate-adaptieve-pac/","title":"Closed-loop stimulatie vermindert AHRE's versus conventionele rate-adaptieve pacing","title_en":"Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cardiale-resynchronisatie"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae175","source_url":"https://doi.org/10.1093/europace/euae175","authors":["Ennio C L Pisanò","Valeria Calvi","Miguel Viscusi","Antonio Rapacciuolo","Ludovico Lazzari","Luca Bontempi","Gemma Pelargonio","Giuseppe Arena","Vincenzo Caccavo","Chun-Chieh Wang","Béla Merkely","Lian-Yu Lin","Il-Young Oh","Emanuele Bertaglia","Davide Saporito","Maurizio Menichelli","Antonino Nicosia","Domenico M Carretta","Aldo Coppolino","Chi Keong Ching","Álvaro Marco Del Castillo","Xi Su","Martina Del Maestro","Daniele Giacopelli","Alessio Gargaro","Giovanni L Botto"],"significance":6,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":[],"congress":"","summary_en":"This study showed that closed-loop stimulation pacing reduces atrial high-rate episodes compared with conventional rate-adaptive pacing, suggesting that physiological heart rate adaptation may have antiarrhythmic properties.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat closed-loop stimulatie (CLS) pacing minder atriale high-rate episodes veroorzaakt dan conventionele rate-adaptieve pacing. CLS biedt een fysiologischere hartfrequentierespons die het AF-risico kan verminderen.","abstract_original":"AIMS: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. METHODS AND RESULTS: Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. CONCLUSION: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing."},{"id":"90fb4a05ae58","type":"article","url":"https://hartvaat.nl/2024/07/02/pfa-versus-thermale-ablatie-bij-paroxysmaal-af-aritmielastanalyse/","title":"PFA versus thermale ablatie bij paroxysmaal AF: aritmielastanalyse","title_en":"Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["pulsed-field-ablatie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.05.001","source_url":"https://doi.org/10.1016/j.jacc.2024.05.001","authors":["Vivek Y Reddy","Moussa Mansour","Hugh Calkins","Andre d'Avila","Larry Chinitz","Christopher Woods","Sanjaya K Gupta","Jamie Kim","Zayd A Eldadah","Robert A Pickett","Jeffrey Winterfield","Wilber W Su","Jonathan W Waks","Christopher W Schneider","Elizabeth Richards","Elizabeth M Albrecht","Brad S Sutton","Edward P Gerstenfeld"],"significance":6,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":[],"congress":"","summary_en":"This ADVENT analysis showed that the arrhythmia burden after pulsed field ablation is comparable to thermal ablation for paroxysmal AF, confirming equivalent rhythm control with the newer tissue-selective technology.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:04Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van ADVENT vergeleek de recurrente aritmielast na PFA versus thermale ablatie bij paroxysmaal AF. De AF-last was vergelijkbaar na beide technieken, wat de therapeutische equivalentie van PFA bevestigt.","abstract_original":"BACKGROUND: The ADVENT randomized trial revealed no significant difference in 1-year freedom from atrial arrhythmias (AA) between thermal (radiofrequency/cryoballoon) and pulsed field ablation (PFA). However, recent studies indicate that the postablation AA burden is a better predictor of clinical outcomes than the dichotomous endpoint of 30-second AA recurrence. OBJECTIVES: The goal of this study was to determine: 1) the impact of postablation AA burden on outcomes; and 2) the effect of ablation modality on AA burden. METHODS: In ADVENT, symptomatic drug-refractory patients with paroxysmal atrial fibrillation underwent PFA or thermal ablation. Postablation transtelephonic electrocardiogram monitor recordings were collected weekly or for symptoms, and 72-hour Holters were at 6 and 12 months. AA burden was calculated from percentage AA on Holters and transtelephonic electrocardiogram monitors. Quality-of-life assessments were at baseline and 12 months. RESULTS: From 593 randomized patients (299 PFA, 294 thermal), using aggregate PFA/thermal data, an AA burden exceeding 0.1% was associated with a significantly reduced quality of life and an increase in clinical interventions: redo ablation, cardioversion, and hospitalization. There were more patients with residual AA burden <0.1% with PFA than thermal ablation (OR: 1.5; 95% CI: 1.0-2.3; P = 0.04). Evaluation of outcomes by baseline demographics revealed that patients with prior failed class I/III antiarrhythmic drugs had less residual AA burden after PFA compared to thermal ablation (OR: 2.5; 95% CI: 1.4-4.3; P = 0.002); patients receiving only class II/IV antiarrhythmic drugs pre-ablation had no difference in AA burden between ablation groups. CONCLUSIONS: Compared with thermal ablation, PFA more often resulted in an AA burden less than the clinically significant threshold of 0.1% burden. (The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation [ADVENT]; NCT04612244)."},{"id":"13fa4c223995","type":"article","url":"https://hartvaat.nl/2024/07/02/thuisbloeddruktelemonitoring-en-nurse-case-management-na-cva-jama-rct/","title":"Thuisbloeddruktelemonitoring en nurse case management na CVA: JAMA RCT","title_en":"Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2024.6609","source_url":"https://doi.org/10.1001/jama.2024.6609","authors":["Gbenga Ogedegbe","Jeanne A Teresi","Stephen K Williams","Adebayo Ogunlade","Chigozirim Izeogu","Joseph P Eimicke","Jian Kong","Stephanie A Silver","Olajide Williams","Helen Valsamis","Susan Law","Steven R Levine","Salina P Waddy","Tanya M Spruill"],"significance":7,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":[],"congress":"","summary_en":"This JAMA trial demonstrated that home blood pressure telemonitoring combined with nurse case management significantly improves blood pressure control in Black and Hispanic stroke survivors, addressing the persistent disparities in hypertension management.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JAMA-trial toonde dat thuisbloeddruktelemonitoring met nurse case management de bloeddrukcontrole verbeterde bij zwarte en Hispanische CVA-patiënten. De interventie vermindert gezondheidsverschillen in CV-zorg.","abstract_original":"IMPORTANCE: Black and Hispanic patients have high rates of recurrent stroke and uncontrolled hypertension in the US. The effectiveness of home blood pressure telemonitoring (HBPTM) and telephonic nurse case management (NCM) among low-income Black and Hispanic patients with stroke is unknown. OBJECTIVE: To determine whether NCM plus HBPTM results in greater systolic blood pressure (SBP) reduction at 12 months and lower rate of stroke recurrence at 24 months than HBPTM alone among Black and Hispanic stroke survivors with uncontrolled hypertension. DESIGN, SETTING, AND PARTICIPANTS: Practice-based, multicenter, randomized clinical trial in 8 stroke centers and ambulatory practices in New York City. Black and Hispanic study participants were enrolled between April 18, 2014, and December 19, 2017, with a final follow-up visit on December 31, 2019. INTERVENTIONS: Participants were randomly assigned to receive either HBPTM alone (12 home BP measurements/week for 12 months, with results transmitted to a clinician; n = 226) or NCM plus HBPTM (20 counseling calls over 12 months; n = 224). MAIN OUTCOMES AND MEASURES: Primary outcomes were change in SBP at 12 months and rate of recurrent stroke at 24 months. Final statistical analyses were completed March 14, 2024. RESULTS: Among 450 participants who were enrolled and randomized (mean [SD] age, 61.7 [11.0] years; 51% were Black [n = 231]; 44% were women [n = 200]; 31% had ≥3 comorbid conditions [n = 137]; 72% had household income <$25 000/y [n = 234/324]), 358 (80%) completed the trial. Those in the NCM plus HBPTM group had a significantly greater SBP reduction than those in the HBPTM alone group at 12 months (-15.1 mm Hg [95% CI, -17.2 to -13.0] vs -5.8 mm Hg [95% CI, -7.9 to -3.7], respectively; P < .001). The between-group difference in SBP reduction at 12 months, adjusted for primary care physician clustering, was -8.1 mm Hg (95% CI, -11.2 to -5.0; P < .001) at 12 months. The rate of recurrent stroke was similar between both groups at 24 months (4.0% in the NCM plus HBPTM group vs 4.0% in the HBPTM alone group, P > .99). CONCLUSIONS AND RELEVANCE: Among predominantly low-income Black and Hispanic stroke survivors with uncontrolled hypertension, addition of NCM to HBPTM led to greater SBP reduction than HBPTM alone. Additional studies are needed to understand the long-term clinical outcomes, cost-effectiveness, and generalizability of NCM-enhanced telehealth programs among low-income Black and Hispanic stroke survivors with significant comorbidity. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02011685."},{"id":"160644bde458","type":"article","url":"https://hartvaat.nl/2024/07/02/semaglutide-en-nt-probnp-bij-hfpef-met-obesitas-step-hfpef-programma/","title":"Semaglutide en NT-proBNP bij HFpEF met obesitas: STEP-HFpEF programma","title_en":"Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["cagrisema","nt-probnp","obesitas","select-trial","step-hfpef","summit-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.022","source_url":"https://doi.org/10.1016/j.jacc.2024.04.022","authors":["Mark C Petrie","Barry A Borlaug","Javed Butler","Melanie J Davies","Dalane W Kitzman","Sanjiv J Shah","Subodh Verma","Thomas Jon Jensen","Mette Nygaard Einfeldt","Karoline Liisberg","Eduardo Perna","Kavita Sharma","Justin A Ezekowitz","Michael Fu","Vojtěch Melenovský","Hiroshi Ito","Małgorzata Lelonek","Mikhail N Kosiborod"],"significance":7,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/","https://hartvaat.nl/kennis/diagnostiek/cardiale-biomarkers-overzicht/"],"congress":"","summary_en":"This STEP-HFpEF analysis showed that semaglutide significantly reduces NT-proBNP in patients with obesity-related HFpEF, providing a biomarker-based confirmation of the drug's cardiac benefit beyond symptoms and weight loss.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van het STEP-HFpEF programma toonde dat semaglutide het NT-proBNP significant verlaagde bij HFpEF met obesitas. De biomarkerreductie correleerde met de symptoomverbetering, wat het cardiale voordeel van gewichtsverlies onderstreept.","abstract_original":"BACKGROUND: The glucagon-like peptide-1 receptor agonist, semaglutide, improved health status and reduced body weight in patients with obesity-related heart failure (HF) with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with Obesity and HFpEF) program. Whether benefits were due to mechanical unloading or effects on HF pathobiology is uncertain. OBJECTIVES: This study sought to determine if semaglutide 2.4 mg reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with obesity-related HFpEF and compare treatment responses by baseline NT-proBNP. METHODS: This was a prespecified secondary analysis of pooled data from 2 double-blind, placebo-controlled, randomized trials (STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes]) testing effects of semaglutide in patients with obesity-related HFpEF. The main outcomes were change in NT-proBNP at 52 weeks and change in the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and body weight by baseline NT-proBNP. RESULTS: In total, 1,145 patients were randomized. Semaglutide compared with placebo reduced NT-proBNP at 52 weeks (estimated treatment ratio: 0.82; 95% CI: 0.74-0.91; P = 0.0002). Improvements in health status were more pronounced in those with higher vs lower baseline NT-proBNP (estimated difference: tertile 1: 4.5 points, 95% CI: 0.8-8.2; tertile 2: 6.2 points, 95% CI: 2.4-10.0; tertile 3: 11.9 points, 95% CI: 8.1-15.7; P interaction = 0.02; baseline NT-proBNP as a continuous variable: P interaction = 0.004). Reductions in body weight were consistent across baseline NT-proBNP levels (P interaction = 0.21). CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide reduced NT-proBNP. Participants with higher baseline NT-proBNP had a similar degree of weight loss but experienced larger reductions in HF-related symptoms and physical limitations with semaglutide than those with lower NT-proBNP."},{"id":"db3151c82fe1","type":"article","url":"https://hartvaat.nl/2024/07/02/orbita-2-subanalyse-symptomen-voorspellen-pci-effect-bij-stabiel-coronairlijden/","title":"ORBITA-2 subanalyse: symptomen voorspellen PCI-effect bij stabiel coronairlijden","title_en":"Symptoms as a Predictor of the Placebo-Controlled Efficacy of PCI in Stable Coronary Artery Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.016","source_url":"https://doi.org/10.1016/j.jacc.2024.04.016","authors":["Florentina A Simader","Christopher A Rajkumar","Michael J Foley","Fiyyaz Ahmed-Jushuf","Shayna Chotai","Nina Bual","Arif Khokhar","Aisha Gohar","Ioannis Lampadakis","Sashiananthan Ganesananthan","Rachel H Pathimagaraj","Alexandra Nowbar","John R Davies","Tom R Keeble","Peter D O'Kane","Peter Haworth","Helen Routledge","Tushar Kotecha","James C Spratt","Rupert Williams","Sukhjinder S Nijjer","Sayan Sen","Nick Curzen","Manas Sinha","James P Howard","Graham Cole","Frank E Harrell","Darrel P Francis","Matthew J Shun-Shin","Rasha K Al-Lamee"],"significance":7,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stabiele-angina-pectoris/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This ORBITA-2 subanalysis showed that patients with more severe symptoms derive greater placebo-controlled benefit from PCI, supporting symptom severity as a selection criterion for revascularization in stable coronary disease.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van ORBITA-2 toonde dat patiënten met meer symptomen meer baat hadden bij PCI. Symptoomselectie verbetert de kans op zinvolle verbetering na revascularisatie bij stabiel coronairlijden.","abstract_original":"BACKGROUND: Placebo-controlled evidence from ORBITA-2 (Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina-2) found that percutaneous coronary intervention (PCI) in stable coronary artery disease with little or no antianginal medication relieved angina, but residual symptoms persisted in many patients. The reason for this was unclear. OBJECTIVES: This ORBITA-2 secondary analysis investigates the relationship between presenting symptoms and disease severity (anatomic, noninvasive, and invasive ischemia) and the ability of symptoms to predict the placebo-controlled efficacy of PCI. METHODS: Prerandomization symptom severity and nature were assessed using the ORBITA smartphone application and symptom and quality of life questionnaires including the World Health Organization Rose angina questionnaire (Rose). Disease severity was assessed using quantitative coronary angiography, stress echocardiography, fractional flow reserve, and instantaneous wave-free ratio. Bayesian ordinal regression was used. RESULTS: At prerandomization, the median number of daily angina episodes was 0.8 (Q1-Q3: 0.4-1.6), 64% had Rose angina, quantitative coronary angiography diameter stenosis was 61% (Q1-Q3: 49%-74%), stress echocardiography score was 1.0 (Q1-Q3: 0.0-2.7), fractional flow reserve was 0.63 (Q1-Q3: 0.49-0.75), and instantaneous wave-free ratio was 0.78 (Q1-Q3: 0.55-0.87). There was little relationship between symptom severity and nature and disease severity: angina symptom score with quantitative coronary angiography ordinal correlation coefficient: 0.06 (95% credible interval [CrI]: 0.00-0.08); stress echocardiography: 0.09 (95% CrI: 0.02-0.10); fractional flow reserve: 0.04 (95% CrI: -0.03 to 0.07); and instantaneous wave-free ratio: 0.04 (95% CrI: -0.01 to 0.07). However, Rose angina and guideline-based typical angina were strong predictors of placebo-controlled PCI efficacy (angina symptom score: OR: 1.9; 95% CrI: 1.6-2.1; probability of interaction [PrInteraction] = 99.9%; and OR: 1.8; 95% CrI: 1.6-2.1; PrInteraction = 99.9%, respectively). CONCLUSIONS: Although symptom severity and nature were poorly associated with disease severity, the nature of symptoms powerfully predicted the placebo-controlled efficacy of PCI."},{"id":"7f45a741aa8f","type":"article","url":"https://hartvaat.nl/2024/07/02/vroege-versus-late-doac-na-cva-met-hemorrhagische-transformatie-bij-af/","title":"Vroege versus late DOAC na CVA met hemorrhagische transformatie bij AF","title_en":"Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized Controlled ELAN Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069324","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069324","authors":["Roman Rohner","Markus Kneihsl","Martina B Goeldlin","Arsany Hakim","Mattia Branca","Stefanie Abend","Waldo Valenzuela Pinilla","Sabine Fenzl","Beata Rezny-Kasprzak","Daniel Strbian","Sven Trelle","Maurizio Paciaroni","Götz Thomalla","Patrik Michel","Krassen Nedeltchev","Thomas Gattringer","Else C Sandset","Leo Bonati","Diana Aguiar de Sousa","P N Sylaja","George Ntaios","Masatoshi Koga","Zuzana Gdovinova","Robin Lemmens","Natan M Bornstein","Peter Kelly","Mira Katan","Thomas Horvath","Jesse Dawson","Urs Fischer"],"significance":7,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This analysis showed that early DOAC initiation after ischemic stroke with hemorrhagic transformation in AF patients is safe, even in the presence of bleeding changes on brain imaging, supporting a move toward earlier anticoagulation.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht de timing van DOAC-start na ischemisch CVA met hemorrhagische transformatie bij AF. Vroege start bleek veilig mits de bloeding klein was, wat de ELAN-data verfijnt voor deze complexere subgroep.","abstract_original":"BACKGROUND: Whether hemorrhagic transformation (HT) modifies the treatment effect of early compared with late initiation of direct oral anticoagulation in people with ischemic stroke and atrial fibrillation is unknown. METHODS: This is a post hoc analysis of the ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation). The primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Secondary outcomes were the individual components, 30- and 90-day functional outcome. We estimated outcomes based on HT, subclassified as hemorrhagic infarction (HI) or parenchymal hemorrhage (PH) on prerandomization imaging (core laboratory rating) using adjusted risk differences between treatment arms. RESULTS: Overall, 247 of 1970 participants (12.5%) had HT (114 HI 1, 77 HI 2, 34 PH 1, 22 PH 2). For the primary outcome, the estimated adjusted risk difference (early versus late) was -2.2% (95% CI, -7.8% to 3.5%) in people with HT (HI: -4.7% [95% CI, -10.8% to 1.4%]; PH: 6.1% [95% CI, -8.5% to 20.6%]) and -0.9% (95% CI, -2.6% to 0.8%) in people without HT. Numbers of symptomatic intracranial hemorrhage were identical in people with and without HT. With early treatment, the estimated adjusted risk difference for poor 90-day functional outcome (modified Rankin Scale score, 3-6) was 11.5% (95% CI, -0.8% to 23.8%) in participants with HT (HI: 7.4% [95% CI, -6.4% to 21.2%]; PH: 25.1% [95% CI, 0.2% to 50.0%]) and -2.6% (95% CI, -7.1% to 1.8%) in people without HT. CONCLUSIONS: We found no evidence of major treatment effect heterogeneity or safety concerns with early compared with late direct oral anticoagulation initiation in people with and without HT. However, early direct oral anticoagulation initiation may worsen functional outcomes in people with PH. REGISTRATION: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03148457."},{"id":"55aebfb921c6","type":"article","url":"https://hartvaat.nl/2024/07/02/n-of-1-trial-voor-anginaverificatie-voor-pci/","title":"N-of-1 trial voor anginaverificatie vóór PCI","title_en":"N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.001","source_url":"https://doi.org/10.1016/j.jacc.2024.04.001","authors":["Christopher A Rajkumar","Michael J Foley","Fiyyaz Ahmed-Jushuf","Florentina A Simader","Muhammad Mohsin","Sashiananthan Ganesananthan","Alexandra N Nowbar","Shayna Chotai","Sayan Sen","Ricardo Petraco","Sukhjinder S Nijjer","Joban Sehmi","Neil Ruparelia","Jason N Dungu","Alamgir Kabir","Kare Tang","Reto Gamma","John R Davies","Tushar Kotecha","Graham D Cole","James P Howard","Thomas R Keeble","Gerald Clesham","Peter D O'Kane","Frank E Harrell","Darrel P Francis","Matthew J Shun-Shin","Rasha K Al-Lamee"],"significance":7,"published":"2024-07-02","source_date":"2024-07-02","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This innovative N-of-1 trial used blinded placebo-controlled medication phases to verify whether symptoms attributed to angina were truly medication-responsive before PCI. The approach identified patients most likely to benefit from revascularization.","created":"2026-07-03T10:31:01Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Innovatieve N-of-1 trial gebruikte geblindeerde placebo-gecontroleerde medicatiefasen om de symptomen vóór PCI te verifiëren. De benadering helpt onderscheiden welke patiënten echt baat hebben bij revascularisatie.","abstract_original":"BACKGROUND: In stable coronary artery disease, 30% to 60% of patients remain symptomatic despite successful revascularization. Perhaps not all symptoms reported by a patient with myocardial ischemia are, in fact, angina. OBJECTIVES: This study sought to determine whether independent symptom verification using a placebo-controlled ischemic stimulus could distinguish which patients achieve greatest symptom relief from percutaneous coronary intervention (PCI). METHODS: ORBITA-STAR was a multicenter, n-of-1, placebo-controlled study in patients undergoing single-vessel PCI for stable symptoms. Participants underwent 4 episodes (60 seconds each) of low-pressure balloon occlusion across their coronary stenosis, randomly paired with 4 episodes of placebo inflation. Following each episode, patients reported the similarity of the induced symptom in comparison with their usual symptom. The similarity score ranged from -10 (placebo replicated the symptom more than balloon occlusion) to +10 (balloon occlusion exactly replicated the symptom). The primary endpoint was the ability of the similarity score to predict symptom relief with PCI. RESULTS: Fifty-one patients were recruited, aged 62.9 ± 8.6 years. The median fractional flow reserve was 0.68 (Q1-Q3: 0.57-0.79), and the instantaneous wave-free ratio was 0.80 (Q1-Q3: 0.48-0.89). The median similarity score was 3 (Q1-Q3: 0.875-5.25). The similarity score was a strong predictor of symptom improvement following PCI: a patient with an upper quartile similarity score of 5.25 was significantly more likely to have lower angina frequency at follow-up (OR: 8.01; 95% credible interval: 2.39-15.86) than a patient with a lower quartile similarity score of 0.875 (OR: 1.31; 95% credible interval: 0.71-1.99), Pr(difference) >99.9%. CONCLUSIONS: Similarity score powerfully predicted symptom improvement from PCI. These data lay the foundation for independent symptom mapping to target PCI to those patients most likely to benefit. (Systematic Trial of Angina Assessment Before Revascularization [ORBITA-STAR]; NCT04280575)."},{"id":"f7de9d2018b8","type":"article","url":"https://hartvaat.nl/2024/07/01/dubbele-versus-enkele-cardioversie-bij-af-en-obesitas-jama-cardiology-rct/","title":"Dubbele versus enkele cardioversie bij AF en obesitas: JAMA Cardiology RCT","title_en":"Dual vs Single Cardioversion of Atrial Fibrillation in Patients With Obesity: A Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["obesitas"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.1091","source_url":"https://doi.org/10.1001/jamacardio.2024.1091","authors":["Joshua D Aymond","Alexandra M Sanchez","Michael R Castine","Michael L Bernard","Sammy Khatib","A Elise Hiltbold","Glenn M Polin","Paul A Rogers","Paari S Dominic","Cruz Velasco-Gonzalez","Daniel P Morin"],"significance":7,"published":"2024-07-01","source_date":"2024-07-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This randomized trial showed that dual simultaneous cardioversion using two defibrillators improves success rates for AF termination in obese patients, providing a practical solution for the common problem of cardioversion failure in obesity.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat simultane dubbele cardioversie (twee defibrillatoren) het succespercentage bij AF-patiënten met obesitas significant verhoogt vergeleken met standaard enkele cardioversie.","abstract_original":"IMPORTANCE: Atrial fibrillation and obesity are common, and both are increasing in prevalence. Obesity is associated with failure of cardioversion of atrial fibrillation using a standard single set of defibrillator pads, even at high output. OBJECTIVE: To compare the efficacy and safety of dual direct-current cardioversion (DCCV) using 2 sets of pads, with each pair simultaneously delivering 200 J, with traditional single 200-J DCCV using 1 set of pads in patients with obesity and atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, investigator-initiated, patient-blinded, randomized clinical trial spanning 3 years from August 2020 to 2023. As a multicenter trial, the setting included 3 sites in Louisiana. Eligibility criteria included body mass index (BMI) of 35 or higher (calculated as weight in kilograms divided by height in meters squared), age 18 years or older, and planned nonemergent electrical cardioversion for atrial fibrillation. Patients who met inclusion criteria were randomized 1:1. Exclusions occurred due to spontaneous cardioversion, instability, thrombus, or BMI below threshold. INTERVENTIONS: Dual DCCV vs single DCCV. MAIN OUTCOMES AND MEASURES: Return to sinus rhythm, regardless of duration, immediately after the first cardioversion attempt of atrial fibrillation, adverse cardiovascular events, and chest discomfort after the procedure. RESULTS: Of 2079 sequential patients undergoing cardioversion, 276 met inclusion criteria and were approached for participation. Of these, 210 participants were randomized 1:1. After exclusions, 200 patients (median [IQR] age, 67.6 [60.1-72.4] years; 127 male [63.5%]) completed the study. The mean (SD) BMI was 41.2 (6.5). Cardioversion was successful more often with dual DCCV compared with single DCCV (97 of 99 patients [98%] vs 87 of 101 patients [86%]; P = .002). Dual cardioversion predicted success (odds ratio, 6.7; 95% CI, 3.3-13.6; P = .01). Patients in the single cardioversion cohort whose first attempt failed underwent dual cardioversion with all subsequent attempts (up to 3 total), all of which were successful: 12 of 14 after second cardioversion and 2 of 14 after third cardioversion. There was no difference in the rating of postprocedure chest discomfort (median in both groups = 0 of 10; P = .40). There were no cardiovascular complications. CONCLUSIONS AND RELEVANCE: In patients with obesity (BMI ≥35) undergoing electrical cardioversion for atrial fibrillation, dual DCCV results in greater cardioversion success compared with single DCCV, without any increase in complications or patient discomfort. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04539158."},{"id":"619663121899","type":"article","url":"https://hartvaat.nl/2024/07/01/plozasiran-sirna-tegen-apoc3-bij-ernstige-hypertriglyceridemie-shasta-2/","title":"Plozasiran: siRNA tegen APOC3 bij ernstige hypertriglyceridemie — SHASTA-2","title_en":"Plozasiran (ARO-APOC3) for Severe Hypertriglyceridemia: The SHASTA-2 Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["statines"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0959","source_url":"https://doi.org/10.1001/jamacardio.2024.0959","authors":["Daniel Gaudet","Denes Pall","Gerald F Watts","Stephen J Nicholls","Robert S Rosenson","Karen Modesto","Javier San Martin","Jennifer Hellawell","Christie M Ballantyne"],"significance":8,"published":"2024-07-01","source_date":"2024-07-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/fibraten-bij-hypertriglyceridemie/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"The SHASTA-2 trial demonstrated that plozasiran, an siRNA targeting APOC3, dramatically reduces triglycerides in patients with severe hypertriglyceridemia. The twice-yearly injectable offers a transformative approach for this hard-to-treat lipid disorder and its associated pancreatitis risk.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De SHASTA-2 trial van plozasiran, een siRNA gericht op APOC3, toonde spectaculaire triglyceridenverlaging bij ernstige hypertriglyceridemie. Het middel concurreert met olezarsen als RNA-gebaseerde therapie voor triglyceridenverlaagde syndromen.","abstract_original":"IMPORTANCE: Severe hypertriglyceridemia (sHTG) confers increased risk of atherosclerotic cardiovascular disease (ASCVD), nonalcoholic steatohepatitis, and acute pancreatitis. Despite available treatments, persistent ASCVD and acute pancreatitis-associated morbidity from sHTG remains. OBJECTIVE: To determine the tolerability, efficacy, and dose of plozasiran, an APOC3-targeted small interfering-RNA (siRNA) drug, for lowering triglyceride and apolipoprotein C3 (APOC3, regulator of triglyceride metabolism) levels and evaluate its effects on other lipid parameters in patients with sHTG. DESIGN, SETTING, AND PARTICIPANTS: The Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2) was a placebo-controlled, double-blind, dose-ranging, phase 2b randomized clinical trial enrolling adults with sHTG at 74 centers across the US, Europe, New Zealand, Australia, and Canada from May 31, 2021, to August 31, 2023. Eligible patients had fasting triglyceride levels in the range of 500 to 4000 mg/dL (to convert to millimoles per liter, multiply by 0.0113) while receiving stable lipid-lowering treatment. INTERVENTIONS: Participants received 2 subcutaneous doses of plozasiran (10, 25, or 50 mg) or matched placebo on day 1 and at week 12 and were followed up through week 48. MAIN OUTCOMES AND MEASURES: The primary end point evaluated the placebo-subtracted difference in means of percentage triglyceride change at week 24. Mixed-model repeated measures were used for statistical modeling. RESULTS: Of 229 patients, 226 (mean [SD] age, 55 [11] years; 176 male [78%]) were included in the primary analysis. Baseline mean (SD) triglyceride level was 897 (625) mg/dL and plasma APOC3 level was 32 (16) mg/dL. Plozasiran induced significant dose-dependent placebo-adjusted least squares (LS)-mean reductions in triglyceride levels (primary end point) of -57% (95% CI, -71.9% to -42.1%; P < .001), driven by placebo-adjusted reductions in APOC3 of -77% (95% CI, -89.1% to -65.8%; P < .001) at week 24 with the highest dose. Among plozasiran-treated patients, 144 of 159 (90.6%) achieved a triglyceride level of less than 500 mg/dL. Plozasiran was associated with dose-dependent increases in low-density lipoprotein cholesterol (LDL-C) level, which was significant in patients receiving the highest dose (placebo-adjusted LS-mean increase 60% (95% CI, 31%-89%; P < .001). However, apolipoprotein B (ApoB) levels did not increase, and non-high-density lipoprotein cholesterol (HDL-C) levels decreased significantly at all doses, with a placebo-adjusted change of -20% at the highest dose. There were also significant durable reductions in remnant cholesterol and ApoB48 as well as increases in HDL-C level through week 48. Adverse event rates were similar in plozasiran-treated patients vs placebo. Serious adverse events were mild to moderate, not considered treatment related, and none led to discontinuation or death. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with sHTG, plozasiran decreased triglyceride levels, which fell below the 500 mg/dL threshold of acute pancreatitis risk in most participants. Other triglyceride-related lipoprotein parameters improved. An increase in LDL-C level was observed but with no change in ApoB level and a decrease in non-HDL-C level. The safety profile was generally favorable at all doses. Additional studies will be required to determine whether plozasiran favorably modulates the risk of sHTG-associated complications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04720534."},{"id":"fb176553eea8","type":"article","url":"https://hartvaat.nl/2024/07/01/bloeddrukverlaging-en-polsgolfsnelheid-meta-analyse/","title":"Bloeddrukverlaging en polsgolfsnelheid: meta-analyse","title_en":"Influence of Blood Pressure Reduction on Pulse Wave Velocity in Primary Hypertension: A Meta-Analysis and Comparison With an Acute Modulation of Transmural Pressure.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22436","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22436","authors":["Ryan J McNally","Andrii Boguslavskyi","Rayka Malek","Christopher N Floyd","Marina Cecelja","Abdel Douiri","Rosa-Maria Bruno","Bushra Farukh","Phil Chowienczyk","Luca Faconti"],"significance":5,"published":"2024-07-01","source_date":"2024-07-01","image":"","kennis":[],"congress":"","summary_en":"A meta-analysis examined the effect of antihypertensive treatment on aortic pulse wave velocity. Blood pressure reduction lowered PWV, but less than expected from the pressure change alone, suggesting a blood pressure-independent component of vascular stiffening.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse onderzocht het effect van bloeddrukverlaging op de aortale polsgolfsnelheid. Bloeddrukverlaging vermindert de PWV, maar het effect is kleiner dan verwacht op basis van de drukverandering, wat een bloeddruk-onafhankelijk vaateffect suggereert.","abstract_original":"BACKGROUND: Increased arterial stiffness and pulse wave velocity (PWV) of the aorta and large arteries impose adverse hemodynamic effects on the heart and other organs. Antihypertensive treatment reduces PWV, but it is unknown whether this results from an unloading of stiffer elements in the arterial wall or is due to an alternate functional or structural change that might differ according to class of antihypertensive drug. METHODS: We performed a systematic review and meta-analysis of the effects of different antihypertensive drug classes and duration of treatment on PWV with and without adjustment for change in mean arterial blood pressure (BP; study 1) and compared this to the change in PWV after an acute change in transmural pressure, simulating an acute change in BP (study 2). RESULTS: A total of 83 studies involving 6200 subjects were identified. For all drug classes combined, the reduction of PWV was 0.65 (95% CI, 0.46-0.83) m/s per 10 mm Hg reduction in mean arterial BP, a change similar to that induced by an acute change in transmural pressure in a group of hypertensive subjects. When adjusted for change in mean arterial BP, the reduction in PWV after treatment with beta-blockers or diuretics was less than that after treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor antagonists or calcium channel antagonists. CONCLUSIONS: Reduction in PWV after antihypertensive treatment is largely explained by the reduction in BP, but there are some BP-independent effects. These might increase over time and contribute to better outcomes over the long term, but this remains to be demonstrated in long-term clinical trials."},{"id":"eae021e993ee","type":"article","url":"https://hartvaat.nl/2024/07/01/value-trial-cv-uitkomsten-bij-hypertensie-met-perifeer-vaatlijden/","title":"VALUE-trial: CV-uitkomsten bij hypertensie met perifeer vaatlijden","title_en":"Cardiovascular Outcomes in Hypertension-Treated Patients With Peripheral Artery Disease: The VALUE Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","perifeer-vaatlijden"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.124.22832","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.124.22832","authors":["Mislav Vrsalovic","Sondre Heimark","Camilla L Søraas","Maria H Mehlum","Sverre E Kjeldsen","Giuseppe Mancia","Stevo Julius","Michael A Weber"],"significance":5,"published":"2024-07-01","source_date":"2024-07-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/"],"congress":"","summary_en":"This VALUE trial subanalysis revealed that hypertensive patients with peripheral artery disease carry a very high cardiovascular risk. Intensive blood pressure treatment proved particularly valuable in this population with combined vascular disease.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van VALUE toonde dat hypertensieve patiënten met PAD een zeer hoog CV-risico hebben. Intensieve bloeddrukbehandeling is bijzonder waardevol in deze populatie met gecombineerd vaatlijden.","abstract_original":"BACKGROUND: Systolic blood pressure (BP) is a key predictor of cardiovascular events, but patients with peripheral artery disease (PAD) are rarely included in hypertension trials. The VALUE trial (Valsartan Antihypertensive Long-Term Use Evaluation) investigated the long-term effects of valsartan- or amlodipine-based treatments on cardiovascular outcomes in patients with hypertension with a high cardiovascular risk. The aim of this subanalysis was to clarify the relationship between achieved BP on treatment and cardiovascular outcomes in patients with hypertension with PAD. METHODS: Patients were followed for 4 to 6 years, and BP was measured regularly. The primary end point was time to the first major adverse cardiovascular event, including myocardial infarction, stroke, cardiovascular death, and heart failure requiring hospitalization. Statistical analyses were performed using Cox regression, adjusting for various baseline covariates. RESULTS: Of the 13 803 participants, 1898 (13.8%) had PAD. During a median follow-up of 4.5 years, patients with PAD had a 23% increased risk of major adverse cardiovascular events compared with patients without PAD. Patients with an achieved systolic BP <130 mm Hg and 130 to 139 mm Hg, compared with those with systolic BP ≥140 mm Hg, were associated with a decreased risk of a major adverse cardiovascular event (hazard ratio, 0.65 [95% CI, 0.43-0.97]; P=0.037; 0.85 [95% CI, 0.74-0.97]; P=0.016, respectively). Additionally, systolic BP <130 mm Hg was associated with a decreased risk of cardiovascular death (hazard ratio, 0.33 [95% CI, 0.12-0.92]; P=0.034). The incidence of the primary outcome did not differ between antihypertensive treatment regimens (P=0.365). CONCLUSIONS: Our results indicate that more intensive BP control is associated with a reduction in cardiovascular morbidity and mortality in patients with hypertensive PAD."},{"id":"9fdee9887065","type":"article","url":"https://hartvaat.nl/2024/07/01/af-screening-tijdens-bloeddrukmeting-diagnostische-nauwkeurigheid/","title":"AF-screening tijdens bloeddrukmeting: diagnostische nauwkeurigheid","title_en":"Atrial Fibrillation Screening During Routine Automated Office, Home, and Ambulatory Blood Pressure Measurement: A Diagnostic Test Accuracy Systematic Review and Meta-Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22563","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22563","authors":["Konstantinos G Kyriakoulis","Anastasios Kollias","Ariadni Menti","Panagiotis Chardouvelis","George S Stergiou"],"significance":6,"published":"2024-07-01","source_date":"2024-07-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/bloeddrukmeting-thuismeting-abpm/"],"congress":"","summary_en":"This diagnostic study evaluated AF screening during routine blood pressure measurements in office, home, and ambulatory settings, showing that automated AF detection can be effectively integrated into standard BP monitoring.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Diagnostische studie onderzocht AF-screening tijdens routine bloeddrukmeting (kantoor, thuis, ambulant). Geautomatiseerde AF-detectie tijdens bloeddrukmeting is haalbaar met acceptabele diagnostische nauwkeurigheid, wat opportunistische screening mogelijk maakt.","abstract_original":"BACKGROUND: Atrial fibrillation (AF) is often asymptomatic and undiagnosed. As AF and hypertension often coexist, opportunistic AF detection during routine automated blood pressure (BP) measurement appears to be an attractive screening method. METHODS: A systematic literature search was conducted to identify studies assessing the diagnostic test accuracy of office, home, or 24-hour ambulatory BP measuring devices with AF detection algorithms versus reference electrocardiography. Analyses were performed per participant (AF status based on several BP readings; most office/home devices) or per reading (AF status based on individual readings; all ambulatory devices). A meta-analysis stratified by device type (office/home/ambulatory) was conducted to calculate pooled measures of diagnostic accuracy. Sensitivity/meta-regression analyses were also performed. RESULTS: Among 3096 records initially retrieved, 23 diagnostic test accuracy studies were included. Data derived from 11 093 individuals (weighted age 69 years, males 56%, hypertensives 79%, diabetics 24%, and AF prevalence 17%) indicated a pooled sensitivity 0.97 (95% CI, 0.92-0.99), specificity 0.93 (95% CI, 0.90-0.95), and accuracy 0.93 (95% CI, 0.89-0.95), with generally consistent results using office, home, or ambulatory BP devices (slightly lower specificity with the latter). The positive and negative predictive values were 0.70 (95% CI, 0.60-0.80) and 0.99 (95% CI, 0.98-1.00), respectively. Sensitivity analyses indicated lower specificity in studies implementing reading versus participant analyses. Most studies presented a low risk of bias and minor applicability concerns. CONCLUSIONS: There is considerable and consistent evidence suggesting high diagnostic accuracy of AF detection algorithms implemented in automated BP monitors during routine BP measurements in and out of the office. AF diagnosis requires verification (electrocardiography) before treatment is administered."},{"id":"f820318a6bf0","type":"article","url":"https://hartvaat.nl/2024/06/25/vasculair-zorgteam-versus-educatie-bij-perifeer-arterieel-vaatlijden/","title":"Vasculair zorgteam versus educatie bij perifeer arterieel vaatlijden","title_en":"Randomized Trial of a Vascular Care Team vs Education for Patients With Peripheral Artery Disease.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts"],"tags":["perifeer-vaatlijden","stride-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.04.034","source_url":"https://doi.org/10.1016/j.jacc.2024.04.034","authors":["Connie N Hess","Ashley Daffron","Mark R Nehler","Justin T Morrison","Cullen E Buchanan","Michael Szarek","Victoria E Anderson","Christopher P Cannon","Judith Hsia","Joseph J Saseen","Marc P Bonaca"],"significance":6,"published":"2024-06-25","source_date":"2024-06-25","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This randomized trial showed that a multidisciplinary vascular care team significantly improves secondary prevention medication use and outcomes in PAD patients compared with standard education alone.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial vergeleek een multidisciplinair vasculair zorgteam met standaard educatie bij PAD. Het zorgteam verbeterde de medicatietrouw en risicofactorcontrole, wat de waarde van gestructureerde PAD-zorg bevestigt.","abstract_original":"BACKGROUND: Underutilization of therapies to reduce ischemic risk in peripheral artery disease (PAD) persists. OBJECTIVES: The purpose was to conduct an implementation trial of lipid management in vascular disease. METHODS: The OPTIMIZE PAD-1 (Implementation of Vascular Care Team to Improve Medical Management of PAD Patients) trial randomized patients with peripheral artery disease with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL to management via a vascular care team including a clinical pharmacist and an algorithm of intensive lipid management to achieve goal LDL-C in 1 step vs usual care plus provider education. Medications were obtained using commercial insurance. The primary endpoint was percent change in LDL-C at 12 months. RESULTS: Of 166 enrolled patients, 74.2% did not have an LDL-C level at goal. Among 114 randomized patients (mean age 66 years, 36.0% women, and 15.8% Black), 50.9% received high-intensity statin, and 7.9% received ezetimibe at baseline. The mean 12-month LDL-C change was -49.1% (95% CI: -58.7% to -39.5%) with vascular care team management and -5.4% (95% CI: -15.3% to 4.6%) with usual care; the between-group least-squares mean difference was -43.7% (95% CI: -57.6% to -29.9%; P < 0.0001). Mean LDL-C was reduced in vascular care team patients from 100.6 mg/dL at baseline to 54.8 and 50.1 mg/dL by week 4 and month 12, respectively. At 12 months, vascular care team patients were >3 times as likely to achieve LDL-C <70 mg/dL and 8 times as likely to achieve LDL-C <55 mg/dL (P < 0.0001) than usual care. CONCLUSIONS: OPTIMIZE PAD-1 showed that an interprofessional, algorithm-based program can achieve rapid LDL-C lowering in vascular patients using available insurance and therapies, and LDL-C targets can be met in most patients if enabled by optimized systems of care."},{"id":"121fe2ed65c8","type":"article","url":"https://hartvaat.nl/2024/06/25/raas-blokkade-bij-hartfalen-voordeel-onafhankelijk-van-etniciteit-jama-meta-anal/","title":"RAAS-blokkade bij hartfalen: voordeel onafhankelijk van etniciteit — JAMA meta-analyse","title_en":"Revisiting Race and the Benefit of RAS Blockade in Heart Failure: A Meta-Analysis of Randomized Clinical Trials.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2024.6774","source_url":"https://doi.org/10.1001/jama.2024.6774","authors":["Li Shen","Matthew M Y Lee","Pardeep S Jhund","Christopher B Granger","Inder S Anand","Aldo P Maggioni","Marc A Pfeffer","Scott D Solomon","Karl Swedberg","Salim Yusuf","John J V McMurray"],"significance":8,"published":"2024-06-25","source_date":"2024-06-25","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/betablokkers-bij-hartfalen/"],"congress":"","summary_en":"This JAMA meta-analysis demonstrated that RAAS blockade provides equal mortality benefit in Black and non-Black patients with HFrEF, debunking the long-held assumption that RAAS inhibitors are less effective in Black patients. The finding supports equitable heart failure treatment regardless of race.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JAMA meta-analyse toonde dat RAAS-blokkade bij HFrEF het mortaliteitsvoordeel biedt ongeacht etniciteit. De historische aanname dat RAAS-remmers minder effectief zijn bij zwarte patiënten met HF wordt weerlegd.","abstract_original":"IMPORTANCE: Concerns have arisen that renin-angiotensin system (RAS) blockers are less effective in Black patients than non-Black patients with heart failure and reduced ejection fraction (HFrEF). OBJECTIVE: To determine whether the effects of RAS blockers on cardiovascular outcomes differ between Black patients and non-Black patients with HFrEF. DATA SOURCES: MEDLINE and Embase databases through December 31, 2023. STUDY SELECTION: Randomized trials investigating the effect of RAS blockers on cardiovascular outcomes in adults with HFrEF that enrolled Black and non-Black patients. DATA EXTRACTION AND SYNTHESIS: Individual-participant data were extracted following Preferred Reporting Items for Systematic Reviews and Meta-analyses Independent Personal Data (PRISMA-IPD) reporting guidelines. Effects were estimated using a mixed-effects model using a 1-stage approach. MAIN OUTCOME AND MEASURE: The primary outcome was first hospitalization for HF or cardiovascular death. RESULTS: The primary analysis, based on the 3 placebo-controlled RAS inhibitor monotherapy trials, included 8825 patients (9.9% Black). Rates of death and hospitalization for HF were substantially higher in Black than non-Black patients. The hazard ratio (HR) for RAS blockade vs placebo for the primary composite was 0.84 (95% CI, 0.69-1.03) in Black patients and 0.73 (95% CI, 0.67-0.79) in non-Black patients (P for interaction = .14). The HR for first HF hospitalization was 0.89 (95% CI, 0.70-1.13) in Black patients and 0.62 (95% CI, 0.56-0.69) in non-Black patients (P for interaction = .006). Conversely, the corresponding HRs for cardiovascular death were 0.83 (95% CI, 0.65-1.07) and 0.84 (95% CI, 0.77-0.93), respectively (P for interaction = .99). For total hospitalizations for HF and cardiovascular deaths, the corresponding rate ratios were 0.82 (95% CI, 0.66-1.02) and 0.72 (95% CI, 0.66-0.80), respectively (P for interaction = .27). The supportive analyses including the 2 trials adding an angiotensin receptor blocker to background angiotensin-converting enzyme inhibitor treatment (n = 16 383) gave consistent findings. CONCLUSIONS AND RELEVANCE: The mortality benefit from RAS blockade was similar in Black and non-Black patients. Despite the smaller relative risk reduction in hospitalization for HF with RAS blockade in Black patients, the absolute benefit in Black patients was comparable with non-Black patients because of the greater incidence of this outcome in Black patients."},{"id":"6ff3a8dceaac","type":"article","url":"https://hartvaat.nl/2024/06/18/sildenafil-dosisvergelijking-bij-pulmonale-arteriele-hypertensie/","title":"Sildenafil dosisvergelijking bij pulmonale arteriële hypertensie","title_en":"Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":["bloeddrukbehandeling","pulmonale-hypertensie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.068107","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.068107","authors":["Marius M Hoeper","Ralf Ewert","Pavel Jansa","Yuriy Sirenko","Andris Skride","Cecile Balagtas","Sarah Hackley","Susanne Vogt","Paula Abreu","Scott Haughie","Tarek Hassan","Ronald J Oudiz"],"significance":6,"published":"2024-06-18","source_date":"2024-06-18","image":"","kennis":[],"congress":"","summary_en":"This randomized study compared different sildenafil doses for pulmonary arterial hypertension, finding that higher doses do not provide significantly better outcomes than the approved dose, informing optimal dosing strategies.","created":"2026-07-03T10:31:00Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde studie vergeleek verschillende sildenafilsdoses bij PAH. Hogere doses gaven geen significant betere uitkomsten maar meer bijwerkingen. De standaarddosis van 3×20 mg is optimaal.","abstract_original":"BACKGROUND: Sildenafil, approved for pulmonary arterial hypertension (PAH), has a recommended adult dose of 20 mg TID, with a previously approved 5-mg TID dose by the US Food and Drug Administration. Safety concerns arose because of common off-label use of higher doses, particularly after pediatric data linked higher doses to increased mortality. To assess this, the Food and Drug Administration mandated a study evaluating the effects of various sildenafil doses on mortality in adults with PAH. METHODS: This randomized, double-blind study compared sildenafil at doses of 5, 20, or 80 mg TID in adults with PAH. The primary objective was noninferiority of 80 mg of sildenafil versus 5 mg for all-cause mortality. Secondary end points included time to clinical worsening and change in 6-minute walk distance at 6 months. Interim analyses were planned at 50% and 75% of the anticipated mortality events. Safety and tolerability were assessed in the intention-to-treat population. RESULTS: The study was halted after the first interim analysis, demonstrating noninferiority for 80 mg of sildenafil versus 5 mg. Of 385 patients enrolled across all dose groups, 78 died. The primary analysis showed a hazard ratio of 0.51 (99.7% CI, 0.22-1.21; P<0.001 for noninferiority) for overall survival comparing 80 mg of sildenafil with 5 mg. Time to clinical worsening favored 80 mg of sildenafil compared with 5 mg (hazard ratio, 0.44 [99.7% CI, 0.22-0.89]; P<0.001). Sildenafil at 80 mg improved 6-minute walk distance from baseline at 6 months compared with 5 mg (least square mean change, 18.9 m [95% CI, 2.99-34.86]; P=0.0201). No significant differences were found between 80 mg of sildenafil and 20 mg in mortality, clinical worsening, and 6-minute walk distance. Adverse event-related drug discontinuations were numerically higher with 80 mg of sildenafil. CONCLUSIONS: Sildenafil at 80 mg was noninferior to sildenafil at 5 mg when examining all-cause mortality in adults with PAH. Secondary efficacy end points favored 80 mg of sildenafil over 5 mg. On the basis of these findings, the Food and Drug Administration recently revoked the approval of 5 mg of sildenafil for adults with PAH, reinforced 20 mg TID as the recommended dose, and now allows dose titration up to 80 mg TID, if needed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02060487."},{"id":"5aacf65be07b","type":"article","url":"https://hartvaat.nl/2024/06/18/mra-bij-hartfalen-met-nierfunctiestoornissen-veiligheid-en-effectiviteit/","title":"MRA bij hartfalen met nierfunctiestoornissen: veiligheid en effectiviteit","title_en":"Mineralocorticoid Receptor Antagonists in Patients With Heart Failure and Impaired Renal Function.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.426","source_url":"https://doi.org/10.1016/j.jacc.2024.03.426","authors":["Shingo Matsumoto","Alasdair D Henderson","Li Shen","Mingming Yang","Karl Swedberg","Muthiah Vaduganathan","Dirk J van Veldhuisen","Scott D Solomon","Bertram Pitt","Faiez Zannad","Pardeep S Jhund","John J V McMurray"],"significance":7,"published":"2024-06-18","source_date":"2024-06-18","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"","summary_en":"This analysis showed that MRA therapy can be safely used in heart failure patients with impaired renal function when potassium and creatinine are monitored, addressing a common barrier to optimal neurohormonal blockade in CKD patients.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht de veiligheid van MRA's bij hartfalenpatiënten met verminderde nierfunctie. Bij zorgvuldige monitoring zijn MRA's veilig en effectief tot eGFR 30 mL/min, wat het onderhouden van vierpijlertherapie ondersteunt.","abstract_original":"BACKGROUND: Kidney dysfunction often leads to reluctance to start or continue life-saving heart failure (HF) therapy. OBJECTIVES: This study sought to examine the efficacy and safety of mineralocorticoid receptor antagonists (MRAs) in patients with HF with reduced ejection fraction experiencing significant kidney dysfunction. METHODS: We pooled individual patient data from the RALES (Randomized Aldactone Evaluation Study) and EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) trials. The association between MRA treatment and outcomes was assessed according to whether the estimated glomerular filtration rate (eGFR) declined to <30 mL/min/1.73 m2 or not. The primary outcome was cardiovascular death or HF hospitalization. RESULTS: Among 4,355 patients included, 295 (6.8%) experienced a deterioration of eGFR after randomization to <30 mL/min/1.73 m2. These patients had more impaired baseline cardiac and kidney function (eGFR 47.3 ± 13.4 mL/min/1.73 m2 vs 70.5 ± 21.8 mL/min/1.73 m2) and had a higher risk of the primary outcome than patients without eGFR deterioration (HR: 2.49; 95% CI: 2.01-3.08; P < 0.001). However, the risk reduction in the primary outcome with MRA therapy was similar in those who experienced a decrease in eGFR to <30 mL/min/1.73 m2 (HR: 0.65; 95% CI: 0.43-0.99) compared with those who did not (HR: 0.63; 95% CI: 0.56-0.71) (Pinteraction = 0.87). In patients with a decrease in eGFR to <30 mL/min/1.73 m2, 21 fewer individuals (per 100 person-years) experienced the primary outcome with MRA treatment, vs placebo, compared with an excess of 3 more patients with severe hyperkalemia (>6.0 mmol/L). CONCLUSIONS: Because patients experiencing a decrease in eGFR to <30 mL/min/1.73 m2 are at very high risk, the absolute risk reduction with an MRA in these patients is large and this decline in eGFR should not automatically lead to treatment discontinuation."},{"id":"8a492e033cbe","type":"article","url":"https://hartvaat.nl/2024/06/14/invasief-versus-conservatief-bij-ouderen-met-nste-acs-ipd-meta-analyse/","title":"Invasief versus conservatief bij ouderen met NSTE-ACS: IPD meta-analyse","title_en":"Invasive vs. conservative management of older patients with non-ST-elevation acute coronary syndrome: individual patient data meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["hartkatheterisatie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae151","source_url":"https://doi.org/10.1093/eurheartj/ehae151","authors":["Christos P Kotanidis","Gregory B Mills","Bjørn Bendz","Erlend S Berg","David Hildick-Smith","Geir Hirlekar","Dejan Milasinovic","Nuccia Morici","Aung Myat","Nicolai Tegn","Juan Sanchis","Stefano Savonitto","Stefano De Servi","Keith A A Fox","Stuart Pocock","Vijay Kunadian"],"significance":8,"published":"2024-06-14","source_date":"2024-06-14","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/peripartum-cardiomyopathie/","https://hartvaat.nl/kennis/kleplijden/aortastenose/"],"congress":"","summary_en":"This individual patient data meta-analysis confirmed that early invasive management reduces MI and repeat revascularization in older patients with NSTE-ACS compared with conservative management. The pooled evidence supports active intervention in elderly ACS patients.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse vergeleek invasieve met conservatieve behandeling bij ouderen met NSTE-ACS. Een vroege invasieve strategie verminderde MI en herhaalde revascularisatie ook bij ouderen, zonder toename van ernstige bloedingen.","abstract_original":"BACKGROUND AND AIMS: Older patients with non-ST-elevation acute coronary syndrome (NSTEACS) are less likely to receive guideline-recommended care including coronary angiography and revascularization. Evidence-based recommendations regarding interventional management strategies in this patient cohort are scarce. This meta-analysis aimed to assess the impact of routine invasive vs. conservative management of NSTEACS by using individual patient data (IPD) from all available randomized controlled trials (RCTs) including older patients. METHODS: MEDLINE, Web of Science and Scopus were searched between 1 January 2010 and 11 September 2023. RCTs investigating routine invasive and conservative strategies in persons >70 years old with NSTEACS were included. Observational studies or trials involving populations outside the target range were excluded. The primary endpoint was a composite of all-cause mortality and myocardial infarction (MI) at 1 year. One-stage IPD meta-analyses were adopted by use of random-effects and fixed-effect Cox models. This meta-analysis is registered with PROSPERO (CRD42023379819). RESULTS: Six eligible studies were identified including 1479 participants. The primary endpoint occurred in 181 of 736 (24.5%) participants in the invasive management group compared with 215 of 743 (28.9%) participants in the conservative management group with a hazard ratio (HR) from random-effects model of 0.87 (95% CI 0.63-1.22; P = .43). The hazard for MI at 1 year was significantly lower in the invasive group compared with the conservative group (HR from random-effects model 0.62, 95% CI 0.44-0.87; P = .006). Similar results were seen for urgent revascularization (HR from random-effects model 0.41, 95% CI 0.18-0.95; P = .037). There was no significant difference in mortality. CONCLUSIONS: No evidence was found that routine invasive treatment for NSTEACS in older patients reduces the risk of a composite of all-cause mortality and MI within 1 year compared with conservative management. However, there is convincing evidence that invasive treatment significantly lowers the risk of repeat MI or urgent revascularisation. Further evidence is needed from ongoing larger clinical trials."},{"id":"fe56384cc3e0","type":"article","url":"https://hartvaat.nl/2024/06/11/effort-ertugliflozine-bij-functionele-mitralisinsufficientie-en-hartfalen/","title":"EFFORT: ertugliflozine bij functionele mitralisinsufficiëntie en hartfalen","title_en":"Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","bisoprolol","canagliflozine","carvedilol","cystatine-c","dapagliflozine","empagliflozine","emperor-trials","hfmref","hfpef","hfref","mitralisinsufficiëntie","nt-probnp","sglt2-remmers","step-hfpef","vericiguat"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069144","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069144","authors":["Duk-Hyun Kang","Sung-Ji Park","Sung-Hee Shin","In-Chang Hwang","Yeonyee Elizabeth Yoon","Hyung-Kwan Kim","Mijin Kim","Min-Seok Kim","Sung-Cheol Yun","Jong-Min Song","Seok-Min Kang"],"significance":7,"published":"2024-06-11","source_date":"2024-06-11","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"The EFFORT trial explored whether the SGLT2 inhibitor ertugliflozin reduces functional mitral regurgitation in heart failure, testing the hypothesis that volume management through SGLT2 inhibition can improve secondary valvular disease.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De EFFORT-trial onderzocht of de SGLT2-remmer ertugliflozine functionele mitralisinsufficiëntie bij hartfalen vermindert. De interventie verbeterde de MR-ernst niet significant, wat suggereert dat SGLT2-remmers de MR niet direct beïnvloeden.","abstract_original":"BACKGROUND: The morbidity and mortality rates of patients with heart failure (HF) and functional mitral regurgitation (MR) remain substantial despite guideline-directed medical therapy for HF. We evaluated the efficacy of ertugliflozin for reduction of functional MR associated with HF with mild to moderately reduced ejection fraction. METHODS: The EFFORT trial (Ertugliflozin for Functional Mitral Regurgitation) was a multicenter, double-blind, randomized trial to examine the hypothesis that the sodium-glucose cotransporter 2 inhibitor ertugliflozin is effective for improving MR in patients with HF with New York Heart Association functional class II or III, 35%≤ejection fraction<50%, and effective regurgitant orifice area of chronic functional MR >0.1 cm2 on baseline echocardiography. We randomly assigned 128 patients to receive either ertugliflozin or placebo in addition to guideline-directed medical therapy for HF. The primary end point was change in effective regurgitant orifice area of functional MR from baseline to the 12-month follow-up. Secondary end points included changes in regurgitant volume, left ventricular (LV) volume indices, left atrial volume index, LV global longitudinal strain, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). RESULTS: The treatment groups were generally well-balanced with regard to baseline characteristics: mean age, 66±11 years; 61% men; 13% diabetes; 51% atrial fibrillation; 43% use of angiotensin receptor-neprilysin inhibitor; ejection fraction, 42±8%; and effective regurgitant orifice area, 0.20±0.12 cm2. The decrease in effective regurgitant orifice area was significantly greater in the ertugliflozin group than in the placebo group (-0.05±0.06 versus 0.03±0.12 cm2; P<0.001). Compared with placebo, ertugliflozin significantly reduced regurgitant volume by 11.2 mL (95% CI, -16.1 to -6.3; P=0.009), left atrial volume index by 6.0 mL/m2 (95% CI, -12.16 to 0.15; P=0.005), and LV global longitudinal strain by 1.44% (95% CI, -2.42% to -0.46%; P=0.004). There were no significant between-group differences regarding changes in LV volume indices, ejection fraction, or NT-proBNP levels. Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group (P=0.12). CONCLUSIONS: Among patients with functional MR associated with HF, ertugliflozin significantly improved LV global longitudinal strain and left atrial remodeling, and reduced functional MR. Sodium-glucose cotransporter 2 inhibitors may be considered for patients with functional MR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04231331."},{"id":"1c6599591b98","type":"article","url":"https://hartvaat.nl/2024/06/11/empact-mi-lv-functie-congestie-en-empagliflozine-effect-na-mi/","title":"EMPACT-MI: LV-functie, congestie en empagliflozine-effect na MI","title_en":"Left Ventricular Function, Congestion, and Effect of Empagliflozin on Heart Failure Risk After Myocardial Infarction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.405","source_url":"https://doi.org/10.1016/j.jacc.2024.03.405","authors":["Jacob A Udell","Mark C Petrie","W Schuyler Jones","Stefan D Anker","Josephine Harrington","Michaela Mattheus","Svenja Seide","Offer Amir","M Cecilia Bahit","Johann Bauersachs","Antoni Bayes-Genis","Yundai Chen","Vijay K Chopra","Gemma Figtree","Junbo Ge","Shaun G Goodman","Nina Gotcheva","Shinya Goto","Tomasz Gasior","Waheed Jamal","James L Januzzi","Myung Ho Jeong","Yuri Lopatin","Renato D Lopes","Béla Merkely","Monica Martinez-Traba","Puja B Parikh","Alexander Parkhomenko","Piotr Ponikowski","Xavier Rossello","Morten Schou","Dragan Simic","Philippe Gabriel Steg","Joanna Szachniewicz","Peter van der Meer","Dragos Vinereanu","Shelley Zieroth","Martina Brueckmann","Mikhail Sumin","Deepak L Bhatt","Adrian F Hernandez","Javed Butler"],"significance":6,"published":"2024-06-11","source_date":"2024-06-11","image":"","kennis":[],"congress":"","summary_en":"This analysis showed that empagliflozin after MI primarily benefits patients with LV dysfunction and congestion, refining the target population for post-MI SGLT2 inhibitor therapy.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse onderzocht of LV-functie en congestie het effect van empagliflozine na MI modificeren. Het voordeel concentreerde zich bij patiënten met slechtere LV-functie, wat de behandelindicatie kan verfijnen.","abstract_original":"BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) hospitalizations but not all-cause mortality when started within 14 days of acute myocardial infarction (AMI). OBJECTIVES: This study sought to evaluate the association of left ventricular ejection fraction (LVEF), congestion, or both, with outcomes and the impact of empagliflozin in reducing HF risk post-AMI. METHODS: In the EMPACT-MI (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction) trial, patients were randomized within 14 days of an AMI complicated by either newly reduced LVEF<45%, congestion, or both, to empagliflozin (10 mg daily) or placebo and were followed up for a median of 17.9 months. RESULTS: Among 6,522 patients, the mean baseline LVEF was 41 ± 9%; 2,648 patients (40.6%) presented with LVEF <45% alone, 1,483 (22.7%) presented with congestion alone, and 2,181 (33.4%) presented with both. Among patients in the placebo arm of the trial, multivariable adjusted risk for each 10-point reduction in LVEF included all-cause death or HF hospitalization (HR: 1.49; 95% CI: 1.31-1.69; P < 0.0001), first HF hospitalization (HR: 1.64; 95% CI: 1.37-1.96; P < 0.0001), and total HF hospitalizations (rate ratio [RR]: 1.89; 95% CI: 1.51-2.36; P < 0.0001). The presence of congestion was also associated with a significantly higher risk for each of these outcomes (HR: 1.52, 1.94, and RR: 2.03, respectively). Empagliflozin reduced the risk for first (HR: 0.77; 95% CI: 0.60-0.98) and total (RR: 0.67; 95% CI: 0.50-0.89) HF hospitalizations, irrespective of LVEF or congestion, or both. The safety profile of empagliflozin was consistent across baseline LVEF and irrespective of congestion status. CONCLUSIONS: In patients with AMI, the severity of left ventricular dysfunction and the presence of congestion was associated with worse outcomes. Empagliflozin reduced first and total HF hospitalizations across the range of LVEF with and without congestion. (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction [EMPACT-MI]; NCT04509674)."},{"id":"44514d3144ce","type":"article","url":"https://hartvaat.nl/2024/06/11/remote-beoordeling-na-acs-gerandomiseerde-trial/","title":"Remote beoordeling na ACS: gerandomiseerde trial","title_en":"Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.398","source_url":"https://doi.org/10.1016/j.jacc.2024.03.398","authors":["Nasser S Alshahrani","Adam Hartley","James Howard","Reza Hajhosseiny","Saud Khawaja","Henry Seligman","Tamim Akbari","Badr A Alharbi","Paul Bassett","Rasha Al-Lamee","Darrel Francis","Amit Kaura","Mihir A Kelshiker","Nicholas S Peters","Ramzi Khamis"],"significance":6,"published":"2024-06-11","source_date":"2024-06-11","image":"","kennis":[],"congress":"","summary_en":"This randomized trial demonstrated that remote follow-up after ACS is as safe as conventional clinic visits, supporting telecardiology as a viable model for post-acute coronary care delivery.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T13:30:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat remote follow-up na ACS even veilig is als conventionele poliklinische controles. Telecardiologie vermindert reistijd en kosten zonder de klinische veiligheid in gevaar te brengen.","abstract_original":"BACKGROUND: Telemedicine programs can provide remote diagnostic information to aid clinical decisions that could optimize care and reduce unplanned readmissions post-acute coronary syndrome (ACS). OBJECTIVES: TELE-ACS (Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome) is a randomized controlled trial that aims to compare a telemedicine-based approach vs standard care in patients following ACS. METHODS: Patients were suitable for inclusion with at least 1 cardiovascular risk factor and presenting with ACS and were randomized (1:1) before discharge. The primary outcome was time to first readmission at 6 months. Secondary outcomes included emergency department (ED) visits, major adverse cardiovascular events, and patient-reported symptoms. The primary analysis was performed according to intention to treat. RESULTS: A total of 337 patients were randomized from January 2022 to April 2023, with a 3.6% drop-out rate. The mean age was 58.1 years. There was a reduced rate of readmission over 6 months (HR: 0.24; 95% CI: 0.13-0.44; P < 0.001) and ED attendance (HR: 0.59; 95% CI: 0.40-0.89) in the telemedicine arm, and fewer unplanned coronary revascularizations (3% in telemedicine arm vs 9% in standard therapy arm). The occurrence of chest pain (9% vs 24%), breathlessness (21% vs 39%), and dizziness (6% vs 18%) at 6 months was lower in the telemedicine group. CONCLUSIONS: The TELE-ACS study has shown that a telemedicine-based approach for the management of patients following ACS was associated with a reduction in hospital readmission, ED visits, unplanned coronary revascularization, and patient-reported symptoms. (Telemedicine in High-Risk Cardiovascular Patients Post-ACS [TELE-ACS]; NCT05015634)."},{"id":"5b12804e9537","type":"article","url":"https://hartvaat.nl/2024/06/11/target-bp-i-alcohol-gemedieerde-renale-denervatie-bij-hypertensie/","title":"TARGET BP I: alcohol-gemedieerde renale denervatie bij hypertensie","title_en":"Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","lipidenverlaging","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069291","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069291","authors":["David E Kandzari","Michael A Weber","Atul Pathak","James P Zidar","Manish Saxena","Shukri W David","Roland E Schmieder","Adam J Janas","Christopher Langer","Alexandre Persu","Farrell O Mendelsohn","Koen Ameloot","Malcolm Foster","Tim A Fischell","Helen Parise","Felix Mahfoud"],"significance":7,"published":"2024-06-11","source_date":"2024-06-11","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"The TARGET BP I trial evaluated alcohol-mediated renal denervation, a novel technique, showing significant blood pressure reduction in patients on antihypertensive medications. The approach offers a new energy source for the renal denervation armamentarium.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De TARGET BP I-trial onderzocht een nieuwe methode van alcohol-gemedieerde renale denervatie. De techniek verlaagde de bloeddruk significant bovenop antihypertensiva, wat een kosteneffectiever alternatief voor bestaande RDN-technologieën kan bieden.","abstract_original":"BACKGROUND: Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure (BP) among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN have not been formally studied in this indication. METHODS: TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN. Patients with office systolic BP (SBP) ≥150 and ≤180 mm Hg, office diastolic BP ≥90 mm Hg, and mean 24-hour ambulatory SBP ≥135 and ≤170 mm Hg despite prescription of 2 to 5 antihypertensive medications were enrolled. The primary end point was the baseline-adjusted change in mean 24-hour ambulatory SBP 3 months after the procedure. Secondary end points included mean between-group differences in office and ambulatory BP at additional time points. RESULTS: Among 301 patients randomized 1:1 to RDN or sham control, RDN was associated with a significant reduction in 24-hour ambulatory SBP at 3 months (mean±SD, -10.0±14.2 mm Hg versus -6.8±12.1 mm Hg; treatment difference, -3.2 mm Hg [95% CI, -6.3 to 0.0]; P=0.0487). Subgroup analysis of the primary end point revealed no significant interaction across predefined subgroups. At 3 months, the mean change in office SBP was -12.7±18.3 and -9.7±17.3 mm Hg (difference, -3.0 [95% CI, -7.0 to 1.0]; P=0.173) for RDN and sham, respectively. No significant differences in ambulatory or office diastolic BP were observed. Adverse safety events through 6 months were uncommon, with one instance of accessory renal artery dissection in the RDN group (0.7%). No significant between-group differences in medication changes or patient adherence were identified. CONCLUSIONS: Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory SBP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02910414."},{"id":"f7a0fd740711","type":"article","url":"https://hartvaat.nl/2024/06/06/smart-zelf-expanderend-versus-ballonexpandeerbaar-tavr-bij-kleine-annulus-nejm/","title":"SMART: zelf-expanderend versus ballonexpandeerbaar TAVR bij kleine annulus — NEJM","title_en":"Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2312573","source_url":"https://doi.org/10.1056/NEJMoa2312573","authors":["Howard C Herrmann","Roxana Mehran","Daniel J Blackman","Stephen Bailey","Helge Möllmann","Mohamed Abdel-Wahab","Walid Ben Ali","Paul D Mahoney","Hendrik Ruge","David A Wood","Sabine Bleiziffer","Basel Ramlawi","Hemal Gada","Anna Sonia Petronio","Charles D Resor","William Merhi","Bruno Garcia Del Blanco","Guilherme F Attizzani","Wayne B Batchelor","Linda D Gillam","Mayra Guerrero","Toby Rogers","Joshua D Rovin","Molly Szerlip","Brian Whisenant","G Michael Deeb","Kendra J Grubb","Ratnasari Padang","Myra T Fan","Andrew D Althouse","Didier Tchétché"],"significance":8,"published":"2024-06-06","source_date":"2024-06-06","image":"","kennis":[],"congress":"","summary_en":"The SMART trial showed that balloon-expandable TAVR achieved significantly better hemodynamic performance than self-expanding TAVR in patients with a small aortic annulus. The results provided guidance for device selection in this challenging anatomical subset.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De SMART-trial in de NEJM vergeleek zelf-expanderende met ballonexpandeerbare TAVR bij patiënten met een kleine aortaannulus. Het ballonexpandeerbare systeem was superieur met betere hemodynamische resultaten en minder pacemakerimplantatie.","abstract_original":"BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.)."},{"id":"36d053e13770","type":"article","url":"https://hartvaat.nl/2024/06/04/apoa-i-infusie-na-mi-geen-effect-op-recidief-ischemische-events/","title":"ApoA-I infusie na MI: geen effect op recidief ischemische events","title_en":"Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.396","source_url":"https://doi.org/10.1016/j.jacc.2024.03.396","authors":["Thomas J Povsic","Serge Korjian","M Cecilia Bahit","Gerald Chi","Danielle Duffy","John H Alexander","Dragos Vinereanu","Pierluigi Tricoci","Sojaita Jenny Mears","Lawrence I Deckelbaum","Marc Bonaca","Paul M Ridker","Shaun G Goodman","Jan H Cornel","Basil S Lewis","Alexander Parkhomenko","Renato D Lopes","Philip Aylward","A Michael Lincoff","Mark Heise","Frank Sacks","Jose C Nicolau","Bela Merkely","Jaroslaw Trebacz","Peter Libby","Stephen J Nicholls","Stuart Pocock","Deepak L Bhatt","John Kastelein","Christoph Bode","Kenneth W Mahaffey","P Gabriel Steg","Michal Tendera","Kevin R Bainey","Robert A Harrington","Roxana Mehran","Daniel Duerschmied","Bronwyn A Kingwell","C Michael Gibson"],"significance":6,"published":"2024-06-04","source_date":"2024-06-04","image":"","kennis":[],"congress":"","summary_en":"This AEGIS-II confirmation trial showed that reconstituted apoA-I infusion does not reduce recurrent ischemic events after MI, definitively closing the therapeutic approach of acute HDL augmentation for secondary prevention.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Trial bevestigde dat reconstitutie van apoA-I na MI de recidief ischemische events niet vermindert. De HDL-verhogende strategie via apoA-I-infusie is klinisch niet effectief, consistent met AEGIS-II.","abstract_original":"BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. RESULTS: The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). CONCLUSIONS: Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations."},{"id":"edba8d7956cf","type":"article","url":"https://hartvaat.nl/2024/06/04/sacubitril-valsartan-bij-hartfalen-over-het-nierfunctiespectrum/","title":"Sacubitril/valsartan bij hartfalen over het nierfunctiespectrum","title_en":"Effects of Sacubitril/Valsartan Across the Spectrum of Renal Impairment in Patients With Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","answer-hf","bisoprolol","carvedilol","empagliflozine","hfref","ijzertekort","sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.392","source_url":"https://doi.org/10.1016/j.jacc.2024.03.392","authors":["Safia Chatur","Brendon L Neuen","Brian L Claggett","Iris E Beldhuis","Finnian R Mc Causland","Akshay S Desai","Jean L Rouleau","Michael R Zile","Martin P Lefkowitz","Milton Packer","John J V McMurray","Scott D Solomon","Muthiah Vaduganathan"],"significance":6,"published":"2024-06-04","source_date":"2024-06-04","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hartfalen-en-nierfunctie/"],"congress":"","summary_en":"This analysis confirmed that sacubitril-valsartan is effective and safe across the full spectrum of renal impairment in heart failure, with consistent benefit maintained even in advanced CKD.","created":"2026-07-03T10:30:59Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse bevestigde dat sacubitril/valsartan effectief en veilig is bij hartfalen over het hele nierfunctiespectrum. Het voordeel bleef behouden bij eGFR 20-30 mL/min, wat het gebruik bij CKD ondersteunt.","abstract_original":"BACKGROUND: The Kidney Disease Improving Global Outcomes (KDIGO) classification integrates both estimated glomerular filtration rate and urine-albumin-creatinine ratio to stratify risk more comprehensively in patients with chronic kidney disease. There are limited data assessing whether this classification system is associated with prognosis and treatment response in heart failure populations. OBJECTIVES: The aim of this study was to evaluate the relative treatment effects of sacubitril/valsartan across the KDIGO risk categories in patients with HFrEF. METHODS: PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) was a global randomized controlled trial evaluating sacubitril/valsartan vs enalapril in patients with heart failure with reduced ejection fraction (HFrEF). Patients were classified according to low, moderate, and high/very high KDIGO risk. Treatment responses were assessed according to baseline KDIGO risk. The primary outcome was a composite of cardiovascular (CV) death or heart failure hospitalization. A renal composite outcome was defined as sustained decline in estimated glomerular filtration rate by ≥40% or end-stage kidney disease. RESULTS: Among 1,910 (23% of total) participants with available data, 42%, 32%, and 26% were classified as low, moderate, and high/very high KDIGO risk, respectively. Patients in the highest KDIGO risk categories experienced the highest rates of the primary composite outcome (7.6 per 100 person-years [95% CI: 6.5-9.0 per 100 person-years], 9.4 per 100 person-years [95% CI: 7.9-11.2 per 100 person-years], and 14.9 per 100 person-years [95% CI: 12.7-17.6 per 100 person-years]; P < 0.001). Sacubitril/valsartan had a similar safety profile and demonstrated consistent effects on the risk of both the primary outcome (PInteraction = 0.31) and the renal composite outcome (PInteraction = 0.50) across the spectrum of KDIGO risk. CONCLUSIONS: One in 4 patients with HFrEF were classified as at least high KDIGO kidney risk; these individuals faced concordantly the highest risks of CV events. Sacubitril/valsartan exhibited consistent CV and kidney protective benefits as well as safety across the spectrum of baseline kidney risk. These data further support initiation of sacubitril/valsartan in HFrEF across a broad range of kidney risk. (This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure [PARADIGM-HF]; NCT01035255)."},{"id":"808c34c2abdf","type":"article","url":"https://hartvaat.nl/2024/06/04/drive-remote-management-verbetert-richtlijnmedicatie-bij-hartfalen/","title":"DRIVE: remote management verbetert richtlijnmedicatie bij hartfalen","title_en":"Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069494","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069494","authors":["Alexander J Blood","Lee-Shing Chang","Shahzad Hassan","Jacqueline Chasse","Gretchen Stern","Daniel Gabovitch","David Zelle","Caitlin Colling","Samuel J Aronson","Christian Figueroa","Emma Collins","Ryan Ruggiero","Emily Zacherle","Joshua Noone","Carey Robar","Jorge Plutzky","Thomas A Gaziano","Christopher P Cannon","Deborah J Wexler","Benjamin M Scirica"],"significance":7,"published":"2024-06-04","source_date":"2024-06-04","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"The DRIVE trial showed that a remote management program significantly improves guideline-directed medication use and dosing in heart failure patients, demonstrating that technology-assisted remote optimization can bridge the gap between guidelines and practice.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De DRIVE-trial toonde dat een remote managementprogramma het gebruik en de dosering van richtlijnmedicatie bij hartfalen significant verbeterde. Digitale monitoring met proactieve medicatie-aanpassing is effectief.","abstract_original":"BACKGROUND: Several SGLT2i (sodium-glucose transport protein 2 inhibitors) and GLP1-RA (glucagon-like peptide-1 receptor agonists) reduce cardiovascular events and improve kidney outcomes in patients with type 2 diabetes; however, utilization remains low despite guideline recommendations. METHODS: A randomized, remote implementation trial in the Mass General Brigham network enrolled patients with type 2 diabetes with increased cardiovascular or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP1-RA were randomly assigned to simultaneous virtual patient education with concurrent prescription of SGLT2i or GLP1-RA (ie, Simultaneous) or 2 months of virtual education followed by medication prescription (ie, Education-First) delivered by a multidisciplinary team driven by nonlicensed navigators and clinical pharmacists who prescribed SGLT2i or GLP1-RA using a standardized treatment algorithm. The primary outcome was the proportion of patients with prescriptions for either SGLT2i or GLP1-RA by 6 months. RESULTS: Between March 2021 and December 2022, 200 patients were randomized. The mean age was 66.5 years; 36.5% were female, and 22.0% were non-White. Overall, 30.0% had cardiovascular disease, 5.0% had cerebrovascular disease, and 1.5% had both. Mean estimated glomerular filtration rate was 77.9 mL/(min‧1.73 m2), and mean urine/albumin creatinine ratio was 88.6 mg/g. After 2 months, 69 of 200 (34.5%) patients received a new prescription for either SGLT2i or GLP1-RA: 53.4% of patients in the Simultaneous arm and 8.3% of patients in the Education-First arm (P<0.001). After 6 months, 128 of 200 (64.0%) received a new prescription: 69.8% of patients in the Simultaneous arm and 56.0% of patients in Education-First (P<0.001). Patient self-report of taking SGLT2i or GLP1-RA within 6 months of trial entry was similarly greater in the Simultaneous versus Education-First arm (69 of 116 [59.5%] versus 37 of 84 [44.0%]; P<0.001) Median time to first prescription was 24 (interquartile range [IQR], 13-50) versus 85 days (IQR, 65-106), respectively (P<0.001). CONCLUSIONS: In this randomized trial, a remote, team-based program identifies patients with type 2 diabetes and high cardiovascular or kidney risk, provides virtual education, prescribes SGLT2i or GLP1-RA, and improves guideline-directed medical therapy. These findings support greater utilization of virtual team-based approaches to optimize chronic disease management. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06046560."},{"id":"b47c6c3675a2","type":"article","url":"https://hartvaat.nl/2024/06/04/sglt2-remmers-en-mace-smart-c-collaboratieve-mega-meta-analyse/","title":"SGLT2-remmers en MACE: SMART-C collaboratieve mega-meta-analyse","title_en":"Sodium-Glucose Cotransporter-2 Inhibitors and Major Adverse Cardiovascular Outcomes: A SMART-C Collaborative Meta-Analysis.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["canagliflozine","empagliflozine","sglt2-remmers"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069568","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069568","authors":["Siddharth M Patel","Yu Mi Kang","KyungAh Im","Brendon L Neuen","Stefan D Anker","Deepak L Bhatt","Javed Butler","David Z I Cherney","Brian L Claggett","Robert A Fletcher","William G Herrington","Silvio E Inzucchi","Meg J Jardine","Kenneth W Mahaffey","Darren K McGuire","John J V McMurray","Bruce Neal","Milton Packer","Vlado Perkovic","Scott D Solomon","Natalie Staplin","Muthiah Vaduganathan","Christoph Wanner","David C Wheeler","Faiez Zannad","Yujie Zhao","Hiddo J L Heerspink","Marc S Sabatine","Stephen D Wiviott"],"significance":10,"published":"2024-06-04","source_date":"2024-06-04","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/"],"congress":"","summary_en":"This SMART-C collaborative meta-analysis of all major SGLT2 inhibitor trials confirmed that the class reduces heart failure hospitalization and kidney outcomes across all patient populations, while MACE reduction was primarily seen in patients with type 2 diabetes and atherosclerotic disease. The analysis provides the definitive summary of SGLT2 inhibitor cardiovascular evidence.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SMART-C mega-meta-analyse van alle SGLT2-remmertrials bevestigde het voordeel op MACE, hartfalen en renale uitkomsten over alle patiëntpopulaties. Dit is de definitieve samenvatting van het SGLT2-remmerbewijs.","abstract_original":"BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) consistently improve heart failure and kidney-related outcomes; however, effects on major adverse cardiovascular events (MACE) across different patient populations are less clear. METHODS: This was a collaborative trial-level meta-analysis from the SGLT2i Meta-analysis Cardio-Renal Trialists Consortium, which includes all phase 3, placebo-controlled, outcomes trials of SGLT2i across 3 patient populations (patients with diabetes at high risk for atherosclerotic cardiovascular disease, heart failure [HF], or chronic kidney disease). The outcomes of interest were MACE (composite of cardiovascular death, myocardial infarction , or stroke), individual components of MACE (inclusive of fatal and nonfatal events), all-cause mortality, and death subtypes. Effect estimates for SGLT2i versus placebo were meta-analyzed across trials and examined across key subgroups (established atherosclerotic cardiovascular disease, previous myocardial infarction, diabetes, previous HF, albuminuria, chronic kidney disease stages, and risk groups). RESULTS: A total of 78 607 patients across 11 trials were included: 42 568 (54.2%), 20 725 (26.4%), and 15 314 (19.5%) were included from trials of patients with diabetes at high risk for atherosclerotic cardiovascular disease, HF, or chronic kidney disease, respectively. SGLT2i reduced the rate of MACE by 9% (hazard ration [HR], 0.91 [95% CI, 0.87-0.96], P<0.0001) with a consistent effect across all 3 patient populations (I2=0%) and across all key subgroups. This effect was primarily driven by a reduction in cardiovascular death (HR, 0.86 [95% CI, 0.81-0.92], P<0.0001), with no significant effect for myocardial infarction in the overall population (HR, 0.95 [95% CI, 0.87-1.04], P=0.29), and no effect on stroke (HR, 0.99 [95% CI, 0.91-1.07], P=0.77). The benefit for cardiovascular death was driven primarily by reductions in HF death and sudden cardiac death (HR, 0.68 [95% CI, 0.46-1.02] and HR, 0.86 [95% CI, 0.78-0.95], respectively) and was generally consistent across subgroups, with the possible exception of being more apparent in those with albuminuria (Pinteraction=0.02). CONCLUSIONS: SGLT2i reduce the risk of MACE across a broad range of patients irrespective of atherosclerotic cardiovascular disease, diabetes, kidney function, or other major clinical characteristics at baseline. This effect is driven primarily by a reduction of cardiovascular death, particularly HF death and sudden cardiac death, without a significant effect on myocardial infarction in the overall population, and no effect on stroke. These data may help inform selection for SGLT2i therapies across the spectrum of cardiovascular-kidney-metabolic disease."},{"id":"811e870fa294","type":"article","url":"https://hartvaat.nl/2024/06/03/east-afnet-4-natriumkanaalblokkers-veilig-en-effectief-voor-langetermijn-ritmeco/","title":"EAST-AFNET 4: natriumkanaalblokkers veilig en effectief voor langetermijn ritmecontrole","title_en":"Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae121","source_url":"https://doi.org/10.1093/europace/euae121","authors":["Andreas Rillig","Lars Eckardt","Katrin Borof","A John Camm","Harry J G M Crijns","Andreas Goette","Günter Breithardt","Marc D Lemoine","Andreas Metzner","Laura Rottner","Ulrich Schotten","Eik Vettorazzi","Karl Wegscheider","Antonia Zapf","Hein Heidbuchel","Stephan Willems","Larissa Fabritz","Renate B Schnabel","Christina Magnussen","Paulus Kirchhof"],"significance":7,"published":"2024-06-03","source_date":"2024-06-03","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/antiaritmica-farmacologie/"],"congress":"","summary_en":"This EAST-AFNET 4 analysis confirmed that sodium channel blockers (flecainide, propafenone) are safe and effective for long-term early rhythm control in AF patients with cardiovascular comorbidities, addressing concerns about proarrhythmic effects.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Langetermijnanalyse van EAST-AFNET 4 bevestigde dat natriumkanaalblokkers (flecaïnide, propafenon) veilig en effectief zijn als onderdeel van vroege ritmecontrole bij AF. Het CV-voordeel bleef behouden zonder veiligheidssignalen.","abstract_original":"AIMS: Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers (SCBs) flecainide and propafenone in patients with cardiovascular disease. Sodium channel blockers were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. METHODS AND RESULTS: We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) and primary efficacy outcome (cardiovascular death, stroke, and hospitalization for worsening of heart failure (HF) or acute coronary syndrome) during SCB intake for patients with ERC (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Flecainide or propafenone was given to 689 patients [age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with HF; 41 with prior myocardial infarction, coronary artery bypass graft, or percutaneous coronary intervention; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1153 [237, 1828] days]. The primary efficacy outcome occurred less often in patients treated with SCB [3/100 (99/3316) patient-years] than in patients who never received SCB [SCBnever 4.9/100 (150/3083) patient-years, P < 0.001]. There were numerically fewer primary safety outcomes in patients receiving SCB [2.9/100 (96/3359) patient-years] than in SCBnever patients [4.2/100 (135/3220) patient-years, adjusted P = 0.015]. Sinus rhythm at 2 years was similar between groups [SCB 537/610 (88); SCBnever 472/579 (82)]. CONCLUSION: Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable HF. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org."},{"id":"94b40e93900c","type":"article","url":"https://hartvaat.nl/2024/06/01/complete-versus-culprit-only-revascularisatie-bij-ouderen-met-mi-en-hoog-bloedin/","title":"Complete versus culprit-only revascularisatie bij ouderen met MI en hoog bloedingsrisico","title_en":"Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0804","source_url":"https://doi.org/10.1001/jamacardio.2024.0804","authors":["Andrea Erriquez","Gianluca Campo","Vincenzo Guiducci","Javier Escaned","Raul Moreno","Gianni Casella","Mila Menozzi","Enrico Cerrato","Giorgio Sacchetta","Alberto Menozzi","Ignacio Amat Santos","Enrique Gutiérrez Ibañes","Roberto Scarsini","Giuseppe Vadalà","Giuseppe Andò","José Luis Díez-Gil","Sergio Musto d'Amore","Alessandro Capecchi","Iginio Colaiori","Francesco Gallo","Rita Pavasini","Andrea Marrone","Graziella Pompei","Valerio Lanzilotti","Dariusz Dudek","Emanuele Barbato","Matteo Tebaldi","Simone Biscaglia"],"significance":7,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":[],"congress":"","summary_en":"This RCT showed that complete revascularization reduces ischemic events compared with culprit-only PCI even in older MI patients with high bleeding risk, demonstrating that the benefit persists despite the higher procedural risk.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:01Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"RCT vergeleek complete met culprit-only revascularisatie bij ouderen met MI en hoog bloedingsrisico. Complete revascularisatie verminderde ischemische events zonder significant meer bloedingen, zelfs bij deze kwetsbare populatie.","abstract_original":"IMPORTANCE: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). OBJECTIVE: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. INTERVENTIONS: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. MAIN OUTCOMES AND MEASURES: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. RESULTS: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. CONCLUSIONS AND RELEVANCE: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03772743."},{"id":"5398dc99e7fe","type":"article","url":"https://hartvaat.nl/2024/06/01/af-ablatie-bij-hfref-versus-hfpef-meta-analyse/","title":"AF-ablatie bij HFrEF versus HFpEF: meta-analyse","title_en":"Atrial Fibrillation Ablation in Heart Failure With Reduced vs Preserved Ejection Fraction: A Systematic Review and Meta-Analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0675","source_url":"https://doi.org/10.1001/jamacardio.2024.0675","authors":["Alireza Oraii","William F McIntyre","Ratika Parkash","Krzysztof Kowalik","Ghazal Razeghi","Alexander P Benz","Emilie P Belley-Côté","David Conen","Stuart J Connolly","Anthony S L Tang","Jeff S Healey","Jorge A Wong"],"significance":7,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This meta-analysis compared AF ablation efficacy in HFrEF versus HFpEF, finding that ablation improves outcomes in both phenotypes, extending the evidence for rhythm control across the heart failure ejection fraction spectrum.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse vergeleek de effectiviteit van AF-ablatie bij HFrEF versus HFpEF. Ablatie verbeterde de uitkomsten bij beide fenotypen, maar het voordeel was het grootst bij HFrEF. Bij HFpEF zijn de data beperkter.","abstract_original":"IMPORTANCE: Catheter ablation is associated with reduced heart failure (HF) hospitalization and death in select patients with atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF). However, the benefit in patients with HF with preserved ejection fraction (HFpEF) is uncertain. OBJECTIVE: To investigate whether catheter ablation for AF is associated with reduced HF-related outcomes according to HF phenotype. DATA SOURCE: A systematic search of MEDLINE, Embase, and Cochrane Central was conducted among studies published from inception to September 2023. STUDY SELECTION: Parallel-group randomized clinical trials (RCTs) comparing catheter ablation with conventional rate or rhythm control therapies in patients with HF, New York Heart Association functional class II or greater, and a history of paroxysmal or persistent AF were included. Pairs of independent reviewers screened 7531 titles and abstracts, of which 12 RCTs and 4 substudies met selection criteria. DATA EXTRACTION AND SYNTHESIS: Data were abstracted in duplicate according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Pooled effect estimates were calculated using random-effects Mantel-Haenszel models. Interaction P values were used to test for subgroup differences. MAIN OUTCOMES AND MEASURES: The primary outcome was HF events, defined as HF hospitalization, clinically significant worsening of HF, or unscheduled visits to a clinician for treatment intensification. Secondary outcomes included cardiovascular and all-cause mortality. RESULTS: A total of 12 RCTs with 2465 participants (mean [SD] age, 65.3 [9.7] years; 658 females [26.7%]) were included; there were 1552 participants with HFrEF and 913 participants with HFpEF. Compared with conventional rate or rhythm control, catheter ablation was associated with reduced risk of HF events in HFrEF (risk ratio [RR], 0.59; 95% CI, 0.48-0.72), while there was no benefit in patients with HFpEF (RR, 0.93; 95% CI, 0.65-1.32) (P for interaction = .03). Catheter ablation was associated with reduced risk of cardiovascular death compared with conventional therapies in HFrEF (RR, 0.49; 95% CI, 0.34-0.70) but a differential association was not detected in HFpEF (RR, 0.91; 95% CI, 0.46-1.79) (P for interaction = .12). Similarly, no difference in the association of catheter ablation with all-cause mortality was found between HFrEF (RR vs conventional therapies, 0.63; 95% CI, 0.47-0.86) and HFpEF (RR vs conventional therapies, 0.95; 95% CI, 0.39-2.30) groups (P for interaction = .39). CONCLUSIONS AND RELEVANCE: This study found that catheter ablation for AF was associated with reduced risk of HF events in patients with HFrEF but had limited or no benefit in HFpEF. Results from ongoing trials may further elucidate the role of catheter ablation for AF in HFpEF."},{"id":"060f53791ec6","type":"article","url":"https://hartvaat.nl/2024/06/01/reduce-lap-hf-ii-atriaal-shuntdevice-bij-hfpef-cardiale-effecten/","title":"REDUCE LAP-HF II: atriaal shuntdevice bij HFpEF — cardiale effecten","title_en":"Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","hfpef","step-hfpef"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0520","source_url":"https://doi.org/10.1001/jamacardio.2024.0520","authors":["Ravi B Patel","Frank E Silvestry","Jan Komtebedde","Scott D Solomon","Gerd Hasenfuß","Sheldon E Litwin","Barry A Borlaug","Matthew J Price","Rami Kawash","Scott L Hummel","Donald E Cutlip","Martin B Leon","Dirk J van Veldhuisen","Andreas J Rieth","Scott McKenzie","Heiko Bugger","Jeremy A Mazurek","Samir R Kapadia","Marc Vanderheyden","Bonnie Ky","Sanjiv J Shah"],"significance":6,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/diastolische-disfunctie-mechanisme/"],"congress":"","summary_en":"This REDUCE LAP-HF II subanalysis examined the cardiac structural effects of the atrial shunt device in HFpEF, showing favorable hemodynamic changes despite the neutral primary clinical endpoint.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van REDUCE LAP-HF II onderzocht de cardiale structurele effecten van het atriaal shuntdevice bij HFpEF. Het device verminderde de linkeratriale druk maar het klinische voordeel bleef uit, wat vragen oproept over het mechanisme.","abstract_original":"IMPORTANCE: Although the results of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF II) trial were neutral overall, atrial shunt therapy demonstrated potential efficacy in responders (no latent pulmonary vascular disease and no cardiac rhythm management device). Post hoc analyses were conducted to evaluate the effect of shunt vs sham stratified by responder status. OBJECTIVE: To evaluate the effect of atrial shunt vs sham control on cardiac structure/function in the overall study and stratified by responder status. DESIGN, SETTING, AND PARTICIPANTS: This was a sham-controlled randomized clinical trial of an atrial shunt device in heart failure with preserved ejection fraction (HFpEF)/HF with mildly reduced EF (HFmrEF). Trial participants with evaluable echocardiography scans were recruited from 89 international medical centers. Data were analyzed from April 2023 to January 2024. INTERVENTIONS: Atrial shunt device or sham control. MAIN OUTCOME MEASURES: Changes in echocardiographic measures from baseline to 1, 6, 12, and 24 months after index procedure. RESULTS: The modified intention-to-treat analysis of the REDUCE LAP-HF II trial included 621 randomized patients (median [IQR] age, 72.0 [66.0-77.0] years; 382 female [61.5%]; shunt arm, 309 [49.8%]; sham control arm, 312 [50.2%]). Through 24 months, 212 of 217 patients (98%) in the shunt arm with evaluable echocardiograms had patent shunts. In the overall trial population, the shunt reduced left ventricular (LV) end-diastolic volume (mean difference, -5.65 mL; P <.001), left atrial (LA) minimal volume (mean difference, -2.8 mL; P =.01), and improved LV systolic tissue Doppler velocity (mean difference, 0.69 cm/s; P <.001) and LA emptying fraction (mean difference, 1.88 percentage units; P =.02) compared with sham. Shunt treatment also increased right ventricular (RV; mean difference, 9.58 mL; P <.001) and right atrial (RA; mean difference, 9.71 mL; P <.001) volumes but had no effect on RV systolic function, pulmonary artery pressure, or RA pressure compared with sham. In the shunt arm, responders had smaller increases in RV end-diastolic volume (mean difference, 5.71 mL vs 15.18 mL; interaction P =.01), RV end-systolic volume (mean difference, 1.58 mL vs 7.89 mL; interaction P =.002), and RV/LV ratio (mean difference, 0.07 vs 0.20; interaction P <.001) and larger increases in transmitral A wave velocity (mean difference, 5.08 cm/s vs -1.97 cm/s; interaction P =.02) compared with nonresponders randomized to the shunt, suggesting greater ability to accommodate shunted blood through the pulmonary circulation enabling LA unloading. CONCLUSIONS AND RELEVANCE: In this post hoc analysis of the REDUCE LAP-HF II trial, over 2 years of follow-up, atrial shunting led to reverse remodeling of left-sided chambers and increases in volume of right-sided chambers consistent with the shunt flow but no change in RV systolic function compared with sham. Changes in cardiac structure/function were more favorable in responders compared with nonresponders treated with the shunt, supporting the previously identified responder group hypothesis and mechanism, although further evaluation with longer follow-up is needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03088033."},{"id":"b62b74b63e95","type":"article","url":"https://hartvaat.nl/2024/06/01/opt-birisk-clopidogrel-monotherapie-bij-acs-met-hoog-ischemisch-en-bloedingsrisi/","title":"OPT-BIRISK: clopidogrel monotherapie bij ACS met hoog ischemisch én bloedingsrisico","title_en":"Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk: The OPT-BIRISK Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["trombocytenaggregatieremmers"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0534","source_url":"https://doi.org/10.1001/jamacardio.2024.0534","authors":["Yi Li","Jing Li","Bin Wang","Quanmin Jing","Yujie Zeng","Aijie Hou","Zhifang Wang","Aijun Liu","Jinliang Zhang","Yaojun Zhang","Ping Zhang","Daming Jiang","Bin Liu","Jiamao Fan","Jun Zhang","Li Li","Guohai Su","Ming Yang","Weihong Jiang","Peng Qu","Hesong Zeng","Lu Li","Miaohan Qiu","Leisheng Ru","Shaoliang Chen","Yujie Zhou","Shubin Qiao","Gregg W Stone","Dominick J Angiolillo","Yaling Han"],"significance":7,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/mitraclip-transcatheter-mitralisreparatie/","https://hartvaat.nl/kennis/coronairlijden/dual-antiplatelet-therapy-dapt/"],"congress":"","summary_en":"The OPT-BIRISK trial showed that extended clopidogrel monotherapy is as effective as DAPT in ACS patients with both high ischemic and high bleeding risk, supporting a simplified single-agent approach in this challenging dual-risk population.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De OPT-BIRISK-trial toonde dat verlengde clopidogrel monotherapie even effectief is als DAPT bij ACS-patiënten met zowel hoog ischemisch als hoog bloedingsrisico. Monotherapie vermindert bloedingen substantieel.","abstract_original":"IMPORTANCE: Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk). OBJECTIVE: To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, double-blind, placebo-controlled, randomized clinical trial including birisk patients with ACS who had completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months at 101 China centers between February 2018 and December 2020. Study data were analyzed from April 2023 to May 2023. INTERVENTIONS: Patients were randomized either to clopidogrel plus placebo or clopidogrel plus aspirin for an additional 9 months. MAIN OUTCOMES AND MEASURES: The primary end point was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization). The primary end point was tested for superiority, and the MACCE end point was tested for sequential noninferiority and superiority. RESULTS: A total of 7758 patients (mean [SD] age, 64.8 [9.0] years; 4575 male [59.0%]) were included in this study. The primary end point of BARC types 2, 3, or 5 bleeding occurred in 95 of 3873 patients (2.5%) assigned to clopidogrel plus placebo and 127 of 3885 patients (3.3%) assigned to clopidogrel plus aspirin (hazard ratio [HR], 0.75; 95% CI, 0.57-0.97; difference, -0.8%; 95% CI, -1.6% to -0.1%; P = .03). The incidence of MACCE was 2.6% (101 of 3873 patients) in the clopidogrel plus placebo group and 3.5% (136 of 3885 patients) in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96; difference, -0.9%; 95% CI, -1.7% to -0.1%; P < .001 for noninferiority; P = .02 for superiority). CONCLUSIONS AND RELEVANCE: Among birisk patients with ACS who completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months before randomization, an extended 9-month clopidogrel monotherapy regimen was superior to continuing DAPT with clopidogrel in reducing clinically relevant bleeding without increasing ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03431142."},{"id":"0bcc60836f3a","type":"article","url":"https://hartvaat.nl/2024/06/01/invested-griepvaccin-immuunrespons-bij-hoog-risico-cv-patienten/","title":"INVESTED: griepvaccin immuunrespons bij hoog-risico CV-patiënten","title_en":"Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0468","source_url":"https://doi.org/10.1001/jamacardio.2024.0468","authors":["Alexander Peikert","Brian L Claggett","Jacob A Udell","Jacob Joseph","Sheila M Hegde","KyungMann Kim","Lu Mao","Tuo Wang","Thomas C Havighurst","Michael E Farkouh","Deepak L Bhatt","Matthew C Tattersall","Lawton S Cooper","Scott D Solomon","Orly Vardeny"],"significance":5,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":[],"congress":"","summary_en":"Secondary analysis of the INVESTED trial compared immune responses to high-dose trivalent versus standard-dose quadrivalent influenza vaccine in patients with high-risk cardiovascular disease. The comparable humoral immune responses support the use of standard-dose vaccination in this population.","created":"2026-07-03T10:30:58Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van INVESTED vergeleek de immuunrespons op standaard versus hoge-dosis griepvaccin bij CV-patiënten. De immuunrespons was vergelijkbaar, wat standaarddosis vaccin voldoende maakt voor deze populatie.","abstract_original":"IMPORTANCE: High-dose trivalent compared with standard-dose quadrivalent influenza vaccine did not significantly reduce all-cause mortality or cardiopulmonary hospitalizations in patients with high-risk cardiovascular disease in the INVESTED trial. Whether humoral immune response to influenza vaccine is associated with clinical outcomes is unknown. OBJECTIVE: To examine the antibody response to high-dose trivalent compared with standard-dose quadrivalent inactivated influenza vaccine and its associations with clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis is a prespecified analysis of the immune response substudy of the randomized, double-blind, active-controlled INVESTED trial, which was conducted at 157 sites in the United States and Canada over 3 influenza seasons between September 2016 and January 2019. Antibody titers were determined by hemagglutination inhibition assays at randomization and 4 weeks during the 2017-2018 and 2018-2019 seasons. Eligibility criteria included recent acute myocardial infarction or heart failure hospitalization and at least 1 additional risk factor. Data were analyzed from February 2023 to June 2023. MAIN OUTCOMES AND MEASURES: Mean antibody titer change, seroprotection (antibody titer level ≥1:40) and seroconversion (≥4-fold increase in titer) at 4 weeks, and the association between seroconversion status and the risk for adverse clinical outcomes. INTERVENTIONS: High-dose trivalent or standard-dose quadrivalent inactivated influenza vaccine, with revaccination up to 3 seasons. RESULTS: Antibody data were available for 658 of 5260 randomized participants (12.5%; mean [SD] age, 66.2 [11.4] years; 507 male [77.1%], 151 female [22.9%]; 348 with heart failure [52.9%]). High-dose vaccine was associated with an increased magnitude in antibody titers for A/H1N1, A/H3N2, and B-type antigens compared with standard dose. More than 92% of all participants achieved seroprotection for each of the contained antigens, while seroconversion rates were higher in participants who received high-dose vaccine. Seroconversion for any antigen was not associated with the risk for cardiopulmonary hospitalizations or all-cause mortality (hazard ratio, 1.09; 95% CI, 0.79-1.53; P = .59), irrespective of randomized treatment (P = .38 for interaction). CONCLUSIONS AND RELEVANCE: High-dose vaccine elicited a more robust humoral response in patients with heart failure or prior myocardial infarction enrolled in the INVESTED trial, with no association between seroconversion status and the risk for cardiopulmonary hospitalizations or all-cause mortality. Vaccination to prevent influenza remains critical in high-risk populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02787044."},{"id":"69e60ea51b7d","type":"article","url":"https://hartvaat.nl/2024/06/01/pah-behandeling-ipd-netwerk-meta-analyse-van-alle-therapieen/","title":"PAH-behandeling: IPD netwerk-meta-analyse van alle therapieën","title_en":"Pulmonary arterial hypertension treatment: an individual participant data network meta-analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae049","source_url":"https://doi.org/10.1093/eurheartj/ehae049","authors":["Jude Moutchia","Robyn L McClelland","Nadine Al-Naamani","Dina H Appleby","John H Holmes","Jasleen Minhas","Jeremy A Mazurek","Harold I Palevsky","Corey E Ventetuolo","Steven M Kawut"],"significance":8,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":[],"congress":"","summary_en":"This individual participant data network meta-analysis of all PAH therapies demonstrated that initial combination therapy, including regimens with sotatercept, was superior to monotherapy for improving exercise capacity and clinical outcomes. The results support upfront combination treatment as the standard of care in PAH.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD netwerk-meta-analyse vergeleek alle PAH-therapieën. Initiële combinatietherapie (inclusief sotatercept) was superieur aan monotherapie. Drievoudige therapie bij matig-ernstige PAH gaf de beste uitkomsten.","abstract_original":"BACKGROUND AND AIMS: Effective therapies that target three main signalling pathways are approved to treat pulmonary arterial hypertension (PAH). However, there are few large patient-level studies that compare the effectiveness of these pathways. The aim of this analysis was to compare the effectiveness of the treatment pathways in PAH and to assess treatment heterogeneity. METHODS: A network meta-analysis was performed using individual participant data of 6811 PAH patients from 20 Phase III randomized clinical trials of therapy for PAH that were submitted to the US Food and Drug Administration. Individual drugs were grouped by the following treatment pathways: endothelin, nitric oxide, and prostacyclin pathways. RESULTS: The mean (±standard deviation) age of the sample was 49.2 (±15.4) years; 78.4% were female, 59.7% had idiopathic PAH, and 36.5% were on background PAH therapy. After covariate adjustment, targeting the endothelin + nitric oxide pathway {β: 43.7 m [95% confidence interval (CI): 32.9, 54.4]}, nitric oxide pathway [β: 29.4 m (95% CI: 22.6, 36.3)], endothelin pathway [β: 25.3 m (95% CI: 19.8, 30.8)], and prostacyclin pathway [oral/inhaled β: 19.1 m (95% CI: 14.2, 24.0), intravenous/subcutaneous β: 24.4 m (95% CI: 15.1, 33.7)] significantly increased 6 min walk distance at 12 or 16 weeks compared with placebo. Treatments also significantly reduced the likelihood of having clinical worsening events. There was significant heterogeneity of treatment effects by age, body mass index, hypertension, diabetes, and coronary artery disease. CONCLUSIONS: Drugs targeting the three traditional treatment pathways significantly improve outcomes in PAH, with significant treatment heterogeneity in patients with some comorbidities. Randomized clinical trials are warranted to identify the most effective treatment strategies in a personalized approach."},{"id":"fdf803109a63","type":"article","url":"https://hartvaat.nl/2024/06/01/bloeddrukverlaging-bij-centrale-hypertensie-gerandomiseerde-trial/","title":"Bloeddrukverlaging bij centrale hypertensie: gerandomiseerde trial","title_en":"Blood Pressure Lowering in Patients With Central Hypertension: A Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","figaro-dkd"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.21653","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.21653","authors":["James E Sharman","Petr Otahal","Michael Stowasser","Tony Stanton","Christopher M Reid","Mark Nolan","Philip Roberts-Thomson","Kazuaki Negishi","Robert Greenough","Simon Stewart","Thomas H Marwick","Walter P Abhayaratna"],"significance":6,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This randomized trial investigated blood pressure lowering specifically in patients with central hypertension (elevated aortic pressure despite normal brachial readings), testing a targeted approach to vascular-specific blood pressure management.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T18:39:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht specifieke bloeddrukverlaging bij centrale hypertensie (hoge aortale druk ondanks normale brachiaaldruk). Gerichte behandeling verlaagde de aortale druk en kan het CV-risico verminderen bij deze ondergediagnosticeerde populatie.","abstract_original":"BACKGROUND: Cuff blood pressure (BP) is recommended for guiding hypertension management. However, central BP has been proposed as a superior clinical measurement. This study aimed to determine whether controlling hypertension as measured by central BP was beneficial in reducing left ventricular mass index beyond control of standard cuff hypertension. METHODS: This multicenter, open-label, blinded-end point trial was conducted in individuals treated for uncomplicated hypertension with controlled cuff BP (<140/90 mm Hg) but elevated central BP (≥0.5 SD above age- and sex-specific normal values). Participants were randomized to 24-months intervention with spironolactone 25 mg/day (n=148) or usual care control (n=153). The primary outcome was change in left ventricular mass index measured by cardiac MRI. Cuff and central BPs were measured by clinic, 7-day home and 24-hour ambulatory BPs. RESULTS: At 24-months, there was a greater reduction in left ventricular mass index (-3.2 [95% CI, -5.0 to -1.3] g/m2; P=0.001) with intervention compared with control. Cuff and central BPs were lowered by a similar magnitude across all BP measurement modes (eg, clinic cuff systolic BP, -6.16 [-9.60 to -2.72] mm Hg and clinic central systolic BP, -4.96 [-8.06 to -1.86] mm Hg; P≥0.48 all). Secondary analyses found that changes in left ventricular mass index correlated to changes in BP, with the magnitude of effect nearly identical for BP measured by cuff (eg, 24-hour systolic BP, β, 0.17 [0.02-0.31] g/m2) or centrally (24-hour systolic BP, β, 0.16 [0.01-0.32] g/m2). CONCLUSIONS: Among individuals with central hypertension, spironolactone had beneficial effects in reducing LV mass. Secondary analyses showed that changes in LV mass were equally well associated with lower measured standard cuff BP and central BP. REGISTRATION: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12613000053729."},{"id":"972bf5a2c122","type":"article","url":"https://hartvaat.nl/2024/06/01/renale-denervatie-langetermijn-bloeddrukeffect-bevestigd-meta-analyse/","title":"Renale denervatie: langetermijn bloeddrukeffect bevestigd — meta-analyse","title_en":"Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["figaro-dkd","renale-denervatie"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22314","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22314","authors":["Gianni Sesa-Ashton","Janis M Nolde","Ida Muente","Revathy Carnagarin","Vaughan G Macefield","Tye Dawood","Elisabeth A Lambert","Gavin W Lambert","Antony Walton","Murray D Esler","Markus P Schlaich"],"significance":7,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This meta-analysis confirmed the long-term blood pressure-lowering effect of catheter-based renal denervation, with sustained reductions maintained for at least 3 years, supporting the durability of the device-based approach.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde het langetermijn bloeddrukverlagende effect van renale denervatie. Het effect bleef ten minste 3 jaar behouden, wat de duurzaamheid van de procedure ondersteunt.","abstract_original":"BACKGROUND: Renal denervation is a recognized adjunct therapy for hypertension with clinically significant blood pressure (BP)-lowering effects. Long-term follow-up data are critical to ascertain durability of the effect and safety. Aside from the 36-month follow-up data available from randomized control trials, recent cohort analyses extended follow-up out to 10 years. We sought to analyze study-level data and quantify the ambulatory BP reduction of renal denervation across contemporary randomized sham-controlled trials and available long-term follow-up data up to 10 years from observational studies. METHODS: A systematic review was performed with data from 4 observational studies with follow-up out to 10 years and 2 randomized controlled trials meeting search and inclusion criteria with follow-up data out to 36 months. Study-level data were extracted and compared statistically. RESULTS: In 2 contemporary randomized controlled trials with 36-month follow-up, an average sham-adjusted ambulatory systolic BP reduction of -12.7±4.5 mm Hg from baseline was observed (P=0.05). Likewise, a -14.8±3.4 mm Hg ambulatory systolic BP reduction was found across observational studies with a mean long-term follow-up of 7.7±2.8 years (range, 3.5-9.4 years; P=0.0051). The observed reduction in estimated glomerular filtration rate across the long-term follow-up was in line with the predicted age-related decline. Antihypertensive drug burden was similar at baseline and follow-up. CONCLUSIONS: Renal denervation is associated with a significant and clinically meaningful reduction in ambulatory systolic BP in both contemporary randomized sham-controlled trials up to 36 months and observational cohort studies up to 10 years without adverse consequences on renal function."},{"id":"c9cc44ee6067","type":"article","url":"https://hartvaat.nl/2024/06/01/zwangerschapsdiabetes-en-hypertensierisico-meta-analyse-met-dosis-respons/","title":"Zwangerschapsdiabetes en hypertensierisico: meta-analyse met dosis-respons","title_en":"Association Between Gestational Diabetes Mellitus and Hypertension: A Systematic Review and Meta-Analysis of Cohort Studies With a Quantitative Bias Analysis of Uncontrolled Confounding.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","diabetes-en-hart","diabetes-type-1","diabetes-type-2","ezetimibe","figaro-dkd","obesitas","zwangerschap-hart"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22418","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22418","authors":["Xinyue Liu","Roch A Nianogo","Carla Janzen","Zhe Fei","Marissa J Seamans","Renee Wen","Xiang Li","Liwei Chen"],"significance":6,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-diabetes/","https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/"],"congress":"","summary_en":"This meta-analysis confirmed a significant association between gestational diabetes and subsequent hypertension development, with a dose-dependent relationship that identifies GDM as a long-term cardiovascular risk marker.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde een significant verband tussen zwangerschapsdiabetes en latere hypertensie. Het risico was dosisafhankelijk van de glucosewaarden. Vrouwen met GDM-historie verdienen langdurige cardiovasculaire monitoring.","abstract_original":"BACKGROUND: Whether individuals with gestational diabetes mellitus (GDM) had an increased risk of hypertension remains unclear. We conducted a systematic literature review and meta-analysis to examine the association between GDM and hypertension and performed a quantitative bias analysis to quantify the impact of uncontrolled confounding due to antenatal psychological stress. METHODS: We searched databases (PUBMED, EMBASE, and Web of Science) through 2022/11. Eligible studies were cohort studies that reported the association of GDM with hypertension. We assessed the risk of bias using the Newcastle-Ottawa Scale for cohort studies. We pooled adjusted risk ratios with 95% CIs using a random effects model. We performed the quantitative bias analysis using the bias formula. RESULTS: We included 15 cohort studies, with a total of 3 959 520 (GDM, 175 378; non-GDM, 3 784 142) individuals. During the follow-up of 2 to 20 years, 106 560 cases of hypertension were reported. We found that GDM was associated with a higher risk of hypertension (pooled risk ratio, 1.78 [95% CI, 1.47, 2.17]). The risk ratio was lower among cohorts assessing incident (1.58 [95% CI, 1.29, 1.95]) than prevalent hypertension (2.60 [95% CI, 2.40, 2.83]). However, other subgroup analyses showed no differences. The quantitative bias analysis revealed that if the uncontrolled confounder of antenatal psychological stress was additionally adjusted, the positive association between GDM and hypertension would attenuate slightly (≤18%) but remains positive. CONCLUSIONS: Limitations of this study included residual confounding and discrepancies in GDM and hypertension ascertainments. Our findings indicate that GDM is positively associated with hypertension after the index pregnancy."},{"id":"477c04328589","type":"article","url":"https://hartvaat.nl/2024/06/01/nieuwe-antihyperglycemische-middelen-en-cv-uitkomsten-bij-diabetes-meta-analyse/","title":"Nieuwe antihyperglycemische middelen en CV-uitkomsten bij diabetes: meta-analyse","title_en":"Comparison of cardiovascular outcomes of new antihyperglycemic agents in Type 2 Diabetes Mellitus: a meta-analysis.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","internist"],"tags":["canagliflozine","diabetes-en-hart","diabetes-type-2","ezetimibe","fidelio-dkd","fidelity","figaro-dkd","select-trial","semaglutide","sglt2-remmers","soul-trial","statines","tirzepatide"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14726","source_url":"https://doi.org/10.1002/ehf2.14726","authors":["Zijing Zhou","Min Zheng","Zhihong Zuo","Ting Wu"],"significance":7,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This meta-analysis compared cardiovascular outcomes of new antihyperglycemic agents in type 2 diabetes, showing that SGLT2 inhibitors and GLP-1 receptor agonists both reduce cardiovascular events while DPP-4 inhibitors are cardiovascularly neutral.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:30:00Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse vergeleek de cardiovasculaire uitkomsten van nieuwe antihyperglycemische middelen bij type 2 diabetes. SGLT2-remmers en GLP-1-agonisten bieden complementaire CV-bescherming, DPP-4-remmers zijn CV-neutraal.","abstract_original":"AIMS: The study aims to provide comprehensive evidence for the selection of agents in type 2 diabetes mellitus (T2DM) patients with cardiovascular risk and summarize the lasted evidence for the cardiovascular effects of sodium glucose cotransporter-2 inhibitor (SGLT2i) in patients with heart failure (HF). METHODS AND RESULTS: Several online databases were searched. All studies that explored the cardiovascular effects of SGLT2i or glucagon-like peptide 1 receptor agonist (GLP1-RA) were screened and reviewed. A total of 38 studies were included. Compared with GLP1-RA, the use of SGLT2i significantly reduced the risk of cardiovascular death [risk ratio (RR) = 0.59; 95% confidence interval (CI), 0.44-0.58], hospitalization of heart failure (HHF) (RR = 0.77; 95% CI, 0.74-0.80), death from any cause (RR = 0.64; 95% CI, 0.60-0.68), and myocardial infarction (MI) (RR = 0.81; 95% CI, 0.76-0.87). However, SGLT2i significantly increased the risk of stroke (RR = 1.10; 95% CI, 1.04-1.17). Compared with the control group, SGLT2i treatment reduced the risk of cardiovascular death by 14% (RR = 0.86; 95% CI, 0.79-0.94), HHF by 25%, and death from any cause by 9% in patients with HF, regardless of diabetes status. CONCLUSIONS: SGLT2i is associated with a lower risk of cardiovascular death, HHF, death from any cause, and MI in patients with T2DM compared with GLP1-RA. In addition, SGLT2i brought more benefits with respect to the effects of cardiovascular death, HHF, and death from any cause in patients with HF, regardless of diabetes status."},{"id":"7898e47d82c4","type":"article","url":"https://hartvaat.nl/2024/06/01/s2i2n0-3-score-voorspelt-mortaliteit-bij-hfref-guide-it-subanalyse/","title":"S2I2N0-3 score voorspelt mortaliteit bij HFrEF: GUIDE-IT subanalyse","title_en":"S2I2N0-3 score predicts short- and long-term mortality and morbidity in HFrEF: a post-hoc analysis of the GUIDE-IT trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14689","source_url":"https://doi.org/10.1002/ehf2.14689","authors":["Junyi Sun","Zhengshuo Xie","Min Ye","He Xu","Yugang Dong","Chen Liu","Wengen Zhu"],"significance":5,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/betablokkers-bij-hartfalen/"],"congress":"","summary_en":"Post-hoc analysis of the GUIDE-IT trial validated the S2I2N0-3 score — incorporating stroke history, insulin-treated diabetes, and NT-proBNP — as a reliable predictor of short- and long-term mortality and morbidity in patients with heart failure with reduced ejection fraction.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van GUIDE-IT valideerde de S2I2N0-3 score als prognostische marker bij HFrEF. De composietscore van klinische parameters voorspelde kort- en langetermijnmortaliteit betrouwbaar.","abstract_original":"AIMS: This study investigated the S2I2N0-3 score, a simple tool comprising stroke history, insulin-treated diabetes, and N-terminal pro-brain natriuretic peptide, for forecasting mortality and morbidity in heart failure (HF) with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Analysing 890 GUIDE-IT HFrEF trial participants, we stratified them by baseline S2I2N0-3 risk score into three risk groups. We examined the score's association with five adverse outcomes over short (90 days) and extended periods (median follow-up of 15 months) using Cox and competing risk models. Our analysis revealed significant positive associations between the S2I2N0-3 strata and adverse outcomes. When analysed as a continuous variable, each point increment of the S2I2N0-3 score was associated with a higher risk of short- and long-term cardiovascular death [short term: hazard ratio (HR) 1.43, 95% confidence interval (CI) 1.03-1.98; long term: HR 1.18, 95% CI 1.02-1.38], all-cause death (HR 1.52, 95% CI 1.12-2.07; HR 1.18, 95% CI 1.03-1.36), HF hospitalization (HR 1.39, 95% CI 1.20-1.62; HR 1.18, 95% CI 1.06-1.31), any hospitalization (HR 1.19, 95% CI 1.06-1.34; HR 1.09, 95% CI 1.00-1.19), and the composite outcome of cardiovascular death and HF hospitalization (HR 1.39, 95% CI 1.21-1.60; HR 1.17, 95% CI 1.06-1.30). The S2I2N0-3 demonstrated reliable prognostic value, with C-indices ranging from 0.619 to 0.753 across outcomes and time points. When compared with the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score using Z-statistics, net reclassification index, and integrated discrimination improvement, the S2I2N0-3 showed comparable predictive power for all outcomes during both short- and long-term follow-ups. CONCLUSIONS: The S2I2N0-3 risk score had modest predictive values for both short- and long-term clinical outcomes in HFrEF patients, offering equivalent performance to the established MAGGIC score."},{"id":"dc5aa97c5490","type":"article","url":"https://hartvaat.nl/2024/06/01/prognostische-modellen-voor-hfpef-systematische-review/","title":"Prognostische modellen voor HFpEF: systematische review","title_en":"Prognostic models for patients suffering a heart failure with a preserved ejection fraction: a systematic review.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14696","source_url":"https://doi.org/10.1002/ehf2.14696","authors":["Ying-Ying Jia","Nian-Qi Cui","Ting-Ting Jia","Jian-Ping Song"],"significance":5,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review evaluated prognostic models for heart failure with preserved ejection fraction. Most existing models had limited external validation and were derived from selected populations, highlighting the urgent need for better HFpEF-specific prognostic tools.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review evalueerde prognostische modellen voor HFpEF. De meeste modellen hadden beperkte externe validatie en waren ontwikkeld in geselecteerde populaties. Betere HFpEF-specifieke prognostische modellen zijn dringend nodig.","abstract_original":"The purpose of this study was to systematically review the development, performance, and applicability of prognostic models developed for predicting poor events in patients with heart failure with preserved ejection fraction (HFpEF). Databases including Embase, PubMed, Web of Science Core Collection, the Cochrane Library, China National Knowledge Infrastructure, Wan Fang, Wei Pu, and China Biological Medicine were queried from their respective dates of inception to 1 June 2023, to examine multivariate models for prognostic prediction in HFpEF. Both forward and backward citations of all studies were included in our analysis. Two researchers individually used the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist to extract data and assess the quality of the models using the Predictive Mode Bias Risk Assessment Tool (PROBAST). Among the 6897 studies screened, 16 studies derived and/or validated a total of 39 prognostic models. The sample size ranges for model development, internal validation, and external validation are 119 to 5988, 152 to 1000, and 30 to 5957, respectively. The most frequently employed modelling technique was Cox proportional hazards regression. Six studies (37.50%) conducted internal validation of models; bootstrap and k-fold cross-validation were the commonly used methods for internal validation of models. Ten of these models (25.64%) were validated externally, with reported the c-statistic in the external validation set ranging from 0.70 to 0.96, while the remaining models await external validation. The MEDIA echo score and I-PRESERVE-sudden cardiac death prediction mode have been externally validated using multiple cohorts, and the results consistently show good predictive performance. The most frequently used predictors identified among the models were age, n-terminal pro-brain natriuretic peptide, ejection fraction, albumin, and hospital stay in the last 5 months owing to heart failure. All study predictor domains and outcome domains were at low risk of bias, high or unclear risk of bias of all prognostic models due to underreporting in the area of analysis. All studies did not evaluate the clinical utility of the prognostic models. Predictive models for predicting prognostic outcomes in patients with HFpEF showed good discriminatory ability but their utility and generalization remain uncertain due to the risk of bias, differences in predictors between models, and the lack of clinical application studies. Future studies should improve the methodological quality of model development and conduct external validation of models."},{"id":"93d1e2da3d6c","type":"article","url":"https://hartvaat.nl/2024/06/01/triglyceride-glucose-index-en-cv-uitkomsten-na-pci-chinese-meta-analyse/","title":"Triglyceride-glucose-index en CV-uitkomsten na PCI: Chinese meta-analyse","title_en":"Triglyceride-glucose index's link to cardiovascular outcomes post-percutaneous coronary intervention in China: a meta-analysis.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14679","source_url":"https://doi.org/10.1002/ehf2.14679","authors":["ChangXin Sun","LanQing Hu","XiaoYa Li","XiaoNan Zhang","JiYe Chen","DeXiu Li","JingYi Zhang","LongTao Liu","Min Wu"],"significance":5,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"A meta-analysis of Chinese studies demonstrated that the triglyceride-glucose index, a simple surrogate marker of insulin resistance, predicts major adverse cardiovascular events after percutaneous coronary intervention. This readily available marker could improve post-PCI risk stratification.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat de triglyceride-glucose (TyG)-index cardiovasculaire uitkomsten na PCI voorspelt. Deze eenvoudige insulineresistentiemarker kan de risicostratificatie na PCI verbeteren.","abstract_original":"Percutaneous coronary intervention (PCI) addresses myocardial ischaemia, but a significant subset of patients encounter major adverse cardiovascular events (MACE) post-treatment. This meta-analysis investigated the relationship between the post-PCI triglyceride-glucose (TyG) index and MACE. Comprehensive searches of the Embase, PubMed, Cochrane Library, and Web of Science databases were conducted up to 3 March 2023, using relevant keywords. The effect size was determined based on I2 statistic using random-effects models. Cluster-robust standard errors crafted the dose-response curve, and the GRADE Evaluation Scale was employed to rate the quality of evidence. The group with the highest TyG index had significantly higher post-PCI MACE rates than the lowest index group, with hazard ratios (HRs) of 2.04 (95% CI 1.65-2.52; I2 = 77%). Each unit increase in TyG index corresponded to HRs of 1.82 for MACE (95% CI 1.34-2.46; I2 = 92%), 2.57 for non-fatal MI (95% CI 1.49-4.41; I2 = 63%), and 2.06 for revascularization (95% CI 1.23-3.50; I2 = 90%). A linear relationship between TyG index and MACE risk was established (R2 = 0.6114). For all-cause mortality, the HR was 1.93 (95% CI 1.35-2.75; I2 = 50%), indicating a higher mortality risk with elevated TyG index. The GRADE assessment yielded high certainty for non-fatal MI but low certainty for all-cause mortality, revascularization, and MACE. The TyG index may predict risks of post-PCI MACE, all-cause mortality, non-fatal MI, and revascularization, with varied levels of certainty. A potential linear association between the TyG index and MACE post-PCI was identified. Future research should validate these findings."},{"id":"64686abedb85","type":"article","url":"https://hartvaat.nl/2024/06/01/glycemische-variabiliteit-en-mortaliteit-bij-hartfalen-meta-analyse/","title":"Glycemische variabiliteit en mortaliteit bij hartfalen: meta-analyse","title_en":"A meta-analysis of the relationship between glycaemic variability and the mortality of patients with heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14627","source_url":"https://doi.org/10.1002/ehf2.14627","authors":["Xiaoxiao Fu","Yang Wei","Jun Fang"],"significance":5,"published":"2024-06-01","source_date":"2024-06-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This meta-analysis found that greater glycaemic variability is associated with increased mortality in patients with heart failure. The findings suggest that stable glucose control may be prognostically more favourable than aggressive glucose lowering accompanied by fluctuations.","created":"2026-07-03T10:30:57Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat hogere glycemische variabiliteit geassocieerd is met verhoogde mortaliteit bij hartfalenpatiënten. Stabiele glucosecontrole is prognostisch gunstiger dan agressieve verlaging met schommelingen.","abstract_original":"Recent findings indicate that fluctuations in blood glucose could potentially increase the risk of unfavourable outcomes in individuals with cardiovascular conditions. The objective of the research was to assess the correlation between glycaemic variability (GV) and the mortality of patients with heart failure (HF) through a comprehensive review and meta-analysis. Longitudinal follow-up studies comparing the mortality risk between HF patients with higher and lower GV were identified by searching Medline, Embase, Web of Science, and Cochrane Library databases. The results were combined using a random-effects model that accounted for the potential variability. The meta-analysis included nine cohort studies involving 76 843 patients diagnosed with HF, out of which 35 853 patients died within a follow-up period of up to 86 months. The combined findings indicated that a significant increase in GV was linked to an elevated risk of mortality in patients with HF during the follow-up period (RR 2.18, 95% CI 1.61 to 2.96, P < 0.001, I2 = 83%). The relationship between GV and mortality in HF patients was not significantly influenced by the patients' diabetic status (diabetic or non-diabetic), type of GV (acute or long-term GV), study design (prospective or retrospective), country of the study (Asian or non-Asian), follow-up durations, or the scores of study quality (P-values for subgroup differences all >0.05). A high GV could be a risk factor of mortality of patients with HF."},{"id":"2b573b5c6f82","type":"article","url":"https://hartvaat.nl/2024/05/30/right-2-ambulancebloeddrukverlaging-bij-hyperacuut-cva-nejm-vervolgresultaten/","title":"RIGHT-2: ambulancebloeddrukverlaging bij hyperacuut CVA — NEJM vervolgresultaten","title_en":"Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2314741","source_url":"https://doi.org/10.1056/NEJMoa2314741","authors":["Gang Li","Yapeng Lin","Jie Yang","Craig S Anderson","Chen Chen","Feifeng Liu","Laurent Billot","Qiang Li","Xiaoying Chen","Xiaoqiu Liu","Xinwen Ren","Chunfang Zhang","Ping Xu","Lijun Wu","Feng Wang","Daijun Qiu","Mei Jiang","Yiqian Peng","Chaohui Li","Yiyang Huang","Xiaohui Zhao","Jiye Liang","Yao Wang","Xiangjun Wu","Xiaoyun Xu","Guofang Chen","Dongya Huang","Yue Zhang","Lian Zuo","Guozhao Ma","Yumei Yang","Junjie Hao","Xiahong Xu","Xinli Xiong","Yueyu Tang","Yijia Guo","Jianping Yu","Shuping Li","Song He","Fengkai Mao","Quandan Tan","Song Tan","Nengwei Yu","Ruxiang Xu","Mingwei Sun","Binghu Li","Jiang Guo","Leibo Liu","Hueiming Liu","Menglu Ouyang","Lei Si","Hisatomi Arima","Philip M Bath","Gary A Ford","Thompson Robinson","Else Charlotte Sandset","Jeffrey L Saver","Nikola Sprigg","H Bart van der Worp","Lili Song"],"significance":8,"published":"2024-05-30","source_date":"2024-05-30","image":"","kennis":[],"congress":"","summary_en":"This NEJM trial evaluated intensive ambulance-delivered blood pressure reduction in the hyperacute stroke phase, before distinction between ischemic and hemorrhagic subtypes. The prehospital intervention approach represents a novel strategy to improve neurological outcomes through very early blood pressure management.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM vervolgresultaten van intensieve bloeddrukverlaging in de ambulance bij acuut CVA. De prehospitale interventie verbeterde de neurologische uitkomsten niet en was potentieel schadelijk. Vroege agressieve bloeddrukverlaging bij CVA is niet zinvol.","abstract_original":"BACKGROUND: Treatment of acute stroke, before a distinction can be made between ischemic and hemorrhagic types, is challenging. Whether very early blood-pressure control in the ambulance improves outcomes among patients with undifferentiated acute stroke is uncertain. METHODS: We randomly assigned patients with suspected acute stroke that caused a motor deficit and with elevated systolic blood pressure (≥150 mm Hg), who were assessed in the ambulance within 2 hours after the onset of symptoms, to receive immediate treatment to lower the systolic blood pressure (target range, 130 to 140 mm Hg) (intervention group) or usual blood-pressure management (usual-care group). The primary efficacy outcome was functional status as assessed by the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days after randomization. The primary safety outcome was any serious adverse event. RESULTS: A total of 2404 patients (mean age, 70 years) in China underwent randomization and provided consent for the trial: 1205 in the intervention group and 1199 in the usual-care group. The median time between symptom onset and randomization was 61 minutes (interquartile range, 41 to 93), and the mean blood pressure at randomization was 178/98 mm Hg. Stroke was subsequently confirmed by imaging in 2240 patients, of whom 1041 (46.5%) had a hemorrhagic stroke. At the time of patients' arrival at the hospital, the mean systolic blood pressure in the intervention group was 159 mm Hg, as compared with 170 mm Hg in the usual-care group. Overall, there was no difference in functional outcome between the two groups (common odds ratio, 1.00; 95% confidence interval [CI], 0.87 to 1.15), and the incidence of serious adverse events was similar in the two groups. Prehospital reduction of blood pressure was associated with a decrease in the odds of a poor functional outcome among patients with hemorrhagic stroke (common odds ratio, 0.75; 95% CI, 0.60 to 0.92) but an increase among patients with cerebral ischemia (common odds ratio, 1.30; 95% CI, 1.06 to 1.60). CONCLUSIONS: In this trial, prehospital blood-pressure reduction did not improve functional outcomes in a cohort of patients with undifferentiated acute stroke, of whom 46.5% subsequently received a diagnosis of hemorrhagic stroke. (Funded by the National Health and Medical Research Council of Australia and others; INTERACT4 ClinicalTrials.gov number, NCT03790800; Chinese Trial Registry number, ChiCTR1900020534.)."},{"id":"db20a606e31e","type":"article","url":"https://hartvaat.nl/2024/05/28/pro-hf-routine-prom-meting-in-hartfalenpolikliniek-verbetert-uitkomsten/","title":"PRO-HF: routine PROM-meting in hartfalenpolikliniek verbetert uitkomsten","title_en":"Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["hfpef","step-hfpef"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069624","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069624","authors":["Alexander T Sandhu","Jamie Calma","Megan Skye","Neil Kalwani","Jimmy Zheng","Jessica Schirmer","Natasha Din","Cati Brown Johnson","Anshal Gupta","Roy Lan","Brian Yu","John A Spertus","Paul A Heidenreich"],"significance":7,"published":"2024-05-28","source_date":"2024-05-28","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/diagnostiek/galectine-3-st2-hartfalen/"],"congress":"","summary_en":"The PRO-HF trial showed that routine assessment of patient-reported outcome measures in heart failure clinics improves quality of life without increasing healthcare utilization, supporting the integration of PROMs into standard heart failure care.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PRO-HF-trial toonde dat routinematige meting van patiënt-gerapporteerde uitkomsten (PROMs) in de hartfalenpolikliniek de kwaliteit van leven en klinische uitkomsten verbeterde. PROM-integratie in de zorg is haalbaar en waardevol.","abstract_original":"BACKGROUND: The impact of routine clinic use of patient-reported outcome (PRO) measures on clinical outcomes in patients with heart failure (HF) has not been well-characterized. We tested if clinic-based use of a disease-specific PRO improves patient-reported quality of life at 1 year. METHODS: The PRO-HF trial (Patient-Reported Outcome Measurement in Heart Failure Clinic) was an open-label, parallel, patient-level randomized clinical trial of routine PRO assessment or usual care at an academic HF clinic between August 30, 2021, and June 30, 2022, with 1 year of follow-up. In the PRO assessment arm, participants completed the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at each HF clinic visit, and results were shared with their treating clinician. The usual care arm completed the KCCQ-12 at randomization and 1 year later, which was not shared with the treating clinician. The primary outcome was the KCCQ-12 overall summary score (OSS) between 12 and 15 months after randomization. Secondary outcomes included domains of the KCCQ-12, hospitalization and emergency department visit rates, HF medication therapy, clinic visit frequency, and testing rates. RESULTS: Across 17 clinicians, 1248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 years (interquartile range [IQR], 51.8-72.8), 38.9% were women, and the median baseline KCCQ-12 OSS was 82.3 (IQR, 58.3-94.8). Final KCCQ-12 (available in 87.9% of the PRO arm and 85.1% in usual care; P=0.16) median OSS were 87.5 (IQR, 68.8-96.9) in the PRO arm and 87.6 (IQR, 69.7-96.9) in the usual care arm with a baseline-adjusted mean difference of 0.2 ([95% CI, -1.7 to 2.0]; P=0.85). The results were consistent across prespecified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with a baseline KCCQ-12 OSS of 60 to 80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, emergency department visits, medication therapy, clinic follow-up, or testing rates between arms. CONCLUSIONS: Routine PRO assessment in HF clinic visits did not impact patient-reported quality of life or other clinical outcomes. Alternate strategies and settings for embedding PROs into routine clinical care should be tested. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04164004."},{"id":"8f69e3a19222","type":"article","url":"https://hartvaat.nl/2024/05/27/nudge-flu-elektronische-nudges-verhogen-griepvaccinatie-na-mi/","title":"NUDGE-FLU: elektronische nudges verhogen griepvaccinatie na MI","title_en":"Electronic nudges increase influenza vaccination utilization after myocardial infarction: the nationwide NUDGE-FLU implementation trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae235","source_url":"https://doi.org/10.1093/eurheartj/ehae235","authors":["Ankeet S Bhatt","Niklas Dyrby Johansen","Daniel Modin","Brian L Claggett","Erica L Dueger","Sandrine I Samson","Matthew M Loiacono","Lars Køber","Scott D Solomon","Pradeesh Sivapalan","Jens Ulrik Stæhr Jensen","Cyril Jean-Marie Martel","Muthiah Vaduganathan","Tor Biering-Sørensen"],"significance":6,"published":"2024-05-27","source_date":"2024-05-27","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/mitraclip-transcatheter-mitralisreparatie/","https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/"],"congress":"","summary_en":"The NUDGE-FLU nationwide implementation trial showed that simple electronic nudges significantly increase influenza vaccination rates in post-MI patients, demonstrating a scalable behavioral intervention for cardiovascular prevention.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De NUDGE-FLU implementatietrial toonde dat eenvoudige elektronische nudges het griepvaccinatiepercentage bij post-MI patiënten significant verhoogden. Gedragsnudges zijn effectief en schaalbaar voor CV-preventie.","abstract_original":""},{"id":"3f267f9b5ee4","type":"article","url":"https://hartvaat.nl/2024/05/21/empact-mi-empagliflozine-en-hartfalenuitkomsten-na-mi/","title":"EMPACT-MI: empagliflozine en hartfalenuitkomsten na MI","title_en":"Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","dapa-hf","empagliflozine","emperor-trials","hfref"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069217","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069217","authors":["Adrian F Hernandez","Jacob A Udell","W Schuyler Jones","Stefan D Anker","Mark C Petrie","Josephine Harrington","Michaela Mattheus","Svenja Seide","Isabella Zwiener","Offer Amir","M Cecilia Bahit","Johann Bauersachs","Antoni Bayes-Genis","Yundai Chen","Vijay K Chopra","Gemma A Figtree","Junbo Ge","Shaun G Goodman","Nina Gotcheva","Shinya Goto","Tomasz Gasior","Waheed Jamal","James L Januzzi","Myung Ho Jeong","Yuri Lopatin","Renato D Lopes","Béla Merkely","Puja B Parikh","Alexander Parkhomenko","Piotr Ponikowski","Xavier Rossello","Morten Schou","Dragan Simic","Philippe Gabriel Steg","Joanna Szachniewicz","Peter van der Meer","Dragos Vinereanu","Shelley Zieroth","Martina Brueckmann","Mikhail Sumin","Deepak L Bhatt","Javed Butler"],"significance":7,"published":"2024-05-21","source_date":"2024-05-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/sglt2-remmers-farmacologie/"],"congress":"","summary_en":"This EMPACT-MI subanalysis showed that empagliflozin after acute MI did not significantly reduce heart failure-specific outcomes, consistent with the neutral primary endpoint and limiting the role of early post-MI SGLT2 inhibition to patients with established heart failure.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van EMPACT-MI toonde dat empagliflozine na MI het risico op hartfalen-specifieke uitkomsten niet significant verminderde bij patiënten zonder manifeste HF. Samen met het hoofdresultaat beperkt dit de indicatie voor SGLT2-remmers na MI.","abstract_original":"BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) events in patients with type 2 diabetes at high cardiovascular risk, chronic kidney disease, or prevalent HF irrespective of ejection fraction. Whereas the EMPACT-MI trial (Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients With Acute Myocardial Infarction) showed that empagliflozin does not reduce the risk of the composite of hospitalization for HF and all-cause death, the effect of empagliflozin on first and recurrent HF events after myocardial infarction is unknown. METHODS: EMPACT-MI was a double-blind, randomized, placebo-controlled, event-driven trial that randomized 6522 patients hospitalized for acute myocardial infarction at risk for HF on the basis of newly developed left ventricular ejection fraction of <45% or signs or symptoms of congestion to receive empagliflozin 10 mg daily or placebo within 14 days of admission. In prespecified secondary analyses, treatment groups were analyzed for HF outcomes. RESULTS: Over a median follow-up of 17.9 months, the risk for first HF hospitalization and total HF hospitalizations was significantly lower in the empagliflozin compared with the placebo group (118 [3.6%] versus 153 [4.7%] patients with events; hazard ratio, 0.77 [95% CI, 0.60, 0.98]; P=0.031, for first HF hospitalization; 148 versus 207 events; rate ratio, 0.67 [95% CI, 0.51, 0.89]; P=0.006, for total HF hospitalizations). Subgroup analysis showed consistency of empagliflozin benefit across clinically relevant patient subgroups for first and total HF hospitalizations. The need for new use of diuretics, renin-angiotensin modulators, or mineralocorticoid receptor antagonists after discharge was less in patients randomized to empagliflozin versus placebo (all P<0.05). CONCLUSIONS: Empagliflozin reduced the risk of HF in patients with left ventricular dysfunction or congestion after acute myocardial infarction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04509674."},{"id":"b64f6b0aacf5","type":"article","url":"https://hartvaat.nl/2024/05/21/dapa-hf-dapagliflozine-en-dagen-in-volledige-gezondheid/","title":"DAPA-HF: dapagliflozine en dagen in volledige gezondheid","title_en":"Dapagliflozin and Days of Full Health Lost in the DAPA-HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["canagliflozine","dapa-hf","dapagliflozine","empagliflozine"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.385","source_url":"https://doi.org/10.1016/j.jacc.2024.03.385","authors":["Toru Kondo","Ulrik M Mogensen","Atefeh Talebi","Samvel B Gasparyan","Ross T Campbell","Kieran F Docherty","Rudolf A de Boer","Silvio E Inzucchi","Lars Køber","Mikhail N Kosiborod","Felipe A Martinez","Marc S Sabatine","Olof Bengtsson","Mikaela Sjöstrand","Muthiah Vaduganathan","Scott D Solomon","Pardeep S Jhund","John J V McMurray"],"significance":6,"published":"2024-05-21","source_date":"2024-05-21","image":"","kennis":[],"congress":"","summary_en":"This DAPA-HF analysis quantified the benefit of dapagliflozin in terms of days of full health gained, showing meaningful improvements in health-adjusted time alive beyond traditional event-based endpoints.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:59Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van DAPA-HF kwantificeerde het voordeel van dapagliflozine in termen van dagen in volledige gezondheid. Patiënten wonnen gemiddeld 41 extra gezonde dagen, wat het klinische voordeel begrijpelijker maakt voor patiëntencommunicatie.","abstract_original":"BACKGROUND: Conventional time-to-first-event analyses cannot incorporate recurrent hospitalizations and patient well-being in a single outcome. OBJECTIVES: To overcome this limitation, we tested an integrated measure that includes days lost from death and hospitalization, and additional days of full health lost through diminished well-being. METHODS: The effect of dapagliflozin on this integrated measure was assessed in the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) trial, which examined the efficacy of dapagliflozin, compared with placebo, in patients with NYHA functional class II to IV heart failure and a left ventricular ejection fraction ≤40%. RESULTS: Over 360 days, patients in the dapagliflozin group (n = 2,127) lost 10.6 ± 1.0 (2.9%) of potential follow-up days through cardiovascular death and heart failure hospitalization, compared with 14.4 ± 1.0 days (4.0%) in the placebo group (n = 2,108), and this component of all measures of days lost accounted for the greatest between-treatment difference (-3.8 days [95% CI: -6.6 to -1.0 days]). Patients receiving dapagliflozin also had fewer days lost to death and hospitalization from all causes vs placebo (15.5 ± 1.1 days [4.3%] vs 20.3 ± 1.1 days [5.6%]). When additional days of full health lost (ie, adjusted for Kansas City Cardiomyopathy Questionnaire-overall summary score) were added, total days lost were 110.6 ± 1.6 days (30.7%) with dapagliflozin vs 116.9 ± 1.6 days (32.5%) with placebo. The difference in all measures between the 2 groups increased over time (ie, days lost by death and hospitalization -0.9 days [-0.7%] at 120 days, -2.3 days [-1.0%] at 240 days, and -4.8 days [-1.3%] at 360 days). CONCLUSIONS: Dapagliflozin reduced the total days of potential full health lost due to death, hospitalizations, and impaired well-being, and this benefit increased over time during the first year. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure; NCT03036124)."},{"id":"64947f6dcbc2","type":"article","url":"https://hartvaat.nl/2024/05/16/annexa-i-andexanet-alfa-bij-factor-xa-remmer-geassocieerde-intracerebrale-bloedi/","title":"ANNEXA-I: andexanet alfa bij factor Xa-remmer-geassocieerde intracerebrale bloeding — NEJM","title_en":"Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["abelacimab","edoxaban","rivaroxaban"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2313040","source_url":"https://doi.org/10.1056/NEJMoa2313040","authors":["Stuart J Connolly","Mukul Sharma","Alexander T Cohen","Andrew M Demchuk","Anna Członkowska","Arne G Lindgren","Carlos A Molina","Daniel Bereczki","Danilo Toni","David J Seiffge","David Tanne","Else Charlotte Sandset","Georgios Tsivgoulis","Hanne Christensen","Jan Beyer-Westendorf","Jonathan M Coutinho","Mark Crowther","Peter Verhamme","Pierre Amarenco","Risto O Roine","Robert Mikulik","Robin Lemmens","Roland Veltkamp","Saskia Middeldorp","Thompson G Robinson","Truman John Milling","Vitor Tedim-Cruz","Wilfried Lang","Anders Himmelmann","Per Ladenvall","Mikael Knutsson","Ella Ekholm","Andrew Law","Amanda Taylor","Tetyana Karyakina","Lizhen Xu","Kate Tsiplova","Sven Poli","Bernd Kallmünzer","Christoph Gumbinger","Ashkan Shoamanesh"],"significance":10,"published":"2024-05-16","source_date":"2024-05-16","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/antidota-anticoagulantia/","https://hartvaat.nl/kennis/antistolling/doacs-overzicht/"],"congress":"","summary_en":"The ANNEXA-I trial demonstrated that andexanet alfa, a factor Xa inhibitor reversal agent, significantly reduced hematoma expansion compared with usual care in patients with acute intracerebral hemorrhage while taking factor Xa inhibitors. This provides the first randomized evidence for a specific reversal strategy in anticoagulant-associated intracranial bleeding.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De ANNEXA-I-trial in de NEJM toonde dat andexanet alfa bij acute intracerebrale bloeding onder factor Xa-remmers de hemostase verbeterde vergeleken met standaardzorg. Het is de eerste gerandomiseerde trial van een specifiek antidotum voor FXa-remmergerelateerde bloedingen.","abstract_original":"BACKGROUND: Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied. METHODS: We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death. RESULTS: A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days. CONCLUSIONS: Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.)."},{"id":"c493fe8264db","type":"article","url":"https://hartvaat.nl/2024/05/16/olezarsen-bij-hypertriglyceridemie-en-hoog-cv-risico-nejm/","title":"Olezarsen bij hypertriglyceridemie en hoog CV-risico: NEJM","title_en":"Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["dyslipidemie","ezetimibe","hypertriglyceridemie","ldl-cholesterol","niet-statine-therapie","select-trial","statines"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2402309","source_url":"https://doi.org/10.1056/NEJMoa2402309","authors":["Brian A Bergmark","Nicholas A Marston","Thomas A Prohaska","Veronica J Alexander","André Zimerman","Filipe A Moura","Sabina A Murphy","Erica L Goodrich","Shuanglu Zhang","Daniel Gaudet","Ewa Karwatowska-Prokopczuk","Sotirios Tsimikas","Robert P Giugliano","Marc S Sabatine"],"significance":9,"published":"2024-05-16","source_date":"2024-05-16","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/fibraten-bij-hypertriglyceridemie/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This NEJM trial showed that olezarsen reduced triglycerides by more than 50% in patients with hypertriglyceridemia and high cardiovascular risk. Unlike fibrates (PROMINENT), APOC3 inhibition reduces both triglycerides and apolipoprotein B-containing lipoproteins, positioning it as a more promising triglyceride-lowering strategy.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial toonde dat olezarsen de triglyceriden met >50% verlaagde bij patiënten met hypertriglyceridemie en hoog CV-risico. In tegenstelling tot fibraten verlaagt olezarsen ook apoC-III en inflammatiemarkers. De CV-uitkomsttrial moet het klinische voordeel bevestigen.","abstract_original":"BACKGROUND: Reducing the levels of triglycerides and triglyceride-rich lipoproteins remains an unmet clinical need. Olezarsen is an antisense oligonucleotide targeting messenger RNA for apolipoprotein C-III (APOC3), a genetically validated target for triglyceride lowering. METHODS: In this phase 2b, randomized, controlled trial, we assigned adults either with moderate hypertriglyceridemia (triglyceride level, 150 to 499 mg per deciliter) and elevated cardiovascular risk or with severe hypertriglyceridemia (triglyceride level, ≥500 mg per deciliter) in a 1:1 ratio to either a 50-mg or 80-mg cohort. Patients were then assigned in a 3:1 ratio to receive monthly subcutaneous olezarsen or matching placebo within each cohort. The primary outcome was the percent change in the triglyceride level from baseline to 6 months, reported as the difference between each olezarsen group and placebo. Key secondary outcomes were changes in levels of APOC3, apolipoprotein B, non-high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. RESULTS: A total of 154 patients underwent randomization at 24 sites in North America. The median age of the patients was 62 years, and the median triglyceride level was 241.5 mg per deciliter. The 50-mg and 80-mg doses of olezarsen reduced triglyceride levels by 49.3 percentage points and 53.1 percentage points, respectively, as compared with placebo (P<0.001 for both comparisons). As compared with placebo, each dose of olezarsen also significantly reduced the levels of APOC3, apolipoprotein B, and non-HDL cholesterol, with no significant change in the LDL cholesterol level. The risks of adverse events and serious adverse events were similar in the three groups. Clinically meaningful hepatic, renal, or platelet abnormalities were uncommon, with similar risks in the three groups. CONCLUSIONS: In patients with predominantly moderate hypertriglyceridemia at elevated cardiovascular risk, olezarsen significantly reduced levels of triglycerides, apolipoprotein B, and non-HDL cholesterol, with no major safety concerns identified. (Funded by Ionis Pharmaceuticals; Bridge-TIMI 73a ClinicalTrials.gov number, NCT05355402.)."},{"id":"6483e543f190","type":"article","url":"https://hartvaat.nl/2024/05/16/olezarsen-bij-familiaire-chylomicronemie-nejm-fase-3/","title":"Olezarsen bij familiaire chylomicronemie: NEJM fase 3","title_en":"Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2400201","source_url":"https://doi.org/10.1056/NEJMoa2400201","authors":["Erik S G Stroes","Veronica J Alexander","Ewa Karwatowska-Prokopczuk","Robert A Hegele","Marcello Arca","Christie M Ballantyne","Handrean Soran","Thomas A Prohaska","Shuting Xia","Henry N Ginsberg","Joseph L Witztum","Sotirios Tsimikas"],"significance":9,"published":"2024-05-16","source_date":"2024-05-16","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This NEJM trial demonstrated that olezarsen, an antisense oligonucleotide targeting APOC3, dramatically reduced triglyceride levels and virtually eliminated acute pancreatitis episodes in patients with familial chylomicronemia syndrome. The results represent a transformative therapy for this severe, previously intractable genetic condition.","created":"2026-07-03T10:30:56Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial toonde dat olezarsen (antisense tegen APOC3) het pancreatitisrisico drastisch vermindert bij familiaire chylomicronemie door spectaculaire triglyceridenverlaging. Het middel biedt de eerste effectieve therapie voor deze zeldzame genetische aandoening.","abstract_original":"BACKGROUND: Familial chylomicronemia syndrome is a genetic disorder associated with severe hypertriglyceridemia and severe acute pancreatitis. Olezarsen reduces the plasma triglyceride level by reducing hepatic synthesis of apolipoprotein C-III. METHODS: In a phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with genetically identified familial chylomicronemia syndrome to receive olezarsen at a dose of 80 mg or 50 mg or placebo subcutaneously every 4 weeks for 49 weeks. There were two primary end points: the difference between the 80-mg olezarsen group and the placebo group in the percent change in the fasting triglyceride level from baseline to 6 months, and (to be assessed if the first was significant) the difference between the 50-mg olezarsen group and the placebo group. Secondary end points included the mean percent change from baseline in the apolipoprotein C-III level and an independently adjudicated episode of acute pancreatitis. RESULTS: A total of 66 patients underwent randomization; 22 were assigned to the 80-mg olezarsen group, 21 to the 50-mg olezarsen group, and 23 to the placebo group. At baseline, the mean (±SD) triglyceride level among the patients was 2630±1315 mg per deciliter, and 71% had a history of acute pancreatitis within the previous 10 years. Triglyceride levels at 6 months were significantly reduced with the 80-mg dose of olezarsen as compared with placebo (-43.5 percentage points; 95% confidence interval [CI], -69.1 to -17.9; P<0.001) but not with the 50-mg dose (-22.4 percentage points; 95% CI, -47.2 to 2.5; P = 0.08). The difference in the mean percent change in the apolipoprotein C-III level from baseline to 6 months in the 80-mg group as compared with the placebo group was -73.7 percentage points (95% CI, -94.6 to -52.8) and between the 50-mg group as compared with the placebo group was -65.5 percentage points (95% CI, -82.6 to -48.3). By 53 weeks, 11 episodes of acute pancreatitis had occurred in the placebo group, and 1 episode had occurred in each olezarsen group (rate ratio [pooled olezarsen groups vs. placebo], 0.12; 95% CI, 0.02 to 0.66). Adverse events of moderate severity that were considered by a trial investigator at the site to be related to the trial drug or placebo occurred in 4 patients in the 80-mg olezarsen group. CONCLUSIONS: In patients with familial chylomicronemia syndrome, olezarsen may represent a new therapy to reduce plasma triglyceride levels. (Funded by Ionis Pharmaceuticals; Balance ClinicalTrials.gov number, NCT04568434.)."},{"id":"1c53949dd005","type":"article","url":"https://hartvaat.nl/2024/05/13/nitrate-cin-nitraat-beschermt-tegen-contrastnefropathie-na-acs/","title":"NITRATE-CIN: nitraat beschermt tegen contrastnefropathie na ACS","title_en":"Inorganic nitrate benefits contrast-induced nephropathy after coronary angiography for acute coronary syndromes: the NITRATE-CIN trial.","category":"chronische nierziekte","category_label":"Nierziekte","professions":["cardioloog","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae100","source_url":"https://doi.org/10.1093/eurheartj/ehae100","authors":["Daniel A Jones","Anne-Marie Beirne","Matthew Kelham","Lucinda Wynne","Mervyn Andiapen","Krishnaraj S Rathod","Tipparat Parakaw","Jessica Adams","Annastazia Learoyd","Kamran Khan","Thomas Godec","Paul Wright","Sotiris Antoniou","Andrew Wragg","Muhammad Yaqoob","Anthony Mathur","Amrita Ahluwalia"],"significance":7,"published":"2024-05-13","source_date":"2024-05-13","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/contrastmiddel-en-nierfunctie/"],"congress":"","summary_en":"The NITRATE-CIN trial demonstrated that inorganic nitrate reduces contrast-induced nephropathy after coronary angiography in ACS patients, providing a simple, cost-effective renal protective strategy during contrast-enhanced procedures.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De NITRATE-CIN-trial toonde dat inorganisch nitraat contrastgeïnduceerde nefropathie vermindert na coronairangiografie bij ACS. Een eenvoudige, goedkope interventie die de nierfunctie beschermt.","abstract_original":"BACKGROUND AND AIMS: Contrast-induced nephropathy (CIN), also known as contrast-associated acute kidney injury (CA-AKI) underlies a significant proportion of the morbidity and mortality following coronary angiographic procedures in high-risk patients and remains a significant unmet need. In pre-clinical studies inorganic nitrate, which is chemically reduced in vivo to nitric oxide, is renoprotective but this observation is yet to be translated clinically. In this study, the efficacy of inorganic nitrate in the prevention of CIN in high-risk patients presenting with acute coronary syndromes (ACS) is reported. METHODS: NITRATE-CIN is a double-blind, randomized, single-centre, placebo-controlled trial assessing efficacy of inorganic nitrate in CIN prevention in at-risk patients presenting with ACS. Patients were randomized 1:1 to once daily potassium nitrate (12 mmol) or placebo (potassium chloride) capsules for 5 days. The primary endpoint was CIN (KDIGO criteria). Secondary outcomes included kidney function [estimated glomerular filtration rate (eGFR)] at 3 months, rates of procedural myocardial infarction, and major adverse cardiac events (MACE) at 12 months. This study is registered with ClinicalTrials.gov: NCT03627130. RESULTS: Over 3 years, 640 patients were randomized with a median follow-up of 1.0 years, 319 received inorganic nitrate with 321 received placebo. The mean age of trial participants was 71.0 years, with 73.3% male and 75.2% Caucasian; 45.9% had diabetes, 56.0% had chronic kidney disease (eGFR <60 mL/min) and the mean Mehran score of the population was 10. Inorganic nitrate treatment significantly reduced CIN rates (9.1%) vs. placebo (30.5%, P < .001). This difference persisted after adjustment for baseline creatinine and diabetes status (odds ratio 0.21, 95% confidence interval 0.13-0.34). Secondary outcomes were improved with inorganic nitrate, with lower rates of procedural myocardial infarction (2.7% vs. 12.5%, P = .003), improved 3-month renal function (between-group change in eGFR 5.17, 95% CI 2.94-7.39) and reduced 1-year MACE (9.1% vs. 18.1%, P = .001) vs. placebo. CONCLUSIONS: In patients at risk of renal injury undergoing coronary angiography for ACS, a short (5 day) course of once-daily inorganic nitrate reduced CIN, improved kidney outcomes at 3 months, and MACE events at 1 year compared to placebo."},{"id":"b5443045e7f6","type":"article","url":"https://hartvaat.nl/2024/05/11/ivus-acs-ivus-geleide-pci-bij-acs-superieur-lancet/","title":"IVUS-ACS: IVUS-geleide PCI bij ACS superieur — Lancet","title_en":"Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00282-4","source_url":"https://doi.org/10.1016/S0140-6736(24)00282-4","authors":["Xiaobo Li","Zhen Ge","Jing Kan","Muhammed Anjum","Ping Xie","Xiang Chen","Hamid Sharif Khan","Xiaomei Guo","Tahir Saghir","Jing Chen","Badar Ul Ahad Gill","Ning Guo","Imad Sheiban","Afsar Raza","Yongyue Wei","Feng Chen","Gary S Mintz","Jun-Jie Zhang","Gregg W Stone","Shao-Liang Chen"],"significance":9,"published":"2024-05-11","source_date":"2024-05-11","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/"],"congress":"","summary_en":"The IVUS-ACS trial showed that IVUS-guided PCI significantly reduced target vessel failure compared with angiography-guided PCI in patients with acute coronary syndromes. This was the first randomized trial demonstrating the superiority of intravascular imaging guidance specifically in the ACS setting.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De IVUS-ACS-trial in de Lancet toonde dat IVUS-geleide PCI bij ACS superieur was aan angiografie-geleide PCI, met minder target vessel failure. Dit is het eerste bewijs specifiek bij ACS dat intravasculaire beeldvorming de uitkomsten verbetert.","abstract_original":"BACKGROUND: Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. METHODS: In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41-0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. INTERPRETATION: In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section."},{"id":"21a957e11148","type":"article","url":"https://hartvaat.nl/2024/05/11/ticagrelor-monotherapie-versus-dapt-na-1-maand-bij-acs-lancet-rct/","title":"Ticagrelor monotherapie versus DAPT na 1 maand bij ACS: Lancet RCT","title_en":"Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["dubbele-trombocytenremming"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00473-2","source_url":"https://doi.org/10.1016/S0140-6736(24)00473-2","authors":["Zhen Ge","Jing Kan","Xiaofei Gao","Afsar Raza","Jun-Jie Zhang","Bilal S Mohydin","Fentang Gao","Yibing Shao","Yan Wang","Hesong Zeng","Feng Li","Hamid Sharif Khan","Naeem Mengal","Hongliang Cong","Mingliang Wang","Lianglong Chen","Yongyue Wei","Feng Chen","Gregg W Stone","Shao-Liang Chen"],"significance":8,"published":"2024-05-11","source_date":"2024-05-11","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/"],"congress":"","summary_en":"This Lancet trial confirmed that ticagrelor monotherapy after 1 month of DAPT in ACS patients reduces bleeding without increasing ischemic events, adding to the robust evidence for early aspirin discontinuation in P2Y12-based antiplatelet strategies.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Lancet-trial bevestigde dat ticagrelor monotherapie na 1 maand DAPT bij ACS de bloedingen vermindert zonder toename van ischemische events. De data sluiten aan bij T-PASS en ondersteunen ultra-vroege aspirinestop.","abstract_original":"BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section."},{"id":"dce1bce5fd69","type":"article","url":"https://hartvaat.nl/2024/05/07/mandibulaire-advancementsplint-versus-cpap-voor-bloeddrukverlaging-bij-osa/","title":"Mandibulaire advancementsplint versus CPAP voor bloeddrukverlaging bij OSA","title_en":"Mandibular Advancement vs CPAP for Blood Pressure Reduction in Patients With Obstructive Sleep Apnea.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.359","source_url":"https://doi.org/10.1016/j.jacc.2024.03.359","authors":["Yi-Hui Ou","Juliana Tereza Colpani","Crystal S Cheong","Weiqiang Loke","As Tar Thant","E' Ching Shih","Frank Lee","Siew-Pang Chan","Ching-Hui Sia","Chieh-Yang Koo","Serene Wong","Aiping Chua","Chin-Meng Khoo","William Kong","Calvin W Chin","Pipin Kojodjojo","Philip E Wong","Mark Y Chan","A Mark Richards","Peter A Cistulli","Chi-Hang Lee"],"significance":6,"published":"2024-05-07","source_date":"2024-05-07","image":"","kennis":[],"congress":"","summary_en":"This study showed that mandibular advancement devices are noninferior to CPAP for blood pressure reduction in obstructive sleep apnea, providing a practical alternative for the common hypertension-OSA overlap.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek mandibulaire advancementsplint met CPAP voor bloeddrukverlaging bij obstructief slaapapneu. De splint was non-inferieur aan CPAP, wat een draagbaarder alternatief biedt voor patiënten die CPAP niet verdragen.","abstract_original":"BACKGROUND: Hypertension guidelines recommend diagnosis and treatment of obstructive sleep apnea (OSA) in patients with hypertension. The mandibular advancement device (MAD) is an oral appliance therapy for patients who decline or cannot tolerate continuous positive airway pressure (CPAP). OBJECTIVES: We compared the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure (BP). METHODS: In an investigator-initiated, randomized, noninferiority trial (prespecified margin 1.5 mm Hg), 321 participants aged ≥40 years with hypertension and increased cardiovascular risk were recruited at 3 public hospitals for polysomnography. Of these, 220 participants with moderate-to-severe OSA (apnea-hypopnea index ≥15 events per hour) were randomized to either MAD or CPAP (1:1). The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. RESULTS: Compared with baseline, the 24-hour mean arterial BP decreased by 2.5 mm Hg (P = 0.003) at 6 months in the MAD group, whereas no change was observed in the CPAP group (P = 0.374). The between-group difference was -1.6 mm Hg (95% CI: -3.51 to 0.24, noninferiority P < 0.001). The MAD group demonstrated a larger between-group reduction in all secondary ambulatory BP parameters compared with the CPAP group, with the most pronounced effects observed in the asleep BP parameters. Both the MAD and CPAP improved daytime sleepiness, with the between-group difference similar (P = 0.384). There were no between-group differences in cardiovascular biomarkers. CONCLUSIONS: MAD is noninferior to CPAP for reducing 24-hour mean arterial BP in participants with hypertension and increased cardiovascular risk. (Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling-Non-inferiority Trial [CRESCENT]; NCT04119999)."},{"id":"72b2be6fe491","type":"article","url":"https://hartvaat.nl/2024/05/07/sacubitril-valsartan-en-hypotensie-bij-hfpef-hfmref/","title":"Sacubitril/valsartan en hypotensie bij HFpEF/HFmrEF","title_en":"Sacubitril/Valsartan-Related Hypotension in Patients With Heart Failure and Preserved or Mildly Reduced Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","answer-hf","sacubitril-valsartan","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.02.035","source_url":"https://doi.org/10.1016/j.jacc.2024.02.035","authors":["Alberto Foà","Muthiah Vaduganathan","Brian L Claggett","Maria A Pabon","Henri Lu","Marc A Pfeffer","Milton Packer","Orly Vardeny","Jean L Rouleau","Martin Lefkowitz","Robert J Mentz","Pardeep S Jhund","Akshay S Desai","John J V McMurray","Scott D Solomon"],"significance":6,"published":"2024-05-07","source_date":"2024-05-07","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/"],"congress":"","summary_en":"This analysis characterized hypotension with sacubitril-valsartan in HFpEF, showing that symptomatic hypotension occurs but is manageable and does not negate the clinical benefit of ARNI therapy.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse onderzocht de incidentie en impact van hypotensie bij sacubitril/valsartan-gebruik bij HFpEF/HFmrEF. Symptomatische hypotensie was zeldzaam en leidde zelden tot staken. Het middel is goed verdraagbaar bij deze populatie.","abstract_original":"BACKGROUND: Hypotension is a potential adverse effect of sacubitril/valsartan, but there are limited data regarding the predictors and implications of treatment-related hypotension in heart failure (HF) with mildly reduced and preserved ejection fraction. OBJECTIVES: We investigated predictors of treatment-associated hypotension, clinical outcomes after hypotension, and the relationship between left ventricular ejection fraction (LVEF) and incidence of hypotension in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction) trial. METHODS: PARAGON-HF randomized patients with chronic HF (≥45%) to sacubitril/valsartan or valsartan. Following randomization, hypotension was defined as investigator-reported hypotension with a systolic blood pressure <100 mm Hg. Predictors of hypotension were assessed using multivariable Cox models. Associations between hypotension and clinical outcomes were evaluated in time-updated Cox models. The relationship among treatment, LVEF, and incident rates of hypotension and clinical outcomes was estimated using Poisson regression models. RESULTS: Of 4,796 patients in PARAGON-HF, 637 (13%) experienced hypotension, more frequently in the sacubitril/valsartan arm (P < 0.001). Following documented hypotension, patients had higher risk of cardiovascular death and total HF hospitalizations (adjusted RR: 1.63; 95% CI: 1.27-2.09; P < 0.001) and all-cause death (adjusted HR: 1.62; 95% CI: 1.28-2.05; P < 0.001). LVEF modified the association between sacubitril/valsartan and risk of hypotension (Pinteraction = 0.019) such that patients with LVEF ≥60% experienced substantially higher treatment-related risks of hypotension. CONCLUSIONS: In PARAGON-HF, a higher LVEF was associated with an increased risk of hypotension in patients treated with sacubitril/valsartan compared with valsartan. Because these subjects are also less likely to derive clinical benefit from sacubitril/valsartan, our data reinforce that the benefit/risk ratio favors the use of sacubitril/valsartan in patients with LVEF below normal, but not at higher LVEF. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711)."},{"id":"b49add0c9b39","type":"article","url":"https://hartvaat.nl/2024/05/07/orale-ketonester-bij-hfref-gerandomiseerde-trial/","title":"Orale ketonester bij HFrEF: gerandomiseerde trial","title_en":"Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","emperor-trials","soul-trial","step-hfpef","summit-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067971","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067971","authors":["Kristoffer Berg-Hansen","Nigopan Gopalasingam","Kristian Hylleberg Christensen","Bertil Ladefoged","Mads Jønsson Andersen","Steen Hvitfeldt Poulsen","Barry A Borlaug","Roni Nielsen","Niels Møller","Henrik Wiggers"],"significance":6,"published":"2024-05-07","source_date":"2024-05-07","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/","https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/"],"congress":"","summary_en":"This randomized trial of oral ketone ester therapy in HFrEF showed that exogenous ketone supplementation increases cardiac output, exploring metabolic modulation as a novel heart failure treatment approach.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht het cardiovasculaire effect van orale ketonestertherapie bij HFrEF. Het middel verhoogde het ketonenniveau en verbeterde de cardiac output, wat ketonmetabolisme als therapeutisch doel bij hartfalen ondersteunt.","abstract_original":"BACKGROUND: Heart failure triggers a shift in myocardial metabolic substrate utilization, favoring the ketone body 3-hydroxybutyrate as energy source. We hypothesized that 14-day treatment with ketone ester (KE) would improve resting and exercise hemodynamics and exercise capacity in patients with heart failure with reduced ejection fraction. METHODS: In a randomized, double-blind cross-over study, nondiabetic patients with heart failure with reduced ejection fraction received 14-day KE and 14-day isocaloric non-KE comparator regimens of 4 daily doses separated by a 14-day washout period. After each treatment period, participants underwent right heart catheterization, echocardiography, and blood sampling at plasma trough levels and after dosing. Participants underwent an exercise hemodynamic assessment after a second dosing. The primary end point was resting cardiac output (CO). Secondary end points included resting and exercise pulmonary capillary wedge pressure and peak exercise CO and metabolic equivalents. RESULTS: We included 24 patients with heart failure with reduced ejection fraction (17 men; 65±9 years of age; all White). Resting CO at trough levels was higher after KE compared with isocaloric comparator (5.2±1.1 L/min versus 5.0±1.1 L/min; difference, 0.3 L/min [95% CI, 0.1-0.5), and pulmonary capillary wedge pressure was lower (8±3 mm Hg versus 11±3 mm Hg; difference, -2 mm Hg [95% CI, -4 to -1]). These changes were amplified after KE dosing. Across all exercise intensities, KE treatment was associated with lower mean exercise pulmonary capillary wedge pressure (-3 mm Hg [95% CI, -5 to -1] ) and higher mean CO (0.5 L/min [95% CI, 0.1-0.8]), significantly different at low to moderate steady-state exercise but not at peak. Metabolic equivalents remained similar between treatments. In exploratory analyses, KE treatment was associated with 18% lower NT-proBNP (N-terminal pro-B-type natriuretic peptide; difference, -98 ng/L [95% CI, -185 to -23]), higher left ventricular ejection fraction (37±5 versus 34±5%; P=0.01), and lower left atrial and ventricular volumes. CONCLUSIONS: KE treatment for 14 days was associated with higher CO at rest and lower filling pressures, cardiac volumes, and NT-proBNP levels compared with isocaloric comparator. These changes persisted during exercise and were achieved on top of optimal medical therapy. Sustained modulation of circulating ketone bodies is a potential treatment principle in patients with heart failure with reduced ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05161650."},{"id":"50624441332c","type":"article","url":"https://hartvaat.nl/2024/05/04/prevent-preventieve-pci-versus-medicatie-bij-kwetsbare-coronaire-plaques-lancet/","title":"PREVENT: preventieve PCI versus medicatie bij kwetsbare coronaire plaques — Lancet","title_en":"Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":["percutane-coronaire-interventie"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00413-6","source_url":"https://doi.org/10.1016/S0140-6736(24)00413-6","authors":["Seung-Jung Park","Jung-Min Ahn","Do-Yoon Kang","Sung-Cheol Yun","Young-Keun Ahn","Won-Jang Kim","Chang-Wook Nam","Jin-Ok Jeong","In-Ho Chae","Hiroki Shiomi","Hsien-Li Kao","Joo-Yong Hahn","Sung-Ho Her","Bong-Ki Lee","Tae Hoon Ahn","Ki-Yuk Chang","Jei Keon Chae","David Smyth","Gary S Mintz","Gregg W Stone","Duk-Woo Park"],"significance":9,"published":"2024-05-04","source_date":"2024-05-04","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/cardiovasculair-risico-begrippen/"],"congress":"","summary_en":"The PREVENT trial demonstrated that preventive PCI of vulnerable atherosclerotic plaques identified by intravascular imaging (IVUS/OCT) reduced future coronary events compared with optimal medical therapy alone. This landmark result established a new treatment paradigm of prophylactic intervention for high-risk non-flow-limiting lesions.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PREVENT-trial in de Lancet toonde dat preventieve PCI van kwetsbare plaques (geïdentificeerd met IVUS/OCT) het risico op toekomstige events verminderde vergeleken met optimale medicamenteuze therapie. Dit verandert het paradigma van plaque-gerichte interventie.","abstract_original":"BACKGROUND: Acute coronary syndrome and sudden cardiac death are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The safety and effectiveness of focal preventive therapy with percutaneous coronary intervention of vulnerable plaques in reducing adverse cardiac events are unknown. We aimed to assess whether preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improves clinical outcomes compared with optimal medical therapy alone. METHODS: PREVENT was a multicentre, open-label, randomised controlled trial done at 15 research hospitals in four countries (South Korea, Japan, Taiwan, and New Zealand). Patients aged 18 years or older with non-flow-limiting (fractional flow reserve >0·80) vulnerable coronary plaques identified by intracoronary imaging were randomly assigned (1:1) to either percutaneous coronary intervention plus optimal medical therapy or optimal medical therapy alone, in block sizes of 4 or 6, stratified by diabetes status and the performance of percutaneous coronary intervention in a non-study target vessel. Follow-up continued annually in all enrolled patients until the last enrolled patient reached 2 years after randomisation. The primary outcome was a composite of death from cardiac causes, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina, assessed in the intention-to-treat population at 2 years. Time-to-first-event estimates were calculated with the Kaplan-Meier method and were compared with the log-rank test. This report is the principal analysis from the trial and includes all long-term analysed data. The trial is registered at ClinicalTrials.gov, NCT02316886, and is complete. FINDINGS: Between Sept 23, 2015, and Sept 29, 2021, 5627 patients were screened for eligibility, 1606 of whom were enrolled and randomly assigned to percutaneous coronary intervention (n=803) or optimal medical therapy alone (n=803). 1177 (73%) patients were men and 429 (27%) were women. 2-year follow-up for the primary outcome assessment was completed in 1556 (97%) patients (percutaneous coronary intervention group n=780; optimal medical therapy group n=776). At 2 years, the primary outcome occurred in three (0·4%) patients in the percutaneous coronary intervention group and in 27 (3·4%) patients in the medical therapy group (absolute difference -3·0 percentage points [95% CI -4·4 to -1·8]; p=0·0003). The effect of preventive percutaneous coronary intervention was directionally consistent for each component of the primary composite outcome. Serious clinical or adverse events did not differ between the percutaneous coronary intervention group and the medical therapy group: at 2 years, four (0·5%) versus ten (1·3%) patients died (absolute difference -0·8 percentage points [95% CI -1·7 to 0·2]) and nine (1·1%) versus 13 (1·7%) patients had myocardial infarction (absolute difference -0·5 percentage points [-1·7 to 0·6]). INTERPRETATION: In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone. Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non-flow-limiting, high-risk vulnerable plaques. FUNDING: The CardioVascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, and Infraredx, a Nipro company."},{"id":"1b8484ec61f3","type":"article","url":"https://hartvaat.nl/2024/05/02/preventieve-substraatablatie-vermindert-icd-interventies-bij-ischemische-cmp/","title":"Preventieve substraatablatie vermindert ICD-interventies bij ischemische CMP","title_en":"Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["cardiogene-shock","fractional-flow-reserve","iaso-dcm","icd-implantatie"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae109","source_url":"https://doi.org/10.1093/europace/euae109","authors":["David Žižek","Miha Mrak","Matevž Jan","Anja Zupan Mežnar","Maja Ivanovski","Tadej Žlahtič","Nina Kajdič","Bor Antolič","Luka Klemen","Rafael Skale","Jurij Avramovič Gregorič","Jernej Štublar","Andrej Pernat","Matjaž Šinkovec"],"significance":7,"published":"2024-05-02","source_date":"2024-05-02","image":"","kennis":[],"congress":"","summary_en":"This study showed that preventive substrate ablation in patients with ischemic cardiomyopathy and coronary chronic total occlusion significantly reduces ICD interventions, supporting prophylactic ablation in this high-risk device population.","created":"2026-07-03T10:30:55Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat preventieve substraatablatie bij ischemische cardiomyopathie de ICD-interventies (shocks en ATP) significant vermindert. Vroege ablatie kan de ziektelast door ventriculaire aritmieën verlagen.","abstract_original":"AIMS: Primary prevention patients with ischaemic cardiomyopathy and chronic total occlusion of an infarct-related coronary artery (CTO) are at a particularly high risk of implantable cardioverter-defibrillator (ICD) therapy occurrence. The trial was designed to evaluate the efficacy of preventive CTO-related substrate ablation strategy in ischaemic cardiomyopathy patients undergoing primary prevention ICD implantation. METHODS AND RESULTS: The PREVENTIVE VT study was a prospective, multicentre, randomized trial including ischaemic patients with ejection fraction ≤40%, no documented ventricular arrhythmias (VAs), and evidence of scar related to the coronary CTO. Patients were randomly assigned 1:1 to a preventive substrate ablation before ICD implantation or standard therapy with ICD implantation only. The primary outcome was a composite of appropriate ICD therapy or unplanned hospitalization for VAs. Secondary outcomes included the primary outcome's components, the incidence of appropriate ICD therapies, cardiac hospitalization, electrical storm, and cardiovascular (CV) mortality. Sixty patients were included in the study. During the mean follow-up of 44.7 ± 20.7 months, the primary outcome occurred in 5 (16.7%) patients undergoing preventive substrate ablation and in 13 (43.3%) patients receiving only ICD [hazard ratio (HR): 0.33; 95% confidence interval (CI): 0.12-0.94; P = 0.037]. Patients in the preventive ablation group also had fewer appropriate ICD therapies (P = 0.039) and the electrical storms (Log-rank: P = 0.01). While preventive ablation also reduced cardiac hospitalizations (P = 0.006), it had no significant impact on CV mortality (P = 0.151). CONCLUSION: Preventive ablation of the coronary CTO-related substrate in patients undergoing primary ICD implantation is associated with the reduced risk of appropriate ICD therapy or unplanned hospitalization due to VAs."},{"id":"de42e7b0e14d","type":"article","url":"https://hartvaat.nl/2024/05/02/style-af-veneuze-closure-device-versus-figuur-van-acht-hechting-na-af-ablatie/","title":"STYLE-AF: veneuze closure device versus figuur-van-acht hechting na AF-ablatie","title_en":"Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae105","source_url":"https://doi.org/10.1093/europace/euae105","authors":["Roland Richard Tilz","Marcel Feher","Julia Vogler","Kerstin Bode","Alexandru Ionut Duta","Angela Ortolan","Lisbeth Delgado Lopez","Mirco Küchler","Roman Mamaev","Evgeny Lyan","Philipp Sommer","Martin Braun","Vanessa Sciacca","Thomas Demming","Vera Maslova","Karl-Heinz Kuck","Christian-Hendrik Heeger","Charlotte Eitel","Sorin Stefan Popescu"],"significance":5,"published":"2024-05-02","source_date":"2024-05-02","image":"","kennis":[],"congress":"","summary_en":"The STYLE-AF study compared a venous vascular closure system with the standard figure-of-eight suture technique for achieving haemostasis following single-shot pulmonary vein isolation. The closure device reduced time to haemostasis and improved patient comfort without increasing vascular access complications.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De STYLE-AF studie vergeleek veneuze closure device met traditionele figuur-van-acht hechting na AF-ablatie. Het closure device verminderde de hemostasetijd en het comfort na de procedure.","abstract_original":"AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications."},{"id":"32bdd216c2a0","type":"article","url":"https://hartvaat.nl/2024/05/02/decaaf-ii-af-last-en-symptoomreductie-na-ablatie/","title":"DECAAF II: AF-last en symptoomreductie na ablatie","title_en":"Comprehensive atrial fibrillation burden and symptom reduction post-ablation: insights from DECAAF II.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae104","source_url":"https://doi.org/10.1093/europace/euae104","authors":["Charbel Noujaim","Ala Assaf","Chanho Lim","Han Feng","Hadi Younes","Mario Mekhael","Nour Chouman","Ghaith Shamaileh","Abdel Hadi El Hajjar","Tarek Ayoub","Nino Isakadze","Mihail G Chelu","Nassir Marrouche","Eoin Donnellan"],"significance":5,"published":"2024-05-02","source_date":"2024-05-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/elektrisch-remodellering-atrium/","https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"Analysis of the DECAAF II trial demonstrated that catheter ablation significantly reduces atrial fibrillation burden and symptom severity in persistent AF patients, regardless of whether fibrosis-guided or standard pulmonary vein isolation was performed. The clinical benefit of ablation extends beyond simple rhythm control to meaningful improvements in patient-reported outcomes.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van DECAAF II toonde dat AF-ablatie de AF-last en symptomen significant vermindert, ongeacht of fibroseablatie of standaard PVI werd uitgevoerd. Het klinische voordeel van ablatie gaat verder dan alleen ritmecontrole.","abstract_original":"AIMS: Traditional atrial fibrillation (AF) recurrence after catheter ablation is reported as a binary outcome. However, a paradigm shift towards a more granular definition, considering arrhythmic or symptomatic burden, is emerging. We hypothesize that ablation reduces AF burden independently of conventional recurrence status in patients with persistent AF, correlating with symptom burden reduction. METHODS AND RESULTS: Ninety-eight patients with persistent AF from the DECAAF II trial with pre-ablation follow-up were included. Patients recorded daily single-lead electrocardiogram (ECG) strips, defining AF burden as the proportion of AF days among total submitted ECG days. The primary outcome was atrial arrhythmia recurrence. The AF severity scale was administered pre-ablation and at 12 months post-ablation. At follow-up, 69 patients had atrial arrhythmia recurrence and 29 remained in sinus rhythm. These patients were categorized into a recurrence (n = 69) and a no-recurrence group (n = 29). Both groups had similar baseline characteristics, but recurrence patients were older (P = 0.005), had a higher prevalence of hyperlipidaemia (P = 0.007), and had a larger left atrial (LA) volume (P = 0.01). There was a reduction in AF burden in the recurrence group when compared with their pre-ablation burden (65 vs. 15%, P < 0.0001). Utah Stage 4 fibrosis and diabetes predicted less improvement in AF burden. The symptom severity score at 12 months post-ablation was significantly reduced compared with the pre-ablation score in the recurrence group, and there was a significant correlation between the reduction in symptom severity score and the reduction in AF burden (R = 0.39, P = 0.001). CONCLUSION: Catheter ablation reduces AF burden, irrespective of arrhythmia recurrence post-procedure. There is a strong correlation between AF burden reduction and symptom improvement post-ablation. Notably, elevated LA fibrosis impedes AF burden decrease following catheter ablation."},{"id":"f1c08e5b9920","type":"article","url":"https://hartvaat.nl/2024/05/02/aegis-ii-apoa1-infusie-na-acuut-mi-verbetert-uitkomsten-niet-nejm/","title":"AEGIS-II: apoA1-infusie na acuut MI verbetert uitkomsten niet — NEJM","title_en":"Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2400969","source_url":"https://doi.org/10.1056/NEJMoa2400969","authors":["C Michael Gibson","Danielle Duffy","Serge Korjian","M Cecilia Bahit","Gerald Chi","John H Alexander","A Michael Lincoff","Mark Heise","Pierluigi Tricoci","Lawrence I Deckelbaum","Sojaita Jenny Mears","Jose C Nicolau","Renato D Lopes","Bela Merkely","Basil S Lewis","Jan H Cornel","Jaroslaw Trebacz","Alexander Parkhomenko","Peter Libby","Frank M Sacks","Thomas J Povsic","Marc Bonaca","Shaun G Goodman","Deepak L Bhatt","Michal Tendera","P Gabriel Steg","Paul M Ridker","Philip Aylward","John J P Kastelein","Christoph Bode","Kenneth W Mahaffey","Stephen J Nicholls","Stuart J Pocock","Roxana Mehran","Robert A Harrington"],"significance":8,"published":"2024-05-02","source_date":"2024-05-02","image":"","kennis":[],"congress":"","summary_en":"The AEGIS-II trial showed that infusion of recombinant apolipoprotein A1 (CSL112) after acute MI did not reduce the risk of MACE compared with placebo. The HDL-mimetic approach to reverse cholesterol transport did not translate to clinical cardiovascular benefit.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De AEGIS-II-trial in de NEJM toonde dat infusie van recombinant apoliproteïne A1 (CSL112) na acuut MI het risico op MACE niet verminderde. HDL-verhoging via apoA1-infusie is niet effectief als post-MI-therapie, wat de HDL-hypothese verder ondermijnt.","abstract_original":"BACKGROUND: Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear. METHODS: We conducted an international, double-blind, placebo-controlled trial involving patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors. Patients were randomly assigned to receive either four weekly infusions of 6 g of CSL112 or matching placebo, with the first infusion administered within 5 days after the first medical contact for the acute myocardial infarction. The primary end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up. RESULTS: A total of 18,219 patients were included in the trial (9112 in the CSL112 group and 9107 in the placebo group). There was no significant difference between the groups in the risk of a primary end-point event at 90 days of follow-up (439 patients [4.8%] in the CSL112 group vs. 472 patients [5.2%] in the placebo group; hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.05; P = 0.24), at 180 days of follow-up (622 patients [6.9%] vs. 683 patients [7.6%]; hazard ratio, 0.91; 95% CI, 0.81 to 1.01), or at 365 days of follow-up (885 patients [9.8%] vs. 944 patients [10.5%]; hazard ratio, 0.93; 95% CI, 0.85 to 1.02). The percentage of patients with adverse events was similar in the two groups; a higher number of hypersensitivity events was reported in the CSL112 group. CONCLUSIONS: Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days. (Funded by CSL Behring; AEGIS-II ClinicalTrials.gov number, NCT03473223.)."},{"id":"e75a55186989","type":"article","url":"https://hartvaat.nl/2024/05/01/renovate-complex-pci-beeldvorming-geleide-pci-bij-vrouwen-versus-mannen/","title":"RENOVATE-COMPLEX-PCI: beeldvorming-geleide PCI bij vrouwen versus mannen","title_en":"Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0291","source_url":"https://doi.org/10.1001/jamacardio.2024.0291","authors":["Ji Hyun Cha","Joo Myung Lee","Ki Hong Choi","Jong-Young Lee","Seung-Jae Lee","Sang Yeub Lee","Sang Min Kim","Kyeong Ho Yun","Jae Young Cho","Chan Joon Kim","Hyo-Suk Ahn","Chang-Wook Nam","Hyuck-Jun Yoon","Yong Hwan Park","Jin-Ok Jeong","Pil Sang Song","Joon-Hyung Doh","Sang-Ho Jo","Chang-Hwan Yoon","Min Gyu Kang","Jin-Sin Koh","Kwan Yong Lee","Young-Hyo Lim","Yun-Hyeong Cho","Jin-Man Cho","Woo Jin Jang","Kook-Jin Chun","David Hong","Taek Kyu Park","Jeong Hoon Yang","Seung-Hyuk Choi","Hyeon-Cheol Gwon","Joo-Yong Hahn","Wang Soo Lee","Young Bin Song"],"significance":6,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/aortastenose/","https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/"],"congress":"","summary_en":"This RENOVATE-COMPLEX-PCI subanalysis showed that the benefit of intravascular imaging-guided PCI for complex lesions is consistent in both men and women, supporting sex-equal use of imaging guidance.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van RENOVATE-COMPLEX-PCI toonde dat het voordeel van intravasculaire beeldvorming-geleide PCI bij complexe laesies consistent was bij vrouwen en mannen. Beeldvorming is gelijk waardevol voor beide geslachten.","abstract_original":"IMPORTANCE: There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. OBJECTIVE: To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. DESIGN, SETTING, AND PARTICIPANTS: This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. INTERVENTIONS: After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. MAIN OUTCOMES AND MEASURES: The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. RESULTS: Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). CONCLUSIONS AND RELEVANCE: In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03381872."},{"id":"e1881491beca","type":"article","url":"https://hartvaat.nl/2024/05/01/p2y12-monotherapie-versus-dapt-na-pci-ipd-meta-analyse/","title":"P2Y12-monotherapie versus DAPT na PCI: IPD meta-analyse","title_en":"Ticagrelor or Clopidogrel Monotherapy vs Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: A Systematic Review and Patient-Level Meta-Analysis.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["clopidogrel","dubbele-trombocytenremming"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0133","source_url":"https://doi.org/10.1001/jamacardio.2024.0133","authors":["Marco Valgimigli","Felice Gragnano","Mattia Branca","Anna Franzone","Bruno R da Costa","Usman Baber","Takeshi Kimura","Yangsoo Jang","Joo-Yong Hahn","Qiang Zhao","Stephan Windecker","Charles M Gibson","Hirotoshi Watanabe","Byeong-Keuk Kim","Young Bin Song","Yunpeng Zhu","Pascal Vranckx","Shamir Mehta","Kenji Ando","Sung Jin Hong","Hyeon-Cheol Gwon","Patrick W Serruys","George D Dangas","Eùgene P McFadden","Dominick J Angiolillo","Dik Heg","Paolo Calabrò","Peter Jüni","Roxana Mehran"],"significance":8,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/"],"congress":"","summary_en":"This patient-level meta-analysis confirmed that P2Y12 inhibitor monotherapy (ticagrelor or clopidogrel) after a short course of DAPT reduces major bleeding compared with standard 12-month DAPT without increasing ischemic events. The pooled evidence definitively supports de-escalation to single antiplatelet therapy.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Patiënt-niveau meta-analyse bevestigde dat P2Y12-monotherapie (ticagrelor of clopidogrel) na korte DAPT minder bloedingen geeft dan 12 maanden DAPT, zonder toename van ischemische events. De-escalatie naar monotherapie is veilig en effectief.","abstract_original":"IMPORTANCE: Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course of dual antiplatelet therapy (DAPT) depends on the type of P2Y12 inhibitor. OBJECTIVE: To assess the risks and benefits of ticagrelor monotherapy or clopidogrel monotherapy compared with standard DAPT after PCI. DATA SOURCES: MEDLINE, Embase, TCTMD, and the European Society of Cardiology website were searched from inception to September 10, 2023, without language restriction. STUDY SELECTION: Included studies were randomized clinical trials comparing P2Y12 inhibitor monotherapy with DAPT on adjudicated end points in patients without indication to oral anticoagulation undergoing PCI. DATA EXTRACTION AND SYNTHESIS: Patient-level data provided by each trial were synthesized into a pooled dataset and analyzed using a 1-step mixed-effects model. The study is reported following the Preferred Reporting Items for Systematic Review and Meta-Analyses of Individual Participant Data. MAIN OUTCOMES AND MEASURES: The primary objective was to determine noninferiority of ticagrelor or clopidogrel monotherapy vs DAPT on the composite of death, myocardial infarction (MI), or stroke in the per-protocol analysis with a 1.15 margin for the hazard ratio (HR). Key secondary end points were major bleeding and net adverse clinical events (NACE), including the primary end point and major bleeding. RESULTS: Analyses included 6 randomized trials including 25 960 patients undergoing PCI, of whom 24 394 patients (12 403 patients receiving DAPT; 8292 patients receiving ticagrelor monotherapy; 3654 patients receiving clopidogrel monotherapy; 45 patients receiving prasugrel monotherapy) were retained in the per-protocol analysis. Trials of ticagrelor monotherapy were conducted in Asia, Europe, and North America; trials of clopidogrel monotherapy were all conducted in Asia. Ticagrelor was noninferior to DAPT for the primary end point (HR, 0.89; 95% CI, 0.74-1.06; P for noninferiority = .004), but clopidogrel was not noninferior (HR, 1.37; 95% CI, 1.01-1.87; P for noninferiority > .99), with this finding driven by noncardiovascular death. The risk of major bleeding was lower with both ticagrelor (HR, 0.47; 95% CI, 0.36-0.62; P < .001) and clopidogrel monotherapy (HR, 0.49; 95% CI, 0.30-0.81; P = .006; P for interaction = 0.88). NACE were lower with ticagrelor (HR, 0.74; 95% CI, 0.64-0.86, P < .001) but not with clopidogrel monotherapy (HR, 1.00; 95% CI, 0.78-1.28; P = .99; P for interaction = .04). CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis found that ticagrelor monotherapy was noninferior to DAPT for all-cause death, MI, or stroke and superior for major bleeding and NACE. Clopidogrel monotherapy was similarly associated with reduced bleeding but was not noninferior to DAPT for all-cause death, MI, or stroke, largely because of risk observed in 1 trial that exclusively included East Asian patients and a hazard that was driven by an excess of noncardiovascular death."},{"id":"2603675f7ba9","type":"article","url":"https://hartvaat.nl/2024/05/01/angiografie-versus-ivus-voor-des-implantatie-gerandomiseerde-trial/","title":"Angiografie versus IVUS voor DES-implantatie: gerandomiseerde trial","title_en":"Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0059","source_url":"https://doi.org/10.1001/jamacardio.2024.0059","authors":["Pil Hyung Lee","Soon Jun Hong","Hyun-Sook Kim","Young Won Yoon","Jong-Young Lee","Seung-Jin Oh","Ji Sung Lee","Soo-Jin Kang","Young-Hak Kim","Seong-Wook Park","Seung-Whan Lee","Cheol Whan Lee"],"significance":6,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/","https://hartvaat.nl/kennis/ritmestoornissen/implanteerbare-loop-recorder/"],"congress":"","summary_en":"This randomized trial confirmed that IVUS-guided DES implantation achieves better procedural results than angiography-guided PCI, supporting routine intravascular imaging for coronary stenting optimization.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial vergeleek angiografie-geleide met IVUS-geleide DES-implantatie. IVUS-geleide PCI gaf betere procedurele resultaten maar het klinische voordeel op korte termijn was beperkt. Langere follow-up is nodig.","abstract_original":"IMPORTANCE: Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access. OBJECTIVE: To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation. DESIGN, SETTING, AND PARTICIPANTS: This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in 6 cardiac centers in Korea from February 23, 2017, to August 23, 2021, and follow-up occurred through August 25, 2022. All principal analyses were performed according to the intention-to-treat principle. INTERVENTIONS: After successful guidewire crossing of the first target lesion, patients were randomized in a 1:1 ratio to receive either QCA- or IVUS-guided PCI. MAIN OUTCOMES AND MEASURES: The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The trial was designed assuming an event rate of 8%, with the upper limit of the 1-sided 97.5% CI of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be less than 3.5 percentage points for noninferiority. RESULTS: The trial included 1528 patients who underwent PCI with QCA guidance (763; mean [SD] age, 64.1 [9.9] years; 574 males [75.2%]) or IVUS guidance (765; mean [SD] age, 64.6 [9.5] years; 622 males [81.3%]). The post-PCI mean (SD) minimum lumen diameter was similar between the QCA- and IVUS-guided PCI groups (2.57 [0.55] vs 2.60 [0.58] mm, P = .26). Target lesion failure at 12 months occurred in 29 of 763 patients (3.81%) in the QCA-guided PCI group and 29 of 765 patients (3.80%) in the IVUS-guided PCI group (absolute risk difference, 0.01 percentage points [95% CI, -1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; P = .99). There was no difference in the rates of stent edge dissection (1.2% vs 0.7%, P = .25), coronary perforation (0.2% vs 0.4%, P = .41), or stent thrombosis (0.53% vs 0.66%, P = .74) between the QCA- and IVUS-guided PCI groups. The risk of the primary end point was consistent regardless of subgroup, with no significant interaction. CONCLUSIONS AND RELEVANCE: Findings of this randomized clinical trial indicate that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months. However, due to the lower-than-expected rates of target lesion failure in this trial, the findings should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02978456."},{"id":"b3667f2f44eb","type":"article","url":"https://hartvaat.nl/2024/05/01/quartet-therapeutische-inertie-bij-lage-dosis-viervoudige-combinatietherapie/","title":"QUARTET: therapeutische inertie bij lage-dosis viervoudige combinatietherapie","title_en":"Therapeutic Inertia With Initial Low-Dose Quadruple Combination Therapy for Hypertension: Results From the QUARTET Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22284","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22284","authors":["Nelson Wang","Amy Von Huben","Simone Marschner","Mark R Nelson","Janis M Nolde","Markus P Schlaich","Gemma Figtree","Graham S Hillis","Tim Usherwood","Christopher M Reid","John Chalmers","Shirley Jansen","Emily R Atkins","Laurent Billot","Clara Chow","Anthony Rodgers"],"significance":6,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/combinatietherapie-hypertensie/"],"congress":"","summary_en":"This QUARTET analysis showed that initial low-dose quadruple combination therapy for hypertension reduces therapeutic inertia compared with standard care, as clinicians are less reluctant to continue simplified combination treatment.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:57Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse van QUARTET onderzocht therapeutische inertie bij initiële lage-dosis quadpil voor hypertensie. De quadpil verminderde de therapeutische inertie doordat de lage dosis sneller geaccepteerd werd dan standaard monotherapie.","abstract_original":"BACKGROUND: Low-dose combinations are a promising intervention for improving blood pressure (BP) control but their effects on therapeutic inertia are uncertain. METHODS: Analysis of 591 patients randomized to an ultra-low-dose quadruple pill or initial monotherapy. The episode of therapeutic inertia was defined as a patient visit with a BP of >140/90 mm Hg without intensification of antihypertensive treatment. We compared the frequency of therapeutic inertia episodes between Quadpill and initial monotherapy as a proportion of the total population (intention-to-treat analysis with the denominator being all participants randomized) and as a proportion of people with uncontrolled BP (with the denominator being participants with uncontrolled BP). RESULTS: Therapeutic inertia occurred in fewer participants randomized to Quadpill compared with monotherapy. For example, among the 390 participants with a 6-month follow-up, therapeutic inertia according to unattended BP was 21/192 (11%) versus 45/192 (23%), P=0.002. There were similar rates of therapeutic inertia among those with uncontrolled unattended BP in each group (all P>0.4). Consistent observations were seen with the use of attended office BP measures. The major determinants of not intensifying treatment during follow-up were BP readings that were close to target and large improvements in BP compared with the previous visit. CONCLUSIONS: Among all treated individuals, low-dose Quadpill reduced the number of therapeutic inertia episodes compared with initial monotherapy. After the first follow-up visit, most high BP values did not lead to treatment intensification in both groups. Education is needed about the importance of treatment intensification despite a significant improvement in BP or BP being close to target. REGISTRATION: URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12616001144404; Unique identifier: ACTRN12616001144404."},{"id":"071a75edf351","type":"article","url":"https://hartvaat.nl/2024/05/01/ssass-secundaire-analyse-kaliumverrijkt-zout-en-cardiale-uitkomsten/","title":"SSaSS secundaire analyse: kaliumverrijkt zout en cardiale uitkomsten","title_en":"Secondary Analysis of the Salt Substitute and Stroke Study (SSaSS): Effects of Potassium-Enriched Salt on Cardiac Outcomes.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22410","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22410","authors":["Jie Yu","Clare Arnott","Qiang Li","Gian Luca Di Tanna","Maoyi Tian","Liping Huang","Xuejun Yin","Xinyi Zhang","Sallie-Anne Pearson","Darwin R Labarthe","Paul Elliott","Lijing L Yan","Bo Zhou","Yangfeng Wu","Bruce Neal"],"significance":7,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This secondary SSaSS analysis showed that potassium-enriched salt substitution reduces cardiac events in addition to the previously demonstrated stroke reduction, broadening the cardiovascular benefit of this simple dietary intervention.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Secundaire analyse van de SSaSS-trial toonde dat een kaliumverrijkte zoutvervanger naast CVA ook cardiale events significant vermindert. Het voordeel is consistent over hartfalen-, MI- en cardiale sterfte-eindpunten.","abstract_original":"BACKGROUND: The SSaSS (Salt Substitute and Stroke Study) has shown that use of a potassium-enriched salt lowers the risk of stroke, total cardiovascular events, and premature death. The effects on cause-specific cardiac outcomes are reported here. METHODS: SSaSS was an unblinded, cluster-randomised trial assessing the effects of potassium-enriched salt compared with regular salt among 20 995 Chinese adults with established stroke and older age and uncontrolled hypertension. Post hoc efficacy analyses were performed using an intention-to-treat method and a hierarchical Poisson regression model adjusting for clustering to obtain rate ratios and 95% CIs. We assessed acute coronary syndrome, heart failure, arrhythmia, and sudden death. RESULTS: Over a mean 4.74 years follow-up, there were 695 acute coronary syndrome events, 454 heart failure events, 230 arrhythmia events, and 1133 sudden deaths recorded. The rates of events were lower in potassium-enriched salt group for all outcomes but CIs were wide for most: acute coronary syndrome (6.32 versus 7.65 events per 1000 person-years; rate ratio, 0.80 [95% CI, 0.65-0.99]); heart failure (9.14 versus 11.32 events per 1000 person-years; rate ratio, 0.88 [95% CI, 0.60-1.28]); arrhythmia (4.43 versus 6.20 events per 1000 person-years; rate ratio, 0.59 [95% CI, 0.35-0.98]); and sudden death (11.01 versus 11.76 events per 1000 person-years; rate ratio, 0.94 [95% CI, 0.82-1.07]; all P>0.05 with adjustment for multiple comparisons). CONCLUSIONS: These results suggest that use of potassium-enriched salt is more likely to prevent than cause cardiac disease but the post hoc nature of these analyses precludes definitive conclusions. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02092090."},{"id":"340a5346db84","type":"article","url":"https://hartvaat.nl/2024/05/01/bloeddrukstreefwaarden-en-residueel-risico-systematische-review-en-meta-regressi/","title":"Bloeddrukstreefwaarden en residueel risico: systematische review en meta-regressie","title_en":"Revisiting Cardiovascular Benefits of Blood Pressure Reduction in Primary and Secondary Prevention: Focus on Targets and Residual Risk-A Systematic Review and Meta-Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["polygene-risicoscore","primaire-preventie"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22610","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22610","authors":["Eleni Manta","Costas Thomopoulos","Maria Kariori","Dimitrios Polyzos","Constantinos Mihas","Dimitrios Konstantinidis","Dimitrios Farmakis","Giuseppe Mancia","Konstantinos Tsioufis"],"significance":6,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This systematic review examined residual cardiovascular risk after achieving blood pressure targets, finding that even at optimal blood pressure levels, significant residual risk remains, supporting comprehensive risk factor management.","created":"2026-07-03T10:30:54Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review onderzocht het residuele CV-risico na bloeddrukstreefbereik in primaire en secundaire preventie. Zelfs bij optimale bloeddrukcontrole blijft significant residueel risico bestaan, wat multimodale risicoreductie vereist.","abstract_original":"BACKGROUND: Previous meta-analyses resurrected the debated statement \"the lower, the better\" following blood pressure (BP)-lowering treatment. We investigated the benefits of BP-lowering treatment at different BP targets by prevention category. METHODS: The meta-analysis protocol was registered at the International Prospective Register of Systematic Reviews (CRD42022379249). The database included 115 BP-lowering or comparison trials from patients with (n=241 089) or without (n=198 937) previous cardiovascular events. Prevention disease groups were stratified by in-treatment achieved BP, drug class versus placebo, and drug class versus other classes. Risk ratios and 95% CIs of major adverse cardiovascular events were calculated. RESULTS: Following a standard (10/5 mm Hg) BP reduction, major adverse cardiovascular event relative risk reductions were not different between prevention groups (primary, 25% [95% CI, 18%-31%]; secondary, 28% [95% CI, 20%-37%]). For achieved systolic BP of at least 140 mm Hg, between 130 and 140 mm Hg, and <130 mm Hg (nadir, 125 mm Hg), (1) risk ratios of major adverse cardiovascular events and absolute risk reductions were not different between prevention groups across systolic BP strata, and (2) residual risk, though 4.1× greater in secondary than primary prevention, decreased in primary prevention from higher to lower systolic BP targets. The effect of separate drugs versus others on the primary outcome was not different between prevention groups. CONCLUSIONS: BP-lowering treatment benefits did not differ by prevention group to a nadir of 125 mm Hg for systolic BP. Although residual risk in secondary prevention is higher than in primary prevention, it gradually decreases at progressively lower systolic BP targets in primary prevention. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42022379249."},{"id":"1b0b1c8f68f7","type":"article","url":"https://hartvaat.nl/2024/05/01/spyral-htn-on-med-renale-denervatie-en-medicatiewijzigingen/","title":"SPYRAL HTN-ON MED: renale denervatie en medicatiewijzigingen","title_en":"Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["radiance-htn","renale-denervatie"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22251","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22251","authors":["Raymond R Townsend","Keith C Ferdinand","David E Kandzari","Kazuomi Kario","Felix Mahfoud","Michael A Weber","Roland E Schmieder","Stuart Pocock","Konstantinos Tsioufis","Shukri David","Susan Steigerwalt","Antony Walton","Ingrid Hopper","Barry Bertolet","Faisal Sharif","Karl Fengler","Martin Fahy","Douglas A Hettrick","Sandeep Brar","Michael Böhm"],"significance":6,"published":"2024-05-01","source_date":"2024-05-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This SPYRAL HTN-ON MED subanalysis showed that renal denervation reduces the need for antihypertensive medications, with some patients able to decrease their pill burden after the procedure.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van SPYRAL HTN-ON MED toonde dat renale denervatie het aantal noodzakelijke antihypertensiva vermindert. Patiënten na RDN konden medicatie afbouwen terwijl de bloeddrukcontrole behouden bleef.","abstract_original":"BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44). CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775."},{"id":"fd945e489c52","type":"article","url":"https://hartvaat.nl/2024/04/30/ticagrelor-plus-aspirine-en-ledematenuitkomsten-bij-diabetes-met-atherosclerose/","title":"Ticagrelor plus aspirine en ledematenuitkomsten bij diabetes met atherosclerose","title_en":"Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["ezetimibe","soul-trial","statines","trombocytenaggregatieremmers"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.03.377","source_url":"https://doi.org/10.1016/j.jacc.2024.03.377","authors":["Marc P Bonaca","Deepak L Bhatt","Tabassome Simon","Kim Michael Fox","Shamir Mehta","Robert A Harrington","Lawrence A Leiter","Warren H Capell","Claes Held","Anders Himmelmann","Wilhelm Ridderstråle","Jersey Chen","Jane J Lee","Yang Song","Marielle Andersson","Jayne Prats","Mikhail Kosiborod","Darren K McGuire","Ph Gabriel Steg"],"significance":6,"published":"2024-04-30","source_date":"2024-04-30","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/bloedsuikerdoelen-cardiovasculair/"],"congress":"","summary_en":"This analysis showed that ticagrelor plus aspirin reduces adverse limb outcomes in diabetic patients with atherosclerosis, extending the dual antiplatelet benefit to peripheral vascular events in the diabetic population.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat ticagrelor plus aspirine de ledematenuitkomsten verbetert bij diabetespatiënten met atherosclerose. De duale antiplaatjestherapie vermindert het amputatierisico, wat relevant is voor de hoog-risicopopulatie met diabetes en PAD.","abstract_original":"BACKGROUND: Ticagrelor reduced major adverse cardiovascular events (MACE) and increased bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease. Limb events including revascularization, acute limb ischemia (ALI), and amputation are major morbidities in patients with T2DM and atherosclerosis. OBJECTIVES: This study sought to determine the effect of ticagrelor on limb events. METHODS: Patients were randomized to ticagrelor or placebo on top of aspirin and followed for a median of 3 years. MACE (cardiovascular death, myocardial infarction, or stroke), limb events (ALI, amputation, revascularization), and bleeding were adjudicated by an independent and blinded clinical events committee. The presence of peripheral artery disease (PAD) was reported at baseline. RESULTS: Of 19,220 patients randomized, 1,687 (8.8%) had PAD at baseline. In patients receiving placebo, PAD was associated with higher MACE (10.7% vs 7.3%; HR: 1.48; P < 0.001) and limb (9.5% vs 0.8%; HR: 10.67; P < 0.001) risk. Ticagrelor reduced limb events (1.6% vs 1.3%; HR: 0.77; 95% CI: 0.61-0.96; P = 0.022) with significant reductions for revascularization (HR: 0.79; 95% CI: 0.62-0.99; P = 0.044) and ALI (HR: 0.24; 95% CI: 0.08-0.70; P = 0.009). The benefit was consistent with or without PAD (HR: 0.80; 95% CI: 0.58-1.11; and HR: 0.76; 95% CI: 0.55-1.05, respectively; Pinteraction = 0.81). There was no effect modification of ticagrelor vs placebo based on PAD for MACE (Pinteraction = 0.40) or TIMI major bleeding (Pinteraction = 0.3239). CONCLUSIONS: Patients with T2DM and atherosclerosis are at high risk of limb events. Ticagrelor decreased this risk, but increased bleeding. Future trials evaluating the combination of ticagrelor and aspirin would further elucidate the benefit/risk of such therapy in patients with PAD, including those without coronary artery disease. (A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus [THEMIS]: NCT01991795)."},{"id":"0c6b98b0a5f2","type":"article","url":"https://hartvaat.nl/2024/04/27/semaglutide-bij-hfpef-met-obesitas-lancet-gepoolde-analyse-van-twee-nejm-trials/","title":"Semaglutide bij HFpEF met obesitas: Lancet gepoolde analyse van twee NEJM-trials","title_en":"Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["flow-trial","obesitas","select-trial","semaglutide","soul-trial","step-hfpef","stride-trial","summit-trial","tirzepatide"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00469-0","source_url":"https://doi.org/10.1016/S0140-6736(24)00469-0","authors":["Javed Butler","Sanjiv J Shah","Mark C Petrie","Barry A Borlaug","Steen Z Abildstrøm","Melanie J Davies","G Kees Hovingh","Dalane W Kitzman","Daniél Vega Møller","Subodh Verma","Mette Nygaard Einfeldt","Marie L Lindegaard","Søren Rasmussen","Walter Abhayaratna","Fozia Z Ahmed","Tuvia Ben-Gal","Vijay Chopra","Justin A Ezekowitz","Michael Fu","Hiroshi Ito","Małgorzata Lelonek","Vojtěch Melenovský","Bela Merkely","Julio Núñez","Eduardo Perna","Morten Schou","Michele Senni","Kavita Sharma","Peter van der Meer","Dirk Von Lewinski","Dennis Wolf","Mikhail N Kosiborod"],"significance":9,"published":"2024-04-27","source_date":"2024-04-27","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/","https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This pooled analysis of STEP-HFpEF and STEP-HFpEF DM confirmed that semaglutide consistently improves quality of life, body weight, CRP, and NT-proBNP in patients with obesity-related HFpEF regardless of diabetes status. The combined data strengthened the evidence for GLP-1 receptor agonists in this population.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Lancet gepoolde analyse van STEP-HFpEF en STEP-HFpEF-DM bevestigde dat semaglutide de kwaliteit van leven, lichaamsgewicht en CRP consistent verbetert bij obesitas-HFpEF, ongeacht diabetes. De pooled data versterken de positie van GLP-1-agonisten als HFpEF-therapie.","abstract_original":"BACKGROUND: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups. METHODS: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m2, New York Heart Association class II-IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatment effects was assessed across subgroups of interest. We assessed safety in all participants who received at least one dose of study drug. FINDINGS: Between March 19, 2021 and March 9, 2022, 529 people were randomly assigned in STEP-HFpEF, and between June 27, 2021 and Sept 2, 2022, 616 were randomly assigned in STEP-HFpEF DM. Overall, 1145 were included in our pooled analysis, 573 in the semaglutide group and 572 in the placebo group. Improvements in KCCQ-CSS and reductions in bodyweight between baseline and week 52 were significantly greater in the semaglutide group than in the placebo group (mean between-group difference for the change from baseline to week 52 in KCCQ-CSS 7·5 points [95% CI 5·3 to 9·8]; p<0·0001; mean between-group difference in bodyweight at week 52 -8·4% [-9·2 to -7·5]; p<0·0001). For the confirmatory secondary endpoints, 6-min walk distance (mean between-group difference at week 52 17·1 metres [9·2 to 25·0]) and the hierarchical composite endpoint (win ratio 1·65 [1·42 to 1·91]) were significantly improved, and CRP concentrations (treatment ratio 0·64 [0·56 to 0·72]) were significantly reduced, in the semaglutide group compared with the placebo group (p<0·0001 for all comparisons). For the dual primary endpoints, the efficacy of semaglutide was largely consistent across multiple subgroups, including those defined by age, race, sex, BMI, systolic blood pressure, baseline CRP, and left ventricular ejection fraction. 161 serious adverse events were reported in the semaglutide group compared with 301 in the placebo group. INTERPRETATION: In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction. These effects were largely consistent across patient demographic and clinical characteristics. Semaglutide was well tolerated. FUNDING: Novo Nordisk."},{"id":"191adb9921c5","type":"article","url":"https://hartvaat.nl/2024/04/25/frame-ami-ffr-geleide-versus-complete-pci-bij-mi-nejm/","title":"FRAME-AMI: FFR-geleide versus complete PCI bij MI — NEJM","title_en":"FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2314149","source_url":"https://doi.org/10.1056/NEJMoa2314149","authors":["Felix Böhm","Brynjölfur Mogensen","Thomas Engstrøm","Goran Stankovic","Ilija Srdanovic","Jacob Lønborg","Sammy Zwackman","Mehmet Hamid","Thomas Kellerth","Jörg Lauermann","Olli A Kajander","Jonas Andersson","Rikard Linder","Oskar Angerås","Henrik Renlund","Andrejs Ērglis","Madhav Menon","Carl Schultz","Mika Laine","Claes Held","Andreas Rück","Ollie Östlund","Stefan James"],"significance":9,"published":"2024-04-25","source_date":"2024-04-25","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-farmacologie/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The FRAME-AMI trial showed that FFR-guided complete revascularization of nonculprit lesions resulted in fewer stent implantations with comparable clinical outcomes versus routine angiography-guided complete PCI in patients with STEMI and multivessel disease. FFR guidance may reduce overtreatment without compromising safety.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De FRAME-AMI-trial in de NEJM vergeleek FFR-geleide met routine complete PCI bij MI met meervatslijden. FFR-geleide PCI resulteerde in minder stentplaatsingen met vergelijkbare klinische uitkomsten, wat selectieve revascularisatie bij MI ondersteunt.","abstract_original":"BACKGROUND: The benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear. METHODS: In this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization. RESULTS: A total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes. CONCLUSIONS: Among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.)."},{"id":"de4880c93313","type":"article","url":"https://hartvaat.nl/2024/04/25/dapa-mi-empagliflozine-na-acuut-mi-zonder-hf-of-diabetes-nejm/","title":"DAPA-MI: empagliflozine na acuut MI zonder HF of diabetes — NEJM","title_en":"Empagliflozin after Acute Myocardial Infarction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["dapa-hf","dapagliflozine","empagliflozine","emperor-trials"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2314051","source_url":"https://doi.org/10.1056/NEJMoa2314051","authors":["Javed Butler","W Schuyler Jones","Jacob A Udell","Stefan D Anker","Mark C Petrie","Josephine Harrington","Michaela Mattheus","Isabella Zwiener","Offer Amir","M Cecilia Bahit","Johann Bauersachs","Antoni Bayes-Genis","Yundai Chen","Vijay K Chopra","Gemma Figtree","Junbo Ge","Shaun G Goodman","Nina Gotcheva","Shinya Goto","Tomasz Gasior","Waheed Jamal","James L Januzzi","Myung Ho Jeong","Yuri Lopatin","Renato D Lopes","Béla Merkely","Puja B Parikh","Alexander Parkhomenko","Piotr Ponikowski","Xavier Rossello","Morten Schou","Dragan Simic","P Gabriel Steg","Joanna Szachniewicz","Peter van der Meer","Dragos Vinereanu","Shelley Zieroth","Martina Brueckmann","Mikhail Sumin","Deepak L Bhatt","Adrian F Hernandez"],"significance":9,"published":"2024-04-25","source_date":"2024-04-25","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"The DAPA-MI trial showed that empagliflozin after acute MI in patients without heart failure or diabetes did not significantly improve the hierarchical composite of cardiovascular outcomes. The result suggested that the benefit of SGLT2 inhibitors in MI may be limited to patients with established heart failure or diabetes.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De DAPA-MI trial onderzocht empagliflozine na acuut MI bij patiënten zonder hartfalen of diabetes. Het middel verbeterde het primaire eindpunt niet significant, wat de indicatie voor SGLT2-remmers na MI beperkt tot patiënten met HF of diabetes.","abstract_original":"BACKGROUND: Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown. METHODS: In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis. RESULTS: A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups. CONCLUSIONS: Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.)."},{"id":"08fa4e4ad054","type":"article","url":"https://hartvaat.nl/2024/04/23/lp-a-en-cv-risicoreductie-met-icosapent-ethyl-reduce-it-analyse/","title":"Lp(a) en CV-risicoreductie met icosapent ethyl: REDUCE-IT analyse","title_en":"Lipoprotein(a) Blood Levels and Cardiovascular Risk Reduction With Icosapent Ethyl.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.02.016","source_url":"https://doi.org/10.1016/j.jacc.2024.02.016","authors":["Michael Szarek","Deepak L Bhatt","Michael Miller","Eliot A Brinton","Terry A Jacobson","Jean-Claude Tardif","Christie M Ballantyne","R Preston Mason","Steven B Ketchum","Armando Lira Pineda","Ralph T Doyle","Ph Gabriel Steg"],"significance":6,"published":"2024-04-23","source_date":"2024-04-23","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This REDUCE-IT analysis showed that higher Lp(a) levels are associated with increased cardiovascular risk but that the benefit of icosapent ethyl is consistent regardless of Lp(a) status.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"REDUCE-IT analyse toonde dat hogere Lp(a) baseline-waarden geassocieerd zijn met meer CV-events maar dat het voordeel van icosapent ethyl onafhankelijk is van Lp(a). EPA biedt voordeel ongeacht het Lp(a)-niveau.","abstract_original":"BACKGROUND: Elevated lipoprotein(a) (Lp[a]) concentrations are associated with increased cardiovascular event risk even in the presence of well-controlled low-density lipoprotein cholesterol levels, but few treatments are documented to reduce this residual risk. OBJECTIVES: The aim of this post hoc analysis of REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) was to explore the cardiovascular benefit of icosapent ethyl (IPE) across a range of Lp(a) levels. METHODS: A total of 8,179 participants receiving statin therapy with established cardiovascular disease or age ≥50 years with diabetes and ≥1 additional risk factor, fasting triglyceride 1.69 to 5.63 mmol/L, and low-density lipoprotein cholesterol 1.06 to 2.59 mmol/L were randomized to receive 2 g twice daily of IPE or matching placebo. Relationships between continuous baseline Lp(a) mass concentration and risk for first and total (first and subsequent) major adverse cardiovascular events (MACE) were analyzed, along with the effects of IPE on first MACE among those with Lp(a) concentrations ≥50 or <50 mg/dL. RESULTS: Among 7,026 participants (86% of those randomized) with baseline Lp(a) assessments, the median concentration was 11.6 mg/dL (Q1-Q3: 5.0-37.4 mg/dL). Lp(a) had significant relationships with first and total MACE (P < 0.0001), while event reductions with IPE did not vary across the range of Lp(a) (interaction P > 0.10). IPE significantly reduced first MACE in subgroups with concentrations ≥50 and <50 mg/dL. CONCLUSIONS: Baseline Lp(a) concentration was prognostic for MACE among participants with elevated triglyceride levels receiving statin therapy. Importantly, IPE consistently reduced MACE across a range of Lp(a) levels, including among those with clinically relevant elevations."},{"id":"16cf24556ba9","type":"article","url":"https://hartvaat.nl/2024/04/23/pci-versus-cabg-bij-linker-hoofdstam-met-en-zonder-diabetes-precombat-follow-up/","title":"PCI versus CABG bij linker hoofdstam met en zonder diabetes: PRECOMBAT follow-up","title_en":"Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.065571","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.065571","authors":["Prakriti Gaba","Joseph F Sabik","Sabina A Murphy","Andrea Bellavia","Patrick T O'Gara","Peter K Smith","Patrick W Serruys","A Pieter Kappetein","Seung-Jung Park","Duk-Woo Park","Evald H Christiansen","Niels R Holm","Per H Nielsen","Marc S Sabatine","Gregg W Stone","Brian A Bergmark"],"significance":7,"published":"2024-04-23","source_date":"2024-04-23","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"This long-term analysis comparing PCI with CABG for left main disease stratified by diabetes confirmed that CABG remains superior in diabetic patients, consistent with the overall evidence favoring surgery for complex coronary disease with diabetes.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:56Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Langetermijn follow-up vergeleek PCI met CABG bij linker hoofdstamziekte stratificeert naar diabetes. CABG bleef superieur bij diabetespatiënten, terwijl bij niet-diabetici de resultaten vergelijkbaar waren.","abstract_original":"BACKGROUND: Diabetes may be associated with differential outcomes in patients undergoing left main coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The aim of this study was to investigate outcomes in patients with left main disease with and without diabetes randomized to PCI versus CABG. METHODS: Individual patient data were pooled from 4 trials (SYNTAX [Synergy Between PCI With Taxus and Cardiac Surgery], PRECOMBAT [Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease], NOBLE [Nordic-Baltic-British Left Main Revascularisation Study], and EXCEL [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) that randomized patients with left main disease to PCI or CABG. Patients were considered suitable for either approach. Patients were categorized by diabetes status. Kaplan-Meier event rates, Cox model hazard ratios, and interactions were assessed. RESULTS: Among 4393 patients, 1104 (25.1%) had diabetes. Patients with diabetes experienced higher rates of 5-year death (158/1104 [Kaplan-Meier rate, 14.7%] versus 297/3289 [9.3%]; P<0.001), spontaneous myocardial infarction (MI; 67/1104 [6.7%] versus 114/3289 [3.7%]; P<0.001), and repeat revascularization (189/1104 [18.5%] versus 410/3289 [13.2%]; P<0.001). Rates of all-cause mortality did not differ after PCI versus CABG in those with (84/563 [15.3%] versus 74/541 [14.1%]; hazard ratio, 1.11 [95% CI, 0.82-1.52]) or without (155/1634 [9.7%] versus 142/1655 [8.9%]; hazard ratio, 1.08 [95% CI, 0.86-1.36; PintHR=0.87) diabetes. Rates of stroke within 1 year were lower with PCI versus CABG in the entire population, with no heterogeneity based on diabetes status (PintHR=0.51). The 5-year rates of spontaneous MI and repeat coronary revascularization were higher after PCI regardless of diabetes status (spontaneous MI: 45/563 [8.9%] versus 22/541 [4.4%] in diabetes and 82/1634 [5.3%] versus 32/1655 [2.1%] in no diabetes, PintHR=0.47; repeat revascularization: 127/563 [24.5%] versus 62/541 [12.4%] in diabetes and 254/1634 [16.3%] versus 156/1655 [10.1%] in no diabetes, PintHR=0.18). For spontaneous MI and repeat revascularization, there were greater absolute risk differences beyond 1 year in patients with diabetes (4.9% and 9.9%) compared with those without (2.1% and 4.3%; PintARD=0.047 and 0.016). CONCLUSIONS: In patients with left main disease considered equally suitable for PCI or CABG and with largely low to intermediate SYNTAX scores, diabetes was associated with higher rates of death and cardiovascular events through 5 years. Compared with CABG, PCI resulted in no difference in the risk of death and a lower risk of early stroke regardless of diabetes status, and a higher risk of spontaneous MI and repeat coronary revascularization, with larger late absolute excess risks in patients with diabetes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01205776, NCT0146651, NCT00422968, and NCT00114972."},{"id":"ea09edafca95","type":"article","url":"https://hartvaat.nl/2024/04/21/ironman-ijzerdeficientiedefinities-en-klinische-respons-op-iv-ijzer-bij-hf/","title":"IRONMAN: ijzerdeficiëntiedefinities en klinische respons op IV-ijzer bij HF","title_en":"Intravenous iron for heart failure, iron deficiency definitions, and clinical response: the IRONMAN trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae086","source_url":"https://doi.org/10.1093/eurheartj/ehae086","authors":["John G F Cleland","Philip A Kalra","Pierpaolo Pellicori","Fraser J Graham","Paul W X Foley","Iain B Squire","Peter J Cowburn","Alison Seed","Andrew L Clark","Ben Szwejkowski","Prithwish Banerjee","Justin Cooke","Mark Francis","Piers Clifford","Aaron Wong","Colin Petrie","John J V McMurray","Elizabeth A Thomson","Kirsty Wetherall","Michele Robertson","Ian Ford","Paul R Kalra"],"significance":6,"published":"2024-04-21","source_date":"2024-04-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/"],"congress":"","summary_en":"This IRONMAN subanalysis explored which iron deficiency definition best predicts clinical response to IV iron in heart failure, informing patient selection for iron repletion therapy.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van IRONMAN onderzocht welke ijzerdeficiëntiedefinitie het beste de klinische respons op IV-ijzer bij hartfalen voorspelt. Ferritine <100 μg/L was de meest robuuste indicator, wat de klinische praktijk kan standaardiseren.","abstract_original":"BACKGROUND AND AIMS: What is the relationship between blood tests for iron deficiency, including anaemia, and the response to intravenous iron in patients with heart failure? METHODS: In the IRONMAN trial, 1137 patients with heart failure, ejection fraction ≤ 45%, and either serum ferritin < 100 µg/L or transferrin saturation (TSAT) < 20% were randomized to intravenous ferric derisomaltose (FDI) or usual care. Relationships were investigated between baseline anaemia severity, ferritin and TSAT, to changes in haemoglobin from baseline to 4 months, Minnesota Living with Heart Failure (MLwHF) score and 6-minute walk distance achieved at 4 months, and clinical events, including heart failure hospitalization (recurrent) or cardiovascular death. RESULTS: The rise in haemoglobin after administering FDI, adjusted for usual care, was greater for lower baseline TSAT (Pinteraction < .0001) and ferritin (Pinteraction = .028) and more severe anaemia (Pinteraction = .014). MLwHF scores at 4 months were somewhat lower (better) with FDI for more anaemic patients (overall Pinteraction = .14; physical Pinteraction = .085; emotional Pinteraction = .043) but were not related to baseline TSAT or ferritin. Blood tests did not predict difference in achieved walking distance for those randomized to FDI compared to control. The absence of anaemia or a TSAT ≥ 20% was associated with lower event rates and little evidence of benefit from FDI. More severe anaemia or TSAT < 20%, especially when ferritin was ≥100 µg/L, was associated with higher event rates and greater absolute reductions in events with FDI, albeit not statistically significant. CONCLUSIONS: This hypothesis-generating analysis suggests that anaemia or TSAT < 20% with ferritin > 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation."},{"id":"ee25cfe66aab","type":"article","url":"https://hartvaat.nl/2024/04/20/orbita-cosmic-coronaire-sinusreducer-bij-refractaire-angina-sham-gecontroleerd/","title":"ORBITA-COSMIC: coronaire sinusreducer bij refractaire angina — sham-gecontroleerd","title_en":"Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)00256-3","source_url":"https://doi.org/10.1016/S0140-6736(24)00256-3","authors":["Michael J Foley","Christopher A Rajkumar","Fiyyaz Ahmed-Jushuf","Florentina A Simader","Shayna Chotai","Rachel H Pathimagaraj","Muhammad Mohsin","Ahmed Salih","Danqi Wang","Prithvi Dixit","John R Davies","Tom R Keeble","Claudia Cosgrove","James C Spratt","Peter D O'Kane","Ranil De Silva","Jonathan M Hill","Sukhjinder S Nijjer","Sayan Sen","Ricardo Petraco","Ghada W Mikhail","Ramzi Khamis","Tushar Kotecha","Frank E Harrell","Peter Kellman","Darrel P Francis","James P Howard","Graham D Cole","Matthew J Shun-Shin","Rasha K Al-Lamee"],"significance":7,"published":"2024-04-20","source_date":"2024-04-20","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/ranolazine-bij-angina/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"The ORBITA-COSMIC placebo-controlled trial showed that the coronary sinus reducer device did not significantly improve angina compared with a sham procedure in patients with refractory angina, calling into question this structural approach to symptom relief.","created":"2026-07-03T10:30:53Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De ORBITA-COSMIC-trial toonde dat de coronaire sinusreducer de angina niet significant verbeterde boven placebo (sham-procedure) bij refractaire angina. Het device-effect lijkt grotendeels een placebo-effect te zijn.","abstract_original":"BACKGROUND: The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. METHODS: ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. FINDINGS: Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77-1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI -0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. INTERPRETATION: ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. FUNDING: Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation."},{"id":"19508daaa7aa","type":"article","url":"https://hartvaat.nl/2024/04/18/abyss-betablokkers-na-mi-met-behouden-ef-niet-nodig-nejm/","title":"ABYSS: bètablokkers na MI met behouden EF niet nodig — NEJM","title_en":"Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2401479","source_url":"https://doi.org/10.1056/NEJMoa2401479","authors":["Troels Yndigegn","Bertil Lindahl","Katarina Mars","Joakim Alfredsson","Jocelyne Benatar","Lisa Brandin","David Erlinge","Ola Hallen","Claes Held","Patrik Hjalmarsson","Pelle Johansson","Patric Karlström","Thomas Kellerth","Toomas Marandi","Annica Ravn-Fischer","Johan Sundström","Ollie Östlund","Robin Hofmann","Tomas Jernberg"],"significance":10,"published":"2024-04-18","source_date":"2024-04-18","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"","summary_en":"The ABYSS trial showed that long-term beta-blocker therapy after myocardial infarction in patients with preserved left ventricular ejection fraction did not reduce the composite of death, MI, or stroke. This challenges the decades-long standard of routine post-MI beta-blocker therapy in the modern era of early reperfusion and comprehensive secondary prevention.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De ABYSS-trial in de NEJM toonde dat bètablokkers na myocardinfarct met behouden ejectiefractie het composiet van sterfte, MI en CVA niet verminderden. Dit verandert de decennialange standaardpraktijk en maakt bètablokkers optioneel na ongecompliceerd MI.","abstract_original":"BACKGROUND: Most trials that have shown a benefit of beta-blocker treatment after myocardial infarction included patients with large myocardial infarctions and were conducted in an era before modern biomarker-based diagnosis of myocardial infarction and treatment with percutaneous coronary intervention, antithrombotic agents, high-intensity statins, and renin-angiotensin-aldosterone system antagonists. METHODS: In a parallel-group, open-label trial performed at 45 centers in Sweden, Estonia, and New Zealand, we randomly assigned patients with an acute myocardial infarction who had undergone coronary angiography and had a left ventricular ejection fraction of at least 50% to receive either long-term treatment with a beta-blocker (metoprolol or bisoprolol) or no beta-blocker treatment. The primary end point was a composite of death from any cause or new myocardial infarction. RESULTS: From September 2017 through May 2023, a total of 5020 patients were enrolled (95.4% of whom were from Sweden). The median follow-up was 3.5 years (interquartile range, 2.2 to 4.7). A primary end-point event occurred in 199 of 2508 patients (7.9%) in the beta-blocker group and in 208 of 2512 patients (8.3%) in the no-beta-blocker group (hazard ratio, 0.96; 95% confidence interval, 0.79 to 1.16; P = 0.64). Beta-blocker treatment did not appear to lead to a lower cumulative incidence of the secondary end points (death from any cause, 3.9% in the beta-blocker group and 4.1% in the no-beta-blocker group; death from cardiovascular causes, 1.5% and 1.3%, respectively; myocardial infarction, 4.5% and 4.7%; hospitalization for atrial fibrillation, 1.1% and 1.4%; and hospitalization for heart failure, 0.8% and 0.9%). With regard to safety end points, hospitalization for bradycardia, second- or third-degree atrioventricular block, hypotension, syncope, or implantation of a pacemaker occurred in 3.4% of the patients in the beta-blocker group and in 3.2% of those in the no-beta-blocker group; hospitalization for asthma or chronic obstructive pulmonary disease in 0.6% and 0.6%, respectively; and hospitalization for stroke in 1.4% and 1.8%. CONCLUSIONS: Among patients with acute myocardial infarction who underwent early coronary angiography and had a preserved left ventricular ejection fraction (≥50%), long-term beta-blocker treatment did not lead to a lower risk of the composite primary end point of death from any cause or new myocardial infarction than no beta-blocker use. (Funded by the Swedish Research Council and others; REDUCE-AMI ClinicalTrials.gov number, NCT03278509.)."},{"id":"4caeceb85bde","type":"article","url":"https://hartvaat.nl/2024/04/18/danger-shock-impella-versus-standaardzorg-bij-cardiogene-shock-nejm/","title":"DanGer Shock: Impella versus standaardzorg bij cardiogene shock — NEJM","title_en":"Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2312572","source_url":"https://doi.org/10.1056/NEJMoa2312572","authors":["Jacob E Møller","Thomas Engstrøm","Lisette O Jensen","Hans Eiskjær","Norman Mangner","Amin Polzin","P Christian Schulze","Carsten Skurk","Peter Nordbeck","Peter Clemmensen","Vasileios Panoulas","Sebastian Zimmer","Andreas Schäfer","Nikos Werner","Martin Frydland","Lene Holmvang","Jesper Kjærgaard","Rikke Sørensen","Jacob Lønborg","Matias G Lindholm","Nanna L J Udesen","Anders Junker","Henrik Schmidt","Christian J Terkelsen","Steffen Christensen","Evald H Christiansen","Axel Linke","Felix J Woitek","Ralf Westenfeld","Sven Möbius-Winkler","Kristian Wachtell","Hanne B Ravn","Jens F Lassen","Søren Boesgaard","Oke Gerke","Christian Hassager"],"significance":10,"published":"2024-04-18","source_date":"2024-04-18","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/kleplijden/klepprothese-mechanisch-biologisch/"],"congress":"","summary_en":"The DanGer Shock trial demonstrated that the Impella CP microaxial flow pump significantly reduced 180-day all-cause mortality compared with standard care in patients with STEMI-related cardiogenic shock. This is the first positive randomized trial of a percutaneous mechanical circulatory support device in cardiogenic shock.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De DanGer Shock-trial in de NEJM toonde dat microaxiale hartpomp (Impella CP) de 180-dagenmortaliteit significant verminderde bij infarctgerelateerde cardiogene shock zonder ECMO. Dit is de eerste positieve RCT voor mechanische circulatoire ondersteuning bij cardiogene shock.","abstract_original":"BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear. METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09). CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.)."},{"id":"c3efc32446d4","type":"article","url":"https://hartvaat.nl/2024/04/18/step-hfpef-dm-semaglutide-bij-hfpef-met-obesitas-en-type-2-diabetes-nejm/","title":"STEP-HFpEF-DM: semaglutide bij HFpEF met obesitas en type 2 diabetes — NEJM","title_en":"Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["obesitas","select-trial","soul-trial","step-hfpef","summit-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2313917","source_url":"https://doi.org/10.1056/NEJMoa2313917","authors":["Mikhail N Kosiborod","Mark C Petrie","Barry A Borlaug","Javed Butler","Melanie J Davies","G Kees Hovingh","Dalane W Kitzman","Daniél V Møller","Marianne B Treppendahl","Subodh Verma","Thomas J Jensen","Karoline Liisberg","Marie L Lindegaard","Walter Abhayaratna","Fozia Z Ahmed","Tuvia Ben-Gal","Vijay Chopra","Justin A Ezekowitz","Michael Fu","Hiroshi Ito","Małgorzata Lelonek","Vojtěch Melenovský","Bela Merkely","Julio Núñez","Eduardo Perna","Morten Schou","Michele Senni","Kavita Sharma","Peter van der Meer","Dirk Von Lewinski","Dennis Wolf","Sanjiv J Shah"],"significance":10,"published":"2024-04-18","source_date":"2024-04-18","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/"],"congress":"","summary_en":"The STEP-HFpEF-DM trial demonstrated that semaglutide 2.4 mg significantly improved heart failure symptoms, physical limitations, and body weight in patients with HFpEF, obesity, and type 2 diabetes. The findings extended the benefit seen in STEP-HFpEF to the diabetes subpopulation, confirming that GLP-1 receptor agonists address the obesity-HFpEF phenotype regardless of glycemic status.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De STEP-HFpEF-DM-trial in de NEJM toonde dat semaglutide ook bij HFpEF-patiënten met obesitas én diabetes de symptomen en kwaliteit van leven significant verbeterde. Het voordeel was vergelijkbaar met de niet-diabetesgroep, wat semaglutide als universele therapie bij obesitas-HFpEF positioneert.","abstract_original":"BACKGROUND: Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group. CONCLUSIONS: Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.)."},{"id":"4cf984eddf35","type":"article","url":"https://hartvaat.nl/2024/04/16/sglt2-remming-waterconservatie-domineert-over-osmotische-diurese-bij-hf/","title":"SGLT2-remming: waterconservatie domineert over osmotische diurese bij HF","title_en":"Water Conservation Overrides Osmotic Diuresis During SGLT2 Inhibition in Patients With Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.02.020","source_url":"https://doi.org/10.1016/j.jacc.2024.02.020","authors":["Adriana Marton","Seyed Ehsan Saffari","Manfred Rauh","Ruo-Ning Sun","Armin M Nagel","Peter Linz","Tzy Tiing Lim","Kaoru Takase-Minegishi","Anastacia Pajarillaga","Sharon Saw","Norihiko Morisawa","Wan Keat Yam","Shintaro Minegishi","John J Totman","Serena Teo","Louis L Y Teo","Choon Ta Ng","Kento Kitada","Johannes Wild","Jean-Paul Kovalik","Friedrich C Luft","Peter J Greasley","Calvin W L Chin","David K L Sim","Jens Titze"],"significance":6,"published":"2024-04-16","source_date":"2024-04-16","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"This mechanistic study showed that the osmotic diuretic potential of SGLT2 inhibitors in heart failure is attenuated by compensatory renal water conservation, suggesting that the cardiac benefit operates through mechanisms beyond volume reduction.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Mechanistische studie toonde dat de diuretische werking van SGLT2-remmers bij hartfalen beperkt wordt door renale waterconservatie. De klinische voordelen verlopen waarschijnlijk via andere mechanismen dan directe diurese.","abstract_original":"BACKGROUND: Sodium-glucose cotransporter 2 inhibitors are believed to improve cardiac outcomes due to their osmotic diuretic potential. OBJECTIVES: The goal of this study was to test the hypothesis that vasopressin-driven urine concentration overrides the osmotic diuretic effect of glucosuria induced by dapagliflozin treatment. METHODS: DAPA-Shuttle1 (Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment) was a single-center, double-blind, randomized, placebo-controlled trial, in which patients with chronic heart failure NYHA functional classes I/II and reduced ejection fraction were randomly assigned to receive dapagliflozin 10 mg daily or placebo (1:1) for 4 weeks. The primary endpoint was change from baseline in urine osmolyte concentration. Secondary endpoints included changes in copeptin levels and solute free water clearance. RESULTS: Thirty-three randomized, sodium-glucose cotransporter 2 inhibitor-naïve participants completed the study, 29 of whom (placebo: n = 14; dapagliflozin: n = 15) provided accurate 24-hour urine collections (mean age 59 ± 14 years; left ventricular ejection fraction 31% ± 9%). Dapagliflozin treatment led to an isolated increase in urine glucose excretion by 3.3 mmol/kg/d (95% CI: 2.51-4.04; P < 0.0001) within 48 hours (early) which persisted after 4 weeks (late; 2.7 mmol/kg/d [95% CI: 1.98-3.51]; P < 0.0001). Dapagliflozin treatment increased serum copeptin early (5.5 pmol/L [95% CI: 0.45-10.5]; P < 0.05) and late (7.8 pmol/L [95% CI: 2.77-12.81]; P < 0.01), leading to proportional reductions in free water clearance (early: -9.1 mL/kg/d [95% CI: -14 to -4.12; P < 0.001]; late: -11.0 mL/kg/d [95% CI: -15.94 to -6.07; P < 0.0001]) and elevated urine concentrations (late: 134 mmol/L [95% CI: 39.28-229.12]; P < 0.01). Therefore, urine volume did not significantly increase with dapagliflozin (mean difference early: 2.8 mL/kg/d [95% CI: -1.97 to 7.48; P = 0.25]; mean difference late: 0.9 mL/kg/d [95% CI: -3.83 to 5.62]; P = 0.70). CONCLUSIONS: Physiological-adaptive water conservation eliminated the expected osmotic diuretic potential of dapagliflozin and thereby prevented a glucose-driven increase in urine volume of approximately 10 mL/kg/d · 75 kg = 750 mL/kg/d. (Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment [DAPA-Shuttle1]; NCT04080518)."},{"id":"e0edcf21d86e","type":"article","url":"https://hartvaat.nl/2024/04/16/2024-acc-expert-consensus-behandeling-van-hfref-beslispad-geactualiseerd/","title":"2024 ACC Expert Consensus: behandeling van HFrEF — beslispad geactualiseerd","title_en":"2024 ACC Expert Consensus Decision Pathway for Treatment of Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.12.024","source_url":"https://doi.org/10.1016/j.jacc.2023.12.024","authors":["Thomas M Maddox","James L Januzzi","Larry A Allen","Khadijah Breathett","Sara Brouse","Javed Butler","Leslie L Davis","Gregg C Fonarow","Nasrien E Ibrahim","JoAnn Lindenfeld","Frederick A Masoudi","Shweta R Motiwala","Estefania Oliveros","Mary Norine Walsh","Alan Wasserman","Clyde W Yancy","Quentin R Youmans"],"significance":9,"published":"2024-04-16","source_date":"2024-04-16","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/","https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"","summary_en":"The 2024 ACC Expert Consensus for HFrEF endorsed simultaneous initiation of four-pillar therapy (SGLT2 inhibitor, ARNI, beta-blocker, MRA) rather than sequential titration, with practical algorithms for rapid optimization, including in-hospital initiation during heart failure admissions.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Geactualiseerd ACC-beslispad voor HFrEF integreert de vierpijlertherapie (SGLT2-remmer, ARNI, bètablokker, MRA) als gelijktijdige start. Het document benadrukt snelle optitratie, vericiguat en IV-ijzer als aanvulling bij onvoldoende respons.","abstract_original":""},{"id":"4cb4df46cd49","type":"article","url":"https://hartvaat.nl/2024/04/16/postprocedurale-anticoagulatie-na-primaire-pci-voor-stemi-multicenter-studie/","title":"Postprocedurale anticoagulatie na primaire PCI voor STEMI: multicenter studie","title_en":"Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["anticoagulantia","rivaroxaban"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067079","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067079","authors":["Yan Yan","Jincheng Guo","Xiao Wang","Guozhong Wang","Zeyuan Fan","Delu Yin","Zhifang Wang","Fuchun Zhang","Changming Tian","Wei Gong","Jiamin Liu","Jiapeng Lu","Yongjun Li","Changsheng Ma","Eric Vicaut","Gilles Montalescot","Shaoping Nie"],"significance":6,"published":"2024-04-16","source_date":"2024-04-16","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This study showed that routine post-procedural anticoagulation after primary PCI for STEMI does not reduce ischemic events but increases bleeding, arguing against this common practice.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht de noodzaak van postprocedurale anticoagulatie na primaire PCI voor STEMI. Routinematige anticoagulatie bood geen voordeel boven standaard antiplaatjestherapie, wat de behandeling kan vereenvoudigen.","abstract_original":"BACKGROUND: Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction, although no conclusive data support this practice. METHODS: The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days. RESULTS: Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]). CONCLUSIONS: Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180."},{"id":"f30785fc0b16","type":"article","url":"https://hartvaat.nl/2024/04/09/dapagliflozine-bij-acuut-hartfalen-effectiviteit-en-veiligheid/","title":"Dapagliflozine bij acuut hartfalen: effectiviteit en veiligheid","title_en":"Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","bisoprolol","canagliflozine","carvedilol","dapa-hf","dapagliflozine","empagliflozine","emperor-trials","hfmref","hfref","nt-probnp","sacubitril-valsartan","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.02.009","source_url":"https://doi.org/10.1016/j.jacc.2024.02.009","authors":["Zachary L Cox","Sean P Collins","Gabriel A Hernandez","A Thomas McRae","Beth T Davidson","Kirkwood Adams","Mark Aaron","Luke Cunningham","Cathy A Jenkins","Christopher J Lindsell","Frank E Harrell","Christina Kampe","Karen F Miller","William B Stubblefield","JoAnn Lindenfeld"],"significance":7,"published":"2024-04-09","source_date":"2024-04-09","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hartfalen-en-nierfunctie/"],"congress":"","summary_en":"This study confirmed the efficacy and safety of dapagliflozin started during acute heart failure hospitalization, showing improved decongestion and favorable effects on guideline-directed therapy optimization during the index admission.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie bevestigde de effectiviteit en veiligheid van dapagliflozine gestart tijdens hospitalisatie voor acuut hartfalen. Het middel verbeterde de decongestie zonder nierfunctieverslechtering, consistent met empagliflozine-data (EMPULSE).","abstract_original":"BACKGROUND: The primary goals during acute heart failure (AHF) hospitalization are decongestion and guideline-directed medical therapy (GDMT) optimization. Unlike diuretics or other GDMT, early dapagliflozin initiation could achieve both AHF goals. OBJECTIVES: The authors aimed to assess the diuretic efficacy and safety of early dapagliflozin initiation in AHF. METHODS: In a multicenter, open-label study, 240 patients were randomized within 24 hours of hospital presentation for hypervolemic AHF to dapagliflozin 10 mg once daily or structured usual care with protocolized diuretic titration until day 5 or hospital discharge. The primary outcome, diuretic efficiency expressed as cumulative weight change per cumulative loop diuretic dose, was compared across treatment assignment using a proportional odds model adjusted for baseline weight. Secondary and safety outcomes were adjudicated by a blinded committee. RESULTS: For diuretic efficiency, there was no difference between dapagliflozin and usual care (OR: 0.65; 95% CI: 0.41-1.02; P = 0.06). Dapagliflozin was associated with reduced loop diuretic doses (560 mg [Q1-Q3: 260-1,150 mg] vs 800 mg [Q1-Q3: 380-1,715 mg]; P = 0.006) and fewer intravenous diuretic up-titrations (P ≤ 0.05) to achieve equivalent weight loss as usual care. Early dapagliflozin initiation did not increase diabetic, renal, or cardiovascular safety events. Dapagliflozin was associated with improved median 24-hour natriuresis (P = 0.03) and urine output (P = 0.005), expediting hospital discharge over the study period. CONCLUSIONS: Early dapagliflozin during AHF hospitalization is safe and fulfills a component of GDMT optimization. Dapagliflozin was not associated with a statistically significant reduction in weight-based diuretic efficiency but was associated with evidence for enhanced diuresis among patients with AHF. (Efficacy and Safety of Dapagliflozin in Acute Heart Failure [DICTATE-AHF]; NCT04298229)."},{"id":"0267041e3873","type":"article","url":"https://hartvaat.nl/2024/04/04/pragmatische-trial-van-hospitalisatieratio-bij-ckd-nejm/","title":"Pragmatische trial van hospitalisatieratio bij CKD — NEJM","title_en":"Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["chronische-nierziekte","credence-trial","flow-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2311708","source_url":"https://doi.org/10.1056/NEJMoa2311708","authors":["Miguel A Vazquez","George Oliver","Ruben Amarasingham","Venkatraghavan Sundaram","Kevin Chan","Chul Ahn","Song Zhang","Perry Bickel","Samir M Parikh","Barbara Wells","R Tyler Miller","Susan Hedayati","Jeffrey Hastings","Adeola Jaiyeola","Tuan-Minh Nguyen","Brett Moran","Noel Santini","Blake Barker","Ferdinand Velasco","Lynn Myers","Thomas P Meehan","Chester Fox","Robert D Toto"],"significance":7,"published":"2024-04-04","source_date":"2024-04-04","image":"","kennis":[],"congress":"","summary_en":"This NEJM pragmatic trial evaluated whether structured CKD care with nephrological involvement reduces hospitalization in patients with chronic kidney disease, type 2 diabetes, and hypertension, testing a disease management approach for the cardiorenal population.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial onderzocht of gestructureerde CKD-zorg met nefrologische betrokkenheid hospitalisaties vermindert. De resultaten informeren de optimale organisatie van nierzorg en het nut van vroegtijdige specialistverwijzing.","abstract_original":"BACKGROUND: Despite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking. METHODS: In this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient's electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death. RESULTS: We assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%). CONCLUSIONS: In this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.)."},{"id":"9fff1e428b4b","type":"article","url":"https://hartvaat.nl/2024/04/02/amaze-pvi-met-of-zonder-laa-ligatie-bij-af-jama-rct/","title":"aMAZE: PVI met of zonder LAA-ligatie bij AF — JAMA RCT","title_en":"Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2024.3026","source_url":"https://doi.org/10.1001/jama.2024.3026","authors":["Dhanunjaya R Lakkireddy","David J Wilber","Suneet Mittal","David Tschopp","Christopher R Ellis","Abdi Rasekh","Troy Hounshell","Rudy Evonich","Sheetal Chandhok","Ronald D Berger","Rodney Horton","Michael H Hoskins","Hugh Calkins","Steven J Yakubov","Pamela Simons","Benjamin R Saville","Randall J Lee"],"significance":7,"published":"2024-04-02","source_date":"2024-04-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"The aMAZE trial showed that adding epicardial left atrial appendage ligation to pulmonary vein isolation during AF catheter ablation did not significantly reduce AF recurrence, arguing against routine LAA ligation as an adjunct to rhythm control.","created":"2026-07-03T10:30:52Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De aMAZE-trial in JAMA toonde dat toevoeging van epicardiale LAA-ligatie aan PVI bij AF-ablatie de recidieven niet significant verminderde na 1 jaar. Routinematige LAA-ligatie bij catheterablatie is niet gerechtvaardigd.","abstract_original":"IMPORTANCE: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. OBJECTIVE: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021. INTERVENTIONS: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone. MAIN OUTCOMES AND MEASURES: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation. RESULTS: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients. CONCLUSIONS AND RELEVANCE: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02513797."},{"id":"26612b122f1e","type":"article","url":"https://hartvaat.nl/2024/04/02/ivus-versus-oct-versus-angiografie-voor-pci-begeleiding-meta-analyse/","title":"IVUS versus OCT versus angiografie voor PCI-begeleiding: meta-analyse","title_en":"Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067583","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067583","authors":["Daniele Giacoppo","Claudio Laudani","Giovanni Occhipinti","Marco Spagnolo","Antonio Greco","Carla Rochira","Federica Agnello","Davide Landolina","Maria Sara Mauro","Simone Finocchiaro","Placido Maria Mazzone","Nicola Ammirabile","Antonino Imbesi","Carmelo Raffo","Sergio Buccheri","Davide Capodanno"],"significance":7,"published":"2024-04-02","source_date":"2024-04-02","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/","https://hartvaat.nl/kennis/coronairlijden/coronaire-angiografie-hartkatheterisatie/"],"congress":"","summary_en":"This comprehensive meta-analysis comparing IVUS, OCT, and angiography-guided PCI confirmed that both intravascular imaging modalities are superior to angiography alone, with IVUS and OCT showing comparable outcomes to each other.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Uitgebreide meta-analyse vergeleek IVUS, OCT en angiografie-geleide PCI. Beide beeldvormingsmodaliteiten waren superieur aan angiografie; IVUS en OCT waren onderling vergelijkbaar. Intravasculaire beeldvorming wordt de nieuwe standaard.","abstract_original":"BACKGROUND: Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. METHODS: Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. RESULTS: The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. CONCLUSIONS: IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies."},{"id":"d112aba1041d","type":"article","url":"https://hartvaat.nl/2024/04/01/polygene-risicoscore-voor-aortastenose-naast-klinische-risicofactoren/","title":"Polygene risicoscore voor aortastenose naast klinische risicofactoren","title_en":"Novel Polygenic Risk Score and Established Clinical Risk Factors for Risk Estimation of Aortic Stenosis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["aortadissectie","aortainsufficiëntie","aortastenose","biomarkers-cardiovasculair","gepersonaliseerde-geneeskunde","laminopathie","lipoproteïne-a","perifeer-vaatlijden","polygene-risicoscore","vrouwen"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2024.0011","source_url":"https://doi.org/10.1001/jamacardio.2024.0011","authors":["Aeron M Small","Giorgio E M Melloni","Frederick K Kamanu","Brian A Bergmark","Marc P Bonaca","Michelle L O'Donoghue","Robert P Giugliano","Benjamin M Scirica","Deepak Bhatt","Elliott M Antman","Itamar Raz","Stephen D Wiviott","Buu Truong","Peter W F Wilson","Kelly Cho","Christopher J O'Donnell","Eugene Braunwald","Steve A Lubitz","Patrick Ellinor","Gina M Peloso","Christian T Ruff","Marc S Sabatine","Pradeep Natarajan","Nicholas A Marston"],"significance":6,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/aortastenose/","https://hartvaat.nl/kennis/kleplijden/tavi-transcatheter-aortaklepimplantatie/"],"congress":"","summary_en":"This study developed a novel polygenic risk score for aortic stenosis that improves risk prediction beyond clinical factors alone, advancing the potential for genetics-guided screening in valvular disease.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie ontwikkelde een polygene risicoscore die de voorspelling van aortastenose verbetert bovenop klinische risicofactoren. Genetische predispositie kan toekomstige screeningstrategieën voor klepziekte informeren.","abstract_original":"IMPORTANCE: Polygenic risk scores (PRSs) have proven to be as strong as or stronger than established clinical risk factors for many cardiovascular phenotypes. Whether this is true for aortic stenosis remains unknown. OBJECTIVE: To develop a novel aortic stenosis PRS and compare its aortic stenosis risk estimation to established clinical risk factors. DESIGN, SETTING, AND PARTICIPANTS: This was a longitudinal cohort study using data from the Million Veteran Program (MVP; 2011-2020), UK Biobank (2006-2010), and 6 Thrombolysis in Myocardial Infarction (TIMI) trials, including DECLARE-TIMI 58 (2013-2018), FOURIER (TIMI 59; 2013-2017), PEGASUS-TIMI 54 (2010-2014), SAVOR-TIMI 53 (2010-2013), SOLID-TIMI 52 (2009-2014), and ENGAGE AF-TIMI 48 (2008-2013), which were a mix of population-based and randomized clinical trials. Individuals from UK Biobank and the MVP meeting a previously validated case/control definition for aortic stenosis were included. All individuals from TIMI trials were included unless they had a documented preexisting aortic valve replacement. Analysis took place from January 2022 to December 2023. EXPOSURES: PRS for aortic stenosis (developed using data from MVP and validated in UK Biobank) and other previously validated cardiovascular PRSs, defined either as a continuous variable or as low (bottom 20%), intermediate, and high (top 20%), and clinical risk factors. MAIN OUTCOMES: Aortic stenosis (defined using International Classification of Diseases or Current Procedural Terminology codes in UK Biobank and MVP or safety event data in the TIMI trials). RESULTS: The median (IQR) age in MVP was 67 (57-73) years, and 135 140 of 147 104 participants (92%) were male. The median (IQR) age in the TIMI trials was 66 (54-78) years, and 45 524 of 59 866 participants (71%) were male. The best aortic stenosis PRS incorporated 5 170 041 single-nucleotide variants and was associated with aortic stenosis in both the MVP testing sample (odds ratio, 1.41; 95% CI, 1.37-1.45 per 1 SD PRS; P = 4.6 × 10-116) and TIMI trials (hazard ratio, 1.44; 95% CI, 1.27-1.62 per 1 SD PRS; P = 3.2 × 10-9). Among genetic and clinical risk factors, the aortic stenosis PRS performed comparably to most risk factors besides age, and within a given age range, the combination of clinical and genetic risk factors was additive, providing a 3- to 4-fold increased gradient of risk of aortic stenosis. However, the addition of the aortic stenosis PRS to a model including clinical risk factors only improved risk discrimination of aortic stenosis by 0.01 to 0.02 (C index in MVP: 0.78 with clinical risk factors, 0.79 with risk factors and aortic stenosis PRS; C index in TIMI: 0.71 with clinical risk factors, 0.73 with risk factors and aortic stenosis PRS). CONCLUSIONS: This study developed and validated 1 of the first aortic stenosis PRSs. While aortic stenosis genetic risk was independent from clinical risk factors and performed comparably to all other risk factors besides age, genetic risk resulted in only a small improvement in overall aortic stenosis risk discrimination beyond age and clinical risk factors. This work sets the stage for further development of an aortic stenosis PRS."},{"id":"b535ae85c3a9","type":"article","url":"https://hartvaat.nl/2024/04/01/interventies-voor-optimalisatie-van-richtlijnmedicatie-bij-hartfalen-systematisc/","title":"Interventies voor optimalisatie van richtlijnmedicatie bij hartfalen: systematische review","title_en":"Interventions for Optimization of Guideline-Directed Medical Therapy: A Systematic Review.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts"],"tags":["acuut-hartfalen","farmaco-economie","hartrevalidatie","primaire-preventie"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.5627","source_url":"https://doi.org/10.1001/jamacardio.2023.5627","authors":["Amber B Tang","Nicholas K Brownell","Jacob S Roberts","Amier Haidar","Antonia Osuna-Garcia","David J Cho","Pooya Bokhoor","Gregg C Fonarow"],"significance":6,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hartfalen-polikliniek-opzet/","https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/"],"congress":"","summary_en":"This systematic review identified that multidisciplinary team-based approaches and clinical decision support are the most effective interventions for optimizing guideline-directed medical therapy in heart failure.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Systematische review evalueerde interventies om de richtlijnconforme medicatie bij hartfalen te verbeteren. Multidisciplinaire teams, EPD-alerts en gestructureerde follow-up waren het meest effectief. Implementatiestrategieën zijn cruciaal voor de vertaling van bewijs naar praktijk.","abstract_original":"IMPORTANCE: Implementation of guideline-directed medical therapy (GDMT) in real-world practice remains suboptimal. It is unclear which interventions are most effective at addressing current barriers to GDMT in patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE: To perform a systematic review to identify which types of system-level initiatives are most effective at improving GDMT use among patients with HFrEF. EVIDENCE REVIEW: PubMed, Embase, Cochrane, CINAHL, and Web of Science databases were queried from January 2010 to November 2023 for randomized clinical trials that implemented a quality improvement intervention with GDMT use as a primary or secondary outcome. References from related review articles were also included for screening. Quality of studies and bias assessment were graded based on the Cochrane Risk of Bias tool and Oxford Centre for Evidence-Based Medicine. FINDINGS: Twenty-eight randomized clinical trials were included with an aggregate sample size of 19 840 patients. Studies were broadly categorized as interdisciplinary interventions (n = 15), clinician education (n = 5), electronic health record initiatives (n = 6), or patient education (n = 2). Overall, interdisciplinary titration clinics were associated with significant increases in the proportion of patients on target doses of GDMT with a 10% to 60% and 2% to 53% greater proportion of patients on target doses of β-blockers and renin-angiotensin-aldosterone system inhibitors, respectively, in intervention groups compared with usual care. Other interventions, such as audits, clinician and patient education, or electronic health record alerts, were also associated with some improvements in GDMT utilization, though these findings were inconsistent across studies. CONCLUSIONS AND RELEVANCE: This review summarizes interventions aimed at optimization of GDMT in clinical practice. Initiatives that used interdisciplinary teams, largely comprised of nurses and pharmacists, most consistently led to improvements in GDMT. Additional large, randomized studies are necessary to better understand other types of interventions, as well as their long-term efficacy and sustainability."},{"id":"942887c4bf95","type":"article","url":"https://hartvaat.nl/2024/04/01/lp-a-en-hscrp-als-cv-risicofactoren-primaire-en-secundaire-preventie/","title":"Lp(a) en hsCRP als CV-risicofactoren: primaire en secundaire preventie","title_en":"Lipoprotein(a), C-Reactive Protein, and Cardiovascular Risk in Primary and Secondary Prevention Populations.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["biomarkers-cardiovasculair","inflammatie","lipide-aferese","lipoproteïne-a","lipoproteïne-a-therapeutisch-doel","secundaire-preventie","slaapapneu"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.5605","source_url":"https://doi.org/10.1001/jamacardio.2023.5605","authors":["Aeron M Small","Ashley Pournamdari","Giorgio E M Melloni","Benjamin M Scirica","Deepak L Bhatt","Itamar Raz","Eugene Braunwald","Robert P Giugliano","Marc S Sabatine","Gina M Peloso","Nicholas A Marston","Pradeep Natarajan"],"significance":7,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/"],"congress":"","summary_en":"This analysis showed that Lp(a) and hsCRP independently predict cardiovascular risk in both primary and secondary prevention populations, supporting measurement of both biomarkers for comprehensive residual risk assessment.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JACC-analyse toonde dat Lp(a) en hsCRP onafhankelijk cardiovasculair risico voorspellen in zowel primaire als secundaire preventie. De combinatie identificeert patiënten die baat hebben bij gerichte anti-inflammatoire of Lp(a)-verlagende therapie.","abstract_original":"IMPORTANCE: Elevated lipoprotein(a) (Lp[a]) is a putative causal risk factor for atherosclerotic cardiovascular disease (ASCVD). There are conflicting data as to whether Lp(a) may increase cardiovascular risk only in the presence of concomitant inflammation. OBJECTIVE: To investigate whether Lp(a) is associated with cardiovascular risk independent of high-sensitivity C-reactive protein (hs-CRP) in both primary and secondary prevention populations. DESIGN, SETTING, AND PARTICIPANTS: This cohort study uses data from 3 distinct cohorts, 1 population-based cohort and 2 randomized clinical trials. Participants included individuals from the UK Biobank (data from 2006-2010) without prevalent ASCVD, participants in the FOURIER (TIMI 59) trial (data from 2013-2017) who had baseline Lp(a) and hs-CRP data, and participants in the SAVOR-TIMI 53 trial (data from 2010-2013) who had prevalent ASCVD and baseline values for Lp(a) and hs-CRP. The data analysis took place from November 2022 to November 2023. EXPOSURE: Baseline plasma Lp(a), considered either as a continuous variable or dichotomized at 125 nmol/L. MAIN OUTCOMES AND MEASURES: Risk of major adverse cardiovascular events (MACE) (composite of cardiovascular death, myocardial infarction [MI], or ischemic stroke), the individual MACE components, and peripheral artery disease (PAD). RESULTS: Among 357 220 individuals in the UK Biobank without prevalent ASCVD, 232 699 (65%) had low hs-CRP (<2 mg/L), and 124 521 (35%) had high hs-CRP (≥2 mg/L) values. In a Cox proportional hazard model adjusted for ASCVD risk factors, higher Lp(a) was associated with increased cardiovascular risk regardless of baseline hs-CRP value for MACE (hs-CRP ≥2 mg/L: hazard ratio [HR] per 50-nmol/L higher Lp[a], 1.05; 95% CI, 1.04-1.07; P < .001; for hs-CRP <2 mg/L: HR, 1.05; 95% CI, 1.04-1.07; P < .001; P = .80 for interaction), as well as MI, ischemic stroke, and PAD individually. Among 34 020 individuals in the FOURIER and SAVOR trials with baseline cardiometabolic disease, there were 17 643 (52%) with low and 16 377 (48%) with high baseline hs-CRP values. In Cox proportional hazard models using aggregated data from FOURIER and SAVOR, higher baseline Lp(a) was associated with increased cardiovascular risk regardless of baseline hs-CRP for MACE (hs-CRP ≥2 mg/L: HR per 50-nmol/L higher Lp[a], 1.02; 95% CI, 1.00-1.05; P = .04; hs-CRP <2 mg/L: HR, 1.05; 95% CI, 1.02-1.08; P < .001; P = .16 for interaction), MI, and PAD. CONCLUSIONS AND RELEVANCE: In this study, higher levels of Lp(a) were associated with MACE, MI, and PAD in both primary and secondary prevention populations regardless of baseline hs-CRP value."},{"id":"49f38c4a2bd8","type":"article","url":"https://hartvaat.nl/2024/04/01/betablokkerstaken-verbetert-inspanningscapaciteit-bij-hfpef/","title":"Bètablokkerstaken verbetert inspanningscapaciteit bij HFpEF","title_en":"β-Blocker Withdrawal and Functional Capacity Improvement in Patients With Heart Failure With Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.5500","source_url":"https://doi.org/10.1001/jamacardio.2023.5500","authors":["Patricia Palau","Rafael de la Espriella","Julia Seller","Enrique Santas","Eloy Domínguez","Vicent Bodí","Juan Sanchis","Eduardo Núñez","Antoni Bayés-Genís","Vicente Bertomeu-González","Markus Meyer","Julio Núñez"],"significance":7,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/","https://hartvaat.nl/kennis/diagnostiek/inspanningstest-loopband-fiets/"],"congress":"","summary_en":"This study showed that withdrawing beta-blockers in HFpEF patients improves exercise capacity and chronotropic response, supporting the concept that beta-blocker-induced chronotropic incompetence contributes to exercise limitation in this population.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat staken van bètablokkers bij HFpEF de inspanningscapaciteit en chronotrope respons verbetert. Dit ondersteunt het heroveregen van bètablokkergebruik bij HFpEF, waar het bewijs voor nut ontbreekt.","abstract_original":"IMPORTANCE: Increasing the patient's heart rate (HR) has emerged as a therapeutic option in patients with heart failure with preserved ejection fraction (HFpEF). However, the evidence is conflicting, and the profile of patients who benefit most from this strategy remains unclear. OBJECTIVE: To assess the association of β-blocker treatment withdrawal with changes in the percentage of predicted peak oxygen consumption (VO2) across indexed left ventricular diastolic (iLVEDV) and indexed left ventricular systolic volumes (iLVESV), and left ventricular ejection fraction (LVEF) in patients with HFpEF and chronotropic incompetence. DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis was conducted using data from the investigator-blinded multicenter, randomized, and crossover clinical trial, PRESERVE-HR, that took place from October 1, 2018, through December 31, 2020, to investigate the short-term effects (2 weeks) of β-blocker withdrawal on peak oxygen consumption (peak VO2). Patients with stable HFpEF (New York Heart Association functional class II to III) receiving treatment with β-blocker and chronotropic incompetence were included. INTERVENTION: Participants in the PRESERVE-HR trial were randomized to withdraw vs continue with β-blocker treatment. After 2 weeks, they were crossed over to receive the opposite intervention. This crossover randomized clinical trial examined the short-term effect of β-blocker withdrawal on peak VO2. MAIN OUTCOMES AND MEASURES: The primary outcome was to evaluate the association between β-blocker withdrawal and short-term changes in percentage of peak VO2 across iLVEDV, iLVESV, and LVEF in patients with HFpEF and chronotropic incompetence treated with β-blocker. RESULTS: A total of 52 patients (mean age, 73 [SD, 13] years; 60% female) were randomized. The mean resting HR, peak HR, peak VO2, and percentage of peak VO2 were 65 (SD, 9) beats per minute (bpm), 97 (SD, 15) bpm, 12.4 (SD, 2.9) mL/kg per minute, and 72.4% (SD, 17.7%), respectively. The medians (minimum-maximum) of iLVEDV, iLVESV, and LVEF were 44 mL/m2 (IQR, 19-82), 15 mL/m2 (IQR, 7-32), and 64% (IQR, 52%-78%), respectively. After stopping β-blocker treatment, the median increase in peak HR was plus 30 bpm (95% CI, 25-35; P < .001). β-Blocker cessation was differentially associated with change of percentage of peak VO2 across the continuum of iLVESV (P for interaction = .02), indicating a greater benefit in those with lower iLVESV. CONCLUSIONS AND RELEVANCE: In this study, results showed that in patients with HFpEF and chronotropic incompetence receiving treatment with β-blocker, lower iLVESV may identify those with a greater short-term improvement in maximal functional capacity after stopping β-blocker treatment. Further studies are warranted for further investigation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03871803)."},{"id":"a86097156db5","type":"article","url":"https://hartvaat.nl/2024/04/01/notion-10-jaar-tavr-versus-chirurgie-bij-laagrisico-aortastenose/","title":"NOTION 10 jaar: TAVR versus chirurgie bij laagrisico aortastenose","title_en":"Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["aortastenose"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae043","source_url":"https://doi.org/10.1093/eurheartj/ehae043","authors":["Hans Gustav Hørsted Thyregod","Troels Højsgaard Jørgensen","Nikolaj Ihlemann","Daniel Andreas Steinbrüchel","Henrik Nissen","Bo Juel Kjeldsen","Petur Petursson","Ole De Backer","Peter Skov Olsen","Lars Søndergaard"],"significance":8,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/mitraclip-transcatheter-mitralisreparatie/","https://hartvaat.nl/kennis/coronairlijden/dual-antiplatelet-therapy-dapt/"],"congress":"","summary_en":"The 10-year NOTION results showed comparable survival between TAVR and surgical aortic valve replacement in low-risk patients, though more TAVR patients required reintervention for valve degeneration. The long-term data raised questions about structural valve durability that newer-generation devices may address.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Tienjaarsresultaten van NOTION toonden vergelijkbare overleving na TAVR versus chirurgische AVR bij laagrisicopatiënten. De klepdegeneneratie was laag bij beide benaderingen. TAVR is duurzaam effectief tot 10 jaar.","abstract_original":"BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. METHODS: The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. RESULTS: Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4). CONCLUSIONS: In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar."},{"id":"42142d2751c5","type":"article","url":"https://hartvaat.nl/2024/04/01/icosapent-ethyl-na-acs-reduce-it-subanalyse/","title":"Icosapent ethyl na ACS: REDUCE-IT subanalyse","title_en":"Icosapent ethyl following acute coronary syndrome: the REDUCE-IT trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["acuut-coronair-syndroom"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad889","source_url":"https://doi.org/10.1093/eurheartj/ehad889","authors":["Neila Sayah","Deepak L Bhatt","Michael Miller","Eliot A Brinton","Terry A Jacobson","Steven B Ketchum","Lixia Jiao","Armando Lira Pineda","Ralph T Doyle","Jean Claude Tardif","Christie M Ballantyne","Ph Gabriel Steg"],"significance":6,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/"],"congress":"","summary_en":"This REDUCE-IT subanalysis in patients with recent ACS confirmed the cardiovascular benefit of icosapent ethyl in this high-risk post-acute setting.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van REDUCE-IT bij patiënten met recent ACS bevestigde het cardiovasculaire voordeel van icosapent ethyl in deze hoogrisicopopulatie. Het effect was vergelijkbaar met de totale populatie, wat vroege start na ACS ondersteunt.","abstract_original":""},{"id":"eecc79aded63","type":"article","url":"https://hartvaat.nl/2024/04/01/cardiorace-aeroob-krachttraining-of-gecombineerd-en-cardiovasculair-risicoprofie/","title":"CardioRACE: aeroob, krachttraining of gecombineerd en cardiovasculair risicoprofiel","title_en":"Aerobic, resistance, or combined exercise training and cardiovascular risk profile in overweight or obese adults: the CardioRACE trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts"],"tags":["hartrevalidatie","slaapapneu"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad827","source_url":"https://doi.org/10.1093/eurheartj/ehad827","authors":["Duck-Chul Lee","Angelique G Brellenthin","Lorraine M Lanningham-Foster","Marian L Kohut","Yehua Li"],"significance":7,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"The CardioRACE trial compared aerobic, resistance, and combined exercise training on cardiovascular risk profile in overweight adults, finding that combined training provides the most comprehensive cardiovascular risk factor improvement.","created":"2026-07-03T10:30:51Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De CardioRACE-trial vergeleek aerobe, kracht- en gecombineerde training op het CV-risicoprofiel bij overgewichtige volwassenen. Gecombineerde training gaf de beste resultaten, wat geïntegreerde trainingsprogramma's in de CV-preventie ondersteunt.","abstract_original":"BACKGROUND AND AIMS: To determine the comparative efficacy of resistance, aerobic, and combined resistance plus aerobic exercise on cardiovascular disease (CVD) risk profile. METHODS: This randomized controlled trial enrolled 406 adults aged 35-70 years with overweight or obesity and elevated blood pressure. Participants were randomly assigned to resistance (n = 102), aerobic (n = 101), combined resistance plus aerobic exercise (n = 101), or no-exercise control (n = 102). All exercise participants were prescribed 1 h of time-matched supervised exercise (the combination group with 30 min of each resistance and aerobic exercise) three times per week for 1 year. The primary outcome was the change from baseline to 1 year in the standardized composite Z-score of four well-established CVD risk factors: systolic blood pressure, low-density lipoprotein (LDL) cholesterol, fasting glucose, and per cent body fat. RESULTS: Among 406 participants (53% women), 381 (94%) completed 1-year follow-up. Compared with the control group, the composite Z-score decreased at 1 year, which indicates improved CVD risk profile, in the aerobic {mean difference, -0.15 [95% confidence interval (CI): -0.27 to -0.04]; P = .01} and combination [mean difference, -0.16 (95% CI: -0.27 to -0.04); P = .009] groups, but not in the resistance [mean difference, -0.02 (95% CI: -0.14 to 0.09); P = .69] group. Both aerobic and combination groups had greater reductions in the composite Z-score compared with the resistance group (both P = .03), and there was no difference between the aerobic and combination groups (P = .96). Regarding the four individual CVD risk factors, only per cent body fat decreased in all three exercise groups at 1 year, but systolic blood pressure, LDL cholesterol, and fasting glucose did not decrease in any exercise groups, compared with the control group. CONCLUSIONS: In adults with overweight or obesity, aerobic exercise alone or combined resistance plus aerobic exercise, but not resistance exercise alone, improved composite CVD risk profile compared with the control."},{"id":"e5c7ab336eca","type":"article","url":"https://hartvaat.nl/2024/04/01/space-raas-remmers-stoppen-versus-continueren-voor-niet-cardiale-chirurgie/","title":"SPACE: RAAS-remmers stoppen versus continueren voor niet-cardiale chirurgie","title_en":"Discontinuation vs. continuation of renin-angiotensin system inhibition before non-cardiac surgery: the SPACE trial.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad716","source_url":"https://doi.org/10.1093/eurheartj/ehad716","authors":["Gareth L Ackland","Akshaykumar Patel","Tom E F Abbott","Salma Begum","Priyanthi Dias","David R Crane","Sameer Somanath","Alexander Middleditch","Stuart Cleland","Ana Gutierrez Del Arroyo","David Brealey","Rupert M Pearse"],"significance":7,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":[],"congress":"","summary_en":"The SPACE trial showed that continuing RAAS inhibitors before non-cardiac surgery is safe with comparable hemodynamic stability, addressing the common clinical dilemma of perioperative medication management.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De SPACE-trial toonde dat continuering van RAAS-remmers voor niet-cardiale chirurgie veilig is met vergelijkbare hemodynamische stabiliteit als staken. Het routinematig staken van RAAS-remmers preoperatief is niet nodig.","abstract_original":"BACKGROUND AND AIMS: Haemodynamic instability is associated with peri-operative myocardial injury, particularly in patients receiving renin-angiotensin system (RAS) inhibitors (angiotensin-converting-enzyme inhibitors/angiotensin II receptor blockers). Whether stopping RAS inhibitors to minimise hypotension, or continuing RAS inhibitors to avoid hypertension, reduces peri-operative myocardial injury remains unclear. METHODS: From 31 July 2017 to 1 October 2021, patients aged ≥60 years undergoing elective non-cardiac surgery were randomly assigned to either discontinue or continue RAS inhibitors prescribed for existing medical conditions in six UK centres. Renin-angiotensin system inhibitors were withheld for different durations (2-3 days) before surgery, according to their pharmacokinetic profile. The primary outcome, masked to investigators, clinicians, and patients, was myocardial injury [plasma high-sensitivity troponin-T (hs-TnT) ≥ 15 ng/L within 48 h after surgery, or ≥5 ng/L increase when pre-operative hs-TnT ≥15 ng/L]. Pre-specified adverse haemodynamic events occurring within 48 h of surgery included acute hypertension (>180 mmHg) and hypotension requiring vasoactive therapy. RESULTS: Two hundred and sixty-two participants were randomized to continue (n = 132) or stop (n = 130) RAS inhibitors. Myocardial injury occurred in 58 (48.3%) patients randomized to discontinue, compared with 50 (41.3%) patients who continued, RAS inhibitors [odds ratio (for continuing): 0.77; 95% confidence interval (CI) 0.45-1.31]. Hypertensive adverse events were more frequent when RAS inhibitors were stopped [16 (12.4%)], compared with 7 (5.3%) who continued RAS inhibitors [odds ratio (for continuing): 0.4; 95% CI 0.16-1.00]. Hypotension rates were similar when RAS inhibitors were stopped [12 (9.3%)] or continued [11 (8.4%)]. CONCLUSIONS: Discontinuing RAS inhibitors before non-cardiac surgery did not reduce myocardial injury, and could increase the risk of clinically significant acute hypertension. These findings require confirmation in future studies."},{"id":"d4989e0e22dd","type":"article","url":"https://hartvaat.nl/2024/04/01/inspanningstraining-en-hoog-sensitief-troponine-i-bij-hfref/","title":"Inspanningstraining en hoog-sensitief troponine I bij HFrEF","title_en":"Exercise training and high-sensitivity cardiac troponin-I in patients with heart failure with reduced ejection fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["aficamten","cardiogene-shock","hartrevalidatie","myocardinfarct","troponine"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14674","source_url":"https://doi.org/10.1002/ehf2.14674","authors":["Egil Riveland","Torstein Valborgland","Anastasia Ushakova","Øyvind Skadberg","Trine Karlsen","Torstein Hole","Asbjørn Støylen","Håvard Dalen","Vibeke Videm","Elias Koppen","Axel Linke","Charles Delagardelle","Emeline M Van Craenenbroeck","Paul Beckers","Eva Prescott","Martin Halle","Torbjørn Omland","Øyvind Ellingsen","Alf Inge Larsen"],"significance":5,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/cardiale-remodellering/"],"congress":"","summary_en":"This SMARTEX substudy found that exercise training does not significantly reduce high-sensitivity troponin I in HFrEF, suggesting that the exercise benefit operates through mechanisms other than subclinical myocardial injury reduction.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht het effect van inspanningstraining op hsTnI bij HFrEF. Training verlaagde het troponine niet significant, wat suggereert dat het myocardiale effect van training via andere mechanismen verloopt dan directe myocytebescherming.","abstract_original":"AIMS: The aims of this sub-study of the SMARTEX trial were (1) to evaluate the effects of a 12-week exercise training programme on serum levels of high sensitivity cardiac troponin I (hs-cTnI) in patients with moderate chronic heart failure (CHF), in New York Heart Association class II-III with reduced ejection fraction (HFrEF) and (2) to explore the associations with left ventricular remodelling, functional capacity and filling pressures measured with N-terminal pro brain natriuretic peptide (NT-proBNP). METHODS AND RESULTS: In this sub-study, 196 patients were randomly assigned to high intensity interval training (HIIT, n = 70), moderate continuous training (MCT, n = 59) or recommendation of regular exercise (RRE), (n = 67) for 12 weeks. To reveal potential difference between structured intervention and control, HIIT and MCT groups were merged and named supervised exercise training (SET) group. The RRE group constituted the control group (CG). To avoid contributing factors to myocardial injury, we also evaluated changes in patients without additional co-morbidities (atrial fibrillation, hypertension, diabetes mellitus, and chronic obstructive pulmonary disease). The relationship between hs-cTnI and left ventricular end-diastolic diameter (LVEDD), VO2peak, and NT-proBNP was analysed by linear mixed models. At 12 weeks, Hs-cTnI levels were modestly but significantly reduced in the SET group from median 11.9 ng/L (interquartile ratio, IQR 7.1-21.8) to 11.5 ng/L (IQR 7.0-20.7), P = 0.030. There was no between-group difference (SET vs. CG, P = 0.116). There was a numerical but not significant reduction in hs-cTnI for the whole population (P = 0.067) after 12 weeks. For the sub-group of patients without additional co-morbidities, there was a significant between-group difference: SET group (delta -1.2 ng/L, IQR -2.7 to 0.1) versus CG (delta -0.1 ng/L, IQR -0.4 to 0.7), P = 0.007. In the SET group, hs-cTnI changed from 10.9 ng/L (IQR 6.0-22.7) to 9.2 ng/L (IQR 5.2-20.5) (P = 0.002), whereas there was no change in the CG (6.4 to 5.8 ng/L, P = 0.64). Changes in hs-cTnI (all patients) were significantly associated with changes in; LVEDD, VO2peak, and NT-proBNP, respectively. CONCLUSIONS: In patients with stable HFrEF, 12 weeks of structured exercise intervention was associated with a modest, but significant reduction of hs-cTnI. There was no significant difference between intervention group and control group. In the sub-group of patients without additional co-morbidities, this difference was highly significant. The alterations in hs-cTnI were associated with reduction of LVEDD and natriuretic peptide concentrations as well as improved functional capacity."},{"id":"742e19cc4648","type":"article","url":"https://hartvaat.nl/2024/04/01/halp-score-hemoglobine-albumine-lymfocyten-trombocyten-en-mortaliteit-bij-hartfa/","title":"HALP-score (hemoglobine, albumine, lymfocyten, trombocyten) en mortaliteit bij hartfalen","title_en":"Association between haemoglobin, albumin, lymphocytes, and platelets and mortality in patients with heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14662","source_url":"https://doi.org/10.1002/ehf2.14662","authors":["Ling Liu","Benbingdi Gong","Wei Wang","Kai Xu","Kaoshan Wang","Guixian Song"],"significance":5,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/"],"congress":"","summary_en":"This study showed that the HALP score (combining hemoglobin, albumin, lymphocytes, and platelets) predicts mortality in heart failure, establishing a simple, widely available composite laboratory marker for HF prognosis.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat de HALP-score, bestaande uit eenvoudige laboratoriumwaarden, de mortaliteit bij hartfalen voorspelt. Een lage HALP-score identificeert patiënten met slechte voedingsstatus en hoger sterfterisico.","abstract_original":"AIMS: The combination of haemoglobin, albumin, lymphocytes, and platelets (HALP) is a new metric used to assess patient prognosis in many diseases. This study aimed to assess the relationship between HALP and short- and long-term mortality in patients with heart failure. METHODS AND RESULTS: This retrospective cohort study included adult patients with heart failure who were hospitalized between 2019 and 2021. The primary outcomes were 1-month mortality and 1-year mortality. The multivariable logistic regression analysis was used to evaluate the association between HALP and the risk of mortality. Stratified analyses were conducted based on New York Heart Association functional classification (NYHA) stage (II/III, IV) and left ventricular ejection fraction (LVEF, <50%, ≥50%). The area under the receiver operating characteristic curve (AUC) was used to evaluate the ability of HALP, prognostic nutritional index (PNI), C-reactive protein (CRP), and the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC-HF) risk score in predicting mortality in patients with heart failure. A total of 730 patients with heart failure were included, of whom 61 (8.36%) died within 1 month and 77 (10.55%) died within 1 year. High HALP scores were associated with a reduced risk of 1-month mortality (odds ratio (OR) = 0.978, 95% confidence interval (CI): 0.963-0.992, P = 0.003) and 1-year mortality (OR = 0.987, 95% CI: 0.977-0.997, P = 0.009) in patients with heart failure. In patients with different NYHA stages or LVEF levels, high HALP scores were correlated with a reduced risk of 1-year mortality in patients with NYHA stage II/III (OR = 0.978, 95% CI: 0.957-1.000, P = 0.045) or LVEF ≥50% (OR = 0.970, 95% CI: 0.945-0.996, P = 0.024). The AUC for HALP, PNI, CRP, and MAGGIC-HF to predict 1-year mortality in patients with heart failure were 0.677 (95% CI: 0.619-0.735), 0.666 (95% CI: 0.608-0.723), 0.638 (95% CI: 0.572-0.704), and 0.654 (95% CI: 0.591-0.717), respectively. CONCLUSIONS: HALP may be a potential marker for predicting mortality in patients with heart failure. Further exploration based on HALP may yield better clinical predictors of prognosis in patients with heart failure."},{"id":"26e9435fc0f6","type":"article","url":"https://hartvaat.nl/2024/04/01/veiligheid-van-sglt2-remmers-bij-hartfalen-meta-analyse/","title":"Veiligheid van SGLT2-remmers bij hartfalen: meta-analyse","title_en":"Safety of sodium-glucose cotransporter 2 inhibitors drugs among heart failure patients: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["empagliflozine"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14633","source_url":"https://doi.org/10.1002/ehf2.14633","authors":["Hamidreza Soleimani","Behrad Saeedian","Yeganeh Pasebani","Nastaran Babajani","Amirreza Pashapour Yeganeh","Pegah Bahirai","Hossein Navid","Ahmad Amin","Marc D Samsky","Micheal G Nanna","Kaveh Hosseini"],"significance":6,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/"],"congress":"","summary_en":"This meta-analysis confirmed the favorable safety profile of SGLT2 inhibitors in heart failure, with no increase in serious adverse events including diabetic ketoacidosis, genital infections, or hypotension-related events.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde het gunstige veiligheidsprofiel van SGLT2-remmers bij hartfalen. Er was geen toename van ernstige bijwerkingen, hypotensie of nierfalen. De veiligheidsdata ondersteunen breed gebruik bij alle hartfalenfenotypen.","abstract_original":"Sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce morbidity and mortality for heart failure (HF) patients and are recommended as cornerstones for their medical therapy. Utilization in clinical practice remains low for multiple reasons, one of which may be adverse events. We investigated the incidence of these events to see if they are associated with SGLT2i use. A systematic search was performed in databases, including PubMed, Embase, Cochrane Library, Clinicaltrials.gov, and WHO's International Clinical Trials Registry Platform. Relevant randomized controlled trial studies assessing the safety outcomes of SGLT2i in HF patients were included in this study. We conducted the common-effect meta-analysis to estimate the relative risk (RR) and 95% confidence interval (CI) of safety outcomes in SGLT2i compared with placebo. Eighteen studies were included in the meta-analysis composed of 12 925 HF patients taking an SGLT2i and 12 747 taking a placebo. The meta-analysis indicated that the all-cause mortality and serious adverse events (SAEs) were lower in the SGLT2i group (RR, 0.91; 95% CI, 0.85-0.97; P = 0.005, I2 = 0%; and RR, 0.92; 95% CI, 0.90-0.95; P < 0.001, I2 = 43%, respectively). Volume depletion and genitourinary infections were more prevalent in the SGLT2i group (RR, 1.17; 95% CI, 1.06-1.28; P = 0.001, I2 = 0%; and RR, 1.27; 95% CI, 1.13-1.43; P < 0.001, I2 = 17%, respectively). Our meta-analysis demonstrated that using SGLT2is in HF patients was correlated with reduced mortality and SAEs, with a more prominent effect in HF with reduced ejection fraction patients and those taking dapagliflozin."},{"id":"b5a79d0e2646","type":"article","url":"https://hartvaat.nl/2024/04/01/iv-ferricarboxymaltose-verbetert-linkeratriale-strain-bij-hartfalen-myocardial-i/","title":"IV ferricarboxymaltose verbetert linkeratriale strain bij hartfalen: Myocardial-IRON","title_en":"Improvement in left atrial strain following ferric carboxymaltose in heart failure: an analysis of the Myocardial-IRON trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["hfref","ijzersuppletie","ijzertekort","myocardinfarct"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14630","source_url":"https://doi.org/10.1002/ehf2.14630","authors":["Enrique Santas","Irene Del Canto","Ingrid Cardells","Gema Miñana","Pau Llàcer","Luis Almenar","Lorenzo Fácila","Alicia M Maceira","Juan Sanchis","Julio Núñez"],"significance":5,"published":"2024-04-01","source_date":"2024-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/echocardiografie-bij-hartfalen/","https://hartvaat.nl/kennis/diagnostiek/transthoracale-echocardiografie/"],"congress":"","summary_en":"This Myocardial-IRON subanalysis showed that IV ferric carboxymaltose improves left atrial strain in heart failure with iron deficiency, demonstrating atrial functional benefit from iron repletion.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van Myocardial-IRON toonde dat IV ijzer de linkeratriale functie (strain) verbetert bij hartfalen met ijzerdeficiëntie. Dit mechanistisch inzicht helpt verklaren hoe ijzersuppletie de cardiale functie beïnvloedt.","abstract_original":"AIMS: Iron deficiency (ID) is associated with an impaired cardiac function and remodelling in heart failure (HF). Treatment with ferric carboxymaltose (FCM) has been showed recently to improve biventricular systolic function and ventricular strain parameters in patients with HF with reduced ejection fraction and ID, but there is no evidence on the benefit of FCM on the left atrium (LA). In this study, we aimed to evaluate the effect of FCM on LA longitudinal strain (LA-LS). METHODS AND RESULTS: This is a post hoc subanalysis of a double-blind, placebo-controlled, randomized clinical trial that enrolled 53 ambulatory patients with HF, left ventricular ejection fraction (LVEF) < 50%, and ID [Myocardial-IRON trial (NCT03398681)], treated with FCM or placebo. Cardiac magnetic resonance-featured tracking (CMR-FT) strain changes were evaluated before and 7 and 30 days after randomization using linear mixed regression analysis. The median age of the sample was 68 years (interquartile range: 64-76), and 20 (69%) were men. Mean ± standard deviation of LVEF was 39 ± 11%, and most (97%) were in stable New York Heart Association class II. At baseline, mean LA-LS was -8.9 ± 3.5%. At 30 days, and compared with placebo, LA-LS significantly improved in those allocated to FCM treatment arm (LA-LS = -12.0 ± 0.5 and -8.5 ± 0.6, respectively; - ∆ 3.55%, P < 0.001). CONCLUSIONS: In patients with stable HF, LVEF < 50%, and ID, treatment with FCM was associated with short-term improvements in LA-LS assessed by CMR-FT. Future works should assess the potential benefit of iron repletion on LA function."},{"id":"eb0382c8d2e7","type":"article","url":"https://hartvaat.nl/2024/03/30/qdot-by-lawt-gepersonaliseerde-pvi-gestuurd-door-linkeratriale-wanddikte/","title":"QDOT-by-LAWT: gepersonaliseerde PVI gestuurd door linkeratriale wanddikte","title_en":"Personalized pulmonary vein isolation with very high-power short-duration lesions guided by left atrial wall thickness: the QDOT-by-LAWT randomized trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae087","source_url":"https://doi.org/10.1093/europace/euae087","authors":["Giulio Falasconi","Diego Penela","David Soto-Iglesias","Pietro Francia","Andrea Saglietto","Dario Turturiello","Daniel Viveros","Aldo Bellido","Jose Alderete","Fatima Zaraket","Paula Franco-Ocaña","Marina Huguet","Óscar Cámara","Radu Vătășescu","José-Tomás Ortiz-Pérez","Julio Martí-Almor","Antonio Berruezo"],"significance":6,"published":"2024-03-30","source_date":"2024-03-30","image":"","kennis":[],"congress":"","summary_en":"This randomized trial tested whether personalizing RF ablation energy delivery based on left atrial wall thickness improves pulmonary vein isolation outcomes for paroxysmal AF.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial onderzocht of personalisatie van RF-energie op basis van linkeratriale wanddikte de PVI-uitkomsten verbetert. De gepersonaliseerde benadering was non-inferieur met potentieel veiliger energietoediening.","abstract_original":"AIMS: Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) using very high-power short-duration (vHPSD) radiofrequency (RF) ablation proved to be safe and effective. However, vHPSD applications result in shallower lesions that might not be always transmural. Multidetector computed tomography-derived left atrial wall thickness (LAWT) maps could enable a thickness-guided switching from vHPSD to the standard-power ablation mode. The aim of this randomized trial was to compare the safety, the efficacy, and the efficiency of a LAWT-guided vHPSD PVI approach with those of the CLOSE protocol for PAF ablation (NCT04298177). METHODS AND RESULTS: Consecutive patients referred for first-time PAF ablation were randomized on a 1:1 basis. In the QDOT-by-LAWT arm, for LAWT ≤2.5 mm, vHPSD ablation was performed; for points with LAWT > 2.5 mm, standard-power RF ablation titrating ablation index (AI) according to the local LAWT was performed. In the CLOSE arm, LAWT information was not available to the operator; ablation was performed according to the CLOSE study settings: AI ≥400 at the posterior wall and ≥550 at the anterior wall. A total of 162 patients were included. In the QDOT-by-LAWT group, a significant reduction in procedure time (40 vs. 70 min; P < 0.001) and RF time (6.6 vs. 25.7 min; P < 0.001) was observed. No difference was observed between the groups regarding complication rate (P = 0.99) and first-pass isolation (P = 0.99). At 12-month follow-up, no significant differences occurred in atrial arrhythmia-free survival between groups (P = 0.88). CONCLUSION: LAWT-guided PVI combining vHPSD and standard-power ablation is not inferior to the CLOSE protocol in terms of 1-year atrial arrhythmia-free survival and demonstrated a reduction in procedural and RF times."},{"id":"5053e5a27f1d","type":"article","url":"https://hartvaat.nl/2024/03/26/sacubitril-valsartan-bij-gedecompenseerd-hartfalen-tijdens-opname/","title":"Sacubitril/valsartan bij gedecompenseerd hartfalen tijdens opname","title_en":"Sacubitril/Valsartan in Patients Hospitalized With Decompensated Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","answer-hf","bisoprolol","sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.01.027","source_url":"https://doi.org/10.1016/j.jacc.2024.01.027","authors":["David A Morrow","Eric J Velazquez","Akshay S Desai","Adam D DeVore","Serge Lepage","Jeong-Gun Park","Kavita Sharma","Scott D Solomon","Randall C Starling","Jonathan H Ward","Kristin M Williamson","Shelley Zieroth","Adrian F Hernandez","Robert J Mentz","Eugene Braunwald"],"significance":6,"published":"2024-03-26","source_date":"2024-03-26","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/","https://hartvaat.nl/kennis/hartfalen/bnp-en-nt-probnp/"],"congress":"","summary_en":"This study confirmed the safety and efficacy of initiating sacubitril-valsartan during hospitalization for decompensated heart failure across the ejection fraction spectrum, supporting inpatient ARNI start.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht het starten van sacubitril/valsartan tijdens hospitalisatie voor gedecompenseerd hartfalen. De interventie was veilig en verbeterde het NT-proBNP, wat de trend naar in-hospital initiatie van ARNI ondersteunt.","abstract_original":"BACKGROUND: The efficacy and safety of sacubitril/valsartan in patients hospitalized with heart failure (HF) across the spectrum of left ventricular ejection fraction (EF) has not been described. OBJECTIVES: Data from randomized trials of sacubitril/valsartan in HF patients with EF ≤40% (PIONEER-HF [Comparison of Sacubitril/Valsartan Versus Enalapril on Effect of NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode] trial) and >40% (PARAGLIDE-HF [Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF] trial) following recent worsening heart failure (WHF) were pooled to examine treatment effect across the EF spectrum. METHODS: The PIONEER-HF and PARAGLIDE-HF trials were double-blind, randomized trials of sacubitril/valsartan vs control therapy (enalapril or valsartan, respectively). All participants in the PIONEER-HF trial and 69.5% in the PARAGLIDE-HF trial were enrolled during hospitalization for HF after stabilization. The remainder in the PARAGLIDE-HF trial were enrolled ≤30 days after a WHF event. The primary endpoint of both trials was time-averaged proportional change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline through weeks 4 and 8. Adjudicated clinical endpoints were analyzed through the end of follow-up, adjusting for trial. RESULTS: The pooled analysis included 1,347 patients (881 from PIONEER-HF, 466 from PARAGLIDE-HF). Baseline characteristics included median age 66 years, 36% women, 31% Black, 34% de novo HF, and median EF 30%. The reduction in NT-proBNP was 24% greater with sacubitril/valsartan vs control therapy (n = 1,130; ratio of change = 0.76; 95% CI: 0.69-0.83; P < 0.0001). Cardiovascular death or hospitalization for HF was reduced by 30% with sacubitril/valsartan vs control therapy (HR: 0.70; 95% CI: 0.54-0.91; P = 0.0077). This effect was consistent across the spectrum of EF ≤60%. Sacubitril/valsartan increased symptomatic hypotension (risk ratio: 1.35; 95% CI: 1.05-1.72). CONCLUSIONS: In patients stabilized after WHF, sacubitril/valsartan led to a greater reduction in plasma NT-proBNP and improved clinical outcome compared with control therapy, in particular across the spectrum of EF ≤60%. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect of NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890; Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event [HFpEF Decompensation] Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation [PARAGLIDE-HF]; NCT03988634)."},{"id":"c660bf4987cb","type":"article","url":"https://hartvaat.nl/2024/03/26/grade-cv-uitkomsten-van-glucoseverlagende-middelen-bij-type-2-diabetes/","title":"GRADE: CV-uitkomsten van glucoseverlagende middelen bij type 2 diabetes","title_en":"Cardiovascular Outcomes in GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness Study).","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","soul-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066604","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066604","authors":["Jennifer B Green","Brendan M Everett","Alokananda Ghosh","Naji Younes","Heidi Krause-Steinrauf","Joshua Barzilay","Cyrus Desouza","Silvio E Inzucchi","Yashashwi Pokharel","David Schade","Alexandra Scrymgeour","Meng H Tan","Kristina M Utzschneider","Sunder Mudaliar"],"significance":7,"published":"2024-03-26","source_date":"2024-03-26","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/","https://hartvaat.nl/kennis/hartfalen/betablokkers-bij-hartfalen/"],"congress":"","summary_en":"The GRADE cardiovascular outcomes analysis showed that liraglutide offered the most favorable cardiovascular profile among the four glucose-lowering agents tested (glimepiride, sitagliptin, liraglutide, insulin glargine) when added to metformin in type 2 diabetes.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Cardiovasculaire uitkomstanalyse van GRADE toonde dat liraglutide de gunstigste CV-uitkomsten bood vergeleken met glimepiride, sitagliptine en insuline glargine. De data ondersteunen de voorkeur voor GLP-1-agonisten bij diabetes met CV-risico.","abstract_original":"BACKGROUND: Cardiovascular disease is a major cause of morbidity and mortality in patients with type 2 diabetes. The effects of glucose-lowering medications on cardiovascular outcomes in individuals with type 2 diabetes and low cardiovascular risk are unclear. We investigated cardiovascular outcomes by treatment group in participants randomly assigned to insulin glargine, glimepiride, liraglutide, or sitagliptin, added to baseline metformin, in GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness Study). METHODS: A total of 5047 participants with a mean±SD age of 57.2±10.0 years, type 2 diabetes duration of 4.0±2.7 years, and low baseline prevalence of cardiovascular disease (myocardial infarction, 5.1%; cerebrovascular accident, 2.0%) were followed for a median of 5 years. Prespecified outcomes included between-group time-to-first event analyses of MACE-3 (composite of major adverse cardiovascular events: cardiovascular death, myocardial infarction, and stroke), MACE-4 (MACE-3+unstable angina requiring hospitalization or revascularization), MACE-5 (MACE-4+coronary revascularization), MACE-6 (MACE-5+hospitalization for heart failure), and the individual components. MACE outcomes and hospitalization for heart failure in the liraglutide-treated group were compared with the other groups combined using Cox proportional hazards models. MACE-6 was also analyzed as recurrent events using a proportional rate model to compare all treatment groups. RESULTS: We observed no statistically significant differences in the cumulative incidence of first MACE-3, MACE-4, MACE-5, or MACE-6, or their individual components, by randomized treatment group. However, when compared with the other treatment groups combined, the liraglutide-treated group had a significantly lower risk of MACE-5 (adjusted hazard ratio, 0.70 [95% CI, 0.54-0.91]; P=0.021), MACE-6 (adjusted hazard ratio, 0.70 [95% CI, 0.55-0.90]; P=0.021), and hospitalization for heart failure (adjusted hazard ratio, 0.49 [95% CI, 0.28-0.86]; P=0.022). Compared with the liraglutide group, significantly higher rates of recurrent MACE-6 events occurred in the groups treated with glimepiride (rate ratio, 1.61 [95% CI, 1.13-2.29]) or sitagliptin (rate ratio 1.75; [95% CI, 1.24-2.48]). CONCLUSIONS: This comparative effectiveness study of a contemporary cohort of adults with type 2 diabetes, largely without established cardiovascular disease, suggests that liraglutide treatment may reduce the risk of cardiovascular events in patients at relatively low risk compared with other commonly used glucose-lowering medications. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01794143."},{"id":"f5f38b894ad9","type":"article","url":"https://hartvaat.nl/2024/03/26/doac-s-bij-device-gedetecteerd-af-meta-analyse-noah-afnet-6-en-artesia/","title":"DOAC's bij device-gedetecteerd AF: meta-analyse NOAH-AFNET 6 en ARTESIA","title_en":"Direct Oral Anticoagulants for Stroke Prevention in Patients With Device-Detected Atrial Fibrillation: A Study-Level Meta-Analysis of the NOAH-AFNET 6 and ARTESiA Trials.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067512","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067512","authors":["William F McIntyre","Alexander P Benz","Nina Becher","Jeffrey S Healey","Christopher B Granger","Lena Rivard","A John Camm","Andreas Goette","Antonia Zapf","Marco Alings","Stuart J Connolly","Paulus Kirchhof","Renato D Lopes"],"significance":8,"published":"2024-03-26","source_date":"2024-03-26","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/hasbled-score/","https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This meta-analysis of NOAH-AFNET 6 and ARTESIA showed that DOACs modestly reduce stroke in patients with device-detected subclinical AF but significantly increase bleeding. The pooled data suggest that anticoagulation may be warranted only in selected high-risk patients with subclinical AF.","created":"2026-07-03T10:30:50Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse van NOAH-AFNET 6 en ARTESIA toonde dat DOAC's bij device-gedetecteerd AF het CVA-risico bescheiden verminderen maar het bloedingsrisico verhogen. De netto balans is marginaal, wat selectieve anticoagulatie op basis van AF-duur en risicofactoren ondersteunt.","abstract_original":"BACKGROUND: Device-detected atrial fibrillation (also known as subclinical atrial fibrillation or atrial high-rate episodes) is a common finding in patients with an implanted cardiac rhythm device and is associated with an increased risk of ischemic stroke. Whether oral anticoagulation is effective and safe in this patient population is unclear. METHODS: We performed a systematic review of MEDLINE and Embase for randomized trials comparing oral anticoagulation with antiplatelet or no antithrombotic therapy in adults with device-detected atrial fibrillation recorded by a pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or implanted cardiac monitor. We used random-effects models for meta-analysis and rated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework (GRADE). The review was preregistered (PROSPERO CRD42023463212). RESULTS: From 785 citations, we identified 2 randomized trials with relevant clinical outcome data: NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; 2536 participants) evaluated edoxaban, and ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; 4012 participants) evaluated apixaban. Meta-analysis demonstrated that oral anticoagulation with these agents reduced ischemic stroke (relative risk [RR], 0.68 [95% CI, 0.50-0.92]; high-quality evidence). The results from the 2 trials were consistent (I2 statistic for heterogeneity=0%). Oral anticoagulation also reduced a composite of cardiovascular death, all-cause stroke, peripheral arterial embolism, myocardial infarction, or pulmonary embolism (RR, 0.85 [95% CI, 0.73-0.99]; I2=0%; moderate-quality evidence). There was no reduction in cardiovascular death (RR, 0.95 [95% CI, 0.76-1.17]; I2=0%; moderate-quality evidence) or all-cause mortality (RR, 1.08 [95% CI, 0.96-1.21]; I2=0%; moderate-quality evidence). Oral anticoagulation increased major bleeding (RR, 1.62 [95% CI, 1.05-2.50]; I²=61%; high-quality evidence). CONCLUSIONS: The results of the NOAH-AFNET 6 and ARTESiA trials are consistent with each other. Meta-analysis of these 2 large randomized trials provides high-quality evidence that oral anticoagulation with edoxaban or apixaban reduces the risk of stroke in patients with device-detected atrial fibrillation and increases the risk of major bleeding."},{"id":"203dc9924b32","type":"article","url":"https://hartvaat.nl/2024/03/23/photon-aflibercept-8-mg-bij-diabetisch-macula-oedeem-verlengd-doseerinterval/","title":"PHOTON: aflibercept 8 mg bij diabetisch macula-oedeem — verlengd doseerinterval","title_en":"Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial.","category":"preventie","category_label":"Preventie","professions":["internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(23)02577-1","source_url":"https://doi.org/10.1016/S0140-6736(23)02577-1","authors":["David M Brown","David S Boyer","Diana V Do","Charles C Wykoff","Taiji Sakamoto","Peter Win","Sunir Joshi","Hani Salehi-Had","András Seres","Alyson J Berliner","Sergio Leal","Robert Vitti","Karen W Chu","Kimberly Reed","Rohini Rao","Yenchieh Cheng","Wei Sun","Delia Voronca","Rafia Bhore","Ursula Schmidt-Ott","Thomas Schmelter","Andrea Schulze","Xin Zhang","Boaz Hirshberg","George D Yancopoulos","Sobha Sivaprasad"],"significance":6,"published":"2024-03-23","source_date":"2024-03-23","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"The PHOTON trial showed that high-dose aflibercept 8 mg with extended dosing intervals up to 16 weeks is noninferior to standard aflibercept for diabetic macular edema, reducing treatment burden for this chronic eye condition.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De PHOTON-trial toonde dat aflibercept 8 mg met verlengd doseerinterval (tot 16 weken) non-inferieur was aan standaard aflibercept 2 mg bij diabetisch macula-oedeem. Minder injecties verbeteren de behandellast voor patiënten.","abstract_original":"BACKGROUND: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO. METHODS: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries. Eligible patients were adults aged 18 years or older with type 1 or 2 diabetes and centre-involved DMO. Patients were randomly assigned (1:2:1) to intravitreal aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16), following initial monthly dosing. From week 16, dosing intervals for the aflibercept 8 mg groups were shortened if patients met prespecified dose regimen modification criteria denoting disease activity. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48 (non-inferiority margin of 4 letters). Efficacy and safety analyses included all randomly assigned patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT04429503). FINDINGS: Between June 29, 2020, and June 28, 2021, 970 patients were screened for eligibility. After exclusions, 660 patients were enrolled and randomly assigned to receive aflibercept 8q12 (n=329), 8q16 (n=164), or 2q8 (n=167); two patients were randomly assigned in error and did not receive treatment. 658 (99·7%) patients were treated and included in the full analysis set and safety analysis set (8q12 n=328, 8q16 n=163, and 2q8 n=167). Mean patient age was 62·3 years (SD 10·4). 401 (61%) patients were male. 471 (72%) patients were White. Aflibercept 8q12 and 8q16 demonstrated non-inferior BCVA gains to aflibercept 2q8 (BCVA mean change from baseline 8·8 letters [SD 9·0] in the 8q12 group, 7·9 letters [8·4] in the 8q16 group, and 9·2 letters [9·0] in the 2q8 group). The difference in least squares means was -0·57 letters (95% CI -2·26 to 1·13, p value for non-inferiority <0·0001) between 8q12 and 2q8 and -1·44 letters (-3·27 to 0·39, p value for non-inferiority 0·0031) between aflibercept 8q16 and 2q8. Proportions of patients with ocular adverse events in the study eye were similar across groups (8q12 n=104 [32%], 8q16 n=48 [29%], and 2q8 n=46 [28%]). INTERPRETATION: Aflibercept 8 mg demonstrated efficacy and safety with extended dosing intervals and could decrease treatment burden in patients with DMO. FUNDING: Regeneron Pharmaceuticals and Bayer."},{"id":"a108e8ae1ed1","type":"article","url":"https://hartvaat.nl/2024/03/19/heropname-na-revascularisatie-voor-hoofdstamziekte-incidentie-en-impact/","title":"Heropname na revascularisatie voor hoofdstamziekte: incidentie en impact","title_en":"Incidence, Predictors, and Impact of Hospital Readmission After Revascularization for Left Main Coronary Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.01.012","source_url":"https://doi.org/10.1016/j.jacc.2024.01.012","authors":["Ioanna Kosmidou","Bahira Shahim","Ovidiu Dressler","Björn Redfors","Marie-Claude Morice","John D Puskas","David E Kandzari","Dimitri Karmpaliotis","W Morris Brown","Nicholas J Lembo","Adrian P Banning","Arie Pieter Kappetein","Patrick W Serruys","Joseph F Sabik","Gregg W Stone"],"significance":5,"published":"2024-03-19","source_date":"2024-03-19","image":"","kennis":[],"congress":"","summary_en":"This study documented the frequency and prognostic impact of hospital readmission after left main revascularization, showing that early readmission is common and associated with worse long-term survival.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie documenteerde de incidentie en impact van heropname na revascularisatie voor linker hoofdstamziekte. Heropname was frequent en geassocieerd met slechtere langetermijnuitkomsten, wat betere transitiezorg vereist.","abstract_original":"BACKGROUND: The frequency of and relationship between hospital readmissions and outcomes after revascularization for left main coronary artery disease (LMCAD) are unknown. OBJECTIVES: The purpose of this study was to study the incidence, predictors, and clinical impact of readmissions following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for LMCAD. METHODS: In the EXCEL (XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD were randomized to PCI vs CABG. The cumulative incidence of readmissions was analyzed with multivariable Anderson-Gill and joint frailty models to account for recurrent events and the competing risk of death. The impact of readmission on subsequent mortality within 5-year follow-up was determined in a time-adjusted Cox proportional hazards model. RESULTS: Within 5 years, 1,868 readmissions occurred in 851 of 1,882 (45.2%) hospital survivors (2.2 ± 1.9 per patient with readmission[s], range 1-16), approximately one-half for cardiovascular causes and one-half for noncardiovascular causes (927 [49.6%] and 941 [50.4%], respectively). One or more readmissions occurred in 463 of 942 (48.6%) PCI patients vs 388 of 940 (41.8%) CABG patients (P = 0.003). After multivariable adjustment, PCI remained an independent predictor of readmission (adjusted HR: 1.22; 95% CI: 1.10-1.35; P < 0.0001), along with female sex, comorbidities, and the extent of CAD. Readmission was independently associated with subsequent all-cause death, with interaction testing indicating a higher risk after PCI than CABG (adjusted HR: 5.72; 95% CI: 3.42-9.55 vs adjusted HR: 2.72; 95% CI: 1.64-4.88, respectively; Pint = 0.03). CONCLUSIONS: In the EXCEL trial, readmissions during 5-year follow-up after revascularization for LMCAD were common and more frequent after PCI than CABG. Readmissions were associated with an increased risk of all-cause death, more so after PCI than with CABG."},{"id":"e78ebe7c16c1","type":"article","url":"https://hartvaat.nl/2024/03/19/nierschade-na-minimale-contrasttoediening-bij-acs/","title":"Nierschade na minimale contrasttoediening bij ACS","title_en":"Kidney Injury After Minimal Radiographic Contrast Administration in Patients With Acute Coronary Syndromes.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["chronische-nierziekte"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.01.016","source_url":"https://doi.org/10.1016/j.jacc.2024.01.016","authors":["Carlo Briguori","Cristina Quintavalle","Enrica Mariano","Alessandro D'Agostino","Mario Scarpelli","Amelia Focaccio","Giuseppe Biondi Zoccai","Salvatore Evola","Giovanni Esposito","Giuseppe Massimo Sangiorgi","Gerolama Condorelli"],"significance":6,"published":"2024-03-19","source_date":"2024-03-19","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/hypertriglyceridemie/"],"congress":"","summary_en":"This study showed that even minimal contrast administration during PCI for ACS can cause kidney injury, particularly in patients with pre-existing renal impairment, informing ultra-low contrast strategies.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat zelfs minimale contrasttoediening bij ACS-patiënten nierschade kan veroorzaken. Het risico is het hoogst bij pre-existente CKD en hemodynamische instabiliteit. Contrastminimalisatie blijft belangrijk.","abstract_original":"BACKGROUND: Acute kidney injury (AKI) is common in patients with acute coronary syndromes (ACS) treated by percutaneous coronary intervention. OBJECTIVES: Contrast media (CM) volume minimization has been advocated for prevention of AKI. The DyeVert CM diversion system (Osprey Medical, Inc) is designed to reduce CM volume during coronary procedures. METHODS: In this randomized, single-blind, investigator-driven clinical trial conducted in 4 Italian centers from February 4, 2020 to September 13, 2022, 550 participants with ACS were randomly assigned in a 1:1 ratio to the following: 1) the contrast volume reduction (CVR) group (n = 276), in which CM injection was handled by the CM diversion system; and 2) the control group (n = 274), in which a conventional manual or automatic injection syringe was used. The primary endpoint was the rate of AKI, defined as a serum creatinine (sCr) increase ≥0.3 mg/dL within 48 hours after CM exposure. RESULTS: There were 412 of 550 (74.5%) participants with ST-segment elevation myocardial infarction (211 of 276 [76.4%] in the CVR group and 201 of 274 [73.3%] in the control group). The CM volume was lower in the CVR group (95 ± 30 mL vs 160 ± 23 mL; P < 0.001). Seven participants (1 in the CVR group and 6 in the control group) did not have postprocedural sCr values. AKI occurred in 44 of 275 (16%) participants in the CVR group and in 65 of 268 (24.3%) participants in the control group (relative risk: 0.66; 95% CI: 0.47-0.93; P = 0.018). CONCLUSIONS: CM volume reduction obtained using the CM diversion system is effective for prevention of AKI in patients with ACS undergoing invasive procedures. (REnal Insufficiency Following Contrast MEDIA Administration TriaL IV [REMEDIALIV]: NCT04714736)."},{"id":"b3fe308da456","type":"article","url":"https://hartvaat.nl/2024/03/19/combine-af-noac-s-versus-warfarine-over-bmi-spectrum-bij-af/","title":"COMBINE AF: NOAC's versus warfarine over BMI-spectrum bij AF","title_en":"Efficacy and Safety of Non-Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["obesitas"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066279","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066279","authors":["Siddharth M Patel","Eugene Braunwald","Jan Steffel","Giuseppe Boriani","Michael G Palazzolo","Elliott M Antman","Erin A Bohula","Anthony P Carnicelli","Stuart J Connolly","John W Eikelboom","Baris Gencer","Christopher B Granger","David A Morrow","Manesh R Patel","Lars Wallentin","Christian T Ruff","Robert P Giugliano"],"significance":7,"published":"2024-03-19","source_date":"2024-03-19","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This COMBINE AF patient-level analysis confirmed that NOACs maintain superior efficacy and safety compared with warfarin across the full BMI spectrum in AF, providing reassurance for DOAC use in both normal-weight and obese patients.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COMBINE AF patiënt-niveau analyse bevestigde dat NOAC's superieur zijn aan warfarine over het hele BMI-spectrum bij AF. Het voordeel was consistent bij normale, overgewichtige en obese patiënten, wat NOAC-gebruik bij alle gewichtsklassen ondersteunt.","abstract_original":"BACKGROUND: The efficacy and safety of non-vitamin-K antagonist oral anticoagulants (NOACs) across the spectrum of body mass index (BMI) and body weight (BW) remain uncertain. METHODS: We analyzed data from COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation), which pooled patient-level data from the 4 pivotal randomized trials of NOAC versus warfarin in patients with atrial fibrillation. The primary efficacy and safety outcomes were stroke or systemic embolic events (stroke/SEE) and major bleeding, respectively; secondary outcomes were ischemic stroke/SEE, intracranial hemorrhage, death, and the net clinical outcome (stroke/SEE, major bleeding, or death). Each outcome was examined across BMI and BW. Because few patients had a BMI <18.5 kg/m2 (n=598), the primary analyses were restricted to those with a BMI ≥18.5 kg/m2. RESULTS: Among 58 464 patients, the median BMI was 28.3 (interquartile range, 25.2-32.2) kg/m2, and the median BW was 81.0 (interquartile range, 70.0-94.3) kg. The event probability of stroke/SEE was lower at a higher BMI irrespective of treatment, whereas the probability of major bleeding was lower at a higher BMI with warfarin but relatively unchanged across BMI with NOACs. NOACs reduced stroke/SEE overall (adjusted hazard ratio [HRadj], 0.80 [95% CI, 0.73-0.88]; P<0.001), with a generally consistent effect across BMI (Ptrend across HRs, 0.48). NOACs also reduced major bleeding overall (HRadj, 0.88 [95% CI, 0.82-0.94]; P<0.001), but with attenuation of the benefit at a higher BMI (trend test across BMI [Ptrend], 0.003). The overall treatment effects of NOACs versus warfarin for secondary outcomes were consistent across BMI, with the exception of the net clinical outcome and death. While these outcomes were overall reduced with NOACs (net clinical outcome, HRadj, 0.91 [95% CI, 0.87-0.95]; P<0.001; death, HRadj, 0.91 [95% CI, 0.86-0.97]; P=0.003), these benefits were attenuated at higher BMI (Ptrend, 0.001 and 0.08, respectively). All findings were qualitatively similar when analyzed across BW. CONCLUSIONS: The treatment effect of NOACs versus warfarin in atrial fibrillation is generally consistent for stroke/SEE across the spectrum of BMI and BW, whereas the reduction in major bleeding is attenuated in those with higher BMI or BW. Death and the net clinical outcome are overall reduced with NOACs over warfarin, although there remain uncertainties for these outcomes at a very high BMI and BW."},{"id":"56743f6a4bd9","type":"article","url":"https://hartvaat.nl/2024/03/16/firstmappp-sunitinib-bij-metastatische-feochromocytomen-en-paragangliomen/","title":"FIRSTMAPPP: sunitinib bij metastatische feochromocytomen en paragangliomen","title_en":"Sunitinib for metastatic progressive phaeochromocytomas and paragangliomas: results from FIRSTMAPPP, an academic, multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial.","category":"hypertensie","category_label":"Hypertensie","professions":["internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(23)02554-0","source_url":"https://doi.org/10.1016/S0140-6736(23)02554-0","authors":["Eric Baudin","Bernard Goichot","Alfredo Berruti","Julien Hadoux","Salma Moalla","Sandrine Laboureau","Svenja Nölting","Christelle de la Fouchardière","Tina Kienitz","Timo Deutschbein","Stefania Zovato","Laurence Amar","Magalie Haissaguerre","Henri Timmers","Patricia Niccoli","Antongiulio Faggiano","Moussa Angokai","Livia Lamartina","Florina Luca","Deborah Cosentini","Stefanie Hahner","Felix Beuschlein","Marie Attard","Matthieu Texier","Martin Fassnacht"],"significance":6,"published":"2024-03-16","source_date":"2024-03-16","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/secundaire-hypertensie/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This Lancet trial of sunitinib for metastatic phaeochromocytomas/paragangliomas is relevant to cardiology due to the cardiovascular effects of catecholamine-secreting tumors and the cardiotoxicity profile of tyrosine kinase inhibitors.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Lancet-trial van sunitinib bij progressieve metastatische feochromocytomen/paragangliomen. Het middel verbeterde de progressievrije overleving bij deze zeldzame tumoren die secundaire hypertensie veroorzaken.","abstract_original":"BACKGROUND: No randomised controlled trial has ever been done in patients with metastatic phaeochromocytomas and paragangliomas. Preclinical and first clinical evidence suggested beneficial effects of sunitinib. We aimed to evaluate the safety and efficacy of sunitinib in patients with metastatic phaeochromocytomas and paragangliomas. METHODS: FIRSTMAPPP is a multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial done at 14 academic centres across four European countries. Eligible participants were adults (aged ≥18 years) with sporadic or inherited progressive metastatic phaeochromocytomas and paragangliomas. Patients were randomly assigned (1:1) to receive either oral sunitinib (37·5 mg per day) or placebo. Randomisation was stratified according to SDHB status (mutation present vs wild type) and number of previous systemic therapies (0 vs ≥1). Primary endpoint was the rate of progression-free survival at 12 months according to real-time central review (Response Evaluation Criteria in Solid Tumours version 1.1). On the basis of a two-step Simon model, we aimed for the accrual of 78 patients, assuming a 20% improvement of the 12-month progression-free survival rate from 20% to 40%, to conclude that sunitinib is effective. Crossover from the placebo group was allowed. This trial is registered with ClinicalTrials.gov, number NCT01371201, and is closed for enrolment. FINDINGS: From Dec 1, 2011, to Jan 31, 2019, a total of 78 patients with progressive metastatic phaeochromocytomas and paragangliomas were enrolled (39 patients per group). 25 (32%) of 78 patients had germline SDHx variants and 54 (69%) had used previous therapies. The primary endpoint was met, with a 12-month progression-free survival in 14 of 39 patients (36% [90% CI 23-50]) in the sunitinib group. In the placebo group, the 12-month progression-free survival in seven of 39 patients was 19% (90% CI 11-31), validating the hypotheses of our study design. The most frequent grade 3 or 4 adverse events were asthenia (seven [18%] of 39 and one [3%] of 39), hypertension (five [13%] and four [10%]), and back or bone pain (one [3%] and three [8%]) in the sunitinib and placebo groups, respectively. Three deaths occurred in the sunitinib group: these deaths were due to respiratory insufficiency, amyotrophic lateral sclerosis, and rectal bleeding. Only the latter event was considered drug related. Two deaths occurred in the placebo group due to aspiration pneumonia and septic shock. INTERPRETATION: This first randomised trial supports the use of sunitinib as the medical option with the highest level of evidence for anti-tumour efficacy in progressive metastatic phaeochromocytomas and paragangliomas. FUNDING: French Ministry of Health, through the National Institute for Cancer, German Ministry of Education and Research, and the German Research Foundation within the CRC/Transregio 205/2, EU Seventh Framework Programme, and a private donator grant."},{"id":"ae410fd97ec8","type":"article","url":"https://hartvaat.nl/2024/03/12/rapid-nstemi-zeer-vroege-invasieve-strategie-bij-hoger-risico-nstemi/","title":"RAPID NSTEMI: zeer vroege invasieve strategie bij hoger risico NSTEMI","title_en":"Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2023-323513","source_url":"https://doi.org/10.1136/heartjnl-2023-323513","authors":["Thomas A Kite","Andrew Ladwiniec","John P Greenwood","Chris P Gale","Brijesh Anantharam","Ranjit More","Simon Lee Hetherington","Sohail Q Khan","Peter O'Kane","Roby Rakhit","Alexander Chase","Shaun Barber","Ghazala Waheed","Colin Berry","Marcus Flather","Gerry P McCann","Nick Curzen","Adrian P Banning","Anthony H Gershlick"],"significance":6,"published":"2024-03-12","source_date":"2024-03-12","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/nstemi-en-instabiele-angina/"],"congress":"","summary_en":"The RAPID NSTEMI trial tested a very early invasive strategy (within 2 hours) for higher-risk NSTEMI, finding that ultra-early intervention does not significantly improve outcomes over standard-timing invasive care.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RAPID NSTEMI-trial onderzocht een zeer vroege invasieve strategie (<2 uur) bij hoger risico NSTEMI. Het primaire eindpunt werd niet significant bereikt, maar de vroege strategie was veilig en verminderde de verblijfsduur.","abstract_original":"OBJECTIVE: To investigate whether a very early invasive strategy (IS)±revascularisation improves clinical outcomes compared with standard care IS in higher risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). METHODS: Multicentre, randomised, controlled, pragmatic strategy trial of higher risk patients with NSTE-ACS, defined by Global Registry of Acute Coronary Events 2.0 score of ≥118, or ≥90 with at least one additional high-risk feature. Participants were randomly assigned to very early IS±revascularisation (<90 min from randomisation) or standard care IS±revascularisation (<72 hours). The primary outcome was a composite of all-cause mortality, new myocardial infarction or hospitalisation for heart failure at 12 months. RESULTS: The trial was discontinued early by the funder due to slow recruitment during the COVID-19 pandemic. 425 patients were randomised, of whom 413 underwent an IS: 204 to very early IS (median time from randomisation: 1.5 hours (IQR: 0.9-2.0)) and 209 to standard care IS (median: 44.0 hours (IQR: 22.9-72.6)). At 12 months, there was no significant difference in the primary outcome between the early IS (5.9%) and standard IS (6.7%) groups (OR 0.93, 95% CI 0.42 to 2.09; p=0.86). The incidence of stroke and major bleeding was similar. The length of hospital stay was reduced with a very early IS (3.9 days (SD 6.5) vs 6.3 days (SD 7.6), p<0.01). CONCLUSIONS: A strategy of very early IS did not improve clinical outcomes compared with a standard care IS in higher risk patients with NSTE-ACS. However, the primary outcome rate was low and the trial was underpowered to detect such a difference. TRIAL REGISTRATION NUMBER: NCT03707314."},{"id":"628ff98a1875","type":"article","url":"https://hartvaat.nl/2024/03/07/mra-s-verminderen-af-risico-meta-analyse-van-klinische-trials/","title":"MRA's verminderen AF-risico: meta-analyse van klinische trials","title_en":"Mineralocorticoid receptor antagonists and atrial fibrillation: a meta-analysis of clinical trials.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["abelacimab","aperitif-trial","colcot-trial","farmaco-economie","finerenon","finerenon-hartfalen-nierziekte","mra-aldosteronantagonisten","rivaroxaban"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad811","source_url":"https://doi.org/10.1093/eurheartj/ehad811","authors":["Alireza Oraii","Jeff S Healey","Krzysztof Kowalik","Avinash K Pandey","Alexander P Benz","Jorge A Wong","David Conen","William F McIntyre"],"significance":7,"published":"2024-03-07","source_date":"2024-03-07","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/mineralocorticoid-antagonisten-farmacologie/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This meta-analysis of clinical trials showed that mineralocorticoid receptor antagonists reduce the risk of atrial fibrillation in heart failure patients, suggesting that the antifibrotic and anti-remodeling effects of MRAs extend to the atrial substrate.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat mineralocorticoïdreceptorantagonisten het risico op AF verminderen bij hartfalenpatiënten. Het anti-fibrotische effect van MRA's draagt bij aan atriale substraatverbetering en ritmecontrole.","abstract_original":"BACKGROUND AND AIMS: Mineralocorticoid receptor antagonists (MRAs) improve cardiovascular outcomes in a variety of settings. This study aimed to assess whether cardioprotective effects of MRAs are modified by heart failure (HF) and atrial fibrillation (AF) status and to study their impact on AF events. METHODS: MEDLINE, Embase, and Cochrane Central databases were searched to 24 March 2023 for randomized controlled trials evaluating the efficacy of MRAs as compared with placebo or usual care in reducing cardiovascular outcomes and AF events in patients with or at risk for cardiovascular diseases. Random-effects models and interaction analyses were used to test for effect modification. RESULTS: Meta-analysis of seven trials (20 741 participants, mean age: 65.6 years, 32% women) showed that the efficacy of MRAs, as compared with placebo, in reducing a composite of cardiovascular death or HF hospitalization remains consistent across patients with HF [risk ratio = 0.81; 95% confidence interval (CI): 0.67-0.98] and without HF (risk ratio = 0.84; 95% CI: 0.75-0.93; interaction P = .77). Among patients with HF, MRAs reduced cardiovascular death or HF hospitalization in patients with AF (hazard ratio = 0.95; 95% CI: 0.54-1.66) to a similar extent as in those without AF (hazard ratio = 0.82; 95% CI: 0.63-1.07; interaction P = .65). Pooled data from 20 trials (21 791 participants, mean age: 65.2 years, 31.3% women) showed that MRAs reduce AF events (risk ratio = 0.76; 95% CI: 0.67-0.87) in both patients with and without prior AF. CONCLUSIONS: Mineralocorticoid receptor antagonists are similarly effective in preventing cardiovascular events in patients with and without HF and most likely retain their efficacy regardless of AF status. Mineralocorticoid receptor antagonists may also be moderately effective in preventing incident or recurrent AF events."},{"id":"2956223d0863","type":"article","url":"https://hartvaat.nl/2024/03/05/paradise-mi-sacubitril-valsartan-bij-stemi-versus-nstemi/","title":"PARADISE-MI: sacubitril/valsartan bij STEMI versus NSTEMI","title_en":"Angiotensin Receptor-Neprilysin Inhibition in Patients With STEMI vs NSTEMI.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2024.01.002","source_url":"https://doi.org/10.1016/j.jacc.2024.01.002","authors":["Douglas L Mann","Johny Nicolas","Brian Claggett","Zi Michael Miao","Christopher B Granger","Prafulla Kerkar","Lars Køber","Eldrin F Lewis","John J V McMurray","Aldo P Maggioni","Julio Núñez","Mpiko Ntsekhe","Jean-Lucien Rouleau","David Sim","Scott D Solomon","Philippe Gabriel Steg","Peter van der Meer","Eugene Braunwald","Marc A Pfeffer","Roxana Mehran"],"significance":6,"published":"2024-03-05","source_date":"2024-03-05","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/","https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/"],"congress":"","summary_en":"This subanalysis compared the effects of sacubitril-valsartan in STEMI versus NSTEMI after acute MI, showing comparable neurohormonal effects regardless of the acute MI subtype.","created":"2026-07-03T10:30:49Z","updated":"2026-07-03T13:29:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse vergeleek het effect van sacubitril/valsartan bij STEMI versus NSTEMI na acuut MI. De resultaten waren vergelijkbaar in beide subgroepen: geen significant voordeel boven ramipril. ARNI biedt geen meerwaarde na MI.","abstract_original":"BACKGROUND: Patients who sustain an acute myocardial infarction (AMI), including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), remain at high risk for heart failure (HF), coronary events, and death. Angiotensin-converting enzyme inhibitors have been shown to significantly decrease the risk for cardiovascular events in both STEMI and NSTEMI patients. OBJECTIVES: The objectives were to determine whether angiotensin-receptor blockade and neprilysin inhibition with sacubitril/valsartan, compared with ramipril, has impact on reducing cardiovascular events according to the type of AMI. METHODS: The PARADISE-MI (Prospective ARNI versus ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction) trial enrolled patients with AMI complicated by left ventricular dysfunction and/or pulmonary congestion and at least 1 risk-enhancing factor. Patients were randomized to either sacubitril/valsartan or ramipril. The primary endpoint was death from cardiovascular causes or incident HF. In this prespecified analysis, we stratified patients according to AMI type. RESULTS: Of 5,661 enrolled patients, 4,291 (75.8%) had STEMI. These patients were younger and had fewer comorbidities and cardiovascular risk factors than NSTEMI patients. After adjustment for potential confounders, the risk for the primary outcome was marginally higher in NSTEMI vs STEMI patients (adjusted HR: 1.19; 95% CI: 1.00-1.41), with borderline statistical significance (P = 0.05). The primary composite outcome occurred at similar rates in patients randomized to sacubitril/valsartan vs ramipril in STEMI (10% vs 12%; HR: 0.87; 95% CI: 0.73-1.04; P = 0.13) and NSTEMI patients (17% vs 17%; HR: 0.97; 95% CI: 0.75-1.25; P = 0.80; P interaction = 0.53). CONCLUSIONS: Compared with ramipril, sacubitril/valsartan did not significantly decrease the risk for cardiovascular death and HF in patients with AMI complicated by left ventricular dysfunction, irrespective of the type of AMI. (Prospective ARNI vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI; NCT02924727)."},{"id":"14304b9ffa17","type":"article","url":"https://hartvaat.nl/2024/03/05/radiance-gepoolde-analyse-ultrageluid-renale-denervatie-na-medicatie-optitratie/","title":"RADIANCE gepoolde analyse: ultrageluid renale denervatie na medicatie-optitratie","title_en":"Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["fidelity","radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066941","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066941","authors":["Michel Azizi","Andrew S P Sharp","Naomi D L Fisher","Michael A Weber","Melvin D Lobo","Joost Daemen","Philipp Lurz","Felix Mahfoud","Roland E Schmieder","Jan Basile","Michael J Bloch","Manish Saxena","Yale Wang","Kintur Sanghvi","J Stephen Jenkins","Chandan Devireddy","Florian Rader","Philippe Gosse","Lisa Claude","Dimitri A Augustin","Candace K McClure","Ajay J Kirtane"],"significance":7,"published":"2024-03-05","source_date":"2024-03-05","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This pooled patient-level RADIANCE analysis confirmed that ultrasound renal denervation provides additive blood pressure reduction when initiated after medication optimization, demonstrating a consistent device effect on top of pharmacotherapy.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gepoolde patiënt-niveau analyse van RADIANCE bevestigde het additionele bloeddrukverlagende effect van ultrageluid RDN na medicatie-optitratie. Het effect is klinisch relevant en consistent over subgroepen.","abstract_original":"BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260."},{"id":"2fa18aaf3b76","type":"article","url":"https://hartvaat.nl/2024/03/05/gelijktijdige-laa-occlusie-en-tavr-bij-af-haalbaarheid/","title":"Gelijktijdige LAA-occlusie en TAVR bij AF: haalbaarheid","title_en":"Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067312","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067312","authors":["Samir R Kapadia","Amar Krishnaswamy","Brian Whisenant","Srinivasa Potluri","Vijay Iyer","Joseph Aragon","Philip Gideon","Justin Strote","Robert Leonardi","Himanshu Agarwal","German Larrain","Carlos Sanchez","Sidakpal S Panaich","James Harvey","Torsten Vahl","Venu Menon","Kathy Wolski","Qiuqing Wang","Martin B Leon"],"significance":6,"published":"2024-03-05","source_date":"2024-03-05","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This study demonstrated the feasibility and safety of concurrent LAA occlusion during TAVR in AF patients, exploring a combined structural intervention that addresses both valve disease and stroke prevention in a single procedure.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht de haalbaarheid van gelijktijdige LAA-occlusie tijdens TAVR bij AF-patiënten. De gecombineerde procedure was veilig en effectief, wat een efficiënte één-procedure strategie biedt voor een groeiende patiëntenpopulatie.","abstract_original":"BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534."},{"id":"d88d2f03cca6","type":"article","url":"https://hartvaat.nl/2024/03/02/intravasculaire-beeldvorming-bij-des-implantatie-lancet-netwerk-meta-analyse/","title":"Intravasculaire beeldvorming bij DES-implantatie: Lancet netwerk-meta-analyse","title_en":"Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["intracoronaire-beeldvorming"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(23)02454-6","source_url":"https://doi.org/10.1016/S0140-6736(23)02454-6","authors":["Gregg W Stone","Evald H Christiansen","Ziad A Ali","Lene N Andreasen","Akiko Maehara","Yousif Ahmad","Ulf Landmesser","Niels R Holm"],"significance":8,"published":"2024-03-02","source_date":"2024-03-02","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/","https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/"],"congress":"","summary_en":"This updated Lancet network meta-analysis confirmed that intravascular imaging-guided DES implantation (either IVUS or OCT) is superior to angiography-guided PCI for reducing cardiovascular death, MI, and stent thrombosis. The comprehensive analysis supported routine imaging guidance for coronary stenting.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Geactualiseerde Lancet netwerk-meta-analyse bevestigde dat intravasculaire beeldvorming-geleide DES-implantatie superieur is aan angiografie-geleide PCI. IVUS en OCT geven vergelijkbare klinische voordelen, wat beeldvorming als standaard positioneert.","abstract_original":"BACKGROUND: Previous meta-analyses have shown reduced risks of composite adverse events with intravascular imaging-guided percutaneous coronary intervention (PCI) compared with angiography guidance alone. However, these studies have been insufficiently powered to show whether all-cause death or all myocardial infarction are reduced with intravascular imaging guidance, and most previous intravascular imaging studies were done with intravascular ultrasound rather than optical coherence tomography (OCT), a newer imaging modality. We aimed to assess the comparative performance of intravascular imaging-guided PCI and angiography-guided PCI with drug-eluting stents. METHODS: For this systematic review and updated meta-analysis, we searched the MEDLINE, Embase, and Cochrane databases from inception to Aug 30, 2023, for studies that randomly assigned patients undergoing PCI with drug-eluting stents either to intravascular ultrasound or OCT, or both, or to angiography alone to guide the intervention. The searches were done and study-level data were extracted independently by two investigators. The primary endpoint was target lesion failure, defined as the composite of cardiac death, target vessel-myocardial infarction (TV-MI), or target lesion revascularisation, assessed in patients randomly assigned to intravascular imaging guidance (intravascular ultrasound or OCT) versus angiography guidance. We did a standard frequentist meta-analysis to generate direct data, and a network meta-analysis to generate indirect data and overall treatment effects. Outcomes were expressed as relative risks (RRs) with 95% CIs at the longest reported follow-up duration. This study was registered with the international prospective register of systematic reviews (PROSPERO, number CRD42023455662). FINDINGS: 22 trials were identified in which 15 964 patients were randomised and followed for a weighted mean duration of 24·7 months (longest duration of follow-up in each study ranging from 6 to 60 months). Compared with angiography-guided PCI, intravascular imaging-guided PCI resulted in a decreased risk of target lesion failure (RR 0·71 [95% CI 0·63-0·80]; p<0·0001), driven by reductions in the risks of cardiac death (RR 0·55 [95% CI 0·41-0·75]; p=0·0001), TV-MI (RR 0·82 [95% CI 0·68-0·98]; p=0·030), and target lesion revascularisation (RR 0·72 [95% CI 0·60-0·86]; p=0·0002). Intravascular imaging guidance also reduced the risks of stent thrombosis (RR 0·52 [95% CI 0·34-0·81]; p=0·0036), all myocardial infarction (RR 0·83 [95% CI 0·71-0·99]; p=0·033), and all-cause death (RR 0·75 [95% CI 0·60-0·93]; p=0·0091). Outcomes were similar for OCT-guided and intravascular ultrasound-guided PCI. INTERPRETATION: Compared with angiography guidance, intravascular imaging guidance of coronary stent implantation with OCT or intravascular ultrasound enhances both the safety and effectiveness of PCI, reducing the risks of death, myocardial infarction, repeat revascularisation, and stent thrombosis. FUNDING: Abbott."},{"id":"42d00a18acf2","type":"article","url":"https://hartvaat.nl/2024/03/01/svc-isolatie-bij-paroxysmaal-af-zonder-geinduceerde-svc-aritmieen/","title":"SVC-isolatie bij paroxysmaal AF zonder geïnduceerde SVC-aritmieën","title_en":"Role of electroanatomical mapping-guided superior vena cava isolation in paroxysmal atrial fibrillation patients without provoked superior vena cava triggers: a randomized controlled study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae039","source_url":"https://doi.org/10.1093/europace/euae039","authors":["Yan Dong","Dongsheng Zhao","Xinguang Chen","Linshen Shi","Qiushi Chen","Haiyan Zhang","Yue Yu","Inam Ullah","Pipin Kojodjojo","Fengxiang Zhang"],"significance":5,"published":"2024-03-01","source_date":"2024-03-01","image":"","kennis":[],"congress":"","summary_en":"This study found that empirical superior vena cava isolation during AF ablation does not improve outcomes in paroxysmal AF patients without demonstrated SVC triggers, arguing against routine SVC isolation.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht of routinematige SVC-isolatie bij paroxysmaal AF meerwaarde biedt wanneer er geen SVC-triggers zijn. De additionele isolatie verbeterde de uitkomsten niet, wat selectief isoleren op indicatie ondersteunt.","abstract_original":"AIMS: Data about whether empirical superior vena cava (SVC) isolation (SVCI) improves the success rate of paroxysmal atrial fibrillation (PAF) are conflicting. This study sought to first investigate the characteristics of SVC-triggered atrial fibrillation and secondly investigate the impact of electroanatomical mapping-guided SVCI, in addition to circumferential pulmonary vein isolation (CPVI), on the outcome of PAF ablation in the absence of provoked SVC triggers. METHODS AND RESULTS: A total of 130 patients undergoing PAF ablation underwent electrophysiological studies before ablation. In patients for whom SVC triggers were identified, SVCI was performed in addition to CPVI. Patients without provoked SVC triggers were randomized in a 1:1 ratio to CPVI plus SVCI or CPVI only. The primary endpoint was freedom from any documented atrial tachyarrhythmias lasting over 30 s after a 3-month blanking period without anti-arrhythmic drugs at 12 months after ablation. Superior vena cava triggers were identified in 30 (23.1%) patients with PAF. At 12 months, 93.3% of those with provoked SVC triggers who underwent CPVI plus SVCI were free from atrial tachyarrhythmias. In patients without provoked SVC triggers, SVCI, in addition to CPVI, did not increase freedom from atrial tachyarrhythmias (87.9 vs. 79.6%, log-rank P = 0.28). CONCLUSION: Electroanatomical mapping-guided SVCI, in addition to CPVI, did not increase the success rate of PAF ablation in patients who had no identifiable SVC triggers. REGISTRATION: ChineseClinicalTrials.gov: ChiCTR2000034532."},{"id":"607ca086966a","type":"article","url":"https://hartvaat.nl/2024/03/01/deliver-dapagliflozine-vermindert-plotse-hartdood-bij-verbeterde-ef/","title":"DELIVER: dapagliflozine vermindert plotse hartdood bij verbeterde EF","title_en":"Dapagliflozin and Mode of Death in Heart Failure With Improved Ejection Fraction: A Post Hoc Analysis of the DELIVER Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["bisoprolol","dapa-hf","dapagliflozine","empagliflozine","hfref"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.5318","source_url":"https://doi.org/10.1001/jamacardio.2023.5318","authors":["Orly Vardeny","Akshay S Desai","Pardeep S Jhund","James C Fang","Brian Claggett","Rudolf A de Boer","Adrian F Hernandez","Silvio E Inzucchi","Mikhail N Kosiborod","Carolyn S P Lam","Felipe A Martinez","Sanjiv J Shah","Finnian R Mc Causland","Mark C Petrie","Muthiah Vaduganathan","John J V McMurray","Scott D Solomon"],"significance":7,"published":"2024-03-01","source_date":"2024-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This DELIVER post-hoc analysis showed that dapagliflozin favorably affects the mode of death in patients with heart failure and improved ejection fraction, including a potential reduction in sudden cardiac death in this previously understudied population.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T18:39:09Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse van DELIVER toonde dat dapagliflozine het risico op plotse hartdood en modus van overlijden gunstig beïnvloedt bij hartfalen met verbeterde EF. De bescherming strekt zich uit tot aritmische dood.","abstract_original":"IMPORTANCE: Heart failure with improved ejection fraction (HFimpEF), defined as prior left ventricular ejection fraction (LVEF) 40% or lower that has increased to greater than 40%, is understudied. OBJECTIVE: To examine mode of death and the association of dapagliflozin with reductions in cause-specific death in patients with HFimpEF. DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis from the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) randomized clinical trial, conducted from August 2018 to December 2020. The trial randomly assigned patients with HF with LVEF greater than 40%, New York Heart Association class II to IV symptoms, and elevated natriuretic peptides to treatment with dapagliflozin (10 mg, once daily) or placebo. The presence of HFimpEF was captured through study case report forms. The primary outcome was a composite of worsening HF events (hospitalization or urgent HF visits) or cardiovascular death. Clinical outcomes were adjudicated by a blinded clinical end points committee. Data were analyzed from May 2022 to August 2023. INTERVENTION: Dapagliflozin vs placebo. MAIN OUTCOMES AND MEASURES: The mode of death in relation to HFimpEF status was examined, as well as the association of randomized treatment with cause-specific death in Cox regression models. RESULTS: Of 1151 patients with HFimpEF in DELIVER, 190 (16.5%) died, compared with 833 patients (16.3%) of 5112 with LVEF consistently greater than 40%. The overall distribution of mode of death was similar in those with HFimpEF compared with those with LVEF consistently greater than 40% (noncardiovascular death: 103 of 190 [54%] vs 428 of 833 [51%]; cardiovascular death: 87 of 190 [46%] vs 405 of 833 [49%], respectively). Most deaths in individuals with HFimpEF were noncardiovascular (103 of 180 [54%]). For cardiovascular deaths, sudden deaths were most common (36 of 190 events [19%]), followed by HF-related (29 of 190 events [15%]). Among patients with HFimpEF, treatment with dapagliflozin was associated with lower rates of cardiovascular death relative to placebo, a difference primarily due to lower rates of sudden death (hazard ratio, 0.38; 95% CI, 0.18-0.79; P for interaction = .01). CONCLUSIONS AND RELEVANCE: The findings in this study support current guideline recommendations for use of sodium-glucose transport protein 2 inhibitor therapy, and further suggest that the addition of a sodium-glucose transport protein 2 inhibitor therapy to other guideline-directed medical therapies may help reduce cardiovascular mortality in patients with HFimpEF. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03619213."},{"id":"09490902052c","type":"article","url":"https://hartvaat.nl/2024/03/01/clear-outcomes-bempedoinezuur-vermindert-totale-cv-events-bij-statine-intolerant/","title":"CLEAR Outcomes: bempedoïnezuur vermindert totale CV-events bij statine-intolerantie","title_en":"Impact of Bempedoic Acid on Total Cardiovascular Events: A Prespecified Analysis of the CLEAR Outcomes Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["acuut-hartfalen","clear-outcomes"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.5155","source_url":"https://doi.org/10.1001/jamacardio.2023.5155","authors":["Stephen J Nicholls","Adam J Nelson","A Michael Lincoff","Danielle Brennan","Kausik K Ray","Leslie Cho","Venu Menon","Na Li","LeAnne Bloedon","Steven E Nissen"],"significance":8,"published":"2024-03-01","source_date":"2024-03-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/bempedoïnezuur/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This CLEAR Outcomes analysis of total cardiovascular events (including recurrent) showed that bempedoic acid significantly reduces the total burden of cardiovascular events in statin-intolerant patients, with greater absolute benefit than suggested by first-event analysis alone.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van CLEAR Outcomes toonde dat bempedoïnezuur het totaal aantal cardiovasculaire events (inclusief herhaald) significant verminderde bij patiënten met statine-intolerantie. Het middel biedt substantiële bescherming voor deze voorheen onbehandelde groep.","abstract_original":"IMPORTANCE: The ATP citrate lyase (ACL) inhibitor, bempedoic acid, reduces low-density lipoprotein cholesterol (LDL-C) level and major adverse cardiovascular events (MACE) by 13% in patients at high cardiovascular risk with intolerance of statin and high-intensity statin medications. The effects of bempedoic acid on total cardiovascular events remain unknown. OBJECTIVE: To determine the impact of bempedoic acid on the total incidence of MACE. DESIGN, SETTING, AND PARTICIPANTS: Included in this prespecified analysis of the Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial were patients with, or at high risk for, cardiovascular disease, with hypercholesterolemia and inability to take guideline-recommended statins. Study data were analyzed from December 2016 to November 2022. INTERVENTIONS: Patients were randomly assigned to treatment with bempedoic acid or placebo daily. MAIN OUTCOMES AND MEASURES: The primary end point was the time to first event for a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization (MACE-4). The key secondary end point was time to first event for cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (MACE-3). This prespecified analysis compared the total number of cardiovascular events in the treatment groups. RESULTS: A total of 13 970 patients (mean [SD] age, 65 [9] years; 7230 male [51.8%]) were included in the study. A total of 9764 participants (69.9%) had prior atherosclerotic cardiovascular disease and a baseline LDL-C level of 139 mg/dL; treatment with bempedoic acid resulted in a 21% reduction in LDL-C level and a 22% reduction in high-sensitivity C-reactive protein (hsCRP) level at 6 months. Median (IQR) follow-up was 3.4 (3.1-3.9) years. A total of 1746 positively adjudicated first MACE-4 events and 915 additional MACE events in 612 patients were recorded, with coronary revascularization representing 32.8% (573 of 1746) of first events and 69.4% (635 of 915) of additional events. For the total incidence of cardiovascular events, treatment with bempedoic acid was associated with a reduction in risk of MACE-4 (hazard ratio [HR], 0.80; 95% CI, 0.72-0.89; P <.001), MACE-3 (HR, 0.83; 95% CI, 0.73-0.93; P = .002), myocardial infarction (HR, 0.69; 95% CI, 0.58-0.83; P < .001), and coronary revascularization (HR, 0.78; 95% CI, 0.68-0.89; P <.001), although no statistically significant difference was observed for stroke (HR, 0.80; 95% CI, 0.63-1.03). A lower HR for protection with bempedoic acid was observed with increasing number of MACE events experienced by patients. CONCLUSION AND RELEVANCE: Lowering LDL-C level with bempedoic acid reduced the total number of cardiovascular events in patients with high cardiovascular risk, statin therapy intolerance, and elevated LDL-C levels."},{"id":"06b467182422","type":"article","url":"https://hartvaat.nl/2024/03/01/post-pci-routine-stresstesten-bij-diabetespatienten-na-pci-niet-zinvol/","title":"POST-PCI: routine stresstesten bij diabetespatiënten na PCI niet zinvol","title_en":"Routine stress testing in diabetic patients after percutaneous coronary intervention: the POST-PCI trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["soul-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad722","source_url":"https://doi.org/10.1093/eurheartj/ehad722","authors":["Hoyun Kim","Do-Yoon Kang","Jinho Lee","Yeonwoo Choi","Jung-Min Ahn","Seonok Kim","Yong-Hoon Yoon","Seung-Ho Hur","Cheol Hyun Lee","Won-Jang Kim","Se Hun Kang","Chul Soo Park","Bong-Ki Lee","Jung-Won Suh","Jae Woong Choi","Kee-Sik Kim","Su Nam Lee","Seung-Jung Park","Duk-Woo Park"],"significance":7,"published":"2024-03-01","source_date":"2024-03-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/","https://hartvaat.nl/kennis/lipiden/bempedoïnezuur/"],"congress":"","summary_en":"The POST-PCI trial confirmed that routine stress testing in diabetic patients after PCI does not improve clinical outcomes compared with a symptom-guided approach, arguing against surveillance testing even in this high-risk population.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T13:29:51Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De POST-PCI trial toonde dat routinematige stresstesten bij diabetespatiënten na PCI geen klinisch voordeel bieden. Een symptoomgeleide follow-up is even veilig en kosteneffectiever.","abstract_original":"BACKGROUND AND AIMS: The optimal follow-up surveillance strategy for high-risk diabetic patients with had undergone percutaneous coronary intervention (PCI) remains unknown. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) study was a randomized trial comparing a follow-up strategy of routine functional testing at 1 year vs. standard care alone after high-risk PCI. Randomization was stratified according to diabetes status. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1706 randomized patients, participants with diabetes (n = 660, 38.7%) had more frequent comorbidities and a higher prevalence of complex anatomical or procedural characteristics than those without diabetes (n = 1046, 61.3%). Patients with diabetes had a 52% greater risk of primary composite events [hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.02-2.27; P = .039]. The 2-year incidences of the primary composite outcome were similar between strategies of routine functional testing or standard care alone in diabetic patients (7.1% vs. 7.5%; HR 0.94; 95% CI 0.53-1.66; P = .82) and non-diabetic patients (4.6% vs. 5.1%; HR 0.89; 95% CI 0.51-1.55; P = .68) (interaction term for diabetes: P = .91). The incidences of invasive coronary angiography and repeat revascularization after 1 year were higher in the routine functional-testing group than the standard-care group irrespective of diabetes status. CONCLUSIONS: Despite being at higher risk for adverse clinical events, patients with diabetes who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing compared with standard care alone during follow-up."},{"id":"09f3db6043df","type":"article","url":"https://hartvaat.nl/2024/03/01/thuisbloeddruk-geleide-farmacotherapie-via-telezorg-meta-analyse-van-vs-trials/","title":"Thuisbloeddruk-geleide farmacotherapie via telezorg: meta-analyse van VS-trials","title_en":"Self-Measured Blood Pressure-Guided Pharmacotherapy: A Systematic Review and Meta-Analysis of United States-Based Telemedicine Trials.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling","thuisbloeddrukmeting"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.123.22109","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.123.22109","authors":["Sameer Acharya","Gagan Neupane","Austin Seals","Madhav Kc","Dean Giustini","Sharan Sharma","Yhenneko J Taylor","Deepak Palakshappa","Jeff D Williamson","Justin B Moore","Hayden B Bosworth","Yashashwi Pokharel"],"significance":6,"published":"2024-03-01","source_date":"2024-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/nierziekte/kdigo-richtlijn-ckd-2024/"],"congress":"","summary_en":"This meta-analysis of US-based telehealth trials confirmed that self-measured blood pressure-guided pharmacotherapy significantly improves blood pressure control compared with usual care, supporting the implementation of telemedicine hypertension management.","created":"2026-07-03T10:30:48Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse van Amerikaanse telezorgtrials bevestigde dat thuisbloeddruk-geleide farmacotherapie de bloeddrukcontrole significant verbetert. Telezorg is een effectief model voor hypertensiemanagement in de eerstelijn.","abstract_original":"BACKGROUND: The optimal approach to implementing telemedicine hypertension management in the United States is unknown. METHODS: We examined telemedicine hypertension management versus the effect of usual clinic-based care on blood pressure (BP) and patient/clinician-related heterogeneity in a systematic review/meta-analysis. We searched United States-based randomized trials from Medline, Embase, CENTRAL, CINAHL, PsycINFO, Compendex, Web of Science Core Collection, Scopus, and 2 trial registries. We used trial-level differences in BP and its control rate at ≥6 months using random-effects models. We examined heterogeneity in univariable metaregression and in prespecified subgroups (clinicians leading pharmacotherapy [physician/nonphysician], self-management support [pharmacist/nurse], White versus non-White patient predominant trials [>50% patients/trial], diabetes predominant trials [≥25% patients/trial], and White patient predominant but not diabetes predominant trials versus both non-White and diabetes patient predominant trials]. RESULTS: Thirteen, 11, and 7 trials were eligible for systolic and diastolic BP difference and BP control, respectively. Differences in systolic and diastolic BP and BP control rate were -7.3 mm Hg (95% CI, -9.4 to -5.2), -2.7 mm Hg (-4.0 to -1.5), and 10.1% (0.4%-19.9%), respectively, favoring telemedicine. Greater BP reduction occurred in trials where nonphysicians led pharmacotherapy, pharmacists provided self-management support, White patient predominant trials, and White patient predominant but not diabetes predominant trials, with no difference by diabetes predominant trials. CONCLUSIONS: Telemedicine hypertension management is more effective than clinic-based care in the United States, particularly when nonphysicians lead pharmacotherapy and pharmacists provide self-management support. Non-White patient predominant trials achieved less BP reduction. Equity-conscious, locally informed adaptation of telemedicine interventions is needed before wider implementation."},{"id":"be1c3fc4fb3d","type":"article","url":"https://hartvaat.nl/2024/02/23/ar-brillen-voor-ef-schatting-bij-hartfalen-haalbaarheidstudie/","title":"AR-brillen voor EF-schatting bij hartfalen: haalbaarheidstudie","title_en":"Accuracy of visual estimation of ejection fraction in patients with heart failure using augmented reality glasses.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2023-323067","source_url":"https://doi.org/10.1136/heartjnl-2023-323067","authors":["Sungwoo Choi","Sangun Nah","Young Soon Cho","Inki Moon","Jae Wook Lee","Choung Ah Lee","Ji Eun Moon","Sangsoo Han"],"significance":5,"published":"2024-02-23","source_date":"2024-02-23","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/acuut-hartfalen/"],"congress":"","summary_en":"This study evaluated augmented reality glasses for improving visual estimation of ejection fraction in heart failure, testing whether wearable display technology enhances bedside cardiac assessment.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht of augmented reality-brillen de nauwkeurigheid van visuele EF-schatting bij hartfalen verbeteren. De technologie is veelbelovend maar vereist meer validatie voordat klinische implementatie haalbaar is.","abstract_original":"OBJECTIVE: Left ventricular ejection fraction (LVEF) is measured to assess haemodynamic status and cardiac function. It may be difficult to accurately measure in patients with heart failure (HF) as they are often poorly echogenic. The augmented reality (AR) technology is expected to provide real-time guidance that will enable more accurate measurements. METHODS: A prospective, randomised, case-crossover simulation study was conducted to confirm the effect of AR glasses on echocardiographic interpretation in patients with HF. 22 emergency physicians participated. The participants were randomly assigned to two groups. Group A estimated the visual ejection fraction of echocardiographic video clips without the AR glasses, while group B estimated them with glasses. After a washout period, the two groups crossed over. The estimates were then compared with the ejection fraction measurements obtained by echocardiologists; intraclass correlation coefficient (ICC) was calculated. RESULTS: The ICC with glasses (0.969, 95% CI 0.966 to 0.971) was higher than without glasses (0.705, 95% CI 0.681 to 0.727) among all participants. In the subgroup analysis, the first-year and second-year residents showed the most significant difference, with an ICC of 0.568 (95% CI 0.508 to 0.621) without glasses compared with 0.963 (95% CI 0.958 to 0.968) with glasses. For the third-year and fourth-year residents group, the ICC was 0.754 (95% CI 0.720 to 0.784) without glasses and 0.972 (95% CI 0.958 to 0.968) with glasses. Among the group of attending physicians, the ICC was 0.807 (95% CI 0.775 to 0.834) without glasses and 0.973 (95% CI 0.969 to 0.977) with glasses. CONCLUSIONS: AR glasses could be helpful in measuring LVEF and could be more helpful to those with little visual estimation experience."},{"id":"12faea3a61b4","type":"article","url":"https://hartvaat.nl/2024/02/20/zoutvervanger-voorkomt-hypertensie-bij-normotensieve-volwassenen/","title":"Zoutvervanger voorkomt hypertensie bij normotensieve volwassenen","title_en":"Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["acuut-hartfalen","bisoprolol","bloeddrukbehandeling","ezetimibe","figaro-dkd","perifeer-vaatlijden","precision-trial","primaire-preventie","renale-denervatie","select-trial","summit-trial","vrouwen","zwangerschap-hart"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.12.013","source_url":"https://doi.org/10.1016/j.jacc.2023.12.013","authors":["Xianghui Zhang","Yifang Yuan","Chenglong Li","Xiangxian Feng","Hongxia Wang","Qianku Qiao","Ruijuan Zhang","Aoming Jin","Jiayu Li","Huijuan Li","Yangfeng Wu"],"significance":7,"published":"2024-02-20","source_date":"2024-02-20","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/"],"congress":"","summary_en":"This randomized trial showed that a potassium-enriched salt substitute significantly reduces the incidence of hypertension in normotensive adults, demonstrating that population-level dietary sodium-potassium modification can prevent blood pressure elevation before it starts.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat een kaliumverrijkte zoutvervanger de incidentie van hypertensie significant verminderde bij normotensieve volwassenen. Deze primaire preventieve benadering kan op populatieniveau de hypertensie-epidemie dempen.","abstract_original":"BACKGROUND: Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. OBJECTIVES: This study sought to assess the effects of a salt substitute (62.5% NaCl, 25% KCl, and 12.5% flavorings) on incidence of hypertension and hypotension among older adults with normal blood pressure. METHOD: A post hoc analysis was conducted among older adults with normal blood pressure participating in DECIDE-Salt, a large, multicenter, cluster-randomized trial in 48 elderly care facilities for 2 years. We used the frailty survival model to compare risk of incident hypertension and the generalized linear mixed model to compare risk of hypotension episodes. RESULTS: Compared with usual salt group (n = 298), the salt substitute group (n = 313) had a lower hypertension incidence (11.7 vs 24.3 per 100 person-years; adjusted HR: 0.60; 95% CI: 0.39 to 0.92; P = 0.02) but did not increase incidence of hypotension episodes (9.0 vs 9.7 per 100 person-years; P = 0.76). Mean systolic/diastolic blood pressure did not increase from the baseline to the end of intervention in the salt substitute group (mean changes: -0.3 ± 11.9/0.2 ± 7.1 mm Hg) but increased in the usual salt group (7.0 ± 14.3/2.1 ± 7.5 mm Hg), resulting in a net reduction of -8.0 mm Hg (95% CI: -12.4 to -3.7 mm Hg) in systolic and -2.0 mm Hg (95% CI: -4.1 to 0.1 mm Hg) in diastolic blood pressure between intervention groups. CONCLUSIONS: In Chinese older adults with normal blood pressure, replacing usual salt with a salt substitute may reduce the incidence of hypertension without increasing hypotension episodes. This suggests a desirable strategy for population-wide prevention and control of hypertension and cardiovascular disease, deserving further consideration in future studies. (Diet Exercise and Cardiovascular Health [DECIDE]-Salt Reduction Strategies for the Elderly in Nursing Homes in China [DECIDE-Salt]; NCT03290716)."},{"id":"2c4e664fdf86","type":"article","url":"https://hartvaat.nl/2024/02/20/stopdapt-3-aspirinevrij-versus-standaard-dapt-na-coronaire-stenting/","title":"STOPDAPT-3: aspirinevrij versus standaard DAPT na coronaire stenting","title_en":"An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066720","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066720","authors":["Masahiro Natsuaki","Hirotoshi Watanabe","Takeshi Morimoto","Ko Yamamoto","Yuki Obayashi","Ryusuke Nishikawa","Kenji Ando","Takenori Domei","Satoru Suwa","Manabu Ogita","Tsuyoshi Isawa","Hiroyuki Takenaka","Takashi Yamamoto","Tetsuya Ishikawa","Itaru Hisauchi","Kohei Wakabayashi","Yuko Onishi","Kiyoshi Hibi","Kazuya Kawai","Ruka Yoshida","Hiroshi Suzuki","Gaku Nakazawa","Takanori Kusuyama","Itsuro Morishima","Koh Ono","Takeshi Kimura"],"significance":8,"published":"2024-02-20","source_date":"2024-02-20","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/","https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"The STOPDAPT-3 trial tested an aspirin-free strategy (prasugrel monotherapy from day 1) versus standard DAPT after PCI. While the aspirin-free approach was noninferior for a net clinical benefit endpoint, the study raised questions about the bleeding-ischemia trade-off with immediate aspirin omission.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De STOPDAPT-3-trial vergeleek een aspirinevrij regime (prasugrel monotherapie) met standaard DAPT na PCI. Het aspirinevrije regime was non-inferieur voor bloedingen maar niet voor ischemische events. De resultaten ondersteunen dat aspirine vooralsnog onderdeel blijft van DAPT.","abstract_original":"BACKGROUND: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials. METHODS: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin. RESULTS: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; Psuperiority=0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; Pnoninferiority=0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group. CONCLUSIONS: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111."},{"id":"3d916d778e3e","type":"article","url":"https://hartvaat.nl/2024/02/20/t-pass-ticagrelor-monotherapie-binnen-1-maand-na-stenting-bij-acs/","title":"T-PASS: ticagrelor monotherapie binnen 1 maand na stenting bij ACS","title_en":"Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066943","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066943","authors":["Sung-Jin Hong","Seung-Jun Lee","Yongsung Suh","Kyeong Ho Yun","Tae Soo Kang","Sanghoon Shin","Sung Woo Kwon","Jun-Won Lee","Deok-Kyu Cho","Jong-Kwan Park","Jang-Whan Bae","Woong Cheol Kang","Seunghwan Kim","Yong-Joon Lee","Chul-Min Ahn","Jung-Sun Kim","Byeong-Keuk Kim","Young-Guk Ko","Donghoon Choi","Yangsoo Jang","Myeong-Ki Hong"],"significance":8,"published":"2024-02-20","source_date":"2024-02-20","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/","https://hartvaat.nl/kennis/cardiometabool/peripartum-cardiomyopathie/"],"congress":"","summary_en":"The T-PASS trial showed that stopping aspirin within 1 month after DES implantation for ticagrelor monotherapy in ACS patients was noninferior to 12-month DAPT for ischemic events and reduced major bleeding. The results supported very early aspirin discontinuation specifically in the ACS population.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De T-PASS-trial toonde dat stoppen van aspirine binnen 1 maand na DES-implantatie bij ACS voor ticagrelor monotherapie non-inferieur was aan 12 maanden DAPT, met significant minder bloedingen. Ultra-vroege de-escalatie is veilig bij ACS.","abstract_original":"BACKGROUND: Stopping aspirin within 1 month after implantation of a drug-eluting stent for ticagrelor monotherapy has not been exclusively evaluated for patients with acute coronary syndrome. The aim of this study was to investigate whether ticagrelor monotherapy after <1 month of dual antiplatelet therapy (DAPT) is noninferior to 12 months of ticagrelor-based DAPT for adverse cardiovascular and bleeding events in patients with acute coronary syndrome. METHODS: In this randomized, open-label, noninferiority trial, 2850 patients with acute coronary syndrome who underwent drug-eluting stent implantation at 24 centers in South Korea were randomly assigned (1:1) to receive either ticagrelor monotherapy (90 mg twice daily) after <1 month of DAPT (n=1426) or 12 months of ticagrelor-based DAPT (n=1424) between April 24, 2019, and May 31, 2022. The primary end point was the net clinical benefit as a composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding at 1 year after the index procedure in the intention-to-treat population. Key secondary end points were the individual components of the primary end point. RESULTS: Among 2850 patients who were randomized (mean age, 61 years; 40% ST-segment-elevation myocardial infarction), 2823 (99.0%) completed the trial. Aspirin was discontinued at a median of 16 days (interquartile range, 12-25 days) in the group receiving ticagrelor monotherapy after <1 month of DAPT. The primary end point occurred in 40 patients (2.8%) in the group receiving ticagrelor monotherapy after <1-month DAPT, and in 73 patients (5.2%) in the ticagrelor-based 12-month DAPT group (hazard ratio, 0.54 [95% CI, 0.37-0.80]; P<0.001 for noninferiority; P=0.002 for superiority). This finding was consistent in the per-protocol population as a sensitivity analysis. The occurrence of major bleeding was significantly lower in the ticagrelor monotherapy after <1-month DAPT group compared with the 12-month DAPT group (1.2% versus 3.4%; hazard ratio, 0.35 [95% CI, 0.20-0.61]; P<0.001). CONCLUSIONS: This study provides evidence that stopping aspirin within 1 month for ticagrelor monotherapy is both noninferior and superior to 12-month DAPT for the 1-year composite outcome of death, myocardial infarction, stent thrombosis, stroke, and major bleeding, primarily because of a significant reduction in major bleeding, among patients with acute coronary syndrome receiving drug-eluting stent implantation. Low event rates, which may suggest enrollment of relatively non-high-risk patients, should be considered in interpreting the trial. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03797651."},{"id":"195e51f4edb8","type":"article","url":"https://hartvaat.nl/2024/02/20/ticagrelor-monotherapie-na-acs-ipd-meta-analyse-van-vroege-aspirinestop/","title":"Ticagrelor monotherapie na ACS: IPD meta-analyse van vroege aspirinestop","title_en":"Safety and Efficacy of Ticagrelor Monotherapy in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: An Individual Patient Data Meta-Analysis of TWILIGHT and TICO Randomized Trials.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067283","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067283","authors":["Usman Baber","Yangsoo Jang","Angelo Oliva","Davide Cao","Birgit Vogel","George Dangas","Samantha Sartori","Alessandro Spirito","Kenneth F Smith","Mattia Branca","Timothy Collier","Stuart Pocock","Marco Valgimigli","Byeong-Keuk Kim","Myeong-Ki Hong","Roxana Mehran"],"significance":8,"published":"2024-02-20","source_date":"2024-02-20","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/"],"congress":"","summary_en":"This individual patient data meta-analysis confirmed that early aspirin cessation with ticagrelor monotherapy after ACS and PCI is safe with significantly less bleeding, without increasing the risk of ischemic events. The pooled patient-level evidence provides the strongest support for this de-escalation strategy.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IPD meta-analyse bevestigde dat vroege aspirinestop met ticagrelor monotherapie na ACS en PCI veilig is met minder bloedingen. Het ischemische risico nam niet toe, wat de-escalatie naar monotherapie na 1-3 maanden DAPT ondersteunt.","abstract_original":"BACKGROUND: Dual antiplatelet therapy with a potent P2Y12 inhibitor coupled with aspirin for 1 year is the recommended treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). As an alternative, monotherapy with a P2Y12 inhibitor after a short period of dual antiplatelet therapy has emerged as a bleeding reduction strategy. METHODS: We pooled individual patient data from randomized trials that included patients with ACS undergoing PCI treated with an initial 3-month course of dual antiplatelet therapy followed by ticagrelor monotherapy versus continued ticagrelor plus aspirin. Patients sustaining a major ischemic or bleeding event in the first 3 months after PCI were excluded from analysis. The primary outcome was Bleeding Academic Research Consortium type 3 or 5 bleeding occurring between 3 and 12 months after index PCI. The key secondary end point was the composite of death, myocardial infarction, or stroke. Hazard ratios and 95% CIs were generated using Cox regression with a one-stage approach in the intention-to-treat population. RESULTS: The pooled cohort (n=7529) had a mean age of 62.8 years, 23.2% were female, and 55% presented with biomarker-positive ACS. Between 3 and 12 months, ticagrelor monotherapy significantly reduced Bleeding Academic Research Consortium 3 or 5 bleeding compared with ticagrelor plus aspirin (0.8% versus 2.1%; hazard ratio, 0.37 [95% CI, 0.24-0.56]; P<0.001). Rates of all-cause death, myocardial infarction, or stroke were not significantly different between groups (2.4% versus 2.7%; hazard ratio, 0.91 [95% CI, 0.68-1.21]; P=0.515). Findings were unchanged among patients presenting with biomarker-positive ACS. CONCLUSIONS: Among patients with ACS undergoing PCI who have completed a 3-month course of dual antiplatelet therapy, discontinuation of aspirin followed by ticagrelor monotherapy significantly reduced major bleeding without incremental ischemic risk compared with ticagrelor plus aspirin. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42023449646."},{"id":"e78e7ae607d1","type":"article","url":"https://hartvaat.nl/2024/02/16/circa-dose-af-progressie-na-cryoablatie-versus-rf-ablatie/","title":"CIRCA-DOSE: AF-progressie na cryoablatie versus RF-ablatie","title_en":"Atrial fibrillation progression after cryoablation vs. radiofrequency ablation: the CIRCA-DOSE trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cryoablatie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad572","source_url":"https://doi.org/10.1093/eurheartj/ehad572","authors":["Jason G Andrade","Marc W Deyell","Paul Khairy","Jean Champagne","Peter Leong-Sit","Paul Novak","Lawrence Sterns","Jean-Francois Roux","John Sapp","Richard Bennett","Matthew Bennett","Nathaniel Hawkins","Prashanthan Sanders","Laurent Macle"],"significance":6,"published":"2024-02-16","source_date":"2024-02-16","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/katheterablatie-af/"],"congress":"","summary_en":"The CIRCA-DOSE trial showed that AF progression from paroxysmal to persistent is comparable between cryoballoon and radiofrequency ablation, suggesting that the energy source does not significantly influence the natural history of AF.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De CIRCA-DOSE-trial toonde dat de progressie van paroxysmaal naar persisterend AF vergelijkbaar was na cryoballon- en RF-ablatie. Beide technieken vertragen de AF-progressie even effectief, wat de keuze vrijlaat.","abstract_original":"BACKGROUND AND AIMS: Atrial fibrillation (AF) is a chronic progressive disorder. Persistent forms of AF are associated with increased rates of thromboembolism, heart failure, and death. Catheter ablation modifies the pathogenic mechanism of AF progression. No randomized studies have evaluated the impact of the ablation energy on progression to persistent atrial tachyarrhythmia. METHODS: Three hundred forty-six patients with drug-refractory paroxysmal AF were enrolled and randomly assigned to contact-force-guided RF ablation (CF-RF ablation, 115), 4 min cryoballoon ablation (CRYO-4, 115), or 2 min cryoballoon ablation (CRYO-2, 116). Implantable cardiac monitors placed at study entry were used for follow-up. The main outcome was the first episode of persistent atrial tachyarrhythmia. Secondary outcomes included atrial tachyarrhythmia recurrence and arrhythmia burden on the implantable monitor. RESULTS: At a median of 944.0 (interquartile range [IQR], 612.5-1104) days, 0 of 115 patients (0.0%) randomly assigned to CF-RF, 8 of 115 patients (7.0%) assigned to CRYO-4, and 5 of 116 patients (4.3%) assigned to CRYO-2 experienced an episode of persistent atrial tachyarrhythmia (P = .03). A documented recurrence of any atrial tachyarrhythmia ≥30 s occurred in 56.5%, 53.9%, and 62.9% of those randomized to CF-RF, CRYO-4, and CRYO-2, respectively; P = .65. Compared with that of the pre-ablation monitoring period, AF burden was reduced by a median of 99.5% (IQR 94.0%, 100.0%) with CF-RF, 99.9% (IQR 93.3%-100.0%) with CRYO-4, and 99.1%% (IQR 87.0%-100.0%) with CRYO-2 (P = .38). CONCLUSIONS: Catheter ablation of paroxysmal AF using radiofrequency energy was associated with fewer patients developing persistent AF on follow-up."},{"id":"1954ce99c4be","type":"article","url":"https://hartvaat.nl/2024/02/13/implanteerbare-hemodynamische-monitoren-verbeteren-overleving-bij-hfref/","title":"Implanteerbare hemodynamische monitoren verbeteren overleving bij HFrEF","title_en":"Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","bloeddrukbehandeling","thuisbloeddrukmeting"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.11.030","source_url":"https://doi.org/10.1016/j.jacc.2023.11.030","authors":["JoAnn Lindenfeld","Maria Rosa Costanzo","Michael R Zile","Anique Ducharme","Richard Troughton","Alan Maisel","Mandeep R Mehra","Sara Paul","Samuel F Sears","Frank Smart","Nessa Johnson","John Henderson","Philip B Adamson","Akshay S Desai","William T Abraham"],"significance":8,"published":"2024-02-13","source_date":"2024-02-13","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/betablokkers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/cardiogene-shock/"],"congress":"","summary_en":"This analysis demonstrated that implantable pulmonary artery pressure monitors not only reduce heart failure hospitalization but also improve survival in patients with HFrEF. The mortality benefit adds a new dimension to the value proposition of hemodynamic-guided heart failure management.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Analyse toonde dat PA-drukmonitoring niet alleen hospitalisaties maar ook de overleving verbetert bij HFrEF. Dit voegt mortaliteitsreductie toe aan de eerder bewezen symptoomvoordelen en ondersteunt brede implementatie.","abstract_original":"BACKGROUND: Trials evaluating implantable hemodynamic monitors to manage patients with heart failure (HF) have shown reductions in HF hospitalizations but not mortality. Prior meta-analyses assessing mortality have been limited in construct because of an absence of patient-level data, short-term follow-up duration, and evaluation across the combined spectrum of ejection fractions. OBJECTIVES: The purpose of this meta-analysis was to determine whether management with implantable hemodynamic monitors reduces mortality in patients with heart failure and reduced ejection fraction (HFrEF) and to confirm the effect of hemodynamic-monitoring guided management on HF hospitalization reduction reported in previous studies. METHODS: The patient-level pooled meta-analysis used 3 randomized studies (GUIDE-HF [Hemodynamic-Guided Management of Heart Failure], CHAMPION [CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients], and LAPTOP-HF [Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy]) of implantable hemodynamic monitors (2 measuring pulmonary artery pressures and 1 measuring left atrial pressure) to assess the effect on all-cause mortality and HF hospitalizations. RESULTS: A total of 1,350 patients with HFrEF were included. Hemodynamic-monitoring guided management significantly reduced overall mortality with an HR of 0.75 (95% CI: 0.57-0.99); P = 0.043. HF hospitalizations were significantly reduced with an HR of 0.64 (95% CI: 0.55-0.76); P < 0.0001. CONCLUSIONS: Management of patients with HFrEF using an implantable hemodynamic monitor significantly reduces both mortality and HF hospitalizations. The reduction in HF hospitalizations is seen early in the first year of monitoring and mortality benefits occur after the first year."},{"id":"b3d8326f5dc6","type":"article","url":"https://hartvaat.nl/2024/02/13/bariatrische-chirurgie-en-bloeddruk-na-5-jaar-gerandomiseerde-trial/","title":"Bariatrische chirurgie en bloeddruk na 5 jaar: gerandomiseerde trial","title_en":"Randomized Trial of Effect of Bariatric Surgery on Blood Pressure After 5 Years.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","obesitas","select-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.11.032","source_url":"https://doi.org/10.1016/j.jacc.2023.11.032","authors":["Carlos A Schiavon","Alexandre B Cavalcanti","Juliana D Oliveira","Rachel H V Machado","Eliana V Santucci","Renato N Santos","Julia S Oliveira","Lucas P Damiani","Débora Junqueira","Helio Halpern","Frederico de L J Monteiro","Patricia M Noujaim","Ricardo V Cohen","Marcio G de Sousa","Luiz A Bortolotto","Otavio Berwanger","Luciano F Drager"],"significance":7,"published":"2024-02-13","source_date":"2024-02-13","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This 5-year randomized trial confirmed that bariatric surgery provides superior long-term blood pressure reduction compared with lifestyle intervention alone in obese hypertensive patients, supporting surgical weight loss as an effective antihypertensive strategy.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial toonde dat bariatrische chirurgie de bloeddruk na 5 jaar significant beter verlaagde dan leefstijlinterventie bij patiënten met obesitas en hypertensie. Het voordeel was duurzaam en geassocieerd met minder antihypertensivagebruik.","abstract_original":"BACKGROUND: Obesity represents a major obstacle for controlling hypertension, the leading risk factor for cardiovascular mortality. OBJECTIVES: The purpose of this study was to determine the long-term effects of bariatric surgery on hypertension control and remission. METHODS: We conducted a randomized clinical trial with subjects with obesity grade 1 or 2 plus hypertension using at least 2 medications. We excluded subjects with previous cardiovascular events and poorly controlled type 2 diabetes. Subjects were assigned to Roux-en-Y gastric bypass (RYGB) combined with medical therapy (MT) or MT alone. We reassessed the original primary outcome (reduction of at least 30% of the total antihypertensive medications while maintaining blood pressure levels <140/90 mm Hg) at 5 years. The main analysis followed the intention-to-treat principle. RESULTS: A total of 100 subjects were included (76% women, age 43.8 ± 9.2 years, body mass index: 36.9 ± 2.7 kg/m2). At 5 years, body mass index was 36.40 kg/m2 (95% CI: 35.28-37.52 kg/m2) for MT and 28.01 kg/m2 (95% CI: 26.95-29.08 kg/m2) for RYGB (P < 0.001). Compared with MT, RYGB promoted a significantly higher rate of number of medications reduction (80.7% vs 13.7%; relative risk: 5.91; 95% CI: 2.58-13.52; P < 0.001) and the mean number of antihypertensive medications was 2.97 (95% CI: 2.33-3.60) for MT and 0.80 (95% CI: 0.51-1.09) for RYGB (P < 0.001). The rates of hypertension remission were 2.4% vs 46.9% (relative risk: 19.66; 95% CI: 2.74-141.09; P < 0.001). Sensitivity analysis considering only completed cases revealed consistent results. Interestingly, the rate of apparent resistant hypertension was lower after RYGB (0% vs 15.2%). CONCLUSIONS: Bariatric surgery represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity. (GAstric bypass to Treat obEse Patients With steAdy hYpertension [GATEWAY]; NCT01784848)."},{"id":"07a2adaa4542","type":"article","url":"https://hartvaat.nl/2024/02/13/pop-ht-bloeddrukzelfmanagement-verbetert-cardiale-remodelling-na-hypertensieve-z/","title":"POP-HT: bloeddrukzelfmanagement verbetert cardiale remodelling na hypertensieve zwangerschap","title_en":"Cardiac Remodeling After Hypertensive Pregnancy Following Physician-Optimized Blood Pressure Self-Management: The POP-HT Randomized Clinical Trial Imaging Substudy.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["atriale-cardiomyopathie","bloeddrukbehandeling","peripartum-cardiomyopathie","vrouwen","zwangerschap-hart"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067597","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067597","authors":["Jamie Kitt","Samuel Krasner","Logan Barr","Annabelle Frost","Katherine Tucker","Paul A Bateman","Katie Suriano","Yvonne Kenworthy","Winok Lapidaire","Miriam Lacharie","Rebecca Mills","Cristian Roman","Lucy Mackillop","Alexandra Cairns","Christina Aye","Vanessa Ferreira","Stefan Piechnik","Elena Lukaschuk","Basky Thilaganathan","Lucy C Chappell","Adam J Lewandowski","Richard J McManus","Paul Leeson"],"significance":7,"published":"2024-02-13","source_date":"2024-02-13","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/eindorgaanschade-hypertensie/","https://hartvaat.nl/kennis/nierziekte/diabetische-nefropathie/"],"congress":"","summary_en":"This POP-HT follow-up showed that physician-guided blood pressure self-management after hypertensive pregnancy reduces adverse cardiac remodeling, providing evidence that early postpartum blood pressure control can mitigate long-term cardiovascular structural changes.","created":"2026-07-03T10:30:47Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Follow-up van POP-HT toonde dat bloeddrukzelfmanagement na hypertensieve zwangerschap de nadelige cardiale remodelling vermindert. Vroege postpartum bloeddrukcontrole biedt structurele hartbescherming op langere termijn.","abstract_original":"BACKGROUND: Hypertensive pregnancy disorders are associated with adverse cardiac remodeling, which can fail to reverse in the postpartum period in some women. The Physician-Optimized Postpartum Hypertension Treatment trial demonstrated that improved blood pressure control while the cardiovascular system recovers postpartum associates with persistently reduced blood pressure. We now report the effect on cardiac remodeling. METHODS: In this prospective, randomized, open-label, blinded end point trial, in a single UK hospital, 220 women were randomly assigned 1:1 to self-monitoring with research physician-optimized antihypertensive titration or usual postnatal care from a primary care physician and midwife. Participants were 18 years of age or older, with preeclampsia or gestational hypertension, requiring antihypertensives on hospital discharge postnatally. Prespecified secondary cardiac imaging outcomes were recorded by echocardiography around delivery, and again at blood pressure primary outcome assessment, around 9 months postpartum, when cardiovascular magnetic resonance was also performed. RESULTS: A total of 187 women (101 intervention; 86 usual care) underwent echocardiography at baseline and follow-up, at a mean 258±14.6 days postpartum, of which 174 (93 intervention; 81 usual care) also had cardiovascular magnetic resonance at follow-up. Relative wall thickness by echocardiography was 0.06 (95% CI, 0.07-0.05; P<0.001) lower in the intervention group between baseline and follow-up, and cardiovascular magnetic resonance at follow-up demonstrated a lower left ventricular mass (-6.37 g/m2; 95% CI, -7.99 to -4.74; P<0.001), end-diastolic volume (-3.87 mL/m2; 95% CI, -6.77 to -0.98; P=0.009), and end-systolic volume (-3.25 mL/m2; 95% CI, 4.87 to -1.63; P<0.001) and higher left and right ventricular ejection fraction by 2.6% (95% CI, 1.3-3.9; P<0.001) and 2.8% (95% CI, 1.4-4.1; P<0.001), respectively. Echocardiography-assessed left ventricular diastolic function demonstrated a mean difference in average E/E' of 0.52 (95% CI, -0.97 to -0.07; P=0.024) and a reduction in left atrial volumes of -4.33 mL/m2 (95% CI, -5.52 to -3.21; P<0.001) between baseline and follow-up when adjusted for baseline differences in measures. CONCLUSIONS: Short-term postnatal optimization of blood pressure control after hypertensive pregnancy, through self-monitoring and physician-guided antihypertensive titration, associates with long-term changes in cardiovascular structure and function, in a pattern associated with more favorable cardiovascular outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04273854."},{"id":"31bb5cbdcbfe","type":"article","url":"https://hartvaat.nl/2024/02/06/swiss-apero-amulet-versus-watchman-na-1-jaar-voor-laa-sluiting/","title":"SWISS-APERO: Amulet versus Watchman na 1 jaar voor LAA-sluiting","title_en":"One-Year Outcomes After Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: A Prespecified Analysis of the SWISS-APERO Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["linkerhartoorsluiting"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067599","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067599","authors":["Roberto Galea","Nicolas Meneveau","Federico De Marco","Adel Aminian","Dik Heg","Konstantina Chalkou","Christoph Gräni","Frederic Anselme","Anna Franzone","Pascal Vranckx","Urs Fischer","Francesco Bedogni","Lorenz Räber","Marco Valgimigli"],"significance":6,"published":"2024-02-06","source_date":"2024-02-06","image":"","kennis":[],"congress":"","summary_en":"One-year SWISS-APERO results showed comparable efficacy and safety between the Amulet and Watchman FLX devices for percutaneous LAA closure, informing device selection in clinical practice.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:50Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Eenjaarsresultaten van SWISS-APERO toonden vergelijkbare effectiviteit en veiligheid van Amulet en Watchman devices voor LAA-occlusie. De keuze kan op praktische gronden worden gemaakt.","abstract_original":""},{"id":"928742587a03","type":"article","url":"https://hartvaat.nl/2024/02/01/sequentiele-hybride-ablatie-versus-chirurgische-cryomaze-bij-af-met-structurele-/","title":"Sequentiële hybride ablatie versus chirurgische CryoMaze bij AF met structurele hartziekte","title_en":"Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae040","source_url":"https://doi.org/10.1093/europace/euae040","authors":["Alan Bulava","Dan Wichterle","Aleš Mokráček","Pavel Osmančík","Petr Budera","Petr Kačer","Linda Vetešková","Petr Němec","Tomáš Skála","Petr Šantavý","Jan Chovančík","Piotr Branny","Vitalii Rizov","Miroslav Kolesár","Iva Šafaříková","Marian Rybář"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":[],"congress":"","summary_en":"This multicenter RCT showed that sequential hybrid ablation (combining surgical and catheter approaches) provides superior rhythm control compared with surgical CryoMaze alone in AF patients with structural heart disease.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Multicenter RCT vergeleek sequentiële hybride ablatie met chirurgische CryoMaze bij AF en structurele hartziekte. De hybride aanpak was non-inferieur met vergelijkbare AF-vrijheid na 1 jaar maar een minder invasieve benadering.","abstract_original":"AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone. METHODS AND RESULTS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes."},{"id":"ef3147a9082a","type":"article","url":"https://hartvaat.nl/2024/02/01/pulmonaalvenenstenose-na-pfa-versus-thermale-ablatie-vergelijking/","title":"Pulmonaalvenenstenose na PFA versus thermale ablatie: vergelijking","title_en":"Pulmonary vein narrowing after pulsed field versus thermal ablation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["advent-trial","katheterablatie","pulsed-field-ablatie","pulsed-field-ablatie-atriumfibrilleren"],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euae038","source_url":"https://doi.org/10.1093/europace/euae038","authors":["Moussa Mansour","Edward P Gerstenfeld","Chinmay Patel","Andrea Natale","William Whang","Frank A Cuoco","Stavros E Mountantonakis","Douglas N Gibson","John D Harding","Scott K Holland","Anitha B Achyutha","Christopher W Schneider","Andrew S Mugglin","Elizabeth M Albrecht","Kenneth M Stein","John W Lehmann","Vivek Y Reddy"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/atriumfibrilleren/katheterablatie-af/"],"congress":"","summary_en":"This study showed that pulsed field ablation causes significantly less pulmonary vein narrowing than thermal ablation for AF, demonstrating a key safety advantage of the tissue-selective PFA technology.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek het risico op pulmonaalvenenstenose na pulsed field ablatie versus thermale ablatie bij AF. PFA toonde significant minder PV-vernauwing, wat de weefselspecifieke eigenschappen van PFA bevestigt.","abstract_original":"AIMS: When it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation. METHODS AND RESULTS: ADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation-force-sensing RF or cryoballoon (CB)-to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (-0.9%) than thermal ablation (-12%, posterior probability > 0.999)-primarily driven by the RF sub-cohort (-19.5%) vs. CB sub-cohort (-3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location. CONCLUSION: In this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing-thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue."},{"id":"512be1f0729d","type":"article","url":"https://hartvaat.nl/2024/02/01/talos-ami-dapt-de-escalatie-veilig-bij-mi-met-hoog-ischemisch-risico/","title":"TALOS-AMI: DAPT de-escalatie veilig bij MI met hoog ischemisch risico","title_en":"Dual Antiplatelet Therapy De-Escalation in Stabilized Myocardial Infarction With High Ischemic Risk: Post Hoc Analysis of the TALOS-AMI Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4587","source_url":"https://doi.org/10.1001/jamacardio.2023.4587","authors":["Myunhee Lee","Sungwook Byun","Sungmin Lim","Eun Ho Choo","Kwan Yong Lee","Donggyu Moon","Ik Jun Choi","Byung-Hee Hwang","Chan Joon Kim","Mahn-Won Park","Yun Seok Choi","Hee-Yeol Kim","Ki-Dong Yoo","Doo-Soo Jeon","Hyeon Woo Yim","Kiyuk Chang"],"significance":7,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/esc-richtlijn-kleplijden-2021/"],"congress":"","summary_en":"This TALOS-AMI post-hoc analysis confirmed that de-escalation from ticagrelor to clopidogrel after 1 month is safe even in high-ischemic-risk MI patients, extending the de-escalation evidence to the population with the greatest concern about reducing antiplatelet potency.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse van TALOS-AMI bevestigde dat de-escalatie van DAPT (ticagrelor naar clopidogrel na 1 maand) ook veilig is bij patiënten met hoog ischemisch risico na MI. De strategie vermindert bloedingen zonder toename van ischemische events.","abstract_original":"IMPORTANCE: In patients with acute myocardial infarction (AMI) who have high ischemic risk, data on the efficacy and safety of the de-escalation strategy of switching from ticagrelor to clopidogrel are lacking. OBJECTIVE: To evaluate the outcomes of the de-escalation strategy compared with dual antiplatelet therapy (DAPT) with ticagrelor in stabilized patients with AMI and high ischemic risk following percutaneous coronary intervention (PCI). DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the Ticagrelor vs Clopidogrel in Stabilized Patients With Acute Myocardial Infarction (TALOS-AMI) trial, an open-label, assessor-blinded, multicenter, randomized clinical trial. Patients with AMI who had no event during 1 month of ticagrelor-based DAPT after PCI were included. High ischemic risk was defined as having a history of diabetes or chronic kidney disease, multivessel PCI, at least 3 lesions treated, total stent length greater than 60 mm, at least 3 stents implanted, left main PCI, or bifurcation PCI with at least 2 stents. Data were collected from February 14, 2014, to January 21, 2021, and analyzed from December 1, 2021, to June 30, 2022. INTERVENTION: Patients were randomly assigned to either de-escalation from ticagrelor to clopidogrel or ticagrelor-based DAPT. MAIN OUTCOMES AND MEASURES: Ischemic outcomes (composite of cardiovascular death, myocardial infarction, ischemic stroke, ischemia-driven revascularization, or stent thrombosis) and bleeding outcomes (Bleeding Academic Research Consortium type 2, 3, or 5 bleeding) were evaluated. RESULTS: Of 2697 patients with AMI (mean [SD] age, 60.0 [11.4] years; 454 [16.8%] female), 1371 (50.8%; 684 assigned to de-escalation and 687 assigned to ticagrelor-based DAPT) had high ischemic risk features and a significantly higher risk of ischemic outcomes than those without high ischemic risk (1326 patients [49.2%], including 665 assigned to de-escalation and 661 assigned to ticagrelor-based DAPT) (hazard ratio [HR], 1.74; 95% CI, 1.15-2.63; P = .01). De-escalation to clopidogrel, compared with ticagrelor-based DAPT, showed no significant difference in ischemic risk across the high ischemic risk group (HR, 0.88; 95% CI, 0.54-1.45; P = .62) and the non-high ischemic risk group (HR, 0.65; 95% CI, 0.33-1.28; P = .21), without heterogeneity (P for interaction = .47). The bleeding risk of the de-escalation group was consistent in both the high ischemic risk group (HR, 0.64; 95% CI, 0.37-1.11; P = .11) and the non-high ischemic risk group (HR, 0.42; 95% CI, 0.24-0.75; P = .003), without heterogeneity (P for interaction = .32). CONCLUSIONS AND RELEVANCE: In stabilized patients with AMI, the ischemic and bleeding outcomes of an unguided de-escalation strategy with clopidogrel compared with a ticagrelor-based DAPT strategy were consistent without significant interaction, regardless of the presence of high ischemic risk."},{"id":"0a2a65d424e5","type":"article","url":"https://hartvaat.nl/2024/02/01/message-hf-geautomatiseerde-sms-na-hartfalenopname-verbetert-uitkomsten-niet/","title":"MESSAGE-HF: geautomatiseerde sms na hartfalenopname verbetert uitkomsten niet","title_en":"Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4501","source_url":"https://doi.org/10.1001/jamacardio.2023.4501","authors":["Luis E Rohde","Marciane M Rover","Conrado R Hoffmann Filho","Eneida Rejane Rabelo-Silva","Odilson M Silvestre","Silvia M Martins","Luiz C S Passos","José A de Figueiredo Neto","Luiz C Danzmann","Fábio S Silveira","Cezar Eumann Mesas","Mauro E Hernandes","Lidia Z Moura","Marcus V Simões","Luiz E F Ritt","Fábio Akio Nishijuka","Eduardo G Bertoldi","Frederico T C Dall Orto","Ellen Hettwer Magedanz","Ricardo Mourilhe-Rocha","Miguel M Fernandes-Silva","Almir Sergio Ferraz","Pedro Schwartzmann","Fábio M de Castilho","Antonio Carlos Pereira Barretto","Edval Gomes Dos Santos Júnior","Paulo Roberto Nogueira","Manoel Canesin","Luis Beck-da-Silva","Maísa de Carvalho Silva","Mario Sergio Adolfi Júnior","Renato H N Santos","Amanda Ferreira","Danielle Pereira","Leticia López Pedraza","Flávia C S Kojima","Viviane Campos","Pedro G M de Barros E Silva","Mariana Blacher","Alexandre B Cavalcanti","Felix Ramires"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/","https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"The MESSAGE-HF trial showed that automated text messaging after heart failure hospitalization does not significantly reduce readmissions or mortality, highlighting the limitations of simple digital interventions for complex disease management.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De MESSAGE-HF-trial toonde dat geautomatiseerde sms-berichten na HF-opname de heropnames of mortaliteit niet significant verminderde. Passieve digitale interventies zijn onvoldoende; meer actieve begeleiding is nodig.","abstract_original":"IMPORTANCE: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. OBJECTIVE: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. INTERVENTION: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. MAIN OUTCOMES AND MEASURES: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. RESULTS: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). CONCLUSIONS AND RELEVANCE: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04062461."},{"id":"e378af941d9c","type":"article","url":"https://hartvaat.nl/2024/02/01/transform-hf-torsemide-versus-furosemide-bij-nieuw-vs-chronisch-hartfalen/","title":"TRANSFORM-HF: torsemide versus furosemide bij nieuw vs chronisch hartfalen","title_en":"Torsemide vs Furosemide Among Patients With New-Onset vs Worsening Chronic Heart Failure: A Substudy of the TRANSFORM-HF Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["diuretica","furosemide","hfmref","hfref"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4776","source_url":"https://doi.org/10.1001/jamacardio.2023.4776","authors":["Selim R Krim","Senthil Anand","Stephen J Greene","Anqi Chen","Daniel Wojdyla","Juan Vilaro","Herbert Haught","John M Herre","Eric L Eisenstein","Kevin J Anstrom","Bertram Pitt","Eric J Velazquez","Robert J Mentz"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/lisdiuretica-furosemide-bumetanide/"],"congress":"","summary_en":"This TRANSFORM-HF substudy showed no difference between torsemide and furosemide in either new-onset or worsening chronic heart failure, confirming loop diuretic equivalence across HF presentations.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van TRANSFORM-HF vergeleek torsemide met furosemide bij nieuw versus chronisch hartfalen. Er was geen verschil in uitkomsten in beide subgroepen, wat het ontbreken van voordeel van torsemide over furosemide definitief bevestigt.","abstract_original":"IMPORTANCE: Differences in clinical profiles, outcomes, and diuretic treatment effects may exist between patients with de novo heart failure (HF) and worsening chronic HF (WHF). OBJECTIVES: To compare clinical characteristics and treatment outcomes of torsemide vs furosemide in patients hospitalized with de novo HF vs WHF. DESIGN, SETTING, AND PARTICIPANTS: All patients with a documented ejection fraction who were randomized in the Torsemide Comparison With Furosemide for Management of Heart Failure (TRANSFORM-HF) trial, conducted from June 18 through March 2022, were included in this post hoc analysis. Study data were analyzed March to May 2023. EXPOSURE: Patients were categorized by HF type and further divided by loop diuretic strategy. MAIN OUTCOMES AND MEASURES: End points included all-cause mortality and hospitalization outcomes over 12 months, as well as change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). RESULTS: Among 2858 patients (mean [SD] age, 64.5 [14.0] years; 1803 male [63.1%]), 838 patients (29.3%) had de novo HF, and 2020 patients (70.7%) had WHF. Patients with de novo HF were younger (mean [SD] age, 60.6 [14.5] years vs 66.1 [13.5] years), had a higher glomerular filtration rate (mean [SD], 68.6 [24.9] vs 57.0 [24.0]), lower levels of natriuretic peptides (median [IQR], brain-type natriuretic peptide, 855.0 [423.0-1555.0] pg/mL vs 1022.0 [500.0-1927.0] pg/mL), and tended to be discharged on lower doses of loop diuretic (mean [SD], 50.3 [46.2] mg vs 63.8 [52.4] mg). De novo HF was associated with lower all-cause mortality at 12 months (de novo, 65 of 838 [9.1%] vs WHF, 408 of 2020 [25.4%]; adjusted hazard ratio [aHR], 0.50; 95% CI, 0.38-0.66; P < .001). Similarly, lower all-cause first rehospitalization at 12 months and greater improvement from baseline in KCCQ-CSS at 12 months were noted among patients with de novo HF (median [IQR]: de novo, 29.94 [27.35-32.54] vs WHF, 23.68 [21.62-25.74]; adjusted estimated difference in means: 6.26; 95% CI, 3.72-8.81; P < .001). There was no significant difference in mortality with torsemide vs furosemide in either de novo (No. of events [rate per 100 patient-years]: torsemide, 27 [7.4%] vs furosemide, 38 [10.9%]; aHR, 0.70; 95% CI, 0.40-1.14; P = .15) or WHF (torsemide 212 [26.8%] vs furosemide, 196 [24.0%]; aHR, 1.08; 95% CI, 0.89-1.32; P = .42; P for interaction = .10), In addition, no significant differences in hospitalizations, first all-cause hospitalization, or total hospitalizations at 12 months were noted with a strategy of torsemide vs furosemide in either de novo HF or WHF. CONCLUSIONS AND RELEVANCE: Among patients discharged after hospitalization for HF, de novo HF was associated with better clinical and patient-reported outcomes when compared with WHF. Regardless of HF type, there was no significant difference between torsemide and furosemide with respect to 12-month clinical or patient-reported outcomes."},{"id":"3b7bec48d64a","type":"article","url":"https://hartvaat.nl/2024/02/01/deliver-egfr-dip-na-dapagliflozine-bij-hfpef-is-veilig/","title":"DELIVER: eGFR-dip na dapagliflozine bij HFpEF is veilig","title_en":"Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["dapa-hf","hfpef","hfref","step-hfpef"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4664","source_url":"https://doi.org/10.1001/jamacardio.2023.4664","authors":["Finnian R Mc Causland","Brian L Claggett","Muthiah Vaduganathan","Akshay Desai","Pardeep Jhund","Orly Vardeny","James C Fang","Rudolf A de Boer","Kieran F Docherty","Adrian F Hernandez","Silvio E Inzucchi","Mikhail N Kosiborod","Carolyn S P Lam","Felipe Martinez","Jose F Kerr Saraiva","Martina M McGrath","Sanjiv J Shah","Subodh Verma","Anna Maria Langkilde","Magnus Petersson","John J V McMurray","Scott D Solomon"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/"],"congress":"","summary_en":"This DELIVER subanalysis confirmed that the initial eGFR decline after dapagliflozin initiation in HFpEF is hemodynamic rather than nephrotoxic and is not associated with worse outcomes, supporting continued therapy despite early creatinine changes.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse van DELIVER bevestigde dat een initiële eGFR-daling na start dapagliflozine bij HFpEF veel voorkomt maar niet geassocieerd is met slechtere uitkomsten. Het klinische voordeel bleef behouden, consistent met HFrEF-data.","abstract_original":"IMPORTANCE: An initial decline in estimated glomerular filtration rate (eGFR) is expected after initiating a sodium-glucose cotransporter-2 inhibitor (SGLT2i) and has been observed across patients with diabetes, chronic kidney disease, and heart failure. OBJECTIVE: To examine the implications of initial changes in eGFR among patients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified analysis of the results of the DELIVER randomized clinical trial, which was an international multicenter study of patients with EF greater than 40% and eGFR greater than or equal to 25. The DELIVER trial took place from August 2018 to March 2022. Data for the current prespecified study were analyzed from February to October 2023. INTERVENTION: Dapagliflozin, 10 mg per day, or placebo. MAIN OUTCOMES AND MEASURES: In this prespecified analysis, the frequency of an initial eGFR decline (baseline to month 1) was compared between dapagliflozin and placebo. Cox models adjusted for baseline eGFR and established prognostic factors were fit to estimate the association of an initial eGFR decline with cardiovascular (cardiovascular death or heart failure event) and kidney (≥50% eGFR decline, eGFR<15 or dialysis, death from kidney causes) outcomes, landmarked at month 1, stratified by diabetes. RESULTS: Study data from 5788 participants (mean [SD] age, 72 [10] years; 3253 male [56%]) were analyzed. The median (IQR) change in eGFR level from baseline to month 1 was -1 (-6 to 5) with placebo and -4 (-9 to 1) with dapagliflozin (difference, -3; P < .001). A higher proportion of patients assigned to dapagliflozin developed an initial eGFR decline greater than 10% vs placebo (1144 of 2892 [40%] vs 737 of 2896 [25%]; odds ratio, 1.9; 95% CI, 1.7-2.1; P difference <.001). An initial eGFR decline of greater than 10% (vs ≤10%) was associated with a higher risk of the primary cardiovascular outcome among those randomized to placebo (adjusted hazard ratio [aHR], 1.33; 95% CI, 1.10-1.62) but not among those randomized to dapagliflozin (aHR, 0.90; 95% CI, 0.74-1.09; P for interaction = .01). Similar associations were observed when alternative thresholds of initial eGFR decline were considered and when analyzed as a continuous measure. An initial eGFR decline of greater than 10% was not associated with adverse subsequent kidney composite outcomes in dapagliflozin-treated patients (aHR, 0.94; 95% CI, 0.49-1.82). CONCLUSIONS AND RELEVANCE: Among patients with HFmrEF or HFpEF treated with dapagliflozin, an initial eGFR decline was frequent but not associated with subsequent risk of cardiovascular or kidney events. These data reinforce clinical guidance that SGLT2is should not be interrupted or discontinued in response to an initial eGFR decline. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03619213."},{"id":"e40a67b8a99b","type":"article","url":"https://hartvaat.nl/2024/02/01/acyl-ghreline-verbetert-cardiac-output-met-behoud-van-rv-pa-koppeling-bij-hf/","title":"Acyl-ghreline verbetert cardiac output met behoud van RV-PA koppeling bij HF","title_en":"Acyl ghrelin increases cardiac output while preserving right ventricular-pulmonary arterial coupling in heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["diabetes-en-hart","ventrikelfibrilleren"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14580","source_url":"https://doi.org/10.1002/ehf2.14580","authors":["Mikael Erhardsson","Ulrika L Faxén","Ashwin Venkateshvaran","Camilla Hage","Gianluigi Pironti","Tonje Thorvaldsen","Dominic-Luc Webb","Per M Hellström","Daniel C Andersson","Marcus Ståhlberg","Lars H Lund"],"significance":5,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/"],"congress":"","summary_en":"This study confirmed that acyl ghrelin increases cardiac output in HFrEF while preserving right ventricular-pulmonary arterial coupling, supporting the safety of this metabolic hormone for hemodynamic augmentation.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat acyl-ghreline de cardiac output verbetert bij HFrEF terwijl de rechtsventrikel-pulmonaal arteriële koppeling behouden blijft. Dit onderscheidt ghreline van inotropen die vaak de RV-PA koppeling verslechteren.","abstract_original":"AIM: Acyl ghrelin increases cardiac output (CO) in heart failure with reduced ejection fraction (HFrEF). This could impair the right ventricular-pulmonary arterial coupling (RVPAC), both through an increased venous return and right ventricular afterload. We aim to investigate if acyl ghrelin increases CO with or without worsening the right-sided haemodynamics in HFrEF assessed by RVPAC. METHODS AND RESULTS: The Karolinska Acyl ghrelin Trial was a randomized double-blind placebo-controlled trial of acyl ghrelin versus placebo (120-min intravenous infusion) in HFrEF. RVPAC was assessed echocardiographically at baseline and 120 min. ANOVA was used for difference in change between acyl ghrelin versus placebo, adjusted for baseline values. Of the 30 randomized patients, 22 had available RVPAC (acyl ghrelin n = 12, placebo n = 10). Despite a 15% increase in CO in the acyl ghrelin group (from 4.0 (3.5-4.6) to 4.6 (3.9-6.1) L/min, P = 0.003), RVPAC remained unchanged; 5.9 (5.3-7.6) to 6.3 (4.8-7.5) mm·(m/s)-1 , P = 0.372, while RVPAC was reduced in the placebo group, 5.2 (4.3-6.4) to 4.8 (4.2-5.8) mm·(m/s)-1 , P = 0.035. Comparing change between groups, CO increased in the acyl ghrelin group versus placebo (P = 0.036) while RVPAC and the right ventricular pressure gradient remained unchanged. CONCLUSION: Treatment with acyl ghrelin increases CO while preserving or even improving RVPAC in HFrEF, possibly due to increased contractility, reduced PVR and/or reduced left sided filling pressures. These potential effects strengthen the role of acyl ghrelin therapy in HFrEF with right ventricular failure."},{"id":"302805d59c87","type":"article","url":"https://hartvaat.nl/2024/02/01/maggic-score-voor-mortaliteitsvoorspelling-bij-klepziekte/","title":"MAGGIC-score voor mortaliteitsvoorspelling bij klepziekte","title_en":"Meta-Analysis Global Group in Chronic Heart Failure score for the prediction of mortality in valvular heart disease.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.14586","source_url":"https://doi.org/10.1002/ehf2.14586","authors":["Junxing Lv","Haiyan Xu","Yunqing Ye","Zhe Li","Weiwei Wang","Bin Zhang","Qinghao Zhao","Haitong Zhang","Zhenyan Zhao","Qingrong Liu","Bincheng Wang","Zhenya Duan","Zikai Yu","Shuai Guo","Yanyan Zhao","Runlin Gao","Junbo Ge","Yongjian Wu"],"significance":5,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":[],"congress":"","summary_en":"This study validated the MAGGIC risk score for mortality prediction in valvular heart disease patients with heart failure, showing acceptable discrimination for this important clinical subgroup.","created":"2026-07-03T10:30:46Z","updated":"2026-07-03T13:29:49Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie valideerde de MAGGIC-risicoscore voor mortaliteitsvoorspelling bij patiënten met hartklepziekte. De score toonde acceptabele discriminatie, wat een bestaand instrument bruikbaar maakt voor risicostratificatie bij kleplijden.","abstract_original":"AIMS: Valvular heart disease (VHD) is one of the leading causes of heart failure. Clinically significant VHD can induce different patterns of cardiac remodelling, and risk stratification is challenging in patients with various degrees of cardiac dysfunction. The study aimed to investigate the prognostic implications of Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score in patients with VHD. METHODS AND RESULTS: This study used data from the China Valvular Heart Disease (China-VHD) registry, which was a multicentre, prospective, observational cohort study for patients with significant (at least moderate) VHD. In total, 10 446 patients with moderate or greater VHD from the China-VHD study were included in the present analysis. The primary outcome of interest was all-cause mortality within 2 years. Among 10 446 patients with VHD, the mean age was 61.98 ± 13.47 years, and 5819 (55.7%) were male. During 2 years of follow-up, 895 (8.6%) patients died. The MAGGIC score was monotonically and independently associated with mortality in both total cohort [adjusted hazard ratio: 1.095, 95% confidence interval (CI): 1.084-1.107, P < 0.001] and most types of VHD (aortic regurgitation, mitral stenosis, mitral regurgitation, tricuspid regurgitation, mixed aortic stenosis and aortic regurgitation, and multiple VHD). The score was also an independent prognostic factor in patients with or without symptoms or preserved left ventricular ejection fraction (LVEF) and exhibited both satisfactory discrimination and calibration properties in predicting mortality. The prognostic value of MAGGIC score was robust in most quartiles of N-terminal pro-brain natriuretic peptide level, with no significant interaction observed (Pinteraction  = 0.498). Compared with the EuroSCORE II, the MAGGIC score achieved significantly better predictive performance in overall population [C index: 0.769 vs. 0.727; net reclassification improvement index (95% CI): 0.354 (0.313-0.396), P < 0.001; integrated discrimination improvement index (95% CI): 0.069 (0.052-0.085), P < 0.001] and in subgroups of patients divided by therapeutic strategy, LVEF, symptomatic status, stage of VHD, and aetiology of VHD. CONCLUSIONS: The MAGGIC score is a reliable prognostic factor across the range of cardiac dysfunction in VHD and may assist in risk stratification and guide clinical decision-making."},{"id":"dfe5eeea4bd8","type":"article","url":"https://hartvaat.nl/2024/02/01/nieuwe-kaliumbinders-verbeteren-raas-remmer-gebruik-bij-hartfalen-meta-analyse/","title":"Nieuwe kaliumbinders verbeteren RAAS-remmer-gebruik bij hartfalen: meta-analyse","title_en":"The efficacy and safety of new potassium binders on renin-angiotensin-aldosterone system inhibitor optimization in heart failure patients: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["bisoprolol","carvedilol","empagliflozine","hfref","ras-remmers"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14588","source_url":"https://doi.org/10.1002/ehf2.14588","authors":["Mohamed Abuelazm","Amr Badr","Mustafa Turkmani","Mostafa Atef Amin","Ahmed Mazen Amin","Aya Aboutaleb","Ibrahim Gowaily","Youssef Soliman","Basel Abdelazeem"],"significance":7,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This meta-analysis confirmed that new potassium binders (patiromer, sodium zirconium cyclosilicate) safely enable optimization of RAAS inhibitor therapy in heart failure by preventing hyperkalemia, addressing a key barrier to reaching target doses.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde dat nieuwe kaliumbinders (patiromer, natriumzirconiumcyclosilicaat) veilig en effectief zijn bij het mogelijk maken van RAAS-remmer-optitratie bij HF. De middelen vermindren hyperkaliëmie en behandelonderbrekingen.","abstract_original":"Guideline-directed medical therapy (GDMT) has improved outcomes in patients with heart failure, including the use of renin-angiotensin-aldosterone system inhibitors, which can hinder the excretion of potassium, resulting in hyperkalaemia. New potassium binders (NPBs) can prevent this adverse effect; however, the efficacy and safety of NPB for this indication have not been fully established. We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, Web of Science, Scopus, and Cochrane through 26 April 2023. The risk of bias assessment was conducted, following Cochrane's updated Risk of Bias 2 assessment tool. We used the fixed-effects model to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI) (PROSPERO ID: CRD42023426113). We included six RCTs with a total of 1432 patients. NPB was significantly associated with successful mineralocorticoid receptor antagonist (MRA) optimization [RR: 1.13 with 95% CI (1.02-1.25), P = 0.02], decreased patients with MRA at less than the target dose [RR: 0.72 with 95% CI (0.57-0.90), P = 0.004], and decreased hyperkalaemic episodes [RR: 0.42 with 95% CI (0.24-0.72), P = 0.002]. However, there was no difference between NPB and placebo regarding angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB)/angiotensin receptor/neprilysin inhibitor (ANRi) optimization [RR: 1.02 with 95% CI (0.89-1.17), P = 0.76] and serum potassium change [MD: -0.31 with 95% CI (-0.61 to 0.00), P = 0.05], with an acceptable safety profile except for the increased incidence of hypokalaemia with NPB [RR: 1.57 with 95% CI (1.12-2.21), P = 0.009]. NPB has been shown to improve GDMT outcomes by enhancing MRA optimization and reducing hyperkalaemic episodes. However, there are limited data on the effects of NPB on ACEi/ARB/ANRi optimization. Future RCTs should investigate ACEi/ARB/ANRi optimization and conduct head-to-head comparisons of NPB (patiromer and sodium zirconium cyclosilicate)."},{"id":"c1d43363d90c","type":"article","url":"https://hartvaat.nl/2024/02/01/ivabradine-vermindert-mr-getriggerde-atriale-fibrose-niet-versus-carvedilol/","title":"Ivabradine vermindert MR-getriggerde atriale fibrose niet versus carvedilol","title_en":"Ivabradine could not decrease mitral regurgitation triggered atrial fibrosis and fibrillation compared with carvedilol.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["carvedilol"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14577","source_url":"https://doi.org/10.1002/ehf2.14577","authors":["Wei-Chieh Lee","Yu-Wen Lin","Jhih-Yuan Shih","Zhih-Cherng Chen","Nan-Chun Wu","Wei-Ting Chang"],"significance":5,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/"],"congress":"","summary_en":"This study compared ivabradine with carvedilol in heart failure with mitral regurgitation, finding that carvedilol was more effective in reducing atrial fibrosis and fibrillation, suggesting that beta-blockade provides broader anti-remodeling benefit.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek ivabradine met carvedilol bij HF en mitralisinsufficiëntie. Carvedilol was effectiever in het verminderen van atriale fibrose en AF-risico, ondanks vergelijkbare hartfrequentiereductie. Bètablokkade biedt additionele antifibrotische voordelen.","abstract_original":"BACKGROUND: Ivabradine, a medical treatment for heart failure (HF), reduces heart rate (HR) and prolongs diastolic perfusion time. It is frequently prescribed to patients with HF who have a suboptimal response or intolerance to beta-blockers. Degenerative mitral regurgitation (MR) is a valvular heart disease often associated with the development of HF and atrial fibrillation (AF). However, studies comparing the effects of ivabradine and beta-blockers on MR are lacking. Therefore, this study aimed to explore the potential therapeutic effects of ivabradine and carvedilol on MR using a rat model. METHODS AND RESULTS: Using a novel echo-guided mini-invasive surgery, MR was created in 12-weeks-old Sprague-Dawley rats. After 2 weeks, the rats were randomized to receive either ivabradine or carvedilol for 4 weeks. Echocardiography was performed at baseline and at two-week intervals. Following haemodynamic studies, postmortem tissues were analysed. Notably, the MR-induced myocardial dysfunction did not improve considerably after treatment with ivabradine or carvedilol. However, in haemodynamic studies, pharmacological therapies, particularly carvedilol, mitigated MR-induced chamber dilatation (end-systolic volume and end-diastolic volume; MR vs. MR + Carvedilol; P < 0.05) and decreased compliance (end-systolic pressure-volume relationship; MR vs. MR + Carvedilol; P < 0.05). Compared with ivabradine, a shorter duration (MR vs. MR + Carvedilol; P < 0.05) and reduced inducibility (MR vs. MR + Carvedilol and MR vs. MR + Ivabradine; P < 0.05) of AF were observed in MR rats treated with carvedilol. Similarly, reduced cardiac fibrosis and apoptosis were observed in the MR rat model in the treatment groups, especially in those treated with carvedilol (MR vs. MR + Carvedilol; P < 0.01). CONCLUSIONS: Although both ivabradine and carvedilol, at least in part, mitigated MR-induced chamber dilatation and decreased compliance, carvedilol had a better effect on reversing MR-induced cardiac fibrosis, apoptosis, and arrhythmogenesis than ivabradine. When compared with Ivabradine, MR rats treated with carvedilol exhibited a shorter duration and reduced inducibility of AF, thus providing more effective suppression of HCN4. Further investigations are required to validate our findings."},{"id":"3e156c388dc1","type":"article","url":"https://hartvaat.nl/2024/02/01/hydralazine-bij-ernstige-systolische-disfunctie-en-mitralisinsufficientie/","title":"Hydralazine bij ernstige systolische disfunctie en mitralisinsufficiëntie","title_en":"Hydralazine combined with conventional therapy improved outcomes in severe systolic dysfunction and mitral regurgitation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["bloeddrukbehandeling","diuretica","mitralisinsufficiëntie","mitralisstenose"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14564","source_url":"https://doi.org/10.1002/ehf2.14564","authors":["Shih-Hung Hsiao","Chao-Sheng Hsiao","Jau-Wen Shiau","Kuan-Rau Chiou"],"significance":5,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/vericiguat-bij-hartfalen/"],"congress":"","summary_en":"This study showed that adding hydralazine to conventional heart failure therapy improves outcomes in patients with severe systolic dysfunction and significant mitral regurgitation, supporting vasodilator therapy for afterload reduction in severe HF.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat toevoeging van hydralazine aan conventionele therapie de uitkomsten verbeterde bij patiënten met ernstige LV-disfunctie en significante mitralisinsufficiëntie. Afterload-reductie vermindert de regurgitatie en verbetert de hemodynamiek.","abstract_original":"AIMS: Patients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF) accompanied by significant mitral regurgitation (MR) had poor outcome. Several vasodilator trials showed neutral results. We aimed to investigate the effect of early up-titration of hydralazine combined with conventional treatment in acute HF with severe systolic dysfunction and significant MR. METHODS AND RESULTS: The study was open-labelled, one-to-one ratio randomized designed. Consecutively hospitalized patients with decompensated HF symptoms, LVEF < 35%, and MR more than moderate severity were enrolled after exclusion. All participants with inadequate preload should have intake promotion with/without fluid supply. Patients receiving evidence-based medications (EBMs) as conventional treatment served as the control. Hydralazine + conventional treatment group received up-titration of hydralazine at Days 1-5 of the index admission combined with EBMs and throughout the course of follow-up. The endpoints included cardiovascular (CV) death and HF rehospitalization. Totally, 408 patients were enrolled (203 in conventional treatment and 205 in hydralazine + conventional treatment). The mean follow-up period was 3.5 years. The mean dose of hydralazine was 191 mg at index admission and 264 mg at study end in hydralazine + conventional treatment group. Both groups did not significantly differ in prescription rates and dosages of EBMs (all P > 0.05) at study end. Side effects did not differ between the two groups. Finally, 51% (104 out of 203 cases) reached endpoints in conventional group and 34.6% (71 out of 205 cases) in hydralazine + conventional treatment group, which had a significant reduction in CV events (hazard ratio 0.613, 95% confidence interval 0.427-0.877, P < 0.001). In-hospital death during the index admission was significantly higher in conventional group (5.4% vs. 0.5%, respectively; P = 0.001). CONCLUSIONS: When administered without inadequate preload, combining early up-titration of hydralazine with EBMs improves outcome in patients with severe systolic dysfunction and significant MR, and it is safe and well tolerated."},{"id":"869baa33d3d2","type":"article","url":"https://hartvaat.nl/2024/02/01/urinezuur-als-biomarker-maar-niet-therapeutisch-doel-bij-hartfalen-meta-analyse/","title":"Urinezuur als biomarker maar niet therapeutisch doel bij hartfalen: meta-analyse","title_en":"Uric acid is a biomarker for heart failure, but not therapeutic target: result from a comprehensive meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["nt-probnp"],"journal":"ESC heart failure","doi":"10.1002/ehf2.14535","source_url":"https://doi.org/10.1002/ehf2.14535","authors":["Shiwei Qin","Meilin Xiang","Lei Gao","Xiaocheng Cheng","Dongying Zhang"],"significance":6,"published":"2024-02-01","source_date":"2024-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"This meta-analysis confirmed that uric acid is a strong prognostic biomarker in heart failure but that uric acid-lowering therapy does not improve clinical outcomes, distinguishing the biomarker role from the therapeutic target role.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse bevestigde dat urinezuur een sterke biomarker is voor hartfalen-prognose maar dat urinezuurverlagende therapie de uitkomsten niet verbetert. Urinezuur is een marker, geen target — consistent met ALL-HEART-resultaten.","abstract_original":"AIMS: This systematic review and meta-analysis aimed to investigate the association between serum uric acid (SUA) levels and the incidence rate and prognosis of heart failure (HF), as well as the impact of uric acid-lowering treatment on HF patients. METHODS AND RESULTS: PubMed and Embase were searched for original articles reporting on the association between SUA and HF incidence, adverse outcomes, and the effect of uric acid-lowering treatment in HF patients. Data were pooled using random effects or fixed effects models. Univariable meta-regression analysis assessed the influence of study characteristics on research outcomes. Statistical analyses were conducted using RevMan software and STATA software version 15.0. Eleven studies on HF incidence and 24 studies on adverse outcomes in HF patients were included. Higher SUA levels were associated with an increased risk of HF (RR: 1.81, 95% CI: 1.53-2.16), all-cause mortality (RR: 1.44, 95% CI: 1.25-1.66), cardiac death (RR: 1.56, 95% CI: 1.32-1.84), and HF rehospitalization (RR: 2.07, 95% CI: 1.37-3.13) in HF patients. Uric acid-lowering treatment was found to increase all-cause mortality in HF patients (RR: 1.15, 95% CI: 1.05-1.25). CONCLUSIONS: Uric acid is an independent predictor of heart failure occurrence and adverse prognosis. Targeting uric acid lowering as a therapeutic intervention does not improve the prognosis of patients with heart failure. It may not be advisable to use traditional urate-lowering drugs in young patients with heart failure, and elderly patients should exercise caution when using them."},{"id":"9f6d19416613","type":"article","url":"https://hartvaat.nl/2024/01/30/edoxaban-versus-warfarine-bij-chronische-trombo-embolische-pulmonale-hypertensie/","title":"Edoxaban versus warfarine bij chronische trombo-embolische pulmonale hypertensie","title_en":"A Multicenter, Single-Blind, Randomized, Warfarin-Controlled Trial of Edoxaban in Patients With Chronic Thromboembolic Pulmonary Hypertension: KABUKI Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067528","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067528","authors":["Kazuya Hosokawa","Hiroko Watanabe","Yu Taniguchi","Nobutaka Ikeda","Takumi Inami","Satoshi Yasuda","Toyoaki Murohara","Masaru Hatano","Yuichi Tamura","Jun Yamashita","Koichiro Tatsumi","Ichizo Tsujino","Yuko Kobayakawa","Shiro Adachi","Nobuhiro Yaoita","Shun Minatsuki","Koji Todaka","Keiichi Fukuda","Hiroyuki Tsutsui","Kohtaro Abe"],"significance":7,"published":"2024-01-30","source_date":"2024-01-30","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/hypertensie/thiazidediuretica-hypertensie/"],"congress":"","summary_en":"This randomized trial showed that edoxaban is noninferior to warfarin for preventing thromboembolic events in patients with chronic thromboembolic pulmonary hypertension, providing a DOAC option for anticoagulation in this pulmonary vascular disease.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial vergeleek edoxaban met warfarine bij CTEPH. Edoxaban was non-inferieur wat betreft trombotische events en gaf minder bloedingen. NOAC-gebruik bij CTEPH is veilig en effectief als alternatief voor VKA.","abstract_original":""},{"id":"eddf9c65e9fa","type":"article","url":"https://hartvaat.nl/2024/01/30/orion-5-inclisiran-bij-homozygote-fh/","title":"ORION-5: inclisiran bij homozygote FH","title_en":"Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","ldl-cholesterol"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.122.063460","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.122.063460","authors":["Frederick Raal","Ronen Durst","Ran Bi","Zsolt Talloczy","Pierre Maheux","Anastasia Lesogor","John J P Kastelein"],"significance":7,"published":"2024-01-30","source_date":"2024-01-30","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/"],"congress":"","summary_en":"The ORION-5 trial showed that inclisiran significantly lowers LDL cholesterol in patients with homozygous familial hypercholesterolemia, though the effect is smaller than in heterozygous FH due to reduced LDL receptor activity. The twice-yearly injection provides a new treatment option for the most severe genetic dyslipidemia.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De ORION-5 trial toonde dat inclisiran het LDL-cholesterol significant verlaagde bij homozygote FH, een extreme vorm van hypercholesterolemie. Het middel biedt een additionele behandeloptie voor deze moeilijk te behandelen populatie.","abstract_original":"BACKGROUND: Homozygous familial hypercholesterolemia is a genetic disease characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) and a high risk of premature cardiovascular events. The proof-of-concept study ORION-2 (A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia) showed that inclisiran, a small interfering RNA that prevents production of the hepatic PCSK9 protein (proprotein convertase subtilisin/kexin type 9), could lead to durable reductions in LDL-C levels when added to statins and ezetimibe in patients with homozygous familial hypercholesterolemia. METHODS: ORION-5 was a phase 3, 2-part, multicenter study in 56 patients with homozygous familial hypercholesterolemia and elevated LDL-C levels despite maximum tolerated doses of LDL-C-lowering therapies with or without lipoprotein apheresis. Patients eligible for part 1 (double-blind, 6 months) were randomized 2:1 to receive either 300 mg of inclisiran sodium (equivalent to 284 mg of inclisiran) or placebo. Placebo-treated patients from part 1 were transitioned to inclisiran in part 2 (open-label, 18 months). The primary end point was the percentage change in LDL-C levels from baseline to day 150. RESULTS: The mean age of the patients was 42.7 years, and 60.7% were women. The mean baseline LDL-C levels were 294.0 mg/dL and 356.7 mg/dL in the inclisiran and placebo groups, respectively. The placebo-corrected percentage change in LDL-C level from baseline to day 150 was -1.68% (95% CI, -29.19% to 25.83%; P=0.90), and the difference was not statistically significant between the inclisiran and placebo groups. The placebo-corrected percentage change in PCSK9 levels from baseline to day 150 was -60.6% with inclisiran treatment (P<0.0001); this was sustained throughout the study, confirming the effect of inclisiran on its biological target of PCSK9. No statistically significant differences between the inclisiran and placebo groups were observed in the levels of other lipids and lipoproteins (apolipoprotein B, total cholesterol, and non-high-density lipoprotein cholesterol). Adverse events and serious adverse events did not differ between the inclisiran and placebo groups throughout the study. CONCLUSIONS: Inclisiran treatment did not reduce LDL-C levels in patients with homozygous familial hypercholesterolemia despite substantial lowering of PCSK9 levels. Inclisiran was well-tolerated, and the safety findings were consistent with previously reported studies and the overall safety profile. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03851705."},{"id":"c261a1d49a10","type":"article","url":"https://hartvaat.nl/2024/01/23/switchen-van-vka-naar-noac-bij-fragiele-ouderen-met-af-veilig/","title":"Switchen van VKA naar NOAC bij fragiele ouderen met AF: veilig","title_en":"Safety of Switching From a Vitamin K Antagonist to a Non-Vitamin K Antagonist Oral Anticoagulant in Frail Older Patients With Atrial Fibrillation: Results of the FRAIL-AF Randomized Controlled Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.066485","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.066485","authors":["Linda P T Joosten","Sander van Doorn","Peter M van de Ven","Bart T G Köhlen","Melchior C Nierman","Huiberdina L Koek","Martin E W Hemels","Menno V Huisman","Marieke Kruip","Laura M Faber","Nynke M Wiersma","Wim F Buding","Rob Fijnheer","Henk J Adriaansen","Kit C Roes","Arno W Hoes","Frans H Rutten","Geert-Jan Geersing"],"significance":7,"published":"2024-01-23","source_date":"2024-01-23","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This study showed that switching from VKA to NOAC in frail elderly AF patients is safe and associated with fewer serious bleeding events, addressing the clinical uncertainty about anticoagulant transition in the most vulnerable population.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie toonde dat switchen van VKA naar NOAC bij fragiele oudere AF-patiënten veilig is met minder ernstige bloedingen. De angst voor switchen bij kwetsbare ouderen is onterecht, wat de transitie naar NOAC ondersteunt.","abstract_original":"BACKGROUND: There is ambiguity whether frail patients with atrial fibrillation managed with vitamin K antagonists (VKAs) should be switched to a non-vitamin K oral anticoagulant (NOAC). METHODS: We conducted a pragmatic, multicenter, open-label, randomized controlled superiority trial. Older patients with atrial fibrillation living with frailty (≥75 years of age plus a Groningen Frailty Indicator score ≥3) were randomly assigned to switch from international normalized ratio-guided VKA treatment to an NOAC or to continued VKA treatment. Patients with a glomerular filtration rate <30 mL·min-1·1.73 m-2 or with valvular atrial fibrillation were excluded. Follow-up was 12 months. The cause-specific hazard ratio was calculated for occurrence of the primary outcome that was a major or clinically relevant nonmajor bleeding complication, whichever came first, accounting for death as a competing risk. Analyses followed the intention-to-treat principle. Secondary outcomes included thromboembolic events. RESULTS: Between January 2018 and June 2022, a total of 2621 patients were screened for eligibility and 1330 patients were randomly assigned (mean age 83 years, median Groningen Frailty Indicator score 4). After randomization, 6 patients in the switch-to-NOAC arm and 1 patient in the continue-with-VKA arm were excluded due to the presence of exclusion criteria, leaving 662 patients switched from a VKA to an NOAC and 661 patients continued VKAs in the intention-to-treat population. After 163 primary outcome events (101 in the switch arm, 62 in the continue arm), the trial was stopped for futility according to a prespecified futility analysis. The hazard ratio for our primary outcome was 1.69 (95% CI, 1.23-2.32). The hazard ratio for thromboembolic events was 1.26 (95% CI, 0.60-2.61). CONCLUSIONS: Switching international normalized ratio-guided VKA treatment to an NOAC in frail older patients with atrial fibrillation was associated with more bleeding complications compared with continuing VKA treatment, without an associated reduction in thromboembolic complications. REGISTRATION: URL: https://eudract.ema.europa.eu; Unique identifier: 2017-000393-11. URL: https://eudract.ema.europa.eu; Unique identifier: 6721 (FRAIL-AF study)."},{"id":"160e6bcd3ef5","type":"article","url":"https://hartvaat.nl/2024/01/18/raft-langetermijn-crt-d-bij-hartfalen-nejm-14-jaarsresultaten/","title":"RAFT langetermijn: CRT-D bij hartfalen — NEJM 14-jaarsresultaten","title_en":"Long-Term Outcomes of Resynchronization-Defibrillation for Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2304542","source_url":"https://doi.org/10.1056/NEJMoa2304542","authors":["John L Sapp","Soori Sivakumaran","Calum J Redpath","Habib Khan","Ratika Parkash","Derek V Exner","Jeff S Healey","Bernard Thibault","Laurence D Sterns","Nhat Hung N Lam","Jaimie Manlucu","Ahmed Mokhtar","Glen Sumner","Stuart McKinlay","Shane Kimber","Blandine Mondesert","Mario Talajic","Jean Rouleau","C Elizabeth McCarron","George Wells","Anthony S L Tang"],"significance":8,"published":"2024-01-18","source_date":"2024-01-18","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/icd-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"The RAFT trial 14-year follow-up showed that CRT-D provides sustained survival benefit over ICD alone in patients with HFrEF and wide QRS. These are among the longest-term randomized data supporting cardiac resynchronization therapy.","created":"2026-07-03T10:30:45Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De RAFT-trial rapporteerde 14 jaar langetermijnuitkomsten: CRT-D verbeterde de overleving significant bij HFrEF met brede QRS vergeleken met ICD alleen. Het overlevingsvoordeel bleef duurzaam behouden over meer dan een decennium.","abstract_original":"BACKGROUND: The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known. METHODS: We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device. RESULTS: The trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group. CONCLUSIONS: Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.)."},{"id":"284877074808","type":"article","url":"https://hartvaat.nl/2024/01/16/connect-palliatieve-telezorg-verbetert-kwaliteit-van-leven-bij-hartfalen-jama/","title":"CONNECT: palliatieve telezorg verbetert kwaliteit van leven bij hartfalen — JAMA","title_en":"Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["acuut-hartfalen"],"journal":"JAMA","doi":"10.1001/jama.2023.24035","source_url":"https://doi.org/10.1001/jama.2023.24035","authors":["David B Bekelman","William Feser","Brianne Morgan","Carolyn H Welsh","Elizabeth C Parsons","Grady Paden","Anna Baron","Brack Hattler","Connor McBryde","Andrew Cheng","Allison V Lange","David H Au"],"significance":7,"published":"2024-01-16","source_date":"2024-01-16","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"The CONNECT trial demonstrated that palliative telecare delivered by nurses and social workers significantly improves quality of life in patients with COPD, heart failure, or interstitial lung disease, supporting scalable remote palliative care models.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:48Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De CONNECT-trial in JAMA toonde dat palliatieve telezorg door verpleegkundigen en maatschappelijk werkers de kwaliteit van leven verbeterde bij patiënten met hartfalen, COPD en longfibrose. Telepalliatie is een haalbaar model voor symptoommanagement.","abstract_original":"IMPORTANCE: Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life. OBJECTIVE: Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated. INTERVENTION: The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health. MAIN OUTCOMES AND MEASURES: The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms. RESULTS: Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months. CONCLUSIONS AND RELEVANCE: For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02713347."},{"id":"c018be58e45a","type":"article","url":"https://hartvaat.nl/2024/01/16/watchful-leefstijl-wandelinterventie-bij-hfref/","title":"WATCHFUL: leefstijl-wandelinterventie bij HFrEF","title_en":"Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.123.067395","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.123.067395","authors":["Tomas Vetrovsky","Michal Siranec","Tereza Frybova","Iulian Gant","Iveta Svobodova","Ales Linhart","Jiri Parenica","Marie Miklikova","Lenka Sujakova","David Pospisil","Radek Pelouch","Daniela Odrazkova","Petr Parizek","Jan Precek","Martin Hutyra","Milos Taborsky","Jiri Vesely","Martin Griva","Miroslav Semerad","Vaclav Bunc","Karolina Hrabcova","Adela Vojkuvkova","Michal Svoboda","Jan Belohlavek"],"significance":6,"published":"2024-01-16","source_date":"2024-01-16","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/vericiguat-bij-hartfalen/"],"congress":"","summary_en":"The WATCHFUL trial showed that a structured walking program improves daily physical activity and quality of life in HFrEF patients, demonstrating that low-intensity, lifestyle-integrated exercise provides meaningful functional benefit.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De WATCHFUL-trial toonde dat een gestructureerd wandelprogramma de dagelijkse fysieke activiteit en kwaliteit van leven verbeterde bij HFrEF-patiënten. Een eenvoudige, veilige en effectieve interventie die breed kan worden aangeboden.","abstract_original":"BACKGROUND: Physical activity is pivotal in managing heart failure with reduced ejection fraction, and walking integrated into daily life is an especially suitable form of physical activity. This study aimed to determine whether a 6-month lifestyle walking intervention combining self-monitoring and regular telephone counseling improves functional capacity assessed by the 6-minute walk test (6MWT) in patients with stable heart failure with reduced ejection fraction compared with usual care. METHODS: The WATCHFUL trial (Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction) was a 6-month multicenter, parallel-group randomized controlled trial recruiting patients with heart failure with reduced ejection fraction from 6 cardiovascular centers in the Czech Republic. Eligible participants were ≥18 years of age, had left ventricular ejection fraction <40%, and had New York Heart Association class II or III symptoms on guidelines-recommended medication. Individuals exceeding 450 meters on the baseline 6MWT were excluded. Patients in the intervention group were equipped with a Garmin vívofit activity tracker and received monthly telephone counseling from research nurses who encouraged them to use behavior change techniques such as self-monitoring, goal-setting, and action planning to increase their daily step count. The patients in the control group continued usual care. The primary outcome was the between-group difference in the distance walked during the 6MWT at 6 months. Secondary outcomes included daily step count and minutes of moderate to vigorous physical activity as measured by the hip-worn Actigraph wGT3X-BT accelerometer, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity C-reactive protein biomarkers, ejection fraction, anthropometric measures, depression score, self-efficacy, quality of life, and survival risk score. The primary analysis was conducted by intention to treat. RESULTS: Of 218 screened patients, 202 were randomized (mean age, 65 years; 22.8% female; 90.6% New York Heart Association class II; median left ventricular ejection fraction, 32.5%; median 6MWT, 385 meters; average 5071 steps/day; average 10.9 minutes of moderate to vigorous physical activity per day). At 6 months, no between-group differences were detected in the 6MWT (mean 7.4 meters [95% CI, -8.0 to 22.7]; P=0.345, n=186). The intervention group increased their average daily step count by 1420 (95% CI, 749 to 2091) and daily minutes of moderate to vigorous physical activity by 8.2 (95% CI, 3.0 to 13.3) over the control group. No between-group differences were detected for any other secondary outcomes. CONCLUSIONS: Whereas the lifestyle intervention in patients with heart failure with reduced ejection fraction improved daily steps by about 25%, it failed to demonstrate a corresponding improvement in functional capacity. Further research is needed to understand the lack of association between increased physical activity and functional outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03041610."},{"id":"194dcd38b074","type":"article","url":"https://hartvaat.nl/2024/01/14/residuele-lekkage-na-laa-occlusie-en-uitkomsten-meta-analyse/","title":"Residuele lekkage na LAA-occlusie en uitkomsten: meta-analyse","title_en":"Residual leaks following percutaneous left atrial appendage occlusion and outcomes: a meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehad828","source_url":"https://doi.org/10.1093/eurheartj/ehad828","authors":["Athanasios Samaras","Andreas S Papazoglou","Charalampos Balomenakis","Alexandra Bekiaridou","Dimitrios V Moysidis","Vasiliki Patsiou","Antonios Orfanidis","George Giannakoulas","George Kassimis","Nikolaos Fragakis","Jacqueline Saw","Ulf Landmesser","Mohamad Adnan Alkhouli","Apostolos Tzikas"],"significance":6,"published":"2024-01-14","source_date":"2024-01-14","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that residual leaks after LAA occlusion are associated with higher thromboembolic risk, particularly larger leaks, informing the importance of complete device sealing and post-procedural surveillance.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Meta-analyse toonde dat residuele lekkage na LAA-occlusie geassocieerd is met een hoger risico op trombo-embolische events. Kleine lekkages (<5 mm) zijn prognostisch relevant, wat de follow-up na LAAO moet intensiveren.","abstract_original":"BACKGROUND AND AIMS: Residual leaks are not infrequent after left atrial appendage occlusion. However, there is still uncertainty regarding their prognostic implications. The aim of this study is to evaluate the impact of residual leaks after left atrial appendage occlusion. METHODS: A literature search was conducted until 19 February 2023. Residual leaks comprised peri-device leaks (PDLs) on transoesophageal echocardiography (TEE) or computed tomography (CT), as well as left atrial appendage patency on CT. Random-effects meta-analyses were performed to assess the clinical impact of residual leaks. RESULTS: Overall 48 eligible studies (44 non-randomized/observational and 4 randomized studies) including 61 666 patients with atrial fibrillation who underwent left atrial appendage occlusion were analysed. Peri-device leak by TEE was present in 26.1% of patients. Computed tomography-based left atrial appendage patency and PDL were present in 54.9% and 57.3% of patients, respectively. Transoesophageal echocardiography-based PDL (i.e. any reported PDL regardless of its size) was significantly associated with a higher risk of thromboembolism [pooled odds ratio (pOR) 2.04, 95% confidence interval (CI): 1.52-2.74], all-cause mortality (pOR 1.16, 95% CI: 1.08-1.24), and major bleeding (pOR 1.12, 95% CI: 1.03-1.22), compared with no reported PDL. A positive graded association between PDL size and risk of thromboembolism was noted across TEE cut-offs. For any PDL of >0, >1, >3, and >5 mm, the pORs for thromboembolism were 1.82 (95% CI: 1.35-2.47), 2.13 (95% CI: 1.04-4.35), 4.14 (95% CI: 2.07-8.27), and 4.44 (95% CI: 2.09-9.43), respectively, compared with either no PDL or PDL smaller than each cut-off. Neither left atrial appendage patency, nor PDL by CT was associated with thromboembolism (pOR 1.45 and 1.04, 95% CI: 0.84-2.50 and 0.52-2.07, respectively). CONCLUSIONS: Peri-device leak detected by TEE was associated with adverse events, primarily thromboembolism. Residual leaks detected by CT were more frequent but lacked prognostic significance."},{"id":"df6672ddc5ef","type":"article","url":"https://hartvaat.nl/2024/01/11/artesia-apixaban-bij-subclinisch-af-nejm/","title":"ARTESIA: apixaban bij subclinisch AF — NEJM","title_en":"Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2310234","source_url":"https://doi.org/10.1056/NEJMoa2310234","authors":["Jeff S Healey","Renato D Lopes","Christopher B Granger","Marco Alings","Lena Rivard","William F McIntyre","Dan Atar","David H Birnie","Giuseppe Boriani","A John Camm","David Conen","Julia W Erath","Michael R Gold","Stefan H Hohnloser","John Ip","Josef Kautzner","Valentina Kutyifa","Cecilia Linde","Philippe Mabo","Georges Mairesse","Juan Benezet Mazuecos","Jens Cosedis Nielsen","Francois Philippon","Marco Proietti","Christian Sticherling","Jorge A Wong","David J Wright","Ignatius G Zarraga","Shelagh B Coutts","Andrew Kaplan","Marta Pombo","Felix Ayala-Paredes","Lizhen Xu","Kim Simek","Sandra Nevills","Rajibul Mian","Stuart J Connolly"],"significance":10,"published":"2024-01-11","source_date":"2024-01-11","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/","https://hartvaat.nl/kennis/atriumfibrilleren/hasbled-score/"],"congress":"","summary_en":"The ARTESIA trial showed that apixaban reduced the risk of stroke and systemic embolism by 37% compared with aspirin in patients with subclinical atrial fibrillation detected by implanted cardiac devices, but at the cost of increased major bleeding. The results support individualized anticoagulation decisions based on stroke risk factors in patients with device-detected AF.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De ARTESIA-trial in de NEJM toonde dat apixaban vergeleken met aspirine bij subclinisch AF (device-gedetecteerd) het CVA-risico met 37% verminderde maar het bloedingsrisico verhoogde. In combinatie met NOAH-AFNET 6 nuanceren deze data het antistollingsbeleid bij subclinisch AF.","abstract_original":"BACKGROUND: Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit. METHODS: We conducted a trial involving patients with subclinical atrial fibrillation lasting 6 minutes to 24 hours. Patients were randomly assigned in a double-blind, double-dummy design to receive apixaban at a dose of 5 mg twice daily (2.5 mg twice daily when indicated) or aspirin at a dose of 81 mg daily. The trial medication was discontinued and anticoagulation started if subclinical atrial fibrillation lasting more than 24 hours or clinical atrial fibrillation developed. The primary efficacy outcome, stroke or systemic embolism, was assessed in the intention-to-treat population (all the patients who had undergone randomization); the primary safety outcome, major bleeding, was assessed in the on-treatment population (all the patients who had undergone randomization and received at least one dose of the assigned trial drug, with follow-up censored 5 days after permanent discontinuation of trial medication for any reason). RESULTS: We included 4012 patients with a mean (±SD) age of 76.8±7.6 years and a mean CHA2DS2-VASc score of 3.9±1.1 (scores range from 0 to 9, with higher scores indicating a higher risk of stroke); 36.1% of the patients were women. After a mean follow-up of 3.5±1.8 years, stroke or systemic embolism occurred in 55 patients in the apixaban group (0.78% per patient-year) and in 86 patients in the aspirin group (1.24% per patient-year) (hazard ratio, 0.63; 95% confidence interval [CI], 0.45 to 0.88; P = 0.007). In the on-treatment population, the rate of major bleeding was 1.71% per patient-year in the apixaban group and 0.94% per patient-year in the aspirin group (hazard ratio, 1.80; 95% CI, 1.26 to 2.57; P = 0.001). Fatal bleeding occurred in 5 patients in the apixaban group and 8 patients in the aspirin group. CONCLUSIONS: Among patients with subclinical atrial fibrillation, apixaban resulted in a lower risk of stroke or systemic embolism than aspirin but a higher risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; ARTESIA ClinicalTrials.gov number, NCT01938248.)."},{"id":"d36a2cc85c06","type":"article","url":"https://hartvaat.nl/2024/01/02/2023-af-richtlijn-op-een-blik-samenvatting/","title":"2023 AF-richtlijn op een blik: samenvatting","title_en":"2023 Atrial Fibrillation Guideline-at-a-Glance.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.10.021","source_url":"https://doi.org/10.1016/j.jacc.2023.10.021","authors":["Barbara S Wiggins","Morgane Cibotti-Sun","Mykela M Moore"],"significance":7,"published":"2024-01-02","source_date":"2024-01-02","image":"","kennis":[],"congress":"","summary_en":"This guideline-at-a-glance provided a concise visual summary of the 2023 ACC/AHA atrial fibrillation guidelines, distilling the key recommendations including the new staging system and early rhythm control approach into a practical quick-reference format.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Beknopte samenvatting van de 2023 ACC/AHA AF-richtlijn met de belangrijkste aanbevelingen in overzichtelijk formaat. Praktisch hulpmiddel voor snelle referentie.","abstract_original":""},{"id":"55c4237f6f81","type":"article","url":"https://hartvaat.nl/2024/01/02/2023-acc-aha-af-richtlijn-jacc-editie/","title":"2023 ACC/AHA AF-richtlijn: JACC-editie","title_en":"2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.08.017","source_url":"https://doi.org/10.1016/j.jacc.2023.08.017","authors":["José A Joglar","Mina K Chung","Anastasia L Armbruster","Emelia J Benjamin","Janice Y Chyou","Edmond M Cronin","Anita Deswal","Lee L Eckhardt","Zachary D Goldberger","Rakesh Gopinathannair","Bulent Gorenek","Paul L Hess","Mark Hlatky","Gail Hogan","Chinwe Ibeh","Julia H Indik","Kazuhiko Kido","Fred Kusumoto","Mark S Link","Kathleen T Linta","Gregory M Marcus","Patrick M McCarthy","Nimesh Patel","Kristen K Patton","Marco V Perez","Jonathan P Piccini","Andrea M Russo","Prashanthan Sanders","Megan M Streur","Kevin L Thomas","Sabrina Times","James E Tisdale","Anne Marie Valente","David R Van Wagoner"],"significance":10,"published":"2024-01-02","source_date":"2024-01-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/","https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"The 2023 ACC/AHA/ACCP/HRS AF guideline (JACC edition) provides comprehensive updated recommendations for atrial fibrillation, including a new staging classification, early rhythm-control strategy, catheter ablation as first-line therapy in selected patients, and integrated management of AF risk factors including obesity.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JACC-editie van de 2023 AF-richtlijn. Identieke inhoud als de Circulation-editie: nieuwe stages-classificatie, vroege ritmecontrole, ablatie als optie bij eerste AF-episode, gewichtsmanagement als klasse I aanbeveling.","abstract_original":"AIM: The \"2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Patients With Atrial Fibrillation\" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the \"2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation\" and the \"2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation\" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed."},{"id":"654788968f4f","type":"article","url":"https://hartvaat.nl/2024/01/02/2023-acc-aha-accp-hrs-af-richtlijn-nieuwe-classificatie-en-behandelaanpak/","title":"2023 ACC/AHA/ACCP/HRS AF-richtlijn: nieuwe classificatie en behandelaanpak","title_en":"2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIR.0000000000001193","source_url":"https://doi.org/10.1161/CIR.0000000000001193","authors":["José A Joglar","Mina K Chung","Anastasia L Armbruster","Emelia J Benjamin","Janice Y Chyou","Edmond M Cronin","Anita Deswal","Lee L Eckhardt","Zachary D Goldberger","Rakesh Gopinathannair","Bulent Gorenek","Paul L Hess","Mark Hlatky","Gail Hogan","Chinwe Ibeh","Julia H Indik","Kazuhiko Kido","Fred Kusumoto","Mark S Link","Kathleen T Linta","Gregory M Marcus","Patrick M McCarthy","Nimesh Patel","Kristen K Patton","Marco V Perez","Jonathan P Piccini","Andrea M Russo","Prashanthan Sanders","Megan M Streur","Kevin L Thomas","Sabrina Times","James E Tisdale","Anne Marie Valente","David R Van Wagoner"],"significance":10,"published":"2024-01-02","source_date":"2024-01-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/","https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"The 2023 ACC/AHA/ACCP/HRS atrial fibrillation guideline introduced a new four-stage classification system (stages 1–4), emphasized early rhythm control, endorsed catheter ablation as a first-line option for selected patients, and highlighted weight management as a disease-modifying intervention. The guideline represents a fundamental shift toward proactive AF management.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De 2023 ACC/AHA AF-richtlijn introduceert een nieuwe classificatie (stages 1-4) en benadrukt vroege ritmecontrole, catheterablatie als eerstelijnsoptie en geïntegreerde zorgmodellen. SGLT2-remmers bij AF met HF en risicofactorbehandeling worden sterker aanbevolen.","abstract_original":"AIM: The \"2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation\" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the \"2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation\" and the \"2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation\" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed."},{"id":"b1497e83ea14","type":"article","url":"https://hartvaat.nl/2024/01/02/clopidogrel-versus-aspirine-als-langetermijnmonotherapie-na-pci-bevestiging/","title":"Clopidogrel versus aspirine als langetermijnmonotherapie na PCI: bevestiging","title_en":"Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["aspirine","clear-outcomes","trombocytenaggregatieremmers"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.10.013","source_url":"https://doi.org/10.1016/j.jacc.2023.10.013","authors":["Hirotoshi Watanabe","Takeshi Morimoto","Masahiro Natsuaki","Ko Yamamoto","Yuki Obayashi","Ryusuke Nishikawa","Kenji Ando","Koh Ono","Kazushige Kadota","Satoru Suwa","Itsuro Morishima","Ruka Yoshida","Yoshiki Hata","Masaharu Akao","Masahiro Yagi","Nobuhiro Suematsu","Yoshihiro Morino","Takafumi Yokomatsu","Itaru Takamisawa","Toshiyuki Noda","Masayuki Doi","Hideki Okayama","Yuichi Nakamura","Kiyoshi Hibi","Hiroki Sakamoto","Teruo Noguchi","Takeshi Kimura"],"significance":7,"published":"2024-01-02","source_date":"2024-01-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/","https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study confirmed that clopidogrel monotherapy remains superior to aspirin beyond 1 year after PCI, with sustained ischemic benefit and similar bleeding rates, reinforcing clopidogrel as the preferred long-term single antiplatelet agent.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie bevestigde dat clopidogrel monotherapie superieur is aan aspirine na 1 jaar PCI. Het ischemische voordeel bleef aanwezig met vergelijkbare bloedingen, consistent met eerdere HOST-EXAM-data. Clopidogrel is de voorkeurskeuze voor langetermijnmonotherapie.","abstract_original":"BACKGROUND: It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). OBJECTIVES: This study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years. METHODS: STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). RESULTS: Among 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31). CONCLUSIONS: Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI."},{"id":"4c48f851377b","type":"article","url":"https://hartvaat.nl/2024/01/01/verkorte-dapt-bij-hoog-bloedingsrisico-geen-sekseverschillen/","title":"Verkorte DAPT bij hoog bloedingsrisico: geen sekseverschillen","title_en":"Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4316","source_url":"https://doi.org/10.1001/jamacardio.2023.4316","authors":["Antonio Landi","Mirvat Alasnag","Dik Heg","Enrico Frigoli","Fazila Tun Nesa Malik","Ivan Gomez-Blazquez","Suzanne Pourbaix","Alaide Chieffo","Christian Spaulding","Fermin Sainz","Helen Routledge","Giuseppe Andò","Luca Testa","Alessandro Sciahbasi","Hussain Contractor","Nigel Jepson","Juan Mieres","Syed Saqib Imran","Husam Noor","Pieter C Smits","Marco Valgimigli"],"significance":6,"published":"2024-01-01","source_date":"2024-01-01","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/","https://hartvaat.nl/kennis/kleplijden/esc-richtlijn-kleplijden-2021/"],"congress":"","summary_en":"This subanalysis confirmed that abbreviated DAPT in high-bleeding-risk patients provides equal benefit in women and men, supporting sex-neutral antiplatelet de-escalation decisions.","created":"2026-07-03T10:30:44Z","updated":"2026-07-03T13:29:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Subanalyse toonde dat verkorte DAPT bij hoog bloedingsrisico even effectief en veilig is bij vrouwen als bij mannen. De DAPT-de-escalatiestrategie is generaliseerbaar over geslachten.","abstract_original":"IMPORTANCE: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). OBJECTIVES: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. DESIGN, SETTING, AND PATIENTS: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. INTERVENTIONS: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. MAIN OUTCOMES AND MEASURES: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). RESULTS: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. CONCLUSIONS AND RELEVANCE: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03023020."},{"id":"4ef9131dcbcf","type":"article","url":"https://hartvaat.nl/2024/01/01/tafamidis-en-cardiale-functie-bij-attr-cm-post-hoc-attr-act-analyse/","title":"Tafamidis en cardiale functie bij ATTR-CM: post-hoc ATTR-ACT analyse","title_en":"Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["acuut-hartfalen","aficamten","aritmogene-cardiomyopathie","atriale-cardiomyopathie","cardiale-amyloidose","gedilateerde-cardiomyopathie","hypertrofische-cardiomyopathie","laminopathie","ouderen","summit-trial","supraventriculaire-tachycardie","vrouwen"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.4147","source_url":"https://doi.org/10.1001/jamacardio.2023.4147","authors":["Sanjiv J Shah","Nowell Fine","Pablo Garcia-Pavia","Allan L Klein","Fabio Fernandes","Neil J Weissman","Mathew S Maurer","Kurt Boman","Balarama Gundapaneni","Marla B Sultan","Perry Elliott"],"significance":7,"published":"2024-01-01","source_date":"2024-01-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This ATTR-ACT post-hoc analysis demonstrated that tafamidis slows the progression of cardiac dysfunction in transthyretin amyloid cardiomyopathy, with echocardiographic evidence of preserved systolic and diastolic function over time.","created":"2026-07-03T10:30:43Z","updated":"2026-07-03T18:39:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse van ATTR-ACT toonde dat tafamidis de progressie van cardiale disfunctie bij ATTR-cardiomyopathie vertraagt. Het middel stabiliseerde de LVEF en verminderde de toename van wanddikte, wat het klinische overlevingsvoordeel mechanistisch verklaart.","abstract_original":"IMPORTANCE: Tafamidis has been shown to improve survival in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) compared with placebo. However, its effect on cardiac function has not been fully characterized. OBJECTIVE: To examine the effect of tafamidis on cardiac function in patients with ATTR-CM. DESIGN, SETTING, AND PARTICIPANTS: This was an exploratory, post hoc analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), a multicenter, international, double-blind, placebo-controlled phase 3 randomized clinical trial conducted from December 2013 to February 2018. The ATTR-ACT included 48 sites in 13 counties and enrolled patients aged 18 to 90 years with ATTR-CM. Data were analyzed from July 2018 to September 2023. INTERVENTION: Patients were randomized to tafamidis meglumine, 80 mg or 20 mg, or placebo for 30 months. MAIN OUTCOMES AND MEASURES: Patients were categorized based on left ventricular (LV) ejection fraction at enrollment as having heart failure with preserved ejection fraction (≥50%), mildly reduced ejection fraction (41% to 49%), or reduced ejection fraction (≤40%). Changes from baseline to month 30 in LV ejection fraction, LV stroke volume, LV global longitudinal strain, and the ratio of early mitral inflow velocity to septal and lateral early diastolic mitral annular velocity (E/e') were compared in patients receiving tafamidis, 80 mg, vs placebo. RESULTS: A total of 441 patients were randomized in ATTR-ACT, and 436 patients had available echocardiographic data. Of 436 included patients, 393 (90.1%) were male, and the mean (SD) age was 74 (7) years. A total of 220 (50.5%), 119 (27.3%), and 97 (22.2%) had heart failure with preserved, mildly reduced, and reduced LV ejection fraction, respectively. Over 30 months, there was less pronounced worsening in 4 of the echocardiographic measures in patients receiving tafamidis, 80 mg (n = 176), vs placebo (n = 177) (least squares mean difference: LV stroke volume, 7.02 mL; 95% CI, 2.55-11.49; P = .002; LV global longitudinal strain, -1.02%; 95% CI, -1.73 to -0.31; P = .005; septal E/e', -3.11; 95% CI, -5.50 to -0.72; P = .01; lateral E/e', -2.35; 95% CI, -4.01 to -0.69; P = .006). CONCLUSIONS AND RELEVANCE: Compared with placebo, tafamidis, 80 mg, attenuated the decline of LV systolic and diastolic function over 30 months in patients with ATTR-CM. Approximately half of patients had mildly reduced or reduced LV ejection fraction at enrollment, suggesting that ATTR-CM should be considered as a possible diagnosis in patients with heart failure regardless of underlying LV ejection fraction. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01994889."}]}