{"generated":"2026-08-28T16:42:09Z","year":"2019","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":"dca017fb81a3","type":"article","url":"https://hartvaat.nl/2019/12/26/laaggedoseerd-colchicine-na-myocardinfarct-nejm-colcot/","title":"Laaggedoseerd colchicine na myocardinfarct: NEJM COLCOT","title_en":"Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["colchicine","colcot-trial","inflammatoire-cardiomyopathie"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1912388","source_url":"https://doi.org/10.1056/NEJMoa1912388","authors":["Jean-Claude Tardif","Simon Kouz","David D Waters","Olivier F Bertrand","Rafael Diaz","Aldo P Maggioni","Fausto J Pinto","Reda Ibrahim","Habib Gamra","Ghassan S Kiwan","Colin Berry","José López-Sendón","Petr Ostadal","Wolfgang Koenig","Denis Angoulvant","Jean C Grégoire","Marc-André Lavoie","Marie-Pierre Dubé","David Rhainds","Mylène Provencher","Lucie Blondeau","Andreas Orfanos","Philippe L L'Allier","Marie-Claude Guertin","François Roubille"],"significance":10,"published":"2019-12-26","source_date":"2019-12-26","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/","https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/"],"congress":"","summary_en":"The COLCOT trial demonstrated that low-dose colchicine (0.5 mg daily) initiated within 30 days of MI significantly reduced the composite of cardiovascular death, cardiac arrest, MI, stroke, or urgent coronary revascularization. This landmark study provided definitive evidence for targeted anti-inflammatory therapy in secondary cardiovascular prevention.","created":"2026-07-03T10:28:20Z","updated":"2026-07-03T13:27:31Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Landmark NEJM COLCOT-trial die aantoonde dat laaggedoseerd colchicine (0.5 mg/dag) cardiovasculaire events significant vermindert na recent myocardinfarct. Definitief bewijs voor anti-inflammatoire secundaire preventie met een goedkoop middel.","abstract_original":"BACKGROUND: Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis. METHODS: We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed. RESULTS: A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03). CONCLUSIONS: Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.)."},{"id":"ef20efa73cd9","type":"article","url":"https://hartvaat.nl/2019/12/24/langetermijnfollow-up-van-complete-versus-laesie-only-revascularisatie-bij-stemi/","title":"Langetermijnfollow-up van complete versus laesie-only revascularisatie bij STEMI: CvLPRIT","title_en":"Long-Term Follow-Up of Complete Versus Lesion-Only Revascularization in STEMI and Multivessel Disease: The CvLPRIT Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.10.033","source_url":"https://doi.org/10.1016/j.jacc.2019.10.033","authors":["Anthony H Gershlick","Amerjeet S Banning","Emma Parker","Duolao Wang","Charley A Budgeon","Damian J Kelly","Peter O Kane","Miles Dalby","Simon L Hetherington","Gerry P McCann","John P Greenwood","Nick Curzen"],"significance":6,"published":"2019-12-24","source_date":"2019-12-24","image":"","kennis":[],"congress":"","summary_en":"Long-term CvLPRIT follow-up confirmed that complete revascularization in STEMI with multivessel disease provides durable benefit over culprit-only PCI, with sustained event reduction over extended follow-up.","created":"2026-07-03T10:28:20Z","updated":"2026-07-03T13:27:31Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"CvLPRIT langetermijnfollow-up van complete versus culprit-only revascularisatie bij STEMI met multivatenlijden.","abstract_original":"BACKGROUND: Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure). OBJECTIVES: The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints. METHODS: CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions. RESULTS: The median follow-up (achieved in >90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint. CONCLUSIONS: Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605)."},{"id":"dd5dfb8d2362","type":"article","url":"https://hartvaat.nl/2019/12/17/uitkomsten-van-vrouwen-versus-mannen-na-nste-acs/","title":"Uitkomsten van vrouwen versus mannen na NSTE-ACS","title_en":"Outcomes of Women Compared With Men After Non-ST-Segment Elevation Acute Coronary Syndromes.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.065","source_url":"https://doi.org/10.1016/j.jacc.2019.09.065","authors":["Amy A Sarma","Eugene Braunwald","Christopher P Cannon","Jianping Guo","KyungAh Im","Elliott M Antman","C Michael Gibson","L Kristin Newby","Robert P Giugliano","David A Morrow","Stephen D Wiviott","Marc S Sabatine","Michelle L O'Donoghue"],"significance":6,"published":"2019-12-17","source_date":"2019-12-17","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This analysis of sex differences in NSTE-ACS outcomes showed that women have different risk profiles and treatment patterns that may contribute to outcome disparities, supporting sex-aware management approaches.","created":"2026-07-03T10:28:20Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 sekseverschillen in uitkomsten na NSTE-ACS. Vrouwen hebben mogelijk andere risicoprofielen en behandelpatronen.","abstract_original":"BACKGROUND: It remains disputed whether women are at excess risk of adverse outcomes versus men after non-ST-segment elevation acute coronary syndromes (NSTEACS) or whether differences are explained by discordant risk factors. OBJECTIVES: A sex-specific analysis of cardiovascular outcomes after NSTEACS across trials conducted by the Thrombolysis In Myocardial Infarction (TIMI) Study Group was performed to determine the impact of sex on cardiovascular outcomes in this dataset. METHODS: Ten TIMI trials were identified that enrolled >2,500 patients with NSTEACS within 30 days of hospitalization. Cox proportional hazards models were used to examine the association of sex with major adverse cardiovascular events (MACE) (cardiovascular death, myocardial infarction, or stroke) after adjusting for relevant risk factors in individual trials; point estimates were then combined by using random effects models. Individual components of the composite outcome and all-cause mortality were also analyzed. RESULTS: Among 68,730 patients with NSTEACS, 19,827 (29%) were women. Women were older and more frequently had hypertension, diabetes, prior heart failure, and renal impairment than men. Before considering relevant confounders, women were at similar risk of MACE compared with men (hazard ratio [HR]: 1.04; 95% confidence interval [CI]: 0.99 to 1.09; p = 0.16) but at higher risk of all-cause death (HR: 1.12; 95% CI: 1.01 to 1.24; p = 0.03). After adjustment for baseline differences, risks of MACE (HR: 0.93; 95% CI: 0.88 to 0.98; p < 0.01) and all-cause death (HR: 0.84; 95% CI: 0.78 to 0.90; p < 0.0001) were lower among women compared with men. CONCLUSIONS: After accounting for cardiovascular risk factors, women enrolled in clinical trials were at lower risk of MACE than men after NSTEACS. Women, however, remain undertreated with many evidence-based therapies."},{"id":"38e7315f0020","type":"article","url":"https://hartvaat.nl/2019/12/17/uitgebreide-vasodilatatie-versus-standaardzorg-bij-acuut-hf-jama-galactic-hf-pil/","title":"Uitgebreide vasodilatatie versus standaardzorg bij acuut HF: JAMA GALACTIC-HF pilot","title_en":"Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf"],"journal":"JAMA","doi":"10.1001/jama.2019.18598","source_url":"https://doi.org/10.1001/jama.2019.18598","authors":["Nikola Kozhuharov","Assen Goudev","Dayana Flores","Micha T Maeder","Joan Walter","Samyut Shrestha","Danielle Menosi Gualandro","Mucio Tavares de Oliveira Junior","Zaid Sabti","Beat Müller","Markus Noveanu","Thenral Socrates","Ronny Ziller","Antoni Bayés-Genís","Alessandro Sionis","Patrick Simon","Eleni Michou","Samuel Gujer","Tommaso Gori","Philip Wenzel","Otmar Pfister","David Conen","Ioannis Kapos","Richard Kobza","Hans Rickli","Tobias Breidthardt","Thomas Münzel","Paul Erne","Christian Mueller","Christian Mueller","Paul Erne","Beat Müller","Hans Rickli","Micha Maeder","Mucio Tavares de Oliveira","Thomas Münzel","Antoni Bayés-Genís","Alessandro Sionis","Assen Goudev","Bojidar Dimov","Sabine Hartwiger","Nisha Arenja","Bettina Glatz","Natascha Herr","Rahel Isenrich","Tamina Mosimann","Raphael Twerenbold","Jasper Boeddinghaus","Thomas Nestelberger","Christian Puelacher","Michael Freese","Janine Vögele","Kathrin Meissner","Jasmin Martin","Ivo Strebel","Desiree Wussler","Carmela Schumacher","Stefan Osswald","Fabian Vogt","Jonas Hilti","Sara Barata","Deborah Schneider","Jonas Schwarz","Brigitte Fitze","Sabine Hartwiger","Nisha Arenja","Bettina Glatz","Natascha Herr","Rahel Isenrich","Tamina Mosimann","Raphael Twerenbold","Jasper Boeddinghaus","Thomas Nestelberger","Christian Puelacher","Michael Freese","Janine Vögele","Kathrin Meissner","Jasmin Martin","Ivo Strebel","Desiree Wussler","Carmela Schumacher","Stefan Osswald","Fabian Vogt","Jonas Hilti","Sara Barata","Deborah Schneider","Jonas Schwarz","Brigitte Fitze","Nisha Arenja","Katharina Rentsch","Aline Bossa","Sergio Jallad","Alexandre Soeiro","Dimitar Georgiev","Thomas Jansen","Gabriele Gebel","Matthias Bossard","Michael Christ"],"significance":7,"published":"2019-12-17","source_date":"2019-12-17","image":"","kennis":[],"congress":"","summary_en":"This JAMA trial of a comprehensive vasodilation strategy versus usual care in acute heart failure did not improve mortality or rehospitalization, adding to the evidence that vasodilator-based approaches in acute HF do not improve outcomes.","created":"2026-07-03T10:28:20Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar een strategie van uitgebreide vasodilatatie versus standaardzorg bij acuut HF op mortaliteit en heropname.","abstract_original":"IMPORTANCE: Short-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF). OBJECTIVE: To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF. DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019. INTERVENTIONS: Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan. MAIN OUTCOMES AND MEASURES: The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days. RESULTS: Among 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%). CONCLUSIONS AND RELEVANCE: Among patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00512759."},{"id":"da6fbb12be65","type":"article","url":"https://hartvaat.nl/2019/12/17/biomarkers-in-risicobeoordeling-voor-antihypertensieve-therapie-acc-aha-2017/","title":"Biomarkers in risicobeoordeling voor antihypertensieve therapie: ACC/AHA 2017","title_en":"Incorporation of Biomarkers Into Risk Assessment for Allocation of Antihypertensive Medication According to the 2017 ACC/AHA High Blood Pressure Guideline: A Pooled Cohort Analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["biomarkers-cardiovasculair"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.043337","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.043337","authors":["Ambarish Pandey","Kershaw V Patel","Wanpen Vongpatanasin","Colby Ayers","Jarett D Berry","Robert J Mentz","Michael J Blaha","John W McEvoy","Paul Muntner","Muthiah Vaduganathan","Adolfo Correa","Javed Butler","Daichi Shimbo","Vijay Nambi","Christopher deFilippi","Stephen L Seliger","Christie M Ballantyne","Elizabeth Selvin","James A de Lemos","Parag H Joshi"],"significance":6,"published":"2019-12-17","source_date":"2019-12-17","image":"","kennis":[],"congress":"","summary_en":"This study tested whether incorporating cardiovascular biomarkers (troponin, NT-proBNP) improves risk stratification for antihypertensive therapy allocation according to the 2017 ACC/AHA guidelines.","created":"2026-07-03T10:28:20Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de meerwaarde van biomarkers voor risicostratificatie en toewijzing van antihypertensieve therapie volgens de 2017 ACC/AHA-richtlijn.","abstract_original":"BACKGROUND: Risk for atherosclerotic cardiovascular disease was a novel consideration for antihypertensive medication initiation in the 2017 American College of Cardiology/American Heart Association Blood Pressure (BP) guideline. Whether biomarkers of chronic myocardial injury (high-sensitivity cardiac troponin T ≥6 ng/L] and stress (N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥100 pg/mL) can inform cardiovascular (CV) risk stratification and treatment decisions among adults with elevated BP and hypertension is unclear. METHODS: Participant-level data from 3 cohort studies (Atherosclerosis Risk in Communities Study, Dallas Heart Study, and Multiethnic Study of Atherosclerosis) were pooled, excluding individuals with prevalent CV disease and those taking antihypertensive medication at baseline. Participants were analyzed according to BP treatment group from the 2017 American College of Cardiology/American Heart Association BP guideline and those with high BP (120 to 159/<100 mm Hg) were further stratified by biomarker status. Cumulative incidence rates for CV event (atherosclerotic cardiovascular disease or heart failure), and the corresponding 10-year number needed to treat to prevent 1 event with intensive BP lowering (to target systolic BP <120 mm Hg), were estimated for BP and biomarker-based subgroups. RESULTS: The study included 12 987 participants (mean age, 55 years; 55% women; 21.5% with elevated high-sensitivity cardiac troponin T; 17.7% with elevated NT-proBNP) with 825 incident CV events over 10-year follow-up. Participants with elevated BP or hypertension not recommended for antihypertensive medication with versus without either elevated high-sensitivity cardiac troponin T or NT-proBNP had a 10-year CV incidence rate of 11.0% and 4.6%, with a 10-year number needed to treat to prevent 1 event for intensive BP lowering of 36 and 85, respectively. Among participants with stage 1 or stage 2 hypertension recommended for antihypertensive medication with BP <160/100 mm Hg, those with versus without an elevated biomarker had a 10-year CV incidence rate of 15.1% and 7.9%, with a 10-year number needed to treat to prevent 1 event of 26 and 49, respectively. CONCLUSIONS: Elevations in high-sensitivity cardiac troponin T or NT-proBNP identify individuals with elevated BP or hypertension not currently recommended for antihypertensive medication who are at high risk for CV events. The presence of nonelevated biomarkers, even in the setting of stage 1 or stage 2 hypertension, was associated with lower risk. Incorporation of biomarkers into risk assessment algorithms may lead to more appropriate matching of intensive BP control with patient risk."},{"id":"717c6d3a3679","type":"article","url":"https://hartvaat.nl/2019/12/17/alirocumab-en-cva-reductie-odyssey-outcomes/","title":"Alirocumab en CVA-reductie: ODYSSEY OUTCOMES","title_en":"Effect of Alirocumab on Stroke in ODYSSEY OUTCOMES.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["cerebrovasculair"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.043826","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.043826","authors":["J Wouter Jukema","Laurien E Zijlstra","Deepak L Bhatt","Vera A Bittner","Rafael Diaz","Heinz Drexel","Shaun G Goodman","Yong-Un Kim","Robert Pordy","Željko Reiner","Matthew T Roe","Hung-Fat Tse","Pablo Carlos Montenegro Valdovinos","Harvey D White","Andreas M Zeiher","Michael Szarek","Gregory G Schwartz","Philippe Gabriel Steg"],"significance":7,"published":"2019-12-17","source_date":"2019-12-17","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis confirmed that alirocumab reduces ischemic stroke after ACS, demonstrating the cerebrovascular benefit of PCSK9 inhibition alongside the previously established coronary benefit.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ODYSSEY OUTCOMES analyse naar het effect van alirocumab op CVA-incidentie. Bevestigt cerebrovasculair voordeel van PCSK9-remming.","abstract_original":"BACKGROUND: Lowering of atherogenic lipoproteins, including low-density lipoprotein cholesterol (LDL-C), reduces the risk of ischemic stroke. However, concerns have been raised about very low LDL-C levels and a potential increased risk of hemorrhagic stroke. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins, despite intensive statin therapy, targeting LDL-C levels of 25 to 50 mg/dL and avoiding sustained LDL-C <15 mg/dL. This prespecified analysis was designed to assess the effect of alirocumab on ischemic and hemorrhagic stroke. We hypothesized that for patients treated with alirocumab there would be a reduction in risk of ischemic stroke without increasing hemorrhagic stroke, irrespective of baseline LDL-C and of history of cerebrovascular disease. METHODS: Patients were randomized to alirocumab or placebo 1 to 12 months after acute coronary syndrome. The risk of nonfatal or fatal ischemic or hemorrhagic stroke was evaluated, stratified by baseline LDL-C concentration and history of cerebrovascular disease. A potential association of very low achieved LDL-C with alirocumab treatment at month 4 and subsequent hemorrhagic stroke was assessed. RESULTS: Median follow-up was 2.8 years. In total, 263 ischemic and 33 hemorrhagic strokes occurred. Alirocumab reduced the risk of any stroke (HR, 0.72 [95% CI, 0.57-0.91]) and ischemic stroke (HR, 0.73 [95% CI, 0.57-0.93]) without increasing hemorrhagic stroke (HR, 0.83 [95% CI, 0.42-1.65]). In total, 7164 (37.9%), 6128 (32.4%), and 5629 (29.7%) patients had a baseline LDL-C of <80, 80 to 100, and >100 mg/dL, respectively. The treatment effect on stroke appeared numerically greater for patients with higher baseline LDL-C, but there was no formal evidence of heterogeneity (Pinteraction=0.31). The effect of alirocumab on stroke was similar among 944 patients (5.0%) with a history of previous cerebrovascular disease and among those without a history of cerebrovascular disease (Pinteraction=0.37). There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. CONCLUSIONS: In patients with recent acute coronary syndrome and dyslipidemia despite intensive statin therapy, alirocumab decreased the risk of stroke, irrespective of baseline LDL-C and history of cerebrovascular disease, over a median follow-up of 2.8 years. Furthermore, risk of hemorrhagic stroke did not depend on achieved LDL-C levels within the alirocumab group. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402."},{"id":"b37f28833b03","type":"article","url":"https://hartvaat.nl/2019/12/17/echo-uitkomsten-na-mitraclip-bij-secundaire-mr-coapt-echocardiografisch/","title":"Echo-uitkomsten na MitraClip bij secundaire MR: COAPT echocardiografisch","title_en":"Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["echocardiografie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.017","source_url":"https://doi.org/10.1016/j.jacc.2019.09.017","authors":["Federico M Asch","Paul A Grayburn","Robert J Siegel","Saibal Kar","D Scott Lim","Jonathan G Zaroff","Jacob M Mishell","Brian Whisenant","Michael J Mack","JoAnn Lindenfeld","William T Abraham","Gregg W Stone","Neil J Weissman"],"significance":6,"published":"2019-12-17","source_date":"2019-12-17","image":"","kennis":[],"congress":"","summary_en":"This COAPT echocardiographic analysis demonstrated that transcatheter MitraClip repair produces sustained reduction in MR severity and favorable left ventricular remodeling over time in heart failure patients.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COAPT echocardiografische analyse naar de resultaten van transcatheter mitraalklepherstel op klep- en kamerfunctie.","abstract_original":"BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation, patients treated with transcatheter mitral valve repair (TMVr) through leaflet approximation had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: The purpose of this study was to describe the echocardiographic patient qualification process for the COAPT trial, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes. METHODS: A novel echocardiographic algorithm was implemented for grading mitral regurgitation severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and were analyzed by a core laboratory. RESULTS: A total of 614 patients were randomized to TMVr plus maximally tolerated GDMT or GDMT alone. Mean baseline left ventricular (LV) ejection fraction was 31.3 ± 9.3%, LV end-diastolic volume was 192.7 ± 71 ml, and effective regurgitant orifice area was 0.41 ± 0.15 cm2. The beneficial effect of TMVr compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual mitral regurgitation characteristics. The LV ejection fraction decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVr (p < 0.05). CONCLUSIONS: HF patients in the COAPT trial with 3+ or 4+ secondary mitral regurgitation, selected using strict echocardiographic criteria, benefitted from TMVr with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079)."},{"id":"f8300dfb32c7","type":"article","url":"https://hartvaat.nl/2019/12/10/nierfunctiestoornis-en-betablokkereffectiviteit-bij-hartfalen/","title":"Nierfunctiestoornis en bètablokkereffectiviteit bij hartfalen","title_en":"Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["bisoprolol"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.059","source_url":"https://doi.org/10.1016/j.jacc.2019.09.059","authors":["Dipak Kotecha","Simrat K Gill","Marcus D Flather","Jane Holmes","Milton Packer","Giuseppe Rosano","Michael Böhm","John J V McMurray","John Wikstrand","Stefan D Anker","Dirk J van Veldhuisen","Luis Manzano","Thomas G von Lueder","Alan S Rigby","Bert Andersson","John Kjekshus","Hans Wedel","Frank Ruschitzka","John G F Cleland","Kevin Damman","Josep Redon","Andrew J S Coats"],"significance":6,"published":"2019-12-10","source_date":"2019-12-10","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This study showed that beta-blockers maintain their mortality benefit in heart failure patients with moderate renal impairment, supporting continued beta-blocker therapy regardless of kidney function status.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de impact van nierfunctiestoornis op de effectiviteit van bètablokkers bij hartfalen.","abstract_original":"BACKGROUND: Moderate and moderately severe renal impairment are common in patients with heart failure and reduced ejection fraction, but whether beta-blockers are effective is unclear, leading to underuse of life-saving therapy. OBJECTIVES: This study sought to investigate patient prognosis and the efficacy of beta-blockers according to renal function using estimated glomerular filtration rate (eGFR). METHODS: Analysis of 16,740 individual patients with left ventricular ejection fraction <50% from 10 double-blind, placebo-controlled trials was performed. The authors report all-cause mortality on an intention-to-treat basis, adjusted for baseline covariates and stratified by heart rhythm. RESULTS: Median eGFR at baseline was 63 (interquartile range: 50 to 77) ml/min/1.73 m2; 4,584 patients (27.4%) had eGFR 45 to 59 ml/min/1.73 m2, and 2,286 (13.7%) 30 to 44 ml/min/1.73 m2. Over a median follow-up of 1.3 years, eGFR was independently associated with mortality, with a 12% higher risk of death for every 10 ml/min/1.73 m2 lower eGFR (95% confidence interval [CI]: 10% to 15%; p < 0.001). In 13,861 patients in sinus rhythm, beta-blockers reduced mortality versus placebo; adjusted hazard ratio (HR): 0.73 for eGFR 45 to 59 ml/min/1.73 m2 (95% CI: 0.62 to 0.86; p < 0.001) and 0.71 for eGFR 30 to 44 ml/min/1.73 m2 (95% CI: 0.58 to 0.87; p = 0.001). The authors observed no deterioration in renal function over time in patients with moderate or moderately severe renal impairment, no difference in adverse events comparing beta-blockers with placebo, and higher mortality in patients with worsening renal function on follow-up. Due to exclusion criteria, there were insufficient patients with severe renal dysfunction (eGFR <30 ml/min/1.73 m2) to draw conclusions. In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR. CONCLUSIONS: Patients with heart failure, left ventricular ejection fraction <50% and sinus rhythm should receive beta-blocker therapy even with moderate or moderately severe renal dysfunction."},{"id":"8ea8b1bce8ce","type":"article","url":"https://hartvaat.nl/2019/12/10/echocardiografische-kenmerken-bij-hfpef/","title":"Echocardiografische kenmerken bij HFpEF","title_en":"Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","dapa-hf","echocardiografie","hfpef","hfref","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.063","source_url":"https://doi.org/10.1016/j.jacc.2019.09.063","authors":["Amil M Shah","Maja Cikes","Narayana Prasad","Guichu Li","Stoyan Getchevski","Brian Claggett","Adel Rizkala","Ilya Lukashevich","Eileen O'Meara","John J Ryan","Sanjiv J Shah","Wilfred Mullens","Michael R Zile","Carolyn S P Lam","John J V McMurray","Scott D Solomon"],"significance":5,"published":"2019-12-10","source_date":"2019-12-10","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/","https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/"],"congress":"","summary_en":"This PARAGON-HF analysis characterized the echocardiographic features of HFpEF patients, providing imaging phenotyping data that may inform future treatment strategies for this heterogeneous condition.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T18:38:46Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar echocardiografische kenmerken van patiënten met hartfalen en behouden ejectiefractie.","abstract_original":"BACKGROUND: The PARAGON-HF (Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction) trial tested the efficacy of sacubitril-valsartan in patients with heart failure with preserved ejection fraction (HFpEF). Existing data on cardiac structure and function in patients with HFpEF suggest significant heterogeneity. OBJECTIVES: The aim of this study was to characterize cardiac structure and function, quantify their associations with clinical outcomes, and contextualize these findings with other HFpEF studies. METHODS: Echocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6 months of enrollment. Associations with incident first heart failure hospitalization or cardiovascular death were assessed using Cox proportional hazards models adjusted for age, sex, region of enrollment, randomized treatment, N-terminal pro-brain natriuretic peptide, and clinical risk factors. RESULTS: Average age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation. The mean left ventricular (LV) ejection fraction was 58.6 ± 9.8%, prevalence of LV hypertrophy was 21%, prevalence of left atrial enlargement was 83%, prevalence of elevated E/e' ratio was 53%, and prevalence of pulmonary hypertension was 31%. Heart failure hospitalization or cardiovascular death occurred in 288 patients at 2.8-year median follow-up. In fully adjusted models, higher LV mass index (hazard ratio [HR]: 1.05 per 10 g/m2; 95% confidence interval [CI]: 1.00 to 1.10; p = 0.03), E/e' ratio (HR: 1.04 per unit; 95% CI: 1.02 to 1.06; p < 0.001), pulmonary artery systolic pressure (HR: 1.51 per 10 mm Hg; 95% CI: 1.29 to 1.76; p < 0.001), and right ventricular end-diastolic area (HR: 1.04 per cm2; 95% CI: 1.01 to 1.07; p = 0.003) were each associated with this composite, while LV ejection fraction and left atrial size were not (p > 0.05 for all). Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates. CONCLUSIONS: Diastolic dysfunction, left atrial enlargement, and pulmonary hypertension were common in PARAGON-HF. LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement were independently predictive of incident heart failure hospitalization or cardiovascular death. Echocardiographic differences among HFpEF trials despite similar clinical event rates highlight the heterogeneity of this syndrome. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711)."},{"id":"b9ec4b5439fb","type":"article","url":"https://hartvaat.nl/2019/12/07/dubbele-versus-triple-antitrombotische-therapie-bij-af-na-pci-veiligheid-en-werk/","title":"Dubbele versus triple antitrombotische therapie bij AF na PCI: veiligheid en werkzaamheid","title_en":"Safety and efficacy outcomes of double vs. triple antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: a systematic review and meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["dubbele-trombocytenremming"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz732","source_url":"https://doi.org/10.1093/eurheartj/ehz732","authors":["Giuseppe Gargiulo","Andreas Goette","Jan Tijssen","Lars Eckardt","Thorsten Lewalter","Pascal Vranckx","Marco Valgimigli"],"significance":7,"published":"2019-12-07","source_date":"2019-12-07","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This comprehensive analysis of dual versus triple antithrombotic therapy in AF patients after PCI synthesized evidence from multiple trials, confirming the safety advantage of dual therapy while maintaining similar ischemic protection.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 analyse van veiligheid en werkzaamheid van dubbele versus triple antitrombotische therapie bij AF na PCI. Synthese van alle beschikbare trials.","abstract_original":"AIMS: To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). METHODS AND RESULTS: A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AF patients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56-0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01-2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17-0.65; P = 0.001; I2 = 0%). CONCLUSION: Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac-mainly stent-related-but not cerebrovascular ischaemic occurrences."},{"id":"193c593d8b91","type":"article","url":"https://hartvaat.nl/2019/12/07/individueel-levenslang-voordeel-en-bloedingsrisico-van-rivaroxaban-plus-aspirine/","title":"Individueel levenslang voordeel en bloedingsrisico van rivaroxaban plus aspirine: COMPASS","title_en":"Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz404","source_url":"https://doi.org/10.1093/eurheartj/ehz404","authors":["Tamar I de Vries","John W Eikelboom","Jackie Bosch","Jan Westerink","Jannick A N Dorresteijn","Marco Alings","Leanne Dyal","Scott D Berkowitz","Yolanda van der Graaf","Keith A A Fox","Frank L J Visseren"],"significance":7,"published":"2019-12-07","source_date":"2019-12-07","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/esc-richtlijn-kleplijden-2021/"],"congress":"","summary_en":"This COMPASS analysis estimated the individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin, providing a personalized risk-benefit framework for dual-pathway inhibition in stable atherosclerotic disease.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:30Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COMPASS analyse die het geschatte individuele levenslange voordeel en bloedingsrisico van rivaroxaban plus aspirine berekende bij stabiel vaatlijden.","abstract_original":"AIMS: Adding rivaroxaban to aspirin in patients with stable atherosclerotic disease reduces the recurrence of cardiovascular disease (CVD) but increases the risk of major bleeding. The aim of this study was to estimate the individual lifetime treatment benefit and harm of adding low-dose rivaroxaban to aspirin in patients with stable cardiovascular disease. METHODS AND RESULTS: Patients with established CVD from the COMPASS trial (n = 27 390) and SMART prospective cohort study (n = 8139) were used. Using the pre-existing lifetime SMART-REACH model for recurrent CVD, and a newly developed Fine and Gray competing risk-adjusted lifetime model for major bleeding, individual treatment effects from adding low-dose rivaroxaban to aspirin in patients with stable CVD were estimated, expressed in terms of (i) life-years free of stroke or myocardial infarction (MI) gained; and (ii) life-years free from major bleeding lost. Calibration of the SMART-REACH model for prediction of recurrent CVD events in the COMPASS study was good. The major bleeding risk model as derived in the COMPASS trial showed good external calibration in the SMART cohort. Predicted individual gain in life expectancy free of stroke or MI from added low-dose rivaroxaban had a median of 16 months (range 1-48 months), while predicted individualized lifetime lost in terms of major bleeding had a median of 2 months (range 0-20 months). CONCLUSION: There is a wide distribution in lifetime gain and harm from adding low-dose rivaroxaban to aspirin in individual patients with stable CVD. Using these lifetime models, benefits and bleeding risk can be weighed for each individual patient, which could facilitate treatment decisions in clinical practice."},{"id":"16014bfd8e62","type":"article","url":"https://hartvaat.nl/2019/12/03/natuurlijk-beloop-van-subklinisch-af-gedetecteerd-door-implanteerbare-looprecord/","title":"Natuurlijk beloop van subklinisch AF gedetecteerd door implanteerbare looprecorders","title_en":"Natural History of Subclinical Atrial Fibrillation Detected by Implanted Loop Recorders.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.050","source_url":"https://doi.org/10.1016/j.jacc.2019.09.050","authors":["Søren Zöga Diederichsen","Ketil Jørgen Haugan","Axel Brandes","Mathias Buus Lanng","Claus Graff","Derk Krieger","Christian Kronborg","Anders Gaarsdal Holst","Lars Køber","Søren Højberg","Jesper Hastrup Svendsen"],"significance":6,"published":"2019-12-03","source_date":"2019-12-03","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/holter-monitoring-bij-af/"],"congress":"","summary_en":"This study characterized the natural history of subclinical AF detected by implantable loop recorders, showing that many episodes are transient and short-lived but that a proportion progresses to clinical AF requiring treatment.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het natuurlijk beloop van subklinisch AF gedetecteerd door implanteerbare looprecorders. Progressie en klinische impact.","abstract_original":"BACKGROUND: As new heart rhythm monitoring technologies emerge, subclinical atrial fibrillation (AF) signifies a future challenge to health care systems. The pathological characteristics of this condition are largely unknown. OBJECTIVES: This study sought to characterize the natural history of subclinical AF in at-risk patients from the general population. METHODS: The authors studied 590 individuals ≥70 years of age with ≥1 of hypertension, diabetes, previous stroke, or heart failure, without history of AF, undergoing long-term implantable loop recorder monitoring as part of the LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals) study. Baseline assessments included N-terminal pro-B-type natriuretic peptide (NT-proBNP). All day-to-day heart rhythm and symptom data were extracted from the device. Endpoints included AF burden, AF progression, symptom reports, and heart rate during AF. RESULTS: A total of 685,445 monitoring days were available for analysis. Adjudicated AF episodes lasting ≥6 min were detected in 205 participants (35%). The AF burden was median 0.13% (interquartile range: 0.03% to 1.05%) of the monitoring time and changed by a factor of 1.31 (95% CI: 1.02 to 1.68) per doubling of NT-proBNP. AF episodes were present 2.7% (interquartile range: 1.0% to 15.7%) of monitoring days after debut. Progression to 24-h episodes was seen in 33 of the AF patients (16%), whereas 46 (22%) had no AF episodes in the last 6 months of monitoring or longer. Symptoms were absent in 185 (90%) at debut, and 178 (87%) never reported AF-related symptoms during follow-up. The averaged heart rate during AF was 96 (interquartile range: 83 to 114) beats/min, 24 (interquartile range: 9 to 41) beats/min faster than daytime sinus rates. CONCLUSIONS: Although previously unknown AF was highly prevalent, the burden was low, and progression was limited. In addition, symptoms were scarce, and the heart rate was only modestly elevated. (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals [LOOP]; NCT02036450)."},{"id":"5459bff62c1c","type":"article","url":"https://hartvaat.nl/2019/12/03/timing-van-non-culprit-revascularisatie-bij-stemi-complete-trial/","title":"Timing van non-culprit revascularisatie bij STEMI: COMPLETE-trial","title_en":"Timing of Staged Nonculprit Artery Revascularization in Patients With ST-Segment Elevation Myocardial Infarction: COMPLETE Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.051","source_url":"https://doi.org/10.1016/j.jacc.2019.09.051","authors":["David A Wood","John A Cairns","Jia Wang","Roxana Mehran","Robert F Storey","Helen Nguyen","Brandi Meeks","Vijay Kunadian","Jean-Francois Tanguay","Hahn-Ho Kim","Asim Cheema","Payam Dehghani","Madhu K Natarajan","Sanjit S Jolly","John Amerena","Matyas Keltai","Stefan James","Ota Hlinomaz","Kari Niemela","Khalid AlHabib","Basil S Lewis","Michel Nguyen","Jaydeep Sarma","Vladimir Dzavik","Anthony Della Siega","Shamir R Mehta"],"significance":7,"published":"2019-12-03","source_date":"2019-12-03","image":"","kennis":[],"congress":"","summary_en":"This COMPLETE subanalysis examined the optimal timing of staged nonculprit revascularization in STEMI, finding that both early (during index hospitalization) and later (within 45 days) timing provided similar clinical benefit.","created":"2026-07-03T10:28:19Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COMPLETE subanalyse naar de optimale timing van non-culprit revascularisatie bij STEMI met multivatenlijden.","abstract_original":"BACKGROUND: The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). OBJECTIVES: The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization. METHODS: Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days. RESULTS: For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI. CONCLUSIONS: Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term."},{"id":"5ab0f019f0a7","type":"article","url":"https://hartvaat.nl/2019/12/03/antitrombotische-therapie-bij-af-met-acs-medicamenteus-of-met-pci/","title":"Antitrombotische therapie bij AF met ACS: medicamenteus of met PCI","title_en":"Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.043308","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.043308","authors":["Stephan Windecker","Renato D Lopes","Tyler Massaro","Charlotte Jones-Burton","Christopher B Granger","Ronald Aronson","Gretchen Heizer","Shaun G Goodman","Harald Darius","W Schuyler Jones","Michael Aschermann","David Brieger","Fernando Cura","Thomas Engstrøm","Viliam Fridrich","Sigrun Halvorsen","Kurt Huber","Hyun-Jae Kang","Jose L Leiva-Pons","Basil S Lewis","German Malaga","Nicolas Meneveau","Bela Merkely","Davor Milicic","João Morais","Tatjana S Potpara","Dimitar Raev","Manel Sabaté","Suzanne de Waha-Thiele","Robert C Welsh","Denis Xavier","Roxana Mehran","John H Alexander"],"significance":7,"published":"2019-12-03","source_date":"2019-12-03","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This analysis examined antithrombotic strategies in AF patients with ACS managed with or without PCI, showing that dual therapy (DOAC plus P2Y12 inhibitor) reduces bleeding compared with triple therapy across both treatment approaches.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 antitrombotische strategieën bij AF-patiënten met ACS behandeld medicamenteus of met PCI. Integreert evidence uit meerdere trials.","abstract_original":"BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400."},{"id":"6dda059ac0cb","type":"article","url":"https://hartvaat.nl/2019/12/03/magnesium-resorbeerbare-scaffold-versus-metallic-stent-bij-stemi-biosolve-iii/","title":"Magnesium-resorbeerbare scaffold versus metallic stent bij STEMI: BIOSOLVE-III","title_en":"Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.043467","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.043467","authors":["Manel Sabaté","Fernando Alfonso","Angel Cequier","Sebastián Romaní","Pascual Bordes","Antonio Serra","Andrés Iñiguez","Pablo Salinas","Bruno García Del Blanco","Javier Goicolea","Rosana Hernández-Antolín","Javier Cuesta","Joan Antoni Gómez-Hospital","Luis Ortega-Paz","Josep Gomez-Lara","Salvatore Brugaletta"],"significance":6,"published":"2019-12-03","source_date":"2019-12-03","image":"","kennis":[],"congress":"","summary_en":"This study of a magnesium-based resorbable scaffold in STEMI tested a next-generation bioresorbable technology that addresses the limitations of the withdrawn poly-L-lactic acid Absorb device, including faster resorption and better mechanical properties.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 van een op magnesium gebaseerde resorbeerbare scaffold bij STEMI. Volgende generatie bioresorbeerbare technologie.","abstract_original":"BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348."},{"id":"052853397d92","type":"article","url":"https://hartvaat.nl/2019/12/03/klinisch-significante-bloedingen-met-ticagrelor-versus-clopidogrel-bij-koreaanse/","title":"Klinisch significante bloedingen met ticagrelor versus clopidogrel bij Koreaanse ACS-patiënten","title_en":"Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["trombocytenaggregatieremmers"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.041766","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.041766","authors":["Duk-Woo Park","Osung Kwon","Jae-Sik Jang","Sung-Cheol Yun","Hanbit Park","Do-Yoon Kang","Jung-Min Ahn","Pil Hyung Lee","Seung-Whan Lee","Seong-Wook Park","Si Wan Choi","Sang-Gon Lee","Hyuck-Jun Yoon","Taehoon Ahn","Moo Hyun Kim","Deuk Young Nah","Sung Yun Lee","Jei Keon Chae","Seung-Jung Park"],"significance":5,"published":"2019-12-03","source_date":"2019-12-03","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/farmacologie/p2y12-remmers-vergelijking/"],"congress":"","summary_en":"This study examined sex differences in clinically significant bleeding with ticagrelor versus clopidogrel in Korean ACS patients, evaluating population-specific antiplatelet safety data.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar sekseverschillen in bloedingen met ticagrelor versus clopidogrel bij Koreaanse ACS-patiënten.","abstract_original":"BACKGROUND: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963."},{"id":"636bccd51c3f","type":"article","url":"https://hartvaat.nl/2019/12/01/eerste-en-recidiverende-cv-events-met-liraglutide-bij-diabetes-type-2-leader/","title":"Eerste en recidiverende CV-events met liraglutide bij diabetes type 2: LEADER","title_en":"Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["diabetes-type-2"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.3080","source_url":"https://doi.org/10.1001/jamacardio.2019.3080","authors":["Subodh Verma","Stephen C Bain","John B Buse","Thomas Idorn","Søren Rasmussen","David D Ørsted","Michael A Nauck"],"significance":7,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/","https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/"],"congress":"","summary_en":"This LEADER analysis of first and recurrent cardiovascular events showed that liraglutide reduces the total burden of major cardiovascular events, with even greater benefit than the primary first-event analysis suggested.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 Cardiology LEADER-analyse naar eerste en recidiverende cardiovasculaire events met liraglutide. Totale eventreductie.","abstract_original":"IMPORTANCE: After the occurrence of nonfatal cardiovascular events, recurrent events are highly likely. Most cardiovascular outcomes trials analyze first events only; extending analyses to first and recurrent (total) events can provide clinically meaningful information. OBJECTIVE: To investigate whether liraglutide is associated with reduced first and recurrent total major adverse cardiovascular events (MACE) compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) randomized, double-blind, clinical trial included data from patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015. Data analysis was performed from August 15, 2016, to July 5, 2019. INTERVENTIONS: Patients were randomized 1:1 to receive liraglutide (up to 1.8 mg per day) or placebo, both with standard care, for 3.5 to 5.0 years. MAIN OUTCOMES AND MEASURES: Assessed outcomes were MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points. RESULTS: The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years]). Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years; >1 MACE: 14.4 [8.7] years) compared with patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years). Fewer first and recurrent MACE occurred in the liraglutide group (n = 4668; 608 first and 127 recurrent events) than in the placebo group (n = 4672; 694 first and 176 recurrent events). Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo. For most individual cardiovascular end points, liraglutide was associated with lower risk vs placebo. CONCLUSIONS AND RELEVANCE: These results suggest that liraglutide treatment is associated with reduced total MACE compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. This analysis supports the findings of an absolute benefit of liraglutide treatment with respect to the overall burden of cardiovascular events in this high-risk patient population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01179048."},{"id":"4dc4f83e8d96","type":"article","url":"https://hartvaat.nl/2019/12/01/absorb-scaffold-5-jaarsresultaten-systematische-meta-analyse/","title":"Absorb scaffold 5-jaarsresultaten: systematische meta-analyse","title_en":"Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.4101","source_url":"https://doi.org/10.1001/jamacardio.2019.4101","authors":["Gregg W Stone","Takeshi Kimura","Runlin Gao","Dean J Kereiakes","Stephen G Ellis","Yoshinobu Onuma","Bernard Chevalier","Charles Simonton","Ovidiu Dressler","Aaron Crowley","Ziad A Ali","Patrick W Serruys"],"significance":7,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This systematic meta-analysis of 5-year Absorb bioresorbable scaffold outcomes definitively showed that the early safety concerns persist and worsen over time, with significantly higher rates of scaffold thrombosis and target lesion failure compared with metallic DES.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 Cardiology systematische meta-analyse van 5-jaarsresultaten van de Absorb bioresorbeerbare scaffold. Definitief negatief langetermijnbewijs.","abstract_original":"IMPORTANCE: Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. OBJECTIVE: To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. DATA SOURCES: We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. STUDY SELECTION: Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. DATA EXTRACTION AND SYNTHESIS: Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. MAIN OUTCOMES AND MEASURES: The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. RESULTS: Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. CONCLUSIONS AND RELEVANCE: The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281."},{"id":"eb33318e4e8d","type":"article","url":"https://hartvaat.nl/2019/12/01/geintegreerde-gespecialiseerde-af-poliklinieken-verlagen-totale-mortaliteit-post/","title":"Geïntegreerde gespecialiseerde AF-poliklinieken verlagen totale mortaliteit: post-hoc analyse","title_en":"Integrated specialized atrial fibrillation clinics reduce all-cause mortality: post hoc analysis of a randomized clinical trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":["acuut-hartfalen"],"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/euz209","source_url":"https://doi.org/10.1093/europace/euz209","authors":["Jeroen M L Hendriks","Robert G Tieleman","Hubertus J M Vrijhoef","Petra Wijtvliet","Celine Gallagher","Martin H Prins","Prashanthan Sanders","Harry J G M Crijns"],"significance":7,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This post-hoc analysis showed that integrated specialized AF outpatient clinics reduce all-cause mortality, providing evidence that structured, multidisciplinary AF care improves not just process measures but hard clinical outcomes.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die aantoont dat geïntegreerde gespecialiseerde AF-poliklinieken de totale mortaliteit verlagen. Onderbouwt het AF-CARE model.","abstract_original":"AIMS: An integrated chronic care programme in terms of a specialized outpatient clinic for patients with atrial fibrillation (AF), has demonstrated improved clinical outcomes. The aim of this study is to assess all-cause mortality in patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme. METHODS AND RESULTS: Post hoc analysis of a Prospective Randomized Open Blinded Endpoint Clinical trial to assess all-cause mortality in AF patients. The study included 712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital. In the specialized outpatient clinic (AF-Clinic), comprehensive, multidisciplinary, and patient-centred AF care was provided, i.e. nurse-driven, physician supervised AF treatment guided by software based on the latest guidelines. The control group received usual care by a cardiologist in the regular outpatient setting.After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014]. This included cardiovascular mortality in 4 AF-Clinic patients (1.1%) and 14 patients (3.9%) in usual care (HR 0.28; 95% CI 0.09-0.85; P = 0.025). Further, 9 patients (2.5%) died in the AF-Clinic arm due to a non-cardiovascular reason and 15 patients (4.2%) in the usual care arm (HR 0.59; 95% CI 0.26-1.34; P = 0.206). CONCLUSION: An integrated specialized AF-Clinic reduces all-cause mortality compared with usual care. These findings provide compelling evidence that an integrated approach should be widely implemented in AF management."},{"id":"5f515213266a","type":"article","url":"https://hartvaat.nl/2019/12/01/hoogtepunten-in-hartfalen-2019/","title":"Hoogtepunten in hartfalen 2019","title_en":"Highlights in heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12555","source_url":"https://doi.org/10.1002/ehf2.12555","authors":["Daniela Tomasoni","Marianna Adamo","Carlo Mario Lombardi","Marco Metra"],"significance":5,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This year-in-review summarized the most important heart failure developments in 2019, providing a concise overview of key trials, guidelines, and therapeutic advances in the HF field.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:29Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Jaaroverzicht van de belangrijkste ontwikkelingen in het hartfalenveld in 2019. Samenvattend overzichtsartikel.","abstract_original":"Heart failure (HF) remains a major cause of mortality, morbidity, and poor quality of life. It is an area of active research. This article is aimed to give an update on recent advances in all aspects of this syndrome. Major changes occurred in drug treatment of HF with reduced ejection fraction (HFrEF). Sacubitril/valsartan is indicated as a substitute to ACEi/ARBs after PARADIGM-HF (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.73 to 0.87 for sacubitril/valsartan vs. enalapril for the primary endpoint and Wei, Lin and Weissfeld HR 0.79, 95% CI 0.71-0.89 for recurrent events). Its initiation was then shown as safe and potentially useful in recent studies in patients hospitalized for acute HF. More recently, dapagliflozin and prevention of adverse-outcomes in DAPA-HF trial showed the beneficial effects of the sodium-glucose transporter type 2 inhibitor dapaglifozin vs. placebo, added to optimal standard therapy [HR, 0.74; 95% CI, 0.65 to 0.85;0.74; 95% CI, 0.65 to 0.85 for the primary endpoint]. Trials with other SGLT 2 inhibitors and in other patients, such as those with HF with preserved ejection fraction (HFpEF) or with recent decompensation, are ongoing. Multiple studies showed the unfavourable prognostic significance of abnormalities in serum potassium levels. Potassium lowering agents may allow initiation and titration of mineralocorticoid antagonists in a larger proportion of patients. Meta-analyses suggest better outcomes with ferric carboxymaltose in patients with iron deficiency. Drugs effective in HFrEF may be useful also in HF with mid-range ejection fraction. Better diagnosis and phenotype characterization seem warranted in HF with preserved ejection fraction. These and other burning aspects of HF research are summarized and reviewed in this article."},{"id":"a2cd9b6c0c8e","type":"article","url":"https://hartvaat.nl/2019/12/01/genetische-gevoeligheid-eiwitinname-en-bloeddrukverandering-pounds-lost/","title":"Genetische gevoeligheid, eiwitinname en bloeddrukverandering: POUNDS Lost","title_en":"Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure: The POUNDS Lost Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13510","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13510","authors":["Dianjianyi Sun","Tao Zhou","Xiang Li","Yoriko Heianza","Zhaoxia Liang","George A Bray","Frank M Sacks","Lu Qi"],"significance":5,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This POUNDS Lost trial analysis showed that genetic susceptibility interacts with dietary protein intake to influence blood pressure changes during weight loss, advancing nutrigenomics in hypertension management.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"POUNDS Lost trial analyse naar de interactie tussen genetische gevoeligheid, eiwitinname en bloeddrukverandering. Gepersonaliseerde voedingsinterventie.","abstract_original":"High blood pressure (BP) is closely related to obesity, and weight loss lowers BP. Evidence has shown considerable interpersonal variation of changes in BP among people experiencing weight loss, and such variation might be partly determined by genetic factors. We assessed the changes in systolic and diastolic BP (SBP/DBP) among 692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years. Two separate polygenic scores (SBP/DBP-PGS derived from 52/50 single nucleotide polymorphisms) were built for each participant based on 66 BP-associated single nucleotide polymorphisms. During a 2-year intervention, participants in the bottom versus upper tertile of SBP/DBP-PGS had a greater decrease in SBP (△SBP at 6, 12, and 24 months: -3.84 versus -1.61, -4.76 versus -2.75, -2.49 versus -1.63; P=0.001) or in DBP (△DBP at 6, 12, and 24 months: -3.09 versus -1.34, -2.69 versus -1.44, -1.82 versus -0.53; P<0.001). We also found gene-diet interaction on changes in SBP from baseline to 24 months (Pinteraction=0.009). Among participants assigned to a high-protein diet, those with a lower SBP-polygenic scores had greater decreases in SBP at months 6 (P=0.018), months 12 (P=0.007), and months 24 (P=0.089); while no significant difference was observed across the SBP-polygenic scores tertile groups among those assigned to an average-protein diet (all P values >0.05). Our data indicate that genetic susceptibility may affect BP changes in response to weight-loss diet interventions, and protein intake may modify the genetic associations with changes in BP. This trial was registered at URL: http://www.clinicaltrials.gov. Unique identifier: NCT00072995."},{"id":"94ee18bf56a5","type":"article","url":"https://hartvaat.nl/2019/12/01/gestoorde-glucosetolerantie-en-albuminurie-bij-chronisch-hf-support-trial/","title":"Gestoorde glucosetolerantie en albuminurie bij chronisch HF: SUPPORT-trial","title_en":"Impaired glucose tolerance and albuminuria in patients with chronic heart failure: a subanalysis of the SUPPORT trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["anemie-ckd","answer-hf","chronische-nierziekte","dapa-hf","diabetes-en-hart","fidelio-dkd","figaro-dkd","flow-trial","select-trial","soul-trial","step-hfpef","summit-trial","vrouwen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12516","source_url":"https://doi.org/10.1002/ehf2.12516","authors":["Kotaro Nochioka","Yasuhiko Sakata","Masanobu Miura","Takashi Shiroto","Jun Takahashi","Chie Saga","Yasuko Ikeno","Nobuyuki Shiba","Tsuyoshi Shinozaki","Masafumi Sugi","Makoto Nakagawa","Tatsuya Komaru","Atsushi Kato","Eiji Nozaki","Kaoru Iwabuchi","Tetsuya Hiramoto","Kanichi Inoue","Masatoshi Ohe","Kenji Tamaki","Ichiro Tsuji","Hiroaki Shimokawa"],"significance":5,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This SUPPORT subanalysis evaluated the prevalence and prognostic significance of impaired glucose tolerance and albuminuria in chronic heart failure, identifying metabolic and renal markers of adverse prognosis.","created":"2026-07-03T10:28:18Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SUPPORT subanalyse naar de prevalentie en klinische impact van gestoorde glucosetolerantie en albuminurie bij chronisch hartfalen.","abstract_original":"AIMS: The study aims to evaluate the prognostic significance of impaired glucose tolerance (IGT) with reference to albuminuria in patients with chronic heart failure (CHF). METHODS AND RESULTS: We examined 535 CHF patients (mean 66 years, women 25%) in the control arm of our SUPPORT trial, in which we examined additive impact of olmesartan in hypertensive patients with symptomatic CHF treated with β-blockers and/or angiotensin-converting enzyme inhibitors. We examined the association between glycaemic abnormality (assessed by 75 g of oral glucose tolerance test) and albuminuria for a composite outcome of all-cause death, myocardial infarction, stroke, and HF hospitalization. IGT patients (N = 113, mean 67.2 years) were older and more frequently treated with β-blockers compared with those with normal glucose regulation (N = 142, mean 64.0 years) and those with diabetes mellitus (N = 280, mean 65.7 years). Multivariable Cox proportional hazard models revealed that, as compared with normal glucose regulation (NGR), IGT was associated with increased risk of the outcome when complicated by albuminuria [hazard ratio (HR) 2.25; 95% confidence interval (CI) 1.14-4.42; P = 0.019] but not when uncomplicated by albuminuria (HR 0.76; 95% CI 0.35-1.60, P = 0.47) (P for interaction = 0.041). This was also the case for diabetes mellitus and albuminuria (HR 2.06; 95% CI 1.17-3.61; P = 0.012). Among IGT patients without albuminuria, 21 (29%) developed albuminuria at 1-year visit, which was again associated with poor prognosis (HR 7.36; 95% CI 1.39-38.98, P = 0.019). CONCLUSIONS: These results indicate that IGT is associated with poor prognosis when complicated by albuminuria in CHF patients, demonstrating the importance of combined early stages of glucose intolerance and renal dysfunction in the management of CHF."},{"id":"ed84149a47d0","type":"article","url":"https://hartvaat.nl/2019/12/01/gunstige-effecten-van-ivabradine-bij-hf-met-lage-ef-en-hartfrequentie-77-bpm/","title":"Gunstige effecten van ivabradine bij HF met lage EF en hartfrequentie >77 bpm","title_en":"Beneficial effects of ivabradine in patients with heart failure, low ejection fraction, and heart rate above 77 b.p.m.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["acuut-hartfalen","hfmref","hfpef","hfref","ivabradine"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12513","source_url":"https://doi.org/10.1002/ehf2.12513","authors":["Nadia Bouabdallaoui","Eileen O'Meara","Virginie Bernier","Michel Komajda","Karl Swedberg","Luigi Tavazzi","Jeffrey S Borer","Michael Bohm","Ian Ford","Jean-Claude Tardif"],"significance":5,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/"],"congress":"","summary_en":"This analysis showed that ivabradine provides particular benefit in HFrEF patients with heart rates above 77 bpm despite guideline-directed therapy, supporting risk-stratified heart rate lowering.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T18:38:46Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de voordelen van ivabradine bij hartfalenpatiënten met lage ejectiefractie en hartfrequentie boven 77 bpm.","abstract_original":"AIMS: Ivabradine has been approved in heart failure with reduced ejection fraction (HFrEF) and elevated heart rate despite guideline-directed medical therapy (GDMT) to reduce cardiovascular (CV) death and hospitalization for worsening HF. The median value of 77 b.p.m. is the lower bound selected for the regulatory approval in Canada, South Africa, and Australia. Patient-reported outcomes (PROs) including symptoms, quality of life, and global assessment are considered of major interest in the global plan of care of patients with HF. However, the specific impact of GDMT, and specifically ivabradine, on PRO remains poorly studied. In the subgroup of patients from the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) who had heart rate above the median of 77 b.p.m. (pre-specified analysis) and for whom the potential for improvement was expected to be larger, we aimed (i) to evaluate the effects of ivabradine on PRO (symptoms, quality of life, and global assessment); (ii) to consolidate the effects of ivabradine on the primary composite endpoint of CV death and hospitalization for HF; and (iii) to reassess the effects of ivabradine on left ventricular (LV) remodelling. METHODS AND RESULTS: Comparisons were made according to therapy, and proportional hazards models (adjusted for baseline beta-blocker therapy) were used to estimate the association between ivabradine and various outcomes. In SHIFT, n = 3357 (51.6%) patients had a baseline heart rate > 77 b.p.m. After a median follow-up of 22.9 months (inter-quartile range 18-28 months), ivabradine on top of GDMT improved symptoms (28% vs. 23% improvement in New York Heart Association functional class, P = 0.0003), quality of life (5.3 vs. 2.2 improvement in Kansas City Cardiomyopathy Questionnaire overall summary score, P = 0.005), and global assessment [from both patient (improved in 72.3%) and physician (improved in 61.0%) perspectives] significantly more than did placebo (both P < 0.0001). Ivabradine induced a 25% reduction in the combined endpoint of CV death and hospitalization for HF (hazard ratio 0.75; P < 0.0001), which translates into a number of patients needed to be treated for 1 year of 17. Patients under ivabradine treatment demonstrated a significant reduction in LV dimensions when reassessed at 8 months (P < 0.05). CONCLUSIONS: In patients with chronic HFrEF, sinus rhythm, and a heart rate > 77 b.p.m. while on GDMT, the present analysis brings novel insights into the role of ivabradine in improving the management of HFrEF, particularly with regard to PRO (ISRCTN70429960)."},{"id":"885c3bf642a2","type":"article","url":"https://hartvaat.nl/2019/12/01/hepatorenale-disfunctie-identificeert-hoogrisico-acuut-hf-relax-ahf/","title":"Hepatorenale disfunctie identificeert hoogrisico acuut HF: RELAX-AHF","title_en":"Hepatorenal dysfunction identifies high-risk patients with acute heart failure: insights from the RELAX-AHF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12477","source_url":"https://doi.org/10.1002/ehf2.12477","authors":["Jan Biegus","Biniyam Demissei","Douwe Postmus","Gad Cotter","Beth A Davison","G Michael Felker","Gerasimos Filippatos","Claudio Gimpelewicz","Barry Greenberg","Marco Metra","Thomas Severin","John R Teerlink","Adriaan A Voors","Piotr Ponikowski"],"significance":5,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This RELAX-AHF analysis identified hepatorenal dysfunction as a marker for high-risk patients with acute heart failure, showing that combined liver and kidney impairment predicts worse outcomes.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"RELAX-AHF analyse die hepatorenale disfunctie identificeerde als marker voor hoogrisicopatiënten met acuut hartfalen.","abstract_original":"AIMS: Episodes of acute heart failure (AHF) may lead to end-organ dysfunction. In this post hoc analysis of the Relaxin in Acute Heart Failure trial, we used the MELD-XI (Model of End-Stage Liver Dysfunction) score to examine hepatorenal dysfunction in patients with AHF. METHODS AND RESULTS: On admission, the MELD-XI score was elevated (abnormal) in 918 (82%) patients, with 638 (57%) having isolated renal dysfunction (creatinine > 1 mg/dL), 73 (6.5%) isolated liver dysfunction (bilirubin > 1 mg/dL), and 207 (18.5%) coexisting dysfunction of the kidneys and the liver (both creatinine and bilirubin > 1 mg/dL). The percentage of patients with elevated MELD-XI score remained constant through a 60 day follow-up, as we observed a gradual decrease of liver dysfunction prevalence, counterbalanced by an increase in renal dysfunction. Serelaxin treatment was associated with a lower MELD-XI score on Day 2 and Day 5 (both P < 0.05), but this difference vs. placebo disappeared during longer follow-up. In the multivariable model, an elevated MELD-XI score on admission was associated with higher 180 day mortality: hazard ratios (95% confidence interval) for cardiovascular death were 3.10 (1.22-7.87), and for all-cause death 2.47 (1.19-5.15); both P < 0.05. The addition of the MELD-XI score to a prespecified prognostic model increased the discrimination of the model for all-cause death, but the increment in the C-index was only modest: 0.013 (P = 0.02). CONCLUSIONS: In patients with AHF, hepatorenal dysfunction is prevalent and related to poor outcome. The MELD-XI score is a useful prognosticator in AHF."},{"id":"08575da972ea","type":"article","url":"https://hartvaat.nl/2019/12/01/linkeratriumdimensie-en-cv-uitkomsten-bij-patienten-met-en-zonder-af-meta-analys/","title":"Linkeratriumdimensie en CV-uitkomsten bij patiënten met en zonder AF: meta-analyse","title_en":"Left atrial dimension and cardiovascular outcomes in patients with and without atrial fibrillation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["acuut-hartfalen","farmaco-economie","gepersonaliseerde-geneeskunde","laminopathie","ouderen","pathfinder-trial","vrouwen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-315174","source_url":"https://doi.org/10.1136/heartjnl-2019-315174","authors":["Lorin Froehlich","Pascal Meyre","Stefanie Aeschbacher","Steffen Blum","Daniela Djokic","Michael Kuehne","Stefan Osswald","Beat A Kaufmann","David Conen"],"significance":6,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that left atrial dimension predicts cardiovascular outcomes in both patients with and without AF, establishing atrial enlargement as a universal cardiovascular risk marker beyond arrhythmia context.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T18:38:46Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het verband tussen linkeratriumgrootte en cardiovasculaire uitkomsten, ongeacht de aanwezigheid van AF.","abstract_original":"OBJECTIVE: The prognostic value of left atrial (LA) dimensions may differ between patients with and without atrial fibrillation (AF). METHODS: MEDLINE and EMBASE were searched for studies that investigated the association between LA echocardiographic parameters measured by transthoracic echocardiography and cardiovascular outcomes in patients with or without AF. Data were independently abstracted by two reviewers and pooled using random-effects meta-analysis. The primary outcome was incident stroke or thromboembolic events. Secondary outcomes were heart failure, all-cause mortality and major adverse cardiac events (MACE). RESULTS: Twenty-three studies of patients with AF (14 939 patients) and 68 studies of patients without AF (50 720 patients) in this systematic review. Increasing LA diameter was significantly associated with stroke and thromboembolic events in patients without AF (risk ratio (RR) 1.38, 95% CI 1.02 to 1.87; p=0.03), but not in patients with AF (RR 1.02, 95% CI 0.98 to 1.07; p=0.27; p for difference=0.05). Increasing LA diameter index was significantly associated with MACE in patients with AF (RR 1.13, 95% CI 1.09 to 1.17; p<0.001) and in patients without AF (RR 2.98, 95% CI 1.90 to 4.66; p<0.001), with stronger effects in non-AF populations (p for difference <0.001). Greater LA volume index was significantly associated with the risk of MACE in patients with AF (RR 1.01, 95% CI 1.00 to 1.02; p=0.03) and in non-AF populations (RR 1.08, 95% CI 1.05 to 1.10; p<0.001), the association being stronger in individuals without AF (p for difference <0.001). CONCLUSIONS: Larger LA parameters were associated with various adverse cardiovascular events. Many of these associations were stronger in individuals without AF, highlighting the potential importance of LA myopathy."},{"id":"300a6036f67c","type":"article","url":"https://hartvaat.nl/2019/12/01/orale-morfine-bij-dyspneu-bij-chronisch-hartfalen-gerandomiseerde-placebogecontr/","title":"Orale morfine bij dyspneu bij chronisch hartfalen: gerandomiseerde placebogecontroleerde trial","title_en":"Oral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["anemie-ckd","bisoprolol","carvedilol","pathfinder-trial","soul-trial","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12498","source_url":"https://doi.org/10.1002/ehf2.12498","authors":["Miriam J Johnson","Sarah Cockayne","David C Currow","Kerry Bell","Kate Hicks","Caroline Fairhurst","Rhian Gabe","David Torgerson","Laura Jefferson","Stephen Oxberry","Justin Ghosh","Karen J Hogg","Jeremy Murphy","Victoria Allgar","John G F Cleland","Andrew L Clark"],"significance":6,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This randomized placebo-controlled trial of oral modified-release morphine for breathlessness in chronic heart failure showed modest symptom benefit, providing the first controlled data for opioid use in heart failure-related dyspnea.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar orale gemodificeerde-afgifte morfine bij dyspneu bij chronisch hartfalen. Palliatieve symptoombehandeling.","abstract_original":"AIMS: Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. METHODS AND RESULTS: Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39-89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, -0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. CONCLUSIONS: We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects."},{"id":"ee867a42c1bf","type":"article","url":"https://hartvaat.nl/2019/12/01/gewichtsverandering-en-risico-op-af-systematische-review-en-meta-analyse/","title":"Gewichtsverandering en risico op AF: systematische review en meta-analyse","title_en":"Weight change and the risk of incident atrial fibrillation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-314931","source_url":"https://doi.org/10.1136/heartjnl-2019-314931","authors":["Nicholas R Jones","Kathryn S Taylor","Clare J Taylor","Paul Aveyard"],"significance":6,"published":"2019-12-01","source_date":"2019-12-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-en-beroerte/"],"congress":"","summary_en":"This meta-analysis showed that weight change, particularly weight gain, is associated with increased risk of incident atrial fibrillation, supporting weight management as a strategy for AF prevention.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het verband tussen gewichtsverandering en het risico op incident atriumfibrilleren. Ondersteunt gewichtsmanagement als AF-preventie.","abstract_original":"BACKGROUND: The prevalence of obesity is increasing globally and this could partly explain the worldwide increase in the prevalence of atrial fibrillation (AF), as both overweight and obesity are established risk factors. However, the relationship between weight change and risk of incident AF, independent of starting weight, remains uncertain. METHODS: MEDLINE, Embase, Pubmed, Web of Science, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Trials Register-clinicaltrials.gov, CINAHL and the WHO ICTRP were searched from inception to July 2018.We included randomised controlled trials and cohort studies across all healthcare settings but excluded studies of bariatric surgery. A random effects model was used to calculate pooled hazard ratios. The primary outcome was the risk of incident AF in relation to weight change. RESULTS: Ten studies, including 108 996 people, met our inclusion criteria. For a 5% gain in weight, the incidence of AF increased by 13% (HR 1.13, 95% CI 1.04 to 1.23, I2=70%, n>20 411 in five studies; study size was unknown for one study). A 5% loss in body weight was not associated with a significant change in the incidence of AF (HR 1.04, 95% CI 0.94 to 1.16, I2=73%, n=40 704 in five studies). CONCLUSIONS: Weight gain may increase the risk of AF, but there was no clear evidence that non-surgical weight loss altered AF incidence. Strategies to prevent weight gain in the population may reduce the global burden of AF. Given the lack of studies and methodological limitations, further research is needed."},{"id":"ef25b707801d","type":"article","url":"https://hartvaat.nl/2019/11/26/werkzaamheid-en-veiligheid-van-stents-bij-stemi-jacc-analyse/","title":"Werkzaamheid en veiligheid van stents bij STEMI: JACC analyse","title_en":"Efficacy and Safety of Stents in ST-Segment Elevation Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.038","source_url":"https://doi.org/10.1016/j.jacc.2019.09.038","authors":["Ply Chichareon","Rodrigo Modolo","Carlos Collet","Erhan Tenekecioglu","Maarten A Vink","Pyung Chun Oh","Jung-Min Ahn","Carmine Musto","Luis S Díaz de la Llera","Young-Seok Cho","Roberto Violini","Seung-Jung Park","Harry Suryapranata","Jan J Piek","Robbert J de Winter","Joanna J Wykrzykowska","Christian Spaulding","Woong Chol Kang","Ton Slagboom","Sjoerd H Hofma","Inge F Wijnbergen","Emilio Di Lorenzo","Nico H Pijls","Lorenz Räber","Salvatore Brugaletta","Manel Sabaté","Hans-Peter Stoll","Gregg W Stone","Stephan Windecker","Yoshinobu Onuma","Patrick W Serruys"],"significance":5,"published":"2019-11-26","source_date":"2019-11-26","image":"","kennis":[],"congress":"","summary_en":"This analysis compared the efficacy and safety of different drug-eluting stent types in STEMI, finding no clear superiority of any specific DES platform in the primary PCI setting.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 werkzaamheid en veiligheid van verschillende stenttypen bij STEMI.","abstract_original":"BACKGROUND: To date, no specific drug-eluting stent (DES) has fully proven its superiority over others in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. OBJECTIVES: The purpose of this study was to compare the safety and efficacy of coronary artery stents in STEMI patients in a patient-level network meta-analysis. METHODS: Eligible studies were dedicated randomized controlled trials comparing different stents in STEMI patients undergoing percutaneous coronary intervention with at least 12 months of clinical follow-up. Of 19 studies identified from the published data, individual patient data were collected in 15 studies with 10,979 patients representing 87.7% of patients in the overall network of evidence. The primary endpoint was the composite of cardiac death, reinfarction, or target lesion revascularization. RESULTS: Overall, 8,487 (77.3%) of 10,979 STEMI patients were male and the mean age was 60.7 years. At a median follow-up of 3 years, compared with bare-metal stents (BMS), patients treated with paclitaxel-, sirolimus-, everolimus-, or biolimus-eluting stents had a significantly lower risk of the primary endpoint (adjusted hazard ratios [HRs]: 0.74 [95% confidence interval (CI): 0.63 to 0.88], 0.65 [95% CI: 0.49 to 0.85], 0.70 [95% CI: 0.53 to 0.91], and 0.66 [95% CI: 0.49 to 0.88], respectively). The risk of primary endpoint was not different between patients treated with BMS and zotarolimus-eluting stents (adjusted HR: 0.83 [95% CI: 0.51 to 1.38]). Among patients treated with DES, no significant difference in the risk of the primary outcome was demonstrated. Treatment with second-generation DES was associated with significantly lower risk of definite or probable stent thrombosis compared with BMS (adjusted HR: 0.61 [95% CI: 0.42 to 0.89]) and first-generation DES (adjusted HR: 0.56 [95% CI: 0.36 to 0.88]). CONCLUSIONS: In STEMI patients, DES were superior to BMS with respect to long-term efficacy. No difference in long-term efficacy and safety was observed among specific DES. Second-generation were superior to first-generation DES in reducing stent thrombosis. (Clinical Outcomes After Primary Percutaneous Coronary Intervention [PCI] Using Contemporary Drug-Eluting Stent [DES]: Evidence From the Individual Patient Data Network Meta-Analysis; CRD42018104053)."},{"id":"566ce13f6236","type":"article","url":"https://hartvaat.nl/2019/11/26/interatriale-shunt-en-pulmonale-vaatfunctie-bij-hfpef/","title":"Interatriale shunt en pulmonale vaatfunctie bij HFpEF","title_en":"Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.1062","source_url":"https://doi.org/10.1016/j.jacc.2019.08.1062","authors":["Masaru Obokata","Yogesh N V Reddy","Sanjiv J Shah","David M Kaye","Finn Gustafsson","Gerd Hasenfuβ","Elke Hoendermis","Sheldon E Litwin","Jan Komtebedde","Carolyn Lam","Daniel Burkhoff","Barry A Borlaug"],"significance":6,"published":"2019-11-26","source_date":"2019-11-26","image":"","kennis":[],"congress":"","summary_en":"This study evaluated the effects of an interatrial shunt device on pulmonary vascular function in HFpEF, showing that reducing left atrial pressure through controlled shunting improves pulmonary hemodynamics.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T13:27:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de effecten van een interatriale shunt op pulmonale vaatfunctie bij HFpEF.","abstract_original":"BACKGROUND: Implantation of an interatrial shunt device (IASD) in patients with heart failure (HF) reduces left atrial hypertension by shunting oxygenated blood to the right heart and lungs. The attendant increases in pulmonary blood flow (Qp) and oxygen content may alter pulmonary vascular function, while left-to-right shunting might compromise systemic perfusion. OBJECTIVES: The authors hypothesized that IASD would improve indexes of pulmonary artery (PA) function at rest and during exercise in HF patients without reducing systemic blood flow (Qs). METHODS: This is a pooled analysis from 2 trials assessing the effects of the IASD on resting and exercise hemodynamics in HF patients (n = 79) with EF ≥40% with baseline and repeated hemodynamic evaluation between 1 and 6 months. Patients with pulmonary vascular resistance (PVR) >4 WU or right ventricular dysfunction were excluded. RESULTS: Qp and PA oxygen content increased by 27% and 7% following IASD. These changes were associated with salutary effects on pulmonary vascular function (17% reduction in PVR, 12% reduction in PA elastance [pulmonary Ea], and 24% increase in PA compliance). Qp increased during exercise to a greater extent following IASD compared with baseline, which was associated with reductions in exercise PVR and pulmonary Ea. Patients with increases in PA compliance following IASD experienced greater improvements in supine exercise duration. There was no reduction in Qs following IASD at rest or during exercise. CONCLUSIONS: Implantation of an IASD improves pulmonary vascular function at rest and during exercise in selected patients with HF and EF ≥40%, without compromising systemic perfusion. Further study is warranted to identify underlying mechanisms and long-term pulmonary hemodynamic effects of IASD. (REDUCE LAP-HF Trial [REDUCE LAP-HF]; NCT01913613; and REDUCE LAP-HF Randomized Trial I [REDUCE LAP-HF I]; NCT02600234)."},{"id":"ee53b4721dd9","type":"article","url":"https://hartvaat.nl/2019/11/26/2019-aha-acc-prestatie-en-kwaliteitsmaten-voor-hoge-bloeddruk/","title":"2019 AHA/ACC prestatie- en kwaliteitsmaten voor hoge bloeddruk","title_en":"2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.10.001","source_url":"https://doi.org/10.1016/j.jacc.2019.10.001","authors":["Donald E Casey","Randal J Thomas","Vivek Bhalla","Yvonne Commodore-Mensah","Paul A Heidenreich","Dhaval Kolte","Paul Muntner","Sidney C Smith","John A Spertus","John R Windle","Gregory D Wozniak","Boback Ziaeian"],"significance":7,"published":"2019-11-26","source_date":"2019-11-26","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/nhg-standaard-cvr-2019/"],"congress":"","summary_en":"This AHA/ACC document defined clinical performance and quality measures for hypertension management in adults, establishing benchmarks for healthcare systems to assess and improve blood pressure control quality.","created":"2026-07-03T10:28:17Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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/ACC klinische prestatie- en kwaliteitsmaten voor volwassenen met hoge bloeddruk. Kwaliteitsindicatoren voor het hypertensiebeleid.","abstract_original":""},{"id":"e12d0572dd5d","type":"article","url":"https://hartvaat.nl/2019/11/26/cryoballon-versus-rf-ablatie-bij-af-beoordeeld-met-continue-monitoring-cryo-firs/","title":"Cryoballon versus RF-ablatie bij AF beoordeeld met continue monitoring: CRYO-FIRST","title_en":"Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cryoablatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.042622","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.042622","authors":["Jason G Andrade","Jean Champagne","Marc Dubuc","Marc W Deyell","Atul Verma","Laurent Macle","Peter Leong-Sit","Paul Novak","Mariano Badra-Verdu","John Sapp","Iqwal Mangat","Clarence Khoo","Christian Steinberg","Matthew T Bennett","Anthony S L Tang","Paul Khairy"],"significance":7,"published":"2019-11-26","source_date":"2019-11-26","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/","https://hartvaat.nl/kennis/atriumfibrilleren/nhg-standaard-atriumfibrilleren-2024/"],"congress":"","summary_en":"The CRYO-FIRST trial comparing cryoballoon with radiofrequency ablation as first-line AF treatment, assessed by continuous monitoring, provided additional data on the relative merits of these two energy sources for initial rhythm control.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:27Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"CRYO-FIRST gerandomiseerde trial die cryoballon vergeleek met RF-ablatie bij AF als eerstelijnsbehandeling, beoordeeld met continue monitoring.","abstract_original":"BACKGROUND: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. METHODS: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. RESULTS: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (P=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (P=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs cryoballoon groups). CONCLUSIONS: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522."},{"id":"4dee2b34005d","type":"article","url":"https://hartvaat.nl/2019/11/21/ticagrelor-met-of-zonder-aspirine-na-pci-bij-hoog-risico-nejm-twilight/","title":"Ticagrelor met of zonder aspirine na PCI bij hoog risico: NEJM TWILIGHT","title_en":"Ticagrelor with or without Aspirin in High-Risk Patients after PCI.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["trombocytenaggregatieremmers"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1908419","source_url":"https://doi.org/10.1056/NEJMoa1908419","authors":["Roxana Mehran","Usman Baber","Samin K Sharma","David J Cohen","Dominick J Angiolillo","Carlo Briguori","Jin Y Cha","Timothy Collier","George Dangas","Dariusz Dudek","Vladimír Džavík","Javier Escaned","Robert Gil","Paul Gurbel","Christian W Hamm","Timothy Henry","Kurt Huber","Adnan Kastrati","Upendra Kaul","Ran Kornowski","Mitchell Krucoff","Vijay Kunadian","Steven O Marx","Shamir R Mehta","David Moliterno","E Magnus Ohman","Keith Oldroyd","Gennaro Sardella","Samantha Sartori","Richard Shlofmitz","P Gabriel Steg","Giora Weisz","Bernhard Witzenbichler","Ya-Ling Han","Stuart Pocock","C Michael Gibson"],"significance":10,"published":"2019-11-21","source_date":"2019-11-21","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The TWILIGHT trial showed that ticagrelor monotherapy after 3 months of dual antiplatelet therapy significantly reduced clinically relevant bleeding without increasing ischemic events in high-risk patients after PCI. This established P2Y12 inhibitor monotherapy as a safe de-escalation strategy for selected patients.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:27Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Landmark NEJM TWILIGHT-trial die aantoonde dat ticagrelor monotherapie (na 3 maanden DAPT) het bloedingsrisico significant vermindert zonder meer ischemische events bij hoogrisico-PCI. Paradigma van P2Y12-monotherapie.","abstract_original":"BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.)."},{"id":"f94b83c94e25","type":"article","url":"https://hartvaat.nl/2019/11/21/dapagliflozine-bij-hartfalen-met-verminderde-ejectiefractie-nejm-dapa-hf/","title":"Dapagliflozine bij hartfalen met verminderde ejectiefractie: NEJM DAPA-HF","title_en":"Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["acuut-hartfalen","answer-hf","dapa-hf","dapagliflozine","empagliflozine","emperor-trials","hfmref","hfpef","hfref","pathfinder-trial","step-hfpef"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1911303","source_url":"https://doi.org/10.1056/NEJMoa1911303","authors":["John J V McMurray","Scott D Solomon","Silvio E Inzucchi","Lars Køber","Mikhail N Kosiborod","Felipe A Martinez","Piotr Ponikowski","Marc S Sabatine","Inder S Anand","Jan Bělohlávek","Michael Böhm","Chern-En Chiang","Vijay K Chopra","Rudolf A de Boer","Akshay S Desai","Mirta Diez","Jaroslaw Drozdz","Andrej Dukát","Junbo Ge","Jonathan G Howlett","Tzvetana Katova","Masafumi Kitakaze","Charlotta E A Ljungman","Béla Merkely","Jose C Nicolau","Eileen O'Meara","Mark C Petrie","Pham N Vinh","Morten Schou","Sergey Tereshchenko","Subodh Verma","Claes Held","David L DeMets","Kieran F Docherty","Pardeep S Jhund","Olof Bengtsson","Mikaela Sjöstrand","Anna-Maria Langkilde"],"significance":10,"published":"2019-11-21","source_date":"2019-11-21","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 DAPA-HF trial demonstrated that dapagliflozin reduced the composite of worsening heart failure or cardiovascular death in patients with HFrEF regardless of the presence of diabetes. This transformative result established SGLT2 inhibitors as a fourth pillar of heart failure therapy alongside ACE inhibitors/ARBs, beta-blockers, and mineralocorticoid antagonists.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Landmark NEJM DAPA-HF-trial — het meest impactvolle cardiologische onderzoek van het decennium. Dapagliflozine vermindert het risico op verslechtering van hartfalen en cardiovasculaire dood significant bij patiënten met HFrEF, ongeacht de aanwezigheid van diabetes. Veranderde het behandelparadigma van hartfalen permanent door SGLT2-remmers toe te voegen als vierde pijler van de farmacotherapie.","abstract_original":"BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.)."},{"id":"769b1c0d6418","type":"article","url":"https://hartvaat.nl/2019/11/21/rivaroxaban-en-cva-tia-bij-hf-met-coronairlijden-en-sinusritme-commander-hf/","title":"Rivaroxaban en CVA/TIA bij HF met coronairlijden en sinusritme: COMMANDER HF","title_en":"A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz427","source_url":"https://doi.org/10.1093/eurheartj/ehz427","authors":["Mandeep R Mehra","Muthiah Vaduganathan","Min Fu","João Pedro Ferreira","Stefan D Anker","John G F Cleland","Carolyn S P Lam","Dirk J van Veldhuisen","William M Byra","Theodore E Spiro","Hsiaowei Deng","Faiez Zannad","Barry Greenberg"],"significance":6,"published":"2019-11-21","source_date":"2019-11-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This COMMANDER HF analysis specifically examined the effect of low-dose rivaroxaban on stroke and TIA in heart failure patients with sinus rhythm, finding no significant cerebrovascular benefit with anticoagulation in this population.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:27Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"COMMANDER HF analyse specifiek naar het effect van rivaroxaban op CVA en TIA bij hartfalenpatiënten.","abstract_original":"AIMS: Stroke is often a devastating event among patients with heart failure with reduced ejection (HFrEF). In COMMANDER HF, rivaroxaban 2.5 mg b.i.d. did not reduce the composite of first occurrence of death, stroke, or myocardial infarction compared with placebo in patients with HFrEF, coronary artery disease (CAD), and sinus rhythm. We now examine the incidence, timing, type, severity, and predictors of stroke or a transient ischaemic attack (TIA), and seek to establish the net clinical benefit of treatment with low-dose rivaroxaban. METHODS AND RESULTS: In this double-blind, randomized trial, 5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with rivaroxaban 2.5 mg b.i.d. or placebo in addition to antiplatelet therapy, after an episode of worsening HF. The primary neurological outcome for this post hoc analysis was time to first event of any stroke or TIA. Over a median follow-up of 20.5 (25th-75th percentiles 20.0-20.9) months, 150 all-cause stroke (127) or TIA (23) events occurred (ischaemic stroke in 82% and haemorrhagic stroke in 11% of stroke events). Overall, 47.5% of first-time strokes were either disabling (16.5%) or fatal (31%). Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score were predictors of stroke/TIA. Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49-0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event. The principal safety endpoint of fatal bleeding or bleeding into a critical space, occurred at a similar rate on rivaroxaban and placebo (0.44 events vs. 0.55 events per 100 patient-years). CONCLUSIONS: Patients with HFrEF and CAD are at risk for stroke or TIA in the period following an episode of worsening heart failure in the absence of atrial fibrillation. Most strokes are of ischaemic origin and nearly half are either disabling or fatal. Rivaroxaban at a dose of 2.5 mg b.i.d. reduced rates of stroke or TIA compared with placebo in this population. TRIAL REGISTRATION: COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure); ClinicalTrials.gov NCT01877915."},{"id":"52de19829ae4","type":"article","url":"https://hartvaat.nl/2019/11/21/diureticastaken-bij-stabiel-mild-hf-zonder-vochtretentie/","title":"Diureticastaken bij stabiel mild HF zonder vochtretentie","title_en":"Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy: a double-blind, multicentre, randomized trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","dapa-hf","diuretica","emperor-trials","finearts-hf","hfmref","hfpef","hfref","step-hfpef"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz554","source_url":"https://doi.org/10.1093/eurheartj/ehz554","authors":["Luis E Rohde","Marciane M Rover","Jose A Figueiredo Neto","Luiz C Danzmann","Eduardo G Bertoldi","Marcus V Simões","Odilson M Silvestre","Antonio L P Ribeiro","Lidia Zytynski Moura","Luis Beck-da-Silva","Debora Prado","Roberto T Sant'Anna","Leonardo H Bridi","André Zimerman","Priscila Raupp da Rosa","Andréia Biolo"],"significance":6,"published":"2019-11-21","source_date":"2019-11-21","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/icd-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/vochtstatus-bewaking-hartfalen/"],"congress":"","summary_en":"This study tested short-term diuretic withdrawal in stable outpatients with mild heart failure receiving optimal medical therapy, showing that many patients can safely reduce or stop loop diuretics when well-compensated.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die het kortdurend staken van diuretica onderzocht bij stabiele poliklinische hartfalenpatiënten met milde symptomen en optimale therapie.","abstract_original":"AIMS: Although loop diuretics are widely used to treat heart failure (HF), there is scarce contemporary data to guide diuretic adjustments in the outpatient setting. METHODS AND RESULTS: In a prospective, randomized and double-blind protocol, we tested the safety and tolerability of withdrawing low-dose furosemide in stable HF outpatients at 11 HF clinics in Brazil. The trial had two blindly adjudicated co-primary outcomes: (i) symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale evaluated at 4 time-points (baseline, Day 15, Day 45, and Day 90) and (ii) the proportion of patients maintained without diuretic reuse during follow-up. We enrolled 188 patients (25% females; 59 ± 13 years old; left ventricular ejection fraction = 32 ± 8%) that were randomized to furosemide withdrawal (n = 95) or maintenance (n = 93). For the first co-primary endpoint, no significant difference in patients' assessment of dyspnoea was observed in the comparison of furosemide withdrawal with continuous administration [median AUC 1875 (interquartile range, IQR 383-3360) and 1541 (IQR 474-3124), respectively; P = 0.94]. For the second co-primary endpoint, 70 patients (75.3%) in the withdrawal group and 77 patients (83.7%) in the maintenance group were free of furosemide reuse during follow-up (odds ratio for additional furosemide use with withdrawal 1.69, 95% confidence interval 0.82-3.49; P = 0.16). Heart failure-related events (hospitalizations, emergency room visits, and deaths) were infrequent and similar between groups (P = 1.0). CONCLUSIONS: Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse. Diuretic discontinuation may deserve consideration in stable outpatients with no signs of fluid retention receiving optimal medical therapy. CLINICALTRIALS.GOV IDENTIFIER: NCT02689180."},{"id":"e500327750a7","type":"article","url":"https://hartvaat.nl/2019/11/19/beeldvorming-geleide-versus-routinezorg-bij-nstemi-jacc/","title":"Beeldvorming-geleide versus routinezorg bij NSTEMI: JACC","title_en":"Initial Imaging-Guided Strategy Versus Routine Care in Patients With Non-ST-Segment Elevation Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.09.027","source_url":"https://doi.org/10.1016/j.jacc.2019.09.027","authors":["Martijn W Smulders","Bas L J H Kietselaer","Joachim E Wildberger","Pieter C Dagnelie","Hans-Peter Brunner-La Rocca","Alma M A Mingels","Yvonne J M van Cauteren","Ralph A L J Theunissen","Mark J Post","Simon Schalla","Sander M J van Kuijk","Marco Das","Raymond J Kim","Harry J G M Crijns","Sebastiaan C A M Bekkers"],"significance":6,"published":"2019-11-19","source_date":"2019-11-19","image":"","kennis":[],"congress":"","summary_en":"This study compared an initial imaging-guided strategy with routine invasive care in NSTEMI patients, testing whether non-invasive risk stratification can safely select patients for conservative management.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:27Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Vergelijking van initiële beeldvorming-geleide strategie versus routinezorg bij NSTEMI.","abstract_original":"BACKGROUND: Patients with non-ST-segment elevation myocardial infarction and elevated high-sensitivity cardiac troponin levels often routinely undergo invasive coronary angiography (ICA), but many do not have obstructive coronary artery disease. OBJECTIVES: This study investigated whether cardiovascular magnetic resonance imaging (CMR) or computed tomographic angiography (CTA) may serve as a safe gatekeeper for ICA. METHODS: This randomized controlled trial (NCT01559467) in 207 patients (age 64 years; 62% male patients) with acute chest pain, elevated high-sensitivity cardiac troponin T levels (>14 ng/l), and inconclusive electrocardiogram compared a CMR- or CTA-first strategy with a control strategy of routine clinical care. Follow-up ICA was recommended when initial CMR or CTA suggested myocardial ischemia, infarction, or obstructive coronary artery disease (≥70% stenosis). Primary efficacy and secondary safety endpoints were referral to ICA during hospitalization and 1-year outcomes (major adverse cardiac events and complications), respectively. RESULTS: The CMR- and CTA-first strategies reduced ICA compared with routine clinical care (87% [p = 0.001], 66% [p < 0.001], and 100%, respectively), with similar outcome (hazard ratio: CMR vs. routine, 0.78 [95% confidence interval: 0.37 to 1.61]; CTA vs. routine, 0.66 [95% confidence interval: 0.31 to 1.42]; and CMR vs. CTA, 1.19 [95% confidence interval: 0.53 to 2.66]). Obstructive coronary artery disease after ICA was found in 61% of patients in the routine clinical care arm, in 69% in the CMR-first arm (p = 0.308 vs. routine), and in 85% in the CTA-first arm (p = 0.006 vs. routine). In the non-CMR and non-CTA arms, follow-up CMR and CTA were performed in 67% and 13% of patients and led to a new diagnosis in 33% and 3%, respectively (p < 0.001). CONCLUSIONS: A novel strategy of implementing CMR or CTA first in the diagnostic process in non-ST-segment elevation myocardial infarction is a safe gatekeeper for ICA."},{"id":"291fbfea9ebd","type":"article","url":"https://hartvaat.nl/2019/11/19/evolocumab-voor-vroege-ldl-verlaging-bij-acs-evopacs/","title":"Evolocumab voor vroege LDL-verlaging bij ACS: EVOPACS","title_en":"Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS).","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["bempedoïnezuur","dyslipidemie","ezetimibe","ldl-cholesterol","lipide-aferese","lipidenverlaging","statines","yellow-iii"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.010","source_url":"https://doi.org/10.1016/j.jacc.2019.08.010","authors":["Konstantinos C Koskinas","Stephan Windecker","Giovanni Pedrazzini","Christian Mueller","Stéphane Cook","Christian M Matter","Olivier Muller","Jonas Häner","Baris Gencer","Carmela Crljenica","Poorya Amini","Olga Deckarm","Juan F Iglesias","Lorenz Räber","Dik Heg","François Mach"],"significance":7,"published":"2019-11-19","source_date":"2019-11-19","image":"","kennis":[],"congress":"","summary_en":"The EVOPACS study showed that early in-hospital initiation of evolocumab in ACS patients produces rapid and substantial LDL cholesterol reduction within days, establishing the feasibility and efficacy of PCSK9 inhibition in the acute setting.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:27Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"EVOPACS studie naar vroege evolocumab-toediening bij ACS voor snelle LDL-cholesterolreductie in de acute fase.","abstract_original":"BACKGROUND: Although guidelines recommend in-hospital initiation of high-intensity statin therapy in patients with acute coronary syndromes (ACS), low-density lipoprotein cholesterol (LDL-C) target levels are frequently not attained. Evolocumab, a rapidly acting, potent LDL-C-lowering drug, has not been studied in the acute phase of ACS. OBJECTIVES: The purpose of this study was to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab initiated during the in-hospital phase of ACS. METHODS: The authors conducted an investigator-initiated, randomized, double-blind, placebo-controlled trial involving 308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/l on high-intensity statin for at least 4 weeks; ≥2.3 mmol/l on low- or moderate-intensity statin; or ≥3.2 mmol/l on no stable dose of statin). Patients were randomly assigned 1:1 to receive subcutaneous evolocumab 420 mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40 mg. The primary endpoint was percentage change in calculated LDL-C from baseline to 8 weeks. RESULTS: Most patients (78.2%) had not been on previous statin treatment. Mean LDL-C levels decreased from 3.61 to 0.79 mmol/l at week 8 in the evolocumab group, and from 3.42 to 2.06 mmol/l in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% confidence interval: -45.2 to -36.2; p < 0.001). LDL-C levels <1.8 mmol/l were achieved at week 8 by 95.7% of patients in the evolocumab group versus 37.6% in the placebo group. Adverse events and centrally adjudicated cardiovascular events were similar in both groups. CONCLUSIONS: In this first randomized trial assessing a PCSK9 antibody in the very high-risk setting of ACS, evolocumab added to high-intensity statin therapy was well tolerated and resulted in substantial reduction in LDL-C levels, rendering >95% of patients within currently recommended target levels. (EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes [EVOPACS]; NCT03287609)."},{"id":"acd6424e1608","type":"article","url":"https://hartvaat.nl/2019/11/19/empagliflozine-en-lv-massa-bij-diabetes-type-2-met-coronairlijden-empa-heart/","title":"Empagliflozine en LV-massa bij diabetes type 2 met coronairlijden: EMPA-HEART","title_en":"Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["answer-hf","dapa-hf","diabetes-en-hart","diabetes-type-2","empagliflozine","emperor-trials","figaro-dkd","obesitas","slaapapneu","soul-trial"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.042375","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.042375","authors":["Subodh Verma","C David Mazer","Andrew T Yan","Tamique Mason","Vinay Garg","Hwee Teoh","Fei Zuo","Adrian Quan","Michael E Farkouh","David H Fitchett","Shaun G Goodman","Ronald M Goldenberg","Mohammed Al-Omran","Richard E Gilbert","Deepak L Bhatt","Lawrence A Leiter","Peter Jüni","Bernard Zinman","Kim A Connelly"],"significance":8,"published":"2019-11-19","source_date":"2019-11-19","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"The EMPA-HEART trial demonstrated that empagliflozin significantly reduced left ventricular mass index in patients with type 2 diabetes and coronary artery disease, providing the first randomized evidence of direct structural cardiac effects from SGLT2 inhibition.","created":"2026-07-03T10:28:16Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"EMPA-HEART trial die aantoonde dat empagliflozine de linkerkamermassa vermindert bij diabetespatiënten met coronairlijden. Structureel cardioprotectief effect.","abstract_original":"BACKGROUND: SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. METHODS: Between November 2016 and April 2018, we recruited 97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5% to 10.0%, known coronary artery disease, and estimated glomerular filtration rate ≥60mL/min/1.73m2. The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). RESULTS: Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m2, LV mass indexed to body surface area 60.7 [11.9] g/m2), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m2 and 0.01 g/m2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35 g/m2; 95% CI, -5.9 to -0.81g/m2, P=0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference -6.8mmHg, 95% CI -11.2 to -2.3mmHg, P=0.003), diastolic blood pressure (adjusted difference -3.2mmHg; 95% CI, -5.8 to -0.6mmHg, P=0.02) and elevation of hematocrit (P=0.0003). CONCLUSIONS: Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02998970."},{"id":"8a5fde696939","type":"article","url":"https://hartvaat.nl/2019/11/16/vergelijking-van-eerstelijns-antihypertensiva-lancet-systematische-multinational/","title":"Vergelijking van eerstelijns antihypertensiva: Lancet systematische multinationale analyse","title_en":"Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)32317-7","source_url":"https://doi.org/10.1016/S0140-6736(19)32317-7","authors":["Marc A Suchard","Martijn J Schuemie","Harlan M Krumholz","Seng Chan You","RuiJun Chen","Nicole Pratt","Christian G Reich","Jon Duke","David Madigan","George Hripcsak","Patrick B Ryan"],"significance":9,"published":"2019-11-16","source_date":"2019-11-16","image":"","kennis":[],"congress":"","summary_en":"This comprehensive multinational analysis compared all first-line antihypertensive drug classes across millions of patients. Thiazide and thiazide-like diuretics showed the most favorable overall effectiveness-to-safety balance, while ACE inhibitors were associated with a higher risk of angioedema and cough compared with ARBs.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 systematische vergelijking van werkzaamheid en veiligheid van alle eerstelijns antihypertensiva over meerdere nationale databases. Grootste vergelijkende effectiviteitsanalyse ooit.","abstract_original":"BACKGROUND: Uncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in the absence of comorbid indications. Randomised trials have not further refined this choice. METHODS: We developed a comprehensive framework for real-world evidence that enables comparative effectiveness and safety evaluation across many drugs and outcomes from observational data encompassing millions of patients, while minimising inherent bias. Using this framework, we did a systematic, large-scale study under a new-user cohort design to estimate the relative risks of three primary (acute myocardial infarction, hospitalisation for heart failure, and stroke) and six secondary effectiveness and 46 safety outcomes comparing all first-line classes across a global network of six administrative claims and three electronic health record databases. The framework addressed residual confounding, publication bias, and p-hacking using large-scale propensity adjustment, a large set of control outcomes, and full disclosure of hypotheses tested. FINDINGS: Using 4·9 million patients, we generated 22 000 calibrated, propensity-score-adjusted hazard ratios (HRs) comparing all classes and outcomes across databases. Most estimates revealed no effectiveness differences between classes; however, thiazide or thiazide-like diuretics showed better primary effectiveness than angiotensin-converting enzyme inhibitors: acute myocardial infarction (HR 0·84, 95% CI 0·75-0·95), hospitalisation for heart failure (0·83, 0·74-0·95), and stroke (0·83, 0·74-0·95) risk while on initial treatment. Safety profiles also favoured thiazide or thiazide-like diuretics over angiotensin-converting enzyme inhibitors. The non-dihydropyridine calcium channel blockers were significantly inferior to the other four classes. INTERPRETATION: This comprehensive framework introduces a new way of doing observational health-care science at scale. The approach supports equivalence between drug classes for initiating monotherapy for hypertension-in keeping with current guidelines, with the exception of thiazide or thiazide-like diuretics superiority to angiotensin-converting enzyme inhibitors and the inferiority of non-dihydropyridine calcium channel blockers. FUNDING: US National Science Foundation, US National Institutes of Health, Janssen Research & Development, IQVIA, South Korean Ministry of Health & Welfare, Australian National Health and Medical Research Council."},{"id":"8196adde2cb3","type":"article","url":"https://hartvaat.nl/2019/11/12/bempedoinezuur-toegevoegd-aan-statines-bij-hoog-cv-risico-jama-clear-harmony/","title":"Bempedoïnezuur toegevoegd aan statines bij hoog CV-risico: JAMA CLEAR Harmony","title_en":"Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.16585","source_url":"https://doi.org/10.1001/jama.2019.16585","authors":["Anne C Goldberg","Lawrence A Leiter","Erik S G Stroes","Seth J Baum","Jeffrey C Hanselman","LeAnne T Bloedon","Narendra D Lalwani","Pragna M Patel","Xin Zhao","P Barton Duell"],"significance":8,"published":"2019-11-12","source_date":"2019-11-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"The CLEAR Harmony trial showed that bempedoic acid added to maximally tolerated statin therapy produced additional LDL cholesterol lowering with an acceptable safety profile in patients at high cardiovascular risk. The trial established the tolerability of bempedoic acid in a large, long-term study.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 CLEAR Harmony-trial die bempedoïnezuur onderzocht toegevoegd aan maximaal verdragen statines bij patiënten met hoog CV-risico. Additieve LDL-verlaging.","abstract_original":"IMPORTANCE: Additional treatment options are needed for patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with available lipid-lowering therapies. OBJECTIVE: To assess the efficacy of bempedoic acid vs placebo in patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy. DESIGN, SETTING, AND PARTICIPANTS: Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018. A total of 779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy. INTERVENTIONS: Patients were randomized 2:1 to treatment with bempedoic acid (180 mg) (n = 522) or placebo (n = 257) once daily for 52 weeks. MAIN OUTCOMES AND MEASURES: The primary end point was percent change from baseline in LDL-C level at week 12. Secondary measures included changes in levels of lipids, lipoproteins, and biomarkers. RESULTS: Among 779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial. At baseline, mean LDL-C level was 120.4 (SD, 37.9) mg/dL. Bempedoic acid lowered LDL-C levels significantly more than placebo at week 12 (-15.1% vs 2.4%, respectively; difference, -17.4% [95% CI, -21.0% to -13.9%]; P < .001). Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04). Common adverse events included nasopharyngitis (5.2% vs 5.1% with bempedoic acid and placebo, respectively), urinary tract infection (5.0% vs 1.9%), and hyperuricemia (4.2% vs 1.9%). CONCLUSIONS AND RELEVANCE: Among patients at high risk for cardiovascular disease receiving maximally tolerated statins, the addition of bempedoic acid compared with placebo resulted in a significant lowering of LDL-C level over 12 weeks. Further research is needed to assess the durability and clinical effect as well as long-term safety. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02991118."},{"id":"d751aa30f058","type":"article","url":"https://hartvaat.nl/2019/11/12/intensieve-versus-standaard-ambulante-bloeddrukcontrole-en-cerebrovasculaire-uit/","title":"Intensieve versus standaard ambulante bloeddrukcontrole en cerebrovasculaire uitkomsten bij ouderen: INFINITY","title_en":"Effects of Intensive Versus Standard Ambulatory Blood Pressure Control on Cerebrovascular Outcomes in Older People (INFINITY).","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.041603","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.041603","authors":["William B White","Dorothy B Wakefield","Nicola Moscufo","Charles R G Guttmann","Richard F Kaplan","Richard W Bohannon","Douglas Fellows","Charles B Hall","Leslie Wolfson"],"significance":7,"published":"2019-11-12","source_date":"2019-11-12","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/","https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/"],"congress":"","summary_en":"The INFINITY trial showed that intensive ambulatory blood pressure control reduces the progression of cerebral white matter disease in older adults, providing evidence that aggressive blood pressure management may preserve brain health in aging.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"INFINITY gerandomiseerde trial die intensieve versus standaard ambulante bloeddrukcontrole vergeleek op cerebrovasculaire uitkomsten bij oudere patiënten.","abstract_original":"BACKGROUND: Subcortical microvascular disease represented by brain white matter hyperintensity on magnetic resonance imaging is associated with functional decline in older people with hypertension. The effects of 2 levels of 24-hour average systolic blood pressure (BP) on mobility, white matter disease progression, and cognitive function over 3 years were studied. METHODS: This trial was a prospective, randomized, blinded end-points study in patients ≥75 years of age with systolic hypertension and magnetic resonance imaging evidence of white matter hyperintensity lesions. Patients were randomized to a 24-hour mean systolic BP of ≤130 mm Hg (intensive treatment) versus ≤145 mm Hg (standard treatment) with antihypertensive therapies. Primary study outcomes were changes in mobility (gait speed) and accrual of white matter hyperintensity volume after 3 years. Changes in cognitive function (executive processing) and adverse events were also evaluated. RESULTS: In 199 randomized patients, the mean age of the cohort was 80.5 years, and 54% were women; the average 24-hour systolic BP was 149 mm Hg. Goal BPs were achieved after a median treatment period of 3 to 4 months; at that time, the mean 24-hour systolic BP was 127.7 mm Hg in the intensive treatment group and 144.0 mm Hg in the standard treatment group for an average difference of 16.3 mm Hg. Changes in gait speed were not different between treatment groups (0.40±2.0 versus 0.42±2.7 s in the intensive treatment and standard treatment groups, respectively; P=0.91), whereas changes from baseline in white matter hyperintensity volumes were smaller (0.29%) in the intensive treatment group compared with the standard treatment group (0.48%; P=0.03). Cognitive outcomes also were not different between the treatment groups. Major adverse cardiovascular events were higher in the standard treatment group compared with the intensive treatment group (17 versus 4 patients; P=0.01). Falls, with or without injury, and syncope were comparable in the treatment groups. CONCLUSIONS: Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease. Over periods >3 years, a reduction in the accumulation of white matter disease may be a factor in conserving function. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01650402."},{"id":"00e034b1546f","type":"article","url":"https://hartvaat.nl/2019/11/07/5-jaarsuitkomsten-na-pci-of-cabg-bij-hoofdstamlijden-nejm-excel/","title":"5-jaarsuitkomsten na PCI of CABG bij hoofdstamlijden: NEJM EXCEL","title_en":"Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1909406","source_url":"https://doi.org/10.1056/NEJMoa1909406","authors":["Gregg W Stone","A Pieter Kappetein","Joseph F Sabik","Stuart J Pocock","Marie-Claude Morice","John Puskas","David E Kandzari","Dimitri Karmpaliotis","W Morris Brown","Nicholas J Lembo","Adrian Banning","Béla Merkely","Ferenc Horkay","Piet W Boonstra","Ad J van Boven","Imre Ungi","Gabor Bogáts","Samer Mansour","Nicolas Noiseux","Manel Sabaté","Jose Pomar","Mark Hickey","Anthony Gershlick","Pawel E Buszman","Andrzej Bochenek","Erick Schampaert","Pierre Pagé","Rodrigo Modolo","John Gregson","Charles A Simonton","Roxana Mehran","Ioanna Kosmidou","Philippe Généreux","Aaron Crowley","Ovidiu Dressler","Patrick W Serruys"],"significance":9,"published":"2019-11-07","source_date":"2019-11-07","image":"","kennis":[],"congress":"","summary_en":"The 5-year EXCEL results showed no significant difference between PCI and CABG for the primary composite endpoint in left main coronary disease, though controversy arose over differing results depending on whether periprocedural MI was included. The data fueled the ongoing debate about optimal left main revascularization strategy.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 EXCEL 5-jaarsresultaten van PCI versus CABG bij hoofdstamcoronairlijden. Controversieel: veranderde conclusies afhankelijk van MI-definitie.","abstract_original":"BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.)."},{"id":"808d3c1989dd","type":"article","url":"https://hartvaat.nl/2019/11/05/ticagrelor-monotherapie-versus-dapt-vanaf-1-maand-na-des-tico-trial/","title":"Ticagrelor monotherapie versus DAPT vanaf 1 maand na DES: TICO-trial","title_en":"Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.1038","source_url":"https://doi.org/10.1016/j.jacc.2019.08.1038","authors":["Anna Franzone","Eugène McFadden","Sergio Leonardi","Raffaele Piccolo","Pascal Vranckx","Patrick W Serruys","Edouard Benit","Christoph Liebetrau","Luc Janssens","Maurizio Ferrario","Aleksander Zurakowski","Roberto Diletti","Marcello Dominici","Kurt Huber","Ton Slagboom","Paweł Buszman","Leonardo Bolognese","Carlo Tumscitz","Krzysztof Bryniarski","Adel Aminian","Mathias Vrolix","Ivo Petrov","Scot Garg","Christoph Naber","Janusz Prokopczuk","Christian Hamm","Philippe Gabriel Steg","Dik Heg","Peter Jüni","Stephan Windecker","Marco Valgimigli"],"significance":8,"published":"2019-11-05","source_date":"2019-11-05","image":"","kennis":[],"congress":"","summary_en":"The TICO trial demonstrated that ticagrelor monotherapy after 3 months of DAPT reduced bleeding without increasing ischemic events compared with continued DAPT at 1 year after DES implantation. The study added to the growing evidence for early P2Y12 inhibitor monotherapy.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"TICO gerandomiseerde trial die ticagrelor monotherapie vergeleek met DAPT vanaf 1 maand na DES-implantatie. Onderbouwt de strategie van verkorte DAPT met P2Y12-monotherapie.","abstract_original":"BACKGROUND: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. OBJECTIVES: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. METHODS: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. RESULTS: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention. CONCLUSIONS: Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059)."},{"id":"050cc5081b05","type":"article","url":"https://hartvaat.nl/2019/11/05/1-uur-troponine-t-protocol-bij-verdenking-acs-gerandomiseerde-rapid-tnt-trial/","title":"1-uur troponine T-protocol bij verdenking ACS: gerandomiseerde RAPID-TnT-trial","title_en":"A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible Acute Coronary Syndrome in the Emergency Department With High-Sensitivity Troponin T Study (RAPID-TnT).","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.042891","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.042891","authors":["Derek P Chew","Kristina Lambrakis","Andrew Blyth","Anil Seshadri","Michael J R Edmonds","Tom Briffa","Louise A Cullen","Stephen Quinn","Jonathan Karnon","Anthony Chuang","Adam J Nelson","Deborah Wright","Matthew Horsfall","Erin Morton","John K French","Cynthia Papendick"],"significance":7,"published":"2019-11-05","source_date":"2019-11-05","image":"","kennis":[],"congress":"","summary_en":"This randomized trial of a 1-hour high-sensitivity troponin T protocol for suspected ACS demonstrated that rapid rule-out strategies can safely reduce emergency department length of stay without missing acute MI diagnoses.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die een 1-uur hoog-sensitief troponine T-protocol evalueerde voor snelle beoordeling bij verdenking ACS.","abstract_original":"BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505."},{"id":"ff97563b7d76","type":"article","url":"https://hartvaat.nl/2019/11/05/risicoclassificatie-volgens-de-nieuwe-acc-aha-cholesterolrichtlijn-en-stenting-u/","title":"Risicoclassificatie volgens de nieuwe ACC/AHA cholesterolrichtlijn en stenting-uitkomsten","title_en":"Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["dyslipidemie","ezetimibe","statines"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.042551","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.042551","authors":["Matthew T Roe","Qian H Li","Deepak L Bhatt","Vera A Bittner","Rafael Diaz","Shaun G Goodman","Robert A Harrington","J Wouter Jukema","Patricio Lopez-Jaramillo","Renato D Lopes","Michael J Louie","Patrick M Moriarty","Michael Szarek","Robert Vogel","Harvey D White","Andreas M Zeiher","Marie T Baccara-Dinet","Ph Gabriel Steg","Gregory G Schwartz"],"significance":6,"published":"2019-11-05","source_date":"2019-11-05","image":"","kennis":[],"congress":"","summary_en":"This analysis applied the 2018 ACC/AHA cholesterol guideline risk categorization to clinical outcomes, validating the guideline's approach to identifying patients who benefit from escalated lipid-lowering therapy.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die de nieuwe ACC/AHA risicoclassificatie voor cholesterolmanagement toepaste op klinische uitkomsten.","abstract_original":"BACKGROUND: The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. METHODS: In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. RESULTS: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; Pinteraction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; Pinteraction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; Pinteraction=0.661). CONCLUSIONS: The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402."},{"id":"d89f6f7d2f41","type":"article","url":"https://hartvaat.nl/2019/11/01/aspirine-plus-ticagrelor-bij-acs-voordeel-risicoanalyse-van-global-leaders/","title":"Aspirine plus ticagrelor bij ACS: voordeel-risicoanalyse van GLOBAL LEADERS","title_en":"Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["aspirine","trombocytenaggregatieremmers"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.3355","source_url":"https://doi.org/10.1001/jamacardio.2019.3355","authors":["Mariusz Tomaniak","Ply Chichareon","Yoshinobu Onuma","Efthymios N Deliargyris","Kuniaki Takahashi","Norihiro Kogame","Rodrigo Modolo","Chun Ching Chang","Tessa Rademaker-Havinga","Robert F Storey","George D Dangas","Deepak L Bhatt","Dominick J Angiolillo","Christian Hamm","Marco Valgimigli","Stephan Windecker","Philippe Gabriel Steg","Pascal Vranckx","Patrick W Serruys"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This GLOBAL LEADERS post-hoc analysis assessed the risk-benefit of adding aspirin to ticagrelor in ACS patients, providing data on whether aspirin provides incremental ischemic protection or mainly adds bleeding risk.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"GLOBAL LEADERS post-hoc analyse naar het voordeel en de risico's van aspirine-toevoeging aan ticagrelor bij ACS.","abstract_original":"IMPORTANCE: The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. OBJECTIVE: To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). DESIGN, SETTING, AND PARTICIPANTS: This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. INTERVENTIONS: The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. MAIN OUTCOMES AND MEASURES: The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. RESULTS: Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004). CONCLUSIONS AND RELEVANCE: Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01813435."},{"id":"2bea8086ce91","type":"article","url":"https://hartvaat.nl/2019/11/01/inclisiran-1-of-2-dosis-en-ldl-cholesterol-orion-1-1-jaarsfollow-up/","title":"Inclisiran 1- of 2-dosis en LDL-cholesterol: ORION-1 1-jaarsfollow-up","title_en":"Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","statines"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.3502","source_url":"https://doi.org/10.1001/jamacardio.2019.3502","authors":["Kausik K Ray","Robert M Stoekenbroek","David Kallend","Toshiyuki Nishikido","Lawrence A Leiter","Ulf Landmesser","R Scott Wright","Peter L J Wijngaard","John J P Kastelein"],"significance":7,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/inclisiran-sirna/","https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/"],"congress":"","summary_en":"This 1-year ORION-1 follow-up showed that even 1 or 2 doses of inclisiran provide durable LDL cholesterol reduction lasting well beyond the dosing interval, confirming the long-acting nature of the siRNA approach.","created":"2026-07-03T10:28:15Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 Cardiology 1-jaarsfollow-up van ORION-1 die het effect van 1 of 2 doses inclisiran op LDL-cholesterol evalueerde. Duurzame verlaging met siRNA.","abstract_original":"IMPORTANCE: Sustained reductions in low-density lipoprotein cholesterol (LDL-C) with lipid-lowering therapies that require frequent dosing are reliant on patient adherence, and poor adherence is associated with worse clinical outcomes. OBJECTIVE: To determine whether inclisiran, a small interfering RNA, reduces mean LDL-C exposure with an infrequent dosing regimen. DESIGN, SETTING, AND PARTICIPANTS: Prespecified analysis of a randomized, double-blind, placebo-controlled multicenter phase 2 clinical trial. Participants were followed up monthly for LDL-C levels and proprotein convertase subtilisin-kexin type 9 (PCSK9) measurements as well as safety until their LDL-C levels had returned to within 20% of their change from baseline (maximum 360 days). The study included patients with elevated LDL-C despite maximally tolerated statin therapy. Data were analyzed between January 11, 2016, and June 7, 2017. INTERVENTIONS: One dose (200, 300, or 500 mg on day 1) or 2 doses (100, 200, or 300 mg on days 1 and 90) of inclisiran sodium or placebo. MAIN OUTCOMES AND MEASURES: Duration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions over 1 year. RESULTS: At baseline, among the 501 participants, 65% were men (n = 326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n = 28 of 501), and 69% had established ASCVD (n = 347 of 501). Baseline LDL-C was 128 mg/dL among 501 randomized participants. The percentage of participants who were followed up to day 360 because their LDL-C levels had not returned to within 20% of their change from baseline ranged from 48.3% to 65.0% for those receiving a single dose and between 55.9% and 83.1% of those receiving 2 doses, with similar effects observed for PCSK9. Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses. The 2-dose 300-mg regimen produced the highest proportion of responders at day 360 and the greatest mean reduction in LDL-C over 1 year. Incidence of adverse events was similar through to 1 year. CONCLUSIONS AND RELEVANCE: Treatment with inclisiran resulted in durable reductions in LDL-C over 1 year. Inclisiran may offer a novel approach to LDL-C reduction with the convenience of infrequent dosing. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02597127."},{"id":"7ceffb49f695","type":"article","url":"https://hartvaat.nl/2019/11/01/themis-en-themis-pci-editorial-perspectief/","title":"THEMIS en THEMIS-PCI: editorial perspectief","title_en":"THEMIS and THEMIS-PCI.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz707","source_url":"https://doi.org/10.1093/eurheartj/ehz707","authors":["Deepak L Bhatt","Philippe Gabriel Steg"],"significance":5,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This European Heart Journal editorial discussed the THEMIS and THEMIS-PCI trial results with ticagrelor in stable coronary disease and diabetes, evaluating the narrow risk-benefit balance of intensified antiplatelet therapy.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Editorial in European Heart Journal over de THEMIS- en THEMIS-PCI-trials met ticagrelor bij stabiel coronairlijden en diabetes.","abstract_original":""},{"id":"cb9ce069484d","type":"article","url":"https://hartvaat.nl/2019/11/01/causaal-verband-periodontitis-en-hypertensie-mendeliaanse-randomisatie-en-rct/","title":"Causaal verband periodontitis en hypertensie: Mendeliaanse randomisatie en RCT","title_en":"Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz646","source_url":"https://doi.org/10.1093/eurheartj/ehz646","authors":["Marta Czesnikiewicz-Guzik","Grzegorz Osmenda","Mateusz Siedlinski","Richard Nosalski","Piotr Pelka","Daniel Nowakowski","Grzegorz Wilk","Tomasz P Mikolajczyk","Agata Schramm-Luc","Aneta Furtak","Pawel Matusik","Joanna Koziol","Miroslaw Drozdz","Eva Munoz-Aguilera","Maciej Tomaszewski","Evangelos Evangelou","Mark Caulfield","Tomasz Grodzicki","Francesco D'Aiuto","Tomasz J Guzik"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This study combining Mendelian randomization with a randomized trial provided evidence for a causal link between periodontitis and hypertension, supporting the role of chronic oral inflammation in blood pressure elevation.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die met Mendeliaanse randomisatie en een gerandomiseerde trial bewijs levert voor een causaal verband tussen periodontitis en hypertensie.","abstract_original":"AIMS: Inflammation is an important driver of hypertension. Periodontitis is a chronic inflammatory disease, which could provide a mechanism for pro-hypertensive immune activation, but evidence of a causal relationship in humans is scarce. We aimed to investigate the nature of the association between periodontitis and hypertension. METHODS AND RESULTS: We performed a two-sample Mendelian randomization analysis in the ∼750 000 UK-Biobank/International Consortium of Blood Pressure-Genome-Wide Association Studies participants using single nucleotide polymorphisms (SNPs) in SIGLEC5, DEFA1A3, MTND1P5, and LOC107984137 loci GWAS-linked to periodontitis, to ascertain their effect on blood pressure (BP) estimates. This demonstrated a significant relationship between periodontitis-linked SNPs and BP phenotypes. We then performed a randomized intervention trial on the effects of treatment of periodontitis on BP. One hundred and one hypertensive patients with moderate/severe periodontitis were randomized to intensive periodontal treatment (IPT; sub- and supragingival scaling/chlorhexidine; n = 50) or control periodontal treatment (CPT; supragingival scaling; n = 51) with mean ambulatory 24-h (ABPM) systolic BP (SBP) as primary outcome. Intensive periodontal treatment improved periodontal status at 2 months, compared to CPT. This was accompanied by a substantial reduction in mean SBP in IPT compared to the CPT (mean difference of -11.1 mmHg; 95% CI 6.5-15.8; P < 0.001). Systolic BP reduction was correlated to periodontal status improvement. Diastolic BP and endothelial function (flow-mediated dilatation) were also improved by IPT. These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension. CONCLUSION: A causal relationship between periodontitis and BP was observed providing proof of concept for development of clinical trial in a large cohort of hypertensive patients. ClinicalTrials.gov: NCT02131922."},{"id":"f98904b53532","type":"article","url":"https://hartvaat.nl/2019/11/01/interventies-voor-statinevoorschrijving-bij-primaire-cv-preventie-meta-analyse/","title":"Interventies voor statinevoorschrijving bij primaire CV-preventie: meta-analyse","title_en":"Effectiveness of Interventions Aimed at Increasing Statin-Prescribing Rates in Primary Cardiovascular Disease Prevention: A Systematic Review of Randomized Clinical Trials.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts"],"tags":["atleten","farmaco-economie","fractional-flow-reserve","hartrevalidatie","myocardinfarct","ouderen","primaire-preventie","secundaire-preventie","statines","vrouwen"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.3066","source_url":"https://doi.org/10.1001/jamacardio.2019.3066","authors":["Robert T Sparrow","Anam M Khan","Laura E Ferreira-Legere","Dennis T Ko","Cynthia A Jackevicius","Shaun G Goodman","Todd J Anderson","Dawn Stacey","Ildiko Tiszovszky","Michael E Farkouh","Jack V Tu","Jacob A Udell"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/","https://hartvaat.nl/kennis/preventie/statines-primaire-preventie/"],"congress":"","summary_en":"This meta-analysis evaluated interventions designed to increase statin prescribing for primary cardiovascular prevention, identifying which implementation strategies effectively improve the translation of guidelines to practice.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 Cardiology meta-analyse naar de effectiviteit van interventies om statinevoorschrijving in primaire preventie te verhogen.","abstract_original":"IMPORTANCE: Statins are a cornerstone medication in cardiovascular disease prevention, but their use in clinical practice remains suboptimal, with less than half of people who are indicated for statins actually taking the medication. OBJECTIVE: To perform a systematic review and synthesis of the literature on patient-oriented and physician-oriented interventions aimed at increasing statin-prescribing rates in adults without a history of cardiovascular disease. EVIDENCE REVIEW: PubMed, Embase, and the Cochrane Library were searched for randomized clinical trials published between January 2000 and May 2019. Data abstraction was performed using the Cochrane Public Health Review Group's data collection template, and a narrative synthesis of study results was conducted. The risk of bias in each study was qualitatively assessed, and a funnel plot was created to further evaluate the risk of publication bias. FINDINGS: Among 7948 citations and 128 full-text articles reviewed, 20 studies (of 109 807 patients) were included in the review. Eight trials reported a statistically significant increases in statin-prescribing rates. Among the effective trials, absolute effect sizes ranged from 4.2% (95% CI, 2.2%-6.4%) to 23% (95% CI, 7.3%-38.9%) and odds ratios from 1.29 (95% CI, 1.01-1.66) to 11.8 (95% CI, 8.8-15.9). Patient-education initiatives were the most commonly effective intervention, with 4 of 7 trials indicating increases in statin-prescribing rates. Two trials combined electronic decision-support tools with audit-and-feedback systems, both of which were effective overall. Physician-education programs without dynamic input regarding patient risk or updated treatment recommendations were generally found to be less effective. CONCLUSIONS AND RELEVANCE: While heterogeneous in their interventions and outcomes, a number of interventions have demonstrated increases in statin-prescribing rates, with patient-education initiatives demonstrating more promising results than those focused on physician education alone. As opposed to more education about generic recommendations, tailored patient-focused and physician-focused interventions were more effective when they provided personalized cardiovascular risk information, dynamic decision-support tools, or audit-and-feedback reports in a multicomponent program. There are a number of modestly successful approaches to implement increases in rates of statin prescribing, a proven yet underused cardiovascular disease prevention class of therapy."},{"id":"936d306a7d18","type":"article","url":"https://hartvaat.nl/2019/11/01/determinanten-van-linkeratriumtrombi-bij-geplande-cardioversie-ensure-af/","title":"Determinanten van linkeratriumtrombi bij geplande cardioversie: ENSURE-AF","title_en":"Determinants of left atrium thrombi in scheduled cardioversion: an ENSURE-AF study 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/euz213","source_url":"https://doi.org/10.1093/europace/euz213","authors":["Jose L Merino","Gregory Y H Lip","Hein Heidbuchel","Aron-Ariel Cohen","Raffaele De Caterina","Joris R de Groot","Michael D Ezekowitz","Jean-Yves Le Heuzey","Sakis Themistoclakis","James Jin","Michael Melino","Shannon M Winters","Béla Merkely","Andreas Goette"],"significance":5,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This ENSURE-AF analysis identified determinants of left atrial thrombi in AF patients scheduled for cardioversion, informing pre-cardioversion screening decisions and anticoagulation requirements.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ENSURE-AF analyse naar determinanten van linkeratriumtrombi bij patiënten gepland voor cardioversie van AF.","abstract_original":"AIMS: ENSURE-AF (NCT02072434) was the largest prospective randomized clinical trial of anticoagulation for cardioversion in atrial fibrillation (AF), which also provides the largest prospective dataset for transoesophageal echocardiography (TOE) prior to cardioversion. This ancillary analysis investigated determinants of TOE-detected left atrium thrombi (LAT) in patients scheduled for electrical cardioversion (ECV). METHODS AND RESULTS: The ENSURE-AF multicentre PROBE evaluation trial compared edoxaban 60 mg once daily (QD) with enoxaparin/warfarin in 2199 subjects undergoing ECV of non-valvular AF. Patients were stratified by the use of TOE, anticoagulant experience, and selected edoxaban dose. Electrical cardioversion was cancelled or deferred when TOEdetected LAT. In total, 1183 subjects were stratified to the TOE arm and LAT was reported in 91 (8.2%). In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group. Non-significant trends were seen for higher mean CHA2DS2-VASc score (3.0 ± 1.41 vs. 2.7 ± 1.48, P = 0.0571) and more prevalent anticoagulation use prior to enrolment (60.4% vs. 50.3%, P = 0.0795) in the LAT group. In logistic regression analysis, age (P = 0.0202) and heart failure (P = 0.0064) were independently associated with LAT. CONCLUSION: Elective ECV is commonly cancelled or deferred due to TOE-detected LAT in patients with non-valvular AF. Age ≥75 years and heart failure were associated with the presence of LAT."},{"id":"565bb0d10119","type":"article","url":"https://hartvaat.nl/2019/11/01/metformine-en-linkerventrikelhypertrofie-bij-coronairlijden-zonder-diabetes-gera/","title":"Metformine en linkerventrikelhypertrofie bij coronairlijden zonder diabetes: gerandomiseerde trial","title_en":"A randomized controlled trial of metformin on left ventricular hypertrophy in patients with coronary artery disease without diabetes: the MET-REMODEL trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["credence-trial","diabetes-en-hart","diabetes-type-2","ezetimibe","fidelio-dkd","figaro-dkd","select-trial","soul-trial","summit-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz203","source_url":"https://doi.org/10.1093/eurheartj/ehz203","authors":["Mohapradeep Mohan","Shaween Al-Talabany","Angela McKinnie","Ify R Mordi","Jagdeep S S Singh","Stephen J Gandy","Fatima Baig","Muhammad S Hussain","U Bhalraam","Faisel Khan","Anna-Maria Choy","Shona Matthew","John Graeme Houston","Allan D Struthers","Jacob George","Chim C Lang"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This randomized trial found that metformin reduces left ventricular hypertrophy in non-diabetic patients with coronary artery disease and insulin resistance, demonstrating a pleiotropic cardiac benefit beyond glycemic control.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die metformine onderzocht voor reductie van linkerventrikelhypertrofie bij patiënten met coronairlijden zonder diabetes.","abstract_original":"AIM: We tested the hypothesis that metformin may regress left ventricular hypertrophy (LVH) in patients who have coronary artery disease (CAD), with insulin resistance (IR) and/or pre-diabetes. METHODS AND RESULTS: We randomly assigned 68 patients (mean age 65 ± 8 years) without diabetes who have CAD with IR and/or pre-diabetes to receive either metformin XL (2000 mg daily dose) or placebo for 12 months. Primary endpoint was change in left ventricular mass indexed to height1.7 (LVMI), assessed by magnetic resonance imaging. In the modified intention-to-treat analysis (n = 63), metformin treatment significantly reduced LVMI compared with placebo group (absolute mean difference -1.37 (95% confidence interval: -2.63 to -0.12, P = 0.033). Metformin also significantly reduced other secondary study endpoints such as: LVM (P = 0.032), body weight (P = 0.001), subcutaneous adipose tissue (P = 0.024), office systolic blood pressure (BP, P = 0.022) and concentration of thiobarbituric acid reactive substances, a biomarker for oxidative stress (P = 0.04). The glycated haemoglobin A1C concentration and fasting IR index did not differ between study groups at the end of the study. CONCLUSION: Metformin treatment significantly reduced LVMI, LVM, office systolic BP, body weight, and oxidative stress. Although LVH is a good surrogate marker of cardiovascular (CV) outcome, conclusive evidence for the cardio-protective role of metformin is required from large CV outcomes trials."},{"id":"ee76387f994a","type":"article","url":"https://hartvaat.nl/2019/11/01/bloeddrukvariabiliteit-en-progressie-van-klinische-alzheimer/","title":"Bloeddrukvariabiliteit en progressie van klinische Alzheimer","title_en":"Blood Pressure Variability and Progression of Clinical Alzheimer Disease.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13664","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13664","authors":["Rianne A A de Heus","Marcel G M Olde Rikkert","Phillip J Tully","Brian A Lawlor","Jurgen A H R Claassen"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/albumine-creatinine-ratio/"],"congress":"","summary_en":"This study showed that blood pressure variability predicts the progression of clinical Alzheimer disease, establishing a neuro-vascular pathway linking hemodynamic instability to cognitive decline.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het verband tussen bloeddrukvariabiliteit en progressie van klinische Alzheimer. Neurovasculaire interactie.","abstract_original":"Blood pressure variability (BPV) has been shown to have predictive value over blood pressure (BP) levels alone in stroke patients. We assessed whether BPV predicts cognitive and functional decline in Alzheimer disease, using data from a randomized trial (NILVAD [A European Multicentre Double-blind Placebo-controlled Phase III Trial of Nilvadipine in Mild to Moderate Alzheimer's Disease]). Patients with mild-to-moderate Alzheimer disease were included if they had ≥3 office BP measurements available to determine visit-to-visit BPV. Day-to-day BPV was assessed using home BP measurements in a subsample. The variation independent of mean was used to calculate BPV. Outcomes were change in Alzheimer's Disease Assessment Scale-cognitive subscale-12 and Disability Assessment for Dementia after 1 and 1.5 years. A total of 460 patients aged 72.1 (SD=8.1) years, with mean BP of 134.0/75.1 (10.9/6.3) mm Hg were included. After 1 year, patients in the highest quartile of BPV had deteriorated more on Alzheimer's Disease Assessment Scale-cognitive subscale compared with patients in the lowest quartile (systolic: β, 2.24 [95% CI, 0.11-4.38], P=0.040; diastolic: β, 2.54 [95% CI, 0.33-4.75] P=0.024). This association was still present after 1.5 years (systolic: β, 2.86 [95% CI, 0.35-5.36], P=0.026; diastolic: β, 3.30 [95% CI, 0.67-5.93], P=0.014). There was no effect of visit-to-visit BPV on Disability Assessment for Dementia. Day-to-day BPV was available for 46 patients. Significant associations were observed between day-to-day BPV and deterioration on Alzheimer's Disease Assessment Scale-cognitive subscale (systolic: P=0.036) and Disability Assessment for Dementia (systolic: P=0.020; diastolic: P=0.007) after 1 year, but not after 1.5 years. All associations were adjusted for potential confounders, including intervention group. In conclusion, this post hoc analysis indicates that higher visit-to-visit and day-to-day BPV might be associated with progression of Alzheimer disease. Targeting BPV may be a future target to slow decline in patients with Alzheimer disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02017340."},{"id":"03d3ade36d54","type":"article","url":"https://hartvaat.nl/2019/11/01/acute-egfr-daling-door-enalapril-en-mortaliteit-bij-hf-met-ckd/","title":"Acute eGFR-daling door enalapril en mortaliteit bij HF met CKD","title_en":"Acute declines in estimated glomerular filtration rate on enalapril and mortality and cardiovascular outcomes in patients with heart failure with reduced ejection fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","anemie-ckd","ijzertekort"],"journal":"Kidney international","doi":"10.1016/j.kint.2019.05.019","source_url":"https://doi.org/10.1016/j.kint.2019.05.019","authors":["Wendy McCallum","Hocine Tighiouart","Elaine Ku","Deeb Salem","Mark J Sarnak"],"significance":6,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that acute eGFR declines after enalapril initiation in heart failure patients with renal impairment do not predict adverse long-term outcomes, supporting continued RAAS inhibitor use despite initial creatinine rises.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar acute eGFR-dalingen bij enalapril en de associatie met mortaliteit en cardiovasculaire uitkomsten bij hartfalen met nierziekte.","abstract_original":"Angiotensin-converting enzyme inhibitors are beneficial in heart failure with reduced ejection fraction but are associated with acute declines in estimated glomerular filtration rate (eGFR). Prior studies evaluating thresholds of eGFR decline while using angiotensin-converting enzyme inhibitors in heart failure with reduced ejection have not taken into account this medication-driven decline. Here we used data from the Studies of Left Ventricular Dysfunction (SOLVD) trial of 6245 patients and performed Cox proportional hazards regression models to calculate hazard ratios of all-cause mortality and heart failure hospitalization-associated with percent eGFR decline at two- and six-weeks after randomization to enalapril versus placebo. In reference to placebo with equal degree of percent eGFR decline, any eGFR decline in the enalapril arm was associated with lower hazard of both outcomes. Under a conservative estimate using zero percent eGFR decline in the placebo arm as the reference, up to a 10% decline with enalapril was associated with mortality benefit (hazard ratio 0.87 [95% confidence interval 0.77, 0.99]) while up to a 35% decline was associated with decreased risk of heart failure hospitalization (0.78 [0.61, 0.98]). Under an intermediate estimate, up to a 15% decline with enalapril was associated with a mortality benefit (0.86 [0.77, 0.97]) and all levels of eGFR decline were associated with decreased risk of heart failure hospitalization. There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk. Thus, in patients with reduced ejection fraction heart failure, enalapril is associated with decreased risk of mortality and heart failure hospitalizations. Hence, compelling reasons beyond moderate eGFR decline ought to be considered before its use is withdrawn."},{"id":"80a8fe8a971c","type":"article","url":"https://hartvaat.nl/2019/11/01/hartfalenrisicovoorspelling-bij-congenitale-hartafwijkingen-systematische-review/","title":"Hartfalenrisicovoorspelling bij congenitale hartafwijkingen: systematische review","title_en":"Heart failure risk predictions in adult patients with congenital heart disease: a systematic review.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["congenitale-hartafwijking"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-314977","source_url":"https://doi.org/10.1136/heartjnl-2019-314977","authors":["Fei Wang","Lee Harel-Sterling","Sarah Cohen","Aihua Liu","James M Brophy","Gilles Paradis","Ariane J Marelli"],"significance":5,"published":"2019-11-01","source_date":"2019-11-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review summarized heart failure risk prediction models in adult congenital heart disease, identifying the unique risk factors and limited prediction tools available for this growing patient population.","created":"2026-07-03T10:28:14Z","updated":"2026-07-03T13:27:25Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar hartfalenrisicovoorspelling bij volwassenen met aangeboren hartafwijkingen.","abstract_original":"To summarise existing heart failure (HF) risk prediction models and describe the risk factors for HF-related adverse outcomes in adult patients with congenital heart disease (CHD). We performed a systematic search of MEDLINE, EMBASE and Cochrane databases from January 1996 to December 2018. Studies were eligible if they developed multivariable models for risk prediction of decompensated HF in adult patients with CHD (ACHD), death in patients with ACHD-HF or both, or if they reported corresponding predictors. A standardised form was used to extract information from selected studies. Twenty-five studies met the inclusion criteria and all studies were at moderate to high risk of bias. One study derived a model to predict the risk of a composite outcome (HF, death or arrhythmia) with a c-statistic of 0.85. Two studies applied an existing general HF model to patients with ACHD but did not report model performance. Twenty studies presented predictors of decompensated HF, and four examined patient characteristics associated with mortality (two reported predictors of both). A wide variation in population characteristics, outcome of interest and candidate risk factors was observed between studies. Although there were substantial inconsistencies regarding which patient characteristics were predictive of HF-related adverse outcomes, brain natriuretic peptide, New York Heart Association class and CHD lesion characteristics were shown to be important predictors. To date, evidence in the published literature is insufficient to accurately profile patients with ACHD. High-quality studies are required to develop a unique ACHD-HF prediction model and confirm the predictive roles of potential risk factors."},{"id":"df8b61fc43fc","type":"article","url":"https://hartvaat.nl/2019/10/29/langetermijn-werkzaamheid-en-veiligheid-van-evolocumab-bij-hypercholesterolemie/","title":"Langetermijn werkzaamheid en veiligheid van evolocumab bij hypercholesterolemie","title_en":"Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["bempedoïnezuur","cetp-remmers","diabetes-en-hart","dyslipidemie","ezetimibe","familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","hdl-cholesterol","hypertrofische-cardiomyopathie","laminopathie","ldl-cholesterol","lipide-aferese","lipidenverlaging","niet-statine-therapie","pcsk9-remmers","pelacarsen","plaquekarakterisatie","rosuvastatine","statines","vrouwen","yellow-iii"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.1024","source_url":"https://doi.org/10.1016/j.jacc.2019.08.1024","authors":["Michael J Koren","Marc S Sabatine","Robert P Giugliano","Gisle Langslet","Stephen D Wiviott","Andrea Ruzza","Yuhui Ma","Andrew W Hamer","Scott M Wasserman","Frederick J Raal"],"significance":7,"published":"2019-10-29","source_date":"2019-10-29","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This long-term analysis confirmed that evolocumab maintains consistent LDL cholesterol lowering and cardiovascular event reduction over extended follow-up periods, with no attenuation of efficacy or emergence of late safety signals.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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":"Langetermijnanalyse van werkzaamheid en veiligheid van evolocumab bij patiënten met hypercholesterolemie. Bevestigt duurzame LDL-verlaging zonder veiligheidssignalen.","abstract_original":"BACKGROUND: Evolocumab and other anti-PCSK9 antibodies reduced adverse cardiovascular outcomes in clinical trials of high-risk patients over <3 years median treatment duration. OBJECTIVES: The OSLER-1 trial (Open Label Study of Long Term Evaluation Against LDL-C Trial) evaluated longer-term effects of evolocumab during open-label hypercholesterolemia treatment for up to 5 years. METHODS: Patients randomized to standard of care (SOC) or evolocumab 420 mg monthly (evolocumab + SOC) for year 1. After year 1, patients could enter the all-evolocumab period and receive evolocumab + SOC for an additional 4 years. The authors analyzed the persistence of lipid effects and exposure-dependent safety focusing on yearly rates of adverse events (AEs) and anti-drug antibodies over 4.951 patient-years of observation. RESULTS: A total of 1,255 patients (safety analysis population) randomized into the year 1 SOC-controlled period and received ≥1 evolocumab dose (mean ± SD age 57 ± 12 years; 53% female). A total of 1,151 patients (efficacy analysis population) progressed to the all-evolocumab period (year 2 and beyond). Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization. Mean baseline LDL-C decreased from 140 to 61 mg/dl on treatment. Yearly serious AE rates during evolocumab + SOC ranged from 6.9% to 7.9%, comparable to the 6.8% rate in SOC patients during year 1. Evolocumab discontinuation due to AEs occurred in 5.7% of patients. Two SOC and 2 evolocumab + SOC patients developed new, transient, binding anti-drug antibodies; no neutralizing antibodies were observed. CONCLUSIONS: The OSLER-1 trial demonstrated consistently excellent LDL-C-lowering efficacy, tolerance, and safety of evolocumab, with no neutralizing antibodies detected, throughout the longest-duration study of a PCSK9 inhibitor reported to date. (Open Label Study of Long Term Evaluation Against LDL-C Trial [OSLER-1]; NCT01439880)."},{"id":"081e68357cc5","type":"article","url":"https://hartvaat.nl/2019/10/26/patiromer-voor-spironolactongebruik-bij-resistente-hypertensie-met-ckd-lancet-am/","title":"Patiromer voor spironolactongebruik bij resistente hypertensie met CKD: Lancet AMBER","title_en":"Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","internist"],"tags":["aprocitentan","baxdrostat","figaro-dkd","lorundrostat","renale-denervatie","resistente-hypertensie","resistente-hypertensie-aldosteronremmers"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)32135-X","source_url":"https://doi.org/10.1016/S0140-6736(19)32135-X","authors":["Rajiv Agarwal","Patrick Rossignol","Alain Romero","Dahlia Garza","Martha R Mayo","Suzette Warren","Jia Ma","William B White","Bryan Williams"],"significance":8,"published":"2019-10-26","source_date":"2019-10-26","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/mineralocorticoid-antagonisten-hypertensie/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"The AMBER trial showed that patiromer, a potassium binder, enabled continued use of spironolactone in patients with resistant hypertension and CKD by preventing hyperkalemia. The results established a practical solution for the clinical dilemma of MRA use in CKD patients.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 AMBER-trial die patiromer onderzocht om spironolactongebruik mogelijk te maken bij patiënten met resistente hypertensie en CKD. Kaliummanagement als enabler.","abstract_original":"BACKGROUND: Spironolactone is effective at reducing blood pressure in patients with uncontrolled resistant hypertension. However, the use of spironolactone in patients with chronic kidney disease can be restricted by hyperkalaemia. We evaluated use of the potassium binder patiromer to allow more persistent use of spironolactone in patients with chronic kidney disease and resistant hypertension. METHODS: In this phase 2 multicentre, randomised, double-blind, placebo-controlled study, we enrolled participants aged 18 years and older with chronic kidney disease (estimated glomerular filtration rate 25 to ≤45 mL/min per 1·73 m2) and uncontrolled resistant hypertension from 62 outpatient centres in ten countries (Bulgaria, Croatia, Georgia, Hungary, Ukraine, France, Germany, South Africa, the UK, and the USA). Patients meeting all eligibility criteria at the final screening visit were stratified by local serum potassium measurement (4·3 to <4·7 mmol/L vs 4·7 to 5·1 mmol/L) and history of diabetes. Participants were randomly assigned (1:1) with an interactive web response system to receive either placebo or patiromer (8·4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Participants, the study team that administered treatments and measured blood pressure, and the investigators were masked to assigned treatment groups. Dose titrations were permitted after 1 week (patiromer) and 3 weeks (spironolactone). The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomised patients (intention to treat). The study was registered with Clinicaltrials.gov, NCT03071263. FINDINGS: Between Feb 13, 2017, and Aug 20, 2018, we screened 574 patients. 295 (51%) of 574 patients met all inclusion criteria and were randomly assigned to spironolactone in addition to double-blind treatment with either placebo (n=148) or patiromer (n=147). At week 12, 98 (66%) of 148 patients in the placebo group and 126 (86%) of 147 patients in the patiromer group remained on spironolactone (between-group difference 19·5%, 95% CI 10·0-29·0; p<0·0001). Adverse events were mostly mild or moderate in severity and occurred in 79 (53%) of 148 patients in the placebo group and 82 (56%) of 147 patients in the patiromer group. INTERPRETATION: In patients with resistant hypertension and chronic kidney disease, patiromer enabled more patients to continue treatment with spironolactone with less hyperkalaemia. Persistent spironolactone enablement in this population of patients has clinical relevance for the treatment of resistant hypertension. FUNDING: Relypsa, a Vifor Pharma Group Company."},{"id":"8609b28ecd28","type":"article","url":"https://hartvaat.nl/2019/10/24/genotype-geleide-p2y12-remmerkeuze-bij-primaire-pci-nejm-popular-genetics/","title":"Genotype-geleide P2Y12-remmerkeuze bij primaire PCI: NEJM POPular Genetics","title_en":"A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1907096","source_url":"https://doi.org/10.1056/NEJMoa1907096","authors":["Daniel M F Claassens","Gerrit J A Vos","Thomas O Bergmeijer","Renicus S Hermanides","Arnoud W J van 't Hof","Pim van der Harst","Emanuele Barbato","Carmine Morisco","Richard M Tjon Joe Gin","Folkert W Asselbergs","Arend Mosterd","Jean-Paul R Herrman","Willem J M Dewilde","Paul W A Janssen","Johannes C Kelder","Maarten J Postma","Anthonius de Boer","Cornelis Boersma","Vera H M Deneer","Jurriën M Ten Berg"],"significance":9,"published":"2019-10-24","source_date":"2019-10-24","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The POPular Genetics trial showed that genotype-guided de-escalation from ticagrelor or prasugrel to clopidogrel in CYP2C19 noncarriers after primary PCI was noninferior for thrombotic events and reduced bleeding. The study established pharmacogenomic-guided antiplatelet selection as a viable personalized medicine approach.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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":"NEJM POPular Genetics-trial die genotype-geleide de-escalatie van P2Y12-remming onderzocht bij primaire PCI. Pionierswerk in farmacogenetisch gestuurd antiplaatjesbeleid.","abstract_original":"BACKGROUND: It is unknown whether patients undergoing primary percutaneous coronary intervention (PCI) benefit from genotype-guided selection of oral P2Y12 inhibitors. METHODS: We conducted a randomized, open-label, assessor-blinded trial in which patients undergoing primary PCI with stent implantation were assigned in a 1:1 ratio to receive either a P2Y12 inhibitor on the basis of early CYP2C19 genetic testing (genotype-guided group) or standard treatment with either ticagrelor or prasugrel (standard-treatment group) for 12 months. In the genotype-guided group, carriers of CYP2C19*2 or CYP2C19*3 loss-of-function alleles received ticagrelor or prasugrel, and noncarriers received clopidogrel. The two primary outcomes were net adverse clinical events - defined as death from any cause, myocardial infarction, definite stent thrombosis, stroke, or major bleeding defined according to Platelet Inhibition and Patient Outcomes (PLATO) criteria - at 12 months (primary combined outcome; tested for noninferiority, with a noninferiority margin of 2 percentage points for the absolute difference) and PLATO major or minor bleeding at 12 months (primary bleeding outcome). RESULTS: For the primary analysis, 2488 patients were included: 1242 in the genotype-guided group and 1246 in the standard-treatment group. The primary combined outcome occurred in 63 patients (5.1%) in the genotype-guided group and in 73 patients (5.9%) in the standard-treatment group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.0 to 0.7; P<0.001 for noninferiority). The primary bleeding outcome occurred in 122 patients (9.8%) in the genotype-guided group and in 156 patients (12.5%) in the standard-treatment group (hazard ratio, 0.78; 95% CI, 0.61 to 0.98; P = 0.04). CONCLUSIONS: In patients undergoing primary PCI, a CYP2C19 genotype-guided strategy for selection of oral P2Y12 inhibitor therapy was noninferior to standard treatment with ticagrelor or prasugrel at 12 months with respect to thrombotic events and resulted in a lower incidence of bleeding. (Funded by the Netherlands Organization for Health Research and Development; POPular Genetics ClinicalTrials.gov number, NCT01761786; Netherlands Trial Register number, NL2872.)."},{"id":"7718b58a06e7","type":"article","url":"https://hartvaat.nl/2019/10/24/sacubitril-valsartan-bij-hfpef-nejm-paragon-hf/","title":"Sacubitril/valsartan bij HFpEF: NEJM PARAGON-HF","title_en":"Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["answer-hf","sacubitril-valsartan"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1908655","source_url":"https://doi.org/10.1056/NEJMoa1908655","authors":["Scott D Solomon","John J V McMurray","Inder S Anand","Junbo Ge","Carolyn S P Lam","Aldo P Maggioni","Felipe Martinez","Milton Packer","Marc A Pfeffer","Burkert Pieske","Margaret M Redfield","Jean L Rouleau","Dirk J van Veldhuisen","Faiez Zannad","Michael R Zile","Akshay S Desai","Brian Claggett","Pardeep S Jhund","Sergey A Boytsov","Josep Comin-Colet","John Cleland","Hans-Dirk Düngen","Eva Goncalvesova","Tzvetana Katova","Jose F Kerr Saraiva","Małgorzata Lelonek","Bela Merkely","Michele Senni","Sanjiv J Shah","Jingmin Zhou","Adel R Rizkala","Jianjian Gong","Victor C Shi","Martin P Lefkowitz"],"significance":9,"published":"2019-10-24","source_date":"2019-10-24","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"The PARAGON-HF trial did not meet its primary endpoint of reduced heart failure hospitalization or cardiovascular death with sacubitril-valsartan versus valsartan in HFpEF. However, prespecified subgroup analysis suggested benefit in patients with lower ejection fractions and in women, informing the expanding indication for ARNI.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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":"NEJM PARAGON-HF-trial die sacubitril/valsartan vergeleek met valsartan bij HFpEF. Primaire eindpunt niet gehaald — maar signaal bij lager LVEF-spectrum en vrouwen.","abstract_original":"BACKGROUND: The angiotensin receptor-neprilysin inhibitor sacubitril-valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor-neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear. METHODS: We randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril-valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed. RESULTS: There were 894 primary events in 526 patients in the sacubitril-valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P = 0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril-valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril-valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril-valsartan group. Patients in the sacubitril-valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril-valsartan in patients with lower ejection fraction and in women. CONCLUSIONS: Sacubitril-valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.)."},{"id":"689290c62bd7","type":"article","url":"https://hartvaat.nl/2019/10/22/individualisering-van-revascularisatiestrategie-bij-diabetes-met-multivatenlijde/","title":"Individualisering van revascularisatiestrategie bij diabetes met multivatenlijden","title_en":"Individualizing Revascularization Strategy for Diabetic Patients With Multivessel Coronary Disease.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.083","source_url":"https://doi.org/10.1016/j.jacc.2019.07.083","authors":["Mohammed Qintar","Karin H Humphries","Julie E Park","Suzanne V Arnold","Yuanyuan Tang","Phillip Jones","Adam C Salisbury","Faraz Kureshi","Michael E Farkouh","Valentin Fuster","David J Cohen","John A Spertus"],"significance":6,"published":"2019-10-22","source_date":"2019-10-22","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This analysis developed an individualized approach to revascularization strategy selection (PCI vs CABG) in diabetic patients with multivessel disease, using patient-specific risk modeling rather than one-size-fits-all recommendations.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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":"Analyse naar individualisering van de revascularisatiekeuze (PCI vs CABG) bij diabetespatiënten met multivatencoronairlijden.","abstract_original":"BACKGROUND: In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world. OBJECTIVES: To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built. METHODS: Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry. RESULTS: The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking. CONCLUSIONS: To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments."},{"id":"9a38deb81b65","type":"article","url":"https://hartvaat.nl/2019/10/22/ccta-geleide-therapie-verbetert-uitkomsten-bij-stabiele-pijn-op-de-borst/","title":"CCTA-geleide therapie verbetert uitkomsten bij stabiele pijn op de borst","title_en":"Guiding Therapy by Coronary CT Angiography Improves Outcomes in Patients With Stable Chest Pain.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.085","source_url":"https://doi.org/10.1016/j.jacc.2019.07.085","authors":["Philip D Adamson","Michelle C Williams","Marc R Dweck","Nicholas L Mills","Nicholas A Boon","Marwa Daghem","Rong Bing","Alastair J Moss","Kenneth Mangion","Marcus Flather","John Forbes","Amanda Hunter","John Norrie","Anoop S V Shah","Adam D Timmis","Edwin J R van Beek","Amir A Ahmadi","Jonathon Leipsic","Jagat Narula","David E Newby","Giles Roditi","David A McAllister","Colin Berry"],"significance":7,"published":"2019-10-22","source_date":"2019-10-22","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This SCOT-HEART analysis confirmed that coronary CT angiography-guided therapy improves outcomes in patients with stable chest pain by enabling earlier initiation of preventive treatments based on anatomical disease identification.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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 die aantoont dat CCTA-geleide therapie de uitkomsten verbetert bij patiënten met stabiele pijn op de borst.","abstract_original":"BACKGROUND: Within the SCOT-HEART (Scottish COmputed Tomography of the HEART Trial) trial of patients with stable chest pain, the use of coronary computed tomography angiography (CTA) reduced the rate of death from coronary heart disease or nonfatal myocardial infarction (primary endpoint). OBJECTIVES: This study sought to assess the consistency and mechanisms of the 5-year reduction in this endpoint. METHODS: In this open-label trial, 4,146 participants were randomized to standard care alone or standard care plus coronary CTA. This study explored the primary endpoint by symptoms, diagnosis, coronary revascularizations, and preventative therapies. RESULTS: Event reductions were consistent across symptom and risk categories (p = NS for interactions). In patients who were not diagnosed with angina due to coronary heart disease, coronary CTA was associated with a lower primary endpoint incidence rate (0.23; 95% confidence interval [CI]: 0.13 to 0.35 vs. 0.59; 95% CI: 0.42 to 0.80 per 100 patient-years; p < 0.001). In those who had undergone coronary CTA, rates of coronary revascularization were higher in the first year (hazard ratio [HR]: 1.21; 95% CI: 1.01 to 1.46; p = 0.042) but lower beyond 1 year (HR: 0.59; 95% CI: 0.38 to 0.90; p = 0.015). Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease. Modeling studies demonstrated the plausibility of the observed effect size. CONCLUSIONS: The beneficial effect of coronary CTA on outcomes is consistent across subgroups with plausible underlying mechanisms. Coronary CTA improves coronary heart disease outcomes by enabling better targeting of preventative treatments to those with coronary artery disease. (Scottish COmputed Tomography of the HEART Trial [SCOT-HEART]; NCT01149590)."},{"id":"6b1cdeb1a6fe","type":"article","url":"https://hartvaat.nl/2019/10/22/implanteerbare-monitor-voor-snellere-behandeling-bij-acs/","title":"Implanteerbare monitor voor snellere behandeling bij ACS","title_en":"Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.084","source_url":"https://doi.org/10.1016/j.jacc.2019.07.084","authors":["David R Holmes","Mitchell W Krucoff","Chris Mullin","Ghiath Mikdadi","Dale Presser","David Wohns","Andrew Kaplan","Allen Ciuffo","Arthur L Eberly","Bruce Iteld","David R Fischell","Tim Fischell","David Keenan","M Sasha John","C Michael Gibson"],"significance":6,"published":"2019-10-22","source_date":"2019-10-22","image":"","kennis":[],"congress":"","summary_en":"This study tested whether an implanted cardiac monitor with automated alerting during ACS events reduces treatment delay, exploring technology-enabled earlier presentation for acute coronary syndromes.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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 naar een geïmplanteerde monitor die alarmeert bij ACS-events voor snellere behandeling.","abstract_original":"BACKGROUND: Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome. OBJECTIVES: The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events. METHODS: In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n = 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true- or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms + symptoms, or symptoms only. RESULTS: The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h. CONCLUSIONS: Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's self-normative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF. (AngeLmed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)."},{"id":"c6283296892f","type":"article","url":"https://hartvaat.nl/2019/10/22/sekse-specifieke-troponinedrempels-bij-verdenking-acs/","title":"Sekse-specifieke troponinedrempels bij verdenking ACS","title_en":"Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":["troponine"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.082","source_url":"https://doi.org/10.1016/j.jacc.2019.07.082","authors":["Kuan Ken Lee","Amy V Ferry","Atul Anand","Fiona E Strachan","Andrew R Chapman","Dorien M Kimenai","Steven J R Meex","Colin Berry","Iain Findlay","Alan Reid","Anne Cruickshank","Alasdair Gray","Paul O Collinson","Fred S Apple","David A McAllister","Donogh Maguire","Keith A A Fox","David E Newby","Chris Tuck","Catriona Keerie","Christopher J Weir","Anoop S V Shah","Nicholas L Mills"],"significance":7,"published":"2019-10-22","source_date":"2019-10-22","image":"","kennis":[],"congress":"","summary_en":"This study demonstrated that sex-specific high-sensitivity troponin thresholds improve the diagnostic accuracy for acute coronary syndrome in women, who are systematically underdiagnosed when universal thresholds are applied.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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 naar sekse-specifieke drempelwaarden van hoog-sensitief troponine bij verdenking op ACS. Verbetert de diagnostische accuratesse bij vrouwen.","abstract_original":"BACKGROUND: Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized. OBJECTIVES: The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. METHODS: Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year. RESULTS: A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01). CONCLUSIONS: Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123)."},{"id":"74f7584a382c","type":"article","url":"https://hartvaat.nl/2019/10/22/ticagrelor-monotherapie-bij-multivaten-pci-werkzaamheid-en-veiligheid/","title":"Ticagrelor monotherapie bij multivaten-PCI: werkzaamheid en veiligheid","title_en":"Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.997","source_url":"https://doi.org/10.1016/j.jacc.2019.08.997","authors":["Kuniaki Takahashi","Patrick W Serruys","Ply Chichareon","Chun Chin Chang","Mariusz Tomaniak","Rodrigo Modolo","Norihiro Kogame","Michael Magro","Saqib Chowdhary","Ingo Eitel","Robert Zweiker","Paul Ong","Michael Mundt Ottesen","Jan G P Tijssen","Joanna J Wykrzykowska","Robbert J de Winter","Scot Garg","Hans-Peter Stoll","Christian Hamm","Philippe Gabriel Steg","Yoshinobu Onuma","Marco Valgimigli","Pascal Vranckx","Didier Carrie","Stephan Windecker"],"significance":6,"published":"2019-10-22","source_date":"2019-10-22","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study evaluated ticagrelor monotherapy after short DAPT in patients undergoing multivessel PCI, extending the de-escalation evidence to the complex multi-stent population.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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 naar werkzaamheid en veiligheid van ticagrelor monotherapie bij patiënten die multivaten-PCI ondergaan.","abstract_original":"BACKGROUND: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. OBJECTIVES: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. METHODS: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). CONCLUSIONS: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435)."},{"id":"ea18408b5784","type":"article","url":"https://hartvaat.nl/2019/10/21/digoxine-en-mortaliteit-gerandomiseerd-versus-observationeel-in-de-dig-trial/","title":"Digoxine en mortaliteit: gerandomiseerd versus observationeel in de DIG-trial","title_en":"Digoxin-mortality: randomized vs. observational comparison in the DIG trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz395","source_url":"https://doi.org/10.1093/eurheartj/ehz395","authors":["Lukas Aguirre Dávila","Kristina Weber","Udo Bavendiek","Johann Bauersachs","Janet Wittes","Salim Yusuf","Armin Koch"],"significance":6,"published":"2019-10-21","source_date":"2019-10-21","image":"","kennis":[],"congress":"","summary_en":"This DIG trial analysis compared randomized with observational mortality estimates for digoxin, demonstrating how non-randomized analyses can produce misleading conclusions about drug safety due to confounding by indication.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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 die gerandomiseerde versus observationele mortaliteitsdata voor digoxine vergeleek in de DIG-trial. Methodologisch relevant voor het digoxinedebat.","abstract_original":"AIMS: The Digitalis Investigation Group (DIG) trial, the only large randomized trial of digoxin in heart failure, reported a neutral effect on mortality and a significant reduction in heart failure hospitalizations. Recent observational studies reported increased mortality with digoxin treatment. We present further analyses of the DIG trial displaying the inability to control bias in observational treatment comparisons despite extensive statistical adjustments. METHODS AND RESULTS: Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment. We contrast the main randomization-based result of the DIG trial with the observational non-randomized comparison of patients pre-treated or not pre-treated with digoxin. Mortality [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.12-1.34; P < 0.001] and heart failure hospitalizations (HR 1.47, 95% CI 1.33-1.61; P < 0.001) were significantly higher in patients pre-treated with digoxin even after adjustment for baseline population differences. The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001). This sharply contradicts the neutral effect on mortality and the significant reduction in heart failure hospitalizations observed in the randomized comparison. CONCLUSION: Prescription of digoxin is an indicator of disease severity and worse prognosis, which cannot be fully accounted for by covariate adjustments in the DIG trial where patients were well-characterized. It is unlikely that weaker research approaches (observational studies of administrative data or registries) can provide more reliable estimates of the effects of cardiac glycosides."},{"id":"fc5c54b78bc4","type":"article","url":"https://hartvaat.nl/2019/10/21/cv-biomarkers-bij-acuut-gedecompenseerd-hf-met-sacubitril-valsartan-pioneer-hf/","title":"CV-biomarkers bij acuut gedecompenseerd HF met sacubitril/valsartan: PIONEER-HF","title_en":"Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["answer-hf","sacubitril-valsartan"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz240","source_url":"https://doi.org/10.1093/eurheartj/ehz240","authors":["David A Morrow","Eric J Velazquez","Adam D DeVore","Margaret F Prescott","Carol I Duffy","Yared Gurmu","Kevin McCague","Ricardo Rocha","Eugene Braunwald"],"significance":6,"published":"2019-10-21","source_date":"2019-10-21","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/cardiale-biomarkers-overzicht/","https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"This PIONEER-HF biomarker analysis showed that sacubitril-valsartan produces greater reductions in cardiac troponin and soluble ST2 compared with enalapril in acute heart failure, indicating reduced myocardial stress and fibrosis with ARNI therapy.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"PIONEER-HF biomarkeranalyse die cardiovasculaire biomarkerresponsen vergeleek met sacubitril/valsartan versus enalapril bij acuut HF.","abstract_original":"AIMS: Circulating high-sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2) reflect myocardial stress in patients with heart failure (HF). Production of cyclic guanosine 3'5' monophosphate (cGMP) in response to activation of natriuretic peptide receptors reduces cardiac afterload and preload. We assessed the effects of sacubitril/valsartan on these biomarkers in patients with reduced ejection fraction and acute decompensated HF (ADHF). METHODS AND RESULTS: PIONEER-HF was a randomized, double-blind trial of sacubitril/valsartan vs. enalapril in hospitalized patients with ADHF following haemodynamic stabilization. We measured circulating hsTnT, sST2, and urinary cGMP at baseline, 1, 2 (sST2, cGMP), 4, and 8 weeks (n = 694 with all baseline biomarkers). Ratios of geometric means (timepoint/baseline) were determined and compared as a ratio for sacubitril/valsartan vs. enalapril. Compared with enalapril, sacubitril/valsartan led to a significantly greater decline in hsTnT and sST2. This effect emerged as early as 1 week for sST2 and was significant for both at 4 weeks with a 16% greater reduction in hsTnT (P < 0.001) and 9% greater reduction in sST2 (P = 0.0033). Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week). The significant differences between treatment groups for each biomarker were sustained at 8 weeks. In an exploratory multivariable-adjusted analysis of cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2 at week 1 were significantly associated with subsequent outcome. CONCLUSION: Biomarkers of myocardial stress are elevated in patients with ADHF and associated with outcome. Compared with enalapril, sacubitril/valsartan reduces myocardial injury and haemodynamic stress as reflected by biomarkers, with an onset that is apparent within 1-4 weeks. CLINICAL TRIALS REGISTRATION: NCT02554890 clinical.trials.gov."},{"id":"277a3883c8db","type":"article","url":"https://hartvaat.nl/2019/10/19/remote-ischemische-conditionering-en-mi-uitkomsten-lancet-condi-2-eric-ppci/","title":"Remote ischemische conditionering en MI-uitkomsten: Lancet CONDI-2/ERIC-PPCI","title_en":"Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)32039-2","source_url":"https://doi.org/10.1016/S0140-6736(19)32039-2","authors":["Derek J Hausenloy","Rajesh K Kharbanda","Ulla Kristine Møller","Manish Ramlall","Jens Aarøe","Robert Butler","Heerajnarain Bulluck","Tim Clayton","Ali Dana","Matthew Dodd","Thomas Engstrom","Richard Evans","Jens Flensted Lassen","Erika Frischknecht Christensen","José Manuel Garcia-Ruiz","Diana A Gorog","Jakob Hjort","Richard F Houghton","Borja Ibanez","Rosemary Knight","Freddy K Lippert","Jacob T Lønborg","Michael Maeng","Dejan Milasinovic","Ranjit More","Jennifer M Nicholas","Lisette Okkels Jensen","Alexander Perkins","Nebojsa Radovanovic","Roby D Rakhit","Jan Ravkilde","Alisdair D Ryding","Michael R Schmidt","Ingunn Skogstad Riddervold","Henrik Toft Sørensen","Goran Stankovic","Madhusudhan Varma","Ian Webb","Christian Juhl Terkelsen","John P Greenwood","Derek M Yellon","Hans Erik Bøtker"],"significance":8,"published":"2019-10-19","source_date":"2019-10-19","image":"","kennis":[],"congress":"","summary_en":"The CONDI-2/ERIC-PPCI trial definitively showed that remote ischemic conditioning applied to the arm before primary PCI for STEMI did not improve clinical outcomes at 12 months. The large, multicenter negative result ended the clinical pursuit of this cardioprotective strategy.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"Lancet CONDI-2/ERIC-PPCI trial die remote ischemische conditionering onderzocht bij acuut MI. Definitief negatief — geen klinisch voordeel.","abstract_original":"BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden."},{"id":"a657aa8ac7da","type":"article","url":"https://hartvaat.nl/2019/10/17/ticagrelor-of-prasugrel-bij-acuut-coronair-syndroom-nejm-isar-react-5/","title":"Ticagrelor of prasugrel bij acuut coronair syndroom: NEJM ISAR-REACT 5","title_en":"Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1908973","source_url":"https://doi.org/10.1056/NEJMoa1908973","authors":["Stefanie Schüpke","Franz-Josef Neumann","Maurizio Menichelli","Katharina Mayer","Isabell Bernlochner","Jochen Wöhrle","Gert Richardt","Christoph Liebetrau","Bernhard Witzenbichler","David Antoniucci","Ibrahim Akin","Lorenz Bott-Flügel","Marcus Fischer","Ulf Landmesser","Hugo A Katus","Dirk Sibbing","Melchior Seyfarth","Marion Janisch","Duino Boncompagni","Raphaela Hilz","Wolfgang Rottbauer","Rainer Okrojek","Helge Möllmann","Willibald Hochholzer","Angela Migliorini","Salvatore Cassese","Pasquale Mollo","Erion Xhepa","Sebastian Kufner","Axel Strehle","Stefan Leggewie","Abdelhakim Allali","Gjin Ndrepepa","Helmut Schühlen","Dominick J Angiolillo","Christian W Hamm","Alexander Hapfelmeier","Ralph Tölg","Dietmar Trenk","Heribert Schunkert","Karl-Ludwig Laugwitz","Adnan Kastrati"],"significance":10,"published":"2019-10-17","source_date":"2019-10-17","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/wat-is-coronairlijden/","https://hartvaat.nl/kennis/diagnostiek/cardiale-biomarkers-overzicht/"],"congress":"","summary_en":"The ISAR-REACT 5 trial found that prasugrel was superior to ticagrelor in reducing the composite of death, MI, or stroke in patients with acute coronary syndromes planned for invasive management, with no significant difference in bleeding. This first major head-to-head comparison of newer P2Y12 inhibitors influenced antiplatelet selection in ACS.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"Landmark NEJM ISAR-REACT 5-trial die prasugrel superieur toonde aan ticagrelor bij ACS-patiënten gepland voor PCI. Eerste head-to-head vergelijking met klinische superioriteit.","abstract_original":"BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.)."},{"id":"7f5709f2c627","type":"article","url":"https://hartvaat.nl/2019/10/15/triglyceridenverlaging-en-cv-risicoreductie-over-therapeutische-klassen-meta-ana/","title":"Triglyceridenverlaging en CV-risicoreductie over therapeutische klassen: meta-analyse","title_en":"Association Between Triglyceride Lowering and Reduction of Cardiovascular Risk Across Multiple Lipid-Lowering Therapeutic Classes: A Systematic Review and Meta-Regression Analysis of Randomized Controlled Trials.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","dyslipidemie","ezetimibe","farmaco-economie","fidelity","hypertriglyceridemie","lipidenverlaging","niet-statine-therapie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.041998","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.041998","authors":["Nicholas A Marston","Robert P Giugliano","KyungAh Im","Michael G Silverman","Michelle L O'Donoghue","Stephen D Wiviott","Brian A Ference","Marc S Sabatine"],"significance":8,"published":"2019-10-15","source_date":"2019-10-15","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This meta-analysis demonstrated that the association between triglyceride lowering and cardiovascular risk reduction depends on concomitant reductions in apolipoprotein B-containing lipoproteins. Triglyceride lowering per se, without apoB reduction, does not reliably reduce cardiovascular events.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"Meta-analyse die het verband onderzocht tussen triglyceridenverlaging en cardiovasculaire risicoreductie over meerdere therapeutische klassen. Bevestigt triglyceriden als behandeldoel.","abstract_original":"BACKGROUND: Randomized trials of therapies that primarily lowered triglycerides have not consistently shown reductions in cardiovascular events. METHODS: We performed a systematic review and trial-level meta-regression analysis of 3 classes of lipid-lowering therapies that reduce triglycerides to a greater extent than they do low-density lipoprotein cholesterol (LDL-C): fibrates, niacin, and marine-derived omega-3 fatty acids. Key inclusion criteria were a randomized controlled trial that reported major vascular events. We also incorporated data from a previous meta-regression of 25 statin trials. The main outcome measure was the risk ratio (RR) for major vascular events associated with absolute reductions in lipid parameters. RESULTS: A total of 197 270 participants from 24 trials of nonstatin therapy with 25 218 major vascular events and 177 088 participants from 25 trials of statin therapy with 20 962 major vascular events were included, for a total of 374 358 patients and 46 180 major cardiovascular events. Starting with non-high-density lipoprotein cholesterol, a surrogate for very-low-density lipoproteins and low-density lipoproteins, the RR per 1-mmol/L reduction in non-high-density lipoprotein cholesterol was 0.79 (95% CI, 0.76-0.82; P<0.0001; 0.78 per 40 mg/dL). In a multivariable meta-regression model that included terms for both LDL-C and triglyceride (surrogates for low-density lipoproteins and very-low-density lipoproteins, respectively), the RR was 0.80 (95% CI, 0.76-0.85; P<0.0001) per 1-mmol/L (0.79 per 40 mg/dL) reduction in LDL-C and 0.84 (95% CI, 0.75-0.94; P=0.0026) per 1-mmol/L (0.92 per 40 mg/dL) reduction in triglycerides. REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) was a significant outlier and strongly influential trial in the meta-regression. When removed, the RRs became 0.79 (95% CI, 0.76-0.83; P<0.0001) per 1-mmol/L (0.78 per 40 mg/dL) reduction in LDL-C and 0.91 (95% CI, 0.81-1.006; P=0.06) per 1-mmol/L (0.96 per 40 mg/dL) reduction in triglycerides. In regard to omega-3 dose, each 1 g/d eicosapentaenoic acid administered was associated with a 7% relative risk reduction in major vascular events (RR, 0.93 [95% CI, 0.91-0.95]; P<0.0001), whereas there was no significant association between the dose of docosahexaenoic acid and the relative risk reduction in major vascular events (RR 0.96 [95% CI, 0.89-1.03]). CONCLUSIONS: In randomized controlled trials, triglyceride lowering is associated with a lower risk of major vascular events, even after adjustment for LDL-C lowering, although the effect is less than that for LDL-C and attenuated when REDUCE-IT is excluded. Furthermore, the benefits of marine-derived omega-3 fatty acids, particularly high-dose eicosapentaenoic acid, appear to exceed their lipid-lowering effects."},{"id":"0a84a5b5c226","type":"article","url":"https://hartvaat.nl/2019/10/15/community-health-workers-verbeteren-koppeling-met-hypertensiezorg-in-kenia/","title":"Community health workers verbeteren koppeling met hypertensiezorg in Kenia","title_en":"Community Health Workers Improve Linkage to Hypertension Care in Western Kenya.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.003","source_url":"https://doi.org/10.1016/j.jacc.2019.08.003","authors":["Rajesh Vedanthan","Jemima H Kamano","Allison K DeLong","Violet Naanyu","Cynthia A Binanay","Gerald S Bloomfield","Stavroula A Chrysanthopoulou","Eric A Finkelstein","Joseph W Hogan","Carol R Horowitz","Thomas S Inui","Diana Menya","Vitalis Orango","Eric J Velazquez","Martin C Were","Sylvester Kimaiyo","Valentin Fuster"],"significance":6,"published":"2019-10-15","source_date":"2019-10-15","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/therapietrouw-hypertensie/"],"congress":"","summary_en":"This study demonstrated that community health workers effectively improve linkage to hypertension care in rural Kenya, providing a scalable workforce model for addressing the global hypertension treatment gap in sub-Saharan Africa.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het effect van community health workers op de koppeling met hypertensiezorg in Kenia. Globale hypertensiebestrijding.","abstract_original":"BACKGROUND: Elevated blood pressure (BP) is the leading global risk factor for mortality. Delay in seeking hypertension care is associated with increased mortality. OBJECTIVES: This study investigated whether community health workers, equipped with behavioral communication strategies and smartphone technology, can increase linkage of individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP. METHODS: The study was a cluster randomized trial with 3 arms: 1) usual care (standard training); 2) \"paper-based\" (tailored behavioral communication, using paper-based tools); and 3) \"smartphone\" (tailored behavioral communication, using smartphone technology). The co-primary outcomes were: 1) linkage to care; and 2) change in systolic BP (SBP). A covariate-adjusted mixed-effects model was used, adjusting for differential time to follow-up. Bootstrap and multiple imputation were used to handle missing data. RESULTS: A total of 1,460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone). Average baseline SBP was 159.4 mm Hg. Follow-up measures of linkage were available for 1,128 (77%) and BP for 1,106 (76%). Linkage to care was 49% overall, with significantly greater linkage in the usual care and smartphone arms of the trial. Average overall follow-up SBP was 149.9 mm Hg. Participants in the smartphone arm experienced a modestly greater reduction in SBP versus usual care (-13.1 mm Hg vs. -9.7 mm Hg), but this difference was not statistically significant. Mediation analysis revealed that linkage to care contributed to SBP change. CONCLUSIONS: A strategy combining tailored behavioral communication and mobile health (mHealth) for community health workers led to improved linkage to care, but not statistically significant improvement in SBP reduction. Further innovations to improve hypertension control are needed. (Optimizing Linkage and Retention to Hypertension Care in Rural Kenya [LARK]; NCT01844596)."},{"id":"d7b08caae130","type":"article","url":"https://hartvaat.nl/2019/10/12/edoxaban-versus-vka-gebaseerd-antitrombotisch-regime-na-stenting-bij-af-lancet-e/","title":"Edoxaban- versus VKA-gebaseerd antitrombotisch regime na stenting bij AF: Lancet ENTRUST-AF PCI","title_en":"Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31872-0","source_url":"https://doi.org/10.1016/S0140-6736(19)31872-0","authors":["Pascal Vranckx","Marco Valgimigli","Lars Eckardt","Jan Tijssen","Thorsten Lewalter","Giuseppe Gargiulo","Valerii Batushkin","Gianluca Campo","Zoreslava Lysak","Igor Vakaliuk","Krzysztof Milewski","Petra Laeis","Paul-Egbert Reimitz","Rüdiger Smolnik","Wolfgang Zierhut","Andreas Goette"],"significance":8,"published":"2019-10-12","source_date":"2019-10-12","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"The ENTRUST-AF PCI trial showed that edoxaban-based dual antithrombotic therapy (edoxaban plus P2Y12 inhibitor) met the noninferiority threshold for bleeding compared with VKA-based triple therapy in AF patients after PCI, adding a fourth DOAC to the evidence supporting aspirin-free strategies.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"Lancet ENTRUST-AF PCI trial die edoxaban-gebaseerd duale therapie vergeleek met VKA-gebaseerd triple regime bij AF-patiënten na succesvolle coronaire stenting.","abstract_original":"BACKGROUND: We aimed to assess the safety of edoxaban in combination with P2Y12 inhibition in patients with atrial fibrillation who had percutaneous coronary intervention (PCI). METHODS: ENTRUST-AF PCI was a randomised, multicentre, open-label, non-inferiority phase 3b trial with masked outcome evaluation, done at 186 sites in 18 countries. Patients had atrial fibrillation requiring oral anticoagulation, were aged at least 18 years, and had a successful PCI for stable coronary artery disease or acute coronary syndrome. Participants were randomly assigned (1:1) from 4 h to 5 days after PCI using concealed, stratified, and blocked web-based central randomisation to either edoxaban (60 mg once daily) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist (VKA) in combination with a P2Y12 inhibitor and aspirin (100 mg once daily, for 1-12 months). The edoxaban dose was reduced to 30 mg per day if one or more factors (creatinine clearance 15-50 mL/min, bodyweight ≤60 kg, or concomitant use of specified potent P-glycoprotein inhibitors) were present. The primary endpoint was a composite of major or clinically relevant non-major (CRNM) bleeding within 12 months. The primary analysis was done in the intention-to-treat population and safety was assessed in all patients who received at least one dose of their assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02866175, is closed to new participants, and follow-up is completed. FINDINGS: From Feb 24, 2017, through May 7, 2018, 1506 patients were enrolled and randomly assigned to the edoxaban regimen (n=751) or VKA regimen (n=755). Median time from PCI to randomisation was 45·1 h (IQR 22·2-76·2). Major or CRNM bleeding events occurred in 128 (17%) of 751 patients (annualised event rate 20·7%) with the edoxaban regimen and 152 (20%) of 755 patients (annualised event rate 25·6%) patients with the VKA regimen; hazard ratio 0·83 (95% CI 0·65-1·05; p=0·0010 for non-inferiority, margin hazard ratio 1·20; p=0·1154 for superiority). INTERPRETATION: In patients with atrial fibrillation who had PCI, the edoxaban-based regimen was non-inferior for bleeding compared with the VKA-based regimen, without significant differences in ischaemic events. FUNDING: Daiichi Sankyo."},{"id":"4444c52e43ed","type":"article","url":"https://hartvaat.nl/2019/10/12/pci-versus-cabg-bij-drievaten-of-hoofdstamlijden-lancet-syntax-extended-10-jaars/","title":"PCI versus CABG bij drievaten- of hoofdstamlijden: Lancet SYNTAX extended 10-jaars","title_en":"Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31997-X","source_url":"https://doi.org/10.1016/S0140-6736(19)31997-X","authors":["Daniel J F M Thuijs","A Pieter Kappetein","Patrick W Serruys","Friedrich-Wilhelm Mohr","Marie-Claude Morice","Michael J Mack","David R Holmes","Nick Curzen","Piroze Davierwala","Thilo Noack","Milan Milojevic","Keith D Dawkins","Bruno R da Costa","Peter Jüni","Stuart J Head"],"significance":9,"published":"2019-10-12","source_date":"2019-10-12","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-vs-cabg-afweging/"],"congress":"","summary_en":"The SYNTAX 10-year extended follow-up demonstrated that CABG provided superior long-term survival over PCI in patients with three-vessel or left main coronary disease, driven primarily by lower cardiac mortality. This longest-available randomized comparison reinforced CABG as the preferred revascularization strategy for complex coronary disease.","created":"2026-07-03T10:28:12Z","updated":"2026-07-03T13:27:23Z","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":"Lancet SYNTAX extended 10-jaarsfollow-up van PCI versus CABG bij drievaten- of linker-hoofdstamcoronairlijden. Langst beschikbare vergelijkende follow-up.","abstract_original":"BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 248 (28%) patients had died after PCI and 212 (24%) after CABG (hazard ratio 1·19 [95% CI 0·99-1·43], p=0·066). Among patients with three-vessel disease, 153 (28%) of 546 had died after PCI versus 114 (21%) of 549 after CABG (hazard ratio 1·42 [95% CI 1·11-1·81]), and among patients with left main coronary artery disease, 95 (27%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·92 [0·69-1·22], pinteraction=0·023). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0·60) and no linear trend across SYNTAX score tertiles (ptrend=0·20). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up)."},{"id":"e8b2067e1573","type":"article","url":"https://hartvaat.nl/2019/10/10/complete-revascularisatie-met-multivaten-pci-bij-mi-nejm-complete/","title":"Complete revascularisatie met multivaten-PCI bij MI: NEJM COMPLETE","title_en":"Complete Revascularization with Multivessel PCI for Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1907775","source_url":"https://doi.org/10.1056/NEJMoa1907775","authors":["Shamir R Mehta","David A Wood","Robert F Storey","Roxana Mehran","Kevin R Bainey","Helen Nguyen","Brandi Meeks","Giuseppe Di Pasquale","Jose López-Sendón","David P Faxon","Laura Mauri","Sunil V Rao","Laurent Feldman","P Gabriel Steg","Álvaro Avezum","Tej Sheth","Natalia Pinilla-Echeverri","Raul Moreno","Gianluca Campo","Benjamin Wrigley","Sasko Kedev","Andrew Sutton","Richard Oliver","Josep Rodés-Cabau","Goran Stanković","Robert Welsh","Shahar Lavi","Warren J Cantor","Jia Wang","Juliet Nakamya","Shrikant I Bangdiwala","John A Cairns"],"significance":10,"published":"2019-10-10","source_date":"2019-10-10","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The COMPLETE trial showed that routine complete revascularization of nonculprit lesions during the index hospitalization or shortly thereafter reduced cardiovascular death and MI compared with culprit-only PCI in patients with STEMI and multivessel disease. This provided definitive evidence for a strategy of staged complete revascularization after primary PCI.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:23Z","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":"Landmark NEJM COMPLETE-trial die aantoonde dat complete revascularisatie (routine non-culprit PCI) superieur is aan culprit-only bij MI met multivatenlijden. Definitief bewijs voor volledige revascularisatie.","abstract_original":"BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.)."},{"id":"d849db0ea207","type":"article","url":"https://hartvaat.nl/2019/10/05/biodegradeerbare-versus-duurzame-polymer-des-bij-stemi-gerandomiseerde-trial/","title":"Biodegradeerbare versus duurzame polymer DES bij STEMI: gerandomiseerde trial","title_en":"Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31877-X","source_url":"https://doi.org/10.1016/S0140-6736(19)31877-X","authors":["Juan F Iglesias","Olivier Muller","Dik Heg","Marco Roffi","David J Kurz","Igal Moarof","Daniel Weilenmann","Christoph Kaiser","Maxime Tapponnier","Stefan Stortecky","Sylvain Losdat","Eric Eeckhout","Marco Valgimigli","Ayodele Odutayo","Marcel Zwahlen","Peter Jüni","Stephan Windecker","Thomas Pilgrim"],"significance":6,"published":"2019-10-05","source_date":"2019-10-05","image":"","kennis":[],"congress":"","summary_en":"This randomized trial compared biodegradable polymer sirolimus-eluting with durable polymer everolimus-eluting stents in STEMI patients, evaluating whether ultrathin strut platforms with absorbable coatings improve healing in the acute MI setting.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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 die biodegradeerbare polymer sirolimus-eluting stents vergeleek met duurzame polymer EES bij STEMI.","abstract_original":"BACKGROUND: Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. METHODS: The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031. FINDINGS: Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. INTERPRETATION: In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents. FUNDING: Biotronik."},{"id":"ea861eedb1bf","type":"article","url":"https://hartvaat.nl/2019/10/05/uitgebreide-community-interventie-bij-hypertensie-lancet-hope-4/","title":"Uitgebreide community-interventie bij hypertensie: Lancet HOPE 4","title_en":"A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31949-X","source_url":"https://doi.org/10.1016/S0140-6736(19)31949-X","authors":["Jon-David Schwalm","Tara McCready","Patricio Lopez-Jaramillo","Khalid Yusoff","Amir Attaran","Pablo Lamelas","Paul A Camacho","Fadhlina Majid","Shrikant I Bangdiwala","Lehana Thabane","Shofiqul Islam","Martin McKee","Salim Yusuf"],"significance":7,"published":"2019-10-05","source_date":"2019-10-05","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-diabetes/"],"congress":"","summary_en":"The HOPE 4 cluster-randomized trial demonstrated that a comprehensive community-based intervention combining non-physician health workers with simplified treatment algorithms significantly improves blood pressure and cholesterol control in low- and middle-income settings.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"Lancet HOPE 4 clustergerandomiseerde trial naar een uitgebreide community-gebaseerde interventie voor cardiovasculaire risicoreductie bij hypertensie.","abstract_original":"BACKGROUND: Hypertension is the leading cause of cardiovascular disease globally. Despite proven benefits, hypertension control is poor. We hypothesised that a comprehensive approach to lowering blood pressure and other risk factors, informed by detailed analysis of local barriers, would be superior to usual care in individuals with poorly controlled or newly diagnosed hypertension. We tested whether a model of care involving non-physician health workers (NPHWs), primary care physicians, family, and the provision of effective medications, could substantially reduce cardiovascular disease risk. METHODS: HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019. FINDINGS: All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was -6·40% (95% CI 8·00 to -4·80) in the control group and -11·17% (-12·88 to -9·47) in the intervention group, with a difference of change of -4·78% (95% CI -7·11 to -2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI -14·94 to -7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI -0·60 to -0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention. INTERPRETATION: A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based. FUNDING: Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute. VIDEO ABSTRACT."},{"id":"ff18acb50fb5","type":"article","url":"https://hartvaat.nl/2019/10/03/ticagrelor-bij-stabiel-coronairlijden-met-diabetes-nejm-themis/","title":"Ticagrelor bij stabiel coronairlijden met diabetes: NEJM THEMIS","title_en":"Ticagrelor in Patients with Stable Coronary Disease and Diabetes.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","internist"],"tags":["diabetes-en-hart","figaro-dkd","select-trial","soul-trial","stabiel-coronairlijden"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1908077","source_url":"https://doi.org/10.1056/NEJMoa1908077","authors":["P Gabriel Steg","Deepak L Bhatt","Tabassome Simon","Kim Fox","Shamir R Mehta","Robert A Harrington","Claes Held","Marielle Andersson","Anders Himmelmann","Wilhelm Ridderstråle","Maria Leonsson-Zachrisson","Yuyin Liu","Grzegorz Opolski","Dmitry Zateyshchikov","Junbo Ge","José C Nicolau","Ramón Corbalán","Jan H Cornel","Petr Widimský","Lawrence A Leiter"],"significance":9,"published":"2019-10-03","source_date":"2019-10-03","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"The THEMIS trial showed that ticagrelor added to aspirin modestly reduced cardiovascular events in patients with stable coronary disease and type 2 diabetes but significantly increased major bleeding. The narrow net clinical benefit limited the clinical adoption of this strategy.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"NEJM THEMIS-trial die ticagrelor onderzocht bij patiënten met stabiel coronairlijden en diabetes type 2. De grootste trial van antiplaatjestherapie bij stabiel coronairlijden met diabetes.","abstract_original":"BACKGROUND: Patients with stable coronary artery disease and diabetes mellitus who have not had a myocardial infarction or stroke are at high risk for cardiovascular events. Whether adding ticagrelor to aspirin improves outcomes in this population is unclear. METHODS: In this randomized, double-blind trial, we assigned patients who were 50 years of age or older and who had stable coronary artery disease and type 2 diabetes mellitus to receive either ticagrelor plus aspirin or placebo plus aspirin. Patients with previous myocardial infarction or stroke were excluded. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria. RESULTS: A total of 19,220 patients underwent randomization. The median follow-up was 39.9 months. Permanent treatment discontinuation was more frequent with ticagrelor than placebo (34.5% vs. 25.4%). The incidence of ischemic cardiovascular events (the primary efficacy outcome) was lower in the ticagrelor group than in the placebo group (7.7% vs. 8.5%; hazard ratio, 0.90; 95% confidence interval [CI], 0.81 to 0.99; P = 0.04), whereas the incidence of TIMI major bleeding was higher (2.2% vs. 1.0%; hazard ratio, 2.32; 95% CI, 1.82 to 2.94; P<0.001), as was the incidence of intracranial hemorrhage (0.7% vs. 0.5%; hazard ratio, 1.71; 95% CI, 1.18 to 2.48; P = 0.005). There was no significant difference in the incidence of fatal bleeding (0.2% vs. 0.1%; hazard ratio, 1.90; 95% CI, 0.87 to 4.15; P = 0.11). The incidence of an exploratory composite outcome of irreversible harm (death from any cause, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage) was similar in the ticagrelor group and the placebo group (10.1% vs. 10.8%; hazard ratio, 0.93; 95% CI, 0.86 to 1.02). CONCLUSIONS: In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, those who received ticagrelor plus aspirin had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin. (Funded by AstraZeneca; THEMIS ClinicalTrials.gov number, NCT01991795.)."},{"id":"9a30f11ed31a","type":"article","url":"https://hartvaat.nl/2019/10/01/verbetering-van-communicatie-bij-hartfalenpatientenzorg/","title":"Verbetering van communicatie bij hartfalenpatiëntenzorg","title_en":"Improving Communication in Heart Failure Patient Care.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["acuut-hartfalen"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.058","source_url":"https://doi.org/10.1016/j.jacc.2019.07.058","authors":["Nathan E Goldstein","Harriet Mather","Karen McKendrick","Laura P Gelfman","Mathew D Hutchinson","Rachel Lampert","Hannah I Lipman","Daniel D Matlock","Jacob J Strand","Keith M Swetz","Jill Kalman","Jean S Kutner","Sean Pinney","R Sean Morrison"],"significance":5,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This review discussed strategies for improving communication in heart failure care, focusing on advance care planning, defibrillator deactivation discussions, and shared decision-making with patients and families.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"Review over strategieën voor het verbeteren van communicatie in de hartfalenzorg.","abstract_original":"BACKGROUND: Although implantable cardioverter-defibrillators (ICDs) reduce sudden death, these patients die of heart failure (HF) or other diseases. To prevent shocks at the end of life, clinicians should discuss deactivating the defibrillation function. OBJECTIVES: The purpose of this study was to determine if a clinician-centered teaching intervention and automatic reminders increased ICD deactivation discussions and increased device deactivation. METHODS: In this 6-center, single-blinded, cluster-randomized, controlled trial, primary outcomes were proportion of patients: 1) having ICD deactivation discussions; and 2) having the shocking function deactivated. Secondary outcomes included goals of care conversations and advance directive completion. RESULTS: A total of 525 subjects were included with advanced HF who had an ICD: 301 intervention and 224 control. At baseline, 52% (n = 272) were not candidates for advanced therapies (i.e., cardiac transplant or mechanical circulatory support). There were no differences in discussions (41 [14%] vs. 26 [12%]) or deactivation (33 [11%] vs. 26 [12%]). In pre-specified subgroup analyses of patients who were not candidates for advanced therapies, the intervention increased deactivation discussions (32 [25%] vs. 16 [11%]; odds ratio: 2.90; p = 0.003). Overall, 99 patients died; there were no differences in conversations or deactivations among decedents. SECONDARY OUTCOMES: Among all participants, there was an increase in goals of care conversations (47% intervention vs. 38% control; odds ratio: 1.53; p = 0.04). There were no differences in completion of advance directives. CONCLUSIONS: The intervention increased conversations about ICD deactivation and goals of care. HF clinicians were able to apply new communication techniques based on patients' severity of illness. (An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations [WISDOM]; NCT01459744)."},{"id":"027f68c3b64d","type":"article","url":"https://hartvaat.nl/2019/10/01/quadripolaire-versus-bipolaire-lv-leads-bij-crt-klinische-uitkomsten/","title":"Quadripolaire versus bipolaire LV-leads bij CRT: klinische uitkomsten","title_en":"Clinical outcomes after implantation of quadripolar compared to bipolar left ventricular leads in patients undergoing cardiac resynchronization therapy: a systematic review and meta-analysis.","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/euz196","source_url":"https://doi.org/10.1093/europace/euz196","authors":["Julia W Erath","Alexander P Benz","Stefan H Hohnloser","Mate Vamos"],"significance":5,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-farmacologie/"],"congress":"","summary_en":"This comparison of quadripolar versus bipolar LV leads in CRT patients evaluated whether additional programming options from quadripolar technology translate to improved clinical outcomes.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"Vergelijking van klinische uitkomsten na implantatie van quadripolaire versus bipolaire linkerkamer leads bij CRT.","abstract_original":"AIMS: Some retrospective and prospective studies in heart failure patients with indication for cardiac resynchronization therapy (CRT) suggest better clinical outcomes for quadripolar (QP) left ventricular (LV) leads over bipolar (BP) leads. Although, lead failure remains an important safety concern, when using these more complex, novel electrodes. To evaluate safety and efficacy outcomes for QP vs. BP LV leads in patients receiving CRT. METHODS AND RESULTS: We performed a comprehensive literature search through 2018 in PubMed, Cochrane Library, and Google Scholar databases to identify studies comparing patients with QP and BP LV CRT leads. A total of 12 studies were selected for analysis comprising 31 403 patients (QP lead: 22 429 patients; BP lead: 8974 patients). Eight studies examined the effects of CRT on survival. In these studies, use of QP electrodes was associated with significantly better survival compared to patients with BP LV leads (OR 0.61, 95% CI 0.50-0.76; P < 0.01). Clinical improval measured in New York Heart Association functional class (OR 0.59, 95% CI 0.34-1.01; P = 0.05) and hospitalization rates (OR 0.67, 95% CI 0.55-0.83; P < 0.01) were also improved in patients receiving QP leads. Lead malfunctions defined as LV lead failure resulting in lead deactivation (OR 0.57, 95% CI 0.34-0.98; P = 0.04) or LV lead dislodgement requiring LV lead replacement/repositioning (OR 0.48; 95% CI 0.31-0.75; P < 0.01) were more often encountered among patients with BP leads compared to patients with QP leads. CONCLUSION: Our meta-analysis suggests distinct benefits of QP over BP electrodes in patients undergoing CRT."},{"id":"fcb04254108f","type":"article","url":"https://hartvaat.nl/2019/10/01/sekseverschillen-bij-katheterablatie-van-af-meta-analyse/","title":"Sekseverschillen bij katheterablatie van AF: meta-analyse","title_en":"Sex-related differences in catheter ablation of atrial fibrillation: a systematic review and 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/euz179","source_url":"https://doi.org/10.1093/europace/euz179","authors":["Xiaocheng Cheng","Qiongwen Hu","Lei Gao","Jian Liu","Shu Qin","Dongying Zhang"],"significance":6,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":["https://hartvaat.nl/kennis/ritmestoornissen/katheterablatie-vt/","https://hartvaat.nl/kennis/atriumfibrilleren/screenen-op-af/"],"congress":"","summary_en":"This systematic review and meta-analysis identified sex-related differences in catheter ablation outcomes for AF, showing that women have higher complication rates and potentially different efficacy profiles compared with men.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"Systematische review en meta-analyse naar seksegerelateerde verschillen in uitkomsten na katheterablatie van AF.","abstract_original":"AIMS: The sex-related differences in the clinical outcomes of rhythm and safety after catheter ablation remain unclear. The purpose of this study was to compare the clinical outcomes of catheter ablation for atrial fibrillation (AF) in women and men. METHODS AND RESULTS: The Medline and EMBASE databases were searched for published articles up to December 2018. Studies that met our predefined inclusion criteria were included. The primary endpoints were freedom from AF/atrial tachycardia (AT) recurrence, stroke/transient ischaemic attack (TIA), and all-cause mortality. After literature search and detailed assessment, 19 observational studies (151 370 patients; 34% women) were identified. Our analyses showed that the rate of freedom from AF/AT recurrence was lower in women than men at the 2.4-year follow-up [odds ratio (OR): 0.75, 95% confidence interval (CI) 0.69-0.81; P < 0.0001]. Moreover, women had an increased risk of stroke/TIA (OR: 1.42, 95% CI 1.21-1.67; P < 0.0001) and all-cause mortality (OR: 1.53, 95% CI 1.02-2.28; P = 0.04). Nevertheless, for the endpoint of all-cause mortality, there was no significant difference between the two genders in the subgroup of prospective studies (OR: 1.19, 95% CI 0.69-2.05; P = 0.53). Additionally, women were more likely to experience major complications compared with men (pericardial effusion/tamponade, major bleeding requiring transfusion, and pacemaker implantation). CONCLUSIONS: Women who underwent catheter ablation of AF might experience lower efficacy and a higher risk of stroke/TIA and major complications than men. The reasons for these sex-related differences need to be further studied."},{"id":"a3365606fc9a","type":"article","url":"https://hartvaat.nl/2019/10/01/beeldvorming-bij-cardiale-amyloidose-diagnostische-prestatie-meta-analyse/","title":"Beeldvorming bij cardiale amyloïdose: diagnostische prestatie — meta-analyse","title_en":"Diagnostic performance of imaging investigations in detecting and differentiating cardiac amyloidosis: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["cardiale-amyloidose"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12511","source_url":"https://doi.org/10.1002/ehf2.12511","authors":["Jack Brownrigg","Massimiliano Lorenzini","Matthew Lumley","Perry Elliott"],"significance":7,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review compared the diagnostic performance of cardiac MRI and nuclear scintigraphy for detecting and differentiating cardiac amyloidosis subtypes (AL versus ATTR), informing the non-invasive diagnostic pathway for this increasingly recognized condition.","created":"2026-07-03T10:28:11Z","updated":"2026-07-03T13:27:22Z","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":"Systematische review naar de diagnostische prestatie van beeldvormingstechnieken voor detectie en differentiatie van cardiale amyloïdose.","abstract_original":"AIMS: The study aims to systematically assess the diagnostic performance of cardiac magnetic resonance (CMR) and nuclear scintigraphy (index tests) for the diagnosis and differentiation of subtypes of cardiac amyloidosis. METHODS AND RESULTS: MEDLINE and Embase electronic databases were searched for studies evaluating the diagnostic performance of CMR or nuclear scintigraphy in detecting cardiac amyloidosis and subsequently in differentiating transthyretin amyloidosis (ATTR) from immunoglobulin light-chain (AL) amyloidosis. In this meta-analysis, histopathological examination of tissue from endomyocardial biopsy (EMB) or extra-cardiac organs were reference standards. Pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were calculated, and a random effects meta-analysis was used to estimate diagnostic odds ratios. Methodological quality was assessed using a validated instrument. Of the 2947 studies identified, 27 met the criteria for inclusion. Sensitivity and specificity of CMR in diagnosing cardiac amyloidosis was 85.7% and 92.0% against EMB reference and 78.9% and 93.9% with any organ histology reference. Corresponding sensitivity and specificity of nuclear scintigraphy was 88.4% and 87.2% against EMB reference and 82.0% and 98.8% with histology from any organ. CMR was unable to reliably differentiate ATTR from AL amyloidosis (sensitivity 28.1-99.0% and specificity 11.0-60.0%). Sensitivity and specificity of nuclear scintigraphy in the differentiation of ATTR from AL amyloidosis ranged from 90.9% to 91.5% and from 88.6% to 97.1%. Pooled negative likelihood ratio and positive likelihood ratio for scintigraphy in this setting were 0.1 and 8, with EMB reference standard. Study quality assessed by QUADAS-2 was generally poor with evidence of bias. CONCLUSIONS: Cardiac magnetic resonance is a useful test for diagnosing cardiac amyloidosis but is not reliable in further classifying the disease. Nuclear scintigraphy offers strong diagnostic performance in both the detection of cardiac amyloidosis and differentiating ATTR from AL amyloidosis. Our findings support the use of both imaging modalities in a non-invasive diagnostic algorithm that also tests for the presence of monoclonal protein."},{"id":"b98c3818dab6","type":"article","url":"https://hartvaat.nl/2019/10/01/antihypertensivaklasse-en-vallen-syncope-en-orthostatische-hypotensie-bij-oudere/","title":"Antihypertensivaklasse en vallen, syncope en orthostatische hypotensie bij ouderen: ALLHAT","title_en":"Effects of Antihypertensive Class on Falls, Syncope, and Orthostatic Hypotension in Older Adults: The ALLHAT Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13445","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13445","authors":["Stephen P Juraschek","Lara M Simpson","Barry R Davis","Jennifer L Beach","Anthony Ishak","Kenneth J Mukamal"],"significance":7,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This ALLHAT analysis found that the risk of falls, syncope, and orthostatic hypotension in older adults does not vary significantly by antihypertensive drug class, providing reassurance that all major classes are comparably safe regarding postural complications.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:22Z","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":"ALLHAT-analyse naar de effecten van verschillende antihypertensivaklassen op vallen, syncope en orthostatische hypotensie bij oudere patiënten.","abstract_original":"Hypertension treatment has been implicated in falls, syncope, and orthostatic hypotension (OH), common events among older adults. Whether the choice of antihypertensive agent influences the risk of falls, syncope, and OH in older adults is unknown. ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) was a randomized clinical trial that compared the effects of hypertension first-step therapy on fatal coronary heart disease or nonfatal myocardial infarction (1994-2002). In a subpopulation of ALLHAT participants, age 65 years and older, we determined the relative risk of falls, syncope, OH, or a composite based on Centers for Medicare and Medicaid Services and Veterans Affairs claims, using Cox regression. We also determined the adjusted association of self-reported atenolol use (ascertained at the 1-month visit for indications other than hypertension) on outcomes in Cox models adjusted for age, sex, and race. Among 23 964 participants (mean age 69.8±6.8 years, 45% women, 31% non-Hispanic black) followed for a mean of 4.9 years, we identified 267 falls, 755 syncopes, 249 OH, and 1157 composite claims. There were no significant differences in the cumulative incidences of events across randomized drug assignments. However, amlodipine increased risk of falls during the first year of follow-up compared with chlorthalidone (hazard ratio [95% CI]: 2.24 [1.06-4.74]; P=0.03) or lisinopril (hazard ratio [95% CI]: 2.61 [1.03-6.72]; P=0.04). Atenolol use (N=928) was not associated with any of the 3 individual or composite claims. In older adults, the choice of antihypertensive agent had no effect on risk of fall, syncope, or OH long-term. However, amlodipine increased risk of falls within 1 year of initiation. These short-term findings require confirmation. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542."},{"id":"dc23e153d1e4","type":"article","url":"https://hartvaat.nl/2019/10/01/neuromusculaire-elektrische-stimulatie-bij-acuut-hartfalen-haalbaarheid/","title":"Neuromusculaire elektrische stimulatie bij acuut hartfalen: haalbaarheid","title_en":"Neuromuscular electrical stimulation is feasible in patients with acute heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","ijzersuppletie"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12504","source_url":"https://doi.org/10.1002/ehf2.12504","authors":["Toru Kondo","Sumio Yamada","Daisuke Tanimura","Shingo Kazama","Toshikazu Ishihara","Masafumi Shimojo","Etsuo Iwata","Sayano Kondo","Hiroaki Hiraiwa","Toshiaki Kato","Hiroaki Sano","Yoshifumi Awaji","Takahiro Okumura","Toyoaki Murohara"],"significance":4,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This feasibility study demonstrated that neuromuscular electrical stimulation can be safely implemented in patients with acute heart failure without adverse haemodynamic effects, potentially preserving muscle mass during hospitalisation.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T18:38:45Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Haalbaarheidsstudie van neuromusculaire elektrische stimulatie bij patiënten met acuut hartfalen.","abstract_original":"AIMS: In acute heart failure (AHF), immobilization is caused because of unstable haemodynamics and dyspnoea, leading to protein wasting. Neuromuscular electrical stimulation (NMES) has been reported to preserve muscle mass and improve functional outcomes in chronic disease. NMES may be effective against protein wasting frequently manifested in patients with AHF; however, whether NMES can be implemented safely without any adverse effect on haemodynamics has remained unknown. This study aimed to examine the feasibility of NMES in patients with AHF. METHODS AND RESULTS: Patients with AHF were randomly assigned to the NMES or control group. The intensity of the NMES group was set at 10-20% maximal voluntary contraction level, whereas the control group was limited at a visible or palpable level of muscle contraction. The sessions were performed 5 days per week since the day after admission. Before the study implementation, we set the feasibility criteria with following items: (i) change in systolic blood pressure (BP) > ±20 mmHg during the first session; (ii) increase in heart rate (HR) > +20 b.p.m. during the first session; (iii) development of sustained ventricular arrhythmia, atrial fibrillation (AF), and paroxysmal supraventricular tachycardia during all sessions; (iv) incidence of new-onset AF during the hospitalization period < 40%; and (v) completion of the planned sessions by >70% of patients. The criteria of feasibility were set as follows; the percentage to fill one of (i)-(iii) was <20% of the total subjects, and both (iv) and (v) were satisfied. A total of 73 patients (median age 72 years, 51 men) who completed the first session were analysed (NMES group, n = 34; control group, n = 39). Systolic BP and HR variations were not significantly different between two groups (systolic BP, P = 0.958; HR, P = 0.665). Changes in BP > ±20 mmHg or HR > +20 b.p.m. were observed in three cases in the NMES group (8.8%) and five in the control group (12.8%). New-onset arrhythmia was not observed during all sessions in both groups. During hospitalization, one patient newly developed AF in the NMES group (2.9%), and one developed AF (2.6%) and two lethal ventricular arrhythmia in the control group. Thirty-one patients in the NMES group (91%) and 33 patients in the control group (84%) completed the planned sessions during hospitalization. This study fulfilled the preset feasibility criteria. CONCLUSIONS: NMES is feasible in patients with AHF from immediately after admission."},{"id":"31505b3ebdf5","type":"article","url":"https://hartvaat.nl/2019/10/01/arteriele-golfvormclusters-en-langetermijn-klinisch-nut/","title":"Arteriële golfvormclusters en langetermijn klinisch nut","title_en":"Identification of Distinct Arterial Waveform Clusters and a Longitudinal Evaluation of Their Clinical Usefulness.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12625","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12625","authors":["John D Sluyter","Alun D Hughes","Carlos A Camargo","Simon A McG Thom","Kim H Parker","Bernhard Hametner","Siegfried Wassertheurer","Robert Scragg"],"significance":5,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/cardiovasculaire-risicoschatting-score2/"],"congress":"","summary_en":"This study identified distinct arterial waveform clusters through computational analysis and evaluated their longitudinal clinical utility for cardiovascular risk stratification beyond conventional blood pressure measures.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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 die arteriële golfvormclusters identificeerde en hun langetermijn klinisch nut evalueerde voor cardiovasculaire risicostratificatie.","abstract_original":"Clustering of arterial blood pressure (BP) waveform parameters could summarize complex information into distinct elements, which could be used to investigate cumulative (nonredundant) associations. We investigated this hypothesis in a large, adult population-based study (ViDA trial [Vitamin D Assessment] trial). To interpret the clusters and evaluate their usefulness, we examined their predictors and associations with cardiovascular events. In 4253 adults (mean age 65 years; 55% male) without a prior cardiovascular event, suprasystolic oscillometry was performed, yielding aortic pressure waveforms and several hemodynamic parameters. Participants were followed up for 4.6 years (median), accruing 300 cardiovascular events. Principal component analysis reduced 14 arterial waveform parameters to 3 uncorrelated factors that together explained 90% of the variability of the original data. Factors 1, 2, and 3 appeared to represent BP pulsatility, mean BP, and wave reflection, respectively. Across 6 antihypertensive drug classes, there were no differences in brachial systolic (P=0.23) and diastolic (P=0.13) BP; but there were significant variations in factor 3 (P<0.0001), especially for β-blocker use. The first and third factors were positively associated with cardiovascular events (multivariable-adjusted standardized hazard ratio [95% CI]=1.33 [1.18-1.50] and 1.15 [1.02-1.30], respectively), whereas the second factor had a J-shaped relationship, with a nadir corresponding to a brachial diastolic BP of ≈75 mm Hg. In conclusion, BP pulsatility, mean BP, and wave reflection are prognostically meaningful, distinct aspects of arterial function that can be used to summarize physiological variations in multiple arterial waveform parameters and identify truly cumulative associations when used as cardiovascular risk outcomes."},{"id":"1f2213402e41","type":"article","url":"https://hartvaat.nl/2019/10/01/bardoxolone-en-urine-albumine-creatinine-ratio-bij-diabetes-met-ckd-stadium-4/","title":"Bardoxolone en urine albumine-creatinine ratio bij diabetes met CKD stadium 4","title_en":"Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["chronische-nierziekte","credence-trial","fidelio-dkd","figaro-dkd"],"journal":"Kidney international","doi":"10.1016/j.kint.2019.04.027","source_url":"https://doi.org/10.1016/j.kint.2019.04.027","authors":["Peter Rossing","Geoffrey A Block","Melanie P Chin","Angie Goldsberry","Hiddo J L Heerspink","Peter A McCullough","Colin J Meyer","David Packham","Pablo E Pergola","Bruce Spinowitz","Stuart M Sprague","David G Warnock","Glenn M Chertow"],"significance":6,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This study of bardoxolone methyl in type 2 diabetes with stage 4 CKD examined the effect of Nrf2 pathway activation on kidney function, testing an anti-inflammatory mechanism for slowing kidney disease progression.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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 naar het effect van bardoxolone op de urine albumine-creatinine ratio bij diabetespatiënten met stadium 4 CKD.","abstract_original":"Bardoxolone methyl attenuates inflammation by inducing nuclear factor erythroid-derived 2-related factor 2 and suppressing nuclear factor κB. The Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes (BEACON) trial was a phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial in 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease. BEACON was terminated because of safety concerns, largely related to a significant increase in early heart failure events in patients randomized to bardoxolone methyl. Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio. Herein, we present post hoc analyses characterizing the relation between the urine albumin-to-creatinine ratio and eGFR. The urine albumin-to-creatinine ratio and eGFR were assessed every four weeks through Week 12, followed by assessments every eight weeks thereafter, and 4 weeks after the last dose of bardoxolone methyl was administered. The initial increases in urine albumin-to-creatinine ratio observed in patients randomized to bardoxolone methyl were attenuated after six months. Multivariable regression analysis identified baseline eGFR and eGFR over time as the dominant factors associated with change in the urine albumin-to-creatinine ratio. Relative to placebo, bardoxolone methyl resulted in a significant decrease in albuminuria when indexed to eGFR (least-squared means: -0.035 [95% confidence interval -0.031 to -0.039]). Thus, among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl, changes in albuminuria are directly related to changes in eGFR, challenging the conventional construct that increases in albuminuria universally reflect kidney injury and denote harm."},{"id":"9e4559b8278d","type":"article","url":"https://hartvaat.nl/2019/10/01/bloeddruk-na-stenting-bij-aortacoarctatie-systematische-review-en-meta-analyse/","title":"Bloeddruk na stenting bij aortacoarctatie: systematische review en meta-analyse","title_en":"Medium-term systemic blood pressure after stenting of aortic coarctation: a systematic review and meta-analysis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":["bloeddrukbehandeling"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-314965","source_url":"https://doi.org/10.1136/heartjnl-2019-314965","authors":["Timion A Meijs","Evangeline G Warmerdam","Martijn G Slieker","Gregor J Krings","Mirella M C Molenschot","Folkert J Meijboom","Gertjan T Sieswerda","Pieter A Doevendans","Berto J Bouma","Robbert J de Winter","Barbara J M Mulder","Michiel Voskuil"],"significance":5,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis characterized medium-term blood pressure outcomes after stenting for aortic coarctation, showing that residual hypertension remains common despite successful mechanical repair.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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 naar de middellange-termijn systemische bloeddruk na stenting van aortacoarctatie.","abstract_original":"OBJECTIVE: Long-term prognosis of patients with coarctation of the aorta (CoA) is impaired due to the high prevalence of hypertension and consequent cardiovascular complications. Although stent implantation results in acute anatomical and haemodynamic benefit, limited evidence exists regarding the late clinical outcome. In this meta-analysis, we aimed to evaluate the medium-term effect of stent placement for CoA on systemic blood pressure (BP). METHODS: PubMed, EMBASE and Cochrane databases were searched for non-randomised cohort studies addressing systemic BP ≥12 months following CoA stenting. Meta-analysis was performed on the change in BP from baseline to last follow-up using a random-effects model. Subgroup analyses and meta-regression were conducted to identify sources of heterogeneity between studies. RESULTS: Twenty-six studies with a total of 1157 patients and a median follow-up of 26 months were included for final analysis. Meta-analysis showed a 20.3 mm Hg (95% CI 16.4 to 24.1 mm Hg; p<0.00001) reduction in systolic BP and an 8.2 mm Hg (12 studies; 95% CI 5.2 to 11.3 mm Hg; p<0.00001) reduction in diastolic BP. A concomitant decrease in the use of antihypertensive medication was observed. High systolic BP and peak systolic gradient at baseline and stenting of native CoA were associated with a greater reduction in systolic BP at follow-up. CONCLUSIONS: Stent implantation for CoA is associated with a significant decline in systolic and diastolic BP during medium-term follow-up. The degree of BP reduction appears to be dependent on baseline systolic BP, baseline peak systolic gradient, and whether stenting is performed for native or recurrent CoA."},{"id":"be170a52d133","type":"article","url":"https://hartvaat.nl/2019/10/01/telemedicine-en-mortaliteit-bij-acuut-mi-systematische-review-en-meta-analyse/","title":"Telemedicine en mortaliteit bij acuut MI: systematische review en meta-analyse","title_en":"Impact of telemedicine interventions on mortality in patients with acute myocardial infarction: a systematic review and meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314539","source_url":"https://doi.org/10.1136/heartjnl-2018-314539","authors":["Milena Soriano Marcolino","Luciana Marques Maia","João Antonio Queiroz Oliveira","Laura Defensor Ribeiro Melo","Bruno Leonardo Duarte Pereira","Diomildo Ferreira Andrade-Junior","Eric Boersma","Antonio Luiz Ribeiro"],"significance":7,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that telemedicine interventions significantly reduce mortality in patients with acute myocardial infarction, primarily through faster access to primary PCI and reduced time to reperfusion in remote and underserved areas.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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 die de impact van telemedicine-interventies op mortaliteit bij acuut MI kwantificeerde.","abstract_original":"BACKGROUND: Despite the promise of telemedicine to improve care for ischaemic heart disease, there are significant obstacles to implementation. Demonstrating improvement in patient-centred outcomes is important to support development of these innovative strategies. OBJECTIVE: To assess the impact of telemedicine interventions on mortality after acute myocardial infarction (AMI). METHODS: Articles were searched in MEDLINE, Cochrane Central Register of Controlled Trials, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Base de Dados de Enfermagem (BDENF), Indice Bibliográfico Español en Ciencias de la Salud (IBECs), Web of Science, Scopus and Google Scholar, from January 2004 to January 2018. Study selection and data extraction were performed by two independent reviewers. In-hospital mortality (primary outcome), and door-to-balloon (DTB) time, 30-day mortality and long-term mortality (secondary outcomes) were assessed. Random effects models were applied to estimate pooled results. RESULTS: Thirty non-randomised controlled and seven quasi-experimental studies were included (16 960 patients). They were classified as moderate or serious risk of bias by ROBINS-I (Risk Of Bias In Non-randomized Studies-of Interventions tool). In 31 studies, the intervention was prehospital ECG transmission. Telemedicine was associated with reduced in-hospital mortality compared with usual care (relative risk (RR) 0.63(95% confidence interval[CI] 0.55 to 0.72); I2 <0.001%). DTB time was consistently reduced (mean difference -28 (95% CI -35 to -20) min), but showed large heterogeneity (I2=94%). Thirty-day mortality (RR 0.62;95% CI 0.43 to 0.85) and long-term mortality (RR 0.61(95% CI 0.40 to 0.92)) were also reduced, with moderate heterogeneity (I2=52%). CONCLUSIONS: There is moderate-quality evidence that telemedicine strategies, in particular ECG transmission, combined with the usual care for AMI are associated with reduced in-hospital mortality and very-low quality evidence that they reduce DTB time, 30-day mortality and long-term mortality."},{"id":"8f5ef625c84a","type":"article","url":"https://hartvaat.nl/2019/10/01/lage-arteriele-compliance-en-cv-morbiditeit-bij-aortaklepstenose/","title":"Lage arteriële compliance en CV-morbiditeit bij aortaklepstenose","title_en":"Low systemic arterial compliance is associated with increased cardiovascular morbidity and mortality in aortic valve stenosis.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":["aortainsufficiëntie","aortastenose","perifeer-vaatlijden"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314386","source_url":"https://doi.org/10.1136/heartjnl-2018-314386","authors":["Edda Bahlmann","Dana Cramariuc","Sahrai Saeed","John B Chambers","Christoph A Nienaber","Karl-Heinz Kuck","Mai Tone Lønnebakken","Eva Gerdts"],"significance":6,"published":"2019-10-01","source_date":"2019-10-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that low systemic arterial compliance is independently associated with increased cardiovascular morbidity and mortality in aortic stenosis, adding a hemodynamic parameter beyond traditional valve severity measures.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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 die aantoont dat lage systemische arteriële compliance geassocieerd is met verhoogde CV-morbiditeit en mortaliteit bij aortaklepstenose.","abstract_original":"OBJECTIVE: Lower systemic arterial compliance (SAC) is associated with increased cardiovascular morbidity and mortality in hypertension, but this has not been assessed in a prospective study in aortic valve stenosis (AS). METHODS: Data from 1641 patients (38% women) with initially asymptomatic mild-moderate AS enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study was used. Median follow-up was 4.3 years. SAC was assessed from Doppler stroke volume index to central pulse pressure ratio and considered low if ≤0.64 mL/m², corresponding to the lower tertile in the population. The association of SAC with outcome was assessed in Cox regression analysis and reported as HR and 95% CI. RESULTS: Low SAC at baseline was characterised by older age, female sex, hypertension, obesity, presence of a small aortic root, lower mean aortic gradient and more severe AS by effective aortic valve area (all p<0.01). In Cox regression analysis adjusting for factors, low SAC was associated with higher HRs for cardiovascular death (HR 2.13(95% CI 1.34 to 3.40) and all-cause mortality (HR 1.71(95% CI 1.23 to 2.38)), both p=0.001). The results did not change when systolic or diastolic blood pressure, other measures of AS severity or presence of discordantly graded AS were included in subsequent models. Presence of low SAC did not improve mortality prediction in reclassification analysis. CONCLUSIONS: In patients with AS without diabetes and known cardiovascular disease, but a high prevalence of hypertension, low SAC was associated with higher cardiovascular and all-cause mortality independent of well-known prognosticators. TRIAL REGISTRATION NUMBER: NCT00092677; Post-results."},{"id":"37637b8bf79f","type":"article","url":"https://hartvaat.nl/2019/09/28/ticagrelor-bij-diabetes-met-stabiel-coronairlijden-en-eerder-pci-lancet-themis-p/","title":"Ticagrelor bij diabetes met stabiel coronairlijden en eerder PCI: Lancet THEMIS-PCI","title_en":"Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","stabiel-coronairlijden"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31887-2","source_url":"https://doi.org/10.1016/S0140-6736(19)31887-2","authors":["Deepak L Bhatt","Philippe Gabriel Steg","Shamir R Mehta","Lawrence A Leiter","Tabassome Simon","Kim Fox","Claes Held","Marielle Andersson","Anders Himmelmann","Wilhelm Ridderstråle","Jersey Chen","Yang Song","Rafael Diaz","Shinya Goto","Stefan K James","Kausik K Ray","Alexander N Parkhomenko","Mikhail N Kosiborod","Darren K McGuire","Robert A Harrington"],"significance":8,"published":"2019-09-28","source_date":"2019-09-28","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This THEMIS-PCI subanalysis showed that ticagrelor added to aspirin significantly reduced cardiovascular events in diabetic patients with stable coronary disease and prior PCI, identifying the subgroup with the most favorable risk-benefit profile within the overall neutral THEMIS trial.","created":"2026-07-03T10:28:10Z","updated":"2026-07-03T13:27:21Z","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":"Lancet THEMIS-PCI subanalyse van ticagrelor bij diabetespatiënten met stabiel coronairlijden en eerder PCI. De subgroep met maximaal voordeel.","abstract_original":"BACKGROUND: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. METHODS: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). FINDINGS: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8-3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74-0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, pinteraction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78-1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75-1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48-2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36-3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74-1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75-0·95, p=0·005, in contrast to patients without PCI where it did not, pinteraction=0·012. Benefit was present irrespective of time from most recent PCI. INTERPRETATION: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk. FUNDING: AstraZeneca."},{"id":"d9e102c59043","type":"article","url":"https://hartvaat.nl/2019/09/24/asymptomatische-patienten-met-abnormale-ffr-medicamenteus-versus-pci/","title":"Asymptomatische patiënten met abnormale FFR: medicamenteus versus PCI","title_en":"Asymptomatic Patients With Abnormal Fractional Flow Reserve Treated With Medication Alone or With PCI.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.068","source_url":"https://doi.org/10.1016/j.jacc.2019.07.068","authors":["Stephane Fournier","Yuhei Kobayashi","William F Fearon","Carlos Collet","Bruno Roza da Costa","Gilles Rioufol","Nico H J Pijls","Peter Jüni","Bernard De Bruyne"],"significance":6,"published":"2019-09-24","source_date":"2019-09-24","image":"","kennis":[],"congress":"","summary_en":"This study evaluated outcomes of asymptomatic patients with hemodynamically significant lesions (abnormal FFR) managed with medication alone versus PCI, addressing the clinical dilemma of treating physiologically significant but symptom-free disease.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:21Z","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 naar de uitkomsten van asymptomatische patiënten met abnormale FFR-waarden behandeld met medicatie alleen versus PCI.","abstract_original":""},{"id":"b07d544ff052","type":"article","url":"https://hartvaat.nl/2019/09/24/interne-versus-externe-cardioversie-bij-atriale-aritmieen-met-icd/","title":"Interne versus externe cardioversie bij atriale aritmieën met ICD","title_en":"Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.041320","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.041320","authors":["Jakob Lüker","Kathrin Kuhr","Arian Sultan","Georg Nölker","Hazem Omran","Stephan Willems","René Andrié","Jan W Schrickel","Stefan Winter","Dirk Vollmann","Roland R Tilz","Alexander Jobs","Christian-H Heeger","Andreas Metzner","Sven Meyer","Karl Mischke","Andreas Napp","Andreas Fahrig","Susanne Steinhauser","Johannes Brachmann","Stephan Baldus","Rajiv Mahajan","Prashanthan Sanders","Daniel Steven"],"significance":5,"published":"2019-09-24","source_date":"2019-09-24","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This randomized trial compared internal ICD-delivered cardioversion with external electrical cardioversion for atrial arrhythmias in ICD patients, testing device-based rhythm control for AF in the device-treated population.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:21Z","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":"Gerandomiseerde vergelijking van interne versus externe cardioversie bij atriale aritmieën bij patiënten met een ICD.","abstract_original":"BACKGROUND: Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm. METHODS: Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups. RESULTS: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (P<0.001). Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups. CONCLUSIONS: This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738."},{"id":"e072a3fa8b20","type":"article","url":"https://hartvaat.nl/2019/09/21/orale-antihypertensiva-bij-ernstige-hypertensie-in-de-zwangerschap-lancet-vergel/","title":"Orale antihypertensiva bij ernstige hypertensie in de zwangerschap: Lancet vergelijking","title_en":"Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["huisarts"],"tags":["bloeddrukbehandeling","zwangerschap-hart"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31282-6","source_url":"https://doi.org/10.1016/S0140-6736(19)31282-6","authors":["Thomas Easterling","Shuchita Mundle","Hillary Bracken","Seema Parvekar","Sulabha Mool","Laura A Magee","Peter von Dadelszen","Tara Shochet","Beverly Winikoff"],"significance":7,"published":"2019-09-21","source_date":"2019-09-21","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-zwangerschap/","https://hartvaat.nl/kennis/hypertensie/centrale-middelen-hypertensie/"],"congress":"","summary_en":"This Lancet comparison of nifedipine retard, labetalol, and methyldopa for severe hypertension in pregnancy provided head-to-head efficacy and safety data for the three most commonly used antihypertensive agents in obstetric emergencies.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 vergelijking van nifedipine, labetalol en methyldopa bij ernstige hypertensie in de zwangerschap.","abstract_original":"BACKGROUND: Hypertension is the most common medical disorder in pregnancy, complicating one in ten pregnancies. Treatment of severely increased blood pressure is widely recommended to reduce the risk for maternal complications. Regimens for the acute treatment of severe hypertension typically include intravenous medications. Although effective, these drugs require venous access and careful fetal monitoring and might not be feasible in busy or low-resource environments. We therefore aimed to compare the efficacy and safety of three oral drugs, labetalol, nifedipine retard, and methyldopa for the management of severe hypertension in pregnancy. METHODS: In this multicentre, parallel-group, open-label, randomised controlled trial, we compared these oral antihypertensives in two public hospitals in Nagpur, India. Pregnant women were eligible for the trial if they were aged at least 18 years; they were pregnant with fetuses that had reached a gestational age of at least 28 weeks; they required pharmacological blood pressure control for severe hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg); and were able to swallow oral medications. Women were randomly assigned to receive 10 mg oral nifedipine, 200 mg oral labetalol (hourly, in both of which the dose could be escalated if hypertension was maintained), or 1000 mg methyldopa (a single dose, without dose escalation). Masking of participants, study investigators, and care providers to group allocation was not possible because of different escalation protocols in the study groups. The primary outcome was blood pressure control (defined as 120-150 mm Hg systolic blood pressure and 70-100 mm Hg diastolic blood pressure) within 6 h with no adverse outcomes. This study is registered with ClinicalTrials.gov, number NCT01912677, and the Clinical Trial Registry, India, number ctri/2013/08/003866. FINDINGS: Between April 1, 2015, and Aug 21, 2017, we screened 2307 women for their inclusion in the study. We excluded 1413 (61%) women who were ineligible, declined to participate, had impending eclampsia, were in active labour, or had a combination of these factors. 11 (4%) women in the nifedipine group, ten (3%) women in the labetalol group, and 11 (4%) women in the methyldopa group were ineligible for treatment (because they had only one qualifying blood pressure measurement) or had treatment stopped (because of delivery or transfer elsewhere). 894 (39%) women were randomly assigned to a treatment group and were included in the intention-to-treat analysis: 298 (33%) women were assigned to receive nifedipine, 295 (33%) women were assigned to receive labetalol, and 301 (33%) women were assigned to receive methyldopa. The primary outcome was significantly more common in women in the nifedipine group than in those in the methyldopa group (249 [84%] women vs 230 [76%] women; p=0·03). However, the primary outcome did not differ between the nifedipine and labetalol groups (249 [84%] women vs 228 [77%] women; p=0·05) or the labetalol and methyldopa groups (p=0·80). Seven serious adverse events (1% of births) were reported during the study: one (<1%) woman in the labetalol group had an intrapartum seizure and six (1%) neonates (one [<1%] neonate in the nifedipine group, two [1%] neonates in the labetalol group, and three [1%] neonates in the methyldopa group) were stillborn. No birth had more than one adverse event. INTERPRETATION: All oral antihypertensives reduced blood pressure to the reference range in most women. As single drugs, nifedipine retard use resulted in a greater frequency of primary outcome attainment than labetalol or methyldopa use. All three oral drugs-methyldopa, nifedipine, and labetalol-are viable initial options for treating severe hypertension in low-resource settings. FUNDING: PREEMPT (University of British Columbia, Vancouver, BC, Canada; grantee of Bill & Melinda Gates Foundation)."},{"id":"f5c2ff1d9b30","type":"article","url":"https://hartvaat.nl/2019/09/21/ononderbroken-edoxaban-versus-vka-bij-af-ablatie-eliminate-af/","title":"Ononderbroken edoxaban versus VKA bij AF-ablatie: ELIMINATE-AF","title_en":"Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz190","source_url":"https://doi.org/10.1093/eurheartj/ehz190","authors":["Stefan H Hohnloser","John Camm","Riccardo Cappato","Hans-Christoph Diener","Hein Heidbüchel","Lluís Mont","Carlos A Morillo","Khalid Abozguia","Massimo Grimaldi","Heiko Rauer","Paul-Egbert Reimitz","Rüdiger Smolnik","Christoph Mönninghoff","Josef Kautzner"],"significance":7,"published":"2019-09-21","source_date":"2019-09-21","image":"","kennis":[],"congress":"","summary_en":"The ELIMINATE-AF trial demonstrated that uninterrupted edoxaban is safe and effective compared with VKA during catheter ablation for AF, extending the periprocedural DOAC evidence to include edoxaban alongside dabigatran and rivaroxaban.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"ELIMINATE-AF gerandomiseerde trial van ononderbroken edoxaban versus VKA bij katheterablatie voor AF.","abstract_original":"AIMS: Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested. METHODS AND RESULTS: The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02-1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62). CONCLUSION: Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation."},{"id":"361f012289f9","type":"article","url":"https://hartvaat.nl/2019/09/19/polypil-voor-cv-preventie-bij-onderbehandelde-populatie-nejm/","title":"Polypil voor CV-preventie bij onderbehandelde populatie: NEJM","title_en":"Polypill for Cardiovascular Disease Prevention in an Underserved Population.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts","internist"],"tags":["ouderen"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1815359","source_url":"https://doi.org/10.1056/NEJMoa1815359","authors":["Daniel Muñoz","Prince Uzoije","Cassandra Reynolds","Roslynn Miller","David Walkley","Susan Pappalardo","Phyllis Tousey","Heather Munro","Holly Gonzales","Wenliang Song","Charles White","William J Blot","Thomas J Wang"],"significance":9,"published":"2019-09-19","source_date":"2019-09-19","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/farmacologie/polypil-cardiovasculair/"],"congress":"","summary_en":"This NEJM trial demonstrated that a fixed-dose polypill containing atorvastatin, amlodipine, losartan, and hydrochlorothiazide significantly reduced cardiovascular events in an underserved, predominantly minority population without established cardiovascular disease. The results validated the polypill as a practical population-level prevention strategy.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"NEJM polypil-trial die cardiovasculaire preventie met een vaste combinatiepil onderzocht bij een onderbehandelde populatie. Populatiebrede preventiestrategie.","abstract_original":"BACKGROUND: Persons with low socioeconomic status and nonwhite persons in the United States have high rates of cardiovascular disease. The use of combination pills (also called \"polypills\") containing low doses of medications with proven benefits for the prevention of cardiovascular disease may be beneficial in such persons. However, few data are available regarding the use of polypill therapy in underserved communities in the United States, in which adherence to guideline-based care is generally low. METHODS: We conducted a randomized, controlled trial involving adults without cardiovascular disease. Participants were assigned to the polypill group or the usual-care group at a federally qualified community health center in Alabama. Components of the polypill were atorvastatin (at a dose of 10 mg), amlodipine (2.5 mg), losartan (25 mg), and hydrochlorothiazide (12.5 mg). The two primary outcomes were the changes from baseline in systolic blood pressure and low-density lipoprotein (LDL) cholesterol level at 12 months. RESULTS: The trial enrolled 303 adults, of whom 96% were black. Three quarters of the participants had an annual income below $15,000. The mean estimated 10-year cardiovascular risk was 12.7%, the baseline blood pressure was 140/83 mm Hg, and the baseline LDL cholesterol level was 113 mg per deciliter. The monthly cost of the polypill was $26. At 12 months, adherence to the polypill regimen, as assessed on the basis of pill counts, was 86%. The mean systolic blood pressure decreased by 9 mm Hg in the polypill group, as compared with 2 mm Hg in the usual-care group (difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P = 0.003). The mean LDL cholesterol level decreased by 15 mg per deciliter in the polypill group, as compared with 4 mg per deciliter in the usual-care group (difference, -11 mg per deciliter; 95% CI, -18 to -5; P<0.001). CONCLUSIONS: A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population. (Funded by the American Heart Association Strategically Focused Prevention Research Network and the National Institutes of Health; ClinicalTrials.gov number, NCT02278471.)."},{"id":"6db4c64d4ce4","type":"article","url":"https://hartvaat.nl/2019/09/19/antitrombotische-therapie-bij-af-met-stabiel-coronairlijden-nejm-afire/","title":"Antitrombotische therapie bij AF met stabiel coronairlijden: NEJM AFIRE","title_en":"Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["aperitif-trial","iaso-dcm","rivaroxaban","stabiel-coronairlijden"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1904143","source_url":"https://doi.org/10.1056/NEJMoa1904143","authors":["Satoshi Yasuda","Koichi Kaikita","Masaharu Akao","Junya Ako","Tetsuya Matoba","Masato Nakamura","Katsumi Miyauchi","Nobuhisa Hagiwara","Kazuo Kimura","Atsushi Hirayama","Kunihiko Matsui","Hisao Ogawa"],"significance":10,"published":"2019-09-19","source_date":"2019-09-19","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The AFIRE trial demonstrated that rivaroxaban monotherapy was superior to rivaroxaban plus an antiplatelet agent in patients with atrial fibrillation and stable coronary artery disease, with significantly less bleeding and no increase in ischemic events. The trial was stopped early due to increased mortality in the combination arm, establishing anticoagulant monotherapy as the standard of care.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"Landmark NEJM AFIRE-trial die aantoonde dat rivaroxaban monotherapie superieur is aan rivaroxaban plus antiplaatjes bij AF-patiënten met stabiel coronairlijden. Definitief bewijs voor OAC-monotherapie.","abstract_original":"BACKGROUND: There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease. METHODS: In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority. RESULTS: The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority). CONCLUSIONS: As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.)."},{"id":"76a86b1be3e9","type":"article","url":"https://hartvaat.nl/2019/09/17/ldl-cholesterol-en-micro-versus-macrovasculaire-ziekte-mendeliaanse-randomisatie/","title":"LDL-cholesterol en micro- versus macrovasculaire ziekte: Mendeliaanse randomisatie","title_en":"Impact of LDL Cholesterol on Microvascular Versus Macrovascular Disease: A Mendelian Randomization Study.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["dyslipidemie","ezetimibe","ldl-cholesterol","lipide-aferese","lipidenverlaging","statines"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.037","source_url":"https://doi.org/10.1016/j.jacc.2019.07.037","authors":["Frida Emanuelsson","Børge G Nordestgaard","Anne Tybjærg-Hansen","Marianne Benn"],"significance":6,"published":"2019-09-17","source_date":"2019-09-17","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/"],"congress":"","summary_en":"This Mendelian randomization study examined whether genetically determined LDL cholesterol affects microvascular disease (retinopathy, nephropathy) in addition to macrovascular atherosclerosis, exploring the breadth of LDL's causal role.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"Mendeliaanse randomisatiestudie naar de differentiële impact van LDL-cholesterol op microvasculaire versus macrovasculaire ziekte.","abstract_original":"BACKGROUND: Low-density lipoprotein cholesterol (LDL-C) is causally associated with a high risk of coronary artery disease. Whether this also holds for a spectrum of peripheral vascular diseases is unknown. OBJECTIVES: The purpose of this study was to determine whether high LDL-C causally relates to risk of retinopathy, neuropathy, chronic kidney disease (CKD), and peripheral arterial disease (PAD) in the general population. METHODS: One-sample Mendelian randomization (MR) of 116,419 Danish individuals, 2-sample MR on summary-level data from the Global Lipid Genetics Consortium (GLGC) (n = 94,595) and the UK Biobank (n = 408,455), and meta-analysis of randomized statin trials (n = 64,134) were performed. RESULTS: Observationally, high LDL-C did not associate with high risk of retinopathy or neuropathy. There were stepwise increases in risk of CKD and PAD with higher LDL-C (both p for trend <0.001), with hazard ratios of 1.05 (95% confidence interval [CI]: 0.97 to 1.13) for CKD, and 1.41 (95% CI: 1.23 to 1.62) for PAD in individuals with LDL-C above the 95th percentile versus below the 50th percentile. In genetic, causal analyses in the Copenhagen studies, the risk ratio of disease for a 1 mmol/l higher LDL-C was 1.06 (95% CI: 0.24 to 4.58) for retinopathy, 1.05 (95% CI: 0.64 to 1.72) for neuropathy, 3.83 (95% CI: 2.00 to 7.34) for CKD, and 2.09 (95% CI: 1.30 to 2.38) for PAD. Summary-level data from the GLGC and the UK Biobank for retinopathy, neuropathy, and PAD gave similar results. For CKD, a 1-mmol/l lower LDL-C conferred a higher eGFR of 1.95 ml/min/1.73 m2 (95% CI: 1.88 to 2.02 ml/min/1.73 m2) observationally, 5.92 ml/min/1.73 m2 (95% CI: 4.97 to 6.86 ml/min/1.73 m2) genetically, and 2.69 ml/min/1.73 m2 (95% CI: 1.48 to 3.94 ml/min/1.73 m2) through statin therapy. CONCLUSIONS: High LDL-C was not causally associated with risk of retinopathy and neuropathy; however, high LDL-C was observationally and genetically associated with high risks of PAD and CKD, suggesting that LDL-C is causally involved in the pathogenesis of these diseases."},{"id":"ce379fd97db7","type":"article","url":"https://hartvaat.nl/2019/09/14/crt-non-responder-naar-responder-conversie-more-crt-mpp/","title":"CRT non-responder naar responder conversie: MORE-CRT MPP","title_en":"Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz109","source_url":"https://doi.org/10.1093/eurheartj/ehz109","authors":["Christophe Leclercq","Haran Burri","Antonio Curnis","Peter Paul Delnoy","Christopher A Rinaldi","Johannes Sperzel","Kwangdeok Lee","Leonardo Calò","Alfredo Vicentini","Joaquin Fernandez Concha","Bernard Thibault"],"significance":5,"published":"2019-09-14","source_date":"2019-09-14","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/crt-cardiale-resynchronisatietherapie/"],"congress":"","summary_en":"This MORE-CRT MPP study evaluated whether multipoint pacing can convert CRT non-responders to responders, testing reprogramming to multi-electrode stimulation as a rescue strategy.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"MORE-CRT MPP studie naar de conversie van CRT non-responders naar responders met multipoint pacing.","abstract_original":"AIMS: To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months. METHODS AND RESULTS: The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10). CONCLUSIONS: After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders."},{"id":"f98639e3eac2","type":"article","url":"https://hartvaat.nl/2019/09/12/roxadustat-bij-anemie-bij-langdurige-dialysepatienten-nejm/","title":"Roxadustat bij anemie bij langdurige dialysepatiënten: NEJM","title_en":"Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis.","category":"cholesterol","category_label":"Cholesterol","professions":["internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1901713","source_url":"https://doi.org/10.1056/NEJMoa1901713","authors":["Nan Chen","Chuanming Hao","Bi-Cheng Liu","Hongli Lin","Caili Wang","Changying Xing","Xinling Liang","Gengru Jiang","Zhengrong Liu","Xuemei Li","Li Zuo","Laimin Luo","Jianqin Wang","Ming-Hui Zhao","Zhihong Liu","Guang-Yan Cai","Li Hao","Robert Leong","Chunrong Wang","Cameron Liu","Thomas Neff","Lynda Szczech","Kin-Hung P Yu"],"significance":7,"published":"2019-09-12","source_date":"2019-09-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This NEJM trial confirmed that roxadustat effectively treats anemia in patients on long-term dialysis, with hemoglobin response comparable to epoetin alfa. The oral HIF inhibitor provides a more convenient dosing regimen for dialysis patients.","created":"2026-07-03T10:28:09Z","updated":"2026-07-03T13:27:20Z","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":"NEJM-trial van roxadustat bij anemie bij langdurige dialysepatiënten. Bevestigt werkzaamheid van oraal HIF-remming.","abstract_original":"BACKGROUND: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis. METHODS: In a trial conducted in China, we randomly assigned (in a 2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive roxadustat or epoetin alfa three times per week for 26 weeks. Parenteral iron was withheld except as rescue therapy. The primary end point was the mean change in hemoglobin level from baseline to the average level during weeks 23 through 27. Noninferiority of roxadustat would be established if the lower boundary of the two-sided 95% confidence interval for the difference between the values in the roxadustat group and epoetin alfa group was greater than or equal to -1.0 g per deciliter. Patients in each group had doses adjusted to reach a hemoglobin level of 10.0 to 12.0 g per deciliter. Safety was assessed by analysis of adverse events and clinical laboratory values. RESULTS: A total of 305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period. The mean baseline hemoglobin level was 10.4 g per deciliter. Roxadustat led to a numerically greater mean (±SD) change in hemoglobin level from baseline to weeks 23 through 27 (0.7±1.1 g per deciliter) than epoetin alfa (0.5±1.0 g per deciliter) and was statistically noninferior (difference, 0.2±1.2 g per deciliter; 95% confidence interval [CI], -0.02 to 0.5). As compared with epoetin alfa, roxadustat increased the transferrin level (difference, 0.43 g per liter; 95% CI, 0.32 to 0.53), maintained the serum iron level (difference, 25 μg per deciliter; 95% CI, 17 to 33), and attenuated decreases in the transferrin saturation (difference, 4.2 percentage points; 95% CI, 1.5 to 6.9). At week 27, the decrease in total cholesterol was greater with roxadustat than with epoetin alfa (difference, -22 mg per deciliter; 95% CI, -29 to -16), as was the decrease in low-density lipoprotein cholesterol (difference, -18 mg per deciliter; 95% CI, -23 to -13). Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group. Hyperkalemia and upper respiratory infection occurred at a higher frequency in the roxadustat group, and hypertension occurred at a higher frequency in the epoetin alfa group. CONCLUSIONS: Oral roxadustat was noninferior to parenteral epoetin alfa as therapy for anemia in Chinese patients undergoing dialysis. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652806.)."},{"id":"388d251006f9","type":"article","url":"https://hartvaat.nl/2019/09/12/roxadustat-bij-anemie-bij-nierziekte-zonder-dialyse-nejm/","title":"Roxadustat bij anemie bij nierziekte zonder dialyse: NEJM","title_en":"Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis.","category":"cholesterol","category_label":"Cholesterol","professions":["internist"],"tags":["anemie-ckd","chronische-nierziekte","dialyse","flow-trial","ijzertekort"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1813599","source_url":"https://doi.org/10.1056/NEJMoa1813599","authors":["Nan Chen","Chuanming Hao","Xiaomei Peng","Hongli Lin","Aiping Yin","Li Hao","Ye Tao","Xinling Liang","Zhengrong Liu","Changying Xing","Jianghua Chen","Laimin Luo","Li Zuo","Yunhua Liao","Bi-Cheng Liu","Robert Leong","Chunrong Wang","Cameron Liu","Thomas Neff","Lynda Szczech","Kin-Hung P Yu"],"significance":7,"published":"2019-09-12","source_date":"2019-09-12","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"This NEJM trial demonstrated that roxadustat, an oral HIF prolyl hydroxylase inhibitor, effectively increases hemoglobin in patients with CKD-related anemia not on dialysis, offering an oral alternative to injectable erythropoietin-stimulating agents.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:20Z","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":"NEJM-trial van roxadustat (HIF-prolylhydroxylase-remmer) bij anemie bij CKD-patiënten zonder dialyse. Nieuw oraal alternatief voor EPO.","abstract_original":"BACKGROUND: Roxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron metabolism. In phase 2 studies involving patients with chronic kidney disease, roxadustat increased levels of endogenous erythropoietin to within or near the physiologic range, along with increasing hemoglobin levels and improving iron homeostasis. Additional data are needed regarding the efficacy and safety of roxadustat for the treatment of anemia in patients with chronic kidney disease who are not undergoing dialysis. METHODS: In this phase 3 trial conducted at 29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks in a double-blind manner. All the patients had a hemoglobin level of 7.0 to 10.0 g per deciliter at baseline. The randomized phase of the trial was followed by an 18-week open-label period in which all the patients received roxadustat; parenteral iron was withheld. The primary end point was the mean change from baseline in the hemoglobin level, averaged over weeks 7 through 9. RESULTS: During the primary-analysis period, the mean (±SD) change from baseline in the hemoglobin level was an increase of 1.9±1.2 g per deciliter in the roxadustat group and a decrease of 0.4±0.8 g per deciliter in the placebo group (P<0.001). The mean reduction from baseline in the hepcidin level (associated with greater iron availability) was 56.14±63.40 ng per milliliter in the roxadustat group and 15.10±48.06 ng per milliliter in the placebo group. The reduction from baseline in the total cholesterol level was 40.6 mg per deciliter in the roxadustat group and 7.7 mg per deciliter in the placebo group. Hyperkalemia and metabolic acidosis occurred more frequently in the roxadustat group than in the placebo group. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period. CONCLUSIONS: In Chinese patients with chronic kidney disease who were not undergoing dialysis, those in the roxadustat group had a higher mean hemoglobin level than those in the placebo group after 8 weeks. During the 18-week open-label phase of the trial, roxadustat was associated with continued efficacy. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652819.)."},{"id":"49c1ba505cdf","type":"article","url":"https://hartvaat.nl/2019/09/03/natriuretisch-peptiderespons-en-uitkomsten-bij-chronisch-hfref/","title":"Natriuretisch peptiderespons en uitkomsten bij chronisch HFrEF","title_en":"Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","anemie-ckd","chronische-nierziekte","hfref","nt-probnp","vrouwen"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.06.055","source_url":"https://doi.org/10.1016/j.jacc.2019.06.055","authors":["James L Januzzi","Tariq Ahmad","Hillary Mulder","Adrian Coles","Kevin J Anstrom","Kirkwood F Adams","Justin A Ezekowitz","Mona Fiuzat","Nancy Houston-Miller","Daniel B Mark","Ileana L Piña","Gayle Passmore","David J Whellan","Lawton S Cooper","Eric S Leifer","Patrice Desvigne-Nickens","G Michael Felker","Christopher M O'Connor"],"significance":5,"published":"2019-09-03","source_date":"2019-09-03","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"","summary_en":"This GUIDE-IT analysis showed that natriuretic peptide response patterns during heart failure therapy provide prognostic information even when biomarker-guided titration does not improve overall trial outcomes.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de klinische betekenis van natriuretisch peptiderespons op behandeling bij chronisch hartfalen met verminderde ejectiefractie.","abstract_original":"BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to \"guide\" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type natriuretic peptide (NT-proBNP) was not superior to GDMT alone. OBJECTIVES: The purpose of this study was to examine the prognostic meaning of NT-proBNP changes following heart failure (HF) therapy intensification relative to the goal NT-proBNP value of 1,000 pg/ml explored in the GUIDE-IT trial. METHODS: A total of 638 study participants were included who were alive and had available NT-proBNP results 90 days after randomization. Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality during follow-up and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall scores were analyzed. RESULTS: A total of 198 (31.0%) subjects had an NT-proBNP ≤1,000 pg/ml at 90 days with no difference in achievement of NT-proBNP goal between the biomarker-guided and usual care arms. NT-proBNP ≤1,000 pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009). Regardless of elevated baseline concentration, an NT-proBNP ≤1,000 pg/ml at 90 days was associated with better outcomes and significantly better KCCQ overall scores (p = 0.02). CONCLUSIONS: Patients with heart failure with reduced ejection fraction whose NT-proBNP levels decreased to ≤1,000 pg/ml during GDMT had better outcomes. These findings may help to understand the results of the GUIDE-IT trial. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840)."},{"id":"9b9cb4b77065","type":"article","url":"https://hartvaat.nl/2019/09/03/alirocumab-na-cabg-effecten-op-cv-events-odyssey-outcomes/","title":"Alirocumab na CABG: effecten op CV-events — ODYSSEY OUTCOMES","title_en":"Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.07.015","source_url":"https://doi.org/10.1016/j.jacc.2019.07.015","authors":["Shaun G Goodman","Philip E Aylward","Michael Szarek","Vakhtang Chumburidze","Deepak L Bhatt","Vera A Bittner","Rafael Diaz","Jay M Edelberg","Corinne Hanotin","Robert A Harrington","J Wouter Jukema","Sasko Kedev","Alexia Letierce","Angele Moryusef","Robert Pordy","Gabriel Arturo Ramos López","Matthew T Roe","Margus Viigimaa","Harvey D White","Andreas M Zeiher","Ph Gabriel Steg","Gregory G Schwartz"],"significance":6,"published":"2019-09-03","source_date":"2019-09-03","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES subanalysis showed that alirocumab provides significant cardiovascular benefit in ACS patients with prior CABG, a high-risk population with accelerated graft atherosclerosis.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"ODYSSEY OUTCOMES analyse bij patiënten die eerder CABG ondergingen. Onderzoekt het incrementele voordeel van PCSK9-remming bij post-CABG patiënten.","abstract_original":"BACKGROUND: Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG) are at high risk for recurrent cardiovascular events and death. OBJECTIVES: This study sought to determine the clinical benefit of adding alirocumab to statins in ACS patients with prior CABG in a pre-specified analysis of ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab). METHODS: Patients (n = 18,924) 1 to 12 months post-ACS with elevated atherogenic lipoprotein levels despite high-intensity statin therapy were randomized to alirocumab or placebo subcutaneously every 2 weeks. Median follow-up was 2.8 years. The primary composite endpoint of major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. Patients were categorized by CABG status: no CABG (n = 16,896); index CABG after qualifying ACS, but before randomization (n = 1,025); or CABG before the qualifying ACS (n = 1,003). RESULTS: In each CABG category, hazard ratios (95% confidence intervals) for MACE (no CABG 0.86 [0.78 to 0.95], index CABG 0.85 [0.54 to 1.35], prior CABG 0.77 [0.61 to 0.98]) and death (0.88 [0.75 to 1.03], 0.85 [0.46 to 1.59], 0.67 [0.44 to 1.01], respectively) were consistent with the overall trial results (0.85 [0.78 to 0.93] and 0.85 [0.73 to 0.98], respectively). Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [-2.3% to 4.0%], prior CABG 6.4% [0.9% to 12.0%]) and for death (0.4% [-0.1% to 1.0%], 0.5% [-1.9% to 2.9%], and 3.6% [0.0% to 7.2%]). CONCLUSIONS: Among patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy, alirocumab was associated with large absolute reductions in MACE and death in those with CABG preceding the ACS event. (ODYSSEY OUTCOMES: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402)."},{"id":"71b857d7ebac","type":"article","url":"https://hartvaat.nl/2019/09/03/alirocumab-bij-polyvasculaire-ziekte-na-acs-odyssey-outcomes/","title":"Alirocumab bij polyvasculaire ziekte na ACS: ODYSSEY OUTCOMES","title_en":"Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["ouderen"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.013","source_url":"https://doi.org/10.1016/j.jacc.2019.03.013","authors":["J Wouter Jukema","Michael Szarek","Laurien E Zijlstra","H Asita de Silva","Deepak L Bhatt","Vera A Bittner","Rafael Diaz","Jay M Edelberg","Shaun G Goodman","Corinne Hanotin","Robert A Harrington","Yuri Karpov","Angèle Moryusef","Robert Pordy","Juan C Prieto","Matthew T Roe","Harvey D White","Andreas M Zeiher","Gregory G Schwartz","P Gabriel Steg"],"significance":7,"published":"2019-09-03","source_date":"2019-09-03","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES subanalysis showed that alirocumab provides greater absolute cardiovascular benefit in patients with polyvascular disease after ACS, supporting prioritized PCSK9 inhibitor use in the highest-risk patients with multi-territory atherosclerosis.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"ODYSSEY OUTCOMES subanalyse bij patiënten met polyvasculaire ziekte na ACS. Groter absoluut voordeel bij hoger uitgangsrisico.","abstract_original":"BACKGROUND: Patients with acute coronary syndrome (ACS) and concomitant noncoronary atherosclerosis have a high risk of major adverse cardiovascular events (MACEs) and death. The impact of lipid lowering by proprotein convertase subtilisin-kexin type 9 inhibition in such patients is undetermined. OBJECTIVES: This pre-specified analysis from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) determined whether polyvascular disease influenced risks of MACEs and death and their modification by alirocumab in patients with recent ACS and dyslipidemia despite intensive statin therapy. METHODS: Patients were randomized to alirocumab or placebo 1 to 12 months after ACS. The primary MACEs endpoint was the composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. RESULTS: Median follow-up was 2.8 years. Of 18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyvascular disease in 2 beds (coronary and peripheral artery or cerebrovascular), and 149 had polyvascular disease in 3 beds (coronary, peripheral artery, cerebrovascular). With placebo, the incidence of MACEs by respective vascular categories was 10.0%, 22.2%, and 39.7%. With alirocumab, the corresponding absolute risk reduction was 1.4% (95% confidence interval [CI]: 0.6% to 2.3%), 1.9% (95% CI: -2.4% to 6.2%), and 13.0% (95% CI: -2.0% to 28.0%). With placebo, the incidence of death by respective vascular categories was 3.5%, 10.0%, and 21.8%; the absolute risk reduction with alirocumab was 0.4% (95% CI: -0.1% to 1.0%), 1.3% (95% CI: -1.8% to 4.3%), and 16.2% (95% CI: 5.5% to 26.8%). CONCLUSIONS: In patients with recent ACS and dyslipidemia despite intensive statin therapy, polyvascular disease is associated with high risks of MACEs and death. The large absolute reductions in those risks with alirocumab are a potential benefit for these patients. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab [ODYSSEY OUTCOMES]: NCT01663402)."},{"id":"532343779f2e","type":"article","url":"https://hartvaat.nl/2019/09/01/galnac-geconjugeerd-antisense-tegen-apoc3-triglyceriden-en-atherogene-lipoprotei/","title":"GalNAc-geconjugeerd antisense tegen APOC3: triglyceriden en atherogene lipoproteïnen","title_en":"N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["pelacarsen","yellow-iii"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz209","source_url":"https://doi.org/10.1093/eurheartj/ehz209","authors":["Veronica J Alexander","Shuting Xia","Eunju Hurh","Steven G Hughes","Louis O'Dea","Richard S Geary","Joseph L Witztum","Sotirios Tsimikas"],"significance":7,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":[],"congress":"","summary_en":"This study of a GalNAc-conjugated antisense oligonucleotide targeting APOC3 mRNA demonstrated potent triglyceride reduction with improved hepatic targeting and lower dosing requirements, advancing the next generation of apoC-III-lowering therapies.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"Studie naar een GalNAc-geconjugeerde antisense-oligonucleotide tegen APOC3-mRNA voor verlaging van triglyceriden en atherogene lipoproteïnen. Volgende generatie lipidentherapie.","abstract_original":"AIMS: Elevated apolipoprotein C-III (apoC-III) levels are associated with hypertriglyceridaemia and coronary heart disease. AKCEA-APOCIII-LRx is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits apoC-III protein synthesis. METHODS AND RESULTS: The safety, tolerability, and efficacy of AKCEA-APOCIII-LRx was assessed in a double-blind, placebo-controlled, dose-escalation Phase 1/2a study in healthy volunteers (ages 18-65) with triglyceride levels ≥90 or ≥200 mg/dL. Single-dose cohorts were treated with 10, 30, 60, 90, and 120 mg subcutaneously (sc) and multiple-dose cohorts were treated with 15 and 30 mg weekly sc for 6 weeks or 60 mg every 4 weeks sc for 3 months. In the single-dose cohorts treated with 10, 30, 60, 90, or 120 mg of AKCEA-APOCIII-LRx, median reductions of 0, -42%, -73%, -81%, and -92% in apoC-III, and -12%, -7%, -42%, -73%, and -77% in triglycerides were observed 14 days after dosing. In multiple-dose cohorts of 15 and 30 mg weekly and 60 mg every 4 weeks, median reductions of -66%, -84%, and -89% in apoC-III, and -59%, -73%, and -66% in triglycerides were observed 1 week after the last dose. Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed. AKCEA-APOCIII-LRx was well tolerated with one injection site reaction of mild erythema, and no flu-like reactions, platelet count reductions, liver, or renal safety signals. CONCLUSION: Treatment of hypertriglyceridaemic subjects with AKCEA-APOCIII-LRx results in a broad improvement in the atherogenic lipid profile with a favourable safety and tolerability profile. ClinicalTrials.gov Identifier: NCT02900027."},{"id":"00ef35989660","type":"article","url":"https://hartvaat.nl/2019/09/01/simvastatine-ezetimibe-versus-simvastatine-na-acs-bij-75-plussers-jama-cardiolog/","title":"Simvastatine-ezetimibe versus simvastatine na ACS bij 75-plussers: JAMA Cardiology","title_en":"Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.2306","source_url":"https://doi.org/10.1001/jamacardio.2019.2306","authors":["Richard G Bach","Christopher P Cannon","Robert P Giugliano","Jennifer A White","Yuliya Lokhnygina","Erin A Bohula","Robert M Califf","Eugene Braunwald","Michael A Blazing"],"significance":7,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This analysis of patients aged 75 or older from IMPROVE-IT confirmed that intensive lipid lowering with simvastatin-ezetimibe remains effective and safe in the elderly after ACS, supporting aggressive LDL management regardless of age.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"JAMA Cardiology analyse bij ≥75-jarigen die simvastatine-ezetimibe vergeleek met simvastatine monotherapie na ACS. Intensieve therapie ook bij ouderen.","abstract_original":"IMPORTANCE: Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients. OBJECTIVE: To determine the effect on outcomes and risks of combination ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS). DESIGN, SETTING, PARTICIPANTS: In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models. INTERVENTIONS: Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years). MAIN OUTCOMES AND MEASURES: The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Individual adverse ischemic and safety end points and lipid variables were also analyzed. RESULTS: Of 18 144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization. Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction). The rate of adverse events did not increase with simvastatin-ezetimibe vs simvastatin-placebo among younger or older patients. CONCLUSIONS AND RELEVANCE: In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simvastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older. Addition of ezetimibe to simvastatin was not associated with any significant increase in safety issues among older patients. These results may have implications for guideline recommendations regarding lowering of lipid levels in the elderly. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00202878."},{"id":"ef073b4c8ded","type":"article","url":"https://hartvaat.nl/2019/09/01/ifr-versus-ffr-bij-diabetespatienten-jama-cardiology/","title":"iFR versus FFR bij diabetespatiënten: JAMA Cardiology","title_en":"Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.2298","source_url":"https://doi.org/10.1001/jamacardio.2019.2298","authors":["Joo Myung Lee","Ki Hong Choi","Bon-Kwon Koo","Hakim-Moulay Dehbi","Joon-Hyung Doh","Chang-Wook Nam","Eun-Seok Shin","Christopher M Cook","Rasha Al-Lamee","Ricardo Petraco","Sayan Sen","Iqbal S Malik","Sukhjinder S Nijjer","Hernán Mejía-Rentería","Eduardo Alegria-Barrero","Ali Alghamdi","John Altman","Sérgio B Baptista","Ravinay Bhindi","Waldemar Bojara","Salvatore Brugaletta","Pedro Canas Silva","Carlo Di Mario","Andrejs Erglis","Robert T Gerber","Olaf Going","Tobias Härle","Farrel Hellig","Ciro Indolfi","Luc Janssens","Allen Jeremias","Rajesh K Kharbanda","Ahmed Khashaba","Yuetsu Kikuta","Florian Krackhardt","Mika Laine","Sam J Lehman","Hitoshi Matsuo","Martijin Meuwissen","Giampaolo Niccoli","Jan J Piek","Flavo Ribichini","Habib Samady","James Sapontis","Arnold H Seto","Murat Sezer","Andrew S P Sharp","Jasvindar Singh","Hiroaki Takashima","Suneel Talwar","Nobuhiro Tanaka","Kare Tang","Eric Van Belle","Niels van Royen","Hugo Vinhas","Christiaan J Vrints","Darren Walters","Hiroyoshi Yokoi","Bruce Samuels","Chris Buller","Manesh R Patel","Patrick Serruys","Javier Escaned","Justin E Davies"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This analysis compared iFR with FFR-guided revascularization specifically in diabetic patients, confirming equivalent outcomes with both physiological indices in this high-risk population where accurate lesion assessment is critical.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"JAMA Cardiology analyse die iFR vergeleek met FFR specifiek bij diabetespatiënten. Onderzoekt of functionele evaluatie equivalent is bij deze subgroep.","abstract_original":"IMPORTANCE: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated. OBJECTIVE: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial. DESIGN, SETTING, AND PARTICIPANTS: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015. INTERVENTIONS: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred. MAIN OUTCOMES AND MEASURES: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups. RESULTS: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25). CONCLUSIONS AND RELEVANCE: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02053038."},{"id":"4cdcb8c87a4c","type":"article","url":"https://hartvaat.nl/2019/09/01/elektrisch-versus-beeldvorming-geleide-lv-leadplaatsing-bij-crt-gerandomiseerde-/","title":"Elektrisch versus beeldvorming-geleide LV-leadplaatsing bij CRT: gerandomiseerde trial","title_en":"Electrically vs. imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial.","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/euz184","source_url":"https://doi.org/10.1093/europace/euz184","authors":["Charlotte Stephansen","Anders Sommer","Mads Brix Kronborg","Jesper Møller Jensen","Bjarne Linde Nørgaard","Christian Gerdes","Jens Kristensen","Henrik Kjærulf Jensen","Daniel Benjamin Fyenbo","Kirsten Bouchelouche","Jens Cosedis Nielsen"],"significance":5,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":[],"congress":"","summary_en":"This double-blinded randomized trial compared electrically guided with imaging-guided LV lead placement for CRT, testing whether combining both optimization techniques improves resynchronization outcomes.","created":"2026-07-03T10:28:08Z","updated":"2026-07-03T13:27:19Z","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":"Gerandomiseerde trial die elektrisch geleide vergeleek met beeldvorming-geleide linkerkamer leadplaatsing bij CRT.","abstract_original":"AIMS: To test in a double-blinded, randomized trial whether the combination of electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd) optimization results in superior increase in LV ejection fraction (LVEF) in cardiac resynchronization therapy (CRT) recipients. METHODS AND RESULTS: Stratified according to presence of ischaemic heart disease, 122 patients were randomized 1:1 to LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group). Follow-up was 6 months. Primary endpoint was absolute increase in LVEF. Additional outcome measures were changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications. Analysis was intention-to-treat. A larger increase in LVEF was observed in the intervention group (11 ± 10 vs. 7 ± 11%; 95% confidence interval 0.4-7.9%, P = 0.03); when adjusting for pre-specified baseline covariates this difference did not maintain statistical significance (P = 0.09). Clinical response, LV reverse remodelling, and complication rates did not differ between treatment groups. CONCLUSION: Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response. Larger long-term studies are warranted to investigate the effect of an electrically guided CRT strategy."},{"id":"f9784f2f8e56","type":"article","url":"https://hartvaat.nl/2019/09/01/remote-monitoring-en-patientgerapporteerde-uitkomsten-bij-europese-hf-patienten-/","title":"Remote monitoring en patiëntgerapporteerde uitkomsten bij Europese HF-patiënten met ICD","title_en":"Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial.","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/euz140","source_url":"https://doi.org/10.1093/europace/euz140","authors":["Henneke Versteeg","Ivy Timmermans","Jos Widdershoven","Geert-Jan Kimman","Sébastien Prevot","Thomas Rauwolf","Marcoen F Scholten","Edgar Zitron","Philippe Mabo","Johan Denollet","Susanne S Pedersen","Mathias Meine"],"significance":5,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":[],"congress":"","summary_en":"This European REMOTE-CIED study was the first randomized trial designed to evaluate the effect of remote patient monitoring on patient-reported outcomes in heart failure patients with ICDs, addressing the patient-centered value of telemonitoring.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:19Z","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":"Studie naar het effect van remote monitoring op patiëntgerapporteerde uitkomsten bij Europese hartfalenpatiënten met een ICD.","abstract_original":"AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586."},{"id":"f396ebb49509","type":"article","url":"https://hartvaat.nl/2019/09/01/alirocumab-en-mi-types-odyssey-outcomes-inzichten/","title":"Alirocumab en MI-types: ODYSSEY OUTCOMES-inzichten","title_en":"Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz299","source_url":"https://doi.org/10.1093/eurheartj/ehz299","authors":["Harvey D White","Ph Gabriel Steg","Michael Szarek","Deepak L Bhatt","Vera A Bittner","Rafael Diaz","Jay M Edelberg","Andrejs Erglis","Shaun G Goodman","Corinne Hanotin","Robert A Harrington","J Wouter Jukema","Renato D Lopes","Kenneth W Mahaffey","Angele Moryusef","Robert Pordy","Matthew T Roe","Piyamitr Sritara","Pierluigi Tricoci","Andreas M Zeiher","Gregory G Schwartz"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis examined the effect of alirocumab on different types of myocardial infarction (Type 1 spontaneous, Type 2 demand, Type 4 PCI-related), showing differential risk reduction across MI subtypes.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:19Z","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":"ODYSSEY OUTCOMES analyse naar het effect van alirocumab op verschillende types myocardinfarct.","abstract_original":"AIMS: The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin-kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI. METHODS AND RESULTS: Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI. CONCLUSION: After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types."},{"id":"acf04b6d548f","type":"article","url":"https://hartvaat.nl/2019/09/01/icd-en-overleving-bij-gevorderd-hf-met-continue-flow-lvad/","title":"ICD en overleving bij gevorderd HF met continue-flow LVAD","title_en":"Implantable cardioverter-defibrillators and survival in advanced heart failure patients with continuous-flow left ventricular assist devices: a systematic review and meta-analysis.","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/euz125","source_url":"https://doi.org/10.1093/europace/euz125","authors":["Ahmed Elkaryoni","Firas Al Badarin","Muhammad Shahzeb Khan","Karim Ellakany","Nikitha Potturi","Jasmin Poonia","Kevin F Kennedy","Anthony Magalski","Brett W Sperry","Alan P Wimmer"],"significance":5,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/lvad-ventrikelondersteunende-systemen/"],"congress":"","summary_en":"This study evaluated whether maintaining an ICD provides survival benefit in advanced heart failure patients already supported by continuous-flow LVADs, testing the incremental value of defibrillation in mechanically supported patients.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:19Z","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":"Studie naar de meerwaarde van ICD bij gevorderd hartfalen met LVAD-ondersteuning.","abstract_original":"AIMS: Implantable cardioverter-defibrillators (ICDs) implantation in heart failure (HF) patients with reduced ejection fraction improves survival by reducing mortality secondary to arrhythmic events. Whether advanced HF patients treated with continuous-flow left ventricular assist devices (CF-LVADs) derive similar benefit is controversial. METHODS AND RESULTS: We searched PubMed, Cochrane Central Register of Controlled Trials, Embase, and Scopus from inception through November 2018 for studies examining the association between ICD implantation and all-cause mortality in patients with advanced HF and CF-LVADs. Analyses were performed using a random-effects model. Hazard ratios (HRs) were calculated with 95% confidence intervals (CIs). Heterogeneity and publication bias were formally assessed, using I2 and funnel plots, respectively. Eight observational studies with a total of 6416 patients (ICD group = 3450, no ICD group = 2966) met inclusion criteria. The majority of patients (84.6%) came from the two largest observational studies. There was no difference in mortality in the ICD and no ICD groups (HR 0.96, 95% CI 0.73-1.27, P = 0.79, I2 = 42%), and ICD implantation post-CF-LVAD was not associated with an improvement in mortality (HR 0.87, 95% CI 0.48-1.57, P = 0.64, I2 = 0%). Additionally, there was no significant difference in the likelihood of transplantation (HR 1.10, 95% CI 0.93-1.30, P = 0.28, I2 = 26%) or non-mortality adverse events between the two groups. CONCLUSION: Implantable cardioverter-defibrillator use was not associated with improved survival in advanced HF patients with CF-LVADs. These findings underscore the need to formally study the efficacy of ICDs in this population in a dedicated randomized controlled study."},{"id":"9902dcf950d8","type":"article","url":"https://hartvaat.nl/2019/09/01/persisterende-arteriele-wandinflammatie-bij-verhoogd-lp-a-ondanks-lage-ldl/","title":"Persisterende arteriële wandinflammatie bij verhoogd Lp(a) ondanks lage LDL","title_en":"Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["anemie-ckd","aortainsufficiëntie","aspirine","cetp-remmers","diabetes-en-hart","dyslipidemie","ezetimibe","inflammatie","ldl-cholesterol","lipide-aferese","lipidenverlaging","lipoproteïne-a","lipoproteïne-a-therapeutisch-doel","niet-statine-therapie","ouderen","pcsk9-remmers","pelacarsen","perifeer-vaatlijden","soul-trial","statines"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy862","source_url":"https://doi.org/10.1093/eurheartj/ehy862","authors":["Lotte C A Stiekema","Erik S G Stroes","Simone L Verweij","Helina Kassahun","Lisa Chen","Scott M Wasserman","Marc S Sabatine","Venkatesh Mani","Zahi A Fayad"],"significance":7,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/"],"congress":"","summary_en":"This imaging study showed that arterial wall inflammation persists in patients with elevated Lp(a) despite strong LDL cholesterol lowering with statins and PCSK9 inhibitors, suggesting that Lp(a)-driven inflammation requires specific Lp(a)-lowering therapy.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:18Z","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 die aantoont dat arteriële wandinflammatie persisteert bij patiënten met verhoogd Lp(a) ondanks sterke LDL-verlaging. Lp(a) als onafhankelijke inflammatoire risicofactor.","abstract_original":"AIMS: Subjects with lipoprotein(a) [Lp(a)] elevation have increased arterial wall inflammation and cardiovascular risk. In patients at increased cardiovascular risk, arterial wall inflammation is reduced following lipid-lowering therapy by statin treatment or lipoprotein apheresis. However, it is unknown whether lipid-lowering treatment in elevated Lp(a) subjects alters arterial wall inflammation. We evaluated whether evolocumab, which lowers both low-density lipoprotein cholesterol (LDL-C) and Lp(a), attenuates arterial wall inflammation in patients with elevated Lp(a). METHODS AND RESULTS: In this multicentre, randomized, double-blind, placebo-controlled study, 129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0 [155.5-301.5] nmol/L [80.0 (62.5-121.0) mg/dL]; mean [standard deviation (SD)] LDL-C 3.7 [1.0] mmol/L [144.0 (39.7) mg/dL]; National Cholesterol Education Program high risk, 25.6%} were randomized to monthly subcutaneous evolocumab 420 mg or placebo. Compared with placebo, evolocumab reduced LDL-C by 60.7% [95% confidence interval (CI) 65.8-55.5] and Lp(a) by 13.9% (95% CI 19.3-8.5). Among evolocumab-treated patients, the Week 16 mean (SD) LDL-C level was 1.6 (0.7) mmol/L [60.1 (28.1) mg/dL], and the median (IQR) Lp(a) level was 188.0 (140.0-268.0) nmol/L [75.2 (56.0-107.2) mg/dL]. Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR)] in the index vessel (left carotid, right carotid, or thoracic aorta) was assessed by 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography. Week 16 index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%) [treatment difference -3.0% (95% CI -7.4% to 1.4%); P = 0.18]. CONCLUSION: Evolocumab treatment in patients with median baseline Lp(a) 200.0 nmol/L led to a large reduction in LDL-C and a small reduction in Lp(a), resulting in persistent elevated Lp(a) levels. The latter may have contributed to the unaltered arterial wall inflammation."},{"id":"89d1836a3bee","type":"article","url":"https://hartvaat.nl/2019/09/01/edoxaban-versus-warfarine-naar-gemiddelde-bloeddruk-bij-af-met-hypertensie/","title":"Edoxaban versus warfarine naar gemiddelde bloeddruk bij AF met hypertensie","title_en":"Edoxaban Versus Warfarin Stratified by Average Blood Pressure in 19 679 Patients With Atrial Fibrillation and a History of Hypertension in the ENGAGE AF-TIMI 48 Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13138","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13138","authors":["Sungha Park","Brian A Bergmark","Minggao Shi","Hans-Joachim Lanz","Namsik Chung","Christian T Ruff","Elliott M Antman","Eugene Braunwald","Robert P Giugliano"],"significance":5,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This ENGAGE AF-TIMI 48 analysis stratified edoxaban versus warfarin outcomes by average blood pressure in AF patients with hypertension, informing the interplay between anticoagulation choice and blood pressure management.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"ENGAGE AF-TIMI 48 analyse die edoxaban versus warfarine vergeleek gestratificeerd naar gemiddelde bloeddruk bij AF-patiënten met hypertensie.","abstract_original":"Hypertension is a risk factor for both stroke and bleeding in patients with atrial fibrillation. Data are sparse regarding the interaction between blood pressure and the efficacy and safety of direct oral anticoagulants. In the ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48), 19,679 patients with atrial fibrillation and hypertension were categorized according to average systolic blood pressure (SBP) and diastolic blood pressure (DBP). The primary efficacy and safety end points were the time to the first stroke or systemic embolic event and the time to the first International Society of Thrombosis and Hemostasis major bleeding event, respectively. Risk was calculated using Cox proportional hazards models based on average SBP and DBP and adjusting for 18 clinical characteristics. The efficacy and safety of a higher dose edoxaban regimen (60/30 mg) versus warfarin were evaluated with stratification by average SBP and DBP. Stroke/systemic embolic event occurred significantly more frequently in patients with elevated average SBP (hazard ratio, 2.01; 95% CI, 1.50-2.70 for SBP ≥150 mm Hg relative to 130-139 mm Hg) or DBP (hazard ratio, 2.36; 95% CI, 1.76-3.16 for DBP ≥90 mm Hg relative to 75-<85 mm Hg). The higher dose edoxaban regimen reduced stroke/systemic embolic event across the full range of SBP (Pinteraction=0.55) and DBP (Pinteraction=0.44) compared with warfarin. The higher dose edoxaban regimen reduced the risk of major bleeding events, including intracranial hemorrhage, without modification by average SBP (Pinteraction=0.29). The relative safety of edoxaban was most pronounced in patients with elevated DBP (Pinteraction=0.007). The efficacy and safety of edoxaban were consistent across the full range of SBP, while the superior safety of edoxaban was most pronounced among patients with elevated DBP."},{"id":"955d2a6df476","type":"article","url":"https://hartvaat.nl/2019/09/01/interactieve-mobiele-gezondheidsinterventie-en-bloeddrukmanagement/","title":"Interactieve mobiele gezondheidsinterventie en bloeddrukmanagement","title_en":"Interactive Mobile Health Intervention and Blood Pressure Management in Adults.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13273","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13273","authors":["Xiaomei Lu","Huijun Yang","Xue Xia","Xiangfeng Lu","Jinchun Lin","Fangchao Liu","Dongfeng Gu"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This study demonstrated that an interactive mobile health intervention improves blood pressure management in adults with hypertension, supporting the use of smartphone-based tools for sustained blood pressure control.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar een interactieve mobiele gezondheidsinterventie voor bloeddrukmanagement bij volwassenen met hypertensie.","abstract_original":"Despite the availability of effective drugs, blood pressure (BP) control remains poor among most populations. To explore the effects of interactive mobile health (mhealth) intervention on BP management and find out the optimal target population, we performed a systematic review and meta-analysis of randomized controlled trials to estimate the pooled effects of mhealth intervention on BP control. PubMed, EMBASE, Cochrane Library, and CNKI were searched to identify eligible randomized controlled trials published between January 15, 2007 and April 28, 2019, and bibliographies of eligible articles were further reviewed. Random-effect models were utilized to pool estimates of net changes in systolic BP and diastolic BP between mhealth intervention group and control group. Eleven randomized controlled trials met the inclusion criteria, with a total sample size of 4271 participants. Compared with the control group, mhealth intervention was associated with significant changes in systolic BP and diastolic BP of -3.85 mm Hg; 95% CI, -4.74 to -2.96 and -2.19 mm Hg; 95% CI, -3.16 to -1.23, respectively. Subgroup analyses revealed consistent effects across study duration and intervention intensity subgroups. In addition, participants with inadequate BP control at recruitment might gain more benefits with mhealth intervention. Therefore, interactive mhealth intervention may be a useful tool for improving BP control among adults, especially among those with inadequate BP control."},{"id":"5d67c61feeb4","type":"article","url":"https://hartvaat.nl/2019/09/01/oac-bij-af-met-kleplijden-en-bioprothese-overzicht/","title":"OAC bij AF met kleplijden en bioprothese: overzicht","title_en":"Oral anticoagulants in atrial fibrillation with valvular heart disease and bioprosthetic heart valves.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["anticoagulantia","anticoagulatie-kwetsbare-ouderen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-314767","source_url":"https://doi.org/10.1136/heartjnl-2019-314767","authors":["Aaqib H Malik","Srikanth Yandrapalli","Wilbert S Aronow","Julio A Panza","Howard A Cooper"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doacs-overzicht/"],"congress":"","summary_en":"This review summarized the evidence for oral anticoagulant use in AF patients with native valvular heart disease and bioprosthetic valves, guiding DOAC prescription in these common clinical scenarios.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:18Z","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":"Overzicht van de evidence voor orale anticoagulantia bij AF met kleplijden en bioprothese-hartkleppen.","abstract_original":"OBJECTIVE: Current guidelines endorse the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). However, little is known about their safety and efficacy in valvular heart disease (VHD). Similarly, there is a paucity of data regarding NOACs use in patients with a bioprosthetic heart valve (BPHV). We, therefore, performed a network meta-analysis in the subgroups of VHD and meta-analysis in patients with a BPHV. METHODS: PubMed, Cochrane and Embase were searched for randomised controlled trials. Summary effects were estimated by the random-effects model. The outcomes of interest were a stroke or systemic embolisation (SSE), myocardial infarction (MI), all-cause mortality, major adverse cardiac events, major bleeding and intracranial haemorrhage (ICH). RESULTS: In patients with VHD, rivaroxaban was associated with more ICH and major bleeding than other NOACs, while edoxaban 30 mg was associated with least major bleeding. Data combining all NOACs showed a significant reduction in SSE, MI and ICH (0.70, [0.57 to 0.85; p<0.001]; 0.70 [0.50 to 0.99; p<0.002]; and 0.46 [0.24 to 0.86; p<0.01], respectively). Analysis of 280 patients with AF and a BPHV showed similar outcomes with NOACs and warfarin. CONCLUSIONS: NOACs performed better than warfarin for a reduction in SSE, MI and ICH in patients with VHD. Individually NOACs performed similarly to each other except for an increased risk of ICH and major bleeding with rivaroxaban and a reduced risk of major bleeding with edoxaban 30 mg. In patients with a BPHV, results with NOACs seem similar to those with warfarin and this needs to be further explored in larger studies."},{"id":"3700a04ea7e5","type":"article","url":"https://hartvaat.nl/2019/09/01/advance-care-planning-bij-hartfalen-systematische-review/","title":"Advance care planning bij hartfalen: systematische review","title_en":"Clinician-targeted interventions to improve advance care planning in heart failure: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["pathfinder-trial"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2019-314758","source_url":"https://doi.org/10.1136/heartjnl-2019-314758","authors":["Markus Schichtel","Bee Wee","Rafael Perera","Igho Onakpoya","Charlotte Albury","Sarah Barber"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This systematic review and meta-analysis evaluated clinician-targeted interventions to improve advance care planning in heart failure, identifying effective strategies for overcoming clinician reluctance to initiate end-of-life discussions.","created":"2026-07-03T10:28:07Z","updated":"2026-07-03T13:27:18Z","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":"Systematische review en meta-analyse van interventies gericht op het verbeteren van advance care planning bij hartfalen.","abstract_original":"OBJECTIVE: Advance care planning (ACP) is widely advocated to contribute to better outcomes for patients suffering from heart failure. But clinicians appear hesitant to engage with ACP. Our aim was to identify interventions with the greatest potential to engage clinicians with ACP in heart failure. METHODS: A systematic review and meta-analysis. We searched CINAHL, Cochrane Central Register of Controlled Trials, Database of Systematic Reviews, Embase, ERIC, Ovid MEDLINE, Science Citation Index and PsycINFO for randomised controlled trials (RCTs) from inception to January 2018. Three reviewers independently extracted data, assessed risk of bias (Cochrane risk of bias tool), the quality of evidence (GRADE) and intervention synergy according to Template for Intervention Description and Replication. ORs were calculated for pooled effects. RESULTS: Of 14 175 articles screened, we assessed the full text of 131 studies. 13 RCTs including 3709 participants met all of the inclusion criteria. The intervention categories of patient-mediated interventions (OR 5.23; 95% CI 2.36 to 11.61), reminder systems (OR 3.65; 95% CI 1.47 to 9.04) and educational meetings (OR 2.35; 95% CI 1.29 to 4.26) demonstrated a favourable effect to engage clinicians with the completion of ACP. CONCLUSION: The review provides evidence from 13 published RCTs and suggests that interventions that involve patients to change clinical practice, reminder systems and educational meetings have the greatest effect in improving the implementation of ACP in heart failure."},{"id":"53f5d5bfbfef","type":"article","url":"https://hartvaat.nl/2019/09/01/antistolling-bij-hf-met-sinusritme-systematische-review-en-meta-analyse/","title":"Antistolling bij HF met sinusritme: systematische review en meta-analyse","title_en":"Anticoagulation therapy in heart failure and sinus rhythm: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314381","source_url":"https://doi.org/10.1136/heartjnl-2018-314381","authors":["Simon A S Beggs","Rasmus Rørth","Roy S Gardner","John J V McMurray"],"significance":7,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"This meta-analysis found that anticoagulation therapy does not significantly reduce mortality or cardiovascular events in heart failure patients in sinus rhythm, consistent with the COMMANDER HF result and arguing against routine anticoagulation without AF.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:18Z","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":"Meta-analyse naar het effect van antistollingstherapie bij hartfalenpatiënten in sinusritme (zonder AF). Syntheseert het COMMANDER HF- en WARCEF-bewijs.","abstract_original":"OBJECTIVE: Heart failure is a prothrombotic state, and it has been hypothesised that thrombosis and embolism cause non-fatal and fatal events in heart failure and reduced ejection fraction (HFrEF). We sought to determine the effect of anticoagulant therapy on clinical outcomes in patients with HFrEF who are in sinus rhythm. METHODS: We conducted an updated systematic review and meta-analysis to examine the effect of anticoagulation therapy in patients with HFrEF in sinus rhythm. Our analysis compared patients randomised to anticoagulant therapy with those randomised to antiplatelet therapy, placebo or control, and examined the endpoints of all-cause mortality, (re)hospitalisation for worsening heart failure, non-fatal myocardial infarction, non-fatal stroke of any aetiology and major haemorrhage. RESULTS: Five trials were identified that met the prespecified search criteria. Compared with control therapy, anticoagulant treatment did not reduce all-cause mortality (risk ratio [RR] 0.99, 95% CI 0.90 to 1.08), (re)hospitalisation for heart failure (RR 0.97, 95% CI 0.82 to 1.13) or non-fatal myocardial infarction (RR 0.92, 95% CI 0.75 to 1.13). Anticoagulation did reduce the rate of non-fatal stroke (RR 0.63, 95% CI 0.49 to 0.81, p=0.001), but this was offset by an increase in the incidence of major haemorrhage (RR 1.88, 95% CI 1.49 to 2.38, p=0.001). CONCLUSIONS: Our meta-analysis provides evidence to oppose the hypothesis that thrombosis or embolism plays an important role in the morbidity and mortality associated with HFrEF, with the exception of stroke-related morbidity."},{"id":"01e01ce7e033","type":"article","url":"https://hartvaat.nl/2019/09/01/metformine-en-aorta-aneurysma-systematische-review-en-meta-analyse/","title":"Metformine en aorta-aneurysma: systematische review en meta-analyse","title_en":"Metformin prescription and aortic aneurysm: systematic review and meta-analysis.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314639","source_url":"https://doi.org/10.1136/heartjnl-2018-314639","authors":["Xinyu Yu","Dingsheng Jiang","Jing Wang","Rui Wang","Taiqiang Chen","Kan Wang","Mouniir Sha Ahmad Durgahee","Xiang Wei","Shiyi Cao"],"significance":6,"published":"2019-09-01","source_date":"2019-09-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that metformin use is associated with reduced risk of aortic aneurysm and slower aneurysm growth, suggesting a pleiotropic vascular protective effect beyond glycemic control.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:18Z","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":"Meta-analyse naar het verband tussen metforminegebruik en het risico op aorta-aneurysma. Pleiotrope bescherming van metformine.","abstract_original":"OBJECTIVE: To assess the association of metformin prescription with the risk of aortic aneurysm, aortic aneurysm events and the enlargement of abdominal aortic aneurysm (AAA). DESIGN: Systematic review and meta-analysis. METHODS: We searched PubMed, Embase and Scopus for epidemiological studies up to November 2018. We included observational studies which evaluated the association of metformin prescription with the risk of aortic aneurysm disease, and we also included studies involving progression and enlargement of AAA. The Newcastle-Ottawa Scale was used to assess the quality of included studies. Random-effect meta-analyses were conducted in line with the between-study heterogeneity. Sensitivity analyses were performed to identify the source of heterogeneity. RESULTS: Eight studies enrolling 29 587 participants met the inclusion criteria and were included in this systematic review. We found that metformin prescription could significantly limit the enlargement of aortic aneurysm (weighted mean difference: -0.83 mm/year, 95% CI -1.38 to -0.28, I2=89.6%) among patients with AAA. Metformin prescription status may be associated with a decreased risk of aortic aneurysm and aortic aneurysm events. CONCLUSIONS: According to the available epidemiological evidence, metformin prescription could limit the expansion of AAA among patients with this disease, and may be involved with a lower incidence of aortic aneurysm and aortic aneurysm events. Randomised controlled trials are needed to confirm whether metformin could reduce the enlargement of AAA in patients with or without diabetes."},{"id":"5c89bdb0a4fc","type":"article","url":"https://hartvaat.nl/2019/08/29/orale-semaglutide-en-cv-uitkomsten-bij-diabetes-type-2-nejm-pioneer-6/","title":"Orale semaglutide en CV-uitkomsten bij diabetes type 2: NEJM PIONEER 6","title_en":"Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["diabetes-type-2","select-trial","semaglutide","soul-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1901118","source_url":"https://doi.org/10.1056/NEJMoa1901118","authors":["Mansoor Husain","Andreas L Birkenfeld","Morten Donsmark","Kathleen Dungan","Freddy G Eliaschewitz","Denise R Franco","Ole K Jeppesen","Ildiko Lingvay","Ofri Mosenzon","Sue D Pedersen","Cees J Tack","Mette Thomsen","Tina Vilsbøll","Mark L Warren","Stephen C Bain"],"significance":9,"published":"2019-08-29","source_date":"2019-08-29","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"The PIONEER 6 trial established the cardiovascular safety of oral semaglutide in patients with type 2 diabetes at high cardiovascular risk, meeting the noninferiority threshold for MACE versus placebo. This was the first cardiovascular safety trial for an oral GLP-1 receptor agonist.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:18Z","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 PIONEER 6-trial die cardiovasculaire non-inferioriteit bevestigde van orale semaglutide bij diabetes type 2. Eerste orale GLP-1-agonist CV-veiligheidstrial.","abstract_original":"BACKGROUND: Establishing cardiovascular safety of new therapies for type 2 diabetes is important. Safety data are available for the subcutaneous form of the glucagon-like peptide-1 receptor agonist semaglutide but are needed for oral semaglutide. METHODS: We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascular risk factors only). The primary outcome in a time-to-event analysis was the first occurrence of a major adverse cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The trial was designed to rule out 80% excess cardiovascular risk as compared with placebo (noninferiority margin of 1.8 for the upper boundary of the 95% confidence interval for the hazard ratio for the primary outcome). RESULTS: A total of 3183 patients were randomly assigned to receive oral semaglutide or placebo. The mean age of the patients was 66 years; 2695 patients (84.7%) were 50 years of age or older and had cardiovascular or chronic kidney disease. The median time in the trial was 15.9 months. Major adverse cardiovascular events occurred in 61 of 1591 patients (3.8%) in the oral semaglutide group and 76 of 1592 (4.8%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.57 to 1.11; P<0.001 for noninferiority). Results for components of the primary outcome were as follows: death from cardiovascular causes, 15 of 1591 patients (0.9%) in the oral semaglutide group and 30 of 1592 (1.9%) in the placebo group (hazard ratio, 0.49; 95% CI, 0.27 to 0.92); nonfatal myocardial infarction, 37 of 1591 patients (2.3%) and 31 of 1592 (1.9%), respectively (hazard ratio, 1.18; 95% CI, 0.73 to 1.90); and nonfatal stroke, 12 of 1591 patients (0.8%) and 16 of 1592 (1.0%), respectively (hazard ratio, 0.74; 95% CI, 0.35 to 1.57). Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84). Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide. CONCLUSIONS: In this trial involving patients with type 2 diabetes, the cardiovascular risk profile of oral semaglutide was not inferior to that of placebo. (Funded by Novo Nordisk; PIONEER 6 ClinicalTrials.gov number, NCT02692716.)."},{"id":"3ac9cb435884","type":"article","url":"https://hartvaat.nl/2019/08/27/canagliflozine-bij-diabetes-type-2-met-ckd-primaire-en-secundaire-preventie/","title":"Canagliflozine bij diabetes type 2 met CKD: primaire en secundaire preventie","title_en":"Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["chronische-nierziekte","credence-trial","fidelio-dkd","figaro-dkd"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.042007","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.042007","authors":["Kenneth W Mahaffey","Meg J Jardine","Severine Bompoint","Christopher P Cannon","Bruce Neal","Hiddo J L Heerspink","David M Charytan","Robert Edwards","Rajiv Agarwal","George Bakris","Scott Bull","George Capuano","Dick de Zeeuw","Tom Greene","Adeera Levin","Carol Pollock","Tao Sun","David C Wheeler","Yshai Yavin","Hong Zhang","Bernard Zinman","Norman Rosenthal","Barry M Brenner","Vlado Perkovic"],"significance":7,"published":"2019-08-27","source_date":"2019-08-27","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"This CREDENCE subanalysis demonstrated that canagliflozin reduces cardiovascular events in both primary and secondary prevention populations with type 2 diabetes and CKD, showing consistent cardiorenal benefit across the risk spectrum.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:18Z","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":"CREDENCE-analyse naar canagliflozine bij diabetes met CKD voor zowel primaire als secundaire cardiovasculaire preventie.","abstract_original":"BACKGROUND: Canagliflozin reduces the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, but effects on specific cardiovascular outcomes are uncertain, as are effects in people without previous cardiovascular disease (primary prevention). METHODS: In CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation), 4401 participants with type 2 diabetes mellitus and chronic kidney disease were randomly assigned to canagliflozin or placebo on a background of optimized standard of care. RESULTS: Primary prevention participants (n=2181, 49.6%) were younger (61 versus 65 years), were more often female (37% versus 31%), and had shorter duration of diabetes mellitus (15 years versus 16 years) compared with secondary prevention participants (n=2220, 50.4%). Canagliflozin reduced the risk of major cardiovascular events overall (hazard ratio [HR], 0.80 [95% CI, 0.67-0.95]; P=0.01), with consistent reductions in both the primary (HR, 0.68 [95% CI, 0.49-0.94]) and secondary (HR, 0.85 [95% CI, 0.69-1.06]) prevention groups (P for interaction=0.25). Effects were also similar for the components of the composite including cardiovascular death (HR, 0.78 [95% CI, 0.61-1.00]), nonfatal myocardial infarction (HR, 0.81 [95% CI, 0.59-1.10]), and nonfatal stroke (HR, 0.80 [95% CI, 0.56-1.15]). The risk of the primary composite renal outcome and the composite of cardiovascular death or hospitalization for heart failure were also consistently reduced in both the primary and secondary prevention groups (P for interaction >0.5 for each outcome). CONCLUSIONS: Canagliflozin significantly reduced major cardiovascular events and kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, including in participants who did not have previous cardiovascular disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02065791."},{"id":"15942f265a9f","type":"article","url":"https://hartvaat.nl/2019/08/24/polypil-voor-primaire-en-secundaire-cv-preventie-lancet-polyiran/","title":"Polypil voor primaire en secundaire CV-preventie: Lancet PolyIran","title_en":"Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31791-X","source_url":"https://doi.org/10.1016/S0140-6736(19)31791-X","authors":["Gholamreza Roshandel","Masoud Khoshnia","Hossein Poustchi","Karla Hemming","Farin Kamangar","Abdolsamad Gharavi","Mohammad Reza Ostovaneh","Alireza Nateghi","Masoud Majed","Behrooz Navabakhsh","Shahin Merat","Akram Pourshams","Mahdi Nalini","Fatemeh Malekzadeh","Masoumeh Sadeghi","Noushin Mohammadifard","Nizal Sarrafzadegan","Mohammad Naemi-Tabiei","Abdolreza Fazel","Paul Brennan","Arash Etemadi","Paolo Boffetta","Neil Thomas","Tom Marshall","Kar Keung Cheng","Reza Malekzadeh"],"significance":8,"published":"2019-08-24","source_date":"2019-08-24","image":"","kennis":["https://hartvaat.nl/kennis/preventie/primaire-preventie-overzicht/","https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/"],"congress":"","summary_en":"The PolyIran trial, a pragmatic cluster-randomized study, demonstrated that a cardiovascular polypill reduced major cardiovascular events in an Iranian population when used for both primary and secondary prevention. The results validated the polypill strategy in a middle-income country setting.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:17Z","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":"Lancet PolyIran clustergerandomiseerde trial die de effectiviteit van een polypil onderzocht voor primaire en secundaire cardiovasculaire preventie. Populatiebrede preventiestrategie.","abstract_original":"BACKGROUND: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. METHODS: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985. FINDINGS: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; pinteraction=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group. INTERPRETATION: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs. FUNDING: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou."},{"id":"0ffeaadd0dbb","type":"article","url":"https://hartvaat.nl/2019/08/24/hypertensiezorg-in-44-lage-en-middeninkomenslanden-lancet/","title":"Hypertensiezorg in 44 lage- en middeninkomenslanden: Lancet","title_en":"The state of hypertension care in 44 low-income and middle-income countries: a cross-sectional study of nationally representative individual-level data from 1·1 million adults.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)30955-9","source_url":"https://doi.org/10.1016/S0140-6736(19)30955-9","authors":["Pascal Geldsetzer","Jennifer Manne-Goehler","Maja-Emilia Marcus","Cara Ebert","Zhaxybay Zhumadilov","Chea S Wesseh","Lindiwe Tsabedze","Adil Supiyev","Lela Sturua","Silver K Bahendeka","Abla M Sibai","Sarah Quesnel-Crooks","Bolormaa Norov","Kibachio J Mwangi","Omar Mwalim","Roy Wong-McClure","Mary T Mayige","Joao S Martins","Nuno Lunet","Demetre Labadarios","Khem B Karki","Gibson B Kagaruki","Jutta M A Jorgensen","Nahla C Hwalla","Dismand Houinato","Corine Houehanou","Mohamed Msaidié","David Guwatudde","Mongal S Gurung","Gladwell Gathecha","Maria Dorobantu","Albertino Damasceno","Pascal Bovet","Brice W Bicaba","Krishna K Aryal","Glennis Andall-Brereton","Kokou Agoudavi","Andrew Stokes","Justine I Davies","Till Bärnighausen","Rifat Atun","Sebastian Vollmer","Lindsay M Jaacks"],"significance":8,"published":"2019-08-24","source_date":"2019-08-24","image":"","kennis":[],"congress":"","summary_en":"This Lancet cross-sectional analysis of 44 low- and middle-income countries identified where patients are lost along the hypertension care continuum, quantifying the massive global treatment gap that accounts for the disproportionate cardiovascular burden in these settings.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 cross-sectionele analyse van hypertensiezorg in 44 lage- en middeninkomenslanden. Identificeert mondiale behandelkloven.","abstract_original":"BACKGROUND: Evidence from nationally representative studies in low-income and middle-income countries (LMICs) on where in the hypertension care continuum patients are lost to care is sparse. This information, however, is essential for effective targeting of interventions by health services and monitoring progress in improving hypertension care. We aimed to determine the cascade of hypertension care in 44 LMICs-and its variation between countries and population groups-by dividing the progression in the care process, from need of care to successful treatment, into discrete stages and measuring the losses at each stage. METHODS: In this cross-sectional study, we pooled individual-level population-based data from 44 LMICs. We first searched for nationally representative datasets from the WHO Stepwise Approach to Surveillance (STEPS) from 2005 or later. If a STEPS dataset was not available for a LMIC (or we could not gain access to it), we conducted a systematic search for survey datasets; the inclusion criteria in these searches were that the survey was done in 2005 or later, was nationally representative for at least three 10-year age groups older than 15 years, included measured blood pressure data, and contained data on at least two hypertension care cascade steps. Hypertension was defined as a systolic blood pressure of at least 140 mm Hg, diastolic blood pressure of at least 90 mm Hg, or reported use of medication for hypertension. Among those with hypertension, we calculated the proportion of individuals who had ever had their blood pressure measured; had been diagnosed with hypertension; had been treated for hypertension; and had achieved control of their hypertension. We weighted countries proportionally to their population size when determining this hypertension care cascade at the global and regional level. We disaggregated the hypertension care cascade by age, sex, education, household wealth quintile, body-mass index, smoking status, country, and region. We used linear regression to predict, separately for each cascade step, a country's performance based on gross domestic product (GDP) per capita, allowing us to identify countries whose performance fell outside of the 95% prediction interval. FINDINGS: Our pooled dataset included 1 100 507 participants, of whom 192 441 (17·5%) had hypertension. Among those with hypertension, 73·6% of participants (95% CI 72·9-74·3) had ever had their blood pressure measured, 39·2% of participants (38·2-40·3) had been diagnosed with hypertension, 29·9% of participants (28·6-31·3) received treatment, and 10·3% of participants (9·6-11·0) achieved control of their hypertension. Countries in Latin America and the Caribbean generally achieved the best performance relative to their predicted performance based on GDP per capita, whereas countries in sub-Saharan Africa performed worst. Bangladesh, Brazil, Costa Rica, Ecuador, Kyrgyzstan, and Peru performed significantly better on all care cascade steps than predicted based on GDP per capita. Being a woman, older, more educated, wealthier, and not being a current smoker were all positively associated with attaining each of the four steps of the care cascade. INTERPRETATION: Our study provides important evidence for the design and targeting of health policies and service interventions for hypertension in LMICs. We show at what steps and for whom there are gaps in the hypertension care process in each of the 44 countries in our study. We also identified countries in each world region that perform better than expected from their economic development, which can direct policy makers to important policy lessons. Given the high disease burden caused by hypertension in LMICs, nationally representative hypertension care cascades, as constructed in this study, are an important measure of progress towards achieving universal health coverage. FUNDING: Harvard McLennan Family Fund, Alexander von Humboldt Foundation."},{"id":"9fe93ef233cb","type":"article","url":"https://hartvaat.nl/2019/08/24/trends-in-hypertensiedetectie-behandeling-en-controle-in-12-hoge-inkomenslanden-/","title":"Trends in hypertensiedetectie, behandeling en controle in 12 hoge-inkomenslanden: Lancet","title_en":"Long-term and recent trends in hypertension awareness, treatment, and control in 12 high-income countries: an analysis of 123 nationally representative surveys.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31145-6","source_url":"https://doi.org/10.1016/S0140-6736(19)31145-6","authors":[],"significance":8,"published":"2019-08-24","source_date":"2019-08-24","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-diabetes/"],"congress":"","summary_en":"This Lancet analysis of 123 national surveys across 12 high-income countries mapped trends in hypertension awareness, treatment, and control, revealing that despite improvements, substantial gaps in blood pressure management persist even in well-resourced healthcare systems.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 analyse van lange- en korte-termijntrends in hypertensiemanagement in 12 hoge-inkomenslanden met 123 nationale surveys.","abstract_original":"BACKGROUND: Antihypertensive medicines are effective in reducing adverse cardiovascular events. Our aim was to compare hypertension awareness, treatment, and control, and how they have changed over time, in high-income countries. METHODS: We used data from people aged 40-79 years who participated in 123 national health examination surveys from 1976 to 2017 in 12 high-income countries: Australia, Canada, Finland, Germany, Ireland, Italy, Japan, New Zealand, South Korea, Spain, the UK, and the USA. We calculated the proportion of participants with hypertension, which was defined as systolic blood pressure of 140 mm Hg or more, or diastolic blood pressure of 90 mm Hg or more, or being on pharmacological treatment for hypertension, who were aware of their condition, who were treated, and whose hypertension was controlled (ie, lower than 140/90 mm Hg). FINDINGS: Data from 526 336 participants were used in these analyses. In their most recent surveys, Canada, South Korea, Australia, and the UK had the lowest prevalence of hypertension, and Finland the highest. In the 1980s and early 1990s, treatment rates were at most 40% and control rates were less than 25% in most countries and age and sex groups. Over the time period assessed, hypertension awareness and treatment increased and control rate improved in all 12 countries, with South Korea and Germany experiencing the largest improvements. Most of the observed increase occurred in the 1990s and early-mid 2000s, having plateaued since in most countries. In their most recent surveys, Canada, Germany, South Korea, and the USA had the highest rates of awareness, treatment, and control, whereas Finland, Ireland, Japan, and Spain had the lowest. Even in the best performing countries, treatment coverage was at most 80% and control rates were less than 70%. INTERPRETATION: Hypertension awareness, treatment, and control have improved substantially in high-income countries since the 1980s and 1990s. However, control rates have plateaued in the past decade, at levels lower than those in high-quality hypertension programmes. There is substantial variation across countries in the rates of hypertension awareness, treatment, and control. FUNDING: Wellcome Trust and WHO."},{"id":"ab355c2ca4eb","type":"article","url":"https://hartvaat.nl/2019/08/22/serelaxine-bij-acuut-hartfalen-nejm-relax-ahf-2/","title":"Serelaxine bij acuut hartfalen: NEJM RELAX-AHF-2","title_en":"Effects of Serelaxin in Patients with Acute Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1801291","source_url":"https://doi.org/10.1056/NEJMoa1801291","authors":["Marco Metra","John R Teerlink","Gad Cotter","Beth A Davison","G Michael Felker","Gerasimos Filippatos","Barry H Greenberg","Peter S Pang","Piotr Ponikowski","Adriaan A Voors","Kirkwood F Adams","Stefan D Anker","Alexandra Arias-Mendoza","Patricio Avendaño","Fernando Bacal","Michael Böhm","Guillermo Bortman","John G F Cleland","Alain Cohen-Solal","Maria G Crespo-Leiro","Maria Dorobantu","Luis E Echeverría","Roberto Ferrari","Sorel Goland","Eva Goncalvesová","Assen Goudev","Lars Køber","Juan Lema-Osores","Phillip D Levy","Kenneth McDonald","Pravin Manga","Béla Merkely","Christian Mueller","Burkert Pieske","Jose Silva-Cardoso","Jindřich Špinar","Iain Squire","Janina Stępińska","Walter Van Mieghem","Dirk von Lewinski","Gerhard Wikström","Mehmet B Yilmaz","Nicole Hagner","Thomas Holbro","Tsushung A Hua","Shalini V Sabarwal","Thomas Severin","Peter Szecsödy","Claudio Gimpelewicz"],"significance":8,"published":"2019-08-22","source_date":"2019-08-22","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"The RELAX-AHF-2 trial showed that serelaxin (recombinant human relaxin-2) did not reduce cardiovascular death or worsening heart failure in patients with acute heart failure, failing to confirm the promising phase 2 results. The definitive negative outcome closed development of this vasodilator strategy.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:17Z","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":"NEJM RELAX-AHF-2-trial die serelaxine (recombinant relaxine) onderzocht bij acuut hartfalen. Definitief negatief na de veelbelovende fase-2-resultaten.","abstract_original":"BACKGROUND: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.)."},{"id":"b62a2bf6baf5","type":"article","url":"https://hartvaat.nl/2019/08/20/dna-methylering-in-leukocyten-voorspelt-mi-en-coronairlijden/","title":"DNA-methylering in leukocyten voorspelt MI en coronairlijden","title_en":"Blood Leukocyte DNA Methylation Predicts Risk of Future Myocardial Infarction and Coronary Heart Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.039357","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.039357","authors":["Golareh Agha","Michael M Mendelson","Cavin K Ward-Caviness","Roby Joehanes","TianXiao Huan","Rahul Gondalia","Elias Salfati","Jennifer A Brody","Giovanni Fiorito","Jan Bressler","Brian H Chen","Symen Ligthart","Simonetta Guarrera","Elena Colicino","Allan C Just","Simone Wahl","Christian Gieger","Amy R Vandiver","Toshiko Tanaka","Dena G Hernandez","Luke C Pilling","Andrew B Singleton","Carlotta Sacerdote","Vittorio Krogh","Salvatore Panico","Rosario Tumino","Yun Li","Guosheng Zhang","James D Stewart","James S Floyd","Kerri L Wiggins","Jerome I Rotter","Michael Multhaup","Kelly Bakulski","Steven Horvath","Philip S Tsao","Devin M Absher","Pantel Vokonas","Joel Hirschhorn","M Daniele Fallin","Chunyu Liu","Stefania Bandinelli","Eric Boerwinkle","Abbas Dehghan","Joel D Schwartz","Bruce M Psaty","Andrew P Feinberg","Lifang Hou","Luigi Ferrucci","Nona Sotoodehnia","Giuseppe Matullo","Annette Peters","Myriam Fornage","Themistocles L Assimes","Eric A Whitsel","Daniel Levy","Andrea A Baccarelli"],"significance":6,"published":"2019-08-20","source_date":"2019-08-20","image":"","kennis":[],"congress":"","summary_en":"This study demonstrated that DNA methylation patterns in blood leukocytes predict future myocardial infarction and coronary heart disease risk, advancing epigenetic biomarkers as novel cardiovascular risk predictors.","created":"2026-07-03T10:28:06Z","updated":"2026-07-03T13:27:17Z","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 die aantoont dat DNA-methyleringspatronen in leukocyten het risico op toekomstig MI en coronairlijden voorspellen. Epigenetische risicostratificatie.","abstract_original":"BACKGROUND: DNA methylation is implicated in coronary heart disease (CHD), but current evidence is based on small, cross-sectional studies. We examined blood DNA methylation in relation to incident CHD across multiple prospective cohorts. METHODS: Nine population-based cohorts from the United States and Europe profiled epigenome-wide blood leukocyte DNA methylation using the Illumina Infinium 450k microarray, and prospectively ascertained CHD events including coronary insufficiency/unstable angina, recognized myocardial infarction, coronary revascularization, and coronary death. Cohorts conducted race-specific analyses adjusted for age, sex, smoking, education, body mass index, blood cell type proportions, and technical variables. We conducted fixed-effect meta-analyses across cohorts. RESULTS: Among 11 461 individuals (mean age 64 years, 67% women, 35% African American) free of CHD at baseline, 1895 developed CHD during a mean follow-up of 11.2 years. Methylation levels at 52 CpG (cytosine-phosphate-guanine) sites were associated with incident CHD or myocardial infarction (false discovery rate<0.05). These CpGs map to genes with key roles in calcium regulation (ATP2B2, CASR, GUCA1B, HPCAL1), and genes identified in genome- and epigenome-wide studies of serum calcium (CASR), serum calcium-related risk of CHD (CASR), coronary artery calcified plaque (PTPRN2), and kidney function (CDH23, HPCAL1), among others. Mendelian randomization analyses supported a causal effect of DNA methylation on incident CHD; these CpGs map to active regulatory regions proximal to long non-coding RNA transcripts. CONCLUSION: Methylation of blood-derived DNA is associated with risk of future CHD across diverse populations and may serve as an informative tool for gaining further insight on the development of CHD."},{"id":"19b4c7a5107c","type":"article","url":"https://hartvaat.nl/2019/08/20/fysiologische-versus-rechterkamerpacing-bij-lvef-35/","title":"Fysiologische versus rechterkamerpacing bij LVEF >35%","title_en":"Impact of Physiologic Pacing Versus Right Ventricular Pacing Among Patients With Left Ventricular Ejection Fraction Greater Than 35%: A Systematic Review for the 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["cardiale-resynchronisatie"],"journal":"Circulation","doi":"10.1161/CIR.0000000000000629","source_url":"https://doi.org/10.1161/CIR.0000000000000629","authors":["David J Slotwiner","Merritt H Raitt","Freddy Del-Carpio Munoz","Siva K Mulpuru","Naseer Nasser","Pamela N Peterson"],"significance":6,"published":"2019-08-20","source_date":"2019-08-20","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This study compared physiological pacing (His bundle or biventricular) with conventional right ventricular pacing in patients with LVEF >35%, showing that physiological approaches prevent adverse cardiac remodeling.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:17Z","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 naar de impact van fysiologische pacing (His-bundel of CRT) versus traditionele RV-pacing bij patiënten met LVEF >35%.","abstract_original":"BACKGROUND: It is unclear whether physiologic pacing by either cardiac biventricular pacing (BiVP) or His bundle pacing (HisBP) may prevent adverse structural and functional consequences known to occur among some patients who receive right ventricular pacing (RVP). AIM: Our analysis sought to review existing literature to determine if BiVP and/or HisBP might prevent adverse remodeling and be associated with structural, functional, and clinical advantages compared with RVP among patients without severe left ventricular dysfunction (>35%) who required permanent pacing because of heart block. METHODS: A literature search was conducted using MEDLINE (through PubMed) and Embase to identify randomized trials and observational studies comparing the effects of BiVP or HisBP versus RVP on measurements of left ventricular dimensions, left ventricular ejection fraction (LVEF), heart failure functional classification, quality of life, 6-minute walk, hospitalizations, and mortality. Data from studies that met the appropriate population, intervention, comparator, and outcomes of interest were abstracted for meta-analysis. Studies that reported pooled outcomes among patients with LVEF both above and below 35% could not be included in the meta-analysis because of strict relationships with industry procedures that preclude retrieval of industry-retained unpublished data on the subset of patients with preserved left ventricular function. RESULTS: Evidence from 8 studies, including a total of 679 patients meeting the prespecified criteria for inclusion, was identified. Results were compared for BiVP versus RVP, HisBP versus RVP, and BiVP+HisBP versus RVP. Among patients who received physiologic pacing with either BiVP or HisBP, the LV end-diastolic and end-systolic volumes were significantly lower (mean duration of follow-up: 1.64 years; -2.77 mL [95% CI -4.37 to -1.1 mL]; P=0.001; and -7.09 mL [95% CI -11.27 to -2.91; P=0.0009) and LVEF remained preserved or increased (mean duration of follow-up: 1.57 years; 5.328% [95% CI: 2.86%-7.8%; P<0.0001). Data on clinical impact such as functional status and quality of life were not definitive. Data on hospitalizations were unavailable. There was no effect on mortality. Several studies stratified results by LVEF and found that patients with LVEF >35% but ≤52% were more likely to receive benefit from physiologic pacing. Patients with chronic atrial fibrillation who underwent atrioventricular node ablation and pacemaker implant demonstrated clear improvement in LVEF with BiVP or HisBP versus RVP. CONCLUSION: Among patients with LVEF >35%, the LVEF remained preserved or increased with either BiVP or HisBP compared with RVP. However, patient-centered clinical outcome improvement appears to be limited primarily to patients who have chronic atrial fibrillation with rapid ventricular response rates and have undergone atrioventricular node ablation."},{"id":"9c2465bab67a","type":"article","url":"https://hartvaat.nl/2019/08/20/2018-acc-aha-hrs-richtlijn-voor-bradycardie-en-geleidingsstoornissen/","title":"2018 ACC/AHA/HRS richtlijn voor bradycardie en geleidingsstoornissen","title_en":"2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["bradycardie"],"journal":"Circulation","doi":"10.1161/CIR.0000000000000628","source_url":"https://doi.org/10.1161/CIR.0000000000000628","authors":["Fred M Kusumoto","Mark H Schoenfeld","Coletta Barrett","James R Edgerton","Kenneth A Ellenbogen","Michael R Gold","Nora F Goldschlager","Robert M Hamilton","José A Joglar","Robert J Kim","Richard Lee","Joseph E Marine","Christopher J McLeod","Keith R Oken","Kristen K Patton","Cara N Pellegrini","Kimberly A Selzman","Annemarie Thompson","Paul D Varosy"],"significance":9,"published":"2019-08-20","source_date":"2019-08-20","image":"","kennis":[],"congress":"","summary_en":"The 2018 ACC/AHA/HRS guideline for bradycardia and cardiac conduction delay provided comprehensive updated recommendations for evaluation, pacing indications, and device selection, replacing prior guidelines with contemporary evidence on leadless pacing and physiological pacing strategies.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:17Z","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":"Complete ACC/AHA/HRS 2018 richtlijn voor evaluatie en management van patiënten met bradycardie en cardiale geleidingsvertraging. Vervangt eerdere richtlijnen.","abstract_original":""},{"id":"32b6e130b406","type":"article","url":"https://hartvaat.nl/2019/08/14/langetermijn-ticagrelor-monotherapie-na-1-maand-dapt-bij-complexe-pci-global-lea/","title":"Langetermijn ticagrelor monotherapie na 1 maand DAPT bij complexe PCI: GLOBAL LEADERS","title_en":"Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz453","source_url":"https://doi.org/10.1093/eurheartj/ehz453","authors":["Patrick W Serruys","Kuniaki Takahashi","Ply Chichareon","Norihiro Kogame","Mariusz Tomaniak","Rodrigo Modolo","Chun Chin Chang","Hidenori Komiyama","Osama Soliman","Joanna J Wykrzykowska","Robbert J de Winter","Maurizio Ferrario","Marcello Dominici","Paweł Buszman","Leonardo Bolognese","Carlo Tumscitz","Edouard Benit","Hans-Peter Stoll","Christian Hamm","Philippe Gabriel Steg","Yoshinobu Onuma","Peter Jüni","Stephan Windecker","Pascal Vranckx","Antonio Colombo","Marco Valgimigli"],"significance":6,"published":"2019-08-14","source_date":"2019-08-14","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This GLOBAL LEADERS subanalysis evaluated ticagrelor monotherapy after 1 month of DAPT in patients who underwent complex PCI, extending the de-escalation evidence to the highest-complexity interventional subgroup.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:17Z","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":"GLOBAL LEADERS subanalyse naar de impact van ticagrelor monotherapie na 1 maand DAPT bij complexe PCI-patiënten.","abstract_original":"AIMS: To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION: Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating."},{"id":"6d2eb7600748","type":"article","url":"https://hartvaat.nl/2019/08/13/intensieve-versus-standaard-bloeddruk-en-cerebrale-wittestoflaesies-jama-sprint-/","title":"Intensieve versus standaard bloeddruk en cerebrale wittestoflaesies: JAMA SPRINT MIND MRI","title_en":"Association of Intensive vs Standard Blood Pressure Control With Cerebral White Matter Lesions.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.10551","source_url":"https://doi.org/10.1001/jama.2019.10551","authors":["Ilya M Nasrallah","Nicholas M Pajewski","Alexander P Auchus","Gordon Chelune","Alfred K Cheung","Maryjo L Cleveland","Laura H Coker","Michael G Crowe","William C Cushman","Jeffrey A Cutler","Christos Davatzikos","Lisa Desiderio","Jimit Doshi","Guray Erus","Larry J Fine","Sarah A Gaussoin","Darrin Harris","Karen C Johnson","Paul L Kimmel","Manjula Kurella Tamura","Lenore J Launer","Alan J Lerner","Cora E Lewis","Jennifer Martindale-Adams","Claudia S Moy","Linda O Nichols","Suzanne Oparil","Paula K Ogrocki","Mahboob Rahman","Stephen R Rapp","David M Reboussin","Michael V Rocco","Bonnie C Sachs","Kaycee M Sink","Carolyn H Still","Mark A Supiano","Joni K Snyder","Virginia G Wadley","Jennifer Walker","Daniel E Weiner","Paul K Whelton","Valerie M Wilson","Nancy Woolard","Jackson T Wright","Clinton B Wright","Jeff D Williamson","R Nick Bryan"],"significance":8,"published":"2019-08-13","source_date":"2019-08-13","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/"],"congress":"","summary_en":"The SPRINT MIND MRI substudy showed that intensive blood pressure control significantly reduced the progression of cerebral white matter lesions compared with standard treatment. The imaging findings provided mechanistic support for the potential neuroprotective effects of aggressive blood pressure management.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:17Z","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":"JAMA SPRINT MIND MRI-substudie die aantoont dat intensieve bloeddrukcontrole de progressie van cerebrale wittestoflaesies vermindert. Neurovasculair voordeel van agressieve bloeddrukbehandeling.","abstract_original":"IMPORTANCE: The effect of intensive blood pressure lowering on brain health remains uncertain. OBJECTIVE: To evaluate the association of intensive blood pressure treatment with cerebral white matter lesion and brain volumes. DESIGN, SETTING, AND PARTICIPANTS: A substudy of a multicenter randomized clinical trial of hypertensive adults 50 years or older without a history of diabetes or stroke at 27 sites in the United States. Randomization began on November 8, 2010. The overall trial was stopped early because of benefit for its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. Brain magnetic resonance imaging (MRI) was performed on a subset of participants at baseline (n = 670) and at 4 years of follow-up (n = 449); final follow-up date was July 1, 2016. INTERVENTIONS: Participants were randomized to a systolic blood pressure (SBP) goal of either less than 120 mm Hg (intensive treatment, n = 355) or less than 140 mm Hg (standard treatment, n = 315). MAIN OUTCOMES AND MEASURES: The primary outcome was change in total white matter lesion volume from baseline. Change in total brain volume was a secondary outcome. RESULTS: Among 670 recruited patients who had baseline MRI (mean age, 67.3 [SD, 8.2] years; 40.4% women), 449 (67.0%) completed the follow-up MRI at a median of 3.97 years after randomization, after a median intervention period of 3.40 years. In the intensive treatment group, based on a robust linear mixed model, mean white matter lesion volume increased from 4.57 to 5.49 cm3 (difference, 0.92 cm3 [95% CI, 0.69 to 1.14]) vs an increase from 4.40 to 5.85 cm3 (difference, 1.45 cm3 [95% CI, 1.21 to 1.70]) in the standard treatment group (between-group difference in change, -0.54 cm3 [95% CI, -0.87 to -0.20]). Mean total brain volume decreased from 1134.5 to 1104.0 cm3 (difference, -30.6 cm3 [95% CI, -32.3 to -28.8]) in the intensive treatment group vs a decrease from 1134.0 to 1107.1 cm3 (difference, -26.9 cm3 [95% CI, 24.8 to 28.8]) in the standard treatment group (between-group difference in change, -3.7 cm3 [95% CI, -6.3 to -1.1]). CONCLUSIONS AND RELEVANCE: Among hypertensive adults, targeting an SBP of less than 120 mm Hg, compared with less than 140 mm Hg, was significantly associated with a smaller increase in cerebral white matter lesion volume and a greater decrease in total brain volume, although the differences were small. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01206062."},{"id":"b259a83b2ed3","type":"article","url":"https://hartvaat.nl/2019/08/13/off-pump-versus-on-pump-cabg-bij-hoofdstamcoronairlijden/","title":"Off-pump versus on-pump CABG bij hoofdstamcoronairlijden","title_en":"Off-Pump Versus On-Pump Bypass Surgery for Left Main Coronary Artery Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.05.063","source_url":"https://doi.org/10.1016/j.jacc.2019.05.063","authors":["Umberto Benedetto","John Puskas","Arie Pieter Kappetein","W Morris Brown","Ferenc Horkay","Piet W Boonstra","Gabor Bogáts","Nicolas Noiseux","Ovidiu Dressler","Gianni D Angelini","Gregg W Stone","Patrick W Serruys","Joseph F Sabik","David P Taggart"],"significance":6,"published":"2019-08-13","source_date":"2019-08-13","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/cabg-bypasschirurgie/"],"congress":"","summary_en":"This comparison of off-pump versus on-pump CABG specifically for left main disease addressed concerns about completeness of revascularization and outcomes with the beating-heart approach in this complex surgical indication.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:16Z","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":"Vergelijking van off-pump versus on-pump CABG specifiek bij linker-hoofdstamcoronairlijden.","abstract_original":"BACKGROUND: Concerns remain for a greater risk of incomplete revascularization and reduced survival with off-pump coronary artery bypass grafting (CABG) surgery compared with on-pump surgery particularly in patients with left main disease and extensive underlying myocardial ischemia. OBJECTIVES: This study sought to compare outcomes following off-pump versus on-pump surgery for left main disease by performing a post hoc analysis from the multicenter, randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: The EXCEL trial was designed to compare percutaneous coronary intervention with everolimus-eluting stents versus CABG in patients with left main disease. CABG was performed with or without cardiopulmonary bypass (on-pump vs. off-pump surgery) according to the discretion of the operator. The 3-year outcomes in the off-pump and on-pump groups were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation. RESULTS: Among 923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively. Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007). After IPTW adjustment for baseline differences, off-pump surgery was associated with a significantly increased risk of 3-year all-cause death (8.8% vs. 4.5%; hazard ratio: 1.94; 95% confidence interval: 1.10 to 3.41; p = 0.02) and a nonsignificant difference in the risk for the composite endpoint of death, myocardial infarction, or stroke (11.8% vs. 9.2%; hazard ratio: 1.28; 95% confidence interval: 0.82 to 2.00; p = 0.28). CONCLUSIONS: Among patients with left main disease treated with CABG in the EXCEL trial, off-pump surgery was associated with a lower rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death compared with on-pump surgery."},{"id":"32e4c7bbff92","type":"article","url":"https://hartvaat.nl/2019/08/13/rivaroxaban-met-of-zonder-aspirine-bij-hf-met-coronair-of-perifeer-vaatlijden/","title":"Rivaroxaban met of zonder aspirine bij HF met coronair of perifeer vaatlijden","title_en":"Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.039609","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.039609","authors":["Kelley R Branch","Jeffrey L Probstfield","John W Eikelboom","Jackie Bosch","Aldo P Maggioni","Richard K Cheng","Deepak L Bhatt","Alvaro Avezum","Keith A A Fox","Stuart J Connolly","Olga Shestakovska","Salim Yusuf"],"significance":7,"published":"2019-08-13","source_date":"2019-08-13","image":"","kennis":[],"congress":"","summary_en":"This COMPASS heart failure subanalysis showed that rivaroxaban-based strategies benefit patients with chronic coronary or peripheral artery disease and history of heart failure, extending the dual-pathway inhibition evidence to the heart failure population.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:16Z","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":"COMPASS HF-subanalyse naar rivaroxaban met of zonder aspirine specifiek bij hartfalenpatiënten met coronair of perifeer vaatlijden.","abstract_original":"BACKGROUND: Patients with chronic coronary artery disease or peripheral artery disease and history of heart failure (HF) are at high risk for major adverse cardiovascular events. We explored the effects of rivaroxaban with or without aspirin in these patients. METHODS: The COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized 27 395 participants with chronic coronary artery disease or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg alone. Patients with New York Heart Association functional class III or IV HF or left ventricular ejection fraction (EF) <30% were excluded. The primary major adverse cardiovascular events outcome comprised cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome was major bleeding using modified International Society of Thrombosis and Haemostasis criteria. Investigators recorded a history of HF and EF at baseline, if available. We examined the effects of rivaroxaban on major adverse cardiovascular events and major bleeding in patients with or without a history of HF and an EF <40% or ≥40% at baseline. RESULTS: Of the 5902 participants (22%) with a history of HF, 4971 (84%) had EF recorded at baseline, and 12% had EF <40%. Rivaroxaban and aspirin had similar relative reduction in major adverse cardiovascular events compared with aspirin in participants with HF (5.5% versus 7.9%; hazard ratio [HR], 0.68; 95% CI, 0.53-0.86) and those without HF (3.8% versus 4.7%; HR, 0.79; 95% CI, 0.68-0.93; P for interaction 0.28) but larger absolute risk reduction in those with HF (HF absolute risk reduction 2.4%, number needed to treat=42; no HF absolute risk reduction 1.0%, number needed to treat=103). The primary major adverse cardiovascular events outcome was not statistically different between those with EF <40% (HR, 0.88; 95% CI, 0.55-1.42) and ≥40% (HR, 0.81; 95% CI, 0.67-0.98; P for interaction 0.36). The excess hazard for major bleeding was not different in participants with HF (2.5% versus 1.8%; HR, 1.36; 95% CI, 0.88-2.09) than in those without HF (3.3% versus 1.9%; HR, 1.79; 95% CI, 1.45-2.21; P for interaction 0.26). There were no significant differences in the primary outcomes with rivaroxaban alone. CONCLUSIONS: In patients with chronic coronary artery disease or peripheral artery disease and a history of mild or moderate HF, combination rivaroxaban and aspirin compared with aspirin alone produces similar relative but larger absolute benefits than in those without HF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424."},{"id":"95dca8b59542","type":"article","url":"https://hartvaat.nl/2019/08/08/volanesorsen-en-triglyceriden-bij-familiair-chylomicronemiesyndroom-nejm/","title":"Volanesorsen en triglyceriden bij familiair chylomicronemiesyndroom: NEJM","title_en":"Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["dyslipidemie","ezetimibe","familiaire-hypercholesterolemie-screening","niet-statine-therapie","pelacarsen","select-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1715944","source_url":"https://doi.org/10.1056/NEJMoa1715944","authors":["Joseph L Witztum","Daniel Gaudet","Steven D Freedman","Veronica J Alexander","Andres Digenio","Karren R Williams","Qingqing Yang","Steven G Hughes","Richard S Geary","Marcello Arca","Erik S G Stroes","Jean Bergeron","Handrean Soran","Fernando Civeira","Linda Hemphill","Sotirios Tsimikas","Dirk J Blom","Louis O'Dea","Eric Bruckert"],"significance":8,"published":"2019-08-08","source_date":"2019-08-08","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/fibraten-bij-hypertriglyceridemie/"],"congress":"","summary_en":"This NEJM trial demonstrated that volanesorsen, an antisense oligonucleotide targeting apoC-III, dramatically reduced triglyceride levels in patients with familial chylomicronemia syndrome. As the first targeted therapy for this rare genetic disorder, it addressed a previously unmet therapeutic need.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T13:27:16Z","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":"NEJM-trial van volanesorsen, een antisense tegen apoC-III, bij familiair chylomicronemiesyndroom. Eerste therapie voor deze zeldzame lipidenstoornis.","abstract_original":"BACKGROUND: Familial chylomicronemia syndrome is a rare genetic disorder that is caused by loss of lipoprotein lipase activity and characterized by chylomicronemia and recurrent episodes of pancreatitis. There are no effective therapies. In an open-label study of three patients with this syndrome, antisense-mediated inhibition of hepatic APOC3 mRNA with volanesorsen led to decreased plasma apolipoprotein C-III and triglyceride levels. METHODS: We conducted a phase 3, double-blind, randomized 52-week trial to evaluate the safety and effectiveness of volanesorsen in 66 patients with familial chylomicronemia syndrome. Patients were randomly assigned, in a 1:1 ratio, to receive volanesorsen or placebo. The primary end point was the percentage change in fasting triglyceride levels from baseline to 3 months. RESULTS: Patients receiving volanesorsen had a decrease in mean plasma apolipoprotein C-III levels from baseline of 25.7 mg per deciliter, corresponding to an 84% decrease at 3 months, whereas patients receiving placebo had an increase in mean plasma apolipoprotein C-III levels from baseline of 1.9 mg per deciliter, corresponding to a 6.1% increase (P<0.001). Patients receiving volanesorsen had a 77% decrease in mean triglyceride levels, corresponding to a mean decrease of 1712 mg per deciliter (19.3 mmol per liter) (95% confidence interval [CI], 1330 to 2094 mg per deciliter [15.0 to 23.6 mmol per liter]), whereas patients receiving placebo had an 18% increase in mean triglyceride levels, corresponding to an increase of 92.0 mg per deciliter (1.0 mmol per liter) (95% CI, -301.0 to 486 mg per deciliter [-3.4 to 5.5 mmol per liter]) (P<0.001). At 3 months, 77% of the patients in the volanesorsen group, as compared with 10% of patients in the placebo group, had triglyceride levels of less than 750 mg per deciliter (8.5 mmol per liter). A total of 20 of 33 patients who received volanesorsen had injection-site reactions, whereas none of the patients who received placebo had such reactions. No patients in the placebo group had platelet counts below 100,000 per microliter, whereas 15 of 33 patients in the volanesorsen group had such levels, including 2 who had levels below 25,000 per microliter. No patient had platelet counts below 50,000 per microliter after enhanced platelet-monitoring began. CONCLUSIONS: Volanesorsen lowered triglyceride levels to less than 750 mg per deciliter in 77% of patients with familial chylomicronemia syndrome. Thrombocytopenia and injection-site reactions were common adverse events. (Funded by Ionis Pharmaceuticals and Akcea Therapeutics; APPROACH Clinical Trials.gov number, NCT02211209.)."},{"id":"4f44acb0316c","type":"article","url":"https://hartvaat.nl/2019/08/06/leeftijdsafhankelijke-kenmerken-en-uitkomsten-bij-hfpef/","title":"Leeftijdsafhankelijke kenmerken en uitkomsten bij HFpEF","title_en":"Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen","hfmref","hfpef","hfref","step-hfpef"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.05.052","source_url":"https://doi.org/10.1016/j.jacc.2019.05.052","authors":["Jasper Tromp","Li Shen","Pardeep S Jhund","Inder S Anand","Peter E Carson","Akshay S Desai","Christopher B Granger","Michel Komajda","Robert S McKelvie","Marc A Pfeffer","Scott D Solomon","Lars Køber","Karl Swedberg","Michael R Zile","Bertram Pitt","Carolyn S P Lam","John J V McMurray"],"significance":5,"published":"2019-08-06","source_date":"2019-08-06","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfpef-hartfalen-met-behouden-ejectie/"],"congress":"","summary_en":"This analysis showed that age-related differences in HFpEF are substantial, with younger patients having distinct clinical profiles and potentially different treatment responses compared with elderly HFpEF patients.","created":"2026-07-03T10:28:05Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 leeftijdsafhankelijke klinische kenmerken en uitkomsten bij hartfalen met behouden ejectiefractie.","abstract_original":"BACKGROUND: Although heart failure with preserved ejection fraction (HFpEF) is considered a disease of the elderly, younger patients are not spared from this syndrome. OBJECTIVES: This study therefore investigated the associations among age, clinical characteristics, and outcomes in patients with HFpEF. METHODS: Using data on patients with left ventricular ejection fraction ≥45% from 3 large HFpEF trials (TOPCAT [Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function], I-PRESERVE [Irbesartan in Heart Failure With Preserved Systolic Function], and CHARM Preserved [Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity]), patients were categorized according to age: ≤55 years (n = 522), 56 to 64 years (n = 1,679), 65 to 74 years (n = 3,405), 75 to 84 years (n = 2,464), and ≥85 years (n = 398). This study compared clinical and echocardiographic characteristics, as well as mortality and hospitalization rates, mode of death, and quality of life across age categories. RESULTS: Younger patients (age ≤55 years) with HFpEF were more often obese, nonwhite men, whereas older patients with HFpEF were more often white women with a higher prevalence of atrial fibrillation, hypertension, and chronic kidney disease (eGFR <60 ml/min/1.73 m2). Despite fewer comorbidities, younger patients had worse quality of life compared with older patients (age ≥85 years). Compared with patients age ≤55 years, patients age ≥85 years had higher mortality (hazard ratio: 6.9; 95% confidence interval: 4.2 to 11.4). However, among patients who died, sudden death was, proportionally, the most common mode of death (p < 0.001) in patients age ≤55 years. In contrast, older patients (age ≥85 years) died more often from noncardiovascular causes (34% vs. 20% in patients age ≤55 years; p < 0.001). CONCLUSIONS: Compared with the elderly, younger patients with HFpEF were less likely to be white, were more frequently obese men, and died more often of cardiovascular causes, particularly sudden death. In contrast, elderly patients with HFpEF had more comorbidities and died more often from noncardiovascular causes. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302; Irbesartan in Heart Failure With Preserved Systolic Function [I-PRESERVE]; NCT00095238; Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM Preserved]; NCT00634712)."},{"id":"51dfa0f13e51","type":"article","url":"https://hartvaat.nl/2019/08/06/angptl3-remming-met-monoklonaal-antilichaam-verlaagt-triglyceriden/","title":"ANGPTL3-remming met monoklonaal antilichaam verlaagt triglyceriden","title_en":"Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ace-remmers"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.039107","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.039107","authors":["Zahid Ahmad","Poulabi Banerjee","Sara Hamon","Kuo-Chen Chan","Aurelie Bouzelmat","William J Sasiela","Robert Pordy","Scott Mellis","Hayes Dansky","Daniel A Gipe","Richard L Dunbar"],"significance":7,"published":"2019-08-06","source_date":"2019-08-06","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/fibraten-bij-hypertriglyceridemie/"],"congress":"","summary_en":"This study demonstrated that ANGPTL3 inhibition with a monoclonal antibody (evinacumab) effectively lowers triglycerides in patients with severe hypertriglyceridemia, establishing a new mechanism for treating this difficult lipid disorder.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T13:27:16Z","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":"Studie naar remming van ANGPTL3 met een monoklonaal antilichaam voor triglyceridenverlaging bij ernstige hypertriglyceridemie.","abstract_original":"BACKGROUND: Hypertriglyceridemia is associated with increased cardiovascular risk and may be caused by impaired lipoprotein clearance. Angiopoietin-like protein 3 (ANGPTL3) inhibits lipoprotein lipase activity, increasing triglycerides and other lipids. Evinacumab, an ANGPTL3 inhibitor, reduced triglycerides in healthy human volunteers and in homozygous familial hypercholesterolemic individuals. Results from 2 Phase 1 studies in hypertriglyceridemic subjects are reported here. METHODS: Subjects with triglycerides >150 but ≤450 mg/dL and low-density lipoprotein cholesterol ≥100 mg/dL (n=83 for single ascending dose study [SAD]; n=56 for multiple ascending dose study [MAD]) were randomized 3:1 to evinacumab:placebo. SAD subjects received evinacumab subcutaneously at 75/150/250 mg, or intravenously at 5/10/20 mg/kg, monitored up to day 126. MAD subjects received evinacumab subcutaneously at 150/300/450 mg once weekly, 300/450 mg every 2 weeks, or intravenously at 20 mg/kg once every 4 weeks up to day 56 with 6 months of follow-up. The primary outcomes were incidence and severity of treatment-emergent adverse events. Efficacy analyses included changes in triglycerides and other lipids over time. RESULTS: In the SAD, 32 (51.6%) versus 9 (42.9%) subjects on evinacumab versus placebo reported treatment-emergent adverse events. In the MAD, 21 (67.7%) versus 9 (75.0%) subjects on subcutaneously evinacumab versus placebo and 6 (85.7%) versus 1 (50.0%) on intravenously evinacumab versus placebo reported treatment-emergent adverse events. No serious treatment-emergent adverse events or events leading to death or treatment discontinuation were reported. Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%) SAD, 1 [14.3%] MAD) were observed with evinacumab (none in the placebo groups), which were single elevations and were not dose-related. Dose-dependent reductions in triglycerides were observed in both studies, with maximum reduction of 76.9% at day 3 with 10 mg/kg intravenously (P<0.0001) in the SAD and of 83.1% at day 2 with 20 mg/kg intravenously once every 4 weeks (P=0.0003) in the MAD. Significant reductions in other lipids were observed with most evinacumab doses versus placebo. CONCLUSION: Evinacumab was well-tolerated in 2 Phase 1 studies. Lipid changes in hypertriglyceridemic subjects were similar to those observed with ANGPTL3 loss-of-function mutations. Because the latter is associated with reduced cardiovascular risk, ANGPTL3 inhibition may improve clinical outcomes. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifiers: NCT01749878 and NCT02107872."},{"id":"ffa974a327ff","type":"article","url":"https://hartvaat.nl/2019/08/01/icd-bij-diabetes-met-niet-ischemisch-systolisch-hf-danish-analyse/","title":"ICD bij diabetes met niet-ischemisch systolisch HF: DANISH-analyse","title_en":"The effect of implantable cardioverter-defibrillator in patients with diabetes and non-ischaemic systolic heart failure.","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/euz114","source_url":"https://doi.org/10.1093/europace/euz114","authors":["Rasmus Rørth","Jens Jakob Thune","Jens C Nielsen","Jens Haarbo","Lars Videbæk","Eva Korup","James Signorovitch","Niels E Bruun","Hans Eiskjær","Christian Hassager","Jesper Hastrup Svendsen","Dan E Høfsten","Christian Torp-Pedersen","Steen Pehrson","Lars Køber","Søren L Kristensen"],"significance":6,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This DANISH subanalysis examined whether diabetes modifies the ICD benefit in non-ischemic heart failure, finding that diabetic patients do not derive significantly different survival benefit from prophylactic defibrillator therapy.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T13:27:16Z","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":"DANISH subanalyse naar het effect van ICD bij diabetespatiënten met niet-ischemisch systolisch hartfalen.","abstract_original":"AIMS: Implantable cardioverter-defibrillator (ICD) implantation reduce the risk of sudden cardiac death, but not all-cause death in patients with non-ischaemic systolic heart failure (HF). Whether co-existence of diabetes affects ICD treatment effects is unclear. METHODS AND RESULTS: We examined the effect of ICD implantation on risk of all-cause death, cardiovascular death, and sudden cardiac death (SCD) according to diabetes status at baseline in the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial. Outcomes were analysed by use of cumulative incidence curves and Cox regressions models. Of the 1116 patients enrolled, 211 (19%) had diabetes at baseline. Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV. The risk of device infections and other complications in the ICD group was similar among patients with and without diabetes (6.1% vs. 4.6% P = 0.54). Irrespective of treatment group, diabetes was associated with higher risk of all-cause death, cardiovascular death, and SCD. The treatment effect of ICD in patients with diabetes vs. patients without diabetes was hazard ratio (HR) = 0.92 (0.57-1.50) vs. HR = 0.85 (0.63-1.13); Pinteraction = 0.60 for all-cause mortality, HR = 0.99 (0.58-1.70) vs. HR = 0.70 (0.48-1.01); Pinteraction = 0.25 for cardiovascular death, and HR = 0.81 (0.35-1.88) vs. HR = 0.40 (0.22-0.76); Pinteraction = 0.16 for sudden cardiac death. CONCLUSION: Among patients with non-ischaemic systolic HF, diabetes was associated with higher incidence of all-cause mortality, primarily driven by cardiovascular mortality including SCD. Treatment effect of ICD therapy was not significantly modified by diabetes which might be due to lack of power."},{"id":"96662a3950b7","type":"article","url":"https://hartvaat.nl/2019/08/01/vernakalant-voor-cardioversie-van-recent-onset-af-meta-analyse/","title":"Vernakalant voor cardioversie van recent-onset AF: meta-analyse","title_en":"Vernakalant for cardioversion of recent-onset atrial fibrillation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["acuut-hartfalen","aritmogene-cardiomyopathie","atleten","biomarkers-cardiovasculair","laminopathie","menopauze","ouderen","richtlijnen-esc","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/euz175","source_url":"https://doi.org/10.1093/europace/euz175","authors":["William F McIntyre","Jeff S Healey","Akash K Bhatnagar","Patrick Wang","Jacob A Gordon","Adrian Baranchuk","Bishoy Deif","Richard P Whitlock","Émilie P Belley-Côté"],"significance":6,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review and meta-analysis evaluated vernakalant for pharmacological cardioversion of recent-onset AF, confirming its rapid onset and superior conversion rate compared with other intravenous antiarrhythmic agents.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar vernakalant voor farmacologische cardioversie van recent-onset AF.","abstract_original":"AIMS: To evaluate the efficacy and safety of vernakalant for the cardioversion of atrial fibrillation (AF). METHODS AND RESULTS: We reviewed the literature for randomized trials that compared vernakalant to another drug or placebo in patients with AF of onset ≤7 days. We used a random-effects model to combine quantitative data and rated the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation). From 441 total citations in MEDLINE, EMBASE, and CENTRAL (December 2018), we identified nine trials evaluating 1358 participants. Six trials compared vernakalant to placebo, two trials compared vernakalant to ibutilide, and one trial compared vernakalant to amiodarone. We found significant methodological bias in four trials. For conversion within 90 min, vernakalant was superior to placebo [50% conversion, risk ratio (RR) 5.15; 95% confidence interval (CI); 2.24-11.84, I2 = 91%], whereas we found no significant difference in conversion when vernakalant was compared with an active drug (56% vs. 24% conversion, RR 2.40; 95% CI 0.76-7.58, I2 = 94). Sinus rhythm was maintained at 24 h in 85% (95% CI 80-88%) of patients who converted acutely with vernakalant. Overall, we judged the quality of evidence for efficacy to be low based on inconsistency and suspected publication bias. There was no significant difference in the risk of significant adverse events between vernakalant and comparator (RR 0.95; 95% CI 0.70-1.28, I2 = 0, moderate quality evidence). Vernakalant is safe and effective for rapid and durable restoration of sinus rhythm in patients with recent-onset AF. CONCLUSION: Vernakalant should be a first line option for the pharmacological cardioversion of patients with haemodynamically stable recent-onset AF without severe structural heart disease."},{"id":"2f05ead4c2da","type":"article","url":"https://hartvaat.nl/2019/08/01/temporele-veranderingen-in-coronaire-hemodynamiek-bij-niet-culprit-vaten-na-stem/","title":"Temporele veranderingen in coronaire hemodynamiek bij niet-culprit vaten na STEMI","title_en":"Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.2138","source_url":"https://doi.org/10.1001/jamacardio.2019.2138","authors":["Nina W van der Hoeven","Gladys N Janssens","Guus A de Waard","Henk Everaars","Christopher J Broyd","Casper W H Beijnink","Peter M van de Ven","Robin Nijveldt","Christopher M Cook","Ricardo Petraco","Tim Ten Cate","Clemens von Birgelen","Javier Escaned","Justin E Davies","Maarten A H van Leeuwen","Niels van Royen"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/obesitas-en-hart/"],"congress":"","summary_en":"This study characterized temporal changes in coronary hemodynamic indices (FFR, iFR) in nonculprit vessels after STEMI, showing that microvascular dysfunction resolves over time and may affect the timing of staged PCI decisions.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T13:27:16Z","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":"JAMA Cardiology studie naar temporele veranderingen in hyperemische en rust-hemodynamische indices in niet-culprit vaten na STEMI.","abstract_original":"IMPORTANCE: Percutaneous coronary intervention (PCI) of nonculprit vessels among patients with ST-segment elevation myocardial infarction (STEMI) is associated with improved clinical outcome compared with culprit vessel-only PCI. Fractional flow reserve (FFR) and coronary flow reserve are hyperemic indices used to guide revascularization. Recently, instantaneous wave-free ratio was introduced as a nonhyperemic alternative to FFR. Whether these indices can be used in the acute setting of STEMI continues to be investigated. OBJECTIVE: To assess the value of hemodynamic indices in nonculprit vessels of patients with STEMI from the index event to 1-month follow-up. DESIGN, SETTING, AND PARTICIPANTS: This substudy of the Reducing Micro Vascular Dysfunction in Revascularized STEMI Patients by Off-target Properties of Ticagrelor (REDUCE-MVI) randomized clinical trial enrolled 98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel. Patient enrollment was between May 1, 2015, and September 19, 2017. After successful primary PCI, nonculprit intracoronary hemodynamic measurements were performed and repeated at 1-month follow-up. Cardiac magnetic resonance imaging was performed from 2 to 7 days and 1 month after primary PCI. MAIN OUTCOMES AND MEASURES: The value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance from the index event to 1-month follow-up. RESULTS: Of 73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years. Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06]; P = .12) and there was no change in resting distal pressure/aortic pressure (mean [SD], 0.94 [0.06] vs 0.95 [0.06]; P = .25) from the acute moment to 1-month follow-up. The FFR decreased (mean [SD], 0.88 [0.07] vs 0.86 [0.09]; P = .001) whereas coronary flow reserve increased (mean [SD], 2.9 [1.4] vs 4.1 [2.2]; P < .001). Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance increased from the acute moment to follow-up. The decrease in distal pressure from rest to hyperemia was smaller at the acute moment vs follow-up (mean [SD], 10.6 [11.2] mm Hg vs 14.1 [14.2] mm Hg; P = .05). This blunted acute hyperemic response correlated with final infarct size (ρ, -0.29; P = .02). The resistive reserve ratio was lower at the acute moment vs follow-up (mean [SD], 3.4 [1.7] vs 5.0 [2.7]; P < .001). CONCLUSIONS AND RELEVANCE: In the acute setting of STEMI, nonculprit coronary flow reserve was reduced and FFR was augmented, whereas instantaneous wave-free ratio was not altered. These results may be explained by an increased hyperemic microvascular resistance and a blunted adenosine responsiveness at the acute moment that was associated with infarct size."},{"id":"49561d03d1d8","type":"article","url":"https://hartvaat.nl/2019/08/01/antitrombotische-strategieen-bij-af-na-pci-jama-cardiology-veiligheids-en-werkza/","title":"Antitrombotische strategieën bij AF na PCI: JAMA Cardiology veiligheids- en werkzaamheidsanalyse","title_en":"Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-analysis of Randomized Controlled Trials.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.1880","source_url":"https://doi.org/10.1001/jamacardio.2019.1880","authors":["Renato D Lopes","Hwanhee Hong","Ralf E Harskamp","Deepak L Bhatt","Roxana Mehran","Christopher P Cannon","Christopher B Granger","Freek W A Verheugt","Jianghao Li","Jurriën M Ten Berg","Nikolaus Sarafoff","C Michael Gibson","John H Alexander"],"significance":7,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This JAMA Cardiology analysis evaluated different antithrombotic strategies in AF patients undergoing PCI, synthesizing evidence on dual versus triple therapy to optimize the bleeding-ischemia trade-off.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T18:38:44Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 Cardiology analyse van veiligheid en werkzaamheid van verschillende antitrombotische strategieën bij AF-patiënten na PCI.","abstract_original":"IMPORTANCE: The antithrombotic treatment of patients with atrial fibrillation (AF) and coronary artery disease, in particular with acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), poses a significant treatment dilemma in clinical practice. OBJECTIVE: To study the safety and efficacy of different antithrombotic regimens using a network meta-analysis of randomized controlled trials in this population. DATA SOURCES: PubMed, EMBASE, EBSCO, and Cochrane databases were searched to identify randomized controlled trials comparing antithrombotic regimens. STUDY SELECTION: Four randomized studies were included (n = 10 026; WOEST, PIONEER AF-PCI, RE-DUAL PCI, and AUGUSTUS). DATA EXTRACTION AND SYNTHESIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review and network meta-analysis between 4 regimens using a Bayesian random-effects model. A pre hoc statistical analysis plan was written, and the review protocol was registered at PROSPERO. Data were analyzed between November 2018 and February 2019. MAIN OUTCOMES AND MEASURES: The primary safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding; secondary safety outcomes were combined TIMI major and minor bleeding, trial-defined primary bleeding events, intracranial hemorrhage, and hospitalization. The primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE); secondary efficacy outcomes were individual components of MACE. RESULTS: The overall prevalence of ACS varied from 28% to 61%. The mean age ranged from 70 to 72 years; 20% to 29% of the trial population were women; and most patients were at high risk for thromboembolic and bleeding events. Compared with a regimen of vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT; P2Y12 inhibitor plus aspirin), the odds ratios (ORs) for TIMI major bleeding were 0.58 (95% CI, 0.31-1.08) for VKA plus P2Y12 inhibitor, 0.49 (95% CI, 0.30-0.82) for non-VKA oral anticoagulant (NOAC) plus P2Y12 inhibitor, and 0.70 (95% CI, 0.38-1.23) for NOAC plus DAPT. Compared with VKA plus DAPT, the ORs for MACE were 0.96 (95% CI, 0.60-1.46) for VKA plus P2Y12 inhibitor, 1.02 (95% CI, 0.71-1.47) for NOAC plus P2Y12 inhibitor, and 0.94 (95% CI, 0.60-1.45) for NOAC plus DAPT. CONCLUSIONS AND RELEVANCE: A regimen of NOACs plus P2Y12 inhibitor was associated with less bleeding compared with VKAs plus DAPT. Strategies omitting aspirin caused less bleeding, including intracranial bleeding, without significant difference in MACE, compared with strategies including aspirin. Our results support the use of NOAC plus P2Y12 inhibitor as the preferred regimen post-percutaneous coronary intervention for these high-risk patients with AF. A regimen of VKA plus DAPT should generally be avoided."},{"id":"ab54ccf80196","type":"article","url":"https://hartvaat.nl/2019/08/01/optimale-laesieset-bij-persisterend-af-ablatie-meta-regressie/","title":"Optimale laesieset bij persisterend AF-ablatie: meta-regressie","title_en":"Optimum lesion set and predictors of outcome in persistent atrial fibrillation ablation: a meta-regression 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/euz108","source_url":"https://doi.org/10.1093/europace/euz108","authors":["Arunashis Sau","Sayed Al-Aidarous","James Howard","Joseph Shalhoub","Afzal Sohaib","Matthew Shun-Shin","Paul G Novak","Rick Leather","Laurence D Sterns","Christopher Lane","Prapa Kanagaratnam","Nicholas S Peters","Darrel P Francis","Markus B Sikkel"],"significance":6,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This meta-regression analysis identified the optimal ablation lesion set and predictors of outcome for persistent AF ablation, providing evidence-based guidance on whether additional substrate modification improves results beyond PVI.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T13:27:15Z","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":"Meta-regressieanalyse naar de optimale laesieset en voorspellers van uitkomst bij ablatie van persisterend AF.","abstract_original":"AIMS: Ablation of persistent atrial fibrillation (PsAF) has been performed by many techniques with varying success rates. This may be due to ablation techniques, patient demographics, comorbidities, and trial design. We conducted a meta-regression of studies of PsAF ablation to elucidate the factors affecting atrial fibrillation (AF) recurrence. METHODS AND RESULTS: Databases were searched for prospective studies of PsAF ablation. A meta-regression was performed. Fifty-eight studies (6767 patients) were included. Complex fractionated atrial electrogram (CFAE) ablation reduced freedom from AF by 8.9% [95% confidence interval (CI) -15 to -2.3, P = 0.009). Left atrial appendage [LAA isolation (three study arms)] increased freedom from AF by 39.5% (95% CI 9.1-78.4, P = 0.008). Posterior wall isolation (PWI) (eight study arms) increased freedom from AF by 19.4% (95% CI 3.3-38.1, P = 0.017). Linear ablation or ganglionated plexi ablation resulted in no significant effect on freedom from AF. More extensive ablation increased intraprocedural AF termination; however, intraprocedural AF termination was not associated with improved outcomes. Increased left atrial diameter was associated with a reduction in freedom from AF by 4% (95% CI -6.8% to -1.1%, P = 0.007) for every 1 mm increase in diameter. CONCLUSION: Linear ablation, PWI, and CFAE ablation improves intraprocedural AF termination, but such termination does not predict better long-term outcomes. Study arms including PWI or LAA isolation in the lesion set were associated with improved outcomes in terms of freedom from AF; however, further randomized trials are required before these can be routinely recommended. Left atrial size is the most important marker of AF chronicity influencing outcomes."},{"id":"4cd6d406b62e","type":"article","url":"https://hartvaat.nl/2019/08/01/eenvoudige-techniek-voor-pvi-van-linker-longvenen-gerandomiseerde-studie/","title":"Eenvoudige techniek voor PVI van linker longvenen: gerandomiseerde studie","title_en":"Evaluation of a simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins: a randomized 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/euz115","source_url":"https://doi.org/10.1093/europace/euz115","authors":["Maria Kyriakopoulou","Teresa Strisciuglio","Milad El Haddad","Jan De Pooter","Alexandre Almorad","Katarina Van Beeumen","Philippe Unger","Yves Vandekerckhove","René Tavernier","Mattias Duytschaever","Sébastien Knecht"],"significance":4,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"A randomised study evaluated a simplified catheter stabilisation technique for point-by-point isolation of the left pulmonary veins during AF ablation. The approach aims to improve anterior wall contact and procedural consistency.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T13:27:15Z","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 studie naar een vereenvoudigde techniek voor point-by-point isolatie van de linker longvenen bij AF-ablatie.","abstract_original":"AIMS: We sought to evaluate the efficacy and the safety of a simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement in patients ablated for paroxysmal atrial fibrillation. This consisted of bending the ablation catheter in the left atrium, creating a loop that was cautiously advanced together with the long sheath at the ostium and then within the left superior PV. The curve was then progressively released to reach a stable contact with the anterior part of the left PVs. METHODS AND RESULTS: Eighty consecutive patients (age 64 ± 11 years, left atrial diameter 43 ± 8 mm) undergoing 'CLOSE'-guided PV isolation were prospectively randomized into two groups depending on whether the loop technique was used or not. When using the loop technique, the encirclement of the left PVs was shorter [20 min (interquartile range, IQR 17-24) vs. 26 min (IQR 18-33), P < 0.01] with a high rate of first pass isolation [(100%) vs. (97%), P = 0.9] and adenosine proof isolation [(93%) vs. (95%), P = 0.67]. Most specifically, at the anterior part of the left PVs, there were less dislocations [0 (IQR 0-0) vs. 1 (IQR 0-4), P < 0.001], radiofrequency duration was shorter (272 ± 85 s vs. 378 ± 122 s, P < 0.001), force-time integral was higher [524 gs (IQR 427-687) vs. 398 gs (IQR 354-451), P < 0.001], average contact force was higher [20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14), P < 0.001]. CONCLUSION: This study describes a simple technique to facilitate catheter stability at the anterior part of the left PVs, resulting in more efficient left PV encirclement without compromising safety."},{"id":"cd3766a3fcd3","type":"article","url":"https://hartvaat.nl/2019/08/01/hartfalen-door-kankerbehandeling-kunnen-we-het-voorkomen/","title":"Hartfalen door kankerbehandeling: kunnen we het voorkomen?","title_en":"Heart failure from cancer therapy: can we prevent it?","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","pathfinder-trial","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12493","source_url":"https://doi.org/10.1002/ehf2.12493","authors":["Matthias Totzeck","Raluca I Mincu","Gerd Heusch","Tienush Rassaf"],"significance":7,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This review addressed strategies for preventing cancer therapy-related cardiotoxicity and heart failure, covering screening, monitoring, and cardioprotective interventions in the growing field of cardio-oncology.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 over preventie van cardiotoxiciteit en hartfalen door kankerbehandeling. Cardio-oncologische preventiestrategieën.","abstract_original":"AIMS: Conventional cytotoxic chemotherapy is still among the most effective treatment options for many types of cancer. However, cardiotoxicity, notably the decrease in left ventricular function under these regimens, can impair prognosis. Thus, prevention and treatment of cardiotoxicity are crucial. The present meta-analysis aims to assess the efficacy of beta-blockers or angiotensin-converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs) for prevention of cardiotoxicity. METHODS AND RESULTS: We systematically searched Pubmed, Cochrane, EMBASE, and Web of Science databases for randomized controlled trials published until February 2019. The analysis included randomized studies that reported on left ventricular ejection fraction (LVEF) after 6 months of chemotherapy in cancer patients who received beta-blockers or ACE inhibitors/ARBs for prevention of cardiotoxicity compared with controls. Studies on combination cardioprotective therapies were excluded from the analysis. The primary endpoint was prevention of a decrease in LVEF as defined by the individual study and as assessed by either transthoracic echocardiography or magnetic resonance imaging. We here show that patients under anthracycline-based chemotherapy have a moderate yet significant benefit in LVEF from beta-blockers or ACEs/ARBs. The beta-blocker analysis included 769 cancer patients, and the ACE inhibitors/ARBs analysis included a total of 581 cancer patients. The mean LVEF difference between the beta-blocker group and the control group was 2.57% (95% confidence interval 0.63-4.51, P = 0.009). The mean difference for ACE inhibitors/ARBs was 4.71% (95% confidence interval 0.38-9.03, P = 0.03). However, the beneficial effects throughout the studies were variable as documented by significant heterogeneity between the studies. CONCLUSIONS: Systematic evidence is needed to solidly found recommendations for cardioprotective prevention during chemotherapy. Likewise, trials on other neurohumoral drugs (spironolactone) and lipid-lowering approaches are required to improve protection for cardio-oncology patients."},{"id":"f541b2c4810d","type":"article","url":"https://hartvaat.nl/2019/08/01/hypertensieve-zwangerschapsaandoeningen-en-dna-methylering-bij-pasgeborenen/","title":"Hypertensieve zwangerschapsaandoeningen en DNA-methylering bij pasgeborenen","title_en":"Hypertensive Disorders of Pregnancy and DNA Methylation in Newborns.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":["vrouwen","zwangerschap-hart"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12634","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12634","authors":["Nabila Kazmi","Gemma C Sharp","Sarah E Reese","Florianne O Vehmeijer","Jari Lahti","Christian M Page","Weiming Zhang","Sheryl L Rifas-Shiman","Faisal I Rezwan","Andrew J Simpkin","Kimberley Burrows","Tom G Richardson","Diana L Santos Ferreira","Abigail Fraser","Quaker E Harmon","Shanshan Zhao","Vincent W V Jaddoe","Darina Czamara","Elisabeth B Binder","Maria C Magnus","Siri E Håberg","Wenche Nystad","Ellen A Nohr","Anne P Starling","Katerina J Kechris","Ivana V Yang","Dawn L DeMeo","Augusto A Litonjua","Andrea Baccarelli","Emily Oken","John W Holloway","Wilfried Karmaus","Syed H Arshad","Dana Dabelea","Thorkild I A Sørensen","Hannele Laivuori","Katri Raikkonen","Janine F Felix","Stephanie J London","Marie-France Hivert","Tom R Gaunt","Debbie A Lawlor","Caroline L Relton"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/eindorgaanschade-hypertensie/"],"congress":"","summary_en":"This study examined the epigenetic effects of hypertensive disorders of pregnancy on newborn DNA methylation, identifying methylation changes in genes related to cardiovascular development and immune regulation.","created":"2026-07-03T10:28:04Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de epigenetische gevolgen van hypertensieve zwangerschapsaandoeningen op DNA-methylering bij neonaten.","abstract_original":"Hypertensive disorders of pregnancy (HDP) are associated with low birth weight, shorter gestational age, and increased risk of maternal and offspring cardiovascular diseases later in life. The mechanisms involved are poorly understood, but epigenetic regulation of gene expression may play a part. We performed meta-analyses in the Pregnancy and Childhood Epigenetics Consortium to test the association between either maternal HDP (10 cohorts; n=5242 [cases=476]) or preeclampsia (3 cohorts; n=2219 [cases=135]) and epigenome-wide DNA methylation in cord blood using the Illumina HumanMethylation450 BeadChip. In models adjusted for confounders, and with Bonferroni correction, HDP and preeclampsia were associated with DNA methylation at 43 and 26 CpG sites, respectively. HDP was associated with higher methylation at 27 (63%) of the 43 sites, and across all 43 sites, the mean absolute difference in methylation was between 0.6% and 2.6%. Epigenome-wide associations of HDP with offspring DNA methylation were modestly consistent with the equivalent epigenome-wide associations of preeclampsia with offspring DNA methylation (R2=0.26). In longitudinal analyses conducted in 1 study (n=108 HDP cases; 550 controls), there were similar changes in DNA methylation in offspring of those with and without HDP up to adolescence. Pathway analysis suggested that genes located at/near HDP-associated sites may be involved in developmental, embryogenesis, or neurological pathways. HDP is associated with offspring DNA methylation with potential relevance to development."},{"id":"371d4376248e","type":"article","url":"https://hartvaat.nl/2019/08/01/renale-denervatie-bij-geisoleerde-systolische-hypertensie-vergelijking-van-kathe/","title":"Renale denervatie bij geïsoleerde systolische hypertensie: vergelijking van katheterstechnieken","title_en":"Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["radiance-htn","renale-denervatie"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.13019","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.13019","authors":["Karl Fengler","Karl-Philipp Rommel","Razvan Lapusca","Stephan Blazek","Christian Besler","Philipp Hartung","Maximilian von Roeder","Karl-Patrik Kresoja","Steffen Desch","Holger Thiele","Philipp Lurz"],"significance":6,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/geïsoleerde-systolische-hypertensie/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This study compared different renal denervation catheter techniques in isolated systolic hypertension, a phenotype characterized by arterial stiffness where RDN efficacy may differ from combined hypertension.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die verschillende RDN-katheterstechnieken vergeleek bij geïsoleerde systolische hypertensie.","abstract_original":"Patients with isolated systolic hypertension (ISH) are thought to show a diminished blood pressure (BP)-lowering effect after renal sympathetic denervation (RDN). This conclusion is mostly derived from unipolar radiofrequency catheter ablation studies. Limited data for newer RDN technologies exist. We used data from the RADIOSOUND-HTN (Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension) comparing 3 different RDN approaches to investigate a possible interaction between ISH and RDN response. One hundred twenty patients were stratified by having ISH or combined systolic-diastolic hypertension (CH). Of these, 39 underwent radiofrequency ablation of the renal main arteries, 39 combined radiofrequency ablation of the main and branch arteries, and 42 were treated with ultrasound-based ablation of the main renal artery. Patients with ISH (n=61) were older and had lower systolic and diastolic BP on ambulatory measurement (ambulatory BP measurement) at baseline in comparison to CH (n=59). At 3 months, patients with ISH showed a less pronounced BP-lowering effect of RDN as compared to patients with CH (daytime average -5.9±11.8 versus -13.3±11.7 mm Hg, P=0.001). This difference was significant for radiofrequency ablation of the renal main arteries and ultrasound-based ablation of the main renal artery treatment but did not reach significance in the radiofrequency ablation of the main and branch arteries group. After adjustment for baseline BP values and age, there was no significant difference in BP reduction between ISH and CH. Using unadjusted BP values, RDN seems to be more effective in CH than in ISH. However, adjusting for baseline BP values revealed similar BP reduction in ISH and CH patients, irrespective of the RDN treatment used. The value of ISH as predictor for successful RDN might have been overestimated in the past. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT02920034."},{"id":"2eca03d70f31","type":"article","url":"https://hartvaat.nl/2019/08/01/nilvadipine-en-cerebrale-bloedflow-bij-alzheimer-gerandomiseerde-trial/","title":"Nilvadipine en cerebrale bloedflow bij Alzheimer: gerandomiseerde trial","title_en":"Effects of Nilvadipine on Cerebral Blood Flow in Patients With Alzheimer Disease.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["amlodipine","calciumantagonisten"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12892","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12892","authors":["Daan L K de Jong","Rianne A A de Heus","Anne Rijpma","Rogier Donders","Marcel G M Olde Rikkert","Matthias Günther","Brian A Lawlor","Matthias J P van Osch","Jurgen A H R Claassen"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This randomized trial tested whether nilvadipine (a calcium channel blocker) improves cerebral blood flow in Alzheimer's disease, exploring a vascular approach to neurodegenerative disease treatment.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:15Z","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 naar het effect van nilvadipine (calciumantagonist) op cerebrale bloedflow bij Alzheimer. Vasculaire benadering van neurodegeneratie.","abstract_original":"Cerebrovascular changes, including reduced cerebral blood flow (CBF), occur early in the development of Alzheimer disease and may accelerate disease progression. This randomized, double-blind, placebo-controlled study investigated how 6 months of treatment with the calcium antagonist nilvadipine would affect CBF in patients with mild-to-moderate Alzheimer disease. CBF was measured with magnetic resonance arterial spin labeling in whole-brain gray matter and in a priori defined regions of interest including the hippocampus. Fifty-eight patients were randomly assigned (29 in each group), of whom 22 in both groups had no magnetic resonance exclusion criteria and were medication compliant over 6 months. Mean age was 72.8±6.2 years, mean mini-mental state examination was 20.4±3.4. Nilvadipine treatment lowered systolic blood pressure (Δ=-11.5 [95% CI, -19.7 to -3.2] mm Hg; P<0.01), while whole-brain gray-matter CBF remained stable (Δ=5.4 [95% CI, -6.4 to 17.2] mL/100 g per minute; P=0.36). CBF in the hippocampus increased (left: Δ=24.4 [95% CI, 4.3-44.5] mL/100 g per minute; P=0.02; right: Δ=20.1 [95% CI, -0.6 to 40.8] mL/100 g per minute; P=0.06). There was no significant change in CBF in the posterior cingulate cortex (Δ=5.2 [95% CI, -16.5 to 27.0] mL/100 g per minute; P=0.63) or other regions of interest. In conclusion, nilvadipine reduced blood pressure and increased CBF in the hippocampus, whereas other regions showed stable or small nonsignificant increases in CBF. These findings not only indicate preserved cerebral autoregulation in Alzheimer disease but also point toward beneficial cerebrovascular effects of antihypertensive treatment. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT02017340."},{"id":"ec45b881e9d6","type":"article","url":"https://hartvaat.nl/2019/08/01/endothelinereceptorantagonisme-verbetert-lipidenprofielen-en-verlaagt-pcsk9-bij-/","title":"Endothelinereceptorantagonisme verbetert lipidenprofielen en verlaagt PCSK9 bij pulmonale hypertensie","title_en":"Endothelin Receptor Antagonism Improves Lipid Profiles and Lowers PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in Patients With Chronic Kidney Disease.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","bloeddrukbehandeling","dyslipidemie","endothelineantagonisten","niet-statine-therapie","pcsk9-remmers","precision-trial","pulmonale-hypertensie"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12919","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12919","authors":["Tariq E Farrah","Atul Anand","Peter J Gallacher","Robert Kimmitt","Edwin Carter","James W Dear","Nicholas L Mills","David J Webb","Neeraj Dhaun"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This study showed that endothelin receptor antagonism improves lipid profiles and lowers PCSK9 levels in patients with pulmonary hypertension and CKD, revealing an unexpected lipid-modifying effect of endothelin blockade.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:15Z","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 die aantoont dat endothelinereceptorblokkade het lipidenprofiel verbetert en PCSK9-spiegels verlaagt bij patiënten met pulmonale hypertensie.","abstract_original":"Dyslipidemia is common in chronic kidney disease (CKD). Despite statins, many patients fail to adequately lower lipids and remain at increased risk of cardiovascular disease. Selective ETA (endothelin-A) receptor antagonists reduce cardiovascular disease risk factors. Preclinical data suggest that ETA antagonism has beneficial effects on circulating lipids. We assessed the effects of selective ETA antagonism on circulating lipids and PCSK9 (proprotein convertase subtilisin/kexin type 9) in CKD. This was a secondary analysis of a fully randomized, double-blind, 3-phase crossover study. Twenty-seven subjects with predialysis CKD on optimal cardio- and renoprotective treatment were randomly assigned to receive 6 weeks dosing with placebo, the selective ETA receptor antagonist, sitaxentan, or long-acting nifedipine. We measured circulating lipids and PCSK9 at baseline and then after 3 and 6 weeks. Baseline lipids and PCSK9 did not differ before each study phase. Whereas placebo and nifedipine had no effect on lipids, 6 weeks of ETA antagonism significantly reduced total (-11±1%) and low-density lipoprotein-associated (-20±3%) cholesterol, lipoprotein (a) (-16±2%) and triglycerides (-20±4%); high-density lipoprotein-associated cholesterol increased (+14±2%), P<0.05 versus baseline for all. Additionally, ETA receptor antagonism, but neither placebo nor nifedipine, reduced circulating PCSK9 (-19±2%; P<0.001 versus baseline; P<0.05 versus nifedipine and placebo). These effects were independent of statin use and changes in blood pressure or proteinuria. Selective ETA antagonism improves lipid profiles in optimally-managed patients with CKD, effects that may occur through a reduction in circulating PCSK9. ETA receptor antagonism offers a potentially novel strategy to reduce cardiovascular disease risk in CKD. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00810732."},{"id":"08cd182c0640","type":"article","url":"https://hartvaat.nl/2019/08/01/ijzercarboxymaltose-en-plasmavolumestatus-bij-hf-fair-hf-substudie/","title":"IJzercarboxymaltose en plasmavolumestatus bij HF: FAIR-HF substudie","title_en":"Effect of ferric carboxymaltose on calculated plasma volume status and clinical congestion: a FAIR-HF substudy.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["hfref","ijzersuppletie"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12462","source_url":"https://doi.org/10.1002/ehf2.12462","authors":["Darlington O Okonko","Fadi Jouhra","Huda Abu-Own","Gerasimos Filippatos","Josep Comin Colet","Chainey Suki","Claudio Mori","Piotr Ponikowski","Stefan D Anker"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This FAIR-HF substudy showed that intravenous ferric carboxymaltose improves calculated plasma volume status and reduces clinical congestion markers in chronic heart failure, suggesting volume management as a mechanism of IV iron benefit.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:15Z","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":"FAIR-HF substudie naar het effect van intraveneus ijzer op berekende plasmavolumestatus en klinische congestie bij hartfalen.","abstract_original":"AIMS: Iron deficiency worsens symptoms, quality of life, and exercise capacity in chronic heart failure (CHF) and might do so by promoting fluid retention. We assessed whether iron repletion improved congestion in CHF and appraised the prognostic utility of calculated plasma volume status (PVS), a novel index of congestion, in the FAIR-HF data set. METHODS AND RESULTS: In FAIR-HF, 459 iron deficient CHF patients were randomized to intravenous ferric carboxymaltose (FCM) or saline and assessed at 4, 12, and 24 weeks. Using weight and haematocrit, we calculated PVS in 436 patients. At baseline, PVS and weight were -5.5 ± 7.7% and 76.9 ± 14.3 kg, with peripheral oedema evident in 35% of subjects. Higher PVS values correlated to other congestion surrogates such as lower serum albumin. At 4 weeks, FCM was associated with greater reductions in weight (0.02) and PVS (P < 0.0001), and a trend for improved peripheral oedema at 24 weeks (0.07). Irrespective of treatment allocation, patients with a decrease in PVS from baseline to week 24 had higher increments in 6 min walking distance (61.4 m vs. 43.5 m, 0.02) and were more likely to improve their NYHA class (33.3% vs. 15.5%, 0.001). A PVS > -4% at baseline predicted worse outcomes even after adjustment for treatment assignment (hazard ratio 1.88, 95% confidence interval 1.01-3.51, 0.046). CONCLUSIONS: Intravenous iron therapy with FCM is associated with early reductions in PVS and weight, implying that decongestion might be one mechanism via which iron repletion aids CHF patients. Calculated PVS is of prognostic utility in this cohort."},{"id":"c7b59da73dbb","type":"article","url":"https://hartvaat.nl/2019/08/01/empagliflozine-voorkomt-progressie-van-ckd-empa-reg-outcome-renale-analyse/","title":"Empagliflozine voorkomt progressie van CKD: EMPA-REG OUTCOME renale analyse","title_en":"Analysis from the EMPA-REG OUTCOME® trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["chronische-nierziekte","credence-trial","cystatine-c","dapagliflozine","empagliflozine","emperor-trials","fidelio-dkd","flow-trial"],"journal":"Kidney international","doi":"10.1016/j.kint.2019.02.033","source_url":"https://doi.org/10.1016/j.kint.2019.02.033","authors":["Gert J Mayer","Christoph Wanner","Matthew R Weir","Silvio E Inzucchi","Audrey Koitka-Weber","Stefan Hantel","Maximilian von Eynatten","Bernard Zinman","David Z I Cherney"],"significance":8,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"This EMPA-REG OUTCOME analysis confirmed that empagliflozin may help prevent the progression of chronic kidney disease in patients with type 2 diabetes and cardiovascular disease, with consistent renal benefit across baseline kidney function categories.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:14Z","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":"EMPA-REG OUTCOME analyse die bevestigt dat empagliflozine de progressie van chronische nierziekte kan helpen voorkomen bij diabetes type 2.","abstract_original":"In patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease, empagliflozin (EMPA) decreased progression of chronic kidney disease (CKD), likely via a reduction in intraglomerular pressure. Due to prevalent comorbidities, such as hypertension and albuminuria, patients often receive other agents that alter intrarenal hemodynamics, including angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs), calcium channel blockers (CCBs) and diuretics. Nonsteroidal anti-inflammatory drugs (NSAIDs) may also be used by some individuals. In this exploratory, non-prespecified analysis, we investigated whether the kidney benefits of EMPA are altered in individuals already using the medications in these categories. In the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME®) trial, 7020 patients were essentially equally randomized to EMPA 10 mg, 25 mg or placebo added to their standard care. Differences in risk of incident or worsening nephropathy for pooled EMPA vs placebo across subgroups by baseline background medications (to which patients were not randomized) were assessed using a Cox proportional hazards model. Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect. As a representative example, the risk for acute renal failure was overall slightly increased in patients using ACEi/ARBs in all groups (placebo, EMPA 10 mg or EMPA 25 mg) but incidence rates were numerically lower in those assigned to EMPA. Similar patterns were observed for other medications included in this analysis. Thus, EMPA may assist to prevent CKD progression in patients with T2DM with CV disease, irrespective of common background medications that alter intrarenal hemodynamics, and without increasing acute renal adverse events."},{"id":"c6169f11985d","type":"article","url":"https://hartvaat.nl/2019/08/01/hoog-versus-laag-zuurstof-bij-acuut-hartfalen-hilo-hf-pilot/","title":"Hoog versus laag zuurstof bij acuut hartfalen: HiLo-HF pilot","title_en":"High vs. low oxygen therapy in patients with acute heart failure: HiLo-HF pilot trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","hfref","step-hfpef"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12448","source_url":"https://doi.org/10.1002/ehf2.12448","authors":["Nariman Sepehrvand","Wendimagegn Alemayehu","Brian H Rowe","Finlay A McAlister","Sean van Diepen","Michael Stickland","Justin A Ezekowitz"],"significance":5,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":[],"congress":"","summary_en":"This pilot trial compared high versus low supplemental oxygen in acute heart failure, evaluating whether oxygen therapy intensity affects clinical outcomes and biomarkers in the acute HF setting.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:14Z","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":"Pilot trial die hoog versus laag zuurstofgebruik onderzocht bij patiënten met acuut hartfalen.","abstract_original":"AIMS: Most patients with acute heart failure (AHF) are treated with supplemental oxygen during hospitalization. In this study, we investigated the effect of oxygen titrated to high vs. low pulse oximetry targets in patients hospitalized with AHF. METHODS AND RESULTS: In a pilot, open-label randomized controlled trial (RCT), 50 patients who were admitted with AHF were randomized to either high (≥96%) or low (90-92%) SpO2 targets. Oxygen was manually titrated to the assigned target ranges for 72 h. The primary endpoint was the change in N-terminal pro-brain-type natriuretic peptide (NT-proBNP) from randomization to 72 h, and secondary endpoints included patient-reported dyspnoea by visual analogue scale (VAS), patient global assessment (PGA), peak expiratory flow (PEF) within 72 h, and clinical outcomes up to 30 days following hospital discharge. The median age was 73.5 years, and 42% were women. The change in NT-proBNP was -6963 (-13 345, -1253) pg/mL in the high SpO2 group and -2093 (-5692, -353) pg/mL in the low SpO2 group (P = 0.46), and the 72 h to baseline NT-proBNP ratio was similar between groups (0.7 vs. 0.6, P = 0.51). There were no differences between arms in change in dyspnoea VAS (P = 0.86), PGA (P = 0.91), PEF (P = 0.52), in-hospital mortality (4.0% vs. 8.0%, P = 0.50), or 30 day heart failure readmission rates (20.8% vs. 8.7%, P = 0.22). CONCLUSIONS: In this study, no differences were observed in the primary or secondary outcomes for patients randomized to high vs. low SpO2 targets. Further RCTs with larger sample sizes are warranted to determine the efficacy and safety of oxygen therapy in patients with AHF."},{"id":"7f981c757014","type":"article","url":"https://hartvaat.nl/2019/08/01/strain-encoded-mri-voor-beoordeling-van-myocardiale-deformatie/","title":"Strain-encoded MRI voor beoordeling van myocardiale deformatie","title_en":"Strain-encoded magnetic resonance: a method for the assessment of myocardial deformation.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12442","source_url":"https://doi.org/10.1002/ehf2.12442","authors":["Grigorios Korosoglou","Sorin Giusca","Nina P Hofmann","Amit R Patel","Tomas Lapinskas","Burkert Pieske","Henning Steen","Hugo A Katus","Sebastian Kelle"],"significance":4,"published":"2019-08-01","source_date":"2019-08-01","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/cardiale-mri/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This review discusses strain-encoded magnetic resonance imaging as a method for quantifying myocardial deformation in healthy volunteers and patients with cardiovascular pathologies. The fast-SENC technique enables single-heartbeat strain acquisition.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:14Z","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":"Review over strain-encoded MRI als methode voor de beoordeling van myocardiale deformatie bij hartfalen.","abstract_original":"This study aims to assess the usefulness of strain-encoded magnetic resonance (SENC) for the quantification of myocardial deformation ('strain') in healthy volunteers and for the diagnostic workup of patients with different cardiovascular pathologies. SENC was initially described in the year 2001. Since then, the SENC sequence has undergone several technical developments, aiming at the detection of strain during single-heartbeat acquisitions (fast-SENC). Experimental and clinical studies that used SENC and fast-SENC or compared SENC with conventional cine or tagged magnetic resonance in phantoms, animals, healthy volunteers, or patients were systematically searched for in PubMed. Using 'strain-encoded magnetic resonance and SENC' as keywords, three phantom and three animal studies were identified, along with 27 further clinical studies, involving 185 healthy subjects and 904 patients. SENC (i) enabled reproducible assessment of myocardial deformation in vitro, in animals and in healthy volunteers, (ii) showed high reproducibility and substantially lower time spent compared with conventional tagging, (iii) exhibited incremental value to standard cine imaging for the detection of inducible ischaemia and for the risk stratification of patients with ischaemic heart disease, and (iv) enabled the diagnostic classification of patients with transplant vasculopathy, cardiomyopathies, pulmonary hypertension, and diabetic heart disease. SENC has the potential to detect a wide range of myocardial diseases early, accurately, and without the need of contrast agent injection, possibly enabling the initiation of specific cardiac therapies during earlier disease stages. Its one-heartbeat acquisition mode during free breathing results in shorter cardiovascular magnetic resonance protocols, making its implementation in the clinical realm promising."},{"id":"15a015bfca9c","type":"article","url":"https://hartvaat.nl/2019/07/23/ag10-transthyretinestabilisator-bij-symptomatische-attr-cardiomyopathie/","title":"AG10 transthyretinestabilisator bij symptomatische ATTR-cardiomyopathie","title_en":"Transthyretin Stabilization by AG10 in Symptomatic Transthyretin Amyloid Cardiomyopathy.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["aritmogene-cardiomyopathie","cardiomyopathie-gerichte-therapie","laminopathie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.012","source_url":"https://doi.org/10.1016/j.jacc.2019.03.012","authors":["Daniel P Judge","Stephen B Heitner","Rodney H Falk","Mathew S Maurer","Sanjiv J Shah","Ronald M Witteles","Martha Grogan","Van N Selby","Daniel Jacoby","Mazen Hanna","Jose Nativi-Nicolau","Jignesh Patel","Satish Rao","Uma Sinha","Cameron W Turtle","Jonathan C Fox"],"significance":7,"published":"2019-07-23","source_date":"2019-07-23","image":"","kennis":[],"congress":"","summary_en":"This study of AG10 (acoramidis), a potent transthyretin stabilizer, demonstrated near-complete transthyretin stabilization in patients with symptomatic ATTR cardiomyopathy, establishing a second TTR stabilizer alongside tafamidis for cardiac amyloidosis.","created":"2026-07-03T10:28:03Z","updated":"2026-07-03T13:27:14Z","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 van AG10 (acoramidis), een potente transthyretinestabilisator, bij symptomatische ATTR-cardiomyopathie. Nieuw middel naast tafamidis.","abstract_original":"BACKGROUND: Transthyretin (TTR) amyloidosis is an underdiagnosed disease caused by destabilization of TTR due to pathogenic mutations or aging. Both pathogenic and protective mutations illuminate mechanisms of disease and potential interventions. AG10 is a selective, oral TTR stabilizer under development for transthyretin amyloidosis cardiomyopathy (ATTR-CM) that mimics a protective TTR mutation. OBJECTIVES: This randomized, double-blind, placebo-controlled study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of AG10 in ATTR-CM patients with symptomatic, chronic heart failure. METHODS: ATTR-CM, New York Heart Association functional class II to III subjects (n = 49, mutant or wild-type) were randomized 1:1:1 to AG10 400 mg, AG10 800 mg, or placebo twice daily for 28 days. Safety and tolerability were assessed by clinical and laboratory criteria. AG10 plasma levels were measured. TTR stability was assessed by changes in serum TTR, and 2 established ex vivo assays (fluorescent probe exclusion and Western blot). RESULTS: AG10 treatment was well-tolerated, achieved target plasma concentrations and demonstrated near-complete stabilization of TTR. TTR stabilization was more complete and less variable at the higher dose with stabilization by fluorescent probe exclusion of 92 ± 10% (mean ± SD) at trough and 96 ± 9% at peak (both p < 10-12 vs. placebo). Average serum TTR increased by 36 ± 21% and 51 ± 38% at 400 and 800 mg, respectively (both p < 0.0001 vs. placebo). Baseline serum TTR in treated subjects was below normal in 80% of mutant and 33% of wild-type subjects. AG10 treatment restored serum TTR to the normal range in all subjects. CONCLUSIONS: AG10 has the potential to be a safe and effective treatment for patients with ATTR-CM. A phase 3 trial is ongoing. (Study of AG10 in Amyloid Cardiomyopathy; NCT03458130)."},{"id":"29dc80d7017f","type":"article","url":"https://hartvaat.nl/2019/07/20/drug-coated-balloon-bij-de-novo-coronairlaesies-met-hoog-bloedingsrisico-lancet-/","title":"Drug-coated balloon bij de-novo coronairlaesies met hoog bloedingsrisico: Lancet DEBUT","title_en":"Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31126-2","source_url":"https://doi.org/10.1016/S0140-6736(19)31126-2","authors":["Tuomas T Rissanen","Sanna Uskela","Jaakko Eränen","Pirjo Mäntylä","Annika Olli","Hannu Romppanen","Antti Siljander","Mikko Pietilä","Mikko J Minkkinen","Jerry Tervo","Jussi M Kärkkäinen"],"significance":7,"published":"2019-07-20","source_date":"2019-07-20","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/mitraclip-transcatheter-mitralisreparatie/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The DEBUT trial showed that drug-coated balloons are a viable alternative to bare-metal stents in patients with high bleeding risk undergoing PCI for de novo coronary lesions, offering the advantage of short DAPT duration.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"Lancet DEBUT-trial die drug-coated balloons vergeleek met BMS bij de-novo coronairlaesies bij patiënten met hoog bloedingsrisico. Stentloos alternatief.","abstract_original":"BACKGROUND: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. METHODS: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. FINDINGS: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. INTERPRETATIONS: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. FUNDING: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area."},{"id":"82081537b50f","type":"article","url":"https://hartvaat.nl/2019/07/16/edoxaban-versus-warfarine-bij-af-met-leverziekte-engage-af-timi-48/","title":"Edoxaban versus warfarine bij AF met leverziekte: ENGAGE AF-TIMI 48","title_en":"Edoxaban Versus Warfarin in Patients With Atrial Fibrillation and History of Liver Disease.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.04.061","source_url":"https://doi.org/10.1016/j.jacc.2019.04.061","authors":["Arman Qamar","Elliott M Antman","Christian T Ruff","Francesco Nordio","Sabina A Murphy","Laura T Grip","Norton J Greenberger","Ophelia Q P Yin","Youngsook Choi","Hans J Lanz","Michele F Mercuri","Eugene Braunwald","Robert P Giugliano"],"significance":5,"published":"2019-07-16","source_date":"2019-07-16","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/edoxaban/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This ENGAGE AF-TIMI 48 subanalysis showed that edoxaban maintains its favorable profile compared with warfarin in AF patients with liver disease, a population traditionally excluded from anticoagulation trials.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"ENGAGE AF-TIMI 48 subanalyse bij AF-patiënten met een voorgeschiedenis van leverziekte.","abstract_original":"BACKGROUND: Patients with liver disease have increased risk of thrombosis and bleeding but are typically excluded from trials of direct oral anticoagulant agents. OBJECTIVES: This study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), clinical efficacy and safety of edoxaban versus warfarin in patients with atrial fibrillation (AF) and history of liver disease. METHODS: ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction Study 48) was a randomized, double-blind trial comparing edoxaban with warfarin in patients with AF followed for 2.8 years. History of liver disease was defined as investigator-reported liver disease or >2-fold transaminase elevation at randomization. The primary efficacy and safety endpoints of stroke or systemic embolic event (SSEE) and major bleeding were assessed stratified by history of liver disease. PK/PD assessments of edoxaban included endogenous and extrinsic factor Xa activity and edoxaban concentration. RESULTS: Among 21,105 patients, 1,083 (5.1%) had a history of liver disease; they had a higher prevalence of many comorbidities. The adjusted risks of SSEE were similar (adjusted hazard ratio [HRadj]: 0.90; 95% confidence interval [CI]: 0.67 to 1.22; p = 0.50), but major bleeding was more common in patients with liver disease (HRadj: 1.38; 95% CI: 1.10 to 1.74; p = 0.005). There were no significant differences in PK/PD assessment of edoxaban in patients with versus without liver disease. The HRs for higher-dose edoxaban versus warfarin for SSEE were 0.86 (95% CI: 0.73 to 1.01) in patients without and 1.11 (95% CI: 0.54 to 2.30) with liver disease (p for interaction [pint] = 0.47), major bleeding 0.80 (95% CI: 0.70 to 0.91) in patients without and 0.91 (95% CI: 0.56 to 1.47) with liver disease (pint = 0.63). There were no significant differences in hepatic adverse events between the 2 treatment groups. CONCLUSIONS: Among patients with AF receiving oral anticoagulation, bleeding, but not thromboembolic events, was increased in patients with liver disease. A history of liver disease did not alter the relative efficacy and safety of edoxaban compared with warfarin. Hepatic adverse events were similar between edoxaban and warfarin."},{"id":"2f7d240c530d","type":"article","url":"https://hartvaat.nl/2019/07/13/dulaglutide-en-cardiovasculaire-uitkomsten-bij-diabetes-type-2-lancet-rewind/","title":"Dulaglutide en cardiovasculaire uitkomsten bij diabetes type 2: Lancet REWIND","title_en":"Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","figaro-dkd","obesitas","roken","secundaire-preventie","select-trial","soul-trial"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)31149-3","source_url":"https://doi.org/10.1016/S0140-6736(19)31149-3","authors":["Hertzel C Gerstein","Helen M Colhoun","Gilles R Dagenais","Rafael Diaz","Mark Lakshmanan","Prem Pais","Jeffrey Probstfield","Jeffrey S Riesmeyer","Matthew C Riddle","Lars Rydén","Denis Xavier","Charles Messan Atisso","Leanne Dyal","Stephanie Hall","Purnima Rao-Melacini","Gloria Wong","Alvaro Avezum","Jan Basile","Namsik Chung","Ignacio Conget","William C Cushman","Edward Franek","Nicolae Hancu","Markolf Hanefeld","Shaun Holt","Petr Jansky","Matyas Keltai","Fernando Lanas","Lawrence A Leiter","Patricio Lopez-Jaramillo","Ernesto German Cardona Munoz","Valdis Pirags","Nana Pogosova","Peter J Raubenheimer","Jonathan E Shaw","Wayne H-H Sheu","Theodora Temelkova-Kurktschiev"],"significance":10,"published":"2019-07-13","source_date":"2019-07-13","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"The REWIND trial showed that once-weekly dulaglutide reduced the composite of cardiovascular death, nonfatal MI, and nonfatal stroke in patients with type 2 diabetes, including a substantial proportion at primary prevention level. This broadened the evidence for GLP-1 receptor agonists to a lower-risk, more representative diabetes population.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"Lancet REWIND-trial die aantoonde dat dulaglutide cardiovasculaire events vermindert bij diabetes type 2, inclusief primaire preventie. Breedste GLP-1-populatie tot nu toe.","abstract_original":"BACKGROUND: Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. METHODS: This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001). INTERPRETATION: Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors. FUNDING: Eli Lilly and Company."},{"id":"c3629382a1c9","type":"article","url":"https://hartvaat.nl/2019/07/09/alirocumab-en-mortaliteit-na-acs-odyssey-outcomes-analyse/","title":"Alirocumab en mortaliteit na ACS: ODYSSEY OUTCOMES-analyse","title_en":"Effect of Alirocumab on Mortality After Acute Coronary Syndromes.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038840","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038840","authors":["Philippe Gabriel Steg","Michael Szarek","Deepak L Bhatt","Vera A Bittner","Marie-France Brégeault","Anthony J Dalby","Rafael Diaz","Jay M Edelberg","Shaun G Goodman","Corinne Hanotin","Robert A Harrington","J Wouter Jukema","Guillaume Lecorps","Kenneth W Mahaffey","Angèle Moryusef","Petr Ostadal","Alexander Parkhomenko","Robert Pordy","Matthew T Roe","Pierluigi Tricoci","Robert Vogel","Harvey D White","Andreas M Zeiher","Gregory G Schwartz"],"significance":9,"published":"2019-07-09","source_date":"2019-07-09","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis demonstrated that alirocumab reduced all-cause mortality after acute coronary syndrome, particularly in patients with baseline LDL cholesterol ≥100 mg/dL. This was the first PCSK9 inhibitor trial to show a statistically significant mortality reduction.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"ODYSSEY OUTCOMES-analyse die het mortaliteitsvoordeel van alirocumab na ACS kwantificeerde. De eerste PCSK9-remmer die totale mortaliteit significant vermindert.","abstract_original":"BACKGROUND: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. METHODS: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. RESULTS: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths ( P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events ( P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined with achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). CONCLUSIONS: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01663402."},{"id":"36e35b7c8ce5","type":"article","url":"https://hartvaat.nl/2019/07/09/his-correctieve-pacing-versus-biventriculaire-pacing-voor-crt-bij-hartfalen/","title":"His-correctieve pacing versus biventriculaire pacing voor CRT bij hartfalen","title_en":"His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["cardiale-resynchronisatie","linkerbundeltakpacing"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.04.026","source_url":"https://doi.org/10.1016/j.jacc.2019.04.026","authors":["Gaurav A Upadhyay","Pugazhendhi Vijayaraman","Hemal M Nayak","Nishant Verma","Gopi Dandamudi","Parikshit S Sharma","Moeen Saleem","John Mandrola","Davide Genovese","Roderick Tung"],"significance":7,"published":"2019-07-09","source_date":"2019-07-09","image":"","kennis":[],"congress":"","summary_en":"This comparison of His bundle pacing versus conventional biventricular pacing for cardiac resynchronization demonstrated the feasibility and potential superiority of conduction system pacing for CRT in selected heart failure patients.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"Vergelijking van His-bundelpacing versus traditionele biventriculaire pacing voor CRT. Pionierswerk in conduction system pacing.","abstract_original":""},{"id":"20daefb4bcbc","type":"article","url":"https://hartvaat.nl/2019/07/09/2019-aha-acc-hrs-gerichte-update-van-de-af-richtlijn/","title":"2019 AHA/ACC/HRS gerichte update van de AF-richtlijn","title_en":"2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.01.011","source_url":"https://doi.org/10.1016/j.jacc.2019.01.011","authors":["Craig T January","L Samuel Wann","Hugh Calkins","Lin Y Chen","Joaquin E Cigarroa","Joseph C Cleveland","Patrick T Ellinor","Michael D Ezekowitz","Michael E Field","Karen L Furie","Paul A Heidenreich","Katherine T Murray","Julie B Shea","Cynthia M Tracy","Clyde W Yancy"],"significance":9,"published":"2019-07-09","source_date":"2019-07-09","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/atriumfibrilleren/esc-richtlijn-af-2024/"],"congress":"","summary_en":"The 2019 AHA/ACC/HRS focused update on atrial fibrillation management provided new recommendations for anticoagulation including DOACs as first-line therapy, expanded catheter ablation indications, and updated guidance on rhythm versus rate control strategies.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:14Z","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":"Gerichte update van de 2014 AHA/ACC/HRS AF-richtlijn met nieuwe aanbevelingen voor anticoagulatie, ritmestrategie en katheterablatie.","abstract_original":""},{"id":"ac44fa96de49","type":"article","url":"https://hartvaat.nl/2019/07/01/p2y12-remmerwisseling-op-basis-van-cyp2c19-status-na-acs-jama-cardiology/","title":"P2Y12-remmerwisseling op basis van CYP2C19-status na ACS: JAMA Cardiology","title_en":"P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["clopidogrel"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.1510","source_url":"https://doi.org/10.1001/jamacardio.2019.1510","authors":["Thomas J Povsic","E Magnus Ohman","Matthew T Roe","Jennifer White","Frank W Rockhold","Gilles Montalescot","Jan H Cornel","Jose C Nicolau","P Gabriel Steg","Stefan James","Christoph Bode","Robert C Welsh","Alexei N Plotnikov","Hardi Mundl","C Michael Gibson"],"significance":7,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that providing CYP2C19 metabolizer status to physicians led to P2Y12 inhibitor switching in a substantial proportion of patients, demonstrating the feasibility and clinical uptake of pharmacogenomic-guided antiplatelet therapy.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:13Z","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":"JAMA Cardiology studie naar het effect van farmacogenetisch gestuurde P2Y12-remmerwisseling na ACS. Implementatie van precisiegeneeskunde.","abstract_original":"IMPORTANCE: Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown. OBJECTIVE: To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial. DESIGN, SETTING, AND PARTICIPANTS: The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019. INTERVENTIONS: Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization. MAIN OUTCOMES AND MEASURES: Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected. RESULTS: Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated. CONCLUSIONS AND RELEVANCE: Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02293395."},{"id":"48c510f4259a","type":"article","url":"https://hartvaat.nl/2019/07/01/evolocumab-en-totale-cv-events-bij-cardiovasculaire-ziekte-fourier-analyse/","title":"Evolocumab en totale CV-events bij cardiovasculaire ziekte: FOURIER-analyse","title_en":"Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["biomarkers-cardiovasculair"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.0886","source_url":"https://doi.org/10.1001/jamacardio.2019.0886","authors":["Sabina A Murphy","Terje R Pedersen","Zbigniew A Gaciong","Richard Ceska","Marat V Ezhov","Derek L Connolly","J Wouter Jukema","Kalman Toth","Matti J Tikkanen","Kyungah Im","Stephen D Wiviott","Christopher E Kurtz","Narimon Honarpour","Robert P Giugliano","Anthony C Keech","Peter S Sever","Marc S Sabatine"],"significance":7,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/","https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/"],"congress":"","summary_en":"This FOURIER analysis of total cardiovascular events showed that evolocumab reduces the cumulative burden of recurrent events, with an even greater total event reduction than suggested by the first-event analysis alone.","created":"2026-07-03T10:28:02Z","updated":"2026-07-03T13:27:13Z","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":"FOURIER-analyse naar het effect van evolocumab op het totaal aantal (niet alleen eerste) cardiovasculaire events. Kwantificeert het cumulatieve voordeel.","abstract_original":"IMPORTANCE: The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and first cardiovascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, but patients remain at high risk of recurrent cardiovascular events. OBJECTIVE: To evaluate the effect of evolocumab on total cardiovascular events, given the importance of total number of cardiovascular events to patients, clinicians, and health economists. DESIGN, SETTING, AND PARTICIPANTS: Secondary analysis of a randomized, double-blind clinical trial. The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Data were analyzed between May 2017 and February 2019. MAIN OUTCOMES AND MEASURES: The primary end point (PEP) was time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke. In a prespecified analysis, total cardiovascular events were evaluated between treatment arms. RESULTS: The mean age of patients was 63 years, 69% of patients were taking high-intensity statin therapy, and the median LDL-C at baseline was 92 mg/dL (to convert to millimoles per liter, multiply by 0.0259). There were 2907 first PEP events and 4906 total PEP events during the trial. Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85). There were 2192 total primary events in the evolocumab group and 2714 total events in the placebo group. For every 1000 patients treated for 3 years, evolocumab prevented 22 first PEP events and 52 total PEP events. Reductions in total events were driven by fewer total myocardial infarctions (RR, 0.74; 95% CI, 0.65-0.84; P < .001), strokes (RR, 0.77; 95% CI, 0.64-0.93; P = .007), and coronary revascularizations (RR, 0.78; 95% CI, 0.71-0.87; P < .001). CONCLUSIONS AND RELEVANCE: The addition of the PCSK9 inhibitor evolocumab to statin therapy improved clinical outcomes, with significant reductions in total PEP events, driven by decreases in myocardial infarction, stroke, and coronary revascularization. More than double the number of events were prevented with evolocumab vs placebo as compared with the analysis of only first events. These data provide further support for the benefit of continuing aggressive lipid-lowering therapy to prevent recurrent cardiovascular events. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01764633."},{"id":"e1ce6904ff48","type":"article","url":"https://hartvaat.nl/2019/07/01/uitkomsten-van-des-in-kleine-coronairen-naar-strutdikte-jama-cardiology-meta-ana/","title":"Uitkomsten van DES in kleine coronairen naar strutdikte: JAMA Cardiology meta-analyse","title_en":"Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["atleten"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.1776","source_url":"https://doi.org/10.1001/jamacardio.2019.1776","authors":["Rosaly A Buiten","Eline H Ploumen","Paolo Zocca","Carine J M Doggen","Liefke C van der Heijden","Marlies M Kok","Peter W Danse","Carl E Schotborgh","Martijn Scholte","Frits H A F de Man","Gerard C M Linssen","Clemens von Birgelen"],"significance":6,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/"],"congress":"","summary_en":"This meta-analysis compared outcomes of drug-eluting stents by strut thickness (thin, very thin, ultrathin) specifically in small coronary arteries, showing that thinner struts improve outcomes in this challenging lesion subset.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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":"JAMA Cardiology meta-analyse die stentuitkomsten vergeleek naar strutdikte (dun, zeer dun, ultradun) bij kleine coronairarteriën.","abstract_original":"IMPORTANCE: Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. OBJECTIVE: To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. DESIGN: This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019. MAIN OUTCOMES AND MEASURES: Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods. RESULTS: In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis. CONCLUSIONS AND RELEVANCE: Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01674803."},{"id":"f59df00e17a1","type":"article","url":"https://hartvaat.nl/2019/07/01/cv-uitkomsten-en-bereikte-bloeddruk-bij-hoog-cv-risico-met-en-zonder-diabetes/","title":"CV-uitkomsten en bereikte bloeddruk bij hoog CV-risico met en zonder diabetes","title_en":"Cardiovascular outcomes and achieved blood pressure in patients with and without diabetes at high cardiovascular risk.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","diabetes-en-hart","diabetes-type-1","diabetes-type-2","ezetimibe","obesitas","ouderen","perifeer-vaatlijden","primaire-preventie","slaapapneu","soul-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz149","source_url":"https://doi.org/10.1093/eurheartj/ehz149","authors":["Michael Böhm","Helmut Schumacher","Koon K Teo","Eva M Lonn","Felix Mahfoud","Johannes F E Mann","Giuseppe Mancia","Josep Redon","Roland E Schmieder","Nikolaus Marx","Karen Sliwa","Michael A Weber","Bryan Williams","Salim Yusuf"],"significance":6,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":[],"congress":"","summary_en":"This analysis compared cardiovascular outcomes at different achieved blood pressures in high-risk patients with and without diabetes, exploring whether the optimal blood pressure target differs by diabetic status.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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 naar cardiovasculaire uitkomsten en bereikte bloeddruk bij hoogrisicopatiënten met versus zonder diabetes.","abstract_original":"AIMS: Studies have shown a non-linear relationship between systolic blood pressure (SBP) and diastolic blood pressure (DBP) and outcomes, with increased risk observed at both low and high blood pressure (BP) levels. We hypothesized that the BP-risk association is different in individuals with and without diabetes at high cardiovascular risk. METHODS AND RESULTS: We identified patients with (N = 11 487) or without diabetes (N = 19 450), from 30 937 patients, from 133 centres in 44 countries with a median follow-up of 56 months in the ONTARGET/TRANSCEND studies. Patients had a prior history of stroke, myocardial infarction (MI), peripheral artery disease, or were high-risk diabetics. Patients in ONTARGET had been randomized to ramipril 10 mg daily, telmisartan 80 mg daily, or the combination of both. Patients in TRANSCEND were ACE intolerant and randomized to telmisartan 80 mg daily or matching placebo. We analysed the association of mean achieved in-trial SBP and DBP with the composite outcome of cardiovascular death, MI, stroke and hospitalization for congestive heart failure (CHF), the components of the composite, and all-cause death. Data were analysed by Cox regression and restricted cubic splines, adjusting for risk markers including treatment allocation and accompanying cardiovascular treatments. In patients with diabetes, event rates were higher across the whole spectrum of SBP and DBP compared with those without diabetes (P < 0.0001 for the primary composite outcome, P < 0.01 for all other endpoints). Mean achieved in-trial SBP ≥160 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: adjusted hazard ratio (HR) 2.31 (1.93-2.76)/1.66 (1.36-2.02) compared with non-diabetics with SBP 120 to <140 mmHg], with similar findings for all other endpoints in patients with diabetes, and for MI and stroke in patients without diabetes. In-trial SBP <120 mmHg was associated with increased risk for the combined outcome in patients with diabetes [HR 1.53 (1.27-1.85)], and for cardiovascular death and all-cause death in all patients. In-trial DBP ≥90 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: HR 2.32 (1.91-2.82)/1.61 (1.35-1.93) compared with non-diabetics with DBP 70 to <80 mmHg], with similar findings for all other endpoints, but not for CHF hospitalizations in patients without diabetes. In-trial DBP <70 mmHg was associated with increased risk for the combined outcome in all patients [diabetes/no diabetes: HR 1.77 (1.51-2.06)/1.30 (1.16-1.46)], and also for all other endpoints except stroke. CONCLUSION: High on treatment BP levels (≥160 or ≥90 mmHg) are associated with increased risk of cardiovascular outcomes and death. Also low levels (<120 or <70 mmHg) are associated with increased cardiovascular outcomes (except stroke) and death. Patients with diabetes have consistently higher risks over the whole BP range, indicating that achieving optimal BP goals is most impactful in this group. These data favour guidelines taking lower BP boundaries into consideration, in particular in diabetes. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov.Unique identifier: NCT00153101."},{"id":"093b95f12369","type":"article","url":"https://hartvaat.nl/2019/07/01/hospitalisatieredenen-en-mortaliteitsrisico-bij-af-met-dabigatran-versus-warfari/","title":"Hospitalisatieredenen en mortaliteitsrisico bij AF met dabigatran versus warfarine: RE-LY","title_en":"Reasons for hospitalization and risk of mortality in patients with atrial fibrillation treated with dabigatran or warfarin in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) 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/euz021","source_url":"https://doi.org/10.1093/europace/euz021","authors":["Aiman Alak","Stefan H Hohnloser","Mandy Fräßdorf","Paul Reilly","Michael Ezekowitz","Jeff S Healey","Martina Brueckmann","Salim Yusuf","Stuart J Connolly"],"significance":5,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This RE-LY analysis characterized hospitalization patterns and their association with mortality in AF patients on dabigatran versus warfarin, showing that both cardiovascular and non-cardiovascular admissions predict poor outcomes.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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":"RE-LY-analyse naar hospitalisatieredenen en mortaliteitsrisico bij AF-patiënten behandeld met dabigatran versus warfarine.","abstract_original":"AIMS: Hospitalizations are common among patients with atrial fibrillation. This article aimed to analyse the causes and consequences of hospitalizations occurring during the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial. METHODS AND RESULTS: The RE-LY database was used to evaluate predictors of hospitalization using multivariate regression modelling. The relationship between hospitalization and subsequent major adverse cardiac events was evaluated in a time dependent Cox proportional-hazard modelling. Of the 18 113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2 years. First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin. Hospitalization was associated with post-discharge death [absolute event rate 9.1% vs. 2.2%; adjusted hazard ratio (HR) 3.6, 95% confidence interval (CI) 3.2-4.0, P < 0.0001], vascular death (adjusted HR 2.9, 95% CI 2.5-3.3, P < 0.0001), and sudden cardiac death (adjusted HR 2.3; 95% CI 1.8-2.9, P < 0.0001). Cardiovascular hospitalization was also associated with an increased risk of post-discharge death (adjusted HR 2.8, 95% CI 2.5-3.2, P < 0.0001), vascular death (adjusted HR 2.8, 95% CI 2.4-3.2, P < 0.0001), and sudden cardiac death (adjusted HR 2.1, 95% CI 1.6-2.7, P < 0.0001) compared with patients not hospitalized for any cardiovascular reason. CONCLUSION: Hospitalizations are associated an increased risk of with death and cardiovascular death in patients with atrial fibrillation."},{"id":"9918cb0d3999","type":"article","url":"https://hartvaat.nl/2019/07/01/qt-als-voorspeller-van-af-recidief-na-ablatie-en-amiodaronimpact-amio-cat/","title":"QT als voorspeller van AF-recidief na ablatie en amiodaronimpact: AMIO-CAT","title_en":"QT as a predictor of recurrence after atrial fibrillation ablation and the impact of amiodarone: results from the placebo-controlled AMIO-CAT 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/euz028","source_url":"https://doi.org/10.1093/europace/euz028","authors":["Søren Zöga Diederichsen","Stine Darkner","Xu Chen","Arne Johannessen","Steen Pehrson","Jim Hansen","Jesper Hastrup Svendsen"],"significance":5,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":[],"congress":"","summary_en":"This AMIO-CAT analysis evaluated QT interval as a predictor of AF recurrence after ablation and the impact of short-term amiodarone therapy, testing whether ECG markers can identify patients at risk for post-ablation arrhythmia.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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 van de AMIO-CAT-trial naar QT-interval als voorspeller van AF-recidief na ablatie en het effect van amiodaron.","abstract_original":"AIMS: Prolonged corrected QT interval (QTc) might be associated with arrhythmia recurrence after atrial fibrillation (AF) ablation. The effect of short-term amiodarone in this setting remains unknown. This study seeks to quantify short-term amiodarone's impact on QTc, and to investigate QTc and amiodarone treatment as predictors of recurrence of arrhythmia after ablation. METHODS AND RESULTS: The Short-term AMIOdarone treatment after CATheter ablation for atrial fibrillation (AMIO-CAT) trial randomized patients to 8 weeks of oral amiodarone or placebo following AF ablation. Scheduled and symptom-driven 12-lead electrocardiography and 3-day Holter-monitorings were performed. The endpoint was atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting >30 s. The cut-off for prolonged QTc was 450 ms for men and 460 ms for women. A total of 212 patients were included, of which 108 were randomized to amiodarone and 104 to placebo. From baseline to 1 month QTc in the amiodarone group increased by 27 (±30) ms, while at 6 months QTc had normalized. After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023]. Among patients with baseline QTc below median, amiodarone treatment decreased the rate of AF/AT recurrences (HR 0.43, P = 0.008). CONCLUSIONS: Amiodarone increased QTc with 27 ms compared to placebo, and this effect decreased rapidly after drug discontinuation. Prolonged QTc at baseline independently predicted AF/AT recurrence, and baseline QTc identified patients who would possibly benefit from short-term amiodarone following ablation."},{"id":"ea43d39661d4","type":"article","url":"https://hartvaat.nl/2019/07/01/natriumreductie-metaboloom-en-cv-risico-bij-onbehandelde-zwarte-hypertensie/","title":"Natriumreductie, metaboloom en CV-risico bij onbehandelde zwarte hypertensie","title_en":"Sodium Reduction, Metabolomic Profiling, and Cardiovascular Disease Risk in Untreated Black Hypertensives.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","baxdrostat","biomarkers-cardiovasculair","bloeddrukbehandeling","cardio-renaal-metabool","cardiorenal-behandelstrategie","cystatine-c","diabetes-en-hart","endotheel","ezetimibe","farmaco-economie","fidelity","figaro-dkd","hdl-cholesterol","ras-remmers","renale-denervatie","resistente-hypertensie","roken","statines","voeding-hart","vrouwen"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12880","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12880","authors":["Li Chen","Feng J He","Yanbin Dong","Ying Huang","Gregory A Harshfield","Haidong Zhu"],"significance":5,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This study examined how dietary sodium reduction affects the metabolomic profile and cardiovascular risk in untreated Black hypertensive individuals, exploring metabolic pathways that mediate the cardiovascular benefit of sodium restriction.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het effect van natriumreductie op het metabolomisch profiel en cardiovasculair risico bij onbehandelde zwarte hypertensieve patiënten.","abstract_original":"Dietary sodium restriction has multiple beneficial effects on cardiovascular health. The underlying mechanisms are not fully understood, and the roles of metabolomics have been rarely studied. We aimed to test the hypothesis that the reduction in dietary sodium intake would induce changes in metabolomic profiling among black hypertensives, and the changes would be associated with reduced blood pressure (BP) and improved skin capillary density. A total of 64 untreated black hypertensives were included from a randomized, double-blind, placebo-controlled cross-over trial of sodium reduction. The participants were given either 9 slow sodium tablets (10 mmol sodium per tablet) or placebo tablets daily for 6 weeks, they then crossed over to receive the other tablets for another 6 weeks, while on reduced sodium diet aiming at achieving daily sodium intake around 2.0 g. Untargeted metabolomic profiling was performed in paired serum samples, which were collected at the end of each period, so were BP and capillary density. Mixed-effects models were used. There were 34 metabolites identified with raw P's<0.05. Among those, 2 metabolites including β-hydroxyisovalerate and methionine sulfone were significantly increased with sodium reduction (false discovery rate =0.006 and 0.099, respectively). Increased β-hydroxyisovalerate was associated with reduced office systolic BP and ambulatory daytime systolic BP, whereas increased methionine sulfone was associated with reduced 24-hour diastolic BP, ambulatory nighttime diastolic BP, and increased skin capillary density. Our results suggest that dietary sodium reduction increases the circulating levels of β-hydroxyisovalerate and methionine sulfone. Further studies are warranted. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00152074."},{"id":"75ea35115f05","type":"article","url":"https://hartvaat.nl/2019/07/01/kosteneffectiviteit-van-statines-en-ezetimibe-bij-chronische-nierziekte/","title":"Kosteneffectiviteit van statines en ezetimibe bij chronische nierziekte","title_en":"Cost-effectiveness of lipid lowering with statins and ezetimibe in chronic kidney disease.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","anemie-ckd","chronische-nierziekte","cystatine-c","dyslipidemie","ezetimibe","figaro-dkd","ijzertekort","niertransplantatie","niet-statine-therapie","rosuvastatine","statines","vrouwen"],"journal":"Kidney international","doi":"10.1016/j.kint.2019.01.028","source_url":"https://doi.org/10.1016/j.kint.2019.01.028","authors":["Iryna Schlackow","Seamus Kent","William Herrington","Jonathan Emberson","Richard Haynes","Christina Reith","Rory Collins","Martin J Landray","Alastair Gray","Colin Baigent","Borislava Mihaylova"],"significance":6,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"This cost-effectiveness analysis evaluated lipid-lowering with statins and ezetimibe in CKD, comparing different treatment intensities to determine the economically optimal lipid management strategy in kidney disease.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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":"Kosteneffectiviteitsanalyse van lipidenverlaging met statines en ezetimibe bij CKD-patiënten.","abstract_original":"Statin-based treatments reduce cardiovascular disease (CVD) risk in patients with non-dialysis chronic kidney disease (CKD), but it is unclear which regimen is the most cost-effective. We used the Study of Heart and Renal Protection (SHARP) CKD-CVD policy model to evaluate the effect of statins and ezetimibe on quality-adjusted life years (QALYs) and health care costs in the United States (US) and the United Kingdom (UK). Net costs below $100,000/QALY (US) or £20,000/QALY (UK) were considered cost-effective. We investigated statin regimens with or without ezetimibe 10 mg. Treatment effects on cardiovascular risk were estimated per 1-mmol/L reduction in low-density lipoprotein (LDL) cholesterol as reported in the Cholesterol Treatment Trialists' Collaboration meta-analysis, and reductions in LDL cholesterol were estimated for each statin/ezetimibe regimen. In the US, atorvastatin 40 mg ($0.103/day as of January 2019) increased life expectancy by 0.23 to 0.31 QALYs in non-dialysis patients with stages 3B to 5 CKD, at a net cost of $20,300 to $78,200/QALY. Adding ezetimibe 10 mg ($0.203/day) increased life expectancy by an additional 0.05 to 0.07 QALYs, at a net cost of $43,600 to $91,500/QALY. The cost-effectiveness findings and policy implications in the UK were similar. In summary, in patients with non-dialysis-dependent CKD, the evidence suggests that statin/ezetimibe combination therapy is a cost-effective treatment to reduce the risk of CVD."},{"id":"f25249f80098","type":"article","url":"https://hartvaat.nl/2019/07/01/lokale-hemodynamische-krachten-en-fenotype-van-coronaire-plaques/","title":"Lokale hemodynamische krachten en fenotype van coronaire plaques","title_en":"Implications of the local haemodynamic forces on the phenotype of coronary plaques.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314086","source_url":"https://doi.org/10.1136/heartjnl-2018-314086","authors":["Christos V Bourantas","Thomas Zanchin","Antonis Sakellarios","Alexios Karagiannis","Anantharaman Ramasamy","Kyohei Yamaji","Masanori Taniwaki","Dik Heg","Aris Moschovitis","Dimitrios Fotiadis","Lampros Mihalis","Andreas Baumbach","Ryo Torii","Patrick Serruys","Hector M Garcia-Garcia","Stephan Windecker","Lorenz Räber"],"significance":5,"published":"2019-07-01","source_date":"2019-07-01","image":"","kennis":[],"congress":"","summary_en":"This study examined how endothelial shear stress influences dynamic changes in coronary plaque phenotype, linking local hemodynamic forces to the progression or stabilization of vulnerable atherosclerotic lesions.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:13Z","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 naar de implicaties van lokale hemodynamische krachten (shear stress) op het fenotype van coronaire plaques.","abstract_original":"AIM: To examine the effect of endothelial shear stress (ESS) on the dynamic changes in plaque phenotype. METHODS: Patients with myocardial infarction that had intravascular ultrasound-virtual histology (IVUS-VH) and optical coherence tomography (OCT) at baseline and 13-month follow-up were studied. The IVUS-VH data were used to reconstruct the nonculprit vessels, and in the obtained models the ESS was estimated in 3 mm segments. Plaque morphology was derived in each segment from IVUS-VH and OCT. Disease progression was defined as the presence of ≥2 out of the following criteria: reduction in lumen area, increase in plaque burden and change of plaque morphology to a more vulnerable phenotype. Linear mixed effects models were used to assess the effect of ESS in different phenotypes. RESULTS: Sixty-eight vessels were included in the analysis. Low ESS was associated with plaque progression in all phenotypes. The effect of ESS on plaque burden (p for interaction=0.467) and phenotype (p for interaction=0.188) was similar in all plaque types, whereas the effect of ESS on the changes in lumen dimensions was more prominent in disease-free (β=0.70, p<0.001) than fibrotic/fibrocalcific (β=0.28, p<0.001) or lipid-rich plaques (β=0.15, p=0.015). Standalone IVUS-VH misclassified plaque morphology in one-third of the cases leading to erroneous estimations about the effect of ESS on plaque evolution in different phenotypes. CONCLUSIONS: The effect of ESS on plaque progression is similar in all phenotypes and cannot be accurately assessed by standalone IVUS-VH which often misclassifies plaque morphology. Therefore, multimodality imaging should be considered to examine the implications of ESS on plaque evolution. CLINICAL TRIAL REGISTRATION: NCT00962416; Post-results."},{"id":"a4e7001c92ce","type":"article","url":"https://hartvaat.nl/2019/06/25/p2y12-remmer-monotherapie-versus-dapt-na-pci-jama-smart-choice/","title":"P2Y12-remmer monotherapie versus DAPT na PCI: JAMA SMART-CHOICE","title_en":"Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["clopidogrel"],"journal":"JAMA","doi":"10.1001/jama.2019.8146","source_url":"https://doi.org/10.1001/jama.2019.8146","authors":["Joo-Yong Hahn","Young Bin Song","Ju-Hyeon Oh","Woo Jung Chun","Yong Hawn Park","Woo Jin Jang","Eul-Soon Im","Jin-Ok Jeong","Byung Ryul Cho","Seok Kyu Oh","Kyeong Ho Yun","Deok-Kyu Cho","Jong-Young Lee","Young-Youp Koh","Jang-Whan Bae","Jae Woong Choi","Wang Soo Lee","Hyuck Jun Yoon","Seung Uk Lee","Jang Hyun Cho","Woong Gil Choi","Seung-Woon Rha","Joo Myung Lee","Taek Kyu Park","Jeong Hoon Yang","Jin-Ho Choi","Seung-Hyuck Choi","Sang Hoon Lee","Hyeon-Cheol Gwon"],"significance":8,"published":"2019-06-25","source_date":"2019-06-25","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/dual-antiplatelet-therapy-dapt/"],"congress":"","summary_en":"The SMART-CHOICE trial showed that P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to continued 12-month DAPT for cardiovascular events after PCI, supporting the de-escalation to single antiplatelet therapy approach.","created":"2026-07-03T10:28:01Z","updated":"2026-07-03T13:27:12Z","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":"JAMA SMART-CHOICE trial die P2Y12-remmer monotherapie (na 3 maanden DAPT) vergeleek met standaard DAPT na PCI. Onderbouwt de de-escalatiestrategie.","abstract_original":"IMPORTANCE: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. OBJECTIVE: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. DESIGN, SETTING, AND PARTICIPANTS: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. INTERVENTIONS: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). MAIN OUTCOMES AND MEASURES: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%. RESULTS: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95% CI, -∞% to 1.3%]; P = .007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95% CI, 0.63-2.21; P = .61), myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95% CI, 0.31-1.40; P = .28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95% CI, 0.78-6.43; P = .14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P = .02). CONCLUSIONS AND RELEVANCE: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02079194."},{"id":"bd4a4cb28250","type":"article","url":"https://hartvaat.nl/2019/06/25/1-maand-dapt-gevolgd-door-clopidogrel-versus-12-maanden-dapt-jama-stopdapt-2/","title":"1 maand DAPT gevolgd door clopidogrel versus 12 maanden DAPT: JAMA STOPDAPT-2","title_en":"Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["clopidogrel"],"journal":"JAMA","doi":"10.1001/jama.2019.8145","source_url":"https://doi.org/10.1001/jama.2019.8145","authors":["Hirotoshi Watanabe","Takenori Domei","Takeshi Morimoto","Masahiro Natsuaki","Hiroki Shiomi","Toshiaki Toyota","Masanobu Ohya","Satoru Suwa","Kensuke Takagi","Mamoru Nanasato","Yoshiki Hata","Masahiro Yagi","Nobuhiro Suematsu","Takafumi Yokomatsu","Itaru Takamisawa","Masayuki Doi","Toshiyuki Noda","Hideki Okayama","Yoshitane Seino","Tomohisa Tada","Hiroki Sakamoto","Kiyoshi Hibi","Mitsuru Abe","Kazuya Kawai","Koichi Nakao","Kenji Ando","Kengo Tanabe","Yuji Ikari","Keiichi Igarashi Hanaoka","Yoshihiro Morino","Ken Kozuma","Kazushige Kadota","Yutaka Furukawa","Yoshihisa Nakagawa","Takeshi Kimura"],"significance":8,"published":"2019-06-25","source_date":"2019-06-25","image":"","kennis":[],"congress":"","summary_en":"The STOPDAPT-2 trial demonstrated that 1 month of DAPT followed by clopidogrel monotherapy was noninferior and even superior to 12-month standard DAPT for net clinical benefit after PCI. The results supported ultra-short DAPT as a viable strategy with contemporary drug-eluting stents.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"JAMA STOPDAPT-2 gerandomiseerde trial die 1 maand DAPT gevolgd door clopidogrel monotherapie vergeleek met 12 maanden standaard DAPT. Paradigma van verkorte DAPT.","abstract_original":"IMPORTANCE: Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option. OBJECTIVE: To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019. INTERVENTIONS: Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522). MAIN OUTCOMES AND MEASURES: The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding. RESULTS: Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority). CONCLUSIONS AND RELEVANCE: Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02619760."},{"id":"64f83c260540","type":"article","url":"https://hartvaat.nl/2019/06/25/systematische-review-voor-de-2018-aha-acc-cholesterolrichtlijn-jacc/","title":"Systematische review voor de 2018 AHA/ACC cholesterolrichtlijn: JACC","title_en":"Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["statines"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.004","source_url":"https://doi.org/10.1016/j.jacc.2018.11.004","authors":["Peter W F Wilson","Tamar S Polonsky","Michael D Miedema","Amit Khera","Andrzej S Kosinski","Jeffrey T Kuvin"],"significance":8,"published":"2019-06-25","source_date":"2019-06-25","image":"","kennis":[],"congress":"","summary_en":"JACC publication of the systematic review underlying the 2018 AHA/ACC cholesterol guideline, evaluating the evidence for nonstatin lipid-lowering therapies and their effects on cardiovascular outcomes.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"JACC-publicatie van de systematische review voor de cholesterolrichtlijn.","abstract_original":"BACKGROUND: The 2013 American College of Cardiology/American Heart Association guidelines for the treatment of blood cholesterol found little evidence to support the use of nonstatin lipid-modifying medications to reduce atherosclerotic cardiovascular disease (ASCVD) events. Since publication of these guidelines, multiple randomized controlled trials evaluating nonstatin lipid-modifying medications have been published. METHODS: We performed a systematic review to assess the magnitude of benefit and/or harm from additional lipid-modifying therapies compared with statins alone in individuals with known ASCVD or at high risk of ASCVD. We included data from randomized controlled trials with a sample size of >1,000 patients and designed for follow-up >1 year. We performed a comprehensive literature search and identified 10 randomized controlled trials for intensive review, including trials evaluating ezetimibe, niacin, cholesterol-ester transfer protein inhibitors, and PCSK9 inhibitors. The prespecified primary outcome for this review was a composite of fatal cardiovascular events, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: The cardiovascular benefit of nonstatin lipid-modifying therapies varied significantly according to the class of medication. There was evidence for reduced ASCVD morbidity with ezetimibe and 2 PSCK9 inhibitors. Reduced ASCVD mortality rate was reported for 1 PCSK9 inhibitor. The use of ezetimibe/simvastatin versus simvastatin in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) reduced the primary outcome by 1.8% over 7 years (hazard ratio: 0.90; 95% CI: 0.84-0.96], 7-year number needed to treat: 56). The PSCK9 inhibitor evolocumab in the FOURIER study (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) decreased the primary outcome by 1.5% over 2.2 years (hazard ratio: 0.80; 95% CI: 0.73-0.88; 2.2=year number needed to treat: 67). In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab reduced the primary outcome by 1.6% over 2.8 years (hazard ratio: 0.86; 95% CI: 0.79-0.93; 2.8-year number needed to treat: 63). For ezetimibe and the PSCK9 inhibitors, rates of musculoskeletal, neurocognitive, gastrointestinal, or other adverse event risks did not differ between the treatment and control groups. For patients at high risk of ASCVD already on background statin therapy, there was minimal evidence for improved ASCVD risk or adverse events with cholesterol-ester transfer protein inhibitors. There was no evidence of benefit for the addition of niacin to statin therapy. Direct comparisons of the results of the 10 randomized controlled trials were limited by significant differences in sample size, duration of follow-up, and reported primary outcomes. CONCLUSIONS: In a systematic review of the evidence for adding nonstatin lipid-modifying therapies to statins to reduce ASCVD risk, we found evidence of benefit for ezetimibe and PCSK9 inhibitors but not for niacin or cholesterol-ester transfer protein inhibitors."},{"id":"8b3f60356f9e","type":"article","url":"https://hartvaat.nl/2019/06/25/2018-aha-acc-cholesterolrichtlijn-jacc-volledig-rapport/","title":"2018 AHA/ACC cholesterolrichtlijn: JACC volledig rapport","title_en":"2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.003","source_url":"https://doi.org/10.1016/j.jacc.2018.11.003","authors":["Scott M Grundy","Neil J Stone","Alison L Bailey","Craig Beam","Kim K Birtcher","Roger S Blumenthal","Lynne T Braun","Sarah de Ferranti","Joseph Faiella-Tommasino","Daniel E Forman","Ronald Goldberg","Paul A Heidenreich","Mark A Hlatky","Daniel W Jones","Donald Lloyd-Jones","Nuria Lopez-Pajares","Chiadi E Ndumele","Carl E Orringer","Carmen A Peralta","Joseph J Saseen","Sidney C Smith","Laurence Sperling","Salim S Virani","Joseph Yeboah"],"significance":9,"published":"2019-06-25","source_date":"2019-06-25","image":"","kennis":[],"congress":"","summary_en":"JACC publication of the full 2018 AHA/ACC blood cholesterol guideline, providing comprehensive recommendations on risk assessment, statin therapy intensity, and nonstatin therapies including ezetimibe and PCSK9 inhibitors for cardiovascular risk reduction.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"JACC-publicatie van het volledige rapport van de 2018 AHA/ACC cholesterolrichtlijn.","abstract_original":""},{"id":"c930496575f1","type":"article","url":"https://hartvaat.nl/2019/06/25/2018-aha-acc-cholesterolrichtlijn-jacc-executive-summary/","title":"2018 AHA/ACC cholesterolrichtlijn: JACC executive summary","title_en":"2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.002","source_url":"https://doi.org/10.1016/j.jacc.2018.11.002","authors":["Scott M Grundy","Neil J Stone","Alison L Bailey","Craig Beam","Kim K Birtcher","Roger S Blumenthal","Lynne T Braun","Sarah de Ferranti","Joseph Faiella-Tommasino","Daniel E Forman","Ronald Goldberg","Paul A Heidenreich","Mark A Hlatky","Daniel W Jones","Donald Lloyd-Jones","Nuria Lopez-Pajares","Chiadi E Ndumele","Carl E Orringer","Carmen A Peralta","Joseph J Saseen","Sidney C Smith","Laurence Sperling","Salim S Virani","Joseph Yeboah"],"significance":9,"published":"2019-06-25","source_date":"2019-06-25","image":"","kennis":[],"congress":"","summary_en":"JACC publication of the 2018 AHA/ACC cholesterol guideline executive summary, providing key recommendations including risk enhancers, coronary calcium scoring, and LDL thresholds for PCSK9 inhibitor therapy in a concise format for clinical practice.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"JACC-publicatie van de executive summary van de 2018 cholesterolrichtlijn.","abstract_original":""},{"id":"7a8a6144845a","type":"article","url":"https://hartvaat.nl/2019/06/22/des-versus-bms-lancet-ipd-systematische-review-en-meta-analyse/","title":"DES versus BMS: Lancet IPD systematische review en meta-analyse","title_en":"Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)30474-X","source_url":"https://doi.org/10.1016/S0140-6736(19)30474-X","authors":["Raffaele Piccolo","Kaare H Bonaa","Orestis Efthimiou","Olivier Varenne","Andrea Baldo","Philip Urban","Christoph Kaiser","Wouter Remkes","Lorenz Räber","Adam de Belder","Arnoud W J van 't Hof","Goran Stankovic","Pedro A Lemos","Tom Wilsgaard","Jörg Reifart","Alfredo E Rodriguez","Expedito E Ribeiro","Patrick W J C Serruys","Alex Abizaid","Manel Sabaté","Robert A Byrne","Jose M de la Torre Hernandez","William Wijns","Peter Jüni","Stephan Windecker","Marco Valgimigli"],"significance":9,"published":"2019-06-22","source_date":"2019-06-22","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/pci-percutane-coronaire-interventie/"],"congress":"","summary_en":"This Lancet individual patient data meta-analysis provided definitive evidence that new-generation drug-eluting stents are superior to bare-metal stents across all patient subgroups, with reduced target lesion revascularization and no increase in stent thrombosis or mortality. The findings support universal DES use.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"Lancet individuele patiëntdata meta-analyse die definitief DES versus BMS vergeleek. Bevestigt het universele voordeel van drug-eluting stents.","abstract_original":"BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital."},{"id":"c2f21b30c725","type":"article","url":"https://hartvaat.nl/2019/06/21/plaatjesreactiviteit-en-uitkomsten-bij-acs-met-prasugrel-versus-clopidogrel/","title":"Plaatjesreactiviteit en uitkomsten bij ACS met prasugrel versus clopidogrel","title_en":"Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["trombocytenaggregatieremmers"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz202","source_url":"https://doi.org/10.1093/eurheartj/ehz202","authors":["Dániel Aradi","Lisa Gross","Dietmar Trenk","Tobias Geisler","Béla Merkely","Róbert Gábor Kiss","András Komócsi","Csaba András Dézsi","Zoltán Ruzsa","Imre Ungi","Konstantinos D Rizas","Andreas E May","Andreas Mügge","Andreas M Zeiher","Lesca Holdt","Kurt Huber","Franz-Josef Neumann","Lukasz Koltowski","Zenon Huczek","Martin Hadamitzky","Steffen Massberg","Dirk Sibbing"],"significance":5,"published":"2019-06-21","source_date":"2019-06-21","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-farmacologie/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This study evaluated platelet function testing in ACS patients treated with prasugrel versus clopidogrel, showing that while PFT predicts ischemic and bleeding events, its clinical utility for guiding P2Y12 inhibitor selection remains uncertain.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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 naar plaatjesreactiviteit en klinische uitkomsten bij ACS-patiënten behandeld met prasugrel versus clopidogrel.","abstract_original":"AIMS: The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel. METHODS AND RESULTS: Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups. CONCLUSION: Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel."},{"id":"dd73e011e9af","type":"article","url":"https://hartvaat.nl/2019/06/21/impact-van-groot-periprocedureel-mi-op-mortaliteit-na-pci-en-cabg/","title":"Impact van groot periprocedureel MI op mortaliteit na PCI en CABG","title_en":"Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz113","source_url":"https://doi.org/10.1093/eurheartj/ehz113","authors":["Ori Ben-Yehuda","Shmuel Chen","Björn Redfors","Thomas McAndrew","Aaron Crowley","Ioanna Kosmidou","David E Kandzari","John D Puskas","Marie-Claude Morice","David P Taggart","Martin B Leon","Nicholas J Lembo","W Morris Brown","Charles A Simonton","Ovidiu Dressler","Arie Pieter Kappetein","Joseph F Sabik","Patrick W Serruys","Gregg W Stone"],"significance":6,"published":"2019-06-21","source_date":"2019-06-21","image":"","kennis":[],"congress":"","summary_en":"This study quantified the prognostic impact of large periprocedural MI after PCI versus CABG, showing that procedural MI severity differentially affects mortality depending on the revascularization strategy.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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 naar de impact van groot periprocedureel myocardinfarct op mortaliteit na PCI versus CABG. Kwantificeert het belang van periprocedurele schade.","abstract_original":"AIMS: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. METHODS AND RESULTS: By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. CONCLUSION: In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important."},{"id":"6c006339ae71","type":"article","url":"https://hartvaat.nl/2019/06/21/comfortable-ami-5-jaarsuitkomsten-biolimus-versus-bare-metal-stent/","title":"COMFORTABLE AMI 5-jaarsuitkomsten: biolimus versus bare-metal stent","title_en":"Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz074","source_url":"https://doi.org/10.1093/eurheartj/ehz074","authors":["Lorenz Räber","Kyohei Yamaji","Henning Kelbæk","Thomas Engstrøm","Andreas Baumbach","Marco Roffi","Clemens von Birgelen","Masanori Taniwaki","Aris Moschovitis","Serge Zaugg","Miodrag Ostojic","Giovanni Pedrazzini","Dimitrios-Alexios Karagiannis-Voules","Thomas F Lüscher","Ran Kornowski","David Tüller","Vladan Vukcevic","Dik Heg","Stephan Windecker"],"significance":6,"published":"2019-06-21","source_date":"2019-06-21","image":"","kennis":[],"congress":"","summary_en":"The 5-year COMFORTABLE AMI results with intracoronary imaging showed durable benefit of biodegradable biolimus-eluting stents over bare-metal stents in STEMI, confirming long-term safety of this DES platform in acute MI.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T13:27:12Z","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":"5-jaarsresultaten en intracoronaire beeldvorming van de COMFORTABLE AMI-trial die een biodegradeerbare biolimus-stent vergeleek met BMS bij STEMI.","abstract_original":"AIMS: The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown. METHODS AND RESULTS: We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25-0.66, P < 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P < 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES: -0.63 mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11 mm2, 95% CI: -2.27 to 0.04, P = 0.07). CONCLUSION: Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00962416."},{"id":"c0a146c15170","type":"article","url":"https://hartvaat.nl/2019/06/20/vergelijking-van-duale-therapieen-voor-bloeddrukverlaging-bij-afrikaanse-afrikan/","title":"Vergelijking van duale therapieën voor bloeddrukverlaging bij Afrikaanse Afrikanen: NEJM","title_en":"Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","dubbele-trombocytenremming"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1901113","source_url":"https://doi.org/10.1056/NEJMoa1901113","authors":["Dike B Ojji","Bongani Mayosi","Veronica Francis","Motasim Badri","Victoria Cornelius","Wynand Smythe","Nicky Kramer","Felix Barasa","Albertino Damasceno","Anastase Dzudie","Erika Jones","Charles Mondo","Okechukwu Ogah","Elijah Ogola","Mahmoud U Sani","Gabriel L Shedul","Grace Shedul","Brian Rayner","Ikechi G Okpechi","Karen Sliwa","Neil Poulter"],"significance":8,"published":"2019-06-20","source_date":"2019-06-20","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This NEJM trial compared two dual antihypertensive combinations (amlodipine-hydrochlorothiazide versus perindopril-hydrochlorothiazide) in black African patients with hypertension, providing evidence to guide initial combination therapy in this underrepresented population with high hypertension prevalence.","created":"2026-07-03T10:28:00Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 gerandomiseerde trial die twee duale antihypertensivacombinaties vergeleek bij zwarte Afrikanen met hypertensie. Evidencebase voor deze ondervertegenwoordigde populatie.","abstract_original":"BACKGROUND: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. METHODS: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. RESULTS: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, -3.14 mm Hg; 95% confidence interval [CI], -5.90 to -0.38; P = 0.03; and -3.00 mm Hg; 95% CI, -5.8 to -0.20; P = 0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was -0.14 mm Hg (95% CI, -2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups. CONCLUSIONS: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.)."},{"id":"792a4a1ae57c","type":"article","url":"https://hartvaat.nl/2019/06/18/evolocumab-bij-ckd-werkzaamheid-en-veiligheid-in-de-fourier-trial/","title":"Evolocumab bij CKD: werkzaamheid en veiligheid in de FOURIER-trial","title_en":"Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["anemie-ckd","chronische-nierziekte","fidelio-dkd","figaro-dkd","flow-trial","ijzertekort"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.513","source_url":"https://doi.org/10.1016/j.jacc.2019.03.513","authors":["David M Charytan","Marc S Sabatine","Terje R Pedersen","KyungAh Im","Jeong-Gun Park","Armando Lira Pineda","Scott M Wasserman","Prakash Deedwania","Anders G Olsson","Peter S Sever","Anthony C Keech","Robert P Giugliano"],"significance":7,"published":"2019-06-18","source_date":"2019-06-18","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"This FOURIER subanalysis confirmed that evolocumab is effective and safe in patients with chronic kidney disease, with consistent LDL cholesterol lowering and cardiovascular event reduction across CKD severity stages.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"FOURIER-analyse bij patiënten met chronische nierziekte. Bevestigt werkzaamheid en veiligheid van evolocumab bij nierinsufficiëntie.","abstract_original":"BACKGROUND: Data on PCSK9 inhibition in chronic kidney disease (CKD) is limited. OBJECTIVES: The purpose of this study was to compare outcomes with evolocumab and placebo according to kidney function. METHODS: The FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial randomized individuals with clinically evident atherosclerosis and low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dl or non-high-density lipoprotein cholesterol ≥100 mg/dl to evolocumab or placebo. The primary endpoint (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization), key secondary endpoint (cardiovascular death, myocardial infarction, or stroke), and safety were analyzed according to chronic kidney disease (CKD) stage estimated from CKD-epidemiology estimated glomerular filtration rate. RESULTS: There were 8,077 patients with preserved kidney function, 15,034 with stage 2 CKD, and 4,443 with ≥stage 3 CKD. LDL-C reduction with evolocumab compared with placebo at 48 weeks was similar across CKD groups at 59%, 59%, and 58%, respectively. Relative risk reduction for the primary endpoint was similar for preserved function (hazard ratio [HR]: 0.82; 95% CI: 0.71 to 0.94), stage 2 (HR: 0.85; 95% CI: 0.77 to 0.94), and stage ≥3 CKD (HR: 0.89; 95% CI: 0.76 to 1.05); pint = 0.77. Relative risk reduction for the secondary endpoint was similar across CKD stages (pint = 0.75)-preserved function (HR: 0.75; 95% CI: 0.62 to 0.90), stage 2 (HR: 0.82; 95% CI: 0.72 to 0.93), stage ≥3 (HR: 0.79; 95% CI: 0.65 to 0.95). Absolute RRs at 30 months for the secondary endpoint were -2.5% (95% CI: -0.4% to -4.7%) for stage ≥3 CKD compared with -1.7% (95% CI: 0.5% to -2.8%) with preserved kidney function. Adverse events, including estimated glomerular filtration rate decline, were infrequent and similar regardless of CKD stage. CONCLUSIONS: LDL-C lowering and relative clinical efficacy and safety of evolocumab versus placebo were consistent across CKD groups. Absolute reduction in the composite of cardiovascular death, MI, or stroke with evolocumab was numerically greater with more advanced CKD. (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk [FOURIER]; NCT01764633)."},{"id":"22150812bfc8","type":"article","url":"https://hartvaat.nl/2019/06/18/systematische-review-voor-de-2018-aha-acc-cholesterolrichtlijn/","title":"Systematische review voor de 2018 AHA/ACC cholesterolrichtlijn","title_en":"Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["statines"],"journal":"Circulation","doi":"10.1161/CIR.0000000000000626","source_url":"https://doi.org/10.1161/CIR.0000000000000626","authors":["Peter W F Wilson","Tamar S Polonsky","Michael D Miedema","Amit Khera","Andrzej S Kosinski","Jeffrey T Kuvin"],"significance":8,"published":"2019-06-18","source_date":"2019-06-18","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/hdl-functie-en-reverse-cholesterol/"],"congress":"","summary_en":"This systematic review provided the evidence foundation for the 2018 AHA/ACC cholesterol guideline, evaluating nonstatin therapies including ezetimibe, PCSK9 inhibitors, and bile acid sequestrants for their effects on cardiovascular outcomes beyond statin monotherapy.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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 die de evidence base leverde voor de 2018 AHA/ACC cholesterolrichtlijn.","abstract_original":"BACKGROUND: The 2013 American College of Cardiology/American Heart Association guidelines for the treatment of blood cholesterol found little evidence to support the use of nonstatin lipid-modifying medications to reduce atherosclerotic cardiovascular disease (ASCVD) events. Since publication of these guidelines, multiple randomized controlled trials evaluating nonstatin lipid-modifying medications have been published. METHODS: We performed a systematic review to assess the magnitude of benefit and/or harm from additional lipid-modifying therapies compared with statins alone in individuals with known ASCVD or at high risk of ASCVD. We included data from randomized controlled trials with a sample size of >1 000 patients and designed for follow-up >1 year. We performed a comprehensive literature search and identified 10 randomized controlled trials for intensive review, including trials evaluating ezetimibe, niacin, cholesterol-ester transfer protein inhibitors, and PCSK9 inhibitors. The prespecified primary outcome for this review was a composite of fatal cardiovascular events, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: The cardiovascular benefit of nonstatin lipid-modifying therapies varied significantly according to the class of medication. There was evidence for reduced ASCVD morbidity with ezetimibe and 2 PSCK9 inhibitors. Reduced ASCVD mortality rate was reported for 1 PCSK9 inhibitor. The use of ezetimibe/simvastatin versus simvastatin in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) reduced the primary outcome by 1.8% over 7 years (hazard ratio: 0.90; 95% CI: 0.84-0.96], 7-year number needed to treat: 56). The PSCK9 inhibitor evolocumab in the FOURIER study (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) decreased the primary outcome by 1.5% over 2.2 years (hazard ratio: 0.80; 95% CI: 0.73-0.88; 2.2=year number needed to treat: 67). In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab reduced the primary outcome by 1.6% over 2.8 years (hazard ratio: 0.86; 95% CI: 0.79-0.93; 2.8-year number needed to treat: 63). For ezetimibe and the PSCK9 inhibitors, rates of musculoskeletal, neurocognitive, gastrointestinal, or other adverse event risks did not differ between the treatment and control groups. For patients at high risk of ASCVD already on background statin therapy, there was minimal evidence for improved ASCVD risk or adverse events with cholesterol-ester transfer protein inhibitors. There was no evidence of benefit for the addition of niacin to statin therapy. Direct comparisons of the results of the 10 randomized controlled trials were limited by significant differences in sample size, duration of follow-up, and reported primary outcomes. CONCLUSIONS: In a systematic review of the evidence for adding nonstatin lipid-modifying therapies to statins to reduce ASCVD risk, we found evidence of benefit for ezetimibe and PCSK9 inhibitors but not for niacin or cholesterol-ester transfer protein inhibitors."},{"id":"0d06abd1a3cb","type":"article","url":"https://hartvaat.nl/2019/06/18/2018-aha-acc-cholesterolrichtlijn-volledig-rapport/","title":"2018 AHA/ACC cholesterolrichtlijn: volledig rapport","title_en":"2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":[],"journal":"Circulation","doi":"10.1161/CIR.0000000000000625","source_url":"https://doi.org/10.1161/CIR.0000000000000625","authors":["Scott M Grundy","Neil J Stone","Alison L Bailey","Craig Beam","Kim K Birtcher","Roger S Blumenthal","Lynne T Braun","Sarah de Ferranti","Joseph Faiella-Tommasino","Daniel E Forman","Ronald Goldberg","Paul A Heidenreich","Mark A Hlatky","Daniel W Jones","Donald Lloyd-Jones","Nuria Lopez-Pajares","Chiadi E Ndumele","Carl E Orringer","Carmen A Peralta","Joseph J Saseen","Sidney C Smith","Laurence Sperling","Salim S Virani","Joseph Yeboah"],"significance":10,"published":"2019-06-18","source_date":"2019-06-18","image":"","kennis":["https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/"],"congress":"","summary_en":"The full 2018 AHA/ACC Guideline on blood cholesterol management redefined the approach to lipid-lowering therapy by integrating risk enhancers, lifetime risk assessment, and coronary artery calcium scoring into treatment decisions. It endorsed PCSK9 inhibitors for secondary prevention when LDL cholesterol remains above threshold despite maximally tolerated statin therapy.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"Volledige 2018 AHA/ACC-richtlijn voor cholesterolmanagement. Nieuwe concepten: risicoversterkers, coronair calciumscore, levenslangrisicobeoordeling, LDL-drempels voor PCSK9.","abstract_original":"Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, which are based on systematic methods to evaluate and classify evidence, provide a foundation for the delivery of quality cardiovascular care. The ACC and AHA sponsor the development and publication of clinical practice guidelines without commercial support, and members volunteer their time to the writing and review efforts. Clinical practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease (CVD). The focus is on medical practice in the United States, but these guidelines are relevant to patients throughout the world. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients’ interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Recommendations for guideline-directed management and therapy, which encompasses clinical evaluation, diagnostic testing, and both pharmacological and procedural treatments, are effective only when followed by both practitioners and patients. Adherence to recommendations can be enhanced by shared decision-making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. The ACC/AHA Task Force on Clinical Practice Guidelines strives to ensure that the guideline writing committee both contains requisite expertise and is representative of the broader medical community by selecting experts from a broad array of backgrounds, representing different geographic regions, sexes, races, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. The ACC and AHA have rigorous policies and methods to ensure that documents are developed without bias or improper influence. The complete policy on relationships with industry and other entities (RWI) can be found online. Beginning in 2017, numerous modifications to the guidelines have been and continue to be implemented to make guidelines shorter and enhance “user friendliness.” Guidelines are written and presented in a modular knowledge chunk format, in which each chunk includes a table of recommendations, a brief synopsis, recommendation-specific supportive text and, when appropriate, flow diagrams or additional tables. Hyperlinked references are provided for each modular knowledge chunk to facilitate quick access and review. More structured guidelines–including word limits (“targets”) and a web guideline supplement for useful but noncritical tables and figures–are 2 such changes. This Preamble is an abbreviated version, with the detailed version available online. The reader is encouraged to consult the full-text guideline for additional guidance and details, since the executive summary contains mainly the recommendations. 1. In all individuals, emphasize a heart-healthy lifestyle across the life course. A healthy lifestyle reduces atherosclerotic cardiovascular disease (ASCVD) risk at all ages. In younger individuals, healthy lifestyle can reduce development of risk factors and is the foundation of ASCVD risk reduction. In young adults 20 to 39 years of age, an assessment of lifetime risk facilitates the clinician–patient risk discussion (see No. 6) and emphasizes intensive lifestyle efforts. In all age groups, lifestyle therapy is the primary intervention for metabolic syndrome. 2. In patients with clinical ASCVD, reduce low-density lipoprotein cholesterol (LDL-C) with high-intensity statin therapy or maximally tolerated statin therapy. The more LDL-C is reduced on statin therapy, the greater will be subsequent risk reduction. Use a maximally tolerated statin to lower LDL-C levels by ≥50%. 3. In very high-risk ASCVD, use a LDL-C threshold of 70 mg/dL (1.8 mmol/L) to consider addition of nonstatins to statin therapy. Very high-risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. In very high-risk ASCVD patients, it is reasonable to add ezetimibe to maximally tolerated statin therapy when the LDL-C level remains ≥70 mg/dL (≥1.8 mmol/L). In patients at very high risk whose LDL-C level remains ≥70 mg/dL(≥1.8 mmol/L) on maximally tolerated statin and ezetimibe therapy, adding a PCSK9 inhibitor is reasonable, although the long-term safety (>3 years) is uncertain and cost effectiveness is low at mid-2018 list prices. 4. In patients with severe primary hypercholesterolemia (LDL-C level ≥190 mg/dL [=4.9 mmol/L]), without calculating 10-year ASCVD risk, begin high-intensity statin therapy. If the LDL-C level remains ≥100 mg/dL (≥2.6 mmol/L), adding ezetimibe is reasonable. If the LDL-C level on statin plus ezetimibe remains ≥100 mg/dL (≥2.6 mmol/L) and the patient has multiple factors that increase subsequent risk of ASCVD events, a PCSK9 inhibitor may be considered, although the long-term safety (>3 years) is uncertain and economic value is low at mid-2018 list prices. 5. In patients 40 to 75 years of age with diabetes mellitus and LDL-C ≥70 mg/dL (≥1.8 mmol/L), start moderate-intensity statin therapy without calculating 10-year ASCVD risk. In patients with diabetes mellitus at higher risk, especially those with multiple risk factors or those 50 to 75 years of age, it is reasonable to use a high-intensity statin to reduce the LDL-C level by ≥50%. 6. In adults 40 to 75 years of age evaluated for primary ASCVD prevention, have a clinician–patient risk discussion before starting statin therapy. Risk discussion should include a review of major risk factors (eg, cigarette smoking, elevated blood pressure, LDL-C, hemoglobin A1C [if indicated], and calculated 10-year risk of ASCVD); the presence of risk-enhancing factors (see No. 8); the potential benefits of lifestyle and statin therapies; the potential for adverse effects and drug–drug interactions; consideration of costs of statin therapy; and patient preferences and values in shared decision-making. 7. In adults 40 to 75 years of age without diabetes mellitus and with LDL-C levels ≥70 mg/ dL (≥1.8 mmol/L), at a 10-year ASCVD risk of ≥7.5%, start a moderate-intensity statin if a discussion of treatment options favors statin therapy. Risk-enhancing factors favor statin therapy (see No. 8). If risk status is uncertain, consider using coronary artery calcium (CAC) to improve specificity (see No. 9). If statins are indicated, reduce LDL-C levels by ≥30%, and if 10-year risk is ≥20%, reduce LDL-C levels by ≥50%. 8. In adults 40 to 75 years of age without diabetes mellitus and 10-year risk of 7.5% to 19.9% (intermediate risk), risk-enhancing factors favor initiation of statin therapy (see No. 7). Risk-enhancing factors include family history of premature ASCVD; persistently elevated LDL-C levels ≥160 mg/dL (≥4.1 mmol/L); metabolic syndrome; chronic kidney disease; history of preeclampsia or premature menopause (age <40 years); chronic inflammatory disorders (eg, rheumatoid arthritis, psoriasis, or chronic HIV); high-risk ethnic groups (eg, South Asian); persistent elevations of triglycerides ≥175 mg/dL (≥1.97 mmol/L); and, if measured in selected individuals, apolipoprotein B ≥130 mg/dL, high-sensitivity C-reactive protein ≥2.0 mg/L, ankle-brachial index (ABI) <0.9 and lipoprotein (a) ≥50 mg/dL or 125 nmol/L, especially at higher values of lipoprotein (a). Risk-enhancing factors may favor statin therapy in patients at 10-year risk of 5% to 7.5% (borderline risk). 9. In adults 40 to 75 years of age without diabetes mellitus and with LDL-C levels ≥70 mg/dL to 189 mg/dL (≥1.8–4.9 mmol/L), at a 10-year ASCVD risk of ≥7.5% to 19.9%, if a decision about statin therapy is uncertain, consider measuring CAC. If CAC is zero, treatment with statin therapy may be withheld or delayed, except in cigarette smokers, those with diabetes mellitus, and those with a strong family history of premature ASCVD. A CAC score of 1 to 99 favors statin therapy, especially in those =55 years of age. For any patient, if the CAC score is ≥100 Agatston units or ≥75th percentile, statin therapy is indicated unless otherwise deferred by the outcome of clinician–patient risk discussion. 10. Assess adherence and percentage response to LDL-C–lowering medications and lifestyle changes with repeat lipid measurement 4 to 12 weeks after statin initiation or dose adjustment, repeated every 3 to 12 months as needed. Define responses to lifestyle and statin therapy by percentage reductions in LDL-C levels compared with baseline. In ASCVD patients at very high-risk, triggers for adding nonstatin drug therapy are defined by threshold LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) on maximal statin therapy (see No. 3)."},{"id":"3c083f8094ce","type":"article","url":"https://hartvaat.nl/2019/06/18/2018-aha-acc-cholesterolrichtlijn-executive-summary/","title":"2018 AHA/ACC cholesterolrichtlijn: executive summary","title_en":"2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["ezetimibe","ldl-cholesterol","niet-statine-therapie","pcsk9-remmers","statines"],"journal":"Circulation","doi":"10.1161/CIR.0000000000000624","source_url":"https://doi.org/10.1161/CIR.0000000000000624","authors":["Scott M Grundy","Neil J Stone","Alison L Bailey","Craig Beam","Kim K Birtcher","Roger S Blumenthal","Lynne T Braun","Sarah de Ferranti","Joseph Faiella-Tommasino","Daniel E Forman","Ronald Goldberg","Paul A Heidenreich","Mark A Hlatky","Daniel W Jones","Donald Lloyd-Jones","Nuria Lopez-Pajares","Chiadi E Ndumele","Carl E Orringer","Carmen A Peralta","Joseph J Saseen","Sidney C Smith","Laurence Sperling","Salim S Virani","Joseph Yeboah"],"significance":10,"published":"2019-06-18","source_date":"2019-06-18","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/","https://hartvaat.nl/kennis/lipiden/esc-richtlijn-dyslipidemie-2019/"],"congress":"","summary_en":"The 2018 AHA/ACC cholesterol guideline executive summary introduced risk enhancers, coronary artery calcium scoring for shared decision-making, and LDL-cholesterol thresholds for escalating therapy to PCSK9 inhibitors. The guideline shifted the paradigm from fixed-dose statin therapy toward personalized, risk-based LDL management.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"Executive summary van de 2018 AHA/ACC cholesterolrichtlijn met geactualiseerde aanbevelingen voor LDL-management inclusief PCSK9-remmers en risicoversterkers.","abstract_original":""},{"id":"a93caba9a36e","type":"article","url":"https://hartvaat.nl/2019/06/13/canagliflozine-en-renale-uitkomsten-bij-diabetes-type-2-met-nefropathie-nejm-cre/","title":"Canagliflozine en renale uitkomsten bij diabetes type 2 met nefropathie: NEJM CREDENCE","title_en":"Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["canagliflozine","chronische-nierziekte","credence-trial","diabetische-nefropathie","fidelio-dkd","flow-trial","soul-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1811744","source_url":"https://doi.org/10.1056/NEJMoa1811744","authors":["Vlado Perkovic","Meg J Jardine","Bruce Neal","Severine Bompoint","Hiddo J L Heerspink","David M Charytan","Robert Edwards","Rajiv Agarwal","George Bakris","Scott Bull","Christopher P Cannon","George Capuano","Pei-Ling Chu","Dick de Zeeuw","Tom Greene","Adeera Levin","Carol Pollock","David C Wheeler","Yshai Yavin","Hong Zhang","Bernard Zinman","Gary Meininger","Barry M Brenner","Kenneth W Mahaffey"],"significance":10,"published":"2019-06-13","source_date":"2019-06-13","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"The CREDENCE trial demonstrated that canagliflozin significantly reduced the risk of kidney failure, cardiovascular events, and death in patients with type 2 diabetes and chronic kidney disease. As the first dedicated renal outcomes trial for an SGLT2 inhibitor, it established this drug class as a cornerstone of diabetic nephropathy treatment.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"Landmark NEJM CREDENCE-trial die aantoonde dat canagliflozine renale uitkomsten significant verbetert bij diabetische nefropathie. Eerste SGLT2-remmer specifiek voor nierziekte.","abstract_original":"BACKGROUND: Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS: In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin-angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS: The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P = 0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P = 0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P = 0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS: In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years. (Funded by Janssen Research and Development; CREDENCE ClinicalTrials.gov number, NCT02065791.)."},{"id":"20a673b2cb98","type":"article","url":"https://hartvaat.nl/2019/06/11/inspanningsvoordelen-bij-pulmonale-hypertensie-jacc-review/","title":"Inspanningsvoordelen bij pulmonale hypertensie: JACC review","title_en":"Exercise Benefits in Pulmonary Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.489","source_url":"https://doi.org/10.1016/j.jacc.2019.03.489","authors":["Alejandro Santos-Lozano","Carmen Fiuza-Luces","David Fernández-Moreno","Francisco Llavero","Joaquín Arenas","Juan Antonio López","Jesús Vázquez","Pilar Escribano-Subías","José L Zugaza","Alejandro Lucia"],"significance":6,"published":"2019-06-11","source_date":"2019-06-11","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/"],"congress":"","summary_en":"This JACC review summarized the evidence for exercise training in pulmonary hypertension, providing evidence-based guidance on exercise prescription for this population where physical activity was historically discouraged.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"JACC review over de voordelen van inspanningstraining bij pulmonale hypertensie. Evidence-based trainingsadvies.","abstract_original":""},{"id":"8078476e0695","type":"article","url":"https://hartvaat.nl/2019/06/11/ticagrelor-versus-clopidogrel-bij-stemi-na-fibrinolyse-treat-trial/","title":"Ticagrelor versus clopidogrel bij STEMI na fibrinolyse: TREAT-trial","title_en":"Ticagrelor Versus Clopidogrel in Patients With STEMI Treated With Fibrinolysis: TREAT Trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":["trombocytenaggregatieremmers"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.011","source_url":"https://doi.org/10.1016/j.jacc.2019.03.011","authors":["Otavio Berwanger","Renato D Lopes","Diogo D F Moia","Francisco A Fonseca","Lixin Jiang","Shaun G Goodman","Stephen J Nicholls","Alexander Parkhomenko","Oleg Averkov","Carlos Tajer","Germán Malaga","Jose F K Saraiva","Helio P Guimaraes","Pedro G M de Barros E Silva","Lucas P Damiani","Renato H N Santos","Denise M Paisani","Tamiris A Miranda","Nanci Valeis","Leopoldo S Piegas","Christopher B Granger","Harvey D White","Jose C Nicolau"],"significance":7,"published":"2019-06-11","source_date":"2019-06-11","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"The TREAT trial showed no superiority of ticagrelor over clopidogrel in STEMI patients treated with fibrinolytic therapy, confirming clopidogrel as the appropriate P2Y12 inhibitor in the post-fibrinolysis setting.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"TREAT gerandomiseerde trial die ticagrelor vergeleek met clopidogrel bij STEMI-patiënten behandeld met fibrinolyse.","abstract_original":"BACKGROUND: The efficacy of ticagrelor in the long-term post-ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remains uncertain. OBJECTIVES: The purpose of this study was to evaluate the efficacy of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. METHODS: This international, multicenter, randomized, open-label with blinded endpoint adjudication trial enrolled 3,799 patients (age <75 years) with STEMI receiving fibrinolytic therapy. Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300- to 600-mg loading dose, 75 mg daily thereafter). The key outcomes were cardiovascular mortality, myocardial infarction, or stroke, and the same composite outcome with the addition of severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events at 12 months. RESULTS: The combined outcome of cardiovascular mortality, myocardial infarction, or stroke occurred in 129 of 1,913 patients (6.7%) receiving ticagrelor and in 137 of 1,886 patients (7.3%) receiving clopidogrel (hazard ratio: 0.93; 95% confidence interval: 0.73 to 1.18; p = 0.53). The composite of cardiovascular mortality, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events occurred in 153 of 1,913 patients (8.0%) treated with ticagrelor and in 171 of 1,886 patients (9.1%) receiving clopidogrel (hazard ratio: 0.88; 95% confidence interval: 0.71 to 1.09; p = 0.25). The rates of major, fatal, and intracranial bleeding were similar between the ticagrelor and clopidogrel groups. CONCLUSION: Among patients age <75 years with STEMI, administration of ticagrelor after fibrinolytic therapy did not significantly reduce the frequency of cardiovascular events when compared with clopidogrel. (Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis [TREAT]; NCT02298088)."},{"id":"3a09df93ed8f","type":"article","url":"https://hartvaat.nl/2019/06/11/icosapent-ethyl-en-totale-ischemische-events-reduce-it-analyse/","title":"Icosapent-ethyl en totale ischemische events: REDUCE-IT analyse","title_en":"Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.02.032","source_url":"https://doi.org/10.1016/j.jacc.2019.02.032","authors":["Deepak L Bhatt","Ph Gabriel Steg","Michael Miller","Eliot A Brinton","Terry A Jacobson","Steven B Ketchum","Ralph T Doyle","Rebecca A Juliano","Lixia Jiao","Craig Granowitz","Jean-Claude Tardif","John Gregson","Stuart J Pocock","Christie M Ballantyne"],"significance":8,"published":"2019-06-11","source_date":"2019-06-11","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/"],"congress":"","summary_en":"This REDUCE-IT analysis of total ischemic events (not just first events) showed that icosapent ethyl reduced recurrent cardiovascular events by 30%, with a substantial absolute risk reduction. The total event analysis demonstrated even greater benefit than the primary first-event endpoint.","created":"2026-07-03T10:27:59Z","updated":"2026-07-03T13:27:11Z","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":"REDUCE-IT analyse naar het effect op totale (niet alleen eerste) ischemische events met icosapent-ethyl. Kwantificeert het totale eventvoordeel.","abstract_original":"BACKGROUND: In time-to-first-event analyses, icosapent ethyl significantly reduced the risk of ischemic events, including cardiovascular death, among patients with elevated triglycerides receiving statins. These patients are at risk for not only first but also subsequent ischemic events. OBJECTIVES: Pre-specified analyses determined the extent to which icosapent ethyl reduced total ischemic events. METHODS: REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) randomized 8,179 statin-treated patients with triglycerides ≥135 and <500 mg/dl (median baseline of 216 mg/dl) and low-density lipoprotein cholesterol >40 and ≤100 mg/dl (median baseline of 75 mg/dl), and a history of atherosclerosis (71% patients) or diabetes (29% patients) to icosapent ethyl 4 g/day or placebo. The main outcomes were total (first and subsequent) primary composite endpoint events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) and total key secondary composite endpoint events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). As a pre-specified statistical method, we determined differences in total events using negative binomial regression. We also determined differences in total events using other statistical models, including Andersen-Gill, Wei-Lin-Weissfeld (Li and Lagakos modification), both pre-specified, and a post hoc joint frailty analysis. RESULTS: In 8,179 patients, followed for a median of 4.9 years, 1,606 (55.2%) first primary endpoint events and 1,303 (44.8%) subsequent primary endpoint events occurred (which included 762 second events, and 541 third or more events). Overall, icosapent ethyl reduced total primary endpoint events (61 vs. 89 per 1,000 patient-years for icosapent ethyl versus placebo, respectively; rate ratio: 0.70; 95% confidence interval: 0.62 to 0.78; p < 0.0001). Icosapent ethyl also reduced totals for each component of the primary composite endpoint, as well as the total key secondary endpoint events (32 vs. 44 per 1,000 patient-years for icosapent ethyl versus placebo, respectively; rate ratio: 0.72; 95% confidence interval: 0.63 to 0.82; p < 0.0001). CONCLUSIONS: Among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, multiple statistical models demonstrate that icosapent ethyl substantially reduces the burden of first, subsequent, and total ischemic events. (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial [REDUCE-IT]; NCT01492361)."},{"id":"222ddc2b77ff","type":"article","url":"https://hartvaat.nl/2019/06/11/sonotrombolyse-bij-stemi-behandeld-met-primaire-pci/","title":"Sonotrombolyse bij STEMI behandeld met primaire PCI","title_en":"Sonothrombolysis in ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.006","source_url":"https://doi.org/10.1016/j.jacc.2019.03.006","authors":["Wilson Mathias","Jeane M Tsutsui","Bruno G Tavares","Agostina M Fava","Miguel O D Aguiar","Bruno C Borges","Mucio T Oliveira","Alexandre Soeiro","Jose C Nicolau","Henrique B Ribeiro","Hsu Po Chiang","João C N Sbano","Abdulrahman Morad","Andrew Goldsweig","Carlos E Rochitte","Bernardo B C Lopes","José A F Ramirez","Roberto Kalil Filho","Thomas R Porter"],"significance":5,"published":"2019-06-11","source_date":"2019-06-11","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/kleplijden/endocarditis-profylaxe/"],"congress":"","summary_en":"This study evaluated sonothrombolysis (high-intensity ultrasound with intravenous microbubbles) as an adjunctive therapy during primary PCI for STEMI, testing whether acoustic cavitation enhances microvascular reperfusion.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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 naar sonotrombolyse (ultrageluid + microbellen) als adjuvante therapie bij STEMI behandeld met primaire PCI.","abstract_original":"BACKGROUND: Preclinical studies have demonstrated that high mechanical index (MI) impulses from a diagnostic ultrasound transducer during an intravenous microbubble infusion (sonothrombolysis) can restore epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI). OBJECTIVES: This study tested the clinical effectiveness of sonothrombolysis in patients with STEMI. METHODS: Patients with their first STEMI were prospectively randomized to either diagnostic ultrasound-guided high MI impulses during an intravenous Definity (Lantheus Medical Imaging, North Billerica, Massachusetts) infusion before, and following, emergent percutaneous coronary intervention (PCI), or to a control group that received PCI only (n = 50 in each group). A reference first STEMI group (n = 203) who arrived outside the randomization window was also analyzed. Angiographic recanalization before PCI, ST-segment resolution, infarct size by magnetic resonance imaging, and systolic function (LVEF) at 6 months were compared. RESULTS: ST-segment resolution occurred in 16 (32%) high MI PCI versus 2 (4%) PCI-only patients before PCI, and angiographic recanalization was 48% in high MI/PCI versus 20% in PCI only and 21% in the reference group (p < 0.001). Infarct size was reduced (29 ± 22 g high MI/PCI vs. 40 ± 20 g PCI only; p = 0.026). LVEF was not different between groups before treatment (44 ± 11% vs. 43 ± 10%), but increased immediately after PCI in the high MI/PCI group (p = 0.03), and remained higher at 6 months (p = 0.015). Need for implantable defibrillator (LVEF ≤30%) was reduced in the high MI/PCI group (5% vs. 18% PCI only; p = 0.045). CONCLUSIONS: Sonothrombolysis added to PCI improves recanalization rates and reduces infarct size, resulting in sustained improvements in systolic function after STEMI. (Therapeutic Use of Ultrasound in Acute Coronary Artery Disease; NCT02410330)."},{"id":"649bde144665","type":"article","url":"https://hartvaat.nl/2019/06/07/febuxostat-voor-cerebraal-en-cardiorenovasculaire-eventpreventie-freed/","title":"Febuxostat voor cerebraal en cardiorenovasculaire eventpreventie: FREED","title_en":"Febuxostat for Cerebral and CaRdiorenovascular Events PrEvEntion StuDy.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["secundaire-preventie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz119","source_url":"https://doi.org/10.1093/eurheartj/ehz119","authors":["Sunao Kojima","Kunihiko Matsui","Shinya Hiramitsu","Ichiro Hisatome","Masako Waki","Kazuaki Uchiyama","Naoto Yokota","Eiichi Tokutake","Yutaka Wakasa","Hideaki Jinnouchi","Hirokazu Kakuda","Takahiro Hayashi","Naoki Kawai","Hisao Mori","Masahiro Sugawara","Yusuke Ohya","Kazuo Kimura","Yoshihiko Saito","Hisao Ogawa"],"significance":6,"published":"2019-06-07","source_date":"2019-06-07","image":"","kennis":[],"congress":"","summary_en":"The FREED study compared febuxostat with conventional treatment for hyperuricemia on cerebrovascular, cardiovascular, and renal events, testing the hypothesis that uric acid lowering provides vascular protection.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"FREED-studie naar febuxostat voor preventie van cerebrovasculaire en cardiorenale events. Onderzoekt urinezuurverlaging als preventieve strategie.","abstract_original":"AIMS: To compare the occurrence of cerebral, cardiovascular, and renal events in patients with hyperuricaemia treated with febuxostat and those treated with conventional therapy with lifestyle modification. METHODS AND RESULTS: This multicentre, prospective, randomized open-label, blinded endpoint study was done in 141 hospitals in Japan. A total of 1070 patients were included in the intention-to-treat population. Elderly patients with hyperuricaemia (serum uric acid >7.0 to ≤9.0 mg/dL) at risk for cerebral, cardiovascular, or renal disease, defined by the presence of hypertension, Type 2 diabetes, renal disease, or history of cerebral or cardiovascular disease, were randomized to febuxostat and non-febuxostat groups and were observed for 36 months. Cerebral, cardiovascular, and renal events and all deaths were defined as the primary composite event. The serum uric acid level at endpoint (withdrawal or completion of the study) in the febuxostat (n = 537) and non-febuxostat groups (n = 533) was 4.50 ± 1.52 and 6.76 ± 1.45 mg/dL, respectively (P < 0.001). The primary composite event rate was significantly lower in the febuxostat group than in non-febuxostat treatment [hazard ratio (HR) 0.750, 95% confidence interval (CI) 0.592-0.950; P = 0.017] and the most frequent event was renal impairment (febuxostat group: 16.2%, non-febuxostat group: 20.5%; HR 0.745, 95% CI 0.562-0.987; P = 0.041). CONCLUSION: Febuxostat lowers uric acid and delays the progression of renal dysfunction. REGISTRATION: ClinicalTrials.gov (NCT01984749)."},{"id":"3f63c4b4e0db","type":"article","url":"https://hartvaat.nl/2019/06/04/neladenoson-bialanaat-en-inspanningscapaciteit-bij-hfpef-jama-panache/","title":"Neladenoson bialanaat en inspanningscapaciteit bij HFpEF: JAMA PANACHE","title_en":"Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["step-hfpef"],"journal":"JAMA","doi":"10.1001/jama.2019.6717","source_url":"https://doi.org/10.1001/jama.2019.6717","authors":["Sanjiv J Shah","Adriaan A Voors","John J V McMurray","Dalane W Kitzman","Thomas Viethen","Antonieta Bomfim Wirtz","Erya Huang","Akos Ferenc Pap","Scott D Solomon"],"significance":7,"published":"2019-06-04","source_date":"2019-06-04","image":"","kennis":[],"congress":"","summary_en":"The PANACHE trial showed that neladenoson bialanate, an adenosine A1 receptor partial agonist, did not improve exercise capacity in HFpEF, adding to the growing list of failed pharmacological interventions for this heart failure phenotype.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"JAMA PANACHE gerandomiseerde trial van neladenoson bialanaat (adenosine A1-receptoragonist) bij HFpEF. Negatief resultaat voor inspanningscapaciteit.","abstract_original":"IMPORTANCE: Heart failure with preserved ejection fraction (HFpEF) lacks effective treatments. Based on preclinical studies, neladenoson bialanate, a first-in-class partial adenosine A1 receptor agonist, has the potential to improve several heart failure-related cardiac and noncardiac abnormalities but has not been evaluated to treat HFpEF. OBJECTIVES: To determine whether neladenoson improves exercise capacity, physical activity, cardiac biomarkers, and quality of life in patients with HFpEF and to find the optimal dose. DESIGN, SETTING, AND PARTICIPANTS: Phase 2b randomized clinical trial conducted at 76 centers in the United States, Europe, and Japan. Patients (N = 305) with New York Heart Association class II or III HFpEF with elevated natriuretic peptide levels were enrolled between May 10, 2017, and December 7, 2017 (date of final follow-up: June 20, 2018). INTERVENTIONS: Participants were randomized (1:2:2:2:2:3) to neladenoson (n = 27 [5 mg], n = 50 [10 mg], n = 51 [20 mg], n = 50 [30 mg], and n = 51 [40 mg]) or matching placebo (n = 76) for 20 weeks of treatment. MAIN OUTCOMES AND MEASURES: The primary end point was change in 6-minute walk test distance from baseline to 20 weeks (minimal clinically important difference, 40 m). Key safety measures included bradyarrhythmias and adverse events. To evaluate the effects of varying doses of neladenoson, a multiple comparison procedure with 5 modeling techniques (linear, Emax, 2 variations of sigmoidal Emax, and quadratic) was used to evaluate diverse dose-response profiles. RESULTS: Among 305 patients who were randomized (mean age, 74 years; 160 [53%] women; mean 6-minute walk test distance, 321.5 m), 261 (86%) completed the trial and were included in the primary analysis. After 20 weeks of treatment, the mean absolute changes from baseline in 6-minute walk test distance were 0.2 m (95% CI, -12.1 to 12.4 m) for the placebo group; 19.4 m (95% CI, -10.8 to 49.7 m) for the 5 mg of neladenoson group; 29.4 m (95% CI, 3.0 to 55.8 m) for 10 mg of neladenoson group; 13.8 m (95% CI, -2.3 to 29.8 m) for 20 mg of neladenoson group; 16.3 m (95% CI, -1.1 to 33.6 m) for 30 mg of neladenoson group; and 13.0 m (95% CI, -5.9 to 31.9 m) for 40 mg of neladenoson group. Because none of the neladenoson groups achieved the clinically relevant 40-m increase in 6-minute walk test distance from baseline, an optimal dose of neladenoson was not identified. There was no significant dose-response relationship for the change in 6-minute walk test distance among the 5 different dose-response models (P = .05 for Emax; P = .18 for quadratic; P = .21 for sigmoidal Emax 1; P = .39 for linear; and P = .52 for sigmoidal Emax 2). Serious adverse events were similar among the neladenoson groups (61/229 [26.6%]) and the placebo group (21/76 [27.6%]). CONCLUSIONS AND RELEVANCE: Among patients with HFpEF, there was no significant dose-response relationship detected for neladenoson with regard to the change in exercise capacity from baseline to 20 weeks. In light of these findings, novel approaches will be needed if further development of neladenoson for the treatment of patients with HFpEF is pursued. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03098979."},{"id":"4ad16fd78e74","type":"article","url":"https://hartvaat.nl/2019/06/04/microvasculaire-ziekte-en-cv-events-bij-diabetes-type-2/","title":"Microvasculaire ziekte en CV-events bij diabetes type 2","title_en":"Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","ezetimibe","microcirculatie","microvasculaire-angina","ouderen","select-trial","vrouwen"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.002","source_url":"https://doi.org/10.1016/j.jacc.2019.03.002","authors":["Subodh Verma","Christoph Wanner","Isabella Zwiener","Anne Pernille Ofstad","Jyothis T George","David Fitchett","Bernard Zinman"],"significance":6,"published":"2019-06-04","source_date":"2019-06-04","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/"],"congress":"","summary_en":"This study demonstrated that microvascular disease (retinopathy, nephropathy) independently predicts cardiovascular events in type 2 diabetes, supporting microvascular assessment as part of comprehensive cardiovascular risk evaluation.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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 naar de invloed van microvasculaire ziekte op cardiovasculaire events bij diabetes type 2. Retinopathie en nefropathie als CV-risicomodificatoren.","abstract_original":""},{"id":"e2495dedff55","type":"article","url":"https://hartvaat.nl/2019/06/04/profylactische-icd-bij-dialysepatienten-ter-preventie-van-plotse-hartdood/","title":"Profylactische ICD bij dialysepatiënten ter preventie van plotse hartdood","title_en":"Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["dialyse","icd-implantatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.039818","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.039818","authors":["J Wouter Jukema","Rohit J Timal","Joris I Rotmans","Liselotte C R Hensen","Maurits S Buiten","Mihaly K de Bie","Hein Putter","Aeilko H Zwinderman","Lieselot van Erven","M Jacqueline Krol-van Straaten","Nienke Hommes","Bas Gabreëls","Wim van Dorp","Bastiaan van Dam","Charles A Herzog","Martin J Schalij","Ton J Rabelink"],"significance":6,"published":"2019-06-04","source_date":"2019-06-04","image":"","kennis":[],"congress":"","summary_en":"This study evaluated prophylactic ICD implantation in dialysis patients at high risk for sudden cardiac death, testing whether defibrillator therapy improves survival in the end-stage kidney disease population.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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 naar de effectiviteit van profylactische ICD-implantatie bij dialysepatiënten. ICD bij eindstadium nierziekte.","abstract_original":"BACKGROUND: Patients with end-stage renal disease who are undergoing dialysis are reported to be at high risk of sudden cardiac death (SCD), and to date, no therapy has been shown to be effective in reducing this risk. The feasibility and value of prophylactic implantable cardioverter-defibrillator (ICD) implantation to prevent SCD is uncertain. METHODS: We conducted the ICD2 trial (Implantable Cardioverter-Defibrillator in Dialysis Patients), a prospective, randomized, controlled study investigating the value and safety of ICD implantation to prevent SCD in 200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments. The primary end point was SCD. Secondary end points were all-cause mortality and ICD-related complications. RESULTS: The trial was stopped as per the recommendation of the data and safety monitoring board for futility reasons after inclusion of 188 patients, 97 in the ICD group and 91 in the control group. The median duration of follow-up was 6.8 years (interquartile range, 3.8-8.8 years). SCD occurred in 19 of 188 cases (10.1%), 11 of 97 in the ICD group and 8 of 91 in the control group. The cumulative SCD incidence at 5 years was 9.7% (95% CI, 3.3%-16.2%) in the ICD group and 7.9% (95% CI, 1.7-14.0%) in the control group, resulting in a hazard ratio of 1.32 (95% CI, 0.53-3.29; P=0.55). Overall, 99 of 188 patients died (52.7%), 52 in the ICD group and 47 in the control group. Five-year survival probability was 50.6% (95% CI, 39.8%-61.5%) in the ICD group and 54.5% (95% CI, 43.0-66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69-1.52; P=0.92). Among 80 patients who received an ICD, 25 adverse events related to ICD implantation occurred. CONCLUSIONS: In a well-screened and well-treated population undergoing dialysis, prophylactic ICD therapy did not reduce the rate of SCD or all-cause mortality, which remained high. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com . Unique identifier: ISRCTN20479861."},{"id":"7ccb1e5605ef","type":"article","url":"https://hartvaat.nl/2019/06/01/rivaroxaban-en-trombo-embolische-events-bij-hf-met-coronairlijden-en-sinusritme-/","title":"Rivaroxaban en trombo-embolische events bij HF met coronairlijden en sinusritme: COMMANDER HF post-hoc","title_en":"Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.1049","source_url":"https://doi.org/10.1001/jamacardio.2019.1049","authors":["Barry Greenberg","James D Neaton","Stefan D Anker","William M Byra","John G F Cleland","Hsiaowei Deng","Min Fu","David A La Police","Carolyn S P Lam","Mandeep R Mehra","Christopher C Nessel","Theodore E Spiro","Dirk J van Veldhuisen","Catherine M Vanden Boom","Faiez Zannad"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":[],"congress":"","summary_en":"This COMMANDER HF post-hoc analysis examined specific thromboembolic events with rivaroxaban in heart failure patients with coronary disease and sinus rhythm, exploring whether certain vascular event subtypes respond to anticoagulation.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"COMMANDER HF post-hoc analyse naar rivaroxaban en specifieke trombo-embolische events bij HF met coronairlijden en sinusritme.","abstract_original":"IMPORTANCE: Whether anticoagulation benefits patients with heart failure (HF) in sinus rhythm is uncertain. The COMMANDER HF randomized clinical trial evaluated the effects of adding low-dose rivaroxaban to antiplatelet therapy in patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm. Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke. OBJECTIVE: To examine whether low-dose rivaroxaban was associated with reduced thromboembolic events in patients enrolled in the COMMANDER HF trial. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of the COMMANDER HF multicenter, randomized, double-blind, placebo-controlled trial in patients with CAD and worsening HF. The trial randomized 5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017. Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history. Patients were randomized in a 1:1 ratio. Analysis was conducted from June 2018 and January 2019. INTERVENTION: Patients were randomly assigned to receive 2.5 mg of rivaroxaban given orally twice daily or placebo in addition to their standard therapy. MAIN OUTCOMES AND MEASURES: For this post hoc analysis, a thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths because not all of these are caused by thromboembolic events. RESULTS: Of 5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years. Over a median (interquartile range) follow-up of 19.6 (11.7-30.8) months, fewer patients assigned to rivaroxaban compared with placebo had a thromboembolic event including sudden/unwitnessed deaths: 328 (13.1%) vs 390 (15.5%) (hazard ratio, 0.83; 95% CI, 0.72-0.96; P = .01). When sudden/unwitnessed deaths were excluded, the results analyzing thromboembolic events were similar: 153 (6.1%) vs 190 patients (7.6%) with an event (hazard ratio, 0.80; 95% CI, 0.64-0.98; P = .04). CONCLUSIONS AND RELEVANCE: In this study, thromboembolic events occurred frequently in patients with HF, CAD, and sinus rhythm. Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect. While consistent with other studies, these results require confirmation in prospective randomized clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01877915."},{"id":"99118fffcbbe","type":"article","url":"https://hartvaat.nl/2019/06/01/heparinedosering-bij-ononderbroken-dabigatran-versus-warfarine-bij-af-ablatie-re/","title":"Heparinedosering bij ononderbroken dabigatran versus warfarine bij AF-ablatie: RE-CIRCUIT","title_en":"Heparin dosing in uninterrupted anticoagulation with dabigatran vs. warfarin in atrial fibrillation ablation: RE-CIRCUIT study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","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/euz057","source_url":"https://doi.org/10.1093/europace/euz057","authors":["Hugh Calkins","Stephan Willems","Atul Verma","Richard Schilling","Stefan H Hohnloser","Ken Okumura","Matias Nordaby","Eva Kleine","Branislav Bis","Edward P Gerstenfeld"],"significance":5,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"This RE-CIRCUIT analysis characterized heparin dosing requirements during AF ablation with uninterrupted dabigatran versus warfarin, showing that higher heparin doses are needed with dabigatran to achieve target ACT levels.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"RE-CIRCUIT-analyse naar de heparinedosering bij ononderbroken anticoagulatie met dabigatran versus warfarine tijdens AF-ablatie.","abstract_original":"AIMS: To describe heparin dosing requirements in patients who underwent catheter ablation of atrial fibrillation with uninterrupted anticoagulation using dabigatran etexilate (dabigatran) or warfarin to attain therapeutic activated clotting time (ACT) in the RE-CIRCUIT® study. The RE-CIRCUIT study showed significantly fewer major bleeding events in the dabigatran vs. warfarin treatment group. Unfractionated heparin was administered during the procedure to maintain ACT >300 s. METHODS AND RESULTS: Patients were randomly assigned to dabigatran 150 mg bid or international normalized ratio-adjusted warfarin. Ablation was performed with uninterrupted anticoagulation and continued for 8 weeks after the procedure. Heparin was administered after placement of femoral sheaths before or immediately after transseptal puncture. Ablation was performed in 635 patients (dabigatran, 317; warfarin, 318); data were available from 396 patients administered heparin (dabigatran, 191; warfarin, 205). Most frequent time window from last dose of study drug to septal puncture was 0 to <4 h in the dabigatran (41.3%) and 16 to <24 h in the warfarin arms (44.7%). Overall mean (standard deviation) heparin dose was similar between the dabigatran and warfarin groups [12 402 (10 721) vs. 11 910 (8359) IU, respectively]. Heparin dosing requirement to reach therapeutic ACT was lowest when time from last dose of dabigatran to septal puncture was 0 to <4 h. CONCLUSION: Patients treated with dabigatran required a similar amount of unfractionated heparin as those treated with warfarin to achieve an ACT of >300 s during ablation. More heparin units were required when the time from the last dose of dabigatran to septal puncture increased."},{"id":"cf5975dbbbba","type":"article","url":"https://hartvaat.nl/2019/06/01/amiodaron-voor-en-na-electrische-cardioversie-van-af-meta-analyse/","title":"Amiodaron vóór en na electrische cardioversie van AF: meta-analyse","title_en":"Pre- and post-treatment with amiodarone for elective electrical cardioversion of atrial fibrillation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","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/euy310","source_url":"https://doi.org/10.1093/europace/euy310","authors":["Kevin J Um","William F McIntyre","Jeff S Healey","Pablo A Mendoza","Alex Koziarz","Guy Amit","Victor A Chu","Richard P Whitlock","Emilie P Belley-Côté"],"significance":5,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis evaluated pre- and post-treatment with amiodarone for electrical cardioversion of AF, showing that antiarrhythmic preloading improves cardioversion success rates and prevents early AF recurrence.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"Systematische review en meta-analyse naar pre- en postbehandeling met amiodaron bij electrische cardioversie van AF.","abstract_original":"AIMS: Clinicians frequently pre-treat patients with amiodarone to increase the efficacy of electrical cardioversion for atrial fibrillation (AF). Our objective was to determine the precise effects of amiodarone pre- and post-treatment on conversion efficacy and sinus rhythm maintenance. METHODS AND RESULTS: We conducted a systematic review and meta-analysis of trials comparing pre- and post-treatment for electrical cardioversion with amiodarone vs. no therapy on (i) acute restoration and (ii) maintenance of sinus rhythm after 1 year. We searched MEDLINE and EMBASE from inception to July 2018 for randomized controlled trials. We evaluated the risk of bias for individual studies with the Cochrane tool and overall quality of evidence with the GRADE framework. We identified eight eligible studies (n = 1012). Five studies were deemed to have unclear or high risk of selection bias. We found the evidence to be of high quality based on GRADE. Treatment with amiodarone (200-800 mg daily for 1-6 weeks pre-cardioversion; 0-200 mg daily post-cardioversion) was associated with higher rates of acute restoration [relative risk (RR) 1.22, 95% confidence interval (CI) 1.07-1.39, P = 0.004, n = 1012, I2 = 65%] and maintenance of sinus rhythm over 13 months (RR 4.39, 95% CI 2.99-6.45, P < 0.001, n = 695, I2 = 0%). The effects of amiodarone for acute restoration were maintained when considering only studies at low risk of bias (RR 1.22, 95% CI 1.10-1.36, P < 0.001, n = 572, I2 = 0%). Adverse effects were typically non-serious, occurring in 3.4% (6/174) of subjects receiving amiodarone. CONCLUSION: High-quality evidence demonstrated that treatment with amiodarone improved the restoration and maintenance of sinus rhythm after electrical cardioversion of AF. Short-term amiodarone was well-tolerated."},{"id":"0fe2d2de71bc","type":"article","url":"https://hartvaat.nl/2019/06/01/icd-implantatie-en-gezondheidsgerelateerde-kwaliteit-van-leven-danish/","title":"ICD-implantatie en gezondheidsgerelateerde kwaliteit van leven: DANISH","title_en":"The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial.","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/euz018","source_url":"https://doi.org/10.1093/europace/euz018","authors":["Johan S Bundgaard","Jens J Thune","Jens C Nielsen","Regitze Videbæk","Jens Haarbo","Niels E Bruun","Lars Videbæk","David Aagaard","Eva Korup","Gunnar Jensen","Per Hildebrandt","Flemming H Steffensen","Hans Eiskjær","Axel Brandes","Anna M Thøgersen","Thomas M Melchior","Ole D Pedersen","Finn Gustafsson","Kenneth Egstrup","Christian Hassager","Jesper H Svendsen","Dan E Høfsten","Christian Torp-Pedersen","Susanne S Pedersen","Steen Pehrson","Lars Køber","Ulrik M Mogensen"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/hartfalen/icd-bij-hartfalen/"],"congress":"","summary_en":"This DANISH trial analysis showed that ICD implantation does not significantly impact health-related quality of life in non-ischemic heart failure patients, adding patient-centered data to the neutral mortality finding.","created":"2026-07-03T10:27:58Z","updated":"2026-07-03T13:27:10Z","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":"DANISH-trial analyse naar de impact van ICD-implantatie op gezondheidsgerelateerde kwaliteit van leven bij niet-ischemisch hartfalen.","abstract_original":"AIM: The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICD) in Patients with Non-ischaemic Systolic Heart Failure (HF) on Mortality (DANISH) found no overall effect on all-cause mortality. The effect of ICD implantation on health-related quality of life (HRQoL) remains to be established as previous trials have demonstrated conflicting results. We investigated the impact of ICD implantation on HRQoL in patients with non-ischaemic systolic HF, a prespecified secondary endpoint in DANISH. METHODS AND RESULTS: In DANISH, a total of 1116 patients with non-ischaemic systolic HF were randomly assigned (1:1) to ICD implantation or usual clinical care (control). Patients completed disease-specific HRQoL as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ; 0-105, high indicating worse). Changes in HRQoL 8 months after randomization were assessed with a mixed-effects model. At randomization, MLHFQ was completed by 935 (84%) patients (n = 472 in the ICD group and n = 463 in the control group) and was reassessed in 274 (58%) and 292 (63%) patients, respectively after 8 months for the primary analysis. Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months [least square mean -7.0 vs. -4.2 (P = 0.13)]. A clinically relevant improvement (decrease ≥5) in the MLHFQ overall score at 8 months was observed in 151 patients in the ICD group and 148 patients in the control group [55% vs. 51%, respectively (P = 0.25)]. CONCLUSION: Implantable cardioverter-defibrillator implantation in patients with non-ischaemic systolic HF did not significantly alter HRQoL compared with patients randomized to usual clinical care."},{"id":"5130f5100490","type":"article","url":"https://hartvaat.nl/2019/06/01/kosteneffectiviteit-van-telemonitoring-en-zelfmeting-van-bloeddruk-tasminh4/","title":"Kosteneffectiviteit van telemonitoring en zelfmeting van bloeddruk: TASMINH4","title_en":"Cost-Effectiveness of Telemonitoring and Self-Monitoring of Blood Pressure for Antihypertensive Titration in Primary Care (TASMINH4).","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling","digitale-gezondheid","thuisbloeddrukmeting"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12415","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12415","authors":["Mark Monahan","Sue Jowett","Alecia Nickless","Marloes Franssen","Sabrina Grant","Sheila Greenfield","F D Richard Hobbs","James Hodgkinson","Jonathan Mant","Richard J McManus"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/bloeddrukmeting-thuismeting-abpm/","https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This TASMINH4 cost-effectiveness analysis showed that blood pressure telemonitoring and self-monitoring for antihypertensive titration are cost-effective compared with usual care, supporting the economic case for remote blood pressure management.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Kosteneffectiviteitsanalyse van de TASMINH4-trial naar telemonitoring en zelfmeting van bloeddruk voor medicatietitratie bij hypertensie.","abstract_original":"The use of self-monitoring of blood pressure, with or without telemonitoring, to guide therapy decisions by physicians for patients with hypertension has been recently demonstrated to reduce blood pressure compared with using clinic monitoring (usual care). However, both the cost-effectiveness of these strategies compared with usual care, and whether the additional benefit of telemonitoring compared with self-monitoring alone could be considered value for money, are unknown. This study assessed the cost-effectiveness of physician titration of antihypertensive medication using self-monitored blood pressure, with or without telemonitoring, to make hypertension treatment decisions in primary care compared with usual care. A Markov patient-level simulation model was developed taking a UK Health Service/Personal Social Services perspective. The model adopted a lifetime time horizon with 6-month time cycles. At a willingness to pay of £20 000 per quality-adjusted life year, self-monitoring plus telemonitoring was the most cost-effective strategy (£17 424 per quality-adjusted life year gained) compared with usual care or self-monitoring alone (posting the results to the physician). However, deterministic sensitivity analysis showed that self-monitoring alone became the most cost-effective option when changing key assumptions around long-term effectiveness and time horizon. Overall, probabilistic sensitivity analysis suggested that self-monitoring regardless of transmission modality was likely to be cost-effective compared with usual care (89% probability of cost-effectiveness at £20 000/quality-adjusted life year), with high uncertainty as to whether telemonitoring or self-monitoring alone was the most cost-effective option. Self-monitoring in clinical practice is cost-effective and likely to lead to reduced cardiovascular mortality and morbidity."},{"id":"a49530fa55f6","type":"article","url":"https://hartvaat.nl/2019/06/01/mortaliteitsuitkomsten-bij-intensieve-bloeddrukstreefwaarden-bij-ckd/","title":"Mortaliteitsuitkomsten bij intensieve bloeddrukstreefwaarden bij CKD","title_en":"Mortality Outcomes With Intensive Blood Pressure Targets in Chronic Kidney Disease Patients.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","anemie-ckd","bloeddrukbehandeling","chronische-nierziekte","fidelio-dkd","figaro-dkd","flow-trial","ijzertekort"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.119.12697","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.119.12697","authors":["Rahul Aggarwal","Benjamin Petrie","Wasif Bala","Nicholas Chiu"],"significance":7,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/nierziekte/nsaids-en-nierziekte/"],"congress":"","summary_en":"This analysis of intensive blood pressure targets in chronic kidney disease patients showed improved mortality outcomes with lower targets, supporting aggressive blood pressure management in CKD despite concerns about renal hemodynamic effects.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 mortaliteitsuitkomsten bij intensieve bloeddrukcontrole specifiek bij patiënten met chronische nierziekte.","abstract_original":"Hypertension is highly prevalent and morbid in the chronic kidney disease population, and blood pressure (BP) targets for this population are unclear. We aimed to compare all-cause mortality outcomes with intensively targeting systolic BP to <130 mm Hg versus a standard of <140 mm Hg. Individual patient data from 4983 chronic kidney disease patients with hypertension were pooled from 4 multicenter randomized control trials-AASK (African American Study of Kidney Disease and Hypertension), ACCORD (Action to Control Cardiovascular Risk in Diabetes), MDRD (Modification of Diet in Renal Disease), and the SPRINT (Systolic Blood Pressure Intervention Trial). Patients were assigned their trial-assigned randomized intervention group-standard (n=2474) versus intensive (n=2509) BP targets. Additional analyses included excluding patients with a glomerular filtration rate ≥60 mL/min per 1.73 m2 along with those undergoing intensive glycemic control. The primary outcome was all-cause mortality. Average achieved BP was 125.0 mm Hg in the intensive group and 136.9 mm Hg in the standard group. In the primary analysis, the all-cause mortality rate trended towards improved outcomes with intensive treatment but was not statistically significant (hazard ratio: 0.87 [0.69-1.08]; P=0.21). One hundred seventy-three of 2474 patients (1.95% per year) in the standard group and 153 of 2509 patients (1.71% per year) in the intensive group died. After excluding patients with higher glomerular filtration rate values and those undergoing intensive glycemic control, there was a statistically significant decrease in all-cause mortality rate (hazard ratio: 0.79 [0.63-1.00]; P=0.048). An intensive BP target of <130 mm Hg decreases all-cause mortality when compared with a standard target of <140 mm Hg in patients with chronic kidney disease stage 3 or greater who are not undergoing intensive glycemic therapy."},{"id":"d95fd8b5488c","type":"article","url":"https://hartvaat.nl/2019/06/01/bloeddrukverlaging-naar-uitgangsdruk-en-cv-risico-bij-diabetes-type-2/","title":"Bloeddrukverlaging naar uitgangsdruk en CV-risico bij diabetes type 2","title_en":"Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling","diabetes-en-hart","diabetes-type-1","diabetes-type-2","dyslipidemie","obesitas","primaire-preventie","soul-trial","vrouwen"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12414","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12414","authors":["Faisal Rahman","John W McEvoy","Toshiaki Ohkuma","Michel Marre","Pavel Hamet","Stephen Harrap","Giuseppe Mancia","Anthony Rodgers","Elizabeth Selvin","Bryan Williams","Paul Muntner","John Chalmers","Mark Woodward"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/","https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/"],"congress":"","summary_en":"This analysis evaluated blood pressure lowering effects stratified by baseline blood pressure and cardiovascular risk in type 2 diabetes, informing the debate about optimal blood pressure targets in the diabetic population.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T18:38:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 effect van bloeddrukverlaging gestratificeerd naar uitgangsdruk en cardiovasculair risico bij diabetes type 2.","abstract_original":"The optimal blood pressure (BP) goal in patients with diabetes mellitus remains controversial. We examined whether benefits and risks of intensified antihypertensive therapy in diabetes mellitus are influenced by either baseline BP or cardiovascular disease (CVD) risk. We studied 10 948 people with diabetes mellitus, at moderate-to-high risk, in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation). Cox models were used to determine whether baseline BP category or CVD risk modified the outcomes of combination perindopril-indapamide treatment, compared with placebo. During 4.3 years of follow-up, treatment with perindopril-indapamide versus placebo reduced mortality and major vascular (macrovascular or microvascular) events. There was no evidence of differences in these effects, regardless of baseline systolic BP (evaluated down to <120 mm Hg; P for heterogeneity, 0.85), diastolic BP (evaluated down to <70 mm Hg; P=0.49), or whether 10-year CVD risk was ≥20% or <20% ( P=0.08). The effects of randomized treatment on discontinuation of treatment because of cough or hypotension/dizziness were also statistically consistent across subgroups defined by baseline BP and CVD risk (all P ≥0.08). Adults with diabetes mellitus appear to benefit from more intensive BP treatment even at levels of BP and CVD risk that some guidelines do not currently recommend for intervention. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00751972."},{"id":"d850b1c9424a","type":"article","url":"https://hartvaat.nl/2019/06/01/longechogeleide-drooggewichtreductie-en-ambulante-bloeddruk-bij-hemodialyse/","title":"Longechogeleide drooggewichtreductie en ambulante bloeddruk bij hemodialyse","title_en":"The effect of dry-weight reduction guided by lung ultrasound on ambulatory blood pressure in hemodialysis patients: a randomized controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["ambulante-bloeddrukmeting","anemie-ckd","bloeddrukbehandeling","summit-trial"],"journal":"Kidney international","doi":"10.1016/j.kint.2019.02.018","source_url":"https://doi.org/10.1016/j.kint.2019.02.018","authors":["Charalampos Loutradis","Pantelis A Sarafidis","Robert Ekart","Christodoulos Papadopoulos","Vasileios Sachpekidis","Maria Eleni Alexandrou","Dorothea Papadopoulou","Giorgos Efstratiadis","Aikaterini Papagianni","Gerard London","Carmine Zoccali"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":[],"congress":"","summary_en":"This randomized trial of lung ultrasound-guided dry weight reduction in hemodialysis patients showed improved ambulatory blood pressure, demonstrating that point-of-care imaging can optimize fluid management and blood pressure control in dialysis.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T13:27:09Z","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":"Gerandomiseerde trial die longechogeleide drooggewichtreductie onderzocht op ambulante bloeddruk bij hemodialysepatiënten.","abstract_original":"Approximately 85% of hemodialysis patients are hypertensive, but less than 30% achieve adequate blood pressure (BP) control. Reduction of volume overload is fundamental for BP control, but clinical criteria to estimate dry-weight are inaccurate. In the present study we examined the effect of dry-weight reduction with a lung-ultrasound-guided strategy on ambulatory BP in 71 clinically euvolemic hemodialysis patients with hypertension. Patients were equally randomized into an active group, following a strategy for dry-weight reduction guided by pre-hemodialysis lung ultrasound, and a control group with standard-of-care treatment. All patients underwent 48-hour ambulatory BP monitoring (ABPM) at baseline and after eight weeks. Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively. The ultrasonographic-B line change during follow-up was significantly different (-5.3±12.5 in active versus +2.2±7.6 in control group), which corresponded to significant differences in dry weight changes between the groups. The magnitude of reductions in 48-hour systolic BP (-6.61±9.57 vs. -0.67±13.07) and diastolic BP (-3.85±6.34 vs. -0.55±8.28) was significantly greater in the active group. Similarly, intradialytic BP, 44-hour BP, and daytime or night-time systolic/diastolic BP during both days of the interdialytic interval were significantly reduced in the active group but remained unchanged in the control group. The percentage of patients experiencing one or more intradialytic hypotensive episodes was marginally lower in the active group (34.3% vs. 55.6%). Thus, a lung-ultrasound-guided strategy for dry-weight reduction can effectively and safely reduce ambulatory BP levels in hemodialysis patients. Clinical implementation of this simple technique can help increase BP control in this population."},{"id":"7525240ed383","type":"article","url":"https://hartvaat.nl/2019/06/01/klinische-predictieregels-voor-diagnostiek-van-chronisch-hartfalen-systematische/","title":"Klinische predictieregels voor diagnostiek van chronisch hartfalen: systematische review","title_en":"A systematic review of clinical prediction rules for the diagnosis of chronic heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":["vrouwen"],"journal":"ESC heart failure","doi":"10.1002/ehf2.12426","source_url":"https://doi.org/10.1002/ehf2.12426","authors":["Joe Gallagher","Darren McCormack","Shuaiwei Zhou","Fiona Ryan","Chris Watson","Kenneth McDonald","Mark T Ledwidge"],"significance":6,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/acuut-hartfalen/"],"congress":"","summary_en":"This systematic review evaluated clinical prediction rules for diagnosing chronic heart failure in community settings, assessing which tools can help primary care clinicians identify heart failure without specialist referral.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T13:27:09Z","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 van klinische predictieregels voor de diagnose van chronisch hartfalen in de eerstelijn.","abstract_original":"AIMS: This study sought to review the literature for clinical prediction models for the diagnosis of patients with chronic heart failure in the community and to validate the models in a novel cohort of patients with a suspected diagnosis of chronic heart failure. METHODS AND RESULTS: MEDLINE and Embase were searched from 1946 to Q4 2017. Studies were eligible if they contained at least one multivariable model for the diagnosis of chronic heart failure applicable to the primary care setting. The CHARMS checklist was used to evaluate models. We also validated models, where possible, in a novel cohort of patients with a suspected diagnosis of heart failure referred to a rapid access diagnostic clinic. In total, 5310 articles were identified with nine articles subsequently meeting the eligibility criteria. Three models had undergone internal validation, and four had undergone external validation. No clinical impact studies have been completed to date. Area under the curve (AUC) varied from 0.74 to 0.93 and from 0.60 to 0.65 in the novel cohort for clinical models alone with AUC up to 0.89 in combination with electrocardiogram and B-type natriuretic peptide (BNP). The AUC for BNP was 0.86 (95% confidence interval 83.3-88.6%). CONCLUSIONS: This review demonstrates that there are a number of clinical prediction rules relevant to the diagnosis of chronic heart failure in the literature. Clinical impact studies are required to compare the use of clinical prediction rules and biomarker strategies in this setting."},{"id":"b3746747560a","type":"article","url":"https://hartvaat.nl/2019/06/01/zoutsubstituten-met-laag-natrium-en-bloeddruk-cva-en-mortaliteit-meta-analyse/","title":"Zoutsubstituten met laag natrium en bloeddruk, CVA en mortaliteit: meta-analyse","title_en":"Effect of low-sodium salt substitutes on blood pressure, detected hypertension, stroke and mortality.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["bloeddrukbehandeling"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314036","source_url":"https://doi.org/10.1136/heartjnl-2018-314036","authors":["Adrian V Hernandez","Erin E Emonds","Brett A Chen","Alfredo J Zavala-Loayza","Priyaleela Thota","Vinay Pasupuleti","Yuani M Roman","Antonio Bernabe-Ortiz","J Jaime Miranda"],"significance":7,"published":"2019-06-01","source_date":"2019-06-01","image":"","kennis":["https://hartvaat.nl/kennis/preventie/esc-richtlijn-cardiovasculaire-preventie-2021/"],"congress":"","summary_en":"This meta-analysis confirmed that low-sodium salt substitutes significantly lower blood pressure and may reduce stroke and mortality at the population level, supporting this simple dietary intervention as a scalable public health strategy.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het effect van natriumarme zoutsubstituten op bloeddruk, hypertensiedetectie, beroerte en mortaliteit. Populatiebrede preventie.","abstract_original":"OBJECTIVE: A systematic review and meta-analysis was conducted to assess the efficacy of low-sodium salt substitutes (LSSS) as a potential intervention to reduce cardiovascular (CV) diseases. METHODS: Five engines and ClinicalTrials.gov were searched from inception to May 2018. Randomised controlled trials (RCTs) enrolling adult hypertensive or general populations that compared detected hypertension, systolic blood pressure (SBP), diastolic blood pressure (DBP), overall mortality, stroke and other CV risk factors in those receiving LSSS versus regular salt were included. Effects were expressed as risk ratios or mean differences (MD) and their 95% CIs. Quality of evidence assessment followed GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. RESULTS: 21 RCTs (15 in hypertensive (n=2016), 2 in normotensive (n=163) and 4 in mixed populations (n=5224)) were evaluated. LSSS formulations were heterogeneous. Effects were similar across hypertensive, normotensive and mixed populations. LSSS decreased SBP (MD -7.81 mm Hg, 95% CI -9.47 to -6.15, p<0.00001) and DBP (MD -3.96 mm Hg, 95% CI -5.17 to -2.74, p<0.00001) compared with control. Significant increases in urinary potassium (MD 11.46 mmol/day, 95% CI 8.36 to 14.55, p<0.00001) and calcium excretion (MD 2.39 mmol/day, 95% CI 0.52 to 4.26, p=0.01) and decreases in urinary sodium excretion (MD -35.82 mmol/day, 95% CI -57.35 to -14.29, p=0.001) were observed. Differences in detected hypertension, overall mortality, total cholesterol, triglycerides, glucose or BMI were not significant. Quality of evidence was low to very low for most of outcomes. CONCLUSIONS: LSSS significantly decreased SBP and DBP. There was no effect for detected hypertension, overall mortality and intermediate outcomes. Large, long-term RCTs are necessary to clarify salt substitute effects on clinical outcomes."},{"id":"df8254e57b0b","type":"article","url":"https://hartvaat.nl/2019/05/28/canagliflozine-en-hf-uitkomsten-bij-behouden-versus-verminderde-ef-canvas/","title":"Canagliflozine en HF-uitkomsten bij behouden versus verminderde EF: CANVAS","title_en":"Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["canagliflozine","dapa-hf"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.040057","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.040057","authors":["Gemma A Figtree","Karin Rådholm","Terrance D Barrett","Vlado Perkovic","Kenneth W Mahaffey","Dick de Zeeuw","Greg Fulcher","David R Matthews","Wayne Shaw","Bruce Neal"],"significance":7,"published":"2019-05-28","source_date":"2019-05-28","image":"","kennis":[],"congress":"","summary_en":"This CANVAS analysis of heart failure outcomes stratified by ejection fraction showed that canagliflozin reduces heart failure events regardless of baseline LVEF, foreshadowing the later dedicated HFpEF trials with SGLT2 inhibitors.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T13:27:09Z","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":"CANVAS analyse naar het effect van canagliflozine op HF-uitkomsten gestratificeerd naar behouden versus verminderde ejectiefractie bij diabetes type 2.","abstract_original":""},{"id":"a7f700a36e70","type":"article","url":"https://hartvaat.nl/2019/05/28/dapagliflozine-en-cv-uitkomsten-bij-diabetes-type-2-met-eerder-mi/","title":"Dapagliflozine en CV-uitkomsten bij diabetes type 2 met eerder MI","title_en":"Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["canagliflozine","dapagliflozine","diabetes-en-hart","diabetes-type-2","empagliflozine"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.039996","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.039996","authors":["Remo H M Furtado","Marc P Bonaca","Itamar Raz","Thomas A Zelniker","Ofri Mosenzon","Avivit Cahn","Julia Kuder","Sabina A Murphy","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","John P H Wilding","Christian T Ruff","Jose C Nicolau","Ingrid A M Gause-Nilsson","Martin Fredriksson","Anna Maria Langkilde","Marc S Sabatine","Stephen D Wiviott"],"significance":8,"published":"2019-05-28","source_date":"2019-05-28","image":"","kennis":[],"congress":"","summary_en":"This DECLARE-TIMI 58 subanalysis showed that dapagliflozin significantly reduced MACE specifically in patients with type 2 diabetes and prior myocardial infarction, while the broader trial population showed only heart failure benefit. The finding identified the highest-risk subgroup most likely to benefit from SGLT2 inhibition.","created":"2026-07-03T10:27:57Z","updated":"2026-07-03T13:27:09Z","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":"DECLARE-TIMI 58 subanalyse bij patiënten met eerder myocardinfarct — de hoogste risicopopulatie. MACE-voordeel significant in deze subgroep.","abstract_original":"BACKGROUND: Sodium glucose transporter-2 inhibitors reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus and a history of atherosclerotic cardiovascular disease. Because of their baseline risk, patients with previous myocardial infarction (MI) may derive even greater benefit from sodium glucose transporter-2 inhibitor therapy. METHODS: DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) randomized 17 160 patients with type 2 diabetes mellitus and either established atherosclerotic cardiovascular disease (n=6974) or multiple risk factors (n=10 186) to dapagliflozin versus placebo. The 2 primary end points were composite of MACE (cardiovascular death, MI, or ischemic stroke) and the composite of cardiovascular death or hospitalization for heart failure. Those with previous MI (n=3584) made up a prespecified subgroup of interest. RESULTS: In patients with previous MI (n=3584), dapagliflozin reduced the relative risk of MACE by 16% and the absolute risk by 2.6% (15.2% versus 17.8%; hazard ratio [HR], 0.84; 95% CI, 0.72-0.99; P=0.039), whereas there was no effect in patients without previous MI (7.1% versus 7.1%; HR, 1.00; 95% CI, 0.88-1.13; P=0.97; P for interaction for relative difference=0.11; P for interaction for absolute risk difference=0.048), including in patients with established atherosclerotic cardiovascular disease but no history of MI (12.6% versus 12.8%; HR, 0.98; 95% CI, 0.81-1.19). There seemed to be a greater benefit for MACE within 2 years after the last acute event ( P for interaction trend=0.007). The relative risk reductions in cardiovascular death/hospitalization for heart failure were more similar, but the absolute risk reductions tended to be greater: 1.9% (8.6% versus 10.5%; HR, 0.81; 95% CI, 0.65-1.00; P=0.046) and 0.6% (3.9% versus 4.5%; HR, 0.85; 95% CI, 0.72-1.00; P=0.055) in patients with and without previous MI, respectively ( P interaction for relative difference=0.69; P interaction for absolute risk difference=0.010). CONCLUSIONS: Patients with type 2 diabetes mellitus and previous MI are at high risk of MACE and cardiovascular death/hospitalization for heart failure. Dapagliflozin appears to robustly reduce the risk of both composite outcomes in these patients. Future studies should aim to confirm the large clinical benefits with sodium glucose transporter-2 inhibitors we observed in patients with previous MI. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534."},{"id":"7b3728d3f596","type":"article","url":"https://hartvaat.nl/2019/05/28/dapagliflozine-en-hartfalen-en-mortaliteit-bij-diabetes-type-2-declare-timi-58-h/","title":"Dapagliflozine en hartfalen en mortaliteit bij diabetes type 2: DECLARE-TIMI 58 HF-analyse","title_en":"Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["dapa-hf","dapagliflozine","empagliflozine"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.040130","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.040130","authors":["Eri T Kato","Michael G Silverman","Ofri Mosenzon","Thomas A Zelniker","Avivit Cahn","Remo H M Furtado","Julia Kuder","Sabina A Murphy","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","John P H Wilding","Marc P Bonaca","Christian T Ruff","Akshay S Desai","Shinya Goto","Peter A Johansson","Ingrid Gause-Nilsson","Per Johanson","Anna Maria Langkilde","Itamar Raz","Marc S Sabatine","Stephen D Wiviott"],"significance":8,"published":"2019-05-28","source_date":"2019-05-28","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/"],"congress":"","summary_en":"This DECLARE-TIMI 58 heart failure analysis confirmed that dapagliflozin significantly reduces heart failure hospitalization and cardiovascular death in patients with type 2 diabetes, with the greatest benefit in those with prior heart failure. The results strengthened the heart failure prevention role of SGLT2 inhibitors.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:09Z","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":"DECLARE-TIMI 58 analyse specifiek naar het effect van dapagliflozine op hartfalen en mortaliteit bij diabetes type 2. Bevestigt het HF-preventieve effect.","abstract_original":"BACKGROUND: In DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the composite end point of cardiovascular death/hospitalization for heart failure (HHF) in a broad population of patients with type 2 diabetes mellitus. However, the impact of baseline left ventricular ejection fraction (EF) on the clinical benefit of sodium-glucose cotransporter 2 inhibition is unknown. METHODS: In the DECLARE-TIMI 58 trial, baseline heart failure (HF) status was collected from all patients, and EF was collected when available. HF with reduced EF (HFrEF) was defined as EF <45%. Outcomes of interest were the composite of cardiovascular death/HHF, its components, and all-cause mortality. RESULTS: Of 17 160 patients, 671 (3.9%) had HFrEF, 1316 (7.7%) had HF without known reduced EF, and 15 173 (88.4%) had no history of HF at baseline. Dapagliflozin reduced cardiovascular death/HHF more in patients with HFrEF (hazard ratio [HR], 0.62 [95% CI, 0.45-0.86]) than in those without HFrEF (HR, 0.88 [95% CI, 0.76-1.02]; P for interaction=0.046), in whom the treatment effect of dapagliflozin was similar in those with HF without known reduced EF (HR, 0.88 [95% CI, 0.66-1.17]) and those without HF (HR, 0.88 [95% CI, 0.74-1.03]). Whereas dapagliflozin reduced HHF both in those with (HR, 0.64 [95% CI, 0.43-0.95]) and in those without HFrEF (HR, 0.76 [95% CI, 0.62-0.92]), it reduced cardiovascular death only in patients with HFrEF (HR, 0.55 [95% CI, 0.34-0.90]) but not in those without HFrEF (HR, 1.08 [95% CI, 0.89-1.31]; P for interaction=0.012). Likewise, dapagliflozin reduced all-cause mortality in patients with HFrEF (HR, 0.59 [95% CI, 0.40-0.88;) but not in those without HFrEF (HR, 0.97 [95% CI, 0.86-1.10]; P for interaction=0.016). CONCLUSIONS: In the first sodium-glucose cotransporter 2 inhibitor cardiovascular outcome trial to evaluate patients with type 2 diabetes mellitus stratified by EF, we found that dapagliflozin reduced HHF in patients with and without HFrEF and reduced cardiovascular death and all-cause mortality in patients with HFrEF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534."},{"id":"94a474631d26","type":"article","url":"https://hartvaat.nl/2019/05/21/vroegtijdig-staken-van-ticagrelor-bij-secundaire-cv-preventie-jacc-review/","title":"Vroegtijdig staken van ticagrelor bij secundaire CV-preventie: JACC review","title_en":"Premature Ticagrelor Discontinuation in Secondary Prevention of Atherosclerotic CVD: JACC Review Topic of the Week.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.03.470","source_url":"https://doi.org/10.1016/j.jacc.2019.03.470","authors":["Sameer Arora","Kamal Shemisa","Muthiah Vaduganathan","Arman Qamar","Ankur Gupta","Sushil K Garg","Dharam J Kumbhani","Helen Mayo","Houman Khalili","Ambarish Pandey","Sandeep R Das"],"significance":6,"published":"2019-05-21","source_date":"2019-05-21","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/"],"congress":"","summary_en":"This JACC review addressed the clinical consequences and management of premature ticagrelor discontinuation in secondary cardiovascular prevention, a common practical challenge affecting antiplatelet treatment effectiveness.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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":"JACC review over de klinische consequenties en management van vroegtijdig staken van ticagrelor bij secundaire cardiovasculaire preventie.","abstract_original":"Ticagrelor is a cornerstone of modern antithrombotic therapy alongside aspirin in patients with acute coronary syndrome and after percutaneous coronary intervention. Adverse effects such as bleeding and dyspnea have been associated with premature ticagrelor discontinuation, which may limit any potential advantage of ticagrelor over clopidogrel. The randomized trials of ticagrelor captured adverse events, offering the opportunity to more precisely quantify these effects across studies. Therefore, a meta-analysis of 4 randomized clinical trials of ticagrelor conducted between January 2007 and June 2017 was performed to quantify the incidence and causes of premature ticagrelor discontinuation. Among 66,870 patients followed for a median 18 months, premature ticagrelor discontinuation was seen in 25%; bleeding was the most common cause of discontinuation followed by dyspnea. Versus the comparators, the relative risk of dyspnea-related discontinuation during follow-up was 6.4-fold higher, the relative risk of bleeding was 3.2-fold higher, and the relative risk of discontinuation due to any adverse event was 59% higher for patients receiving ticagrelor. Understanding these potential barriers to adherence to ticagrelor is crucial for informed patient-physician decision making and can inform future efforts to improve ticagrelor adherence. This review discusses the incidence, causes, and biological mechanisms of ticagrelor-related adverse effects and offers strategies to improve adherence to ticagrelor."},{"id":"3d37dfebded2","type":"article","url":"https://hartvaat.nl/2019/05/21/pacemakerimplantatie-na-mitralisklepchirurgie-met-af-ablatie/","title":"Pacemakerimplantatie na mitralisklepchirurgie met AF-ablatie","title_en":"Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.02.062","source_url":"https://doi.org/10.1016/j.jacc.2019.02.062","authors":["Joseph J DeRose","Donna M Mancini","Helena L Chang","Michael Argenziano","François Dagenais","Gorav Ailawadi","Louis P Perrault","Michael K Parides","Wendy C Taddei-Peters","Michael J Mack","Donald D Glower","Babatunde A Yerokun","Pavan Atluri","John C Mullen","John D Puskas","Karen O'Sullivan","Nancy M Sledz","Hugo Tremblay","Ellen Moquete","Bart S Ferket","Alan J Moskowitz","Alexander Iribarne","Annetine C Gelijns","Patrick T O'Gara","Eugene H Blackstone","A Marc Gillinov"],"significance":5,"published":"2019-05-21","source_date":"2019-05-21","image":"","kennis":[],"congress":"","summary_en":"This study documented the incidence of permanent pacemaker implantation after mitral valve surgery combined with AF ablation, showing that concomitant rhythm surgery increases the need for permanent pacing.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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 naar de incidentie van pacemakerimplantatie na mitralisklepchirurgie gecombineerd met AF-ablatie.","abstract_original":"BACKGROUND: The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone. OBJECTIVES: This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS. METHODS: A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality. RESULTS: Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class. CONCLUSIONS: AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)."},{"id":"d24ec48c1c26","type":"article","url":"https://hartvaat.nl/2019/05/21/aflibercept-versus-fotocoagulatie-versus-observatie-bij-diabetisch-maculaoedeem-/","title":"Aflibercept versus fotocoagulatie versus observatie bij diabetisch maculaoedeem: JAMA DRCR.net","title_en":"Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.5790","source_url":"https://doi.org/10.1001/jama.2019.5790","authors":["Carl W Baker","Adam R Glassman","Wesley T Beaulieu","Andrew N Antoszyk","David J Browning","Kakarla V Chalam","Sandeep Grover","Lee M Jampol","Chirag D Jhaveri","Michele Melia","Cynthia R Stockdale","Daniel F Martin","Jennifer K Sun"],"significance":7,"published":"2019-05-21","source_date":"2019-05-21","image":"","kennis":[],"congress":"","summary_en":"The DRCR.net Protocol V trial compared initial management strategies for center-involving diabetic macular edema, finding that observation is a reasonable initial approach for eyes with good visual acuity, relevant to ophthalmological management in diabetic patients.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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":"JAMA DRCR.net Protocol V-trial naar het initiële management van diabetisch maculaoedeem. Cardio-endocrinologisch relevant.","abstract_original":"IMPORTANCE: Intravitreous injections of antivascular endothelial growth factor agents are effective for treating diabetic macular edema (DME) involving the center of the macula (center-involved DME [CI-DME]) with visual acuity impairment (20/32 or worse). The best approach to treating patients with CI-DME and good visual acuity (20/25 or better) is unknown. OBJECTIVE: To compare vision loss at 2 years among eyes initially managed with aflibercept, laser photocoagulation, or observation. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 91 US and Canadian sites among 702 adults with type 1 or type 2 diabetes. Participants had 1 study eye with CI-DME and visual acuity of 20/25 or better. The first participant was randomized on November 8, 2013, and the final date of follow-up was September 11, 2018. INTERVENTIONS: Eyes were randomly assigned to 2.0 mg of intravitreous aflibercept (n = 226) as frequently as every 4 weeks, focal/grid laser photocoagulation (n = 240), or observation (n = 236). Aflibercept was required for eyes in the laser photocoagulation or observation groups that had decreased visual acuity from baseline by at least 10 letters (≥ 2 lines on an eye chart) at any visit or by 5 to 9 letters (1-2 lines) at 2 consecutive visits. MAIN OUTCOMES AND MEASURES: The primary outcome was at least a 5-letter visual acuity decrease from baseline at 2 years. Antiplatelet Trialists' Collaboration adverse events (defined as myocardial infarction, stroke, or vascular or unknown death) were reported. RESULTS: Among 702 randomized participants (mean age, 59 years; 38% female [n=264]), 625 of 681 (92% excluding deaths) completed the 2-year visit. For eyes with visual acuity that decreased from baseline, aflibercept was initiated in 25% (60/240) and 34% (80/236) in the laser photocoagulation and observation groups, respectively. At 2 years, the percentage of eyes with at least a 5-letter visual acuity decrease was 16% (33/205), 17% (36/212), and 19% (39/208) in the aflibercept, laser photocoagulation, and observation groups, respectively (aflibercept vs laser photocoagulation risk difference, -2% [95% CI, -9% to 5%]; relative risk, 0.88 [95% CI, 0.57-1.35; P = .79]; aflibercept vs observation risk difference, -3% [95% CI, -11% to 4%]; relative risk, 0.83 [95% CI, 0.55-1.27; P = .79]; laser photocoagulation vs observation risk difference, -1% [95% CI, -9% to 6%]; relative risk, 0.95 [95% CI, 0.64-1.41; P = .79]). Antiplatelet Trialists' Collaboration vascular events occurred in 15 (7%), 13 (5%), and 8 (3%) participants in the aflibercept, laser photocoagulation, and observation groups. CONCLUSIONS AND RELEVANCE: Among eyes with CI-DME and good visual acuity, there was no significant difference in vision loss at 2 years whether eyes were initially managed with aflibercept or with laser photocoagulation or observation and given aflibercept only if visual acuity worsened. Observation without treatment unless visual acuity worsens may be a reasonable strategy for CI-DME. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01909791."},{"id":"39f693f0e9a6","type":"article","url":"https://hartvaat.nl/2019/05/21/ijzerisomaltosides-en-skeletspierdenergie-bij-chronisch-hf-met-ijzerdeficientie/","title":"IJzerisomaltosides en skeletspierdenergie bij chronisch HF met ijzerdeficiëntie","title_en":"Effect of Iron Isomaltoside on Skeletal Muscle Energetics in Patients With Chronic Heart Failure and Iron Deficiency.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["anemie-ckd","hfref","ijzersuppletie","ivabradine"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038516","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038516","authors":["Geoffrey Charles-Edwards","Nelson Amaral","Alison Sleigh","Salma Ayis","Norman Catibog","Theresa McDonagh","Mark Monaghan","George Amin-Youssef","Graham J Kemp","Ajay M Shah","Darlington O Okonko"],"significance":6,"published":"2019-05-21","source_date":"2019-05-21","image":"","kennis":[],"congress":"","summary_en":"This mechanistic study showed that intravenous iron repletion improves skeletal muscle energetics in chronic heart failure patients with iron deficiency, providing a physiological explanation for the exercise capacity improvement seen with IV iron therapy.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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 naar het effect van intraveneus ijzer op skeletspierenergievoorziening bij chronisch hartfalen met ijzerdeficiëntie. Mechanisme achter het functionele voordeel.","abstract_original":"BACKGROUND: Iron repletion augments exercise capacity in chronic heart failure (HF), but there is a lack of mechanistic data explaining how iron could augment exercise performance despite minimal changes in hemoglobin (Hb). Besides Hb, iron is an obligate component of mitochondrial enzymes that generate cellular energy in the form of adenosine triphosphate and phosphocreatine (PCr). Dynamic phosphorus magnetic resonance spectroscopy is a noninvasive tool that quantifies in vivo muscle energetics by measuring the kinetics of PCr recovery after exertion. We tested the hypothesis that intravenous iron repletion in chronic HF enhances skeletal muscle energetics as reflected by shorter PCr recovery half-times (PCr t1/2) on phosphorus magnetic resonance spectroscopy. METHODS: We enrolled 40 patients (50% anemic) with chronic HF, New York Heart Association class ≥II, left ventricular ejection fraction ≤45%, and iron deficiency (ferritin<100 μg/L or 100-300 μg/L with transferrin saturation <20%). Subjects underwent stratified (anemic versus nonanemic) randomization (1:1) to a single, double-blinded, total dose infusion of iron isomaltoside or saline placebo with end points reassessed early at 2 weeks posttreatment to minimize confounding from exercise adaptation. The primary end point was PCr t1/2 at 2 weeks. Secondary end points included ADP recovery half-time (ADP t1/2; energetic marker), iron status, symptoms, Hb, exercise capacity, and safety. RESULTS: In the total population, treatment groups were similar at baseline. At 2 weeks, iron isomaltoside improved PCr t1/2 (adjusted difference, -6.8 s; 95% CI, 11.5 to -2.1; P=0.006), ADP t1/2 (-5.3 s; 95% CI, -9.7 to -0.9; P=0.02), ferritin (304 ng/mL; 95% CI, 217-391; P<0.0001), transferrin saturation (6.8%; 95% CI, 2.7-10.8; P=0.002), New York Heart Association class (-0.23; 95% CI, -0.46 to -0.01; P=0.04), resting respiratory rate (-0.7 breaths/min; 95% CI, -1.2 to -0.2; P=0.009), and postexercise Borg dyspnea score (-2.0; 95% CI, -3.7 to -0.3; P=0.04), but not Hb (2.4 g/L; 95% CI, -3.5 to 8.4; P=0.41). Adverse events were similar between groups. In subgroup analyses, iron isomaltoside improved PCr t1/2 in anemic (-8.4 s; 95% CI, -16.7 to -0.2; P=0.04) and nonanemic (-5.2 s; 95% CI, -10.6 to 0.2; P=0.06) cohorts. CONCLUSIONS: In patients with chronic HF and iron deficiency, a total repletion dose of iron isomaltoside given at a single sitting is well tolerated and associated with faster skeletal muscle PCr t1/2 at 2 weeks, implying better mitochondrial function. Augmented skeletal muscle energetics might therefore be an important mechanism via which iron repletion confers benefits in chronic HF despite minimal Hb changes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005592-13/GB . Unique identifier: EudraCT 2012-005592-13."},{"id":"a688763fc4b7","type":"article","url":"https://hartvaat.nl/2019/05/14/ecls-bij-cardiogene-shock-na-acuut-mi/","title":"ECLS bij cardiogene shock na acuut MI","title_en":"Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.02.044","source_url":"https://doi.org/10.1016/j.jacc.2019.02.044","authors":["Stefan Brunner","Sabina P W Guenther","Korbinian Lackermair","Sven Peterss","Martin Orban","Anne-Laure Boulesteix","Sebastian Michel","Jörg Hausleiter","Steffen Massberg","Christian Hagl"],"significance":6,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study examined extracorporeal life support (VA-ECMO) in cardiogenic shock complicating acute MI, characterizing outcomes and identifying predictors of survival with this rescue therapy.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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 naar extracorporele levenondersteuning bij cardiogene shock na acuut myocardinfarct. ECMO als reddingstherapie.","abstract_original":""},{"id":"47ad1e0653ab","type":"article","url":"https://hartvaat.nl/2019/05/14/rivaroxaban-plus-aspirine-bij-vaatlijden-met-nierdisfunctie-compass/","title":"Rivaroxaban plus aspirine bij vaatlijden met nierdisfunctie: COMPASS","title_en":"Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial.","category":"chronische nierziekte","category_label":"Nierziekte","professions":["cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.02.048","source_url":"https://doi.org/10.1016/j.jacc.2019.02.048","authors":["Keith A A Fox","John W Eikelboom","Olga Shestakovska","Stuart J Connolly","Kaj P Metsarinne","Salim Yusuf"],"significance":7,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/nierziekte-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/nierziekte/contrastmiddel-en-nierfunctie/"],"congress":"","summary_en":"This COMPASS subanalysis showed that low-dose rivaroxaban plus aspirin maintains favorable efficacy and safety in patients with vascular disease and renal dysfunction, supporting dual-pathway inhibition in the CKD population.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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":"COMPASS subanalyse bij patiënten met vaatlijden en nierdisfunctie. Werkzaamheid en veiligheid van laaggedoseerd rivaroxaban bij CKD.","abstract_original":"BACKGROUND: Chronic kidney disease is associated with an increased risk of both bleeding and ischemic cardiovascular events. OBJECTIVE: The purpose of this study was to determine the balance of risks and benefits from the dual pathway antithrombotic regimen (rivaroxaban 2.5 mg twice daily [bd] plus aspirin, compared with aspirin) in vascular patients with or without moderate renal dysfunction. METHODS: This was a secondary analysis of the COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) trial involving 27,395 patients with chronic coronary or peripheral artery disease. RESULTS: In COMPASS, 21,111 patients had an estimated glomerular filtration rate (GFR) at baseline of ≥60 ml/min, 6,276 had a GRF of <60 ml/min. Both the primary efficacy outcome (cardiovascular death, myocardial infarction, or stroke) and major bleeding were more frequent in those with renal dysfunction, and the frequency of these outcome events was inversely related to GFR. However, the primary outcome was consistently reduced with rivaroxaban 2.5 mg bd plus aspirin, irrespective of GFR category (GFR ≥60 ml/min, 3.5% rivaroxaban plus aspirin, 4.5% aspirin alone, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.64 to 0.90; GFR <60 ml/min, 6.4% rivaroxaban plus aspirin, 8.4% aspirin alone, HR: 0.75; 95% CI: 0.60 to 0.94). Major bleeding was more frequent with rivaroxaban 2.5 mg plus aspirin versus aspirin alone in those with GFR ≥60 ml/min (2.9% rivaroxaban plus aspirin, 1.6% aspirin alone, HR: 1.81; 95% CI: 1.44 to 2.28) and similarly in those with GFR <60 ml/min (3.9% rivaroxaban plus aspirin, 2.7% aspirin alone, HR: 1.47, 95% CI: 1.05 to 2.07). CONCLUSIONS: The benefits of the dual pathway COMPASS regimen (rivaroxaban 2.5 mg bd plus aspirin), versus aspirin alone, are preserved in patients with moderate renal dysfunction without evidence of an excess hazard of bleeding."},{"id":"24f30357b6a5","type":"article","url":"https://hartvaat.nl/2019/05/14/dabigatran-duale-therapie-met-ticagrelor-of-clopidogrel-na-pci-bij-af-re-dual-pc/","title":"Dabigatran duale therapie met ticagrelor of clopidogrel na PCI bij AF: RE-DUAL PCI","title_en":"Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["clopidogrel","trombocytenaggregatieremmers"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehz059","source_url":"https://doi.org/10.1093/eurheartj/ehz059","authors":["Jonas Oldgren","Philippe Gabriel Steg","Stefan H Hohnloser","Gregory Y H Lip","Takeshi Kimura","Matias Nordaby","Martina Brueckmann","Eva Kleine","Jurrien M Ten Berg","Deepak L Bhatt","Christopher P Cannon"],"significance":7,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This RE-DUAL PCI subanalysis compared outcomes of dabigatran dual therapy with ticagrelor versus clopidogrel as the P2Y12 inhibitor in AF patients after PCI, informing antiplatelet selection within the dual antithrombotic framework.","created":"2026-07-03T10:27:56Z","updated":"2026-07-03T13:27:08Z","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":"RE-DUAL PCI subanalyse naar dabigatran duale therapie met ticagrelor versus clopidogrel bij AF-patiënten na PCI.","abstract_original":"AIMS: After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment. METHODS AND RESULTS: In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10. CONCLUSION: The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel."},{"id":"07f85b1327c7","type":"article","url":"https://hartvaat.nl/2019/05/14/bmi-en-uitkomsten-bij-af-behandeld-met-edoxaban-of-warfarine-engage-af-timi-48/","title":"BMI en uitkomsten bij AF behandeld met edoxaban of warfarine: ENGAGE AF-TIMI 48","title_en":"Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["obesitas"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy861","source_url":"https://doi.org/10.1093/eurheartj/ehy861","authors":["Giuseppe Boriani","Christian T Ruff","Julia F Kuder","Minggao Shi","Hans J Lanz","Howard Rutman","Michele F Mercuri","Elliott M Antman","Eugene Braunwald","Robert P Giugliano"],"significance":5,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/edoxaban/"],"congress":"","summary_en":"This ENGAGE AF-TIMI 48 analysis showed that the relationship between BMI and outcomes in AF is complex, with both underweight and morbid obesity associated with worse prognosis, regardless of edoxaban versus warfarin treatment.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:08Z","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":"ENGAGE AF-TIMI 48 analyse naar de relatie tussen BMI en uitkomsten bij AF-patiënten op edoxaban of warfarine.","abstract_original":"AIMS: To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF). METHODS AND RESULTS: In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0-3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P < 0.0001), and death (HR 0.91, P < 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P < 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups. CONCLUSION: An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to >40."},{"id":"5a89334ff6d8","type":"article","url":"https://hartvaat.nl/2019/05/14/wanneer-doac-stoppen-voor-af-ablatie-multicenter-analyse/","title":"Wanneer DOAC stoppen vóór AF-ablatie? Multicenter analyse","title_en":"When is it appropriate to stop non-vitamin K antagonist oral anticoagulants before catheter ablation of atrial fibrillation? A multicentre prospective randomized study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy870","source_url":"https://doi.org/10.1093/eurheartj/ehy870","authors":["Hee Tae Yu","Jaemin Shim","Junbeom Park","Tae-Hoon Kim","Jae-Sun Uhm","Jong-Youn Kim","Boyoung Joung","Moon-Hyoung Lee","Young-Hoon Kim","Hui-Nam Pak"],"significance":6,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doacs-overzicht/"],"congress":"","summary_en":"This multicenter study determined the optimal timing for stopping DOACs before catheter ablation for AF, providing practical guidance on the periprocedural DOAC management that minimizes both thrombotic and bleeding risk.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:08Z","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":"Multicenter studie naar het optimale tijdstip om DOAC's te stoppen vóór katheterablatie voor AF. Praktische periprocedurele aanbevelingen.","abstract_original":"AIMS: Although a recent expert consensus statement has recommended periprocedural uninterrupted (UI) non-vitamin K antagonist oral anticoagulants (NOACs) during catheter ablation of atrial fibrillation (AF) as a Class I indication, there have been no clear randomized trials. We investigated the safety and efficacy of UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs in patients undergoing AF ablation. METHODS AND RESULTS: In this prospective, open-label, randomized multicentre trial, 326 patients (75% male, 58 ± 11 years old) scheduled for AF catheter ablation were randomly assigned in a 1:1:1 ratio to UI, SDS, and 24S at three tertiary hospitals. Bridging with low molecular weight heparin was carried out in the patients with persistent AF who were assigned to the 24S group. Dabigatran, rivaroxaban, and apixaban were assigned in order after randomization. The primary endpoint was the incidence of bleeding events within 1 month after ablation. The secondary endpoints included thrombo-embolic and other procedure-related complications. The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139). The incidence of major bleeding up to 1 month after ablation and a post-procedural reduction in the haemoglobin levels did not significantly differ among the treatment groups and different NOACs (P > 0.05). There were no fatal events or thrombo-embolic complications in all the three groups. CONCLUSION: In patients undergoing AF ablation, UI NOACs and SDS or double dose skipped NOACs had a comparable efficacy and safety, regardless of the type of NOAC."},{"id":"83c8506256c2","type":"article","url":"https://hartvaat.nl/2019/05/14/verlaagde-dosis-doac-bij-af-werkzaamheid-en-veiligheid-meta-analyse/","title":"Verlaagde dosis DOAC bij AF: werkzaamheid en veiligheid — meta-analyse","title_en":"Efficacy and safety of reduced-dose non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: a meta-analysis of randomized controlled trials.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","huisarts"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy802","source_url":"https://doi.org/10.1093/eurheartj/ehy802","authors":["Kang-Ling Wang","Renato D Lopes","Manesh R Patel","Harry R Büller","Doreen Su-Yin Tan","Chern-En Chiang","Robert P Giugliano"],"significance":7,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/","https://hartvaat.nl/kennis/antistolling/doacs-overzicht/"],"congress":"","summary_en":"This meta-analysis evaluated the efficacy and safety of reduced-dose DOACs in AF patients, finding that appropriate dose reduction maintains effectiveness while reducing bleeding, but off-label underdosing may compromise stroke prevention.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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 naar de werkzaamheid en veiligheid van verlaagde DOAC-doseringen bij AF. Relevant voor dosisreductie-indicaties.","abstract_original":"AIMS: Non-vitamin K antagonist oral anticoagulants (NOACs) require dose reductions according to patient or clinical factors for patients with atrial fibrillation (AF). In this meta-analysis, we aimed to assess outcomes with reduced-dose NOACs when given as pre-specified in pivotal trials. METHODS AND RESULTS: Aggregated data abstracted from Phase III trials comparing NOACs with warfarin in patients with AF were assessed by treatment using risk ratios (RRs) and 95% confidence intervals (CIs) stratified by patient eligibility for NOAC dose reduction. Irrespective of treatments, annualized rates of stroke or systemic embolism and major bleeding were higher in patients eligible for reduced-dose NOACs than in those eligible for full-dose NOACs (2.70% vs. 1.60% and 4.35% vs. 2.87%, respectively). Effects of reduced-dose NOACs compared with warfarin in patients eligible for reduced-dose NOACs on stroke or systemic embolism [RR 0.84 (95% CI 0.69-1.03)] and on major bleeding [RR 0.70 (95% CI 0.50-0.97)] were consistent with those of full-dose NOACs relative to warfarin in those eligible for full-dose NOACs [RR 0.86 (95% CI 0.77-0.96) for stroke or systemic embolism and RR 0.87 (95% CI 0.70-1.08) for major bleeding; interaction P, 0.89 and 0.26, respectively]. In addition, NOACs were associated with reduced risks of haemorrhagic stroke, intracranial haemorrhage, fatal bleeding, and death regardless of patient eligibility for NOAC dose reduction (interaction P > 0.05 for each). CONCLUSIONS: Patients eligible for reduced-dose NOACs were at elevated risk of thromboembolic and haemorrhagic complications when treated with anticoagulants. NOACs, when appropriately dose-adjusted, had an improved benefit-harm profile compared with warfarin. Our findings highlight the importance of prescribing reduced-dose NOACs for indicated patient populations."},{"id":"c352ab8c91d3","type":"article","url":"https://hartvaat.nl/2019/05/14/edoxaban-bij-aziatische-af-patienten-concentraties-en-anti-xa-activiteit/","title":"Edoxaban bij Aziatische AF-patiënten: concentraties en anti-Xa activiteit","title_en":"Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["abelacimab","edoxaban"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy807","source_url":"https://doi.org/10.1093/eurheartj/ehy807","authors":["Tze-Fan Chao","Shih-Ann Chen","Christian T Ruff","Rose A Hamershock","Michele F Mercuri","Elliott M Antman","Eugene Braunwald","Robert P Giugliano"],"significance":5,"published":"2019-05-14","source_date":"2019-05-14","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/edoxaban/","https://hartvaat.nl/kennis/antistolling/coagulatiescascade/"],"congress":"","summary_en":"This ENGAGE AF-TIMI 48 analysis in Asian AF patients characterized edoxaban pharmacokinetics and anti-factor Xa activity, informing dosing considerations for the Asian population with potentially different drug metabolism.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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":"ENGAGE AF-TIMI 48 analyse bij Aziatische patiënten met AF naar edoxaban-concentraties en anti-factor Xa activiteit.","abstract_original":"AIMS: Prior studies suggested that the risks of ischaemic stroke and bleeding in patients of Asian race with atrial fibrillation (AF) may be higher than that of non-Asians. In the analysis of ENGAGE AF-TIMI 48 trial, we compared clinical outcomes, edoxaban concentration, and anti-factor Xa (anti-FXa) activity, between Asian and non-Asian races. METHODS AND RESULTS: There were 2909 patients of Asian race and 18 195 non-Asian race in the ENGAGE AF-TIMI 48 trial. The risks of thromboembolism and bleeding events were compared for Asians and non-Asians treated with warfarin. The trough levels of edoxaban concentration and anti-FXa activity were also compared and correlated with the efficacy and safety of edoxaban vs. warfarin. Compared to non-Asian patients, the Asian population was on average 2 years younger and 20 kg lighter. In the warfarin group, the adjusted risk of ischaemic stroke did not differ significantly for patients of Asian and non-Asian race [adjusted hazard ratio (aHR) = 1.12, P = 0.56). Asians treated with warfarin had a higher-adjusted risk of intracranial haemorrhage (ICH: aHR 1.71, P = 0.03) compared with non-Asians. The trough edoxaban concentration and anti-FXa activity were 20-25% lower for Asians compared with non-Asians. Compared to warfarin, higher dose edoxaban significantly reduced ICH while preserving the efficacy of stroke prevention in both Asians and non-Asians. Two of three net clinical outcomes appeared to be more favourably reduced with edoxaban in Asians compared with non-Asians (Pint = 0.063 for primary, 0.037 for secondary, and 0.032 for third net clinical outcomes, respectively). CONCLUSION: Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race."},{"id":"9929a09a0da1","type":"article","url":"https://hartvaat.nl/2019/05/07/zwangerschapsgewichtstoename-en-maternale-en-neonatale-uitkomsten-jama-meta-anal/","title":"Zwangerschapsgewichtstoename en maternale en neonatale uitkomsten: JAMA meta-analyse","title_en":"Association of Gestational Weight Gain With Adverse Maternal and Infant Outcomes.","category":"preventie","category_label":"Preventie","professions":["huisarts"],"tags":["zwangerschap-hart"],"journal":"JAMA","doi":"10.1001/jama.2019.3820","source_url":"https://doi.org/10.1001/jama.2019.3820","authors":["Ellis Voerman","Susana Santos","Hazel Inskip","Pilar Amiano","Henrique Barros","Marie-Aline Charles","Leda Chatzi","George P Chrousos","Eva Corpeleijn","Sarah Crozier","Myriam Doyon","Merete Eggesbø","Maria Pia Fantini","Sara Farchi","Francesco Forastiere","Vagelis Georgiu","Davide Gori","Wojciech Hanke","Irva Hertz-Picciotto","Barbara Heude","Marie-France Hivert","Daniel Hryhorczuk","Carmen Iñiguez","Anne M Karvonen","Leanne K Küpers","Hanna Lagström","Debbie A Lawlor","Irina Lehmann","Per Magnus","Renata Majewska","Johanna Mäkelä","Yannis Manios","Monique Mommers","Camilla S Morgen","George Moschonis","Ellen A Nohr","Anne-Marie Nybo Andersen","Emily Oken","Agnieszka Pac","Eleni Papadopoulou","Juha Pekkanen","Costanza Pizzi","Kinga Polanska","Daniela Porta","Lorenzo Richiardi","Sheryl L Rifas-Shiman","Nel Roeleveld","Luca Ronfani","Ana C Santos","Marie Standl","Hein Stigum","Camilla Stoltenberg","Elisabeth Thiering","Carel Thijs","Maties Torrent","Tomas Trnovec","Marleen M H J van Gelder","Lenie van Rossem","Andrea von Berg","Martine Vrijheid","Alet Wijga","Oleksandr Zvinchuk","Thorkild I A Sørensen","Keith Godfrey","Vincent W V Jaddoe","Romy Gaillard"],"significance":6,"published":"2019-05-07","source_date":"2019-05-07","image":"","kennis":[],"congress":"","summary_en":"This JAMA meta-analysis characterized the association between gestational weight gain and adverse maternal and infant outcomes, informing the optimal weight gain recommendations during pregnancy for cardiovascular risk reduction.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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":"JAMA meta-analyse naar de associatie van gewichtstoename tijdens de zwangerschap met maternale en neonatale uitkomsten.","abstract_original":"IMPORTANCE: Both low and high gestational weight gain have been associated with adverse maternal and infant outcomes, but optimal gestational weight gain remains uncertain and not well defined for all prepregnancy weight ranges. OBJECTIVES: To examine the association of ranges of gestational weight gain with risk of adverse maternal and infant outcomes and estimate optimal gestational weight gain ranges across prepregnancy body mass index categories. DESIGN, SETTING, AND PARTICIPANTS: Individual participant-level meta-analysis using data from 196 670 participants within 25 cohort studies from Europe and North America (main study sample). Optimal gestational weight gain ranges were estimated for each prepregnancy body mass index (BMI) category by selecting the range of gestational weight gain that was associated with lower risk for any adverse outcome. Individual participant-level data from 3505 participants within 4 separate hospital-based cohorts were used as a validation sample. Data were collected between 1989 and 2015. The final date of follow-up was December 2015. EXPOSURES: Gestational weight gain. MAIN OUTCOMES AND MEASURES: The main outcome termed any adverse outcome was defined as the presence of 1 or more of the following outcomes: preeclampsia, gestational hypertension, gestational diabetes, cesarean delivery, preterm birth, and small or large size for gestational age at birth. RESULTS: Of the 196 670 women (median age, 30.0 years [quartile 1 and 3, 27.0 and 33.0 years] and 40 937 were white) included in the main sample, 7809 (4.0%) were categorized at baseline as underweight (BMI <18.5); 133 788 (68.0%), normal weight (BMI, 18.5-24.9); 38 828 (19.7%), overweight (BMI, 25.0-29.9); 11 992 (6.1%), obesity grade 1 (BMI, 30.0-34.9); 3284 (1.7%), obesity grade 2 (BMI, 35.0-39.9); and 969 (0.5%), obesity grade 3 (BMI, ≥40.0). Overall, any adverse outcome occurred in 37.2% (n = 73 161) of women, ranging from 34.7% (2706 of 7809) among women categorized as underweight to 61.1% (592 of 969) among women categorized as obesity grade 3. Optimal gestational weight gain ranges were 14.0 kg to less than 16.0 kg for women categorized as underweight; 10.0 kg to less than 18.0 kg for normal weight; 2.0 kg to less than 16.0 kg for overweight; 2.0 kg to less than 6.0 kg for obesity grade 1; weight loss or gain of 0 kg to less than 4.0 kg for obesity grade 2; and weight gain of 0 kg to less than 6.0 kg for obesity grade 3. These gestational weight gain ranges were associated with low to moderate discrimination between those with and those without adverse outcomes (range for area under the receiver operating characteristic curve, 0.55-0.76). Results for discriminative performance in the validation sample were similar to the corresponding results in the main study sample (range for area under the receiver operating characteristic curve, 0.51-0.79). CONCLUSIONS AND RELEVANCE: In this meta-analysis of pooled individual participant data from 25 cohort studies, the risk for adverse maternal and infant outcomes varied by gestational weight gain and across the range of prepregnancy weights. The estimates of optimal gestational weight gain may inform prenatal counseling; however, the optimal gestational weight gain ranges had limited predictive value for the outcomes assessed."},{"id":"689317a3a08b","type":"article","url":"https://hartvaat.nl/2019/05/07/sacubitril-valsartan-of-enalapril-bij-acuut-gedecompenseerd-hf-pioneer-hf-klinis/","title":"Sacubitril/valsartan of enalapril bij acuut gedecompenseerd HF: PIONEER-HF klinische uitkomsten","title_en":"Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["answer-hf","sacubitril-valsartan"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.039331","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.039331","authors":["David A Morrow","Eric J Velazquez","Adam D DeVore","Akshay S Desai","Carol I Duffy","Andrew P Ambrosy","Yared Gurmu","Kevin McCague","Ricardo Rocha","Eugene Braunwald"],"significance":7,"published":"2019-05-07","source_date":"2019-05-07","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/","https://hartvaat.nl/kennis/farmacologie/antiaritmica-farmacologie/"],"congress":"","summary_en":"This PIONEER-HF clinical outcomes analysis confirmed that sacubitril-valsartan initiated during heart failure hospitalization is safe with consistent benefits on heart failure events, supporting the in-hospital ARNI initiation strategy.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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":"PIONEER-HF klinische uitkomstanalyse die sacubitril/valsartan bevestigt als veilig en effectief bij in-hospital gestarte HF-patiënten.","abstract_original":""},{"id":"9b0ad4ad42f5","type":"article","url":"https://hartvaat.nl/2019/05/07/gezondheidsstatus-na-mitraclip-bij-hf-met-secundaire-mr-coapt/","title":"Gezondheidsstatus na MitraClip bij HF met secundaire MR: COAPT","title_en":"Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation: COAPT Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.02.010","source_url":"https://doi.org/10.1016/j.jacc.2019.02.010","authors":["Suzanne V Arnold","Khaja M Chinnakondepalli","John A Spertus","Elizabeth A Magnuson","Suzanne J Baron","Saibal Kar","D Scott Lim","Jacob M Mishell","William T Abraham","JoAnn A Lindenfeld","Michael J Mack","Gregg W Stone","David J Cohen"],"significance":7,"published":"2019-05-07","source_date":"2019-05-07","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This COAPT analysis showed that transcatheter mitral valve repair significantly improves patient-reported health status and quality of life in patients with heart failure and secondary mitral regurgitation, complementing the hard clinical endpoints.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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":"COAPT-analyse naar de gezondheidsstatus en kwaliteit van leven na transcatheter mitraalklepherstel. Patiëntgerapporteerde uitkomsten.","abstract_original":"BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) led to reduced heart failure (HF) hospitalizations and improved survival in patients with symptomatic HF and 3+ to 4+ secondary mitral regurgitation (MR) on maximally-tolerated medical therapy. Given the advanced age and comorbidities of these patients, improvement in health status is also an important treatment goal. OBJECTIVES: The purpose of this study was to understand the health status outcomes of patients with HF and 3+ to 4+ secondary MR treated with TMVr versus standard care. METHODS: The COAPT trial randomized patients with HF and 3+ to 4+ secondary MR to TMVr (n = 302) or standard care (n = 312). Health status was assessed at baseline and at 1, 6, 12, and 24 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey. The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0 to 100; higher = better; minimum clinically important difference = 5 points). RESULTS: At baseline, patients had substantially impaired health status (mean KCCQ-OS 52.4 ± 23.0). While health status was unchanged over time in the standard care arm, patients randomized to TMVr demonstrated substantial improvement in the KCCQ-OS at 1 month (mean between-group difference 15.9 points; 95% confidence interval [CI]: 12.3 to 19.5 points), with only slight attenuation of this benefit through 24 months (mean between-group difference 12.8 points; 95% CI: 7.5 to 18.2 points). At 24 months, 36.4% of TMVr patients were alive with a moderately large (≥10-point) improvement versus 16.6% of standard care patients (p < 0.001), for a number needed to treat of 5.1 patients (95% CI: 3.6 to 8.7 patients). TMVr patients also reported better generic health status at each timepoint (24-month mean difference in SF-36 summary scores: physical 3.6 points; 95% CI: 1.4 to 5.8 points; mental 3.6 points; 95% CI: 0.8 to 6.4 points). CONCLUSIONS: Among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079)."},{"id":"dfd936194109","type":"article","url":"https://hartvaat.nl/2019/05/04/plgf-voor-beoordeling-van-pre-eclampsie-lancet-parrot-stepped-wedge-trial/","title":"PlGF voor beoordeling van pre-eclampsie: Lancet PARROT stepped-wedge trial","title_en":"Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)33212-4","source_url":"https://doi.org/10.1016/S0140-6736(18)33212-4","authors":["Kate E Duhig","Jenny Myers","Paul T Seed","Jenie Sparkes","Jessica Lowe","Rachael M Hunter","Andrew H Shennan","Lucy C Chappell"],"significance":7,"published":"2019-05-04","source_date":"2019-05-04","image":"","kennis":[],"congress":"","summary_en":"The PARROT trial showed that placental growth factor-based testing for suspected preeclampsia reduces the time to diagnosis and improves clinical outcomes, supporting biomarker-guided management of hypertensive disorders of pregnancy.","created":"2026-07-03T10:27:55Z","updated":"2026-07-03T13:27:07Z","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":"Lancet PARROT-trial die placental growth factor onderzocht voor beoordeling van vrouwen met verdenking pre-eclampsie.","abstract_original":"BACKGROUND: Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes. METHODS: We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000-9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031. FINDINGS: Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the concealed testing group withdrew consent to follow-up data collection, so 446 (>99%) women in this group were included in the analyses. The median time to pre-eclampsia diagnosis was 4·1 days with concealed testing versus 1·9 days with revealed testing (time ratio 0·36, 95% CI 0·15-0·87; p=0·027). Maternal severe adverse outcomes were reported in 24 (5%) of 447 women in the concealed testing group versus 22 (4%) of 573 women in the revealed testing group (adjusted odds ratio 0·32, 95% CI 0·11-0·96; p=0·043), but there was no evidence of a difference in perinatal adverse outcomes (15% vs 14%, 1·45, 0·73-2·90) or gestation at delivery (36·6 weeks vs 36·8 weeks; mean difference -0·52, 95% CI -0·63 to 0·73). INTERPRETATION: We found that the availability of PlGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PlGF was implemented, we found a lower incidence of maternal adverse outcomes, consistent with adoption of targeted, enhanced surveillance, as recommended in the clinical management algorithm for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study. FUNDING: National Institute for Health Research."},{"id":"00b9c15e66e4","type":"article","url":"https://hartvaat.nl/2019/05/02/tavr-met-ballonexpandeerbare-klep-bij-laagrisicopatienten-nejm-partner-3/","title":"TAVR met ballonexpandeerbare klep bij laagrisicopatiënten: NEJM PARTNER 3","title_en":"Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1814052","source_url":"https://doi.org/10.1056/NEJMoa1814052","authors":["Michael J Mack","Martin B Leon","Vinod H Thourani","Raj Makkar","Susheel K Kodali","Mark Russo","Samir R Kapadia","S Chris Malaisrie","David J Cohen","Philippe Pibarot","Jonathon Leipsic","Rebecca T Hahn","Philipp Blanke","Mathew R Williams","James M McCabe","David L Brown","Vasilis Babaliaros","Scott Goldman","Wilson Y Szeto","Philippe Genereux","Ashish Pershad","Stuart J Pocock","Maria C Alu","John G Webb","Craig R Smith"],"significance":10,"published":"2019-05-02","source_date":"2019-05-02","image":"","kennis":[],"congress":"","summary_en":"The PARTNER 3 trial showed that TAVR with a balloon-expandable valve was superior to surgery for the composite of death, stroke, or rehospitalization at 1 year in patients with severe aortic stenosis at low surgical risk. This landmark result, alongside Evolut Low Risk, established TAVR as a viable alternative to surgery in virtually all aortic stenosis patients.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:07Z","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":"Landmark NEJM PARTNER 3-trial die TAVR met ballonexpandeerbare klep superieur toonde aan chirurgie bij laagrisicopatiënten. Samen met Evolut het definitieve bewijs.","abstract_original":"BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)."},{"id":"00431fd35882","type":"article","url":"https://hartvaat.nl/2019/05/02/tavr-met-zelfexpanderende-klep-bij-laagrisicopatienten-nejm-evolut-low-risk/","title":"TAVR met zelfexpanderende klep bij laagrisicopatiënten: NEJM Evolut Low Risk","title_en":"Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["ouderen","select-trial","summit-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1816885","source_url":"https://doi.org/10.1056/NEJMoa1816885","authors":["Jeffrey J Popma","G Michael Deeb","Steven J Yakubov","Mubashir Mumtaz","Hemal Gada","Daniel O'Hair","Tanvir Bajwa","John C Heiser","William Merhi","Neal S Kleiman","Judah Askew","Paul Sorajja","Joshua Rovin","Stanley J Chetcuti","David H Adams","Paul S Teirstein","George L Zorn","John K Forrest","Didier Tchétché","Jon Resar","Antony Walton","Nicolo Piazza","Basel Ramlawi","Newell Robinson","George Petrossian","Thomas G Gleason","Jae K Oh","Michael J Boulware","Hongyan Qiao","Andrew S Mugglin","Michael J Reardon"],"significance":10,"published":"2019-05-02","source_date":"2019-05-02","image":"","kennis":[],"congress":"","summary_en":"The Evolut Low Risk trial demonstrated that self-expanding TAVR was noninferior to surgical aortic-valve replacement in low-surgical-risk patients with severe aortic stenosis for the composite of death or disabling stroke at 24 months. Together with PARTNER 3, this trial extended TAVR as a treatment option across the full spectrum of surgical risk.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:07Z","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":"Landmark NEJM Evolut Low Risk-trial die TAVR uitbreidde naar laagrisicopatiënten met ernstige aortaklepstenose. Paradigmashift in de klepbehandeling.","abstract_original":"BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.)."},{"id":"70d6fd01f030","type":"article","url":"https://hartvaat.nl/2019/05/01/kwaliteitsverbetering-bij-acs-in-resource-beperkte-ziekenhuizen-jama-cardiology-/","title":"Kwaliteitsverbetering bij ACS in resource-beperkte ziekenhuizen: JAMA Cardiology China","title_en":"Effect of a Quality of Care Improvement Initiative in Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.0897","source_url":"https://doi.org/10.1001/jamacardio.2019.0897","authors":["Yangfeng Wu","Shenshen Li","Anushka Patel","Xian Li","Xin Du","Tao Wu","Yifei Zhao","Lin Feng","Laurent Billot","Eric D Peterson","Mark Woodward","Lingzhi Kong","Yong Huo","Dayi Hu","Kalipso Chalkidou","Runlin Gao"],"significance":6,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":[],"congress":"","summary_en":"This JAMA Cardiology trial evaluated a quality of care improvement initiative for ACS management in resource-constrained hospitals in China, testing whether structured quality programs can improve outcomes in less-resourced settings.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:07Z","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":"JAMA Cardiology trial naar kwaliteitsverbetering bij ACS in resource-beperkte ziekenhuizen in China.","abstract_original":"IMPORTANCE: Prior observational studies suggest that quality of care improvement (QCI) initiatives can improve the clinical outcomes of acute coronary syndrome (ACS). To our knowledge, this has never been demonstrated in a well-powered randomized clinical trial. OBJECTIVE: To determine whether a clinical pathway-based, multifaceted QCI intervention could improve clinical outcomes among patients with ACS in resource-constrained hospitals in China. DESIGN, SETTING, PARTICIPANTS: This large, stepped-wedge cluster randomized clinical trial was conducted in nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014. We excluded patients who died before or within 10 minutes of hospital arrival. We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5. INTERVENTIONS: The intervention included establishing a QCI team, training clinical staff, implementing ACS clinical pathways, sequential site performance assessment and feedback, online technical support, and patient education. The usual care was the control that was compared. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke. Secondary outcomes included 16 key performance indicators (KPIs) and the composite score developed from these KPIs. RESULTS: Of 29 346 patients (17 639 men [61%]; mean [SD] age for control, 64.1 [11.6] years; mean [SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14 809 (50.5%) were in the control period and 14 537 (49.5%) were in the intervention period. There was no significant difference in the incidence of in-hospital MACE between the intervention and control periods after adjusting for cluster and time effects (3.9% vs 4.4%; odds ratio, 0.93; 95% CI, 0.75-1.15; P = .52). The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge. No unexpected adverse events were reported. CONCLUSIONS AND RELEVANCE: Among resource-constrained Chinese hospitals, introducing a multifaceted QCI intervention had no significant effect on in-hospital MACE, although it improved a few of the care process indicators of evidence-based ACS management. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01398228."},{"id":"bd08020ffb14","type":"article","url":"https://hartvaat.nl/2019/05/01/kwaliteitsverbetering-en-evidence-based-prescriptie-bij-hoog-cv-risico-jama-card/","title":"Kwaliteitsverbetering en evidence-based prescriptie bij hoog CV-risico: JAMA Cardiology","title_en":"Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":["aperitif-trial","biomarkers-cardiovasculair","farmaco-economie","soul-trial"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.0649","source_url":"https://doi.org/10.1001/jamacardio.2019.0649","authors":["M Julia Machline-Carrion","Rafael Marques Soares","Lucas Petri Damiani","Viviane Bezerra Campos","Bruna Sampaio","Francisco H Fonseca","Maria Cristina Izar","Celso Amodeo","Octávio Marques Pontes-Neto","Juliana Yamashita Santos","Samara Pinheiro do Carmo Gomes","José Francisco Kerr Saraiva","Eduardo Ramacciotti","Pedro Gabriel de Melo Barros E Silva","Renato D Lopes","Nilton Brandão da Silva","Hélio Penna Guimarães","Leopoldo Piegas","Airton T Stein","Otávio Berwanger"],"significance":6,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/"],"congress":"","summary_en":"This JAMA Cardiology trial tested whether a multifaceted quality improvement intervention increases evidence-based treatment prescribing in high-risk cardiovascular patients in community practice.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:07Z","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":"JAMA Cardiology trial naar het effect van een kwaliteitsverbeteringsinterventie op het voorschrijven van evidence-based behandeling bij hoog CV-risicopatiënten.","abstract_original":"IMPORTANCE: Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice. OBJECTIVE: To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies. DESIGN, SETTING, AND PARTICIPANTS: In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018. INTERVENTIONS: Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice. MAIN OUTCOMES AND MEASURES: The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications. RESULTS: Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34). CONCLUSIONS AND RELEVANCE: Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02851732."},{"id":"06f62b158531","type":"article","url":"https://hartvaat.nl/2019/05/01/thoracoscopische-versus-katheterablatie-bij-af-langetermijn-fast-trial/","title":"Thoracoscopische versus katheterablatie bij AF: langetermijn FAST-trial","title_en":"Thoracoscopic vs. catheter ablation for atrial fibrillation: long-term follow-up of the FAST 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/euy325","source_url":"https://doi.org/10.1093/europace/euy325","authors":["Manuel Castellá","Dipak Kotecha","Charlotte van Laar","Lisette Wintgens","Yakir Castillo","Johannes Kelder","David Aragon","María Nuñez","Elena Sandoval","Aina Casellas","Lluís Mont","Wim Jan van Boven","Lucas V A Boersma","Bart P van Putte"],"significance":7,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":[],"congress":"","summary_en":"Long-term FAST trial follow-up comparing thoracoscopic with catheter ablation for atrial fibrillation showed sustained superior freedom from AF with the surgical approach, but at the cost of more procedural complications and longer recovery.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:06Z","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":"Langetermijnfollow-up van de FAST gerandomiseerde trial die thoracoscopische vergeleek met katheterablatie bij AF.","abstract_original":"AIMS: Our objectives were to compare effectiveness and long-term prognosis after epicardial thoracoscopic atrial fibrillation (AF) ablation vs. endocardial catheter ablation, in patients with prior failed catheter ablation or high risk of failure. METHODS AND RESULTS: Patients were randomized to thoracoscopic or catheter ablation, consisting of pulmonary vein isolation with optional additional lines (2007-2010). Patients were reassessed in 2016/2017, and those without documented AF recurrence underwent 7-day ambulatory electrocardiography. The primary rhythm outcome was recurrence of any atrial arrhythmia lasting >30 s. The primary clinical endpoint was a composite of death, myocardial infarction, or cerebrovascular event, analysed with adjusted Cox proportional hazard ratios (HRs). One hundred and 24 patients were randomized with 34% persistent AF and mean age 56 years. Arrhythmia recurrence was common at mean follow-up of 7.0 years, but substantially lower with thoracoscopic ablation: 34/61 (56%) compared with 55/63 (87%) with catheter ablation [adjusted HR 0.40, 95% confidence interval (CI) 0.25-0.64; P < 0.001]. Additional ablation procedures were performed in 8 patients (13%) compared with 31 (49%), respectively (P < 0.001). Eleven patients (19%) were on anti-arrhythmic drugs at end of follow-up with thoracoscopy vs. 24 (39%) with catheter ablation (P = 0.012). There was no difference in the composite clinical outcome: 9 patients (15%) in the thoracoscopy arm vs. 10 patients (16%) with catheter ablation (HR 1.11, 95% CI 0.40-3.10; P = 0.84). Pacemaker implantation was required in 6 patients (10%) undergoing thoracoscopy and 3 (5%) in the catheter group (P = 0.27). CONCLUSION: Thoracoscopic AF ablation demonstrated more consistent maintenance of sinus rhythm than catheter ablation, with similar long-term clinical event rates."},{"id":"30686cf5bbb7","type":"article","url":"https://hartvaat.nl/2019/05/01/frequente-premature-atriale-contracties-en-af-hersenischemie-en-mortaliteit-meta/","title":"Frequente premature atriale contracties en AF, hersenischemie en mortaliteit: meta-analyse","title_en":"Frequent premature atrial contractions are associated with atrial fibrillation, brain ischaemia, and mortality: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"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/euy276","source_url":"https://doi.org/10.1093/europace/euy276","authors":["Jelle C L Himmelreich","Wim A M Lucassen","Martijn Heugen","Patrick M M Bossuyt","Hanno L Tan","Ralf E Harskamp","Faridi S van Etten-Jamaludin","Henk C P M van Weert"],"significance":6,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis showed that frequent premature atrial contractions are associated with increased risk of AF, brain ischemia, and mortality, establishing PAC burden as a clinically meaningful risk marker beyond isolated benign ectopy.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die aantoont dat frequente PAC's geassocieerd zijn met AF, hersenischemie en mortaliteit. PAC-last als risicomarker.","abstract_original":"AIMS: Premature atrial contractions (PACs) are a common cardiac phenomenon, traditionally considered to be of little clinical significance. Recent studies, however, suggest that PACs are associated with atrial fibrillation (AF), as well as ischaemic stroke, transient ischaemic attack, and mortality. This systematic review aims to investigate the association between PACs on standard electrocardiogram (ECG) as well as PAC-count on Holter monitor and future detection of AF, brain ischaemia, and all-cause mortality in patients without a history of AF. METHODS AND RESULTS: We searched PubMed, Embase (OVID), and Cochrane Database of Systematic Reviews from inception through 11 April 2018 and performed a systematic review and meta-analysis. We assessed risk of bias using a modified Quality In Prognosis Studies tool. The primary expression of associations in meta-analysis was the unadjusted hazard ratio (HR) using a random effects model. We identified 33 eligible studies including 198 876 patients from Western and East Asian populations with mean age ranging 52-76 years. Frequent PACs on 24-48 h Holter was associated with AF [HR 2.96, 95% confidence interval (CI) 2.33-3.76; 15 cohorts, n = 16 613], first stroke (HR 2.54, 95% CI 1.68-3.83; 3 cohorts, n = 1468), and all-cause mortality (HR 2.14, 95% CI 1.94-2.37; 6 cohorts, n = 7571). There was insufficient evidence to conclude that presence of ≥1 PAC on standard 12-lead ECG is associated with future AF detection. CONCLUSION: In older patients without a history of AF, frequent PACs on 24-48 h Holter are significantly associated with AF, first stroke, and mortality."},{"id":"7b7cf091dcb3","type":"article","url":"https://hartvaat.nl/2019/05/01/walnotendieet-en-24-uurs-ambulante-bloeddruk-bij-ouderen/","title":"Walnotendieet en 24-uurs ambulante bloeddruk bij ouderen","title_en":"Effect of a Walnut Diet on Office and 24-Hour Ambulatory Blood Pressure in Elderly Individuals.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["ambulante-bloeddrukmeting"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12766","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12766","authors":["Mónica Domènech","Mercè Serra-Mir","Irene Roth","Tania Freitas-Simoes","Cinta Valls-Pedret","Montserrat Cofán","Anna López","Aleix Sala-Vila","Carlos Calvo","Sujatha Rajaram","Joan Sabaté","Emilio Ros"],"significance":5,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/bloeddrukmeting-thuismeting-abpm/","https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/"],"congress":"","summary_en":"This study showed that daily walnut consumption modestly reduces 24-hour ambulatory blood pressure in elderly individuals, supporting nut intake as a dietary component of cardiovascular prevention.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het effect van dagelijkse walnotenconsumptie op praktijk- en 24-uurs ambulante bloeddruk bij oudere volwassenen.","abstract_original":"Nut consumption lowers blood cholesterol and is associated with reduced cardiovascular disease, but effects on blood pressure (BP) are inconsistent. We assessed the 2-year effects of a walnut diet versus a control diet on office BP and 24-hours ambulatory BP in free-living elders participating in the Walnuts and Healthy Aging study, a randomized trial testing the effects of walnuts at ≈15% energy on age-related disorders. In a prespecified analysis, we enrolled 305 participants, of whom 236 (75%) completed the study (65% women; age, 69 years; 60% with mild hypertension). Walnuts were well tolerated, and compliance was >98%. Mean baseline office BP was 128/79 mm Hg. Adjusted changes from baseline in mean office systolic BP were -4.61 mm Hg (95% CI, -7.43 to -1.79 mm Hg) in the walnut group and -0.59 mm Hg (-3.38 to 2.21 mm Hg) in controls ( P=0.051). Respective changes in mean systolic 24-hour ambulatory BP were -3.86 mm Hg (CI, -5.45 to -2.26 mm Hg) and -2.00 mm Hg (CI, -3.58 to -0.42 mm Hg; P=0.111). No changes in diastolic BP were observed. In participants in the upper tertile of baseline 24-hour ambulatory systolic BP (>125 mm Hg), mean 2-year systolic 24-hour BP was -8.5 mm Hg (CI, -12 to -5.0 mm Hg) in the walnut group and -2.5 mm Hg (CI, -6.3 to 1.3 mm Hg) in controls ( P=0.034). During the trial, participants in the walnut group required less uptitration of antihypertensive medication and had better overall BP regulation than controls. Walnut consumption reduces systolic BP in elderly subjects, particularly in those with mild hypertension. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01634841 ."},{"id":"62704d3527e7","type":"article","url":"https://hartvaat.nl/2019/05/01/inflammatiemarkers-en-risico-op-hypertensie-meta-analyse-van-cohortstudies/","title":"Inflammatiemarkers en risico op hypertensie: meta-analyse van cohortstudies","title_en":"Inflammation markers and risk of developing hypertension: a meta-analysis of cohort studies.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["biomarkers-cardiovasculair","hs-crp","inflammatie"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314216","source_url":"https://doi.org/10.1136/heartjnl-2018-314216","authors":["Ahmad Jayedi","Kazem Rahimi","Leonelo E Bautista","Milad Nazarzadeh","Mahdieh Sadat Zargar","Sakineh Shab-Bidar"],"significance":7,"published":"2019-05-01","source_date":"2019-05-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/hypertensie-en-ckd/"],"congress":"","summary_en":"This meta-analysis of cohort studies showed that elevated inflammatory markers (CRP, IL-6, TNF-α) are independently associated with the future development of hypertension, establishing inflammation as a potential modifiable pathway in blood pressure elevation.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:06Z","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 die het verband onderzocht tussen inflammatiemarkers en het risico op het ontwikkelen van hypertensie. Inflammatie als oorzakelijke factor.","abstract_original":"OBJECTIVE: To systematically assess the association of circulating inflammation markers with the future risk of hypertension. METHODS: We did a systematic literature search of PubMed and Scopus, from database inception to July 10, 2018. Prospective and retrospective cohort studies evaluating the association of circulating C reactive protein (CRP), high-sensitive CRP (hs-CRP), interleukin 6 (IL-6) and IL-1β to the risk of developing hypertension in the general population were included. The relative risks (RRs) for the top versus bottom tertiles of circulating biomarkers were calculated using a fixed-effects/random-effects model. A potential non-linear dose-response association was tested. RESULTS: Fourteen prospective cohort studies, two retrospective cohort studies and five nested case-control studies involving 142 640 participants and 20 676 cases were identified. The RR for the third versus first tertiles of circulating CRP was 1.23 (95% CI 1.11 to 1.35; I2=59%, n=12). The association remained unchanged after adjustment for body mass index. The RRs for other biomarkers were as follows: hs-CRP (RR 1.20, 95% CI 1.02 to 1.37; I2=74%, n=7), IL-6 (RR 1.51, 95% CI 1.30 to 1.71; I2=0%, n=5), and IL-1β (RR 1.22, 95% CI 0.92 to 1.51; I2=0%, n=3). A non-linear dose-response meta-analysis demonstrated that the risk of hypertension increased linearly with increasing circulating inflammation markers, even within the low-risk and intermediate-risk categories. CONCLUSIONS: Higher levels of circulating CRP, hs-CRP and IL-6, but not IL-1β, were associated with the risk of developing hypertension. The association persisted in subgroups of studies defined by major sources of heterogeneity."},{"id":"275412de9015","type":"article","url":"https://hartvaat.nl/2019/04/30/leefstijl-hba1c-en-overleving-bij-stabiel-coronairlijden-met-diabetes/","title":"Leefstijl, HbA1c en overleving bij stabiel coronairlijden met diabetes","title_en":"Lifestyle, Glycosylated Hemoglobin A1c, and Survival Among Patients With Stable Ischemic Heart Disease and Diabetes.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","ezetimibe","obesitas","stabiel-coronairlijden","tirzepatide"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.067","source_url":"https://doi.org/10.1016/j.jacc.2018.11.067","authors":["G B John Mancini","David J Maron","Pamela M Hartigan","John A Spertus","William J Kostuk","Daniel S Berman","Koon K Teo","William S Weintraub","William E Boden"],"significance":6,"published":"2019-04-30","source_date":"2019-04-30","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/bloedsuikerdoelen-cardiovasculair/"],"congress":"","summary_en":"This study examined the interaction between lifestyle factors, HbA1c control, and survival in patients with stable coronary disease and diabetes, showing that comprehensive risk factor management provides additive benefit.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:06Z","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 naar de interactie van leefstijl en glycemische controle op overleving bij patiënten met stabiel coronairlijden en diabetes.","abstract_original":"BACKGROUND: The importance of glycosylated hemoglobin A1c (A1c) control as part of comprehensive risk factor management in patients with stable ischemic heart disease (SIHD) and diabetes mellitus (DM) is controversial. OBJECTIVES: The purpose of this study was to determine whether a greater number of controlled risk factors at 1 year, including A1c, affects survival in patients with DM and SIHD. METHODS: Of 690 patients with DM followed in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 592 (86%) had complete ascertainment of 7 pre-specified risk factors at baseline and after 1 year: systolic blood pressure, low-density lipoprotein cholesterol, nonsmoking, physical activity, diet adherence, body mass index, and A1c. The primary outcome measure was mortality beyond 1 year after randomization. RESULTS: During a mean follow-up of 7.0 ± 4.2 years beyond 1 year after randomization, 186 subjects died (31.4% overall, 4.5%/year). The greater the number of risk factors controlled at 1 year, the higher the probability of survival (unadjusted log rank p = 0.002). Compared with 0 to 1 controlled risk factors, attaining 3 to 7 goals predicted progressively lower mortality (hazard ratio for control of 6 or 7 risk factors was 0.13; 95% confidence interval: 0.05 to 0.40). Importantly, only 10.3% of subjects achieved control of 6 or 7 risk factors. In multivariate analysis, the strongest predictors of improved survival were no smoking, regular physical activity, dietary adherence, and A1c <7%. CONCLUSIONS: In this high-risk subset of SIHD patients with DM, the number of controlled risk factors, particularly lifestyle behaviors and A1c, were associated with improved survival. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657)."},{"id":"af435a889e28","type":"article","url":"https://hartvaat.nl/2019/04/30/ketonlichaam-3-hydroxybutyraat-bij-chronisch-hartfalen-cardiovasculaire-effecten/","title":"Ketonlichaam 3-hydroxybutyraat bij chronisch hartfalen: cardiovasculaire effecten","title_en":"Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.036459","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.036459","authors":["Roni Nielsen","Niels Møller","Lars C Gormsen","Lars Poulsen Tolbod","Nils Henrik Hansson","Jens Sorensen","Hendrik Johannes Harms","Jørgen Frøkiær","Hans Eiskjaer","Nichlas Riise Jespersen","Søren Mellemkjaer","Thomas Ravn Lassen","Kasper Pryds","Hans Erik Bøtker","Henrik Wiggers"],"significance":7,"published":"2019-04-30","source_date":"2019-04-30","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/harttransplantatie-indicaties/","https://hartvaat.nl/kennis/hartfalen/esc-richtlijn-hartfalen-2021/"],"congress":"","summary_en":"This study demonstrated that infusion of the ketone body 3-hydroxybutyrate improves cardiac output and left ventricular ejection fraction in patients with chronic heart failure, supporting the metabolic hypothesis that ketone utilization is a beneficial cardiac adaptation.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar de cardiovasculaire effecten van behandeling met het ketonlichaam 3-hydroxybutyraat bij chronisch hartfalen. Metabole therapie als nieuw concept.","abstract_original":"BACKGROUND: Myocardial utilization of 3-hydroxybutyrate (3-OHB) is increased in patients with heart failure and reduced ejection fraction (HFrEF). However, the cardiovascular effects of increased circulating plasma-3-OHB levels in these patients are unknown. Consequently, the authors' aim was to modulate circulating 3-OHB levels in HFrEF patients and evaluate: (1) changes in cardiac output (CO); (2) a potential dose-response relationship between 3-OHB levels and CO; (3) the impact on myocardial external energy efficiency (MEE) and oxygen consumption (MVO2); and (4) whether the cardiovascular response differed between HFrEF patients and age-matched volunteers. METHODS: Study 1: 16 chronic HFrEF patients (left ventricular ejection fraction: 37±3%) were randomized in a crossover design to 3-hour of 3-OHB or placebo infusion. Patients were monitored invasively with a Swan-Ganz catheter and with echocardiography. Study 2: In a dose-response study, 8 HFrEF patients were examined at increasing 3-OHB infusion rates. Study 3 to 4: 10 HFrEF patients and 10 age-matched volunteers were randomized in a crossover design to 3-hour 3-OHB or placebo infusion. MEE and MVO2 were evaluated using 11C-acetate positron emission tomography. RESULTS: 3-OHB infusion increased circulating levels of plasma 3-OHB from 0.4±0.3 to 3.3±0.4 mM ( P<0.001). CO rose by 2.0±0.2 L/min ( P<0.001) because of an increase in stroke volume of 20±2 mL ( P<0.001) and heart rate of 7±2 beats per minute (bpm) ( P<0.001). Left ventricular ejection fraction increased 8±1% ( P<0.001) numerically. There was a dose-response relationship with a significant CO increase of 0.3 L/min already at plasma-3-OHB levels of 0.7 mM ( P<0.001). 3-OHB increased MVO2 without altering MEE. The response to 3-OHB infusion in terms of MEE and CO did not differ between HFrEF patents and age-matched volunteers. CONCLUSIONS: 3-OHB has beneficial hemodynamic effects in HFrEF patients without impairing MEE. These beneficial effects are detectable in the physiological concentration range of circulating 3-OHB levels. The hemodynamic effects of 3-OHB were observed in both HFrEF patients and age-matched volunteers. 3-OHB may potentially constitute a novel treatment principle in HFrEF patients."},{"id":"7313684a4a20","type":"article","url":"https://hartvaat.nl/2019/04/30/empagliflozine-antihyperglycemische-en-bloeddrukeffecten-bij-zwarte-diabetespati/","title":"Empagliflozine: antihyperglycemische en bloeddrukeffecten bij zwarte diabetespatiënten","title_en":"Antihyperglycemic and Blood Pressure Effects of Empagliflozin in Black Patients With Type 2 Diabetes Mellitus and Hypertension.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","dapa-hf","diabetes-type-2","empagliflozine","emperor-trials"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.036568","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.036568","authors":["Keith C Ferdinand","Joseph L Izzo","Jisoo Lee","Leslie Meng","Jyothis George","Afshin Salsali","Leo Seman"],"significance":6,"published":"2019-04-30","source_date":"2019-04-30","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"This analysis of empagliflozin effects specifically in Black patients with type 2 diabetes and hypertension showed comparable blood pressure and glycemic benefits to the overall population, addressing racial representation in SGLT2 inhibitor evidence.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:06Z","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 van empagliflozine-effecten op glucose en bloeddruk specifiek bij zwarte patiënten met diabetes type 2 en hypertensie.","abstract_original":"BACKGROUND: Empagliflozin, a sodium-glucose cotransporter 2 inhibitor indicated for type 2 diabetes mellitus (T2DM), can lower blood pressure (BP) and reduce cardiovascular mortality in patients with T2DM and preexisting cardiovascular disease. Its effects in blacks have been understudied. METHODS: In this 24-week study, 150 blacks with T2DM and hypertension had glycohemoglobin (primary end point), office and 24-hour ambulatory BP, body weight, and safety assessments. After a 2-week, open-label, placebo run-in, patients were randomly assigned to once daily empagliflozin (10 mg for the first 4 weeks, then force-titrated to 25 mg until week 24) or placebo. A mixed-effects model for repeated measures was performed on the primary and 2 key secondary end points, and an analysis of covariance for nonrepeated measures with last observation carried forward was performed for 2 other key secondary end points. Hierarchical testing was applied for these end points. RESULTS: Overall, 52.7% of participants were men, mean (SD) age, 56.8 (9.3) years; mean duration of T2DM, 9.3 (7.1) years. The baseline values of key parameters (mean [SD]) were as follows: glycohemoglobin, 8.59 (1.02)%; ambulatory systolic BP, 146.3 (11.0) mm Hg; and ambulatory diastolic BP, 89.4 (8.1) mm Hg. By week 24, the mean (standard error) change in glycohemoglobin in the empagliflozin group was -0.77 (0.15%) in comparison with an increase of 0.07 (0.16%) in the placebo group; placebo-corrected difference, -0.78% (95% CI, -1.18 to -0.38; P=0.0002). Reductions in body weight by week 24 were -2.38 (0.38) empagliflozin and -0.80 (0.47) placebo; the placebo-corrected difference was -1.23 kg (95% CI, -2.39 to -0.07; P=0.0382). Empagliflozin significantly reduced 24-hour ambulatory systolic BP versus placebo by weeks 12 and 24 (placebo-corrected difference, -5.21 mm Hg [95% CI, -9.24 to -1.18; P=0.0117] and -8.39 mm Hg [95% CI, -13.74 to -3.04; P=0.0025], respectively). Diastolic BP was also reduced. CONCLUSIONS: In blacks with T2DM, empagliflozin reduced glycohemoglobin, body weight, and BP. The effect of empagliflozin on BP increased from 12 to 24 weeks, suggesting a full antihypertensive effect takes ≥6 months to be fully realized. At week 24, the placebo-subtracted BP effect was similar to standard antihypertensive monotherapies, suggesting that empagliflozin may be beneficial for this high-risk population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02182830."},{"id":"f84c1e3e623f","type":"article","url":"https://hartvaat.nl/2019/04/25/heartmate-3-lvad-definitief-rapport-nejm-momentum-3-final/","title":"HeartMate 3 LVAD — definitief rapport: NEJM MOMENTUM 3 final","title_en":"A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1900486","source_url":"https://doi.org/10.1056/NEJMoa1900486","authors":["Mandeep R Mehra","Nir Uriel","Yoshifumi Naka","Joseph C Cleveland","Melana Yuzefpolskaya","Christopher T Salerno","Mary N Walsh","Carmelo A Milano","Chetan B Patel","Steven W Hutchins","John Ransom","Gregory A Ewald","Akinobu Itoh","Nirav Y Raval","Scott C Silvestry","Rebecca Cogswell","Ranjit John","Arvind Bhimaraj","Brian A Bruckner","Brian D Lowes","John Y Um","Valluvan Jeevanandam","Gabriel Sayer","Abeel A Mangi","Ezequiel J Molina","Farooq Sheikh","Keith Aaronson","Francis D Pagani","William G Cotts","Antone J Tatooles","Ashok Babu","Don Chomsky","Jason N Katz","Paul B Tessmann","David Dean","Arun Krishnamoorthy","Joyce Chuang","Ia Topuria","Poornima Sood","Daniel J Goldstein"],"significance":9,"published":"2019-04-25","source_date":"2019-04-25","image":"","kennis":[],"congress":"","summary_en":"The final MOMENTUM 3 report confirmed the long-term superiority of the HeartMate 3 fully magnetically levitated LVAD over the HeartMate II, with sustained reductions in pump thrombosis, stroke, and reoperations. The data cemented HeartMate 3 as the definitive standard in mechanical circulatory support.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:06Z","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":"NEJM MOMENTUM 3 definitief rapport van de HeartMate 3 volledig magnetisch zwevende LVAD. Bevestigt de langetermijnsuperioriteit over HeartMate II.","abstract_original":"BACKGROUND: In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS: We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS: This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS: Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)."},{"id":"f8fe1a8ce563","type":"article","url":"https://hartvaat.nl/2019/04/23/hedendaagse-uitkomsten-na-cabg-voor-hoofdstamlijden/","title":"Hedendaagse uitkomsten na CABG voor hoofdstamlijden","title_en":"Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.12.090","source_url":"https://doi.org/10.1016/j.jacc.2018.12.090","authors":["Rodrigo Modolo","Ply Chichareon","Norihiro Kogame","Ovidiu Dressler","Aaron Crowley","Ori Ben-Yehuda","John Puskas","Adrian Banning","David P Taggart","A Pieter Kappetein","Joseph A Sabik","Yoshinobu Onuma","Gregg W Stone","Patrick W Serruys"],"significance":6,"published":"2019-04-23","source_date":"2019-04-23","image":"","kennis":[],"congress":"","summary_en":"This analysis of contemporary CABG outcomes for left main disease showed that surgical results continue to improve over time, informing the benchmark against which percutaneous intervention is compared.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:06Z","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 van hedendaagse uitkomsten na CABG specifiek voor linker-hoofdstamcoronairlijden in de context van de moderne chirurgische praktijk.","abstract_original":"BACKGROUND: Although results of percutaneous coronary intervention (PCI) have been steadily improving, whether surgical outcomes have improved over time is not fully elucidated. OBJECTIVES: This study sought to compare the current outcomes of patients undergoing coronary artery bypass grafting (CABG) with prior surgical results, in the context of randomized trials including the left main (LM) coronary artery stem. METHODS: The authors performed a propensity-matched analysis of patients randomized to CABG in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) (enrollment period 2005 to 2007) and EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) (enrollment period 2010 to 2014) trials. All patients had left main (LM) disease with or without multivessel disease. Adjustment was based on 15 clinical and angiographic variables, including anatomic SYNTAX score, with a 2:1 ratio for the EXCEL and SYNTAX trials, collectively analyzing 909 subjects (n = 580 and n = 329, respectively). The primary endpoint was the composite of all-cause death, myocardial infarction (MI), stroke, or ischemia-driven revascularization at 3 years. RESULTS: Baseline characteristics, anatomic SYNTAX score, number and types of grafts, and duration of hospitalization for the procedures were similar in both groups. CABG procedures in the EXCEL compared with the SYNTAX trial were more often off-pump (29.6% vs. 15.4%; p < 0.001), and guideline-directed medical therapies were used more frequently in the EXCEL surgical cohort. The primary endpoint occurred in 14.0% and 20.9% (p = 0.008) of patients in the EXCEL and SYNTAX trials, respectively. With the exception of MI (4.1% vs. 3.7%), all nonhierarchical events tended to contribute to the improved outcomes in the more recent trial: all-cause death (5.5% vs. 8.5%), stroke (3.1% vs. 5.1%), and ischemia-driven revascularization (7.1% vs. 9.4%) in the EXCEL and SYNTAX trials, respectively. CONCLUSIONS: Over a 5- to 7-year period, significant improvement in event-free survival after surgical revascularization for LM disease at 3 years was noted between the SYNTAX and EXCEL trials, consistent with improving results with cardiac surgery over time. (Synergy Between PCI With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972; Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)."},{"id":"78c17ee26929","type":"article","url":"https://hartvaat.nl/2019/04/23/implanteerbaar-cardiaal-alertsysteem-voor-vroege-herkenning-van-stemi/","title":"Implanteerbaar cardiaal alertsysteem voor vroege herkenning van STEMI","title_en":"Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["icd-implantatie","stemi"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.01.014","source_url":"https://doi.org/10.1016/j.jacc.2019.01.014","authors":["C Michael Gibson","David Holmes","Ghiath Mikdadi","Dale Presser","David Wohns","Megan K Yee","Andrew Kaplan","Allen Ciuffo","Arthur L Eberly","Bruce Iteld","Mitchell W Krucoff"],"significance":6,"published":"2019-04-23","source_date":"2019-04-23","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/peripartum-cardiomyopathie/"],"congress":"","summary_en":"This study evaluated an implantable cardiac alert system for early STEMI recognition, testing whether continuous ECG monitoring with automated alerts can reduce the time to treatment in acute coronary syndromes.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:05Z","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 naar een implanteerbaar cardiaal alertsysteem voor vroege herkenning van STEMI. Technologische innovatie voor snellere behandeling.","abstract_original":"BACKGROUND: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. OBJECTIVES: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. METHODS: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. RESULTS: Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). CONCLUSIONS: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)."},{"id":"a177a902b3cd","type":"article","url":"https://hartvaat.nl/2019/04/23/glp-1-agonisten-versus-sglt2-remmers-voor-cv-en-renale-preventie-vergelijkende-m/","title":"GLP-1-agonisten versus SGLT2-remmers voor CV- en renale preventie: vergelijkende meta-analyse","title_en":"Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["cardiorenal-behandelstrategie","glp1-agonisten","glp1-semaglutide-cardiovasculair","semaglutide","sglt2-remmers","tirzepatide"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038868","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038868","authors":["Thomas A Zelniker","Stephen D Wiviott","Itamar Raz","KyungAh Im","Erica L Goodrich","Remo H M Furtado","Marc P Bonaca","Ofri Mosenzon","Eri T Kato","Avivit Cahn","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","John P H Wilding","Marc S Sabatine"],"significance":9,"published":"2019-04-23","source_date":"2019-04-23","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This comparative meta-analysis showed that GLP-1 receptor agonists predominantly reduce atherosclerotic events (MI, stroke) while SGLT2 inhibitors primarily reduce heart failure hospitalization and renal outcomes. The distinct benefit profiles support tailored drug selection based on individual patient comorbidities.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:05Z","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":"Vergelijkende meta-analyse van GLP-1-agonisten versus SGLT2-remmers voor preventie van cardiovasculaire en renale events. Head-to-head vergelijking van beide klassen.","abstract_original":"BACKGROUND: Glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) have emerged as 2 new classes of antihyperglycemic agents that also reduce cardiovascular risk. The relative benefits in patients with and without established atherosclerotic cardiovascular disease for different outcomes with these classes of drugs remain undefined. METHODS: We performed a systematic review and trial-level meta-analysis of GLP1-RA and SGLT2i cardiovascular outcomes trials using the PubMed and EMBASE databases (Excerpta Medica Database). The primary outcomes were the composite of myocardial infarction, stroke, and cardiovascular death (MACE); hospitalization for heart failure; and progression of kidney disease. RESULTS: In total, data from 8 trials and 77 242 patients, 42 920 (55.6%) in GLP1-RA trials, and 34 322 (44.4%) in SGLT2i trials, were included. Both drug classes reduced MACE in a similar magnitude with GLP1-RA reducing the risk by 12% (hazard ratio [HR], 0.88; 95% CI, 0.84-0.94; P<0.001) and SGLT2i by 11% (HR, 0.89; 95% CI, 0.83-0.96; P=0.001). For both drug classes, this treatment effect was restricted to a 14% reduction in those with established atherosclerotic cardiovascular disease (HR, 0.86; 95% CI, 0.80-0.93; P=0.002), whereas no effect was seen in patients without established atherosclerotic cardiovascular disease (HR, 1.01; 95% CI, 0.87-1.19; P=0.81; P interaction, 0.028). SGLT2i reduced hospitalization for heart failure by 31% (HR, 0.69; 95% CI, 0.61-0.79; P<0.001), whereas GLP1-RA did not have a significant effect (HR, 0.93; 95% CI, 0.83-1.04; P=0.20). Both GLP1-RA (HR, 0.82; 95% CI, 0.75-0.89; P<0.001) and SGLT2i (HR, 0.62; 95% CI, 0.58-0.67; P<0.001) reduced the risk of progression of kidney disease including macroalbuminuria, but only SGLT2i reduced the risk of worsening estimated glomerular filtration rate, end-stage kidney disease, or renal death (HR, 0.55; 95% CI, 0.48-0.64; P<0.001). CONCLUSIONS: In trials reported to date, GLP1-RA and SGLT2i reduce atherosclerotic MACE to a similar degree in patients with established atherosclerotic cardiovascular disease, whereas SGLT2i have a more marked effect on preventing hospitalization for heart failure and progression of kidney disease. Their distinct clinical benefit profiles should be considered in the decision-making process when treating patients with type 2 diabetes mellitus."},{"id":"18be7e958ad8","type":"article","url":"https://hartvaat.nl/2019/04/18/antitrombotische-therapie-na-acs-of-pci-bij-af-nejm-augustus/","title":"Antitrombotische therapie na ACS of PCI bij AF: NEJM AUGUSTUS","title_en":"Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1817083","source_url":"https://doi.org/10.1056/NEJMoa1817083","authors":["Renato D Lopes","Gretchen Heizer","Ronald Aronson","Amit N Vora","Tyler Massaro","Roxana Mehran","Shaun G Goodman","Stephan Windecker","Harald Darius","Jia Li","Oleg Averkov","M Cecilia Bahit","Otavio Berwanger","Andrzej Budaj","Ziad Hijazi","Alexander Parkhomenko","Peter Sinnaeve","Robert F Storey","Holger Thiele","Dragos Vinereanu","Christopher B Granger","John H Alexander"],"significance":10,"published":"2019-04-18","source_date":"2019-04-18","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"The AUGUSTUS trial, using a 2×2 factorial design, demonstrated that apixaban was superior to warfarin (less bleeding) and aspirin offered no ischemic benefit over placebo in patients with atrial fibrillation after ACS or PCI. This trial definitively established dual therapy with a DOAC plus a P2Y12 inhibitor as the preferred antithrombotic strategy.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:05Z","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":"Landmark NEJM AUGUSTUS-trial — 2x2 factorieel: apixaban vs VKA en aspirine vs placebo bij AF-patiënten met ACS of PCI. Definitieve trial voor het duale versus triple therapiedebat.","abstract_original":"BACKGROUND: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. METHODS: In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. RESULTS: Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group. CONCLUSIONS: In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.)."},{"id":"54a7c1e1a9df","type":"article","url":"https://hartvaat.nl/2019/04/18/vroege-of-uitgestelde-cardioversie-bij-recent-onset-af-nejm-race-7-acwas/","title":"Vroege of uitgestelde cardioversie bij recent-onset AF: NEJM RACE 7 ACWAS","title_en":"Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1900353","source_url":"https://doi.org/10.1056/NEJMoa1900353","authors":["Nikki A H A Pluymaekers","Elton A M P Dudink","Justin G L M Luermans","Joan G Meeder","Timo Lenderink","Jos Widdershoven","Jeroen J J Bucx","Michiel Rienstra","Otto Kamp","Jurren M Van Opstal","Marco Alings","Anton Oomen","Charles J Kirchhof","Vincent F Van Dijk","Hemanth Ramanna","Anho Liem","Lukas R Dekker","Brigitte A B Essers","Jan G P Tijssen","Isabelle C Van Gelder","Harry J G M Crijns"],"significance":9,"published":"2019-04-18","source_date":"2019-04-18","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"The RACE 7 ACWAS trial showed that a wait-and-see approach was noninferior to immediate cardioversion for achieving sinus rhythm at 4 weeks in patients with recent-onset symptomatic atrial fibrillation. The results support expectant management as a viable initial strategy in hemodynamically stable patients.","created":"2026-07-03T10:27:53Z","updated":"2026-07-03T13:27:05Z","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":"NEJM RACE 7 ACWAS-trial die aantoonde dat een wait-and-see benadering non-inferieur is aan onmiddellijke cardioversie bij recent-onset AF. Veranderde het acute AF-beleid.","abstract_original":"BACKGROUND: Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.)."},{"id":"3713964a6425","type":"article","url":"https://hartvaat.nl/2019/04/14/aki-en-bloedingen-en-mortaliteit-na-radiale-versus-femorale-toegang-bij-acs/","title":"AKI en bloedingen en mortaliteit na radiale versus femorale toegang bij ACS","title_en":"Association of acute kidney injury and bleeding events with mortality after radial or femoral access in patients with acute coronary syndrome undergoing invasive management: secondary analysis of a randomized clinical trial.","category":"chronische nierziekte","category_label":"Nierziekte","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy860","source_url":"https://doi.org/10.1093/eurheartj/ehy860","authors":["Martina Rothenbühler","Marco Valgimigli","Ayodele Odutayo","Enrico Frigoli","Sergio Leonardi","Pascal Vranckx","Maurizio Turturo","Luciano Moretti","Francesco Amico","Lucia Uguccioni","Marco Contarini","Joan Antoni Gómez-Hospital","Vicente Mainar","Manuela Creaco","Anna Sonia Petronio","Alberto Cremonesi","Corrado Tamburino","Claudio Fresco","Roberto Bonmassari","José Francisco Díaz Fernández","Enrico Romagnoli","Jan Beyersmann","Dik Heg","Peter Jüni"],"significance":5,"published":"2019-04-14","source_date":"2019-04-14","image":"","kennis":[],"congress":"","summary_en":"This MATRIX analysis showed that acute kidney injury and bleeding events are both associated with mortality after ACS, and that radial access reduces both complications compared with femoral access.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:05Z","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 naar de associatie van acute nierschade en bloedingen met mortaliteit na radiale versus femorale toegang bij ACS.","abstract_original":"AIMS: In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. METHODS AND RESULTS: We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49). CONCLUSION: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding."},{"id":"ad4263be1e24","type":"article","url":"https://hartvaat.nl/2019/04/11/coronairangiografie-na-hartstilstand-zonder-st-elevatie-nejm-coact/","title":"Coronairangiografie na hartstilstand zonder ST-elevatie: NEJM COACT","title_en":"Coronary Angiography after Cardiac Arrest without ST-Segment Elevation.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["acuut-hartfalen","hartkatheterisatie"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1816897","source_url":"https://doi.org/10.1056/NEJMoa1816897","authors":["Jorrit S Lemkes","Gladys N Janssens","Nina W van der Hoeven","Lucia S D Jewbali","Eric A Dubois","Martijn Meuwissen","Tom A Rijpstra","Hans A Bosker","Michiel J Blans","Gabe B Bleeker","Rémon Baak","Georgios J Vlachojannis","Bob J W Eikemans","Pim van der Harst","Iwan C C van der Horst","Michiel Voskuil","Joris J van der Heijden","Albertus Beishuizen","Martin Stoel","Cyril Camaro","Hans van der Hoeven","José P Henriques","Alexander P J Vlaar","Maarten A Vink","Bas van den Bogaard","Ton A C M Heestermans","Wouter de Ruijter","Thijs S R Delnoij","Harry J G M Crijns","Gillian A J Jessurun","Pranobe V Oemrawsingh","Marcel T M Gosselink","Koos Plomp","Michael Magro","Paul W G Elbers","Peter M van de Ven","Heleen M Oudemans-van Straaten","Niels van Royen"],"significance":9,"published":"2019-04-11","source_date":"2019-04-11","image":"","kennis":[],"congress":"","summary_en":"The COACT trial demonstrated that immediate coronary angiography did not improve 90-day survival compared with delayed angiography in patients resuscitated from cardiac arrest without ST-segment elevation. The findings argued against routine emergent catheterization in this population.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:05Z","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":"NEJM COACT-trial die onmiddellijke coronairangiografie vergeleek met uitgestelde angiografie na hartstilstand zonder ST-elevatie. Geen voordeel van onmiddellijke strategie.","abstract_original":"BACKGROUND: Ischemic heart disease is a major cause of out-of-hospital cardiac arrest. The role of immediate coronary angiography and percutaneous coronary intervention (PCI) in the treatment of patients who have been successfully resuscitated after cardiac arrest in the absence of ST-segment elevation myocardial infarction (STEMI) remains uncertain. METHODS: In this multicenter trial, we randomly assigned 552 patients who had cardiac arrest without signs of STEMI to undergo immediate coronary angiography or coronary angiography that was delayed until after neurologic recovery. All patients underwent PCI if indicated. The primary end point was survival at 90 days. Secondary end points included survival at 90 days with good cerebral performance or mild or moderate disability, myocardial injury, duration of catecholamine support, markers of shock, recurrence of ventricular tachycardia, duration of mechanical ventilation, major bleeding, occurrence of acute kidney injury, need for renal-replacement therapy, time to target temperature, and neurologic status at discharge from the intensive care unit. RESULTS: At 90 days, 176 of 273 patients (64.5%) in the immediate angiography group and 178 of 265 patients (67.2%) in the delayed angiography group were alive (odds ratio, 0.89; 95% confidence interval [CI], 0.62 to 1.27; P = 0.51). The median time to target temperature was 5.4 hours in the immediate angiography group and 4.7 hours in the delayed angiography group (ratio of geometric means, 1.19; 95% CI, 1.04 to 1.36). No significant differences between the groups were found in the remaining secondary end points. CONCLUSIONS: Among patients who had been successfully resuscitated after out-of-hospital cardiac arrest and had no signs of STEMI, a strategy of immediate angiography was not found to be better than a strategy of delayed angiography with respect to overall survival at 90 days. (Funded by the Netherlands Heart Institute and others; COACT Netherlands Trial Register number, NTR4973.)."},{"id":"87d16669e574","type":"article","url":"https://hartvaat.nl/2019/04/09/rood-vlees-en-cardiovasculaire-risicofactoren-meta-analyse-van-gerandomiseerde-t/","title":"Rood vlees en cardiovasculaire risicofactoren: meta-analyse van gerandomiseerde trials","title_en":"Meta-Analysis of Randomized Controlled Trials of Red Meat Consumption in Comparison With Various Comparison Diets on Cardiovascular Risk Factors.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":["aperitif-trial","biomarkers-cardiovasculair","diabetes-type-2","farmaco-economie","figaro-dkd","inflammatie","ouderen","roken","slaapapneu"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.035225","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.035225","authors":["Marta Guasch-Ferré","Ambika Satija","Stacy A Blondin","Marie Janiszewski","Ester Emlen","Lauren E O'Connor","Wayne W Campbell","Frank B Hu","Walter C Willett","Meir J Stampfer"],"significance":7,"published":"2019-04-09","source_date":"2019-04-09","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/preventie/levenslang-cardiovasculair-risico/"],"congress":"","summary_en":"This meta-analysis of randomized trials comparing red meat consumption with various alternative diets found that red meat consumption does not significantly worsen cardiovascular risk factors compared with high-quality plant protein sources, challenging some dietary guidelines.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:05Z","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 van gerandomiseerde trials die roodvleesconsumptie vergeleek met diverse vergelijkingsdiëten op cardiovasculaire risicofactoren.","abstract_original":"BACKGROUND: Findings among randomized controlled trials evaluating the effect of red meat on cardiovascular disease risk factors are inconsistent. We provide an updated meta-analysis of randomized controlled trials on red meat and cardiovascular risk factors and determine whether the relationship depends on the composition of the comparison diet, hypothesizing that plant sources would be relatively beneficial. METHODS: We conducted a systematic PubMed search of randomized controlled trials published up until July 2017 comparing diets with red meat with diets that replaced red meat with a variety of foods. We stratified comparison diets into high-quality plant protein sources (legumes, soy, nuts); chicken/poultry/fish; fish only; poultry only; mixed animal protein sources (including dairy); carbohydrates (low-quality refined grains and simple sugars, such as white bread, pasta, rice, cookies/biscuits); or usual diet. We performed random-effects meta-analyses comparing differences in changes of blood lipids, apolipoproteins, and blood pressure for all studies combined and stratified by specific comparison diets. RESULTS: Thirty-six studies totaling 1803 participants were included. There were no significant differences between red meat and all comparison diets combined for changes in blood concentrations of total, low-density lipoprotein, or high-density lipoprotein cholesterol, apolipoproteins A1 and B, or blood pressure. Relative to the comparison diets combined, red meat resulted in lesser decreases in triglycerides (weighted mean difference [WMD], 0.065 mmol/L; 95% CI, 0.000-0.129; P for heterogeneity <0.01). When analyzed by specific comparison diets, relative to high-quality plant protein sources, red meat yielded lesser decreases in total cholesterol (WMD, 0.264 mmol/L; 95% CI, 0.144-0.383; P<0.001) and low-density lipoprotein (WMD, 0.198 mmol/L; 95% CI, 0.065-0.330; P=0.003). In comparison with fish, red meat yielded greater decreases in low-density lipoprotein (WMD, -0.173 mmol/L; 95% CI, -0.260 to -0.086; P<0.001) and high-density lipoprotein (WMD, -0.065 mmol/L; 95% CI, -0.109 to -0.020; P=0.004). In comparison with carbohydrates, red meat yielded greater decreases in triglycerides (WMD, -0.181 mmol/L; 95% CI, -0.349 to -0.013). CONCLUSIONS: Inconsistencies regarding the effects of red meat on cardiovascular disease risk factors are attributable, in part, to the composition of the comparison diet. Substituting red meat with high-quality plant protein sources, but not with fish or low-quality carbohydrates, leads to more favorable changes in blood lipids and lipoproteins."},{"id":"31acfca515c2","type":"article","url":"https://hartvaat.nl/2019/04/09/sham-gecontroleerde-rct-s-van-renale-denervatie-meta-analyse/","title":"Sham-gecontroleerde RCT's van renale denervatie: meta-analyse","title_en":"Sham-Controlled Randomized Trials of Catheter-Based Renal Denervation in Patients With Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["fidelity","radiance-htn","renale-denervatie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.12.082","source_url":"https://doi.org/10.1016/j.jacc.2018.12.082","authors":["Partha Sardar","Deepak L Bhatt","Ajay J Kirtane","Kevin F Kennedy","Saurav Chatterjee","Jay Giri","Peter A Soukas","William B White","Sahil A Parikh","Herbert D Aronow"],"significance":8,"published":"2019-04-09","source_date":"2019-04-09","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This meta-analysis of sham-controlled renal denervation trials confirmed a significant blood pressure reduction with catheter-based renal denervation versus sham procedures. By including only rigorously designed studies, the analysis provided the most definitive evidence for the biological efficacy of renal denervation.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:05Z","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 van uitsluitend sham-gecontroleerde gerandomiseerde trials van katheter-gebaseerde renale denervatie. Definitief bewijs in het strengste studieontwerp.","abstract_original":"BACKGROUND: There are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension. OBJECTIVES: The purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials. METHODS: Databases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis. RESULTS: The analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD -3.65 mm Hg, 95% CI: -5.33 to -1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD -4.07 mm Hg, 95% CI: -6.46 to -1.68; p < 0.001), office systolic BP (WMD -5.53 mm Hg, 95% CI: -8.18 to -2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD -1.71 mm Hg, 95% CI: -3.06 to -0.35; p = 0.01), daytime ambulatory diastolic BP (WMD -1.57 mm Hg, 95% CI: -2.73 to -0.42; p = 0.008), and office diastolic BP (WMD -3.37 mm Hg, 95% CI: -4.86 to -1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13). CONCLUSIONS: RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension."},{"id":"c102e28a59d6","type":"article","url":"https://hartvaat.nl/2019/04/09/cabg-of-stenting-bij-hoofdstamlijden-bij-diabetes/","title":"CABG of stenting bij hoofdstamlijden bij diabetes","title_en":"Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","perifeer-vaatlijden","soul-trial"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.01.037","source_url":"https://doi.org/10.1016/j.jacc.2019.01.037","authors":["Milan Milojevic","Patrick W Serruys","Joseph F Sabik","David E Kandzari","Erick Schampaert","Ad J van Boven","Ferenc Horkay","Imre Ungi","Samer Mansour","Adrian P Banning","David P Taggart","Manel Sabaté","Anthony H Gershlick","Andrzej Bochenek","Jose Pomar","Nicholas J Lembo","Nicolas Noiseux","John D Puskas","Aaron Crowley","Ioanna Kosmidou","Roxana Mehran","Ori Ben-Yehuda","Philippe Généreux","Stuart J Pocock","Charles A Simonton","Gregg W Stone","Arie Pieter Kappetein"],"significance":7,"published":"2019-04-09","source_date":"2019-04-09","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This EXCEL subanalysis examined outcomes of CABG versus stenting for left main disease specifically in patients with diabetes, investigating whether diabetes modifies the relative benefit of surgical versus percutaneous revascularization.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:04Z","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 naar CABG versus stenting bij linker-hoofdstamcoronairlijden specifiek bij diabetespatiënten. Diabetes als modificator van de revascularisatiekeuze.","abstract_original":"BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)."},{"id":"b3a640459336","type":"article","url":"https://hartvaat.nl/2019/04/02/inspanningsrevalidatie-bij-hf-ipd-meta-analyse-van-inspanningscapaciteit-en-qol/","title":"Inspanningsrevalidatie bij HF: IPD meta-analyse van inspanningscapaciteit en QoL","title_en":"Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.12.072","source_url":"https://doi.org/10.1016/j.jacc.2018.12.072","authors":["Rod S Taylor","Sarah Walker","Neil A Smart","Massimo F Piepoli","Fiona C Warren","Oriana Ciani","David Whellan","Christopher O'Connor","Steven J Keteyian","Andrew Coats","Constantinos H Davos","Hasnain M Dalal","Kathleen Dracup","Lorraine S Evangelista","Kate Jolly","Jonathan Myers","Birgitta B Nilsson","Claudio Passino","Miles D Witham","Gloria Y Yeh"],"significance":7,"published":"2019-04-02","source_date":"2019-04-02","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This individual patient data meta-analysis of exercise-based cardiac rehabilitation in heart failure confirmed significant improvements in exercise capacity and quality of life, with the benefit consistent across HFrEF and HFpEF phenotypes.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:04Z","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":"Individuele patiëntdata meta-analyse naar het effect van inspanningsrevalidatie op inspanningscapaciteit en kwaliteit van leven bij hartfalen.","abstract_original":"BACKGROUND: Previous systematic reviews have indicated that exercise-based cardiac rehabilitation (ExCR) for patients with heart failure (HF) has a beneficial effect on health-related quality-of-life (HRQoL) and exercise capacity. However, there is uncertainty regarding potential differential effects of ExCR across HF patient subgroups. OBJECTIVES: The authors sought to undertake an individual participant data (IPD) meta-analysis to: 1) assess the impact of ExCR on HRQoL and exercise capacity in patients with HF; and 2) investigate differential effects of ExCR according to a range of patient characteristics: age, sex, ethnicity, New York Heart Association functional class, ischemic etiology, ejection fraction, and exercise capacity. METHODS: A single dataset was produced, comprising randomized trials where ExCR (delivered for 3 weeks or more) was compared with a no exercise control group. Each trial provided IPD on HRQoL or exercise capacity (or both), with follow-up of 6 months or more. One- and 2-stage meta-analysis models were used to investigate the effect of ExCR overall and the interactions between ExCR and participant characteristics. RESULTS: IPD was obtained from 13 trials for 3,990 patients, predominantly (97%) with reduced ejection fraction HF. Compared with the control group, there was a statistically significant difference in favor of ExCR for HRQoL and exercise capacity. At 12-month follow-up, improvements were seen in 6-min walk test (mean 21.0 m; 95% confidence interval: 1.57 to 40.4 m; p = 0.034) and Minnesota Living With HF score (mean improvement 5.9; 95% confidence interval: 1.0 to 10.9; p = 0.018). No consistent evidence was found of differential intervention effects across patient subgroups. CONCLUSIONS: These results, based on an IPD meta-analysis of randomized trials, confirm the benefit of ExCR on HRQoL and exercise capacity and support the Class I recommendation of current international clinical guidelines that ExCR should be offered to all HF patients. (Exercise Training for Chronic Heart Failure [ExTraMATCH II]: protocol for an individual participant data meta-analysis; PROSPERO: international database of systematic reviews CRD42014007170)."},{"id":"7d68f6b23856","type":"article","url":"https://hartvaat.nl/2019/04/02/katheterablatie-versus-antiaritmica-bij-af-mortaliteit-en-cva-jama-cabana/","title":"Katheterablatie versus antiaritmica bij AF: mortaliteit en CVA: JAMA CABANA","title_en":"Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.0693","source_url":"https://doi.org/10.1001/jama.2019.0693","authors":["Douglas L Packer","Daniel B Mark","Richard A Robb","Kristi H Monahan","Tristram D Bahnson","Jeanne E Poole","Peter A Noseworthy","Yves D Rosenberg","Neal Jeffries","L Brent Mitchell","Greg C Flaker","Evgeny Pokushalov","Alexander Romanov","T Jared Bunch","Georg Noelker","Andrey Ardashev","Amiran Revishvili","David J Wilber","Riccardo Cappato","Karl-Heinz Kuck","Gerhard Hindricks","D Wyn Davies","Peter R Kowey","Gerald V Naccarelli","James A Reiffel","Jonathan P Piccini","Adam P Silverstein","Hussein R Al-Khalidi","Kerry L Lee"],"significance":9,"published":"2019-04-02","source_date":"2019-04-02","image":"","kennis":[],"congress":"","summary_en":"The CABANA trial found no significant difference between catheter ablation and drug therapy for the primary endpoint of death, stroke, bleeding, or cardiac arrest in patients with atrial fibrillation in the intention-to-treat analysis. However, per-protocol analysis and subsequent analyses suggested ablation superiority, fueling the ongoing debate.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:04Z","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":"JAMA CABANA hoofdtrial die katheterablatie vergeleek met antiaritmische medicatie op mortaliteit, CVA, bloeding en hartstilstand bij AF. Intention-to-treat neutraal, per-protocol significant.","abstract_original":"IMPORTANCE: Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. OBJECTIVE: To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. DESIGN, SETTING, AND PARTICIPANTS: The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. INTERVENTIONS: The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. MAIN OUTCOMES AND MEASURES: The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. RESULTS: Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P < .001). CONCLUSIONS AND RELEVANCE: Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00911508."},{"id":"7dc4b195fbae","type":"article","url":"https://hartvaat.nl/2019/04/02/katheterablatie-versus-medicamenteus-bij-af-en-kwaliteit-van-leven-jama-cabana-q/","title":"Katheterablatie versus medicamenteus bij AF en kwaliteit van leven: JAMA CABANA QoL","title_en":"Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.0692","source_url":"https://doi.org/10.1001/jama.2019.0692","authors":["Daniel B Mark","Kevin J Anstrom","Shubin Sheng","Jonathan P Piccini","Khaula N Baloch","Kristi H Monahan","Melanie R Daniels","Tristram D Bahnson","Jeanne E Poole","Yves Rosenberg","Kerry L Lee","Douglas L Packer"],"significance":8,"published":"2019-04-02","source_date":"2019-04-02","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/","https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"The CABANA quality-of-life analysis showed that catheter ablation produced significantly greater improvements in quality of life compared with medical therapy in patients with atrial fibrillation, even though the intention-to-treat primary endpoint was neutral. The result highlighted the symptomatic benefit of ablation.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:04Z","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":"JAMA CABANA QoL-analyse die superieure kwaliteit-van-levenverbetering met katheterablatie versus medicamenteuze therapie aantoonde bij AF.","abstract_original":"IMPORTANCE: Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain. OBJECTIVE: To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF. DESIGN, SETTING, AND PARTICIPANTS: An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017. INTERVENTIONS: Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096). MAIN OUTCOMES AND MEASURES: Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points). RESULTS: Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). CONCLUSIONS AND RELEVANCE: Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00911508."},{"id":"ce1951dd97e9","type":"article","url":"https://hartvaat.nl/2019/04/02/pci-bij-chronische-totale-occlusie-gerandomiseerde-decision-cto-trial/","title":"PCI bij chronische totale occlusie: gerandomiseerde DECISION-CTO trial","title_en":"Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.031313","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.031313","authors":["Seung-Whan Lee","Pil Hyung Lee","Jung-Min Ahn","Duk-Woo Park","Sung-Cheol Yun","Seungbong Han","Heejun Kang","Soo-Jin Kang","Young-Hak Kim","Cheol Whan Lee","Seong-Wook Park","Seung Ho Hur","Seung-Woon Rha","Sung-Ho Her","Si Wan Choi","Bong-Ki Lee","Nae-Hee Lee","Jong-Young Lee","Sang-Sig Cheong","Moo Hyun Kim","Young-Keun Ahn","Sang Wook Lim","Sang-Gon Lee","Shirish Hiremath","Teguh Santoso","Wasan Udayachalerm","Jun Jack Cheng","David J Cohen","Toshiya Muramatsu","Etsuo Tsuchikane","Yasushi Asakura","Seung-Jung Park"],"significance":7,"published":"2019-04-02","source_date":"2019-04-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/esc-richtlijn-chronisch-coronairlijden-2024/"],"congress":"","summary_en":"The DECISION-CTO trial comparing PCI with optimal medical therapy for chronic total occlusions was stopped early due to slow enrollment and showed no significant difference in clinical outcomes, reflecting the ongoing uncertainty about the clinical value of CTO recanalization.","created":"2026-07-03T10:27:52Z","updated":"2026-07-03T13:27:04Z","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 DECISION-CTO trial die PCI vergeleek met optimale medicamenteuze therapie bij chronische totale occlusies.","abstract_original":"BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051."},{"id":"8f7ba879d0ff","type":"article","url":"https://hartvaat.nl/2019/04/02/cangrelor-en-gemalen-ticagrelor-bij-stemi-met-primaire-pci/","title":"Cangrelor en gemalen ticagrelor bij STEMI met primaire PCI","title_en":"Platelet Inhibition With Cangrelor and Crushed Ticagrelor in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038317","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038317","authors":["Francesco Franchi","Fabiana Rollini","Andrea Rivas","Mustafa Wali","Maryuri Briceno","Malhar Agarwal","Zubair Shaikh","Ahmed Nawaz","Gabriel Silva","Latonya Been","Ramez Smairat","Marc Kaufman","Andres M Pineda","Siva Suryadevara","Daniel Soffer","Martin M Zenni","Theodore A Bass","Dominick J Angiolillo"],"significance":5,"published":"2019-04-02","source_date":"2019-04-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study characterized platelet inhibition with the combination of intravenous cangrelor and crushed oral ticagrelor in STEMI patients, testing a dual rapid-onset antiplatelet strategy for primary PCI.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:04Z","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 naar plaatjesremming met cangrelor plus gemalen ticagrelor bij STEMI-patiënten die primaire PCI ondergaan.","abstract_original":"BACKGROUND: The platelet inhibitory effects induced by oral P2Y12 receptor antagonists are delayed in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (P-PCI). In turn, this leads to a gap in platelet inhibition, exposing patients to an increased risk of early thrombotic complications and underscoring the need to define strategies associated with more effective platelet inhibition in the peri-primary percutaneous coronary intervention period. Cangrelor is an intravenous P2Y12 inhibitor with prompt and potent antiplatelet effects. However, to date, there are limited data on the effects of cangrelor used in combination with ticagrelor in patients undergoing primary percutaneous coronary intervention. Moreover, questions have emerged on the potential for drug-drug interactions during the transition from cangrelor to oral P2Y12 inhibitors. METHODS: This was a prospective, randomized, double-blind, placebo-controlled pharmacodynamic study conducted in patients undergoing primary percutaneous coronary intervention (n=50) who were randomized to treatment with either cangrelor or matching placebo (bolus followed by 2-hour infusion). All patients received ticagrelor 180-mg loading dose administered as crushed tablets at the time of cangrelor/placebo bolus administration. Pharmacodynamic analyses were performed at 8 time points. Pharmacodynamic effects were measured as P2Y12 reaction units by VerifyNow and platelet reactivity index by vasodilator-stimulated phosphoprotein. RESULTS: Compared with placebo, cangrelor was associated with reduced P2Y12 reaction units as early as 5 minutes after bolus, which persisted during the entire duration of drug infusion, including at 30 minutes (63 [32-93] versus 214 [183-245]; mean difference, 152 [95% CI, 108-195]; P<0·001; primary end point). Parallel findings were shown with platelet reactivity index. Accordingly, high on-treatment platelet reactivity rates were reduced with cangrelor. After discontinuation of cangrelor/placebo infusion, there were no differences in levels of platelet reactivity between groups, ruling out a drug-drug interaction when cangrelor and ticagrelor are concomitantly administered. CONCLUSIONS: In patients undergoing primary percutaneous coronary intervention, cangrelor is an effective strategy to bridge the gap in platelet inhibition associated with the use of oral P2Y12 inhibition induced by ticagrelor. Ticagrelor can be administered as a crushed formulation concomitantly with cangrelor without any apparent drug-drug interaction. The clinical implications of these pharmacodynamic findings warrant investigation in an adequately powered clinical trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03247738."},{"id":"050004102336","type":"article","url":"https://hartvaat.nl/2019/04/01/ffr-verbetering-na-pci-en-uitkomsten-inclusief-symptoomverlichting/","title":"FFR-verbetering na PCI en uitkomsten inclusief symptoomverlichting","title_en":"Association of Improvement in Fractional Flow Reserve With Outcomes, Including Symptomatic Relief, After Percutaneous Coronary Intervention.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.0175","source_url":"https://doi.org/10.1001/jamacardio.2019.0175","authors":["Stephane Fournier","Giovanni Ciccarelli","Gabor G Toth","Anastasios Milkas","Panagiotis Xaplanteris","Pim A L Tonino","William F Fearon","Nico H J Pijls","Emanuele Barbato","Bernard De Bruyne"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This analysis demonstrated that improvement in fractional flow reserve after PCI is associated with better clinical outcomes and symptomatic relief, providing evidence that physiological optimization translates to patient benefit.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:04Z","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":"JAMA Cardiology analyse naar de associatie tussen FFR-verbetering na PCI en klinische uitkomsten inclusief symptoomverlichting.","abstract_original":"IMPORTANCE: Whether the improvement in myocardial perfusion provided by percutaneous coronary intervention (PCI) is associated with symptomatic relief or improved outcomes has not been well investigated. OBJECTIVE: To investigate the prognostic value of the improvement in fractional flow reserve (FFR) after PCI (ΔFFR) on patients' symptoms and 2-year outcomes. DESIGN, SETTING, AND PARTICIPANTS: This study is a post hoc analysis of data from patients undergoing FFR-guided PCI in the randomized clinical trials Fractional Flow Reserve vs Angiography for Multivessel Evaluation (FAME) 1 (NCT00267774; 2009) and FAME 2 (NCT01132495; 2012), with inclusion of 2 years of follow-up data. The FAME 1 trial included patients with multivessel coronary artery disease from 20 medical centers in Europe and the United States. The FAME 2 trial included patients with stable coronary artery disease involving up to 3 vessels from 28 sites in Europe and North America. Lesions from the group in the FAME 1 trial from whom FFR was measured and the group in the FAME 2 trial who received FFR-guided PCI plus medical therapy were analyzed. Data analysis occurred from May 2017 to May 2018. INTERVENTIONS: Measure of post-PCI FFR. MAIN OUTCOMES AND MEASURES: Vessel-oriented clinical events at 2 years, a composite of cardiac death, target vessel-associated myocardial infarction, and target vessel revascularization. RESULTS: This analysis included 639 patients from whom pre-PCI and post-PCI FFR values were available. Of their 837 lesions, 277 were classified into the lowest tertile (ΔFFR≤0.18), 282 into the middle tertile (0.19≤ΔFFR≤0.31), and 278 into the highest tertile (ΔFFR>0.31). Vessel-oriented clinical events were significantly more frequent in the lowest tertile (n = 25 of 277 [9.1%]) compared with the highest tertile (n = 13 of 278 [4.7%]; hazard ratio, 2.01 [95% CI, 1.03-3.92]; P = .04). In addition, a significant association was observed between ΔFFR and symptomatic relief (odds ratio, 1.33 [95% CI, 1.02-1.74]; P = .02). CONCLUSIONS AND RELEVANCE: In this analysis of 2 randomized clinical trials, the larger the improvement in FFR, the larger the symptomatic relief and the lower the event rate. This suggests that measuring FFR before and after PCI provides clinically useful information."},{"id":"c0b388b16854","type":"article","url":"https://hartvaat.nl/2019/04/01/initieel-en-serieel-crp-en-cv-events-en-dood-na-acs-jama-cardiology/","title":"Initieel en serieel CRP en CV-events en dood na ACS: JAMA Cardiology","title_en":"Association of Initial and Serial C-Reactive Protein Levels With Adverse Cardiovascular Events and Death After Acute Coronary Syndrome: A Secondary Analysis of the VISTA-16 Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2019.0179","source_url":"https://doi.org/10.1001/jamacardio.2019.0179","authors":["Preethi Mani","Rishi Puri","Gregory G Schwartz","Steven E Nissen","Mingyuan Shao","John J P Kastelein","Venu Menon","A Michael Lincoff","Stephen J Nicholls"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This analysis showed that both initial and serial CRP levels after ACS independently predict cardiovascular events and mortality, supporting inflammatory biomarker monitoring for residual risk assessment.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:04Z","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":"JAMA Cardiology analyse naar de associatie van initieel en serieel CRP met cardiovasculaire events en dood na ACS.","abstract_original":"IMPORTANCE: Higher baseline high-sensitivity C-reactive protein (hsCRP) levels after an acute coronary syndrome (ACS) are associated with adverse cardiovascular outcomes. The usefulness of serial hsCRP measurements for risk stratifying patients after ACS is not well characterized. OBJECTIVE: To assess whether longitudinal increases in hsCRP measurements during the 16 weeks after ACS are independently associated with a greater risk of a major adverse cardiac event (MACE), all-cause death, and cardiovascular death. DESIGN, SETTING, AND PARTICIPANTS: Secondary analysis of the double-blind, multicenter, randomized clinical Vascular Inflammation Suppression to Treat Acute Coronary Syndromes for 16 Weeks (VISTA-16) trial conducted between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012), which included 5145 patients from 362 academic and community hospitals in Europe, Australia, New Zealand, India, and North America assigned to receive varespladib or placebo on a background of atorvastatin treatment beginning within 96 hours of presentation with an ACS. The present study evaluated data from patients with available baseline and longitudinal hsCRP levels measured at weeks 1, 2, 4, 8, and 16 after randomization to treatment or placebo. Statistical analysis was performed from June 15, 2018, through September 15, 2018. MAIN OUTCOMES AND MEASURES: Outcomes were MACE (composite of cardiovascular death, myocardial infarction, nonfatal stroke, or unstable angina with documented ischemia requiring hospitalization), cardiovascular death, and all-cause death after adjustment for baseline clinical, treatment, and laboratory characteristics, including baseline hsCRP levels. RESULTS: Among 4257 patients in this study, 3141 (73.8%) were men and the mean age was 60.3 years (interquartile range [IQR], 53.5-67.8 years). The median 16-week low-density lipoprotein cholesterol level was 64.9 mg/dL (IQR, 50.3-82.3 mg/dL), and the median hsCRP level was 2.4 mg/L (IQR, 1.1-5.2 mg/L). On multivariable analysis, higher baseline hsCRP level (hazard ratio [HR], 1.36 [95% CI, 1.13-1.63]; P = .001) and higher longitudinal hsCRP level (HR, 1.15 [95% CI, 1.09-1.21]; P < .001) were independently associated with MACE. Similar significant and independent associations were shown between baseline and longitudinal hsCRP levels and cardiovascular death (baseline: HR, 1.61 per SD [95% CI, 1.07-2.41], P = .02; longitudinal: HR, 1.26 per SD [95% CI, 1.19-1.34], P < .001) and between baseline and longitudinal hsCRP levels and all-cause death (baseline: HR, 1.58 per SD [95% CI, 1.07-2.35], P = .02; longitudinal: HR, 1.25 per SD [95% CI, 1.18-1.32], P < .001). CONCLUSIONS AND RELEVANCE: Initial and subsequent increases in hsCRP levels during 16 weeks after ACS were associated with a greater risk of the combined MACE end point, cardiovascular death, and all-cause death despite established background therapies. Serial measurements of hsCRP during clinical follow-up after ACS may help to identify patients at higher risk for mortality and morbidity."},{"id":"2e665484caa2","type":"article","url":"https://hartvaat.nl/2019/04/01/lineaire-versus-focale-cfae-ablatie-bij-niet-paroxysmaal-af/","title":"Lineaire versus focale CFAE-ablatie bij niet-paroxysmaal AF","title_en":"Comparison between linear and focal ablation of complex fractionated atrial electrograms in patients with non-paroxysmal atrial fibrillation: a prospective 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/euy313","source_url":"https://doi.org/10.1093/europace/euy313","authors":["Kwang-No Lee","Jong-Il Choi","Yun Gi Kim","Suk-Kyu Oh","Dong-Hyeok Kim","Dae In Lee","Seung-Young Roh","Jin Hee Ahn","Jaemin Shim","Sang Weon Park","Young-Hoon Kim"],"significance":5,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This study compared linear with focal ablation of complex fractionated atrial electrograms in non-paroxysmal AF, evaluating two approaches to substrate modification beyond pulmonary vein isolation.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:04Z","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":"Vergelijking van lineaire versus focale ablatie van complexe gefractioneerde atriale elektrogrammen bij niet-paroxysmaal AF.","abstract_original":"AIMS: Findings regarding efficacy of substrate modification for non-paroxysmal atrial fibrillation (AF) are inconsistent. We prospectively compared clinical outcomes of complex fractionated atrial electrogram (CFAE)-guided focal ablation (CFA) and CFAE-guided linear ablation (CLA) in patients with non-paroxysmal AF. METHODS AND RESULTS: We randomized 150 patients with non-paroxysmal AF into CFA and CLA groups in a 1:1 ratio. Complex fractionated atrial electrogram distribution was evaluated using an automated algorithm of a three-dimensional mapping system. After pulmonary vein isolation (PVI), CFAE-guided ablation was performed in the left atrium and then in the right atrium (RA). When compared with conventional CFA, CLA was performed based on conventional lines, with additional lines. Atrial fibrillation was not induced after PVI alone or with cavotricuspid isthmus ablation in 20.7% of patients. To achieve the endpoint, additional CFAE-guided RA ablation was required in 42.7% and 36.0% of patients undergoing CFA and CLA, respectively (P = 0.403). Atrial fibrillation was terminated during CFAE-guided ablation in 72.9% and 75.0% of patients undergoing CFA and CLA, respectively (P = 0.792). Termination of atrial tachycardia (AT) or non-inducibility of AF/AT was achieved in 61.3% and 68.0% of patients undergoing CFA and CLA, respectively (P = 0.393). The CLA group showed decreased 1-year freedom from AF/AT recurrence (60.0%, CFA vs. 47.3%, CLA; log rank P = 0.085), but no significant difference throughout the follow-up (22.2 ± 21.0 months) (67.1%, CFA vs. 68.9%, CLA; log rank P = 0.298). CONCLUSION: Long-term efficacy of CFAE-guided ablation was unaffected by the ablation technique in patients with non-paroxysmal AF."},{"id":"40872e9c375f","type":"article","url":"https://hartvaat.nl/2019/04/01/pr-interval-en-pacingmodus-en-af-incidentie-bij-tweekamer-pacemaker/","title":"PR-interval en pacingmodus en AF-incidentie bij tweekamer pacemaker","title_en":"Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: a sub-study of the international randomized MINERVA trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["pacemaker"],"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/euy286","source_url":"https://doi.org/10.1093/europace/euy286","authors":["Giuseppe Boriani","Paolo Pieragnoli","Giovanni Luca Botto","Helmut Puererfellner","Lluis Mont","Matteo Ziacchi","Antonis S Manolis","Michele Gulizia","Raymond Tukkie","Maurizio Landolina","Giuseppe Ricciardi","Manuele Cicconelli","Andrea Grammatico","Mauro Biffi"],"significance":4,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"A MINERVA trial substudy evaluated how PR interval and pacing mode influence the incidence of persistent AF in dual-chamber pacemaker patients. The findings inform programming decisions between DDDR and managed ventricular pacing based on intrinsic AV conduction.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:03Z","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":"Substudie naar de invloed van PR-interval en pacingmodus op de incidentie van persisterend AF bij tweekamer pacemakerpatiënten.","abstract_original":"AIMS: Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients. METHODS AND RESULTS: In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: the risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP. CONCLUSION: Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing."},{"id":"6ed4e3e42ce7","type":"article","url":"https://hartvaat.nl/2019/04/01/upstream-therapie-verbetert-qol-bij-persisterend-af-arrest-af/","title":"Upstream therapie verbetert QoL bij persisterend AF: ARREST-AF","title_en":"Targeted therapy of underlying conditions improves quality of life in patients with persistent atrial fibrillation: results of the RACE 3 study.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"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/euy311","source_url":"https://doi.org/10.1093/europace/euy311","authors":["Ruben R De With","Michiel Rienstra","Marcelle D Smit","Bob Weijs","Victor W Zwartkruis","Anne H Hobbelt","Marco Alings","Jan G P Tijssen","Johan Brügemann","Bastiaan Geelhoed","Hans L Hillege","Raymond Tukkie","Martin E Hemels","Robert G Tieleman","Adelita V Ranchor","Dirk J Van Veldhuisen","Harry J G M Crijns","Isabelle C Van Gelder"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This ARREST-AF follow-up showed that targeted therapy of AF risk factors (obesity, fitness, sleep apnea) improves quality of life in patients with persistent AF, demonstrating patient-centered benefits of aggressive upstream management.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:03Z","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":"ARREST-AF follow-up die aantoont dat gerichte behandeling van onderliggende aandoeningen de kwaliteit van leven verbetert bij persisterend AF.","abstract_original":"AIMS: Atrial fibrillation (AF) reduces quality of life (QoL). We aim to evaluate effects of targeted therapy of underlying conditions on QoL in patients with AF and heart failure (HF). METHODS AND RESULTS: The Routine versus Aggressive risk factor driven upstream rhythm Control for prevention of Early atrial fibrillation in heart failure (RACE 3) study randomized patients with early persistent AF and HF to targeted or conventional therapy. Both groups received guideline-driven treatment. The targeted group received four additional therapies: mineralocorticoid receptor antagonists; statins; angiotensin converting enzyme inhibitors and/or receptor blockers; and cardiac rehabilitation including physical activity, dietary restrictions, and counselling. Quality of life was analysed in 230 patients at baseline and 1 year with available Medical Outcomes Study Short-Form Health Survey (SF-36), University of Toronto AF Severity Scale (AFSS) questionnaires, and European Heart Rhythm Association (EHRA) class. Improvements in SF-36 subscales were larger in the targeted group for physical functioning (Δ12 ± 19 vs. Δ6 ± 22, P = 0.007), physical role limitations (Δ32 ± 41 vs. Δ17 ± 45, P = 0.018), and general health (Δ8 ± 16 vs. Δ0 ± 17, P < 0.001). Dyspnoea at rest improved more (Δ-0.8 ± 1.3 vs. Δ-0.4 ± 1.2, P = 0.018) and EHRA class was lower at 1-year follow-up in the targeted group. Patients with AF at 1 year, improvement in physical functioning (Δ9 ± 9 vs. Δ-3 ± 16, P = 0.001), general health (Δ7 ± 16 vs. Δ-7 ± 19, P = 0.004), and social functioning (Δ6 ± 23 vs. Δ-4 ± 16, P = 0.041) were larger in the targeted group. CONCLUSION: A strategy aiming to treat underlying conditions improved QoL more compared with conventional therapy in patients with early persistent AF and HF. Its benefit was even observed in patients in AF at 1 year. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT00877643."},{"id":"b86feafe2d02","type":"article","url":"https://hartvaat.nl/2019/04/01/periprocedurele-antistolling-en-silent-stroke-na-af-ablatie/","title":"Periprocedurele antistolling en silent stroke na AF-ablatie","title_en":"Impact of periprocedural anticoagulation therapy on the incidence of silent stroke after atrial fibrillation ablation in patients receiving direct oral anticoagulants: uninterrupted vs. interrupted by one dose strategy.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["secundaire-preventie"],"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/euy224","source_url":"https://doi.org/10.1093/europace/euy224","authors":["Tomoyuki Nagao","Hitomi Suzuki","Syun Matsunaga","Yoshinori Nishikawa","Kazuhiro Harada","Kumiko Mamiya","Norihiro Shinoda","Ken Harada","Masataka Kato","Nobuyuki Marui","Tetsuya Amano","Yasuya Inden","Toyoaki Murohara"],"significance":5,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This study evaluated the impact of periprocedural anticoagulation strategy (uninterrupted vs interrupted DOAC) on silent stroke incidence after AF ablation, addressing a subtle but clinically relevant safety endpoint.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:03Z","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":"Studie naar de impact van periprocedurele antistollingstherapie op de incidentie van silent stroke na AF-ablatie.","abstract_original":"AIMS: Data on the comparison between uninterrupted and interrupted by one dose strategies for direct oral anticoagulant (DOAC) use during the periprocedural period of atrial fibrillation (AF) ablation are scarce. The purpose of this study is to investigate the feasibility of uninterrupted DOAC strategy by evaluating the incidence of silent stroke (SS) and perioperative trends in coagulation markers compared with the interrupted strategy. METHODS AND RESULTS: We randomly divided 200 consecutive patients receiving DOACs, who underwent AF ablation into uninterrupted group (UG = 100) and interrupted by one dose group (IG = 100). The rate of SS confirmed by post-operative magnetic resonance imaging and periprocedural trends in coagulation markers was investigated. A significant difference in SS incidence was found between the UG and IG (UG 4%, IG 17%, P < 0.005), although there were no differences in the rate of complications including bleeding and symptomatic thrombo-embolic events between the two groups. Intraoperative cardioversion [odds ratio (OR) 7.27, 95% confidence interval (CI) 1.76-30.0; P < 0.01] and the length of procedure time (OR 1.03, 95% CI 1.01-1.05; P < 0.05) independently predicted the occurrence of SS in the IG. A significant increase in prothrombin fragment 1 + 2 (PF1 + 2) values was observed in the IG compared with the UG on the operative and first post-operative days. CONCLUSION: Silent stroke incidence in the IG was significantly higher than that in the UG; this seems to be supported by the difference in PF1 + 2 values between the UG and IG. Intraoperative cardioversion and procedure time predicted the occurrence of SS in the IG."},{"id":"a67408351588","type":"article","url":"https://hartvaat.nl/2019/04/01/restrictieve-versus-liberale-transfusie-bij-hartchirurgie-meta-analyse/","title":"Restrictieve versus liberale transfusie bij hartchirurgie: meta-analyse","title_en":"Restrictive compared with liberal red cell transfusion strategies in cardiac surgery: a meta-analysis.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy435","source_url":"https://doi.org/10.1093/eurheartj/ehy435","authors":["Nadine Shehata","Nikhil Mistry","Bruno R da Costa","Tiago V Pereira","Richard Whitlock","Gerard F Curley","David A Scott","Gregory M T Hare","Peter Jüni","C David Mazer"],"significance":7,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This meta-analysis of restrictive versus liberal red blood cell transfusion strategies in cardiac surgery consolidated the evidence supporting restrictive thresholds, confirming that lower hemoglobin triggers do not compromise patient safety.","created":"2026-07-03T10:27:51Z","updated":"2026-07-03T13:27:03Z","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 van restrictief versus liberaal transfusiebeleid bij hartchirurgie. Consolideert het TRICS III-bewijs.","abstract_original":"AIMS: To determine whether a restrictive strategy of red blood cell (RBC) transfusion at lower haemoglobin concentrations is inferior to a liberal strategy of RBC transfusion at higher haemoglobin concentrations in patients undergoing cardiac surgery. METHODS AND RESULTS: We conducted a systematic review, meta-analysis, and trial sequential analysis of randomized controlled trials of the effect of restrictive and liberal RBC transfusion strategies on mortality within 30 days of surgery as the primary outcome. Secondary outcomes were those potentially resulting from anaemia-induced tissue hypoxia and transfusion outcomes. We searched the electronic databases MEDLINE, EMBASE, and the Cochrane Library until 17 November 2017. Thirteen trials were included. The risk ratio (RR) of mortality derived from 4545 patients assigned to a restrictive strategy when compared with 4547 transfused according to a liberal strategy was 0.96 [95% confidence interval (CI) 0.76-1.21, I2 = 0]. A restrictive strategy did not have a statistically significant effect on the risk of myocardial infarction (RR 1.01, 95% CI 0.81-1.26; I2=0), stroke (RR 0.93, 95% CI 0.68-1.27, I2 = 0), renal failure (RR 0.96, 95% CI 0.76-1.20, I2 = 0), or infection (RR 1.12, 95% CI 0.98-1.29, I2 = 0). Subgroup analysis of adult and paediatric trials did not show a significant interaction. At approximately 70% of the critical information size, the meta-analysis of mortality crossed the futility boundary for inferiority of the restrictive strategy. CONCLUSION: The current evidence does not support the notion that restrictive RBC transfusion strategies are inferior to liberal RBC strategies in patients undergoing cardiac surgery."},{"id":"dc1def399840","type":"article","url":"https://hartvaat.nl/2019/04/01/icd-mortaliteit-naar-hartfalenetiologie-propensity-matched-analyse/","title":"ICD-mortaliteit naar hartfalenetiologie: propensity-matched analyse","title_en":"Association between mortality and implantable cardioverter-defibrillators by aetiology of heart failure: a propensity-matched analysis of the WARCEF trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12407","source_url":"https://doi.org/10.1002/ehf2.12407","authors":["Tetz C Lee","Min Qian","Lan Mu","Marco R Di Tullio","Susan Graham","Douglas L Mann","Koki Nakanishi","John R Teerlink","Gregory Y H Lip","Ronald S Freudenberger","Ralph L Sacco","Jay P Mohr","Arthur J Labovitz","Piotr Ponikowski","Dirk J Lok","Conrado Estol","Stefan D Anker","Patrick M Pullicino","Richard Buchsbaum","Bruce Levin","John L P Thompson","Shunichi Homma","Siqin Ye"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This propensity-matched analysis examined whether ICD benefit differs by heart failure etiology (ischemic vs non-ischemic), contributing to the ongoing debate about primary prevention defibrillator use in non-ischemic cardiomyopathy.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:03Z","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":"Propensity-matched analyse van de associatie tussen mortaliteit en ICD naar etiologie van hartfalen (ischemisch vs niet-ischemisch).","abstract_original":"AIMS: There is debate on whether the beneficial effect of implantable cardioverter-defibrillators (ICDs) is attenuated in patients with non-ischaemic cardiomyopathy (NICM). We assess whether any ICD benefit differs between patients with NICM and those with ischaemic cardiomyopathy (ICM), using data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial. METHODS AND RESULTS: We performed a post hoc analysis using WARCEF (N = 2293; ICM, n = 991 vs. NICM, n = 1302), where participants received optimal medical treatment. We developed stratified propensity scores for having an ICD at baseline using 41 demographic and clinical variables and created 1:2 propensity-matched cohorts separately for ICM patients with ICD (N = 223 with ICD; N = 446 matched) and NICM patients (N = 195 with ICD; N = 390 matched). We constructed a Cox proportional hazards model to assess the effect of ICD status on mortality for patients with ICM and those with NICM and tested the interaction between ICD status and aetiology of heart failure. During mean follow-up of 3.5 ± 1.8 years, 527 patients died. The presence of ICD was associated with a lower risk of all-cause death among those with ICM (hazard ratio: 0.640; 95% confidence interval: 0.448 to 0.915; P = 0.015) but not among those with NICM (hazard ratio: 0.984; 95% confidence interval: 0.641 to 1.509; P = 0.941). There was weak evidence of interaction between ICD status and the aetiology of heart failure (P = 0.131). CONCLUSIONS: The presence of ICD is associated with a survival benefit in patients with ICM but not in those with NICM."},{"id":"41c634b8d8cb","type":"article","url":"https://hartvaat.nl/2019/04/01/ochtendbeweging-met-of-zonder-zitonderbrekingen-en-bloeddruk-bij-ouderen/","title":"Ochtendbeweging met of zonder zitonderbrekingen en bloeddruk bij ouderen","title_en":"Effect of Morning Exercise With or Without Breaks in Prolonged Sitting on Blood Pressure in Older Overweight/Obese Adults.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12373","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12373","authors":["Michael J Wheeler","David W Dunstan","Kathryn A Ellis","Ester Cerin","Sarah Phillips","Gavin Lambert","Louise H Naylor","Paddy C Dempsey","Bronwyn A Kingwell","Daniel J Green"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/"],"congress":"","summary_en":"This study showed that morning exercise combined with intermittent breaks in prolonged sitting provides additive blood pressure lowering in older overweight adults, supporting a combined activity strategy for sedentary hypertensive patients.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:03Z","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":"Studie naar het effect van ochtendbeweging met of zonder onderbrekingen in langdurig zitten op bloeddruk bij oudere volwassenen met overgewicht.","abstract_original":"Both exercise and breaks in prolonged sitting can reduce blood pressure (BP) in older overweight/obese adults. We investigated whether there is an additive hypotensive effect when exercise is combined with subsequent breaks in sitting. Sex differences and changes in plasma catecholamines as a potential candidate mechanism underlying BP responses were also examined. Sedentary older adults (n=67; 67±7 years; 31.2±4.1 kg/m2) completed 3 conditions in random order-sitting (SIT): uninterrupted sitting (8 hours, control); exercise+sitting (EX+SIT): sitting (1 hour), moderate-intensity walking (30 minutes), uninterrupted sitting (6.5 hours); exercise+breaks (EX+BR): sitting (1 hour), moderate-intensity walking (30 minutes), sitting interrupted every 30 minutes with 3 minutes of light-intensity walking (6.5 hours). Serial BP and plasma epinephrine/norepinephrine measurements occurred during 8 hours. The 8-hour average systolic and diastolic BP (mm Hg 95% CI) was lower in EX+SIT -3.4 (-4.5 to -2.3), -0.8 (-1.6 to -0.04), and EX+BR -5.1 (-6.2 to -4.0), -1.1 (-1.8 to -0.3), respectively, relative to SIT (all P <0.05). There was an additional reduction in average systolic BP of -1.7 (-2.8 to -0.6) in EX+BR relative to EX+SIT ( P=0.003). This additional reduction in systolic BP was driven by women -3.2 (-4.7 to -1.7; P<0.001 EX+BR versus EX+SIT). Average epinephrine decreased in EX+SIT and EX+BR in women (-13% to -12%) but increased in men (+12% to +23%), respectively, relative to SIT ( P<0.05). No differences in average norepinephrine were observed. Morning exercise reduces BP during a period of 8 hours in older overweight/obese adults compared with prolonged sitting. Combining exercise with regular breaks in sitting may be of more benefit for lowering BP in women than in men. Clinical Trial Registration- URL: https://www.anzctr.org.au . Unique identifier: ACTRN12614000737639."},{"id":"97a83458b01f","type":"article","url":"https://hartvaat.nl/2019/04/01/spironolacton-en-lv-massa-bij-hemodialysepatienten-gerandomiseerde-trial/","title":"Spironolacton en LV-massa bij hemodialysepatiënten: gerandomiseerde trial","title_en":"A randomized controlled trial of the effect of spironolactone on left ventricular mass in hemodialysis patients.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["fidelio-dkd","mra-aldosteronantagonisten","spironolacton","summit-trial"],"journal":"Kidney international","doi":"10.1016/j.kint.2018.11.025","source_url":"https://doi.org/10.1016/j.kint.2018.11.025","authors":["Fabian Hammer","Uwe Malzahn","Julian Donhauser","Christoph Betz","Markus P Schneider","Clemens Grupp","Nils Pollak","Stefan Störk","Christoph Wanner","Vera Krane"],"significance":6,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/mineralocorticoid-antagonisten-farmacologie/"],"congress":"","summary_en":"This randomized trial evaluated spironolactone for reducing left ventricular mass in hemodialysis patients, testing MRA therapy in the end-stage kidney disease population where hyperaldosteronism contributes to cardiac hypertrophy.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:03Z","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 naar het effect van spironolacton op linkerventrikelmassa bij hemodialysepatiënten. MRA bij eindstadium nierziekte.","abstract_original":"Mineralocorticoid receptor antagonists have beneficial effects on left ventricular remodeling, cardiac fibrosis, and arrhythmia in heart failure, but efficacy and safety in dialysis patients is less clear. We evaluated the effect of spironolactone on left ventricular mass (LVM), an independent predictor of all-cause and cardiovascular mortality, in hemodialysis patients. In this placebo-controlled, parallel-group trial, 97 hemodialysis patients (23% female; mean age 60.3 years) were randomized to spironolactone 50 mg once daily (n=50) or placebo (n=47). The primary efficacy endpoint was change in LVM index (LVMi) from baseline to 40 weeks as determined by cardiac magnetic resonance imaging. Safety endpoints were development of hyperkalemia and change in residual renal function. There was no significant change in LVMi in participants randomized to spironolactone compared to placebo (-2.86±11.87 vs. 0.41±10.84 g/m2). There was also no difference in the secondary outcomes of mean 24-hour systolic or diastolic ambulatory blood pressure, left ventricular ejection fraction, 6-minute walk test distance, or New York Heart Association functional class. Moderate hyperkalemia (pre-dialysis potassium levels of 6.0-6.5 mmol/L) was more frequent with spironolactone treatment (155 vs. 80 events), but severe hyperkalemia (≥6.5 mmol/L) was not (14 vs. 24 events). Changes in residual urine volume and measured glomerular filtration rate did not differ between groups. There were no deaths in the spironolactone group and 4 deaths in the placebo group. Thus, treatment with 50 mg spironolactone did not change left ventricular mass index, cardiac function, or blood pressure in hemodialysis patients. Spironolactone increased the frequency of moderate hyperkalemia, but did not increase severe hyperkalemia."},{"id":"7cf66131c7d2","type":"article","url":"https://hartvaat.nl/2019/04/01/prehospitale-hypothermie-bij-stemi-gerandomiseerde-trial/","title":"Prehospitale hypothermie bij STEMI: gerandomiseerde trial","title_en":"Out-of-hospital initiation of hypothermia in ST-segment elevation myocardial infarction: a randomised trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313705","source_url":"https://doi.org/10.1136/heartjnl-2018-313705","authors":["Christoph Testori","Dietrich Beitzke","Andreas Mangold","Fritz Sterz","Christian Loewe","Christoph Weiser","Thomas Scherz","Harald Herkner","Irene Lang"],"significance":5,"published":"2019-04-01","source_date":"2019-04-01","image":"","kennis":[],"congress":"","summary_en":"This randomized trial tested prehospital hypothermia initiation in awake STEMI patients for infarct size limitation, evaluating the feasibility of cooling before hospital arrival.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:03Z","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 die prehospitale initiatie van hypothermie onderzocht bij STEMI voor beperking van infarctgrootte.","abstract_original":"OBJECTIVE: To evaluate the effect of prereperfusion hypothermia initiated in the out-of-hospital setting in awake patients with ST-segment elevation myocardial infarction (STEMI) on myocardial salvage measured by cardiac MRI (CMR). METHODS: Hypothermia was initiated within 6 hours of symptom onset by the emergency medical service with surface cooling pads and cold saline, and continued in the cath lab with endovascular cooling (target temperature: ≤35°C at time of reperfusion). Myocardial salvage index (using CMR) was compared in a randomised, controlled, open-label, endpoint blinded trial to a not-cooled group of patients at day 4±2 after the event. RESULTS: After postrandomisation exclusion of 19 patients a total of 101 patients were included in the intention-to-treat analysis (control group: n=54; hypothermia group: n=47). Target temperature was reached in 38/47 patients (81%) in the intervention group. Study-related interventions resulted in a delay in time from first medical contact to reperfusion of 14 min (control group 89±24 min; hypothermia group 103±21 min; p<0.01). Myocardial salvage index was 0.37 (±0.26) in the control group and 0.43 (±0.27) in the hypothermia group (p=0.27). No differences in cardiac biomarkers or clinical outcomes were found. In a CMR follow-up 6 months after the initial event no significant differences were detected. CONCLUSION: Out-of-hospital induced therapeutic hypothermia as an adjunct to primary percutaneous coronary intervention did not improve myocardial salvage in patients with STEMI. TRIAL REGISTRATION NUMBER: NCT01777750."},{"id":"12049147aab9","type":"article","url":"https://hartvaat.nl/2019/03/26/intramyocardiale-mesenchymale-precursorcellen-en-lvad-weaning-jama/","title":"Intramyocardiale mesenchymale precursorcellen en LVAD-weaning: JAMA","title_en":"Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure: A Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.2341","source_url":"https://doi.org/10.1001/jama.2019.2341","authors":["Terrence M Yau","Francis D Pagani","Donna M Mancini","Helena L Chang","Anuradha Lala","Y Joseph Woo","Michael A Acker","Craig H Selzman","Edward G Soltesz","John A Kern","Simon Maltais","Eric Charbonneau","Stephanie Pan","Mary E Marks","Ellen G Moquete","Karen L O'Sullivan","Wendy C Taddei-Peters","Lydia K McGowan","China Green","Eric A Rose","Neal Jeffries","Michael K Parides","Richard D Weisel","Marissa A Miller","Judy Hung","Patrick T O'Gara","Alan J Moskowitz","Annetine C Gelijns","Emilia Bagiella","Carmelo A Milano"],"significance":6,"published":"2019-03-26","source_date":"2019-03-26","image":"","kennis":[],"congress":"","summary_en":"This JAMA study of intramyocardial mesenchymal precursor cell injection in LVAD patients explored whether regenerative cell therapy can promote sufficient myocardial recovery to enable device weaning.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:03Z","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-studie naar intramyocardiale injectie van mesenchymale precursorcellen en het succesvol tijdelijk ontwennen van LVAD-ondersteuning.","abstract_original":"IMPORTANCE: Left ventricular assist device (LVAD) therapy improves myocardial function, but few patients recover sufficiently for explant, which has focused attention on stem cells to augment cardiac recovery. OBJECTIVE: To assess efficacy and adverse effects of intramyocardial injections of mesenchymal precursor cells (MPCs) during LVAD implant. DESIGN, SETTING, AND PARTICIPANTS: A randomized phase 2 clinical trial involving patients with advanced heart failure, undergoing LVAD implant, at 19 North American centers (July 2015-August 2017). The 1-year follow-up ended August 2018. INTERVENTIONS: Intramyocardial injections of 150 million allogeneic MPCs or cryoprotective medium as a sham treatment in a 2:1 ratio (n = 106 vs n = 53). MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the proportion of successful temporary weans (of 3 planned assessments) from LVAD support within 6 months of randomization. This end point was assessed using a Bayesian analysis with a predefined threshold of a posterior probability of 80% to indicate success. The 1-year primary safety end point was the incidence of intervention-related adverse events (myocarditis, myocardial rupture, neoplasm, hypersensitivity reactions, and immune sensitization). Secondary end points included readmissions and adverse events at 6 months and 1-year survival. RESULTS: Of 159 patients (mean age, 56 years; 11.3% women), 155 (97.5%) completed 1-year of follow-up. The posterior probability that MPCs increased the likelihood of successful weaning was 69%; below the predefined threshold for success. The mean proportion of successful temporary weaning from LVAD support over 6 months was 61% in the MPC group and 58% in the control group (rate ratio [RR], 1.08; 95% CI, 0.83-1.41; P = .55). No patient experienced a primary safety end point. Of 10 prespecified secondary end points reported, 9 did not reach statistical significance. One-year mortality was not significantly different between the MPC group and the control group (14.2% vs 15.1%; hazard ratio [HR], 0.89; 95%, CI, 0.38-2.11; P = .80). The rate of serious adverse events was not significantly different between groups (70.9 vs 78.7 per 100 patient-months; difference, -7.89; 95% CI, -39.95 to 24.17; P = .63) nor was the rate of readmissions (0.68 vs 0.75 per 100 patient-months; difference, -0.07; 95% CI, -0.41 to 0.27; P = .68). CONCLUSIONS AND RELEVANCE: Among patients with advanced heart failure, intramyocardial injections of mesenchymal precursor cells, compared with injections of a cryoprotective medium as sham treatment, did not improve successful temporary weaning from left ventricular assist device support at 6 months. The findings do not support the use of intramyocardial mesenchymal stem cells to promote cardiac recovery as measured by temporary weaning from device support. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02362646."},{"id":"cb43a21a1f6f","type":"article","url":"https://hartvaat.nl/2019/03/26/bnp-tijdens-sacubitril-valsartan-paradigm-hf/","title":"BNP tijdens sacubitril/valsartan: PARADIGM-HF","title_en":"B-Type Natriuretic Peptide During Treatment With Sacubitril/Valsartan: The PARADIGM-HF Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["nt-probnp"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.01.018","source_url":"https://doi.org/10.1016/j.jacc.2019.01.018","authors":["Peder Langeland Myhre","Muthiah Vaduganathan","Brian Claggett","Milton Packer","Akshay S Desai","Jean L Rouleau","Michael R Zile","Karl Swedberg","Martin Lefkowitz","Victor Shi","John J V McMurray","Scott D Solomon"],"significance":6,"published":"2019-03-26","source_date":"2019-03-26","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/","https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/"],"congress":"","summary_en":"This PARADIGM-HF analysis clarified the differential behavior of BNP versus NT-proBNP during sacubitril-valsartan therapy, showing that BNP rises due to neprilysin inhibition while NT-proBNP falls, affecting clinical interpretation of biomarker-guided therapy.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:02Z","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":"PARADIGM-HF analyse naar het verloop van BNP (niet NT-proBNP) tijdens sacubitril/valsartan. Relevant voor de interpretatie van biomarkers bij ARNI-gebruik.","abstract_original":"BACKGROUND: Natriuretic peptides are substrates of neprilysin; hence, B-type natriuretic peptide (BNP) concentrations rise with neprilysin inhibition. Thus, the clinical validity of measuring BNP in sacubitril/valsartan-treated patients has been questioned, and use of N-terminal pro-B-type natriuretic peptides (NT-proBNP) has been preferred and recommended. OBJECTIVES: The purpose of this study was to determine the prognostic performance of BNP measurements before and during treatment with sacubitril/valsartan. METHODS: BNP and NT-proBNP were measured before and after 4 to 6 weeks, 8 to 10 weeks, and 9 months of treatment with sacubitril/valsartan in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. We assessed the association of levels of these natriuretic peptides with the subsequent risk of cardiovascular death or hospitalization for HF. RESULTS: Median BNP concentration (before treatment: 202 ng/l [Q1 to Q3: 126 to 335 ng/l]) increased to 235 ng/l (Q1 to Q3: 128 to 422 ng/l) after 8 to 10 weeks of treatment. BNP concentrations doubled in 141 (18%) patients and tripled in 49 (6%) patients during the first 8 to 10 weeks of sacubitril/valsartan. In contrast, such striking increases in NT-proBNP following the use of the neprilysin inhibitor were extremely rare. Treatment with sacubitril/valsartan caused a rightward shift in the distribution of BNP when compared with NT-proBNP, but both peptides retained their prognostic accuracy (C-statistics of 63% to 67% for BNP and C-statistics of 64% to 70% for NT-proBNP) with no difference between the 2 biomarkers. Increases in both BNP and NT-proBNP during 8 to 10 weeks of sacubitril/valsartan were associated with worse outcomes (p = 0.003 and p = 0.005, respectively). CONCLUSIONS: Circulating levels of BNP may increase meaningfully early after initiation of sacubitril/valsartan. In comparison, NT-proBNP is not a substrate of neprilysin inhibition, and thus may lead to less clinical confusion when measured within 8 to 10 weeks of drug initiation. However, during treatment, either biomarker predicts the risk of major adverse outcomes in patients treated with angiotensin receptor-neprilysin inhibitors. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)."},{"id":"3ae6ee75f9da","type":"article","url":"https://hartvaat.nl/2019/03/19/aanbevolen-hf-medicatie-en-bijwerkingen-bij-vrouwen/","title":"Aanbevolen HF-medicatie en bijwerkingen bij vrouwen","title_en":"Recommended Heart Failure Medications and Adverse Drug Reactions in Women.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["acuut-hartfalen"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037585","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037585","authors":["Sophie H Bots","Hester M den Ruijter"],"significance":6,"published":"2019-03-19","source_date":"2019-03-19","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ace-remmers-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This analysis identified sex differences in adverse drug reactions to recommended heart failure medications, showing that women may experience more side effects at standard doses, informing sex-aware dosing strategies.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:02Z","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":"Analyse naar sekseverschillen in bijwerkingen van aanbevolen hartfalenmedicatie. Vrouwen ervaren mogelijk meer bijwerkingen bij standaarddoseringen.","abstract_original":""},{"id":"f737c8cec73c","type":"article","url":"https://hartvaat.nl/2019/03/19/katheterablatie-versus-antiaritmica-en-kwaliteit-van-leven-bij-af-jama-captaf/","title":"Katheterablatie versus antiaritmica en kwaliteit van leven bij AF: JAMA CAPTAF","title_en":"Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.0335","source_url":"https://doi.org/10.1001/jama.2019.0335","authors":["Carina Blomström-Lundqvist","Sigfus Gizurarson","Jonas Schwieler","Steen M Jensen","Lennart Bergfeldt","Göran Kennebäck","Aigars Rubulis","Helena Malmborg","Pekka Raatikainen","Stefan Lönnerholm","Niklas Höglund","David Mörtsell"],"significance":7,"published":"2019-03-19","source_date":"2019-03-19","image":"","kennis":[],"congress":"","summary_en":"The CAPTAF trial showed that catheter ablation significantly improves quality of life compared with antiarrhythmic medication in patients with AF, providing randomized evidence for the symptom benefit of ablation using quality of life as the primary outcome.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:02Z","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 CAPTAF gerandomiseerde trial die katheterablatie vergeleek met antiaritmische medicatie op kwaliteit van leven bij AF.","abstract_original":"IMPORTANCE: Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication. OBJECTIVE: To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or β-blocker, with 4-year follow-up. Study dates were July 2008-September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation. INTERVENTIONS: Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76). MAIN OUTCOMES AND MEASURES: Primary outcome was the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis. RESULTS: Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference -6.8% [95% CI, -12.9% to -0.7%]; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life. TRIAL REGISTRATION: clinicaltrialsregister.eu Identifier: 2008-001384-11."},{"id":"e9b874f9b207","type":"article","url":"https://hartvaat.nl/2019/03/19/management-van-af-jama-klinisch-overzicht/","title":"Management van AF: JAMA klinisch overzicht","title_en":"Management of Patients With Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.1264","source_url":"https://doi.org/10.1001/jama.2019.1264","authors":["Andrew D Beaser","Adam S Cifu"],"significance":8,"published":"2019-03-19","source_date":"2019-03-19","image":"","kennis":[],"congress":"","summary_en":"This comprehensive JAMA clinical review provided a practical overview of atrial fibrillation management, covering diagnosis, risk stratification, anticoagulation selection, rate versus rhythm control, and catheter ablation indications for daily clinical practice.","created":"2026-07-03T10:27:50Z","updated":"2026-07-03T13:27:02Z","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 uitgebreid klinisch overzicht over het management van atriumfibrilleren. Referentiedocument voor de dagelijkse praktijk.","abstract_original":""},{"id":"3eedbf95d2c4","type":"article","url":"https://hartvaat.nl/2019/03/19/lp-a-pcsk9-remming-en-cardiovasculair-risico/","title":"Lp(a), PCSK9-remming en cardiovasculair risico","title_en":"Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":["lipoproteïne-a","pcsk9-remmers","pcsk9-remmers-nieuwe-generatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037184","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037184","authors":["Michelle L O'Donoghue","Sergio Fazio","Robert P Giugliano","Erik S G Stroes","Estella Kanevsky","Ioanna Gouni-Berthold","KyungAh Im","Armando Lira Pineda","Scott M Wasserman","Richard Češka","Marat V Ezhov","J Wouter Jukema","Henrik K Jensen","S Lale Tokgözoğlu","François Mach","Kurt Huber","Peter S Sever","Anthony C Keech","Terje R Pedersen","Marc S Sabatine"],"significance":8,"published":"2019-03-19","source_date":"2019-03-19","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/"],"congress":"","summary_en":"This study demonstrated that elevated lipoprotein(a) remains a significant residual cardiovascular risk factor even after PCSK9 inhibition, and that the Lp(a) reduction achieved with evolocumab partially explains its cardiovascular benefit. The findings supported Lp(a) as an independent therapeutic target.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:02Z","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":"Studie naar de relatie tussen Lp(a)-niveaus, het effect van PCSK9-remming daarop, en het residuele cardiovasculaire risico. Lp(a) als doelwit voor PCSK9-remmers.","abstract_original":"BACKGROUND: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined. METHODS: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration. RESULTS: The median (interquartile range) baseline Lp(a) concentration was 37 (13-165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01-1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%-46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r=0.37; 95% CI, 0.36-0.39; P<0.001). Evolocumab reduced the risk of coronary heart disease death, myocardial infarction, or urgent revascularization by 23% (hazard ratio, 0.77; 95% CI, 0.67-0.88) in patients with a baseline Lp(a) >median, and by 7% (hazard ratio, 0.93; 95% CI, 0.80-1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively. CONCLUSIONS: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633."},{"id":"b1e5c1607d78","type":"article","url":"https://hartvaat.nl/2019/03/14/bempedoinezuur-voor-ldl-verlaging-nejm-veiligheid-en-werkzaamheid/","title":"Bempedoïnezuur voor LDL-verlaging: NEJM veiligheid en werkzaamheid","title_en":"Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1803917","source_url":"https://doi.org/10.1056/NEJMoa1803917","authors":["Kausik K Ray","Harold E Bays","Alberico L Catapano","Narendra D Lalwani","LeAnne T Bloedon","Lulu R Sterling","Paula L Robinson","Christie M Ballantyne"],"significance":9,"published":"2019-03-14","source_date":"2019-03-14","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/","https://hartvaat.nl/kennis/lipiden/inclisiran-sirna/"],"congress":"","summary_en":"This NEJM trial established the safety and LDL-lowering efficacy of bempedoic acid, an oral ACL inhibitor that does not cause muscle-related side effects due to its liver-specific activation. The results positioned bempedoic acid as a promising option for patients intolerant to statins.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:02Z","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":"NEJM-trial die veiligheid en werkzaamheid van bempedoïnezuur aantoonde voor LDL-verlaging. Nieuw oraal middel als aanvulling op of alternatief voor statines.","abstract_original":"BACKGROUND: Short-term studies have shown that bempedoic acid, an inhibitor of ATP citrate lyase, reduces levels of low-density lipoprotein (LDL) cholesterol. Data are limited regarding the safety and efficacy of bempedoic acid treatment in long-term studies involving patients with hypercholesterolemia who are receiving guideline-recommended statin therapy. METHODS: We conducted a randomized, controlled trial involving patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both. Patients had to have an LDL cholesterol level of at least 70 mg per deciliter while they were receiving maximally tolerated statin therapy with or without additional lipid-lowering therapy. (Maximally tolerated statin therapy was defined as the highest intensity statin regimen that a patient was able to maintain, as determined by the investigator.) Patients were randomly assigned in a 2:1 ratio to receive bempedoic acid or placebo. The primary end point was safety, and the principal secondary end point (principal efficacy end point) was the percentage change in the LDL cholesterol level at week 12 of 52 weeks. RESULTS: The trial involved 2230 patients, of whom 1488 were assigned to receive bempedoic acid and 742 to receive placebo. The mean (±SD) LDL cholesterol level at baseline was 103.2±29.4 mg per deciliter. The incidence of adverse events (1167 of 1487 patients [78.5%] in the bempedoic acid group and 584 of 742 [78.7%] in the placebo group) and serious adverse events (216 patients [14.5%] and 104 [14.0%], respectively) did not differ substantially between the two groups during the intervention period, but the incidence of adverse events leading to discontinuation of the regimen was higher in the bempedoic acid group than in the placebo group (162 patients [10.9%] vs. 53 [7.1%]), as was the incidence of gout (18 patients [1.2%] vs. 2 [0.3%]). At week 12, bempedoic acid reduced the mean LDL cholesterol level by 19.2 mg per deciliter, representing a change of -16.5% from baseline (difference vs. placebo in change from baseline, -18.1 percentage points; 95% confidence interval, -20.0 to -16.1; P<0.001). Safety and efficacy findings were consistent, regardless of the intensity of background statin therapy. CONCLUSIONS: In this 52-week trial, bempedoic acid added to maximally tolerated statin therapy did not lead to a higher incidence of overall adverse events than placebo and led to significantly lower LDL cholesterol levels. (Funded by Esperion Therapeutics; CLEAR Harmony ClinicalTrials.gov number, NCT02666664.)."},{"id":"a1e43b9d2f0c","type":"article","url":"https://hartvaat.nl/2019/03/12/empagliflozine-vermindert-mortaliteit-en-hf-hospitalisatie-over-het-cv-risicospe/","title":"Empagliflozine vermindert mortaliteit en HF-hospitalisatie over het CV-risicospecttum: EMPA-REG","title_en":"Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["dapa-hf","empagliflozine","emperor-trials"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037778","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037778","authors":["David Fitchett","Silvio E Inzucchi","Christopher P Cannon","Darren K McGuire","Benjamin M Scirica","Odd Erik Johansen","Steven Sambevski","Stefan Kaspers","Egon Pfarr","Jyothis T George","Bernard Zinman"],"significance":8,"published":"2019-03-12","source_date":"2019-03-12","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/sglt2-remmers-cardiovasculaire-trials/"],"congress":"","summary_en":"This EMPA-REG OUTCOME analysis showed that empagliflozin's benefit on mortality and heart failure hospitalization was consistent across the full spectrum of cardiovascular risk, including patients with lower baseline risk. The findings supported broad use of SGLT2 inhibitors in diabetic cardiovascular populations.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:02Z","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":"EMPA-REG OUTCOME analyse die aantoont dat het voordeel van empagliflozine op mortaliteit en HF-hospitalisatie consistent is over het gehele cardiovasculaire risicospecttum.","abstract_original":"BACKGROUND: In the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, in comparison with placebo, empagliflozin reduced the risks of 3-point major adverse cardiovascular events (3-point MACE), cardiovascular and all-cause death, and hospitalization for heart failure. We investigated whether these effects varied across the spectrum of baseline cardiovascular risk. METHODS: Cardiovascular death, all-cause mortality, 3-point MACE, and hospitalization for heart failure in the pooled empagliflozin and placebo groups were analyzed in subgroups by prior myocardial infarction and stroke at baseline, and by estimated baseline cardiovascular risk based on the 10-point TIMI (Thrombolysis In Myocardial Infarction) Risk Score for Secondary Prevention. RESULTS: Of 7020 patients who received the study drug, 65% had a prior myocardial infarction or stroke, and 12%, 40%, 30%, and 18% were at low, intermediate, high, and highest estimated cardiovascular risk according to TIMI Risk Score for Secondary Prevention (≤2, 3, 4, and ≥5 points, respectively). In the placebo group, 3-point MACE occurred during the trial in 7.3%, 9.4%, 12.6%, and 20.6% of patients at low, intermediate, high, and highest estimated baseline risk, respectively. Relative reductions in risk of cardiovascular death, all-cause mortality, 3-point MACE and hospitalization for heart failure with empagliflozin versus placebo were consistent in patients with and without prior myocardial infarction and/or stroke and across subgroups by TIMI Risk Score for Secondary Prevention at baseline ( P>0.05 for randomized group-by-subgroup interactions). CONCLUSIONS: Despite all patients having atherosclerotic cardiovascular disease, patients in EMPA-REG OUTCOME demonstrated a broad risk spectrum for cardiovascular events. Reductions in key cardiovascular outcomes and mortality with empagliflozin versus placebo were consistent across the range of cardiovascular risk. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676."},{"id":"b8d0f03bccbd","type":"article","url":"https://hartvaat.nl/2019/03/12/arni-bij-functionele-mitralisklepinsufficientie/","title":"ARNI bij functionele mitralisklepinsufficiëntie","title_en":"Angiotensin Receptor Neprilysin Inhibitor for Functional Mitral Regurgitation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["mitralisinsufficiëntie","sacubitril-valsartan"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037077","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037077","authors":["Duk-Hyun Kang","Sung-Ji Park","Sung-Hee Shin","Geu-Ru Hong","Sahmin Lee","Min-Seok Kim","Sung-Cheol Yun","Jong-Min Song","Seung-Woo Park","Jae-Joong Kim"],"significance":6,"published":"2019-03-12","source_date":"2019-03-12","image":"","kennis":[],"congress":"","summary_en":"This study evaluated sacubitril-valsartan for functional mitral regurgitation, testing whether neurohormonal modulation with ARNI therapy can reduce secondary MR severity through favorable ventricular remodeling.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 naar het effect van sacubitril/valsartan op functionele mitralisklepinsufficiëntie. Onderzocht of neurohormonale remming de MR-graad vermindert.","abstract_original":"BACKGROUND: The morbidity and mortality of patients with functional mitral regurgitation (MR) remain high, but no pharmacological therapy has been proven effective. The hypothesis of this study was that sacubitril/valsartan would be superior to valsartan alone in improving functional MR via dual inhibition of the renin-angiotensin system and neprilysin. METHODS: In this double-blind trial, we randomly assigned 118 patients with heart failure with chronic functional MR secondary to left ventricular (LV) dysfunction to receive either sacubitril/valsartan or valsartan, in addition to standard medical therapy for heart failure. The primary end point was the 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, LV end-systolic volume, LV end-diastolic volume, and incomplete mitral leaflet closure area. RESULTS: The decrease in effective regurgitant orifice area was significantly greater in the sacubitril/valsartan group than in the valsartan group (-0.058±0.095 versus -0.018±0.105 cm2; P=0.032) in an intention-to-treat analysis including 117 (99%) patients. Regurgitant volume was also significantly decreased in the sacubitril/valsartan group in comparison with the valsartan group (mean difference, -7.3 mL; 95% CI, -12.6 to -1.9; P=0.009). There were no significant between-group differences regarding the changes in incomplete mitral leaflet closure area and LV volumes, with the exception of LV end-diastolic volume index ( P=0.044). We noted no significant difference in the change of blood pressure between the treatment groups, and 7 patients (12%) in the sacubitril/valsartan group and 9 (16%) in the valsartan group had ≥1 serious adverse events ( P=0.54). CONCLUSIONS: Among patients with secondary functional MR, sacubitril/valsartan reduced MR to a greater extent than did valsartan. Our findings suggest that an angiotensin receptor-neprilysin inhibitor might be considered for optimal medical therapy of patients with heart failure and functional MR. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02687932."},{"id":"961ab3bd9bee","type":"article","url":"https://hartvaat.nl/2019/03/09/ultradunne-sirolimus-eluting-stent-lancet-talent-trial/","title":"Ultradunne sirolimus-eluting stent: Lancet TALENT-trial","title_en":"Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)32467-X","source_url":"https://doi.org/10.1016/S0140-6736(18)32467-X","authors":["Azfar Zaman","Robbert J de Winter","Norihiro Kogame","Chun Chin Chang","Rodrigo Modolo","Ernest Spitzer","Pim Tonino","Sjoerd Hofma","Aleksander Zurakowski","Pieter C Smits","Janusz Prokopczuk","Raul Moreno","Anirban Choudhury","Ivo Petrov","Angel Cequier","Neville Kukreja","Angela Hoye","Andrés Iniguez","Imre Ungi","Antonio Serra","Robert J Gil","Simon Walsh","Gincho Tonev","Anthony Mathur","Bela Merkely","Antonio Colombo","Sander Ijsselmuiden","Osama Soliman","Upendra Kaul","Yoshinobu Onuma","Patrick W Serruys"],"significance":7,"published":"2019-03-09","source_date":"2019-03-09","image":"","kennis":[],"congress":"","summary_en":"The TALENT randomized trial compared a sirolimus-eluting stent with ultra-thin struts (Supraflex) against the Xience everolimus-eluting stent, evaluating the next generation of thin-strut coronary stent technology.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:02Z","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":"Lancet TALENT gerandomiseerde trial van een sirolimus-eluting stent met ultradunne strut bij atherosclerotische laesies.","abstract_original":"BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute."},{"id":"1b753350ff04","type":"article","url":"https://hartvaat.nl/2019/03/09/prehospitaal-nitroglycerine-bij-vermoedelijk-ultra-acuut-cva-lancet-right-2/","title":"Prehospitaal nitroglycerine bij vermoedelijk ultra-acuut CVA: Lancet RIGHT-2","title_en":"Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)30194-1","source_url":"https://doi.org/10.1016/S0140-6736(19)30194-1","authors":[],"significance":7,"published":"2019-03-09","source_date":"2019-03-09","image":"","kennis":[],"congress":"","summary_en":"The RIGHT-2 ambulance-based trial showed that prehospital transdermal glyceryl trinitrate did not improve functional outcomes in patients with ultra-acute presumed stroke, arguing against routine prehospital blood pressure lowering in acute stroke.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:01Z","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":"Lancet RIGHT-2 ambulance-gebaseerde trial die prehospitaal transdermaal nitroglycerine onderzocht bij vermoedelijk ultra-acuut beroerte.","abstract_original":"BACKGROUND: High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure have given variable results, and the management of high blood pressure in ultra-acute stroke remains unclear. We investigated whether transdermal glyceryl trinitrate (GTN; also known as nitroglycerin), a nitric oxide donor, might improve outcome when administered very early after stroke onset. METHODS: We did a multicentre, paramedic-delivered, ambulance-based, prospective, randomised, sham-controlled, blinded-endpoint, phase 3 trial in adults with presumed stroke within 4 h of onset, face-arm-speech-time score of 2 or 3, and systolic blood pressure 120 mm Hg or higher. Participants were randomly assigned (1:1) to receive transdermal GTN (5 mg once daily for 4 days; the GTN group) or a similar sham dressing (the sham group) in UK-based ambulances by paramedics, with treatment continued in hospital. Paramedics were unmasked to treatment, whereas participants were masked. The primary outcome was the 7-level modified Rankin Scale (mRS; a measure of functional outcome) at 90 days, assessed by central telephone follow-up with masking to treatment. Analysis was hierarchical, first in participants with a confirmed stroke or transient ischaemic attack (cohort 1), and then in all participants who were randomly assigned (intention to treat, cohort 2) according to the statistical analysis plan. This trial is registered with ISRCTN, number ISRCTN26986053. FINDINGS: Between Oct 22, 2015, and May 23, 2018, 516 paramedics from eight UK ambulance services recruited 1149 participants (n=568 in the GTN group, n=581 in the sham group). The median time to randomisation was 71 min (IQR 45-116). 597 (52%) patients had ischaemic stroke, 145 (13%) had intracerebral haemorrhage, 109 (9%) had transient ischaemic attack, and 297 (26%) had a non-stroke mimic at the final diagnosis of the index event. In the GTN group, participants' systolic blood pressure was lowered by 5·8 mm Hg compared with the sham group (p<0·0001), and diastolic blood pressure was lowered by 2·6 mm Hg (p=0·0026) at hospital admission. We found no difference in mRS between the groups in participants with a final diagnosis of stroke or transient ischaemic stroke (cohort 1): 3 (IQR 2-5; n=420) in the GTN group versus 3 (2-5; n=408) in the sham group, adjusted common odds ratio for poor outcome 1·25 (95% CI 0·97-1·60; p=0·083); we also found no difference in mRS between all patients (cohort 2: 3 [2-5]; n=544, in the GTN group vs 3 [2-5]; n=558, in the sham group; 1·04 [0·84-1·29]; p=0·69). We found no difference in secondary outcomes, death (treatment-related deaths: 36 in the GTN group vs 23 in the sham group [p=0·091]), or serious adverse events (188 in the GTN group vs 170 in the sham group [p=0·16]) between treatment groups. INTERPRETATION: Prehospital treatment with transdermal GTN does not seem to improve functional outcome in patients with presumed stroke. It is feasible for UK paramedics to obtain consent and treat patients with stroke in the ultra-acute prehospital setting. FUNDING: British Heart Foundation."},{"id":"3ec3c8412960","type":"article","url":"https://hartvaat.nl/2019/03/05/timing-van-prasugrel-start-en-coronairangiografie-bij-nstemi/","title":"Timing van prasugrel-start en coronairangiografie bij NSTEMI","title_en":"Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.055","source_url":"https://doi.org/10.1016/j.jacc.2018.11.055","authors":["Johanne Silvain","Tomasz Rakowski","Benoit Lattuca","Zhenyu Liu","Leonardo Bolognese","Patrick Goldstein","Christian Hamm","Jean-Francois Tanguay","Jur Ten Berg","Petr Widimsky","Debra Miller","Jean-Jacques Portal","Jean-Philippe Collet","Eric Vicaut","Gilles Montalescot","Dariusz Dudek"],"significance":5,"published":"2019-03-05","source_date":"2019-03-05","image":"","kennis":[],"congress":"","summary_en":"This ACCOAST analysis examined the optimal time interval between prasugrel initiation and coronary angiography in NSTEMI, informing the pre-treatment timing strategy for potent P2Y12 inhibition.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:01Z","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":"Studie naar het optimale interval tussen prasugrel-initiatie en coronairangiografie bij NSTEMI.","abstract_original":"BACKGROUND: In the ACCOAST (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction) trial, the prasugrel pre-treatment strategy versus placebo was associated with excess bleeding complications and no improved ischemic outcome in non-ST-segment elevation myocardial infarction (MI). Whether patients with the longest pre-treatment duration had an ischemic benefit is unknown. OBJECTIVES: This pre-specified analysis of the ACCOAST trial aimed to assess the effect of pre-treatment duration with prasugrel (time from randomization to angiography) on outcomes. METHODS: Within the 4,033 patients randomized in the ACCOAST trial, pre-treatment duration was available in 4,001 patients (99.2%). The population of the trial was divided into quartiles of pre-treatment duration (0.1 to 2.5 h, 2.5 to 3.9 h, 3.9 to 13.6 h, and >13.6 h) with an evaluation of the primary efficacy endpoint of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use. Secondary efficacy outcomes including cardiovascular death, MI, or stroke; all-cause death; stent thrombosis and safety outcomes (all coronary artery bypass graft [CABG] or non-CABG TIMI [Thrombolysis In Myocardial Infarction] major bleeding) were also evaluated at 7 days. RESULTS: The primary efficacy outcome of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use did not differ between the quartiles of pre-treatment duration in the trial population (p = 0.17 for interaction). None of the secondary efficacy outcomes were found to be dependent on pre-treatment duration. The safety outcome of all CABG or non-CABG TIMI major bleeding did not differ between the quartiles of pre-treatment duration (p = 0.37 for interaction). CONCLUSIONS: In non-ST-segment elevation MI patients, the excess risk of bleeding and the absence of ischemic benefit were consistent across the quartiles of increasing duration of prasugrel pre-treatment. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287)."},{"id":"e0753d9d11f7","type":"article","url":"https://hartvaat.nl/2019/03/05/inspanningstest-versus-ccta-bij-diabetes-met-verdenking-coronairlijden/","title":"Inspanningstest versus CCTA bij diabetes met verdenking coronairlijden","title_en":"Stress Testing Versus CT Angiography in Patients With Diabetes and Suspected Coronary Artery Disease.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["coronaire-ct-angiografie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.056","source_url":"https://doi.org/10.1016/j.jacc.2018.11.056","authors":["Abhinav Sharma","Adrian Coles","Nishant K Sekaran","Neha J Pagidipati","Michael T Lu","Daniel B Mark","Kerry L Lee","Hussein R Al-Khalidi","Udo Hoffmann","Pamela S Douglas"],"significance":6,"published":"2019-03-05","source_date":"2019-03-05","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"This study compared stress testing with CT angiography for evaluating suspected coronary artery disease specifically in diabetic patients, addressing the optimal non-invasive diagnostic strategy in this high-risk population.","created":"2026-07-03T10:27:49Z","updated":"2026-07-03T13:27:01Z","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":"Vergelijking van inspanningstesten versus CT-angiografie bij diabetespatiënten met verdenking coronairlijden.","abstract_original":"BACKGROUND: The optimal noninvasive test (NIT) for patients with diabetes and stable symptoms of coronary artery disease (CAD) is unknown. OBJECTIVES: The purpose of this study was to assess whether a diagnostic strategy based on coronary computed tomographic angiography (CTA) is superior to functional stress testing in reducing adverse cardiovascular (CV) outcomes (CV death or myocardial infarction [MI]) among symptomatic patients with diabetes. METHODS: PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) was a randomized trial evaluating an initial strategy of CTA versus functional testing in stable outpatients with symptoms suggestive of CAD. The study compared CV outcomes in patients with diabetes (n = 1,908 [21%]) and without diabetes (n = 7,058 [79%]) based on their randomization to CTA or functional testing. RESULTS: Patients with diabetes (vs. without) were similar in age (median 61 years vs. 60 years) and sex (female 54% vs. 52%) but had a greater burden of CV comorbidities. Patients with diabetes who underwent CTA had a lower risk of CV death/MI compared with functional stress testing (CTA: 1.1% [10 of 936] vs. stress testing: 2.6% [25 of 972]; adjusted hazard ratio: 0.38; 95% confidence interval: 0.18 to 0.79; p = 0.01). There was no significant difference in nondiabetic patients (CTA: 1.4% [50 of 3,564] vs. stress testing: 1.3% [45 of 3,494]; adjusted hazard ratio: 1.03; 95% confidence interval: 0.69 to 1.54; p = 0.887; interaction term for diabetes p value = 0.02). CONCLUSIONS: In diabetic patients presenting with stable chest pain, a CTA strategy resulted in fewer adverse CV outcomes than a functional testing strategy. CTA may be considered as the initial diagnostic strategy in this subgroup. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550)."},{"id":"18fd1bff9c05","type":"article","url":"https://hartvaat.nl/2019/03/05/canakinumab-ter-preventie-van-hartfalen-hospitalisatie-cantos-analyse/","title":"Canakinumab ter preventie van hartfalen-hospitalisatie: CANTOS-analyse","title_en":"Anti-Inflammatory Therapy With Canakinumab for the Prevention of Hospitalization for Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["acuut-hartfalen"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038010","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038010","authors":["Brendan M Everett","Jan H Cornel","Mitja Lainscak","Stefan D Anker","Antonio Abbate","Tom Thuren","Peter Libby","Robert J Glynn","Paul M Ridker"],"significance":8,"published":"2019-03-05","source_date":"2019-03-05","image":"","kennis":[],"congress":"","summary_en":"This CANTOS subanalysis demonstrated that canakinumab reduced heart failure hospitalization in post-MI patients with elevated CRP, providing evidence that anti-inflammatory therapy targeting IL-1β may prevent heart failure development in high-inflammatory-risk patients.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:01Z","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":"CANTOS subanalyse die aantoont dat canakinumab hartfalenhospitalisaties vermindert. Inflammatieremming als HF-preventie.","abstract_original":"BACKGROUND: Subclinical inflammation is associated with an increased risk of heart failure and with adverse prognosis in patients with established heart failure. Yet, treatments specifically directed at reducing inflammation in patients with heart failure have not yet shown improved clinical outcomes. We tested the hypothesis that the interleukin-1β inhibitor canakinumab would prevent hospitalization for heart failure (HHF) and the composite of HHF or heart failure-related mortality. METHODS: We randomized 10 061 patients with prior myocardial infarction and high-sensitivity C-reactive protein ≥2 mg/L to canakinumab 50, 150, or 300 mg or placebo, given subcutaneously once every 3 months. In total, 2173 (22%) reported a history of heart failure at baseline. We tested the hypothesis that canakinumab prevents prospectively collected HHF events and the composite of HHF or heart failure-related mortality. RESULTS: A total of 385 patients had an HHF event during a median follow-up of 3.7 years. Patients who had HHF were older, had higher body mass index, and were more likely to have diabetes mellitus, hypertension, and prior coronary bypass surgery. As anticipated, median (quartile 1, 3) baseline concentrations of high-sensitivity C-reactive protein were higher among those who had HHF during follow-up than those who did not (5.7 [3.5, 9.9] mg/L versus 4.2 [2.8, 6.9] mg/L, respectively; P<0.0001). The unadjusted hazard ratios for HHF with each dose of canakinumab compared with placebo were 1.04 (95% CI, 0.79-1.36) for 50 mg, 0.86 (95% CI, 0.65-1.13) for 150 mg, and 0.76 (95% CI, 0.57-1.01) for 300 mg ( P for trend=0.025). The composite of HHF or heart failure-related mortality was also reduced by canakinumab, with unadjusted hazard ratios of 1.00 (95% CI, 0.78-1.29) for 50 mg, 0.88 (95% CI, 0.68-1.13) for 150 mg, and 0.78 (95% CI, 0.60-1.02) for 300 mg ( P for trend=0.042). CONCLUSIONS: These randomized double-blind placebo-controlled data suggest that therapy with canakinumab, an interleukin-1β inhibitor, is related to a dose-dependent reduction in HHF and the composite of HHF or heart failure-related mortality in a population of patients with prior myocardial infarction and elevations in high-sensitivity C-reactive protein. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01327846."},{"id":"d31c123508f3","type":"article","url":"https://hartvaat.nl/2019/03/02/intensieve-bloeddrukverlaging-bij-iv-trombolyse-voor-acuut-cva-lancet-enchanted/","title":"Intensieve bloeddrukverlaging bij IV trombolyse voor acuut CVA: Lancet ENCHANTED","title_en":"Intensive blood pressure reduction with intravenous thrombolysis therapy for acute ischaemic stroke (ENCHANTED): an international, randomised, open-label, blinded-endpoint, phase 3 trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(19)30038-8","source_url":"https://doi.org/10.1016/S0140-6736(19)30038-8","authors":["Craig S Anderson","Yining Huang","Richard I Lindley","Xiaoying Chen","Hisatomi Arima","Guofang Chen","Qiang Li","Laurent Billot","Candice Delcourt","Philip M Bath","Joseph P Broderick","Andrew M Demchuk","Geoffrey A Donnan","Alice C Durham","Pablo M Lavados","Tsong-Hai Lee","Christopher Levi","Sheila O Martins","Veronica V Olavarria","Jeyaraj D Pandian","Mark W Parsons","Octavio M Pontes-Neto","Stefano Ricci","Shoichiro Sato","Vijay K Sharma","Federico Silva","Lili Song","Nguyen H Thang","Joanna M Wardlaw","Ji-Guang Wang","Xia Wang","Mark Woodward","John Chalmers","Thompson G Robinson"],"significance":8,"published":"2019-03-02","source_date":"2019-03-02","image":"","kennis":[],"congress":"","summary_en":"The ENCHANTED blood pressure substudy showed that intensive blood pressure lowering (target 130-140 mmHg) during intravenous thrombolysis for acute ischemic stroke did not improve functional outcomes versus guideline-recommended management, though it reduced intracranial hemorrhage.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:01Z","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":"Lancet ENCHANTED bloeddrukcomponent: intensieve versus standaard bloeddrukverlaging bij patiënten die trombolyse krijgen voor acuut ischemisch CVA.","abstract_original":"BACKGROUND: Systolic blood pressure of more than 185 mm Hg is a contraindication to thrombolytic treatment with intravenous alteplase in patients with acute ischaemic stroke, but the target systolic blood pressure for optimal outcome is uncertain. We assessed intensive blood pressure lowering compared with guideline-recommended blood pressure lowering in patients treated with alteplase for acute ischaemic stroke. METHODS: We did an international, partial-factorial, open-label, blinded-endpoint trial of thrombolysis-eligible patients (age ≥18 years) with acute ischaemic stroke and systolic blood pressure 150 mm Hg or more, who were screened at 110 sites in 15 countries. Eligible patients were randomly assigned (1:1, by means of a central, web-based program) within 6 h of stroke onset to receive intensive (target systolic blood pressure 130-140 mm Hg within 1 h) or guideline (target systolic blood pressure <180 mm Hg) blood pressure lowering treatment over 72 h. The primary outcome was functional status at 90 days measured by shift in modified Rankin scale scores, analysed with unadjusted ordinal logistic regression. The key safety outcome was any intracranial haemorrhage. Primary and safety outcome assessments were done in a blinded manner. Analyses were done on intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01422616. FINDINGS: Between March 3, 2012, and April 30, 2018, 2227 patients were randomly allocated to treatment groups. After exclusion of 31 patients because of missing consent or mistaken or duplicate randomisation, 2196 alteplase-eligible patients with acute ischaemic stroke were included: 1081 in the intensive group and 1115 in the guideline group, with 1466 (67·4%) administered a standard dose among the 2175 actually given intravenous alteplase. Median time from stroke onset to randomisation was 3·3 h (IQR 2·6-4·1). Mean systolic blood pressure over 24 h was 144·3 mm Hg (SD 10·2) in the intensive group and 149·8 mm Hg (12·0) in the guideline group (p<0·0001). Primary outcome data were available for 1072 patients in the intensive group and 1108 in the guideline group. Functional status (mRS score distribution) at 90 days did not differ between groups (unadjusted odds ratio [OR] 1·01, 95% CI 0·87-1·17, p=0·8702). Fewer patients in the intensive group (160 [14·8%] of 1081) than in the guideline group (209 [18·7%] of 1115) had any intracranial haemorrhage (OR 0·75, 0·60-0·94, p=0·0137). The number of patients with any serious adverse event did not differ significantly between the intensive group (210 [19·4%] of 1081) and the guideline group (245 [22·0%] of 1115; OR 0·86, 0·70-1·05, p=0·1412). There was no evidence of an interaction of intensive blood pressure lowering with dose (low vs standard) of alteplase with regard to the primary outcome. INTERPRETATION: Although intensive blood pressure lowering is safe, the observed reduction in intracranial haemorrhage did not lead to improved clinical outcome compared with guideline treatment. These results might not support a major shift towards this treatment being applied in those receiving alteplase for mild-to-moderate acute ischaemic stroke. Further research is required to define the underlying mechanisms of benefit and harm resulting from early intensive blood pressure lowering in this patient group. FUNDING: National Health and Medical Research Council of Australia; UK Stroke Association; Ministry of Health and the National Council for Scientific and Technological Development of Brazil; Ministry for Health, Welfare, and Family Affairs of South Korea; Takeda."},{"id":"f737a3cfaaea","type":"article","url":"https://hartvaat.nl/2019/03/01/trimetazidine-bij-niet-obstructieve-hcm-jama-cardiology-gerandomiseerde-trial/","title":"Trimetazidine bij niet-obstructieve HCM: JAMA Cardiology gerandomiseerde trial","title_en":"Effect of Trimetazidine Dihydrochloride Therapy on Exercise Capacity in Patients With Nonobstructive Hypertrophic Cardiomyopathy: A Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["aficamten","hypertrofische-cardiomyopathie"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2018.4847","source_url":"https://doi.org/10.1001/jamacardio.2018.4847","authors":["Caroline J Coats","Menelaos Pavlou","Oliver T Watkinson","Alexandros Protonotarios","Linda Moss","Rebecca Hyland","Khadija Rantell","Antonis A Pantazis","Maite Tome","William J McKenna","Michael P Frenneaux","Rumana Omar","Perry M Elliott"],"significance":6,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hypertrofische-cardiomyopathie/"],"congress":"","summary_en":"This trial of trimetazidine in nonobstructive hypertrophic cardiomyopathy tested whether optimizing myocardial energy metabolism improves exercise capacity in patients with the obstructive and nonobstructive forms of HCM.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:01Z","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":"JAMA Cardiology trial van trimetazidine bij niet-obstructieve hypertrofische cardiomyopathie voor verbetering van inspanningscapaciteit. Metabole therapie bij HCM.","abstract_original":"IMPORTANCE: Hypertrophic cardiomyopathy causes limiting symptoms in patients, mediated partly through inefficient myocardial energy use. There is conflicting evidence for therapy with inhibitors of myocardial fatty acid metabolism in patients with nonobstructive hypertrophic cardiomyopathy. OBJECTIVE: To determine the effect of oral therapy with trimetazidine, a direct inhibitor of fatty acid β-oxidation, on exercise capacity in patients with symptomatic nonobstructive hypertrophic cardiomyopathy. DESIGN, SETTING, AND PARTICIPANTS: This randomized, placebo-controlled, double-blind clinical trial at The Heart Hospital, University College London Hospitals, London, United Kingdom was performed between May 31, 2012, and September 8, 2014. The trial included 51 drug-refractory symptomatic (New York Heart Association class ≥2) patients aged 24 to 74 years with a maximum left ventricular outflow tract gradient 50 mm Hg or lower and a peak oxygen consumption during exercise of 80% or less predicted value for age and sex. Statistical analysis was performed from March 1, 2016 through July 4, 2018. INTERVENTIONS: Participants were randomly assigned to trimetazidine, 20 mg, 3 times daily (n = 27) or placebo (n = 24) for 3 months. MAIN OUTCOMES AND MEASURES: The primary end point was peak oxygen consumption during upright bicycle ergometry. Secondary end points were 6-minute walk distance, quality of life (Minnesota Living with Heart Failure questionnaire), frequency of ventricular ectopic beats, diastolic function, serum N-terminal pro-brain natriuretic peptide level, and troponin T level. RESULTS: Of 49 participants who received trimetazidine (n = 26) or placebo (n = 23) and completed the study, 34 (70%) were male; the mean (SD) age was 50 (13) years. Trimetazidine therapy did not improve exercise capacity, with patients in the trimetazidine group walking 38.4 m (95% CI, 5.13 to 71.70 m) less than patients in the placebo group at 3 months after adjustment for their baseline walking distance measurements. After adjustment for baseline values, peak oxygen consumption was 1.35 mL/kg per minute lower (95% CI, -2.58 to -0.11 mL/kg per minute; P = .03) in the intervention group after 3 months. CONCLUSIONS AND RELEVANCE: In symptomatic patients with nonobstructive hypertrophic cardiomyopathy, trimetazidine therapy does not improve exercise capacity. Pharmacologic therapy for this disease remains limited. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01696370."},{"id":"e2868e593321","type":"article","url":"https://hartvaat.nl/2019/03/01/ambulante-hartfrequentiereductie-na-renale-denervatie-bij-hypertensie-zonder-med/","title":"Ambulante hartfrequentiereductie na renale denervatie bij hypertensie zonder medicatie","title_en":"Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","bloeddrukbehandeling","chronische-nierziekte","cystatine-c","diuretica","flow-trial","ivabradine","radiance-htn","renale-denervatie","resistente-hypertensie","sacubitril-valsartan"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy871","source_url":"https://doi.org/10.1093/eurheartj/ehy871","authors":["Michael Böhm","Felix Mahfoud","Raymond R Townsend","David E Kandzari","Stuart Pocock","Christian Ukena","Michael A Weber","Satoshi Hoshide","Manesh Patel","Crystal C Tyson","Joachim Weil","Tolga Agdirlioglu","Martin Fahy","Kazuomo Kario"],"significance":5,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/"],"congress":"","summary_en":"This SPYRAL analysis showed that renal denervation reduces ambulatory heart rate in addition to blood pressure, suggesting that sympathetic modulation extends beyond vascular tone to cardiac rate regulation.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SPYRAL-analyse naar het effect van renale denervatie op ambulante hartfrequentie bij hypertensieve patiënten zonder antihypertensiva.","abstract_original":"AIMS: The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population. METHODS AND RESULTS: Patients were enrolled with an office systolic BP (SBP) of ≥150 mmHg and <180 mmHg, office diastolic BP (DBP) of ≥90 mmHg, and a mean ambulatory SBP of ≥140 mmHg and <170 mmHg. Patients were drug naïve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant. CONCLUSION: Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure."},{"id":"bcc61c5150b1","type":"article","url":"https://hartvaat.nl/2019/03/01/ziekenhuisgebaseerde-kwaliteitsinterventies-bij-hartfalen-systematische-review/","title":"Ziekenhuisgebaseerde kwaliteitsinterventies bij hartfalen: systematische review","title_en":"Hospital-based quality improvement interventions for patients with heart failure: a systematic review.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-314129","source_url":"https://doi.org/10.1136/heartjnl-2018-314129","authors":["Anubha Agarwal","Ehete Bahiru","Sang Gune Kyle Yoo","Mark A Berendsen","Sivadasanpillai Harikrishnan","Adrian F Hernandez","Dorairaj Prabhakaran","Mark D Huffman"],"significance":6,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"This systematic review evaluated hospital-based quality improvement interventions for heart failure, characterizing which implementation strategies effectively improve guideline adherence and clinical outcomes.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:01Z","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":"Systematische review van ziekenhuisgebaseerde kwaliteitsverbeteringsinterventies bij hartfalen. Overzicht van effectieve implementatiestrategieën.","abstract_original":"OBJECTIVE: To estimate the direction and magnitude of effect and quality of evidence for hospital-based heart failure (HF) quality improvement interventions on process of care measures and clinical outcomes among patients with acute HF. REVIEW METHODS: We performed a structured search to identify relevant randomised trials evaluating the effect of in-hospital quality improvement interventions for patients hospitalised with HF through February 2017. Studies were independently reviewed in duplicate for key characteristics, outcomes were summarised and a qualitative synthesis was performed due to substantial heterogeneity. RESULTS: From 3615 records, 14 randomised controlled trials were identified for inclusion with multifaceted interventions. There was a trend towards higher in-hospital use of ACE inhibitors (ACE-I; 57.9%vs40.0%) and beta-blockers (BBs; 46.7%vs10.2%) in the intervention than the comparator in one trial (n=429 participants). Five trials (n=78 727 participants) demonstrated no effect of the intervention on use of ACE-I or angiotensin receptor blocker at discharge. Three trials (n=89 660 participants) reported no effect on use of BB at discharge. Two trials (n=419 participants) demonstrated a trend towards lower hospital readmission up to 90 days after discharge. There was no consistent effect of the quality improvement intervention on 30-day all-cause mortality, hospital length of stay and patient-level health-related quality of life. CONCLUSIONS: Randomised trials of hospital-based HF quality improvement interventions do not show a consistent effect on most process of care measures and clinical outcomes. The overall quality of evidence for the prespecified primary and key secondary outcomes was very low to moderate, suggesting that future research will likely influence these estimates. TRIAL REGISTRATION NUMBER: CRD42016049545."},{"id":"eea8629a2370","type":"article","url":"https://hartvaat.nl/2019/03/01/bariatrische-chirurgie-versus-medicamenteus-beleid-op-24-uurs-ambulante-bloeddru/","title":"Bariatrische chirurgie versus medicamenteus beleid op 24-uurs ambulante bloeddruk en resistente HTN","title_en":"Effects of Bariatric Surgery Versus Medical Therapy on the 24-Hour Ambulatory Blood Pressure and the Prevalence of Resistant Hypertension.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12290","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12290","authors":["Carlos A Schiavon","Dimas Ikeoka","Eliana V Santucci","Renato Nakagawa Santos","Lucas P Damiani","Priscila Torres Bueno","Juliana D Oliveira","Camila R Torreglosa","Angela Cristine Bersch-Ferreira","Tamiris A Miranda","Silvana de Barros","Helio Halpern","Frederico L J Monteiro","Ricardo V Cohen","Patricia M Noujaim","Marcio G de Souza","Celso Amodeo","Luiz A Bortolotto","Otavio Berwanger","Alexandre B Cavalcanti","Luciano F Drager"],"significance":7,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/bloeddrukmeting-thuismeting-abpm/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"This study compared the effects of bariatric surgery versus medical therapy on 24-hour ambulatory blood pressure and resistant hypertension prevalence, demonstrating that surgical weight loss achieves superior blood pressure control beyond what medications can provide.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:01Z","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":"Vergelijking van bariatrische chirurgie met medicamenteus beleid op 24-uurs ambulante bloeddruk en prevalentie van resistente hypertensie.","abstract_original":"Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0-1] versus 3 [2.5-4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, -1.63; 95% CI, -2.91 to -0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01784848."},{"id":"c24512c01b43","type":"article","url":"https://hartvaat.nl/2019/03/01/natriumreductie-tot-1000-mg-dag-vermindert-neurovasculaire-transductie-zonder-sy/","title":"Natriumreductie tot 1000 mg/dag vermindert neurovasculaire transductie zonder sympathische activatie","title_en":"Reducing Dietary Sodium to 1000 mg per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12074","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12074","authors":["Matthew C Babcock","Austin T Robinson","Kamila U Migdal","Joseph C Watso","Megan M Wenner","Sean D Stocker","William B Farquhar"],"significance":5,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":[],"congress":"","summary_en":"This study demonstrated that extreme sodium reduction to 1,000 mg/day reduces neurovascular transduction without triggering compensatory sympathetic activation, supporting aggressive dietary sodium targets for blood pressure management.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T13:27:00Z","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":"Studie die aantoont dat extreme natriumreductie de neurovasculaire transductie verbetert zonder compensatoire sympathische activatie.","abstract_original":"The American Heart Association recommends no more than 1500 mg of sodium/day as ideal. Some cohort studies suggest low-sodium intake is associated with increased cardiovascular mortality. Extremely low-sodium diets (≤500 mg/d) elicit activation of the renin-angiotensin-aldosterone system and stimulate sympathetic outflow. The effects of an American Heart Association-recommended diet on sympathetic regulation of the vasculature are unclear. Therefore, we assessed whether a 1000 mg/d diet alters sympathetic outflow and sympathetic vascular transduction compared with the more commonly recommended 2300 mg/d. We hypothesized that sodium reduction from 2300 to 1000 mg/d would not affect resting sympathetic outflow but would reduce sympathetic transduction in healthy young adults. Seventeen participants (age: 26±2 years, 9F/8M) completed 10-day 2300 and 1000 mg/d sodium diets in this randomized controlled feeding study (crossover). We measured resting renin activity, angiotensin II, aldosterone, blood pressure, muscle sympathetic nerve activity, and norepinephrine. We quantified beat-by-beat changes in mean arterial pressure and leg vascular conductance (femoral artery ultrasound) following spontaneous sympathetic bursts to assess sympathetic vascular transduction. Reducing sodium to 1000 mg/d increased renin activity, angiotensin II, and aldosterone ( P<0.01 for all) but did not alter mean arterial pressure (78±2 versus 77±2 mm Hg, P=0.56), muscle sympathetic nerve activity (13.9±1.3 versus 13.9±0.8 bursts/min, P=0.98), or plasma/urine norepinephrine. Sympathetic vascular transduction decreased ( P<0.01). These data suggest that reducing sodium from 2300 to 1000 mg/d stimulates the renin-angiotensin-aldosterone system, does not increase resting basal sympathetic outflow, and reduces sympathetic vascular transduction in normotensive adults."},{"id":"d9612f6d037e","type":"article","url":"https://hartvaat.nl/2019/03/01/mediterraan-dieet-verbetert-systolische-bloeddruk-en-arteriele-stijfheid-bij-oud/","title":"Mediterraan dieet verbetert systolische bloeddruk en arteriële stijfheid bij ouderen","title_en":"Mediterranean-Style Diet Improves Systolic Blood Pressure and Arterial Stiffness in Older Adults.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":["bloeddrukbehandeling","perifeer-vaatlijden"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12259","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12259","authors":["Amy Jennings","Agnes M Berendsen","Lisette C P G M de Groot","Edith J M Feskens","Anna Brzozowska","Ewa Sicinska","Barbara Pietruszka","Nathalie Meunier","Elodie Caumon","Corinne Malpuech-Brugère","Aurelia Santoro","Rita Ostan","Claudio Franceschi","Rachel Gillings","Colette M O' Neill","Sue J Fairweather-Tait","Anne-Marie Minihane","Aedín Cassidy"],"significance":6,"published":"2019-03-01","source_date":"2019-03-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/behandeldoelen-bloeddruk/"],"congress":"","summary_en":"This study demonstrated that a Mediterranean-style diet tailored for older adults improves systolic blood pressure and arterial stiffness, providing dietary evidence specifically for the elderly hypertensive population.","created":"2026-07-03T10:27:48Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die aantoont dat een mediterraan dieet de systolische bloeddruk en arteriële stijfheid verbetert bij oudere volwassenen.","abstract_original":"We aimed to determine the effect of a Mediterranean-style diet, tailored to meet dietary recommendations for older adults, on blood pressure and arterial stiffness. In 12 months, randomized controlled trial (NU-AGE [New Dietary Strategies Addressing the Specific Needs of Elderly Population for Healthy Aging in Europe]), blood pressure was measured in 1294 healthy participants, aged 65 to 79 years, recruited from 5 European centers, and arterial stiffness in a subset of 225 participants. The intervention group received individually tailored standardized dietary advice and commercially available foods to increase adherence to a Mediterranean diet. The control group continued on their habitual diet and was provided with current national dietary guidance. In the 1142 participants who completed the trial (88.2%), after 1 year the intervention resulted in a significant reduction in systolic blood pressure (-5.5 mm Hg; 95% CI, -10.7 to -0.4; P=0.03), which was evident in males (-9.2 mm Hg, P=0.02) but not females (-3.1 mm Hg, P=0.37). The -1.7 mm Hg (95% CI, -4.3 to 0.9) decrease in diastolic pressure after intervention did not reach statistical significance. In a subset (n=225), augmentation index, a measure of arterial stiffness, was improved following intervention (-12.4; 95% CI, -24.4 to -0.5; P=0.04) with no change in pulse wave velocity. The intervention also resulted in an increase in 24-hour urinary potassium (8.8 mmol/L; 95% CI, 0.7-16.9; P=0.03) and in male participants (52%) a reduction in pulse pressure (-6.1 mm Hg; 95% CI, -12.0 to -0.2; P=0.04) and 24-hour urinary sodium (-27.1 mmol/L; 95% CI, -53.3 to -1.0; P=0.04). In conclusion, a Mediterranean-style diet is effective in improving cardiovascular health with clinically relevant reductions in blood pressure and arterial stiffness. Clinical Trial Registration- URL: http://www.clinicialtrials.gov . Unique identifier: NCT01754012."},{"id":"c758668958fc","type":"article","url":"https://hartvaat.nl/2019/02/26/patientgerichte-transitional-care-bij-hf-hospitalisatie-jama-pact-hf/","title":"Patiëntgerichte transitional care bij HF-hospitalisatie: JAMA PACT-HF","title_en":"Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2019.0710","source_url":"https://doi.org/10.1001/jama.2019.0710","authors":["Harriette G C Van Spall","Shun Fu Lee","Feng Xie","Urun Erbas Oz","Richard Perez","Peter R Mitoff","Manish Maingi","Michael C Tjandrawidjaja","Michael Heffernan","Mohammad I Zia","Liane Porepa","Mohamed Panju","Lehana Thabane","Ian D Graham","R Brian Haynes","Dilys Haughton","Kim D Simek","Dennis T Ko","Stuart J Connolly"],"significance":7,"published":"2019-02-26","source_date":"2019-02-26","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"The PACT-HF trial of patient-centered transitional care services for heart failure patients showed no significant reduction in readmission or death, despite improved patient self-care. The result highlighted the difficulty of reducing heart failure readmissions with transitional care alone.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"JAMA PACT-HF gerandomiseerde trial van patiëntgerichte transitional care services bij gehospitaliseerde hartfalenpatiënten.","abstract_original":"IMPORTANCE: Health care services that support the hospital-to-home transition can improve outcomes in patients with heart failure (HF). OBJECTIVE: To test the effectiveness of the Patient-Centered Care Transitions in HF transitional care model in patients hospitalized for HF. DESIGN, SETTING, AND PARTICIPANTS: Stepped-wedge cluster randomized trial of 2494 adults hospitalized for HF across 10 hospitals in Ontario, Canada, from February 2015 to March 2016, with follow-up until November 2016. INTERVENTIONS: Hospitals were randomized to receive the intervention (n = 1104 patients), in which nurse-led self-care education, a structured hospital discharge summary, a family physician follow-up appointment less than 1 week after discharge, and, for high-risk patients, structured nurse homevisits and heart function clinic care were provided to patients, or usual care (n = 1390 patients), in which transitional care was left to the discretion of clinicians. MAIN OUTCOMES AND MEASURES: Primary outcomes were hierarchically ordered as composite all-cause readmission, emergency department (ED) visit, or death at 3 months; and composite all-cause readmission or ED visit at 30 days. Secondary outcomes were B-PREPARED score for discharge preparedness (range: 0 [most prepared] to 22 [least prepared]); the 3-Item Care Transitions Measure (CTM-3) for quality of transition (range: 0 [worst transition] to 100 [best transition]); the 5-level EQ-5D version (EQ-5D-5L) for quality of life (range: 0 [dead] to 1 [full health]); and quality-adjusted life-years (QALY; range: 0 [dead] to 0.5 [full health at 6 months]). RESULTS: Among eligible patients, all 2494 (mean age, 77.7 years; 1258 [50.4%] women) completed the trial. There was no significant difference between the intervention and usual care groups in the first primary composite outcome (545 [49.4%] vs 698 [50.2%] events, respectively; hazard ratio [HR], 0.99 [95% CI, 0.83-1.19]) or in the second primary composite outcome (304 [27.5%] vs 408 [29.3%] events, respectively; HR, 0.93 [95% CI, 0.73-1.18]). There were significant differences between the intervention and usual care groups in the secondary outcomes of mean B-PREPARED score at 6 weeks (16.6 vs 13.9; difference, 2.65 [95% CI, 1.37-3.92]; P < .001); mean CTM-3 score at 6 weeks (76.5 vs 70.3; difference, 6.16 [95% CI, 0.90-11.43]; P = .02); and mean EQ-5D-5L score at 6 weeks (0.7 vs 0.7; difference, 0.06 [95% CI, 0.01 to 0.11]; P = .02) and 6 months (0.7 vs 0.6; difference, 0.06 [95% CI, 0.01-0.12]; P = .02). There was no significant difference in mean QALY between groups at 6 months (0.3 vs 0.3; difference, 0.00 [95% CI, -0.02 to 0.02]; P = .98). CONCLUSIONS AND RELEVANCE: Among patients with HF in Ontario, Canada, implementation of a patient-centered transitional care model compared with usual care did not improve a composite of clinical outcomes. Whether this type of intervention could be effective in other health care systems or locations would require further research. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02112227."},{"id":"6fbefb906b1c","type":"article","url":"https://hartvaat.nl/2019/02/26/sacubitril-valsartan-en-biomarkers-van-extracellulaire-matrixregulatie-bij-hfref/","title":"Sacubitril/valsartan en biomarkers van extracellulaire matrixregulatie bij HFrEF","title_en":"Effects of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFrEF.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["bloeddrukbehandeling","sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.042","source_url":"https://doi.org/10.1016/j.jacc.2018.11.042","authors":["Michael R Zile","Eileen O'Meara","Brian Claggett","Margaret F Prescott","Scott D Solomon","Karl Swedberg","Milton Packer","John J V McMurray","Victor Shi","Martin Lefkowitz","Jean Rouleau"],"significance":5,"published":"2019-02-26","source_date":"2019-02-26","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/ivabradine-bij-hartfalen/","https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"This study showed that sacubitril-valsartan reduces biomarkers of extracellular matrix regulation (collagen turnover, fibrosis) in HFrEF, providing mechanistic evidence for anti-fibrotic effects of combined neprilysin-RAAS inhibition.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"Studie naar het effect van sacubitril/valsartan op biomarkers van extracellulaire matrixregulatie (fibrose) bij HFrEF. Mechanistisch inzicht.","abstract_original":"BACKGROUND: Myocardial fibrosis is an important pathophysiological mechanism underlying the development of heart failure (HF). Given the biochemical targets of sacubitril/valsartan, we hypothesized that circulating biomarkers reflecting the mechanisms that determine extracellular matrix (ECM) homeostasis, including collagen synthesis, processing, and degradation, are altered by sacubitril/valsartan in comparison to enalapril. OBJECTIVES: The purpose of this study was to examine the effects of sacubitril/valsartan on biomarkers of ECM homeostasis and the association between the rate of primary composite outcome (cardiovascular death or HF hospitalization) and these biomarkers. METHODS: Biomarkers at baseline (n = 2,067) and both baseline and 8 months after randomization (n = 1,776) included aldosterone, soluble ST2 (sST2), tissue inhibitor of matrix metalloproteinase (TIMP)-1, matrix metalloproteinase (MMP)-2, MMP-9, Galectin-3 (Gal-3), N-terminal propeptide of collagen I (PINP), and N-terminal propeptide of collagen III (PIIINP). The effects of sacubitril/valsartan on biomarkers were compared with enalapril. Baseline biomarker values and changes from baseline to 8 months were related to primary outcome. RESULTS: At baseline, the profibrotic biomarkers aldosterone, sST2, TIMP-1, Gal-3, PINP, and PIIINP were higher, and biomarkers associated with collagen degradation, MMP-2 and -9, were lower than published referent control values. Eight months after randomization, aldosterone, sST2, TIMP-1, MMP-9, PINP, and PIIINP had decreased more in the sacubitril/valsartan than enalapril group. At baseline, higher values of sST-2, TIMP-1, and PIIINP were associated with higher primary outcome rates. Changes from baseline to 8 months in sST-2 and TIMP-1 were associated with change in outcomes. CONCLUSIONS: Biomarkers associated with profibrotic signaling are altered in HF with reduced ejection fraction, sacubitril/valsartan significantly decreased many of these biomarkers, and these biomarkers have important prognostic value. These findings suggest that sacubitril/valsartan may reduce profibrotic signaling, which may contribute to the improved outcomes. (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":"ceb5a64d3289","type":"article","url":"https://hartvaat.nl/2019/02/26/postprocedurele-bivalirudine-infusie-bij-acs-vol-versus-laag-regime/","title":"Postprocedurele bivalirudine-infusie bij ACS: vol versus laag regime","title_en":"Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.12.023","source_url":"https://doi.org/10.1016/j.jacc.2018.12.023","authors":["Giuseppe Gargiulo","Greta Carrara","Enrico Frigoli","Sergio Leonardi","Pascal Vranckx","Gianluca Campo","Ferdinando Varbella","Paolo Calabrò","Tiziana Zaro","Davide Bartolini","Carlo Briguori","Giuseppe Andò","Maurizio Ferrario","Ugo Limbruno","Salvatore Colangelo","Paolo Sganzerla","Filippo Russo","Marco Stefano Nazzaro","Giovanni Esposito","Giuseppe Ferrante","Andrea Santarelli","Gennaro Sardella","Stephan Windecker","Marco Valgimigli"],"significance":5,"published":"2019-02-26","source_date":"2019-02-26","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This study compared full-dose versus low-dose post-procedural bivalirudin infusion after PCI in ACS patients, testing whether reduced post-procedural anticoagulation maintains efficacy with less bleeding.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"Vergelijking van volledige versus verlaagde postprocedurele bivalirudine-infusie bij ACS-patiënten.","abstract_original":"BACKGROUND: The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear. OBJECTIVES: The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation. METHODS: The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding). RESULTS: Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups. CONCLUSIONS: In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627)."},{"id":"f19e7251bda4","type":"article","url":"https://hartvaat.nl/2019/02/21/laaggedoseerd-methotrexaat-voor-preventie-van-atherosclerotische-events-nejm-cir/","title":"Laaggedoseerd methotrexaat voor preventie van atherosclerotische events: NEJM CIRT","title_en":"Low-Dose Methotrexate for the Prevention of Atherosclerotic Events.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["atherosclerose","secundaire-preventie"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1809798","source_url":"https://doi.org/10.1056/NEJMoa1809798","authors":["Paul M Ridker","Brendan M Everett","Aruna Pradhan","Jean G MacFadyen","Daniel H Solomon","Elaine Zaharris","Virak Mam","Ahmed Hasan","Yves Rosenberg","Erin Iturriaga","Milan Gupta","Michelle Tsigoulis","Subodh Verma","Michael Clearfield","Peter Libby","Samuel Z Goldhaber","Roger Seagle","Cyril Ofori","Mohammad Saklayen","Samuel Butman","Narendra Singh","Michel Le May","Olivier Bertrand","James Johnston","Nina P Paynter","Robert J Glynn"],"significance":9,"published":"2019-02-21","source_date":"2019-02-21","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ezetimib/","https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/"],"congress":"","summary_en":"The CIRT trial showed that low-dose methotrexate did not reduce cardiovascular events in patients with stable atherosclerosis and type 2 diabetes or metabolic syndrome. The negative result, contrasting with positive canakinumab data from CANTOS, demonstrated that not all anti-inflammatory pathways are relevant to atherosclerotic cardiovascular risk.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"NEJM CIRT-trial die aantoonde dat laaggedoseerd methotrexaat géén cardiovasculaire events vermindert — in tegenstelling tot canakinumab. Differentiatie van de inflammatiehypothese.","abstract_original":"BACKGROUND: Inflammation is causally related to atherothrombosis. Treatment with canakinumab, a monoclonal antibody that inhibits inflammation by neutralizing interleukin-1β, resulted in a lower rate of cardiovascular events than placebo in a previous randomized trial. We sought to determine whether an alternative approach to inflammation inhibition with low-dose methotrexate might provide similar benefit. METHODS: We conducted a randomized, double-blind trial of low-dose methotrexate (at a target dose of 15 to 20 mg weekly) or matching placebo in 4786 patients with previous myocardial infarction or multivessel coronary disease who additionally had either type 2 diabetes or the metabolic syndrome. All participants received 1 mg of folate daily. The primary end point at the onset of the trial was a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Near the conclusion of the trial, but before unblinding, hospitalization for unstable angina that led to urgent revascularization was added to the primary end point. RESULTS: The trial was stopped after a median follow-up of 2.3 years. Methotrexate did not result in lower interleukin-1β, interleukin-6, or C-reactive protein levels than placebo. The final primary end point occurred in 201 patients in the methotrexate group and in 207 in the placebo group (incidence rate, 4.13 vs. 4.31 per 100 person-years; hazard ratio, 0.96; 95% confidence interval [CI], 0.79 to 1.16). The original primary end point occurred in 170 patients in the methotrexate group and in 167 in the placebo group (incidence rate, 3.46 vs. 3.43 per 100 person-years; hazard ratio, 1.01; 95% CI, 0.82 to 1.25). Methotrexate was associated with elevations in liver-enzyme levels, reductions in leukocyte counts and hematocrit levels, and a higher incidence of non-basal-cell skin cancers than placebo. CONCLUSIONS: Among patients with stable atherosclerosis, low-dose methotrexate did not reduce levels of interleukin-1β, interleukin-6, or C-reactive protein and did not result in fewer cardiovascular events than placebo. (Funded by the National Heart, Lung, and Blood Institute; CIRT ClinicalTrials.gov number, NCT01594333.)."},{"id":"456be72905f5","type":"article","url":"https://hartvaat.nl/2019/02/19/lv-unloading-tijdens-ecmo-bij-cardiogene-shock/","title":"LV-unloading tijdens ECMO bij cardiogene shock","title_en":"Left Ventricular Unloading During Extracorporeal Membrane Oxygenation in Patients With Cardiogenic Shock.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.10.085","source_url":"https://doi.org/10.1016/j.jacc.2018.10.085","authors":["Juan J Russo","Natasha Aleksova","Ian Pitcher","Etienne Couture","Simon Parlow","Mohammad Faraz","Sarah Visintini","Trevor Simard","Pietro Di Santo","Rebecca Mathew","Derek Y So","Koji Takeda","A Reshad Garan","Dimitrios Karmpaliotis","Hiroo Takayama","Ajay J Kirtane","Benjamin Hibbert"],"significance":6,"published":"2019-02-19","source_date":"2019-02-19","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study evaluated strategies for left ventricular unloading during VA-ECMO in cardiogenic shock, comparing the outcomes of different mechanical approaches to reduce the deleterious effects of LV distension during extracorporeal support.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"Studie naar linkerkamer-ontlasting tijdens ECMO bij patiënten met cardiogene shock. Optimalisatie van mechanische circulatoire ondersteuning.","abstract_original":"BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a widely used form of mechanical circulatory support in patients with refractory cardiogenic shock. A common drawback of this modality is a resultant increase in left ventricular afterload. OBJECTIVES: The purpose of this meta-analysis was to examine the efficacy and safety of left ventricular unloading strategies during VA-ECMO in adult patients with cardiogenic shock. METHODS: The authors performed a systematic search of studies examining left ventricular unloading during VA-ECMO in Medline, EMBASE, and the Cochrane library. The primary outcome was all-cause mortality. Secondary outcomes included limb ischemia, bleeding, need for renal replacement therapy, multiorgan failure, stroke or transient ischemic attack, and hemolysis. RESULTS: Of 2,221 publications identified, 17 observational studies met the inclusion criteria. In total, outcomes in 3,997 patients were included with 1,696 (42%) receiving a concomitant left ventricular unloading strategy while on VA-ECMO (intra-aortic balloon pump 91.7%, percutaneous ventricular assist device 5.5%, pulmonary vein or transseptal left atrial cannulation 2.8%). There were 2,412 deaths (60%) in the total cohort. Mortality was lower in patients with (54%) versus without (65%) left ventricular unloading while on VA-ECMO (risk ratio: 0.79; 95% confidence interval: 0.72 to 0.87; p < 0.00001). Hemolysis was higher in patients who underwent VA-ECMO with left ventricular unloading. Otherwise, secondary outcomes were not demonstrably different in patients treated with VA-ECMO with versus without left ventricular unloading. CONCLUSIONS: In observational studies, left ventricular unloading was associated with decreased mortality in adult patients with cardiogenic shock treated with VA-ECMO. In the absence of prospective randomized data, left ventricular unloading may be considered for appropriately selected patients undergoing VA-ECMO support."},{"id":"d3bf4a22634a","type":"article","url":"https://hartvaat.nl/2019/02/19/langetermijnoverleving-na-multivatenrevascularisatie-bij-diabetes-freedom-follow/","title":"Langetermijnoverleving na multivatenrevascularisatie bij diabetes: FREEDOM follow-on","title_en":"Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","diabetes-type-1","hartrevalidatie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.11.001","source_url":"https://doi.org/10.1016/j.jacc.2018.11.001","authors":["Michael E Farkouh","Michael Domanski","George D Dangas","Lucas C Godoy","Michael J Mack","Flora S Siami","Taye H Hamza","Binita Shah","Giulio G Stefanini","Mandeep S Sidhu","Jean-François Tanguay","Krishnan Ramanathan","Samin K Sharma","John French","Whady Hueb","David J Cohen","Valentin Fuster"],"significance":8,"published":"2019-02-19","source_date":"2019-02-19","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"The FREEDOM long-term follow-up confirmed persistent survival advantage of CABG over PCI in patients with diabetes and multivessel coronary disease, with the mortality difference widening beyond the original trial period. The data reinforced CABG as the preferred revascularization strategy in diabetic patients.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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":"FREEDOM langetermijnfollow-up die het persisterende overlevingsvoordeel van CABG boven PCI bevestigt bij diabetespatiënten met multivatencoronairlijden.","abstract_original":"BACKGROUND: The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period. OBJECTIVES: The purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial. METHODS: The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus-eluting or paclitaxel-eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses. RESULTS: A total of 25 centers (of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range 0 to 13.2 years). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 0.97 to 1.78; p = 0.076). CONCLUSIONS: In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450)."},{"id":"5414ba3e473f","type":"article","url":"https://hartvaat.nl/2019/02/14/gelijkstelling-van-vier-cv-risicoalgoritmen-na-hercalibratie-ipd-meta-analyse/","title":"Gelijkstelling van vier CV-risicoalgoritmen na hercalibratie: IPD meta-analyse","title_en":"Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":["laminopathie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy653","source_url":"https://doi.org/10.1093/eurheartj/ehy653","authors":["Lisa Pennells","Stephen Kaptoge","Angela Wood","Mike Sweeting","Xiaohui Zhao","Ian White","Stephen Burgess","Peter Willeit","Thomas Bolton","Karel G M Moons","Yvonne T van der Schouw","Randi Selmer","Kay-Tee Khaw","Vilmundur Gudnason","Gerd Assmann","Philippe Amouyel","Veikko Salomaa","Mika Kivimaki","Børge G Nordestgaard","Michael J Blaha","Lewis H Kuller","Hermann Brenner","Richard F Gillum","Christa Meisinger","Ian Ford","Matthew W Knuiman","Annika Rosengren","Debbie A Lawlor","Henry Völzke","Cyrus Cooper","Alejandro Marín Ibañez","Edoardo Casiglia","Jussi Kauhanen","Jackie A Cooper","Beatriz Rodriguez","Johan Sundström","Elizabeth Barrett-Connor","Rachel Dankner","Paul J Nietert","Karina W Davidson","Robert B Wallace","Dan G Blazer","Cecilia Björkelund","Chiara Donfrancesco","Harlan M Krumholz","Aulikki Nissinen","Barry R Davis","Sean Coady","Peter H Whincup","Torben Jørgensen","Pierre Ducimetiere","Maurizio Trevisan","Gunnar Engström","Carlos J Crespo","Tom W Meade","Marjolein Visser","Daan Kromhout","Stefan Kiechl","Makoto Daimon","Jackie F Price","Agustin Gómez de la Cámara","J Wouter Jukema","Benoît Lamarche","Altan Onat","Leon A Simons","Maryam Kavousi","Yoav Ben-Shlomo","John Gallacher","Jacqueline M Dekker","Hisatomi Arima","Nawar Shara","Robert W Tipping","Ronan Roussel","Eric J Brunner","Wolfgang Koenig","Masaru Sakurai","Jelena Pavlovic","Ron T Gansevoort","Dorothea Nagel","Uri Goldbourt","Elizabeth L M Barr","Luigi Palmieri","Inger Njølstad","Shinichi Sato","W M Monique Verschuren","Cherian V Varghese","Ian Graham","Oyere Onuma","Philip Greenland","Mark Woodward","Majid Ezzati","Bruce M Psaty","Naveed Sattar","Rod Jackson","Paul M Ridker","Nancy R Cook","Ralph B D'Agostino","Simon G Thompson","John Danesh","Emanuele Di Angelantonio"],"significance":7,"published":"2019-02-14","source_date":"2019-02-14","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lp-a-verhoogd/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This individual participant data meta-analysis compared four cardiovascular risk algorithms after systematic recalibration, showing that after calibration to local populations, all four perform comparably. The finding suggests that algorithm choice matters less than proper calibration.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:27:00Z","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 meta-analyse die vier cardiovasculaire risicoalgoritmen vergeleek na systematische hercalibratie. Na hercalibratie presteren ze vergelijkbaar.","abstract_original":"AIMS: There is debate about the optimum algorithm for cardiovascular disease (CVD) risk estimation. We conducted head-to-head comparisons of four algorithms recommended by primary prevention guidelines, before and after 'recalibration', a method that adapts risk algorithms to take account of differences in the risk characteristics of the populations being studied. METHODS AND RESULTS: Using individual-participant data on 360 737 participants without CVD at baseline in 86 prospective studies from 22 countries, we compared the Framingham risk score (FRS), Systematic COronary Risk Evaluation (SCORE), pooled cohort equations (PCE), and Reynolds risk score (RRS). We calculated measures of risk discrimination and calibration, and modelled clinical implications of initiating statin therapy in people judged to be at 'high' 10 year CVD risk. Original risk algorithms were recalibrated using the risk factor profile and CVD incidence of target populations. The four algorithms had similar risk discrimination. Before recalibration, FRS, SCORE, and PCE over-predicted CVD risk on average by 10%, 52%, and 41%, respectively, whereas RRS under-predicted by 10%. Original versions of algorithms classified 29-39% of individuals aged ≥40 years as high risk. By contrast, recalibration reduced this proportion to 22-24% for every algorithm. We estimated that to prevent one CVD event, it would be necessary to initiate statin therapy in 44-51 such individuals using original algorithms, in contrast to 37-39 individuals with recalibrated algorithms. CONCLUSION: Before recalibration, the clinical performance of four widely used CVD risk algorithms varied substantially. By contrast, simple recalibration nearly equalized their performance and improved modelled targeting of preventive action to clinical need."},{"id":"3a9bfa406132","type":"article","url":"https://hartvaat.nl/2019/02/12/genetisch-risico-op-coronairlijden-en-ontwikkeling-van-hfref-versus-hfpef/","title":"Genetisch risico op coronairlijden en ontwikkeling van HFrEF versus HFpEF","title_en":"Differential Association of Genetic Risk of Coronary Artery Disease With Development of Heart Failure With Reduced Versus Preserved Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["lipoproteïne-a"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038602","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038602","authors":["Ify R Mordi","Ewan R Pearson","Colin N A Palmer","Alexander S F Doney","Chim C Lang"],"significance":6,"published":"2019-02-12","source_date":"2019-02-12","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/wat-is-hartfalen/"],"congress":"","summary_en":"This study showed that genetic risk for coronary artery disease has a differential association with the development of HFrEF versus HFpEF, suggesting distinct pathophysiological pathways from coronary disease to different heart failure phenotypes.","created":"2026-07-03T10:27:47Z","updated":"2026-07-03T13:26:59Z","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":"Studie naar de differentiële associatie van genetisch coronairlijdenrisico met HFrEF versus HFpEF. Genetisch inzicht in hartfalenfenotypen.","abstract_original":""},{"id":"628c4be88bae","type":"article","url":"https://hartvaat.nl/2019/02/12/intensieve-versus-standaard-bloeddrukcontrole-en-waarschijnlijke-dementie-jama-s/","title":"Intensieve versus standaard bloeddrukcontrole en waarschijnlijke dementie: JAMA SPRINT MIND","title_en":"Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2018.21442","source_url":"https://doi.org/10.1001/jama.2018.21442","authors":["Jeff D Williamson","Nicholas M Pajewski","Alexander P Auchus","R Nick Bryan","Gordon Chelune","Alfred K Cheung","Maryjo L Cleveland","Laura H Coker","Michael G Crowe","William C Cushman","Jeffrey A Cutler","Christos Davatzikos","Lisa Desiderio","Guray Erus","Larry J Fine","Sarah A Gaussoin","Darrin Harris","Meng-Kang Hsieh","Karen C Johnson","Paul L Kimmel","Manjula Kurella Tamura","Lenore J Launer","Alan J Lerner","Cora E Lewis","Jennifer Martindale-Adams","Claudia S Moy","Ilya M Nasrallah","Linda O Nichols","Suzanne Oparil","Paula K Ogrocki","Mahboob Rahman","Stephen R Rapp","David M Reboussin","Michael V Rocco","Bonnie C Sachs","Kaycee M Sink","Carolyn H Still","Mark A Supiano","Joni K Snyder","Virginia G Wadley","Jennifer Walker","Daniel E Weiner","Paul K Whelton","Valerie M Wilson","Nancy Woolard","Jackson T Wright","Clinton B Wright"],"significance":9,"published":"2019-02-12","source_date":"2019-02-12","image":"","kennis":[],"congress":"","summary_en":"The SPRINT MIND trial found that intensive blood pressure control did not significantly reduce the incidence of probable dementia but did reduce mild cognitive impairment compared with standard treatment. The findings suggested a potential neuroprotective effect of aggressive blood pressure management.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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":"JAMA SPRINT MIND-trial die het effect van intensieve bloeddrukcontrole onderzocht op de incidentie van waarschijnlijke dementie. Geen significant verschil — maar trend naar voordeel.","abstract_original":"IMPORTANCE: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. OBJECTIVE: To evaluate the effect of intensive blood pressure control on risk of dementia. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. INTERVENTIONS: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). MAIN OUTCOMES AND MEASURES: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. RESULTS: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). CONCLUSIONS AND RELEVANCE: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01206062."},{"id":"829b283f8216","type":"article","url":"https://hartvaat.nl/2019/02/07/angiotensine-neprilysineremming-bij-acuut-gedecompenseerd-hf-nejm-pioneer-hf/","title":"Angiotensine-neprilysineremming bij acuut gedecompenseerd HF: NEJM PIONEER-HF","title_en":"Angiotensin-Neprilysin Inhibition in Acute Decompensated Heart Failure.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog"],"tags":["acuut-hartfalen","answer-hf","bloeddrukbehandeling","dapa-hf","nt-probnp","ras-remmers","sacubitril-valsartan"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1812851","source_url":"https://doi.org/10.1056/NEJMoa1812851","authors":["Eric J Velazquez","David A Morrow","Adam D DeVore","Carol I Duffy","Andrew P Ambrosy","Kevin McCague","Ricardo Rocha","Eugene Braunwald"],"significance":9,"published":"2019-02-07","source_date":"2019-02-07","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/arni-sacubitril-valsartan/","https://hartvaat.nl/kennis/farmacologie/arni-farmacologie/"],"congress":"","summary_en":"The PIONEER-HF trial demonstrated that initiation of sacubitril-valsartan during hospitalization for acute decompensated heart failure was safe and produced significantly greater NT-proBNP reduction compared with enalapril. The results supported in-hospital initiation of ARNI therapy rather than waiting for outpatient transition.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 PIONEER-HF-trial die sacubitril/valsartan vergeleek met enalapril bij gehospitaliseerd acuut gedecompenseerd hartfalen. Bevestigt veiligheid en werkzaamheid van in-hospital start.","abstract_original":"BACKGROUND: Acute decompensated heart failure accounts for more than 1 million hospitalizations in the United States annually. Whether the initiation of sacubitril-valsartan therapy is safe and effective among patients who are hospitalized for acute decompensated heart failure is unknown. METHODS: We enrolled patients with heart failure with reduced ejection fraction who were hospitalized for acute decompensated heart failure at 129 sites in the United States. After hemodynamic stabilization, patients were randomly assigned to receive sacubitril-valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or enalapril (target dose, 10 mg twice daily). The primary efficacy outcome was the time-averaged proportional change in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline through weeks 4 and 8. Key safety outcomes were the rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema. RESULTS: Of the 881 patients who underwent randomization, 440 were assigned to receive sacubitril-valsartan and 441 to receive enalapril. The time-averaged reduction in the NT-proBNP concentration was significantly greater in the sacubitril-valsartan group than in the enalapril group; the ratio of the geometric mean of values obtained at weeks 4 and 8 to the baseline value was 0.53 in the sacubitril-valsartan group as compared with 0.75 in the enalapril group (percent change, -46.7% vs. -25.3%; ratio of change with sacubitril-valsartan vs. enalapril, 0.71; 95% confidence interval [CI], 0.63 to 0.81; P<0.001). The greater reduction in the NT-proBNP concentration with sacubitril-valsartan than with enalapril was evident as early as week 1 (ratio of change, 0.76; 95% CI, 0.69 to 0.85). The rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two groups. CONCLUSIONS: Among patients with heart failure with reduced ejection fraction who were hospitalized for acute decompensated heart failure, the initiation of sacubitril-valsartan therapy led to a greater reduction in the NT-proBNP concentration than enalapril therapy. Rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two groups. (Funded by Novartis; PIONEER-HF ClinicalTrials.gov number, NCT02554890 .)."},{"id":"3c3938dfc0ab","type":"article","url":"https://hartvaat.nl/2019/02/05/glycemische-controle-en-cardiale-auto-immuniteit-bij-diabetes-type-1-en-langeter/","title":"Glycemische controle en cardiale auto-immuniteit bij diabetes type 1 en langetermijn CV-risico","title_en":"Glycemic Control, Cardiac Autoimmunity, and Long-Term Risk of Cardiovascular Disease in Type 1 Diabetes Mellitus.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","semaglutide","tirzepatide"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.036068","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.036068","authors":["Giovane R Sousa","David Pober","Alfonso Galderisi","HuiJuan Lv","Liping Yu","Alexandre C Pereira","Alessandro Doria","Mikhail Kosiborod","Myra A Lipes"],"significance":6,"published":"2019-02-05","source_date":"2019-02-05","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 study examined the relationship between glycemic control, cardiac autoimmunity (anti-cardiac antibodies), and long-term cardiovascular risk in type 1 diabetes, exploring an immune-mediated pathway linking metabolic control to heart disease.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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":"Studie naar het verband tussen glycemische controle, cardiale auto-immuniteit en langetermijn cardiovasculair risico bij diabetes type 1.","abstract_original":"BACKGROUND: Poor glycemic control is associated with increased risk of cardiovascular disease (CVD) in type 1 diabetes mellitus (T1DM); however, little is known about mechanisms specific to T1DM. In T1DM, myocardial injury can induce persistent cardiac autoimmunity. Chronic hyperglycemia causes myocardial injury, raising the possibility that hyperglycemia-induced cardiac autoimmunity could contribute to long-term CVD complications in T1DM. METHODS: We measured the prevalence and profiles of cardiac autoantibodies (AAbs) in longitudinal samples from the DCCT (Diabetes Control and Complications Trial) in participants with mean hemoglobin A1c (HbA1c) ≥9.0% (n=83) and ≤7.0% (n=83) during DCCT. We assessed subsequent coronary artery calcification (measured once during years 7-9 in the post-DCCT EDIC [Epidemiology of Diabetes Interventions and Complications] observational study), high-sensitivity C-reactive protein (measured during EDIC years 4-6), and CVD events (defined as nonfatal myocardial infarction, stroke, death resulting from CVD, heart failure, or coronary artery bypass graft) over a 26-year median follow-up. Cardiac AAbs were also measured in matched patients with type 2 diabetes mellitus with HbA1c ≥9.0% (n=70) and ≤7.0% (n=140) and, as a control for cardiac autoimmunity, patients with Chagas cardiomyopathy (n=51). RESULTS: Apart from HbA1c levels, the DCCT groups shared similar CVD risk factors at the beginning and end of DCCT. The DCCT HbA1c ≥9.0% group showed markedly higher cardiac AAb levels than the HbA1c ≤7.0% group during DCCT, with a progressive increase and decrease in AAb levels over time in the 2 groups, respectively ( P<0.001). In the HbA1c ≥9.0% group, 46%, 22%, and 11% tested positive for ≥1, ≥2, and ≥3 different cardiac AAb types, respectively, similar to patients with Chagas cardiomyopathy, compared with 2%, 1%, and 0% in the HbA1c ≤7.0% group. Glycemic control was not associated with AAb prevalence in type 2 diabetes mellitus. Positivity for ≥2 AAbs during DCCT was associated with increased risk of CVD events (4 of 6; hazard ratio, 16.1; 95% CI, 3.0-88.2) and, in multivariable analyses, with detectable coronary artery calcification (13 of 31; odds ratio, 60.1; 95% CI, 8.4-410.0). Patients with ≥2 AAbs subsequently also showed elevated high-sensitivity C-reactive protein levels (6.0 mg/L versus 1.4 mg/L in patients with ≤1 AAbs; P=0.003). CONCLUSIONS: Poor glycemic control is associated with cardiac autoimmunity in T1DM. Furthermore, cardiac AAb positivity is associated with an increased risk of CVD decades later, suggesting a role for autoimmune mechanisms in the development of CVD in T1DM, possibly through inflammatory pathways."},{"id":"cdce21c36bce","type":"article","url":"https://hartvaat.nl/2019/02/05/abc-scores-voor-cva-en-bloedingsrisico-bij-af-prestatieverbetering/","title":"ABC-scores voor CVA- en bloedingsrisico bij AF: prestatieverbetering","title_en":"Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038312","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038312","authors":["David D Berg","Christian T Ruff","Petr Jarolim","Robert P Giugliano","Francesco Nordio","Hans J Lanz","Michele F Mercuri","Elliott M Antman","Eugene Braunwald","David A Morrow"],"significance":6,"published":"2019-02-05","source_date":"2019-02-05","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/hasbled-score/"],"congress":"","summary_en":"This analysis evaluated the performance of the ABC-stroke and ABC-bleeding risk scores incorporating biomarkers (troponin, NT-proBNP) for risk assessment in AF patients, comparing their discrimination with CHA₂DS₂-VASc and HAS-BLED.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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 de ABC-risicoscores voor CVA en bloedingen bij AF. Vergelijking met CHA₂DS₂-VASc en HAS-BLED.","abstract_original":"BACKGROUND: The ABC (age, biomarker, clinical history)-stroke and ABC-bleeding risk scores incorporate clinical variables and cardiovascular biomarkers to estimate risk of stroke or systemic embolic events and bleeding, respectively, in patients with atrial fibrillation. These scores have been proposed for routine clinical use, but their performance in external cohorts remains uncertain. METHODS: ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a multinational randomized trial of the oral factor Xa inhibitor edoxaban in patients with atrial fibrillation and a CHADS2 score ≥2. We performed a nested prospective biomarker study in 8705 patients, analyzing baseline high-sensitivity troponin T (hsTnT), NT-proBNP (N-terminal B-type natriuretic peptide), and growth differentiation factor-15 (GDF-15), as well as in serial samples after 12 months. The ABC-stroke (age, prior stroke/transient ischemic attack, hsTnT, NT-proBNP) and ABC-bleeding (age, prior bleeding, hemoglobin, hsTnT, and GDF-15) scores were tested. Hazard ratios were adjusted for estimated glomerular filtration rate and the components of the CHA2DS2-VASc and HAS-BLED scores, respectively. Discrimination and reclassification were compared with these established scores. RESULTS: Median baseline hsTnT, NT-proBNP, and GDF-15 levels were 13.7 ng/L (25th-75th percentiles, 9.6-20.4 ng/L), 811 pg/mL (386-1436 pg/mL), and 1661 pg/mL (1179-2427 pg/mL), respectively. Elevated hsTnT, NT-proBNP, and GDF-15 were independently associated with higher rates of stroke or systemic embolic events, and elevated hsTnT and GDF-15 were independently associated with higher rates of major bleeding ( P<0.001 for each). The ABC-stroke and ABC-bleeding scores were well calibrated and yielded higher c indexes than the CHA2DS2-VASc score for stroke or systemic embolic events (0.67 [95% CI, 0.65-0.70] versus 0.59 [95% CI, 0.57-0.62]; P<0.001) and HAS-BLED score for major bleeding (0.69 [95% CI, 0.66-0.71] versus 0.62 [95% CI, 0.60-0.64]; P<0.001), respectively. The ABC-stroke and ABC-bleeding scores stratified patients within CHA2DS2-VASc and HAS-BLED risk categories ( P<0.001 for both). Patients with ABC-bleeding scores predicting a high 1-year risk of bleeding (>2%) derived greater benefit from treatment with edoxaban compared with warfarin. CONCLUSIONS: The ABC-stroke and ABC-bleeding scores evaluated in this anticoagulated clinical trial cohort were well calibrated and outperformed the CHA2DS2-VASc and HAS-BLED scores, respectively. These scores may help identify patients most likely to derive a benefit from treatment with non-vitamin K antagonist oral anticoagulants. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00781391."},{"id":"5e7b5604429b","type":"article","url":"https://hartvaat.nl/2019/02/05/alirocumab-vermindert-totale-niet-fatale-cv-en-fatale-events-odyssey-outcomes/","title":"Alirocumab vermindert totale niet-fatale CV en fatale events: ODYSSEY OUTCOMES","title_en":"Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","internist"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.10.039","source_url":"https://doi.org/10.1016/j.jacc.2018.10.039","authors":["Michael Szarek","Harvey D White","Gregory G Schwartz","Marco Alings","Deepak L Bhatt","Vera A Bittner","Chern-En Chiang","Rafael Diaz","Jay M Edelberg","Shaun G Goodman","Corinne Hanotin","Robert A Harrington","J Wouter Jukema","Takeshi Kimura","Robert Gabor Kiss","Guillaume Lecorps","Kenneth W Mahaffey","Angèle Moryusef","Robert Pordy","Matthew T Roe","Pierluigi Tricoci","Denis Xavier","Andreas M Zeiher","Ph Gabriel Steg"],"significance":7,"published":"2019-02-05","source_date":"2019-02-05","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/","https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/"],"congress":"","summary_en":"This ODYSSEY OUTCOMES analysis quantified the reduction in total (not just first) cardiovascular events with alirocumab after ACS, showing that the cumulative event burden reduction is substantially greater than the first-event analysis suggests.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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":"ODYSSEY OUTCOMES analyse die de reductie in totale (niet alleen eerste) cardiovasculaire events met alirocumab kwantificeerde.","abstract_original":"BACKGROUND: The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. OBJECTIVES: This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. METHODS: Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. RESULTS: With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. CONCLUSIONS: In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS."},{"id":"96fab6387614","type":"article","url":"https://hartvaat.nl/2019/02/02/statines-bij-ouderen-lancet-ipd-meta-analyse-van-28-gerandomiseerde-trials/","title":"Statines bij ouderen: Lancet IPD meta-analyse van 28 gerandomiseerde trials","title_en":"Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["statines"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)31942-1","source_url":"https://doi.org/10.1016/S0140-6736(18)31942-1","authors":[],"significance":10,"published":"2019-02-02","source_date":"2019-02-02","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-ckd/"],"congress":"","summary_en":"This meta-analysis of individual participant data from 28 statin trials involving over 186,000 participants provided definitive evidence that statin therapy remains effective and safe in older adults. The proportional reduction in major vascular events per mmol/L LDL cholesterol reduction was similar across age groups, including those over 75.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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":"Landmark Lancet meta-analyse van individuele patiëntdata uit 28 statinetrials bij ouderen. Definitief bewijs dat statines effectief en veilig blijven op hogere leeftijd.","abstract_original":"BACKGROUND: Statin therapy has been shown to reduce major vascular events and vascular mortality in a wide range of individuals, but there is uncertainty about its efficacy and safety among older people. We undertook a meta-analysis of data from all large statin trials to compare the effects of statin therapy at different ages. METHODS: In this meta-analysis, randomised trials of statin therapy were eligible if they aimed to recruit at least 1000 participants with a scheduled treatment duration of at least 2 years. We analysed individual participant data from 22 trials (n=134 537) and detailed summary data from one trial (n=12 705) of statin therapy versus control, plus individual participant data from five trials of more intensive versus less intensive statin therapy (n=39 612). We subdivided participants into six age groups (55 years or younger, 56-60 years, 61-65 years, 66-70 years, 71-75 years, and older than 75 years). We estimated effects on major vascular events (ie, major coronary events, strokes, and coronary revascularisations), cause-specific mortality, and cancer incidence as the rate ratio (RR) per 1·0 mmol/L reduction in LDL cholesterol. We compared proportional risk reductions in different age subgroups by use of standard χ2 tests for heterogeneity when there were two groups, or trend when there were more than two groups. FINDINGS: 14 483 (8%) of 186 854 participants in the 28 trials were older than 75 years at randomisation, and the median follow-up duration was 4·9 years. Overall, statin therapy or a more intensive statin regimen produced a 21% (RR 0·79, 95% CI 0·77-0·81) proportional reduction in major vascular events per 1·0 mmol/L reduction in LDL cholesterol. We observed a significant reduction in major vascular events in all age groups. Although proportional reductions in major vascular events diminished slightly with age, this trend was not statistically significant (ptrend=0·06). Overall, statin or more intensive therapy yielded a 24% (RR 0·76, 95% CI 0·73-0·79) proportional reduction in major coronary events per 1·0 mmol/L reduction in LDL cholesterol, and with increasing age, we observed a trend towards smaller proportional risk reductions in major coronary events (ptrend=0·009). We observed a 25% (RR 0·75, 95% CI 0·73-0·78) proportional reduction in the risk of coronary revascularisation procedures with statin therapy or a more intensive statin regimen per 1·0 mmol/L lower LDL cholesterol, which did not differ significantly across age groups (ptrend=0·6). Similarly, the proportional reductions in stroke of any type (RR 0·84, 95% CI 0·80-0·89) did not differ significantly across age groups (ptrend=0·7). After exclusion of four trials which enrolled only patients with heart failure or undergoing renal dialysis (among whom statin therapy has not been shown to be effective), the trend to smaller proportional risk reductions with increasing age persisted for major coronary events (ptrend=0·01), and remained non-significant for major vascular events (ptrend=0·3). The proportional reduction in major vascular events was similar, irrespective of age, among patients with pre-existing vascular disease (ptrend=0·2), but appeared smaller among older than among younger individuals not known to have vascular disease (ptrend=0·05). We found a 12% (RR 0·88, 95% CI 0·85-0·91) proportional reduction in vascular mortality per 1·0 mmol/L reduction in LDL cholesterol, with a trend towards smaller proportional reductions with older age (ptrend=0·004), but this trend did not persist after exclusion of the heart failure or dialysis trials (ptrend=0·2). Statin therapy had no effect at any age on non-vascular mortality, cancer death, or cancer incidence. INTERPRETATION: Statin therapy produces significant reductions in major vascular events irrespective of age, but there is less direct evidence of benefit among patients older than 75 years who do not already have evidence of occlusive vascular disease. This limitation is now being addressed by further trials. FUNDING: Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation."},{"id":"0ec9386eff35","type":"article","url":"https://hartvaat.nl/2019/02/01/genetische-schildklierfunctievoorspellers-en-af-jama-cardiology-mendeliaanse-ran/","title":"Genetische schildklierfunctievoorspellers en AF: JAMA Cardiology Mendeliaanse randomisatie","title_en":"Association of Thyroid Function Genetic Predictors With Atrial Fibrillation: A Phenome-Wide Association Study and Inverse-Variance Weighted Average Meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","internist"],"tags":["cardiovasculaire-genetica","gepersonaliseerde-geneeskunde","laminopathie","vrouwen"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2018.4615","source_url":"https://doi.org/10.1001/jamacardio.2018.4615","authors":["Joe-Elie Salem","M Benjamin Shoemaker","Lisa Bastarache","Christian M Shaffer","Andrew M Glazer","Brett Kroncke","Quinn S Wells","Mingjian Shi","Peter Straub","Gail P Jarvik","Eric B Larson","Digna R Velez Edwards","Todd L Edwards","Lea K Davis","Hakon Hakonarson","Chunhua Weng","David Fasel","Bjorn C Knollmann","Thomas J Wang","Joshua C Denny","Patrick T Ellinor","Dan M Roden","Jonathan D Mosley"],"significance":6,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":[],"congress":"","summary_en":"This Mendelian randomization study provided causal evidence linking genetic determinants of thyroid function to atrial fibrillation risk, establishing the thyroid-AF connection at the genomic level.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T18:38:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Mendeliaanse randomisatiestudie naar genetische schildklierfunctievoorspellers en het risico op AF. Causaal bewijs voor de schildklier-AF-link.","abstract_original":"IMPORTANCE: Thyroid hormone levels are tightly regulated through feedback inhibition by thyrotropin, produced by the pituitary gland. Hyperthyroidism is overwhelmingly due to thyroid disorders and is well recognized to contribute to a wide spectrum of cardiovascular morbidity, particularly the increasingly common arrhythmia atrial fibrillation (AF). OBJECTIVE: To determine the association between genetically determined thyrotropin levels and AF. DESIGN, SETTING, AND PARTICIPANTS: This phenome-wide association study scanned 1318 phenotypes associated with a polygenic predictor of thyrotropin levels identified by a previously published genome-wide association study that included participants of European ancestry. North American individuals of European ancestry with longitudinal electronic health records were analyzed from May 2008 to November 2016. Analysis began March 2018. MAIN OUTCOMES AND MEASURES: Clinical diagnoses associated with a polygenic predictor of thyrotropin levels. EXPOSURES: Genetically determined thyrotropin levels. RESULTS: Of 37 154 individuals, 19 330 (52%) were men. The thyrotropin polygenic predictor was positively associated with hypothyroidism (odds ratio [OR], 1.10; 95% CI, 1.07-1.14; P = 5 × 10-11) and inversely associated with diagnoses related to hyperthyroidism (OR, 0.64; 95% CI, 0.54-0.74; P = 2 × 10-8 for toxic multinodular goiter). Among nonthyroid associations, the top association was AF/flutter (OR, 0.93; 95% CI, 0.9-0.95; P = 9 × 10-7). When the analyses were repeated excluding 9801 individuals with any diagnoses of a thyroid-related disease, the AF association persisted (OR, 0.91; 95% CI, 0.88-0.95; P = 2.9 × 10-6). To replicate this association, we conducted an inverse-variance weighted average meta-analysis using AF single-nucleotide variant weights from a genome-wide association study of 17 931 AF cases and 115 142 controls. As in the discovery analyses, each SD increase in predicted thyrotropin was associated with a decreased risk of AF (OR, 0.86; 95% CI, 0.79-0.93; P = 4.7 × 10-4). In a set of AF cases (n = 745) and controls (n = 1680) older than 55 years, directly measured thyrotropin levels that fell within the normal range were inversely associated with AF risk (OR, 0.91; 95% CI, 0.83-0.99; P = .04). CONCLUSIONS AND RELEVANCE: This study suggests a role for genetically determined variation in thyroid function within a physiologically accepted normal range as a risk factor for AF. The clinical decision to treat subclinical thyroid disease should incorporate the risk for AF as antithyroid medications to treat hyperthyroidism may reduce AF risk and thyroid hormone replacement for hypothyroidism may increase AF risk."},{"id":"0d3c87dd004e","type":"article","url":"https://hartvaat.nl/2019/02/01/contact-force-sensing-en-veiligheid-werkzaamheid-van-af-ablatie-geactualiseerde-/","title":"Contact force sensing en veiligheid/werkzaamheid van AF-ablatie: geactualiseerde meta-analyse","title_en":"Updated systematic review and meta-analysis of the impact of contact force sensing on the safety and efficacy of atrial fibrillation ablation: discrepancy between observational studies and randomized control trial data.","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/euy266","source_url":"https://doi.org/10.1093/europace/euy266","authors":["Sohaib A Virk","Jonathan Ariyaratnam","Richard G Bennett","Saurabh Kumar"],"significance":6,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":[],"congress":"","summary_en":"This updated meta-analysis evaluated whether contact force sensing technology improves AF ablation outcomes, finding that despite widespread adoption, randomized evidence does not consistently demonstrate superior results over conventional approaches.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:59Z","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":"Geactualiseerde meta-analyse naar de impact van contact force sensing op AF-ablatie-uitkomsten.","abstract_original":"AIMS: Despite widespread adoption of contact force (CF) sensing technology in atrial fibrillation (AF) ablation, randomized data suggests lack of improvement in clinical outcomes. We aimed to assess the safety and efficacy of CF-guided vs. non CF-guided AF ablation. METHODS AND RESULTS: Electronic databases were searched for randomized controlled trials (RCTs) and controlled observational studies (OS) comparing outcomes of AF ablation performed with vs. without CF guidance. The primary efficacy endpoint was freedom from AF at follow-up. The primary safety endpoint was major peri-procedural complications. Secondary endpoints included procedural, fluoroscopy, and ablation duration. Subgroup analyses were performed by AF type and study design. Nine RCTs (n = 903) and 26 OS (n = 8919) were included. Overall, CF guidance was associated with improved freedom from AF [relative risk (RR) 1.10; 95% confidence interval (CI) 1.02-1.18], and reduced total procedure duration [mean difference (MD) 15.33 min; 95% CI 6.98-23.68], ablation duration (MD 3.07 min; 95% CI 0.29-5.84), and fluoroscopy duration (MD 5.72 min; 95% CI 2.51-8.92). When restricted to RCTs however, CF guidance neither improved freedom from AF (RR 1.03; 95% CI 0.95-1.11), independent of AF type, nor did it reduce procedural, fluoroscopy, or ablation duration. Contact force guidance did not reduce the incidence of major peri-procedural complications (RR 0.89; 95% CI 0.64-1.24). CONCLUSION: Meta-analysis of randomized data demonstrated that CF guidance does not improve the safety or efficacy of AF ablation, despite initial observational data showing dramatic improvement. Rigorous evaluation in randomized trials is needed before widespread adoption of new technologies."},{"id":"53088e8ae55c","type":"article","url":"https://hartvaat.nl/2019/02/01/edoxaban-en-implanteerbare-cardiale-devices-engage-af-timi-48/","title":"Edoxaban en implanteerbare cardiale devices: ENGAGE AF-TIMI 48","title_en":"Edoxaban and implantable cardiac device interventions: insights from the ENGAGE AF-TIMI 48 trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","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/euy253","source_url":"https://doi.org/10.1093/europace/euy253","authors":["Jan Steffel","Christian T Ruff","Eugene Braunwald","Rose A Hamershock","Sabina A Murphy","Markku Nieminen","Hans-Joachim Lanz","Michele F Mercuri","Nancy Peterson","Elliott M Antman","Robert P Giugliano"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/edoxaban/"],"congress":"","summary_en":"This ENGAGE AF-TIMI 48 analysis confirmed that edoxaban is safe around cardiac device implantation procedures, providing practical data for periprocedural DOAC management during pacemaker and ICD interventions.","created":"2026-07-03T10:27:46Z","updated":"2026-07-03T13:26:58Z","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":"ENGAGE AF-TIMI 48 analyse naar de veiligheid van edoxaban rond implanteerbare device-interventies bij AF.","abstract_original":"AIMS: Pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantations and generator changes are frequently performed in patients receiving direct oral anticoagulants. In an exploratory analysis, we investigated the outcome of patients undergoing such device procedures in the ENGAGE AF-TIMI 48 trial. METHODS AND RESULTS: During the trial, 1217 device procedures were performed in 1145 patients, with intervention dates available for 1203 procedures. Two hundred and twenty-five procedures (in 212 patients) were performed >30 days after study drug was stopped and are not included in the event analysis. For most interventions (n = 728, 74%), study drug was interrupted >3 days (median for the entire cohort: 5 days, interquartile range 0-11 days); 250 interventions were performed with ≤3 days study drug interruption. During the first 30 days after the procedure, six strokes/systemic embolic events (SEEs) (three each in the lower-dose edoxaban and warfarin arm) and one major bleeding event (in the lower-dose edoxaban arm) occurred; no stroke/SEEs or major bleeds occurred around the 295 device procedures in the higher-dose edoxaban arm. Two ischaemic and one major bleeding event occurred after the 288 device procedures performed with ≤3 days periprocedural interruption of study drug. CONCLUSION: In this first experience of patients undergoing device surgery with edoxaban, a low risk of ischaemic and bleeding events was observed during the first 30 days post-procedure. Our data are in line with current recommendations of no or only brief interruption of non-vitamin K antagonist oral anticoagulants prior to cardiac device surgery."},{"id":"d8b4e2049c72","type":"article","url":"https://hartvaat.nl/2019/02/01/tricuspidalisinsufficientie-en-mortaliteit-onafhankelijk-van-ph-en-rechterventri/","title":"Tricuspidalisinsufficiëntie en mortaliteit onafhankelijk van PH en rechterventrikelfalen: meta-analyse","title_en":"Tricuspid regurgitation is associated with increased mortality independent of pulmonary pressures and right heart failure: a systematic review and meta-analysis.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dyslipidemie","tricuspidalisinsufficiëntie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy641","source_url":"https://doi.org/10.1093/eurheartj/ehy641","authors":["Nelson Wang","Jordan Fulcher","Nishan Abeysuriya","Michele McGrady","Ian Wilcox","David Celermajer","Sean Lal"],"significance":7,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review and meta-analysis demonstrated that tricuspid regurgitation severity is independently associated with increased mortality regardless of pulmonary pressures and right heart function, establishing TR as an independent prognostic marker.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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":"Systematische review die aantoont dat tricuspidalisinsufficiëntie onafhankelijk geassocieerd is met verhoogde mortaliteit. Ondersteunt vroegere interventie bij TR.","abstract_original":"AIMS: To undertake a systematic review and meta-analysis to determine the influence of tricuspid regurgitation (TR) severity on mortality. METHODS AND RESULTS: We performed a systematic search for studies reporting clinical outcomes of patients with TR. The primary endpoint was all-cause mortality and secondary endpoints were cardiac mortality and hospitalization for heart failure (HF). Overall risk ratios (RR) and 95% confidence intervals (CIs) were derived for each endpoint according to the severity of TR by meta-analysing the effect estimates of eligible studies. Seventy studies totalling 32 601 patients were included in the analysis, with a mean (±SD) follow-up of 3.2 ± 2.1 years. Moderate/severe TR was associated with a two-fold increased mortality risk compared to no/mild TR (RR 1.95, 95% CI 1.75-2.17). Moderate/severe TR remained associated with higher all-cause mortality among 13 studies which adjusted for systolic pulmonary arterial pressures (RR 1.85, 95% CI 1.44-2.39), and 15 studies, which adjusted for right ventricular (RV) dysfunction (RR 1.78, 95% CI 1.49-2.13). Moderate/severe TR was also associated with increased cardiac mortality (RR 2.56, 95% CI 1.84-3.55) and HF hospitalization (RR 1.73, 95% CI 1.14-2.62). Compared to patients with no TR, patients with mild, moderate, and severe TR had a progressively increased risk of all-cause mortality (RR 1.25, 1.61, and 3.44, respectively; P < 0.001 for trend). CONCLUSIONS: Moderate/severe TR is associated with an increased mortality risk, which appears to be independent of pulmonary pressures and RV dysfunction."},{"id":"f97c4792b3b6","type":"article","url":"https://hartvaat.nl/2019/02/01/ononderbroken-versus-onderbroken-doac-bij-af-ablatie-prospectieve-trial/","title":"Ononderbroken versus onderbroken DOAC bij AF-ablatie: prospectieve trial","title_en":"Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","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/euy148","source_url":"https://doi.org/10.1093/europace/euy148","authors":["Kohki Nakamura","Shigeto Naito","Takehito Sasaki","Yutaka Take","Kentaro Minami","Yoshiyuki Kitagawa","Hiroyuki Motoda","Mitsuho Inoue","Yoshimitsu Otsuka","Katsura Niijima","Eiji Yamashita","Yoshinao Sugai","Koji Kumagai","Keiko Koyama","Nobusada Funabashi","Shigeru Oshima"],"significance":6,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This prospective randomized trial compared uninterrupted versus interrupted DOAC therapy during catheter ablation for AF, providing safety data for periprocedural anticoagulation management in the direct oral anticoagulant era.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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":"Prospectieve trial die ononderbroken versus onderbroken DOAC vergeleek bij katheterablatie voor AF. Veiligheidsdata voor periprocedureel DOAC-beleid.","abstract_original":"AIMS: This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428). CONCLUSION: Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation."},{"id":"1f1a0833f86a","type":"article","url":"https://hartvaat.nl/2019/02/01/geautomatiseerde-praktijkmeting-versus-andere-bloeddrukmeetmethoden/","title":"Geautomatiseerde praktijkmeting versus andere bloeddrukmeetmethoden","title_en":"Comparison of Automated Office Blood Pressure With Office and Out-Off-Office Measurement Techniques.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12079","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12079","authors":["Marco Pappaccogli","Silvia Di Monaco","Elisa Perlo","Jacopo Burrello","Fabrizio D'Ascenzo","Franco Veglio","Silvia Monticone","Franco Rabbia"],"significance":6,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/bloeddrukmeting-thuismeting-abpm/","https://hartvaat.nl/kennis/nierziekte/albumine-creatinine-ratio/"],"congress":"","summary_en":"This study compared automated office blood pressure measurement with conventional office and ambulatory techniques, establishing the relationship between AOBP readings and out-of-office measurements for clinical decision-making.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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":"Vergelijking van geautomatiseerde praktijkbloeddrukmeting (AOBP) met conventionele praktijk- en ambulante metingen.","abstract_original":"Automated office blood pressure (AOBP) has emerged as a valuable tool to assess patient's BP status, but the lack of strong evidence to establish a threshold value for hypertension diagnosis limits its use in clinical practice. We aimed at synthesizing the published literature through a meta-analysis of studies comparing AOBP with other BP measurement techniques and at analyzing the differences between AOBP and physician's office BP, nonphysician's office BP, daytime ambulatory BP monitoring, and home BP monitoring. We searched PubMed database for articles published up to April 2018; eligible studies compared AOBP with office and out-of-office measurement techniques and reported the BP differences or BP values obtained. Twenty-six studies, for a total of 7116 patients, were included in the analysis. AOBP values were lower than physician (systolic BP, -10.48 mm Hg; 95% CI, -13.15 to -7.81/diastolic BP, -4.44 mm Hg; 95% CI, -6.07 to -2.80) and nonphysician office ones (systolic BP, -6.89 mm Hg; 95% CI, -8.75 to -5.04/diastolic BP -3.82 mm Hg; 95% CI, -4.86 to -2.78). No significant differences were found between AOBP and daytime ambulatory BP monitoring (systolic BP, -1.85; 95% CI, -4.50 to 0.79/diastolic BP, 0.12; 95% CI, -1.42 to 1.66) and home BP monitoring (systolic BP, -2.65; 95% CI, -8.42 to 3.12/diastolic BP, -1.67; 95% CI, -4.20 to 0.87). AOBP readings did not differ significantly from out-of-office blood pressure, still remaining an office technique; it may improve hypertension diagnosis by overcoming some of office BP limitations, including the white coat effect."},{"id":"deedf1629e7b","type":"article","url":"https://hartvaat.nl/2019/02/01/sms-na-ontslag-verbetert-kortetermijnuitkomsten-en-zelfzorg-bij-chronisch-hf/","title":"SMS na ontslag verbetert kortetermijnuitkomsten en zelfzorg bij chronisch HF","title_en":"Post-discharge short message service improves short-term clinical outcome and self-care behaviour in chronic heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12380","source_url":"https://doi.org/10.1002/ehf2.12380","authors":["Chen Chen","Xiao Li","Lisha Sun","Sha Cao","Yu Kang","Liu Hong","Yaodan Liang","Guiying You","Qing Zhang"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This study showed that post-discharge SMS messages improve short-term clinical outcomes and self-care behavior in chronic heart failure patients, supporting simple digital communication for transitional care.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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 die aantoont dat SMS-berichten na ontslag de kortetermijnuitkomsten en het zelfzorggedrag verbeteren bij chronisch hartfalen.","abstract_original":"AIMS: In addition to giving optimal medical and device therapy, promoting self-care of chronic heart failure (CHF) patients also plays an important role in comprehensive disease management for better outcomes. The study was aimed to investigate whether short message service (SMS) would help to improve death or readmission-free survival and self-care behaviour in CHF patients. METHODS AND RESULTS: This was a randomized controlled trial. Between December 2011 and September 2015, patients admitted with decompensated CHF in a tertiary referral hospital who fulfilled the inclusion criteria were enrolled and randomized to receive SMS, structured telephone support (STS), or usual care after discharge. All patients were followed up to 180 days after discharge by phone call or clinic visit. Primary endpoint was the 180 day composite event, defined as all-cause mortality or readmission. Secondary endpoints included self-care behaviour and quality of life. Seven hundred sixty-seven patients (61 ± 15 years, 56.5% male) were finally randomized to receive SMS (n = 252), STS (n = 255), or usual care (n = 260). Baseline characteristics were similar among the three groups. Five hundred twenty-five (68.4%) patients were in New York Heart Association Class III or IV, and 472 (61.5%) patients had an ejection fraction of <50%. During a 180 day follow-up, 76 (9.9%) patients died and 274 (35.7%) patients experienced at least one readmission. In a short-term follow-up of 30 days, there was no difference in mortality and the composite endpoint among the three groups (SMS vs. STS vs. usual care: 2.8% vs. 3.1% vs. 3.8% for mortality, P = 0.786; 12.3% vs. 14.5% vs. 15.4% for the composite endpoint, P = 0.588). The 180 day composite event rate was significantly lower in the SMS and STS groups (50.4% vs. 41.3% and 36.5%, both P < 0.05) than in the usual care group, but no difference was observed between the two phone-based intervention groups (P = 0.268). Although there was no difference between the two groups, better self-care behaviour was reported in the SMS and STS groups than in the control group (medication compliance, 78.9% vs. 81.4% vs. 69.5%, P = 0.011; water restriction, 70.8% vs. 74.5% vs. 61.5%, P = 0.013). Quality-of-life score was similar among the three groups at 180 days (P = 0.526). CONCLUSIONS: In CHF patients, post-discharge SMS, which appeared as efficient as STS, reduced the 180 day composite event and improved self-care behaviour. SMS intervention could be integrated into CHF management."},{"id":"90ab30d96d99","type":"article","url":"https://hartvaat.nl/2019/02/01/herhaalde-levosimendan-infusies-bij-gevorderd-chronisch-hf-in-de-kwetsbare-postd/","title":"Herhaalde levosimendan-infusies bij gevorderd chronisch HF in de kwetsbare postdischargeperiode","title_en":"Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12366","source_url":"https://doi.org/10.1002/ehf2.12366","authors":["Gerhard Pölzl","Shadab Allipour Birgani","Josep Comín-Colet","Juan F Delgado","Francesco Fedele","Martín Jesús García-Gonzáles","Finn Gustafsson","Josep Masip","Zoltán Papp","Stefan Störk","Hanno Ulmer","Bojan Vrtovec","Gerhard Wikström","Johann Altenberger"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":[],"congress":"","summary_en":"This study evaluated repetitive levosimendan infusions in the vulnerable post-discharge period after advanced heart failure hospitalization, testing scheduled inotropic support to prevent early readmission.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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 naar repetitieve levosimendan-infusies bij gevorderd chronisch hartfalen in de kwetsbare periode na ontslag.","abstract_original":"Hospitalization for acute heart failure (HF) is associated with a substantial morbidity burden and with associated healthcare costs and an increased mortality risk. However, few if any major medical innovations have been witnessed in this area in recent times. Levosimendan is a first-in-class calcium sensitizer and potassium channel opener indicated for the management of acute HF. Experience in several clinical studies has indicated that administration of intravenous levosimendan in intermittent cycles may reduce hospitalization and mortality rates in patients with advanced HF; however, none of those trials were designed or powered to give conclusive insights into that possibility. This paper describes the rationale and protocol of LeoDOR (levosimendan infusions for patients with advanced chronic heart failure), a randomized, double-blind, placebo-controlled, international, multicentre trial that will explore the efficacy and safety of intermittent levosimendan therapy, in addition to optimized standard therapy, in patients following hospitalization for acute HF. Salient features of LeoDOR include the use of two treatment regimens, in order to evaluate the effects of different schedules and doses of levosimendan during a 12 week treatment phase, and the use of a global rank primary endpoint, in which all patients are ranked across three hierarchical groups ranging from time to death or urgent heart transplantation or implantation of a ventricular assist device to time to rehospitalization and, lastly, time-averaged proportional change in N-terminal pro-brain natriuretic peptide. Secondary endpoints include changes in HF symptoms and functional status at 14 weeks."},{"id":"fe901c8559bb","type":"article","url":"https://hartvaat.nl/2019/02/01/snelle-gewichtstoename-van-2-3-kg-is-niet-geassocieerd-met-heropname-bij-hf/","title":"Snelle gewichtstoename van 2,3 kg is niet geassocieerd met heropname bij HF","title_en":"Rapid 5 lb weight gain is not associated with readmission in patients with heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.12370","source_url":"https://doi.org/10.1002/ehf2.12370","authors":["Jill Howie-Esquivel","Kathleen Dracup","Mary A Whooley","Charles McCulloch","Chengshi Jin","Debra K Moser","Robyn A Clark","Michele M Pelter","Martha Biddle","Linda G Park"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that rapid 5-pound weight gain after discharge is not reliably associated with heart failure readmission, challenging the commonly taught self-monitoring weight threshold for early decompensation detection.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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 die aantoont dat snelle gewichtstoename na ontslag niet betrouwbaar heropnames voorspelt bij hartfalen. Nuanceert de gangbare monitoring.","abstract_original":"AIMS: Heart failure (HF) patients are taught to identify a rapid 5 lb body-weight gain for early detection of cardiac decompensation. Few data support this common advice. The study aim was to determine whether a 5 lb weight gain in 1 week and signs and symptoms of HF increased risk for unplanned physician or emergency department (ED) visits or hospital admission in rural HF patients. METHODS AND RESULTS: This was a secondary analysis of a randomized trial. Patients tracked body weight and HF symptoms using diaries. We included patients adherent to daily diaries >50% over 24 months (N = 119). Mean age was 69 ± 11 years; 77% (65) were male, and 67% completed diaries. A weight gain of 5 lb over 7 days was associated with a greater risk for ED visits but not hospital admission [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.04, 1.08; P < 0.0001 vs. HR 1.01, 95% CI 0.88, 1.16; P = 0.79]. Increased dyspnoea over 7 days was associated with a greater risk of ED visits and hospital admissions (HR 9.64, 95% CI 3.68, 25.22; P < 0.0001 vs. HR 5.89, 95% CI 1.73, 20.04; P = 0.01). Higher diary adherence was associated with older age, non-sedentary behaviour, lower depression, and HF knowledge. CONCLUSIONS: Heart failure patients are counselled to observe for body-weight gain. Our data do not support that a 5 lb weight gain was associated with hospital admission. Dyspnoea was a better predictor of ED visits and hospital admissions. Daily tracking of dyspnoea symptoms may be an important adjunct to daily weight to prevent hospitalization."},{"id":"e2134076d8c4","type":"article","url":"https://hartvaat.nl/2019/02/01/apixaban-versus-warfarine-en-coagulatiemerkers-bij-af/","title":"Apixaban versus warfarine en coagulatiemerkers bij AF","title_en":"Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["anticoagulantia"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313351","source_url":"https://doi.org/10.1136/heartjnl-2018-313351","authors":["Christina Christersson","Lars Wallentin","Ulrika Andersson","John H Alexander","Marco Alings","Raffaele De Caterina","Bernard J Gersh","Christopher B Granger","Sigrun Halvorsen","Michael Hanna","Kurt Huber","Elaine M Hylek","Renato D Lopes","Byung-Hee Oh","Agneta Siegbahn"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This biomarker substudy compared the effects of apixaban versus warfarin on coagulation markers and primary hemostasis biomarkers in AF, providing mechanistic insight into their differential anticoagulant actions.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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 die het effect van apixaban versus warfarine op coagulatiemerkers onderzocht bij AF. Mechanistisch inzicht in de anticoagulatie-effecten.","abstract_original":"OBJECTIVES: Compare the effect of apixaban and warfarin on coagulation and primary haemostasis biomarkers in atrial fibrillation (AF). METHODS: The biomarker substudy from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial included 4850 patients with AF randomised to treatment with apixaban or warfarin. Sixty per cent of patients used vitamin K antagonist (VKA) within 7 days before randomisation. Prothrombin fragment 1+2 (F1+2), D-dimer, soluble CD40 ligand (sCD40L) and von Willebrand factor (vWF) antigen were analysed at randomisation and after 2 months of study treatment. RESULTS: In patients not on VKA treatment at randomisation, F1+2 and D-dimer levels were decreased by 25% and 23%, respectively, with apixaban, and by 59% and 38%, respectively, with warfarin (p<0.0001 for treatment differences for both). In patients on VKA at randomisation, F1+2 and D-dimer levels increased by 41% and 10%, respectively, with apixaban and decreased by 37% and 11%, respectively, with warfarin (p<0.0001 for treatment differences for both). sCD40L levels were slightly increased at 2 months, regardless of VKA or randomised treatment. Apixaban and warfarin also both reduced vWF antigen regardless of VKA treatment. The efficacy (stroke) and safety (bleeding) of apixaban compared with warfarin was similar irrespectively of biomarker levels at 2 months. CONCLUSIONS: Treatment with apixaban compared with warfarin for stroke prevention in patients with AF was associated with less reduction in thrombin generation and fibrin turnover. This effect of apixaban could contribute to the clinical results where apixaban was superior to warfarin both in stroke prevention and in reducing bleeding risk. TRIAL REGISTRATION NUMBER: NCT00412984."},{"id":"628988cf994a","type":"article","url":"https://hartvaat.nl/2019/02/01/spironolacton-en-collageenmetabolisme-biomarkers-bij-ongecontroleerde-hypertensi/","title":"Spironolacton en collageenmetabolisme-biomarkers bij ongecontroleerde hypertensie","title_en":"Potential spironolactone effects on collagen metabolism biomarkers in patients with uncontrolled blood pressure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313182","source_url":"https://doi.org/10.1136/heartjnl-2018-313182","authors":["João Pedro Ferreira","Patrick Rossignol","Anne Pizard","Jean-Loup Machu","Timothy Collier","Nicolas Girerd","Anne-Cécile Huby","Arantxa Gonzalez","Javier Diez","Begoña López","Naveed Sattar","John G Cleland","Peter S Sever","Faiez Zannad"],"significance":5,"published":"2019-02-01","source_date":"2019-02-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/","https://hartvaat.nl/kennis/diagnostiek/cardiale-biomarkers-overzicht/"],"congress":"","summary_en":"This study examined spironolactone's effects on collagen metabolism biomarkers as markers of cardiac fibrosis in patients with uncontrolled blood pressure, exploring anti-fibrotic mechanisms of MRA therapy.","created":"2026-07-03T10:27:45Z","updated":"2026-07-03T13:26:58Z","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 naar de effecten van spironolacton op collageenmetabolisme-biomarkers als maat voor cardiale fibrose bij ongecontroleerde bloeddruk.","abstract_original":"BACKGROUND: An increase in myocardial collagen content may contribute to the development of heart failure; this might be inhibited or reversed by mineralocorticoid receptor antagonists (MRAs). We investigated changes in serum concentrations of the collagen synthesis biomarkers N-terminal propeptide of procollagen type III (PIIINP) (primary outcome) and C-terminal propeptide of procollagen type I (PICP) (secondary outcome) after non-randomised initiation of spironolactone as add-on therapy among patients with resistant hypertension enrolled in the 'Anglo-Scandinavian Cardiac Outcomes' trial (ASCOT). METHODS: An age/sex matching plus propensity-scored logistic regression model incorporating variables related to the outcome and spironolactone treatment was created to compare patients treated with spironolactone for a 9-month period versus matched controls. A within-person analysis comparing changes in serum biomarker concentrations in the 9 months before versus after spironolactone treatment was also performed. RESULTS: Patients included in the between-person analysis (n=146) were well matched: the mean age was 63±7 years and 11% were woman. Serum concentrations of PIIINP and PICP rose in 'controls' and fell during spironolactone treatment (adjusted means +0.52 (-0.05 to 1.09) vs -0.41 (-0.97 to 0.16) ng/mL, p=0.031 for PIIINP and +4.54(-1.77 to 10.9) vs -6.36 (-12.5 to -0.21) ng/mL, p=0.023 for PICP). For the within-person analysis (n=173), spironolactone treatment was also associated with a reduction in PICP (beta estimate=-11.82(-17.53 to -6.10) ng/mL, p<0.001) but not in PIIINP levels. CONCLUSIONS: Treatment with spironolactone was associated with a reduction in serum biomarkers of collagen synthesis independently of blood pressure in patients with hypertension, suggesting that spironolactone might exert favourable effects on myocardial collagen synthesis and fibrosis. Whether this effect might contribute to slowing the progression to heart failure is worth investigating."},{"id":"b6210607c436","type":"article","url":"https://hartvaat.nl/2019/01/31/bilaterale-versus-enkele-mammaria-interna-grafts-na-10-jaar-nejm-art/","title":"Bilaterale versus enkele mammaria interna-grafts na 10 jaar: NEJM ART","title_en":"Bilateral versus Single Internal-Thoracic-Artery Grafts at 10 Years.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1808783","source_url":"https://doi.org/10.1056/NEJMoa1808783","authors":["David P Taggart","Umberto Benedetto","Stephen Gerry","Douglas G Altman","Alastair M Gray","Belinda Lees","Mario Gaudino","Vipin Zamvar","Andrzej Bochenek","Brian Buxton","Cliff Choong","Stephen Clark","Marek Deja","Jatin Desai","Ragheb Hasan","Marek Jasinski","Peter O'Keefe","Fernando Moraes","John Pepper","Siven Seevanayagam","Catherine Sudarshan","Uday Trivedi","Stanislaw Wos","John Puskas","Marcus Flather"],"significance":9,"published":"2019-01-31","source_date":"2019-01-31","image":"","kennis":[],"congress":"","summary_en":"The 10-year ART trial results showed no significant survival difference between bilateral and single internal thoracic artery grafts in CABG, contrary to the expectation from observational data. The findings did not support routine use of bilateral mammary grafting over single grafting in coronary bypass surgery.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"NEJM ART-trial 10-jaarsresultaten die geen significant verschil toonden in overleving tussen bilaterale versus enkele mammaria interna-grafts. Onverwacht negatief.","abstract_original":"BACKGROUND: Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS: We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS: A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS: Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265 .)."},{"id":"99c0ee008cd0","type":"article","url":"https://hartvaat.nl/2019/01/29/coronaire-plaquekenmerken-en-adverse-uitkomsten-scot-heart/","title":"Coronaire plaquekenmerken en adverse uitkomsten: SCOT-HEART","title_en":"Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["acuut-coronair-syndroom","bradycardie","inflammatie","spontane-coronairdissectie"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.10.066","source_url":"https://doi.org/10.1016/j.jacc.2018.10.066","authors":["Michelle C Williams","Alastair J Moss","Marc Dweck","Philip D Adamson","Shirjel Alam","Amanda Hunter","Anoop S V Shah","Tania Pawade","Jonathan R Weir-McCall","Giles Roditi","Edwin J R van Beek","David E Newby","Edward D Nicol"],"significance":7,"published":"2019-01-29","source_date":"2019-01-29","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/coronaire-ct-angiografie/"],"congress":"","summary_en":"This SCOT-HEART analysis identified specific coronary plaque characteristics on CT angiography (low-attenuation plaque, positive remodeling) that predict future cardiovascular events, supporting CT-based plaque characterization for risk stratification.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"SCOT-HEART analyse naar coronaire plaquekenmerken op CCTA die geassocieerd zijn met toekomstige cardiovasculaire events.","abstract_original":"BACKGROUND: Unlike most noninvasive imaging modalities, coronary computed tomography angiography can characterize subtypes of atherosclerotic plaque. OBJECTIVES: The purpose of this study was to investigate the prognostic implications of adverse coronary plaque characteristics in patients with suspected coronary artery disease. METHODS: In this SCOT-HEART (Scottish COmputed Tomography of the HEART Trial) post hoc analysis, the presence of adverse plaque (positive remodeling or low attenuation plaque), obstructive disease, and coronary artery calcification within 15 coronary segments was assessed on coronary computed tomography angiography of 1,769 patients who were followed-up for 5 years. RESULTS: Among study participants (mean age 58 ± 10 years; 56% male), 608 (34%) patients had 1 or more adverse plaque features. Coronary heart disease death or nonfatal myocardial infarction was 3 times more frequent in patients with adverse plaque (n = 25 of 608 [4.1%] vs. n = 16 of 1,161 [1.4%]; p < 0.001; hazard ratio [HR]: 3.01; 95% confidence interval (CI): 1.61 to 5.63; p = 0.001) and was twice as frequent in those with obstructive disease (n = 22 of 452 [4.9%] vs. n = 16 of 671 [2.4%]; p = 0.024; HR: 1.99; 95% CI: 1.05 to 3.79; p = 0.036). Patients with both obstructive disease and adverse plaque had the highest event rate, with a 10-fold increase in coronary heart disease death or nonfatal myocardial infarction compared with patients with normal coronary arteries (HR: 11.50; 95% CI: 3.39 to 39.04; p < 0.001). However, these associations were not independent of coronary artery calcium score, a surrogate measure of coronary plaque burden. CONCLUSIONS: Adverse coronary plaque characteristics and overall calcified plaque burden confer an increased risk of coronary heart disease death or nonfatal myocardial infarction. (Scottish COmputed Tomography of the HEART Trial [SCOT-HEART]; NCT01149590)."},{"id":"e08e3d73d418","type":"article","url":"https://hartvaat.nl/2019/01/29/microvasculaire-schade-bij-gerevasculariseerde-stemi-met-ticagrelor-versus-prasu/","title":"Microvasculaire schade bij gerevasculariseerde STEMI met ticagrelor versus prasugrel","title_en":"Evaluation of Microvascular Injury in Revascularized Patients With ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.035931","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.035931","authors":["Maarten A H van Leeuwen","Nina W van der Hoeven","Gladys N Janssens","Henk Everaars","Alexander Nap","Jorrit S Lemkes","Guus A de Waard","Peter M van de Ven","Albert C van Rossum","Tim J F Ten Cate","Jan J Piek","Clemens von Birgelen","Javier Escaned","Marco Valgimigli","Roberto Diletti","Niels P Riksen","Nicolas M van Mieghem","Robin Nijveldt","Niels van Royen"],"significance":5,"published":"2019-01-29","source_date":"2019-01-29","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/trombocytenaggregatieremmers-bij-acs/","https://hartvaat.nl/kennis/diagnostiek/cardiale-mri/"],"congress":"","summary_en":"This cardiac MRI study compared microvascular injury between ticagrelor- and prasugrel-treated STEMI patients, evaluating whether the P2Y12 inhibitor choice affects myocardial tissue-level reperfusion quality.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"Vergelijking van microvasculaire schade bij STEMI behandeld met ticagrelor versus prasugrel middels cardiale MRI.","abstract_original":"BACKGROUND: Despite successful restoration of epicardial vessel patency with primary percutaneous coronary intervention, coronary microvascular injury occurs in a large proportion of patients with ST-segment-elevation myocardial infarction, adversely affecting clinical and functional outcome. Ticagrelor has been reported to increase plasma adenosine levels, which might have a protective effect on the microcirculation. We investigated whether ticagrelor maintenance therapy after revascularized ST-segment-elevation myocardial infarction is associated with less coronary microvascular injury compared to prasugrel maintenance therapy. METHODS: A total of 110 patients with ST-segment-elevation myocardial infarction received a loading dose of ticagrelor and were randomized to maintenance therapy of ticagrelor (n=56) or prasugrel (n=54) after primary percutaneous coronary intervention. The primary outcome was coronary microvascular injury at 1 month, as determined with the index of microcirculatory resistance in the infarct-related artery. Cardiovascular magnetic resonance imaging was performed during the acute phase and at 1 month. RESULTS: The primary outcome of index of microcirculatory resistance was not superior in ticagrelor- or prasugrel-treated patients (ticagrelor, 21 [interquartile range, 15-39] U; prasugrel, 18 [interquartile range, 11-29] U; P=0.08). Recovery of microcirculatory resistance over time was not better in patients with ticagrelor versus prasugrel (ticagrelor, -13.9 U; prasugrel, -13.5 U; P=0.96). Intramyocardial hemorrhage was observed less frequently in patients receiving ticagrelor (23% versus 43%; P=0.04). At 1 month, no difference in infarct size was observed (ticagrelor, 7.6 [interquartile range, 3.7-14.4] g, prasugrel 9.9 [interquartile range, 5.7-16.6] g; P=0.17). The occurrence of microvascular obstruction was not different in patients on ticagrelor (28%) or prasugrel (41%; P=0.35). Plasma adenosine concentrations were not different during the index procedure and during maintenance therapy with ticagrelor or prasugrel. CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction, ticagrelor maintenance therapy was not superior to prasugrel in preventing coronary microvascular injury in the infarct-related territory as assessed by the index of microcirculatory resistance, and this resulted in a comparable infarct size at 1 month. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02422888."},{"id":"6b387efbab42","type":"article","url":"https://hartvaat.nl/2019/01/29/oac-met-of-zonder-antiplaatjes-bij-af-na-pci-1-jaar-gerandomiseerde-trial/","title":"OAC met of zonder antiplaatjes bij AF na PCI >1 jaar: gerandomiseerde trial","title_en":"Open-Label Randomized Trial Comparing Oral Anticoagulation With and Without Single Antiplatelet Therapy in Patients With Atrial Fibrillation and Stable Coronary Artery Disease Beyond 1 Year After Coronary Stent Implantation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.036768","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.036768","authors":["Yukiko Matsumura-Nakano","Satoshi Shizuta","Akihiro Komasa","Takeshi Morimoto","Hisaki Masuda","Hiroki Shiomi","Koji Goto","Kentaro Nakai","Hisashi Ogawa","Atsushi Kobori","Yutaka Kono","Kazuaki Kaitani","Satoru Suwa","Takeshi Aoyama","Mamoru Takahashi","Yasuhiro Sasaki","Yuko Onishi","Toshiaki Mano","Mitsuo Matsuda","Makoto Motooka","Hirofumi Tomita","Moriaki Inoko","Takatoshi Wakeyama","Nobuhisa Hagiwara","Kengo Tanabe","Masaharu Akao","Katsumi Miyauchi","Junji Yajima","Keiichi Hanaoka","Yoshihiro Morino","Kenji Ando","Yutaka Furukawa","Yoshihisa Nakagawa","Koichi Nakao","Ken Kozuma","Kazushige Kadota","Kazuo Kimura","Kazuya Kawai","Takafumi Ueno","Ken Okumura","Takeshi Kimura"],"significance":7,"published":"2019-01-29","source_date":"2019-01-29","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"This open-label randomized trial compared oral anticoagulation alone versus OAC plus single antiplatelet therapy in AF patients more than one year after PCI, addressing the optimal late antithrombotic strategy after the initial combination period.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"Open-label gerandomiseerde trial die OAC alleen vergeleek met OAC plus antiplaatjes bij AF-patiënten >1 jaar na PCI. Late de-escalatie.","abstract_original":"BACKGROUND: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after coronary stenting. METHODS: This study was a prospective, multicenter, open-label, noninferiority trial comparing OAC alone to combined OAC and single APT among patients with atrial fibrillation beyond 1 year after stenting in a 1:1 randomization fashion. The primary end point was a composite of all-cause death, myocardial infarction, stroke, or systemic embolism. The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis classification. Although the trial was designed to enroll 2000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. RESULTS: Mean age was 75.0±7.6 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The mean CHADS2 score was 2.5±1.2. During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; 95% CI, 0.79-1.72; P=0.20 for noninferiority, P=0.45 for superiority). The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; 95% CI, 0.71-1.39; P=0.016 for noninferiority, P=0.96 for superiority). Myocardial infarction occurred in 8 (2.3%) and 4 (1.2%) patients, whereas stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively. CONCLUSIONS: This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. Because patient enrollment was prematurely terminated, the study was underpowered and inconclusive. Future larger studies are required to establish the optimal antithrombotic regimen in this population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01962545."},{"id":"75bac18b4990","type":"article","url":"https://hartvaat.nl/2019/01/29/drie-armen-vergelijkende-renale-denervatie-radiosound-htn/","title":"Drie armen vergelijkende renale denervatie: RADIOSOUND-HTN","title_en":"A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN).","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037654","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037654","authors":["Karl Fengler","Karl-Philipp Rommel","Stephan Blazek","Christian Besler","Philipp Hartung","Maximilian von Roeder","Martin Petzold","Sindy Winkler","Robert Höllriegel","Steffen Desch","Holger Thiele","Philipp Lurz"],"significance":6,"published":"2019-01-29","source_date":"2019-01-29","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/arb-hypertensie/"],"congress":"","summary_en":"The RADIOSOUND-HTN trial compared radiofrequency and ultrasound renal denervation devices in a three-arm design, providing the first randomized comparison of different energy modalities for catheter-based sympathetic ablation.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"RADIOSOUND-HTN driearmige gerandomiseerde trial die verschillende renale denervatie-devices vergeleek bij resistente hypertensie.","abstract_original":"BACKGROUND: Both radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have proven clinical efficacy for the treatment of hypertension. We performed a head-to-head comparison of these technologies. METHODS: Patients with resistant hypertension were randomly assigned in a 1:1:1 manner to receive either treatment with (1) radiofrequency RDN of the main renal arteries; (2) radiofrequency RDN of the main renal arteries, side branches, and accessories; or (3) an endovascular ultrasound-based RDN of the main renal artery. The primary end point was change in systolic daytime ambulatory blood pressure at 3 months. RESULTS: Between June 2015 and June 2018, 120 patients were enrolled (mean age, 64±9 years±SD; mean daytime blood pressure, 153/86±12/13 mm Hg). Of these, 39 were randomly assigned to radiofrequency main renal artery ablation, 39 to combined radiofrequency ablation of the main artery and branches, and 42 to ultrasound-based treatment. Baseline daytime blood pressure, clinical characteristics, and treatment were well balanced between the groups. At 3 months, systolic daytime ambulatory blood pressure decreased by 9.5±12.3 mm Hg ( P<0.001) in the whole cohort. Although blood pressure was significantly more reduced in the ultrasound ablation group than in the radiofrequency ablation group of the main renal artery (-13.2±13.7 versus -6.5±10.3 mm Hg; mean difference, -6.7 mm Hg; global P=0.038 by ANOVA, adjusted P=0.043), no significant difference was found between the radiofrequency ablation groups (-8.3±11.7 mm Hg for additional side branch ablation; mean difference, -1.8 mm Hg; adjusted P>0.99). Similarly, the blood pressure reduction was not found to be significantly different between the ultrasound and the side branch ablation groups. Frequencies of blood pressure response ≥5 mm Hg were not significantly different (global P=0.77). CONCLUSIONS: In patients with resistant hypertension, endovascular ultrasound-based RDN was found to be superior to radiofrequency ablation of the main renal arteries only, whereas a combined approach of radiofrequency ablation of the main arteries, accessories, and side branches was not. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02920034."},{"id":"ec46f70f0d67","type":"article","url":"https://hartvaat.nl/2019/01/24/dapagliflozine-en-cardiovasculaire-uitkomsten-bij-diabetes-type-2-nejm-declare-t/","title":"Dapagliflozine en cardiovasculaire uitkomsten bij diabetes type 2: NEJM DECLARE-TIMI 58","title_en":"Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["canagliflozine","dapa-hf","dapagliflozine","diabetes-type-2","soul-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1812389","source_url":"https://doi.org/10.1056/NEJMoa1812389","authors":["Stephen D Wiviott","Itamar Raz","Marc P Bonaca","Ofri Mosenzon","Eri T Kato","Avivit Cahn","Michael G Silverman","Thomas A Zelniker","Julia F Kuder","Sabina A Murphy","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","John P H Wilding","Christian T Ruff","Ingrid A M Gause-Nilsson","Martin Fredriksson","Peter A Johansson","Anna-Maria Langkilde","Marc S Sabatine"],"significance":10,"published":"2019-01-24","source_date":"2019-01-24","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/glp1-agonisten-cardiologie/","https://hartvaat.nl/kennis/farmacologie/colchicine-cardiovasculair/"],"congress":"","summary_en":"The DECLARE-TIMI 58 trial evaluated dapagliflozin in a broad population of patients with type 2 diabetes including those with only cardiovascular risk factors. While dapagliflozin did not significantly reduce MACE, it lowered heart failure hospitalization, confirming the consistent heart failure benefit of SGLT2 inhibitors even in lower-risk populations.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"NEJM DECLARE-TIMI 58-trial die dapagliflozine onderzocht bij diabetes type 2 met CV-risicofactoren. Bevestigt HF-hospitalisatiereductie maar geen significante MACE-reductie bij een bredere populatie.","abstract_original":"BACKGROUND: The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS: We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to <60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS: We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], <1.3; P<0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P=0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P=0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3% vs. 0.1%, P=0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P<0.001). CONCLUSIONS: In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARE-TIMI 58 ClinicalTrials.gov number, NCT01730534 .)."},{"id":"182803fc72da","type":"article","url":"https://hartvaat.nl/2019/01/22/aspirine-voor-primaire-preventie-jama-meta-analyse-van-cv-events-en-bloedingen/","title":"Aspirine voor primaire preventie: JAMA meta-analyse van CV-events en bloedingen","title_en":"Association of Aspirin Use for Primary Prevention With Cardiovascular Events and Bleeding Events: A Systematic Review and Meta-analysis.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["aspirine","primaire-preventie"],"journal":"JAMA","doi":"10.1001/jama.2018.20578","source_url":"https://doi.org/10.1001/jama.2018.20578","authors":["Sean L Zheng","Alistair J Roddick"],"significance":9,"published":"2019-01-22","source_date":"2019-01-22","image":"","kennis":["https://hartvaat.nl/kennis/preventie/aspirine-primaire-preventie/"],"congress":"","summary_en":"This JAMA meta-analysis of aspirin for primary cardiovascular prevention showed a modest reduction in cardiovascular events offset by increased major bleeding, particularly gastrointestinal and intracranial hemorrhage. The findings informed the paradigm shift against routine aspirin use in primary prevention.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"JAMA meta-analyse die aspirine voor primaire preventie samenvat: bescheiden voordeel op CV-events overschaduwd door bloedingsrisico. Keerpunt in het aspirine-debat.","abstract_original":"IMPORTANCE: The role for aspirin in cardiovascular primary prevention remains controversial, with potential benefits limited by an increased bleeding risk. OBJECTIVE: To assess the association of aspirin use for primary prevention with cardiovascular events and bleeding. DATA SOURCES: PubMed and Embase were searched on Cochrane Library Central Register of Controlled Trials from the earliest available date through November 1, 2018. STUDY SELECTION: Randomized clinical trials enrolling at least 1000 participants with no known cardiovascular disease and a follow-up of at least 12 months were included. Included studies compared aspirin use with no aspirin (placebo or no treatment). DATA EXTRACTION AND SYNTHESIS: Data were screened and extracted independently by both investigators. Bayesian and frequentist meta-analyses were performed. MAIN OUTCOMES AND MEASURES: The primary cardiovascular outcome was a composite of cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke. The primary bleeding outcome was any major bleeding (defined by the individual studies). RESULTS: A total of 13 trials randomizing 164 225 participants with 1 050 511 participant-years of follow-up were included. The median age of trial participants was 62 years (range, 53-74), 77 501 (47%) were men, 30 361 (19%) had diabetes, and the median baseline risk of the primary cardiovascular outcome was 9.2% (range, 2.6%-15.9%). Aspirin use was associated with significant reductions in the composite cardiovascular outcome compared with no aspirin (57.1 per 10 000 participant-years with aspirin and 61.4 per 10 000 participant-years with no aspirin) (hazard ratio [HR], 0.89 [95% credible interval, 0.84-0.95]; absolute risk reduction, 0.38% [95% CI, 0.20%-0.55%]; number needed to treat, 265). Aspirin use was associated with an increased risk of major bleeding events compared with no aspirin (23.1 per 10 000 participant-years with aspirin and 16.4 per 10 000 participant-years with no aspirin) (HR, 1.43 [95% credible interval, 1.30-1.56]; absolute risk increase, 0.47% [95% CI, 0.34%-0.62%]; number needed to harm, 210). CONCLUSIONS AND RELEVANCE: The use of aspirin in individuals without cardiovascular disease was associated with a lower risk of cardiovascular events and an increased risk of major bleeding. This information may inform discussions with patients about aspirin for primary prevention of cardiovascular events and bleeding."},{"id":"5d20463ec544","type":"article","url":"https://hartvaat.nl/2019/01/22/milde-hypothermie-bij-cardiogene-shock-complicerend-mi/","title":"Milde hypothermie bij cardiogene shock complicerend MI","title_en":"Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["cardiogene-shock","myocardinfarct"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.117.032722","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.117.032722","authors":["Georg Fuernau","Johannes Beck","Steffen Desch","Ingo Eitel","Christian Jung","Sandra Erbs","Norman Mangner","Philipp Lurz","Karl Fengler","Alexander Jobs","Reinhard Vonthein","Suzanne de Waha-Thiele","Marcus Sandri","Gerhard Schuler","Holger Thiele"],"significance":6,"published":"2019-01-22","source_date":"2019-01-22","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This study evaluated mild therapeutic hypothermia in cardiogenic shock complicating MI, testing temperature management as a potential adjunctive therapy in the most hemodynamically compromised infarction patients.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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 naar milde hypothermie bij cardiogene shock na myocardinfarct. Onderzoekt temperaatuurmanagement bij de ziekste MI-patiënten.","abstract_original":"BACKGROUND: Experimental trials suggest improved outcome by mild therapeutic hypothermia for cardiogenic shock after acute myocardial infarction. The objective of this study was to investigate the hemodynamic effects of mild therapeutic hypothermia in patients with cardiogenic shock complicating acute myocardial infarction. METHODS: Patients (n=40) with cardiogenic shock undergoing primary percutaneous coronary intervention without classic indications for mild therapeutic hypothermia underwent randomization in a 1:1 fashion to mild therapeutic hypothermia for 24 hours or control. The primary end point was cardiac power index at 24 hours; secondary end points included other hemodynamic parameters and serial measurements of arterial lactate. RESULTS: No relevant differences were observed for the primary end point of cardiac power index at 24 hours (mild therapeutic hypothermia versus control: 0.41 [interquartile range, 0.31-0.52] versus 0.36 [interquartile range, 0.31-0.48] W/m2; P=0.50; median difference, -0.025 W/m2; 95% CI, -0.12 to 0.06). Similarly, all other hemodynamic measurements were not statistically different. Arterial lactate levels at 6, 8, and 10 hours were significantly higher in patients in the mild therapeutic hypothermia group with a slower decline ( P for interaction=0.03). There were no differences in 30-day mortality (60% versus 50%; hazard ratio, 1.27; 95% CI, 0.55-2.94; P=0.55). CONCLUSIONS: In this randomized trial, mild therapeutic hypothermia failed to show a substantial beneficial effect on cardiac power index at 24 hours in patients with cardiogenic shock after acute myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01890317."},{"id":"ee38d3a2cf76","type":"article","url":"https://hartvaat.nl/2019/01/15/lv-unloading-voor-reperfusie-bij-anterieure-stemi-dtu-stemi-pilot/","title":"LV-unloading vóór reperfusie bij anterieure STEMI: DTU-STEMI pilot","title_en":"Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038269","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038269","authors":["Navin K Kapur","Mohamad A Alkhouli","Tony J DeMartini","Haroon Faraz","Zachary H George","Mark J Goodwin","Jaime A Hernandez-Montfort","Vijay S Iyer","Noam Josephy","Sanjog Kalra","Amir Kaki","Richard H Karas","Carey D Kimmelstiel","Gerald C Koenig","Evan Lau","Kapildeo Lotun","Ryan D Madder","Salvatore F Mannino","Perwaiz M Meraj","Jason A Moreland","Jeffrey W Moses","Raymond L Kim","Theodore L Schreiber","James E Udelson","Christian Witzke","David H W Wohns","William W O'Neill"],"significance":7,"published":"2019-01-15","source_date":"2019-01-15","image":"","kennis":[],"congress":"","summary_en":"This pilot study investigated left ventricular unloading with the Impella device before coronary reperfusion in anterior STEMI, testing the novel concept that mechanical unloading prior to restoring blood flow may reduce infarct size.","created":"2026-07-03T10:27:44Z","updated":"2026-07-03T13:26:57Z","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":"Pilot studie naar het ontlasten van de linkerkamer met Impella vóór reperfusie bij anterieure STEMI. Innovatief concept voor infarctgroottereductie.","abstract_original":"BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270."},{"id":"c4bfb6e560c3","type":"article","url":"https://hartvaat.nl/2019/01/15/10-jaarsuitkomsten-van-drie-limus-eluting-stents-coating-vergelijking/","title":"10-jaarsuitkomsten van drie limus-eluting stents: coating vergelijking","title_en":"Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038065","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038065","authors":["Sebastian Kufner","Michael Joner","Anna Thannheimer","Petra Hoppmann","Tareq Ibrahim","Katharina Mayer","Salvatore Cassese","Karl-Ludwig Laugwitz","Heribert Schunkert","Adnan Kastrati","Robert A Byrne"],"significance":6,"published":"2019-01-15","source_date":"2019-01-15","image":"","kennis":[],"congress":"","summary_en":"These 10-year results comparing three limus-eluting stents with different polymer coatings provided the longest randomized follow-up for contemporary DES, showing durable safety with both biodegradable and permanent polymer platforms.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"10-jaarsresultaten die drie limus-eluting stents met verschillende polymeercoatings vergeleek. Zeer langetermijndata voor stentontwerp.","abstract_original":"BACKGROUND: New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up. METHODS: Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients. RESULTS: The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES. CONCLUSIONS: In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676."},{"id":"ee40f2ab8e99","type":"article","url":"https://hartvaat.nl/2019/01/15/linagliptine-en-hartfalenuitkomsten-bij-diabetes-type-2-carmelina/","title":"Linagliptine en hartfalenuitkomsten bij diabetes type 2: CARMELINA","title_en":"Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":["sacubitril-valsartan"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038352","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038352","authors":["Darren K McGuire","John H Alexander","Odd Erik Johansen","Vlado Perkovic","Julio Rosenstock","Mark E Cooper","Christoph Wanner","Steven E Kahn","Robert D Toto","Bernard Zinman","David Baanstra","Egon Pfarr","Sven Schnaidt","Thomas Meinicke","Jyothis T George","Maximilian von Eynatten","Nikolaus Marx"],"significance":6,"published":"2019-01-15","source_date":"2019-01-15","image":"","kennis":[],"congress":"","summary_en":"This CARMELINA analysis confirmed that linagliptin has a neutral effect on heart failure outcomes in high-risk type 2 diabetes patients, maintaining the cardiovascular safety profile of DPP-4 inhibitors without the heart failure signal seen with saxagliptin.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"CARMELINA analyse specifiek naar hartfalenuitkomsten met linagliptine. Bevestigt neutraliteit van DPP-4-remming op HF-risico.","abstract_original":"BACKGROUND: Individuals with type 2 diabetes mellitus are at increased risk for heart failure (HF), particularly those with coexisting atherosclerotic cardiovascular disease and/or kidney disease. Some but not all dipeptidyl peptidase-4 inhibitors have been associated with increased HF risk. We performed secondary analyses of HF and related outcomes with the dipeptidyl peptidase-4 inhibitor linagliptin versus placebo in CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin), a cardiovascular outcomes trial that enrolled participants with type 2 diabetes mellitus and atherosclerotic cardiovascular disease and/or kidney disease. METHODS: Participants in 27 countries with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease were randomized 1:1 to receive once daily oral linagliptin 5 mg or placebo, on top of standard of care. All hospitalization for HF (hHF), cardiovascular outcomes, and deaths were prospectively captured and centrally adjudicated. In prespecified and post hoc analyses of HF and related events, Cox proportional hazards models adjusting for region and baseline history of HF were used. Recurrent hHF events were analyzed using a negative binomial model. In a subset of participants with left ventricular ejection fraction captured within the year before randomization, HF-related outcomes were assessed in subgroups stratified by left ventricular ejection fraction > or ≤50%. RESULTS: CARMELINA enrolled 6979 participants (mean age, 65.9 years; estimated glomerular filtration rate, mL/min per 1.73m2; hemoglobin A1c, 8.0%; 62.9% men; diabetes mellitus duration, 14.8 years), including 1873 (26.8%) with a history of HF at baseline. Median follow-up was 2.2 years. Linagliptin versus placebo did not affect the incidence of hHF (209/3494 [6.0%] versus 226/3485 [6.5%], respectively; hazard ratio [HR], 0.90; 95% CI, 0.74-1.08), the composite of cardiovascular death/hHF (HR, 0.94; 95% CI, 0.82-1.08), or risk for recurrent hHF events (326 versus 359 events, respectively; rate ratio, 0.94; 95% CI, 0.75-1.20). There was no heterogeneity of linagliptin effects on hHF by history of HF at baseline, baseline estimated glomerular filtration rate or urine albumin-creatinine ratio, or prerandomization left ventricular ejection fraction. CONCLUSIONS: In a large, international cardiovascular outcome trial in participants with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease, linagliptin did not affect the risk of hHF or other selected HF-related outcomes, including among participants with and without a history of HF, across the spectrum of kidney disease, and independent of previous left ventricular ejection fraction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01897532."},{"id":"54ee9007cf56","type":"article","url":"https://hartvaat.nl/2019/01/12/visualisatie-van-asymptomatische-atherosclerose-voor-cv-preventie-lancet-vipviza/","title":"Visualisatie van asymptomatische atherosclerose voor CV-preventie: Lancet VIPVIZA","title_en":"Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts"],"tags":["atherosclerose","ezetimibe","hartkatheterisatie","hartrevalidatie","perifeer-vaatlijden","primaire-preventie","secundaire-preventie"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)32818-6","source_url":"https://doi.org/10.1016/S0140-6736(18)32818-6","authors":["Ulf Näslund","Nawi Ng","Anna Lundgren","Eva Fhärm","Christer Grönlund","Helene Johansson","Bernt Lindahl","Bertil Lindahl","Kristina Lindvall","Stefan K Nilsson","Maria Nordin","Steven Nordin","Emma Nyman","Joacim Rocklöv","Davide Vanoli","Lars Weinehall","Patrik Wennberg","Per Wester","Margareta Norberg"],"significance":7,"published":"2019-01-12","source_date":"2019-01-12","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/","https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/"],"congress":"","summary_en":"The VIPVIZA pragmatic trial showed that visualizing atherosclerotic disease through ultrasound imaging and communicating the results to patients and doctors improved cardiovascular risk factor management, demonstrating the power of disease visualization for prevention.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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 VIPVIZA pragmatische trial die beeldvormingvisualisatie van subklinische atherosclerose onderzocht voor optimalisatie van cardiovasculaire preventie.","abstract_original":"BACKGROUND: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention. METHODS: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. Participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed). The primary outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575. FINDINGS: 3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (-0·58 [95% CI -0·86 to -0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]). INTERPRETATION: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification. FUNDING: Västerbotten County Council, the Swedish Research Council, the Heart and Lung Foundation, the Swedish Society of Medicine, and Carl Bennet Ltd, Sweden."},{"id":"0fa3f54ab6b3","type":"article","url":"https://hartvaat.nl/2019/01/10/endoscopische-versus-open-veneoogst-bij-cabg-nejm-regroup/","title":"Endoscopische versus open veneoogst bij CABG: NEJM REGROUP","title_en":"Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1812390","source_url":"https://doi.org/10.1056/NEJMoa1812390","authors":["Marco A Zenati","Deepak L Bhatt","Faisal G Bakaeen","Eileen M Stock","Kousick Biswas","J Michael Gaziano","Rosemary F Kelly","Elaine E Tseng","Jerene Bitondo","Jacquelyn A Quin","G Hossein Almassi","Miguel Haime","Brack Hattler","Ellen DeMatt","Alexandra Scrymgeour","Grant D Huang"],"significance":8,"published":"2019-01-10","source_date":"2019-01-10","image":"","kennis":[],"congress":"","summary_en":"The REGROUP trial demonstrated that endoscopic saphenous vein harvesting was noninferior to open harvesting for vein graft failure after CABG. The result provided reassurance that the less invasive and more widely used endoscopic technique does not compromise graft quality.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"NEJM REGROUP gerandomiseerde trial die endoscopische vergeleek met open veneoogst bij CABG. Geen verschil in graft-falen — geruststellend voor de minder invasieve techniek.","abstract_original":"BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .)."},{"id":"bdfffe4d4037","type":"article","url":"https://hartvaat.nl/2019/01/08/hfref-differentiele-impact-op-mannen-en-vrouwen/","title":"HFrEF: differentiële impact op mannen en vrouwen","title_en":"Differential Impact of Heart Failure With Reduced Ejection Fraction on Men and Women.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2018.09.081","source_url":"https://doi.org/10.1016/j.jacc.2018.09.081","authors":["Pooja Dewan","Rasmus Rørth","Pardeep S Jhund","Li Shen","Valeria Raparelli","Mark C Petrie","William T Abraham","Akshay S Desai","Kenneth Dickstein","Lars Køber","Ulrik M Mogensen","Milton Packer","Jean L Rouleau","Scott D Solomon","Karl Swedberg","Michael R Zile","John J V McMurray"],"significance":6,"published":"2019-01-08","source_date":"2019-01-08","image":"","kennis":[],"congress":"","summary_en":"This study characterized the differential impact of HFrEF on men and women, showing that while women have better survival, they are more likely to be undertreated with guideline-directed therapy, highlighting a persistent care gap.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"Studie naar sekseverschillen in de impact van HFrEF op uitkomsten. Vrouwen hebben een betere prognose maar worden mogelijk onderbehandeld.","abstract_original":"BACKGROUND: Heart failure (HF) trials initiated in the last century highlighted many differences between men and women. Of particular concern was undertreatment of women compared with men, but much has changed during the past 20 years. OBJECTIVES: This study sought to identify these changes, which may give a new perspective on the management of, and outcomes in, women with HF. METHODS: The study analyzed 12,058 men and 3,357 women enrolled in 2 large HF with reduced ejection fraction (HFrEF) trials with near identical inclusion and exclusion criteria and the same principal outcomes. Outcomes were adjusted for other prognostic variables including N-terminal pro-B-type natriuretic peptide. RESULTS: Women were older and more often obese than men were, had slightly higher systolic blood pressure and heart rate, and were less likely to have most comorbidities, except hypertension. Women had more symptoms and signs (e.g., pedal edema 23.4% vs 19.9%; p < 0.0001) and worse quality of life-median Kansas City Cardiomyopathy Questionnaire Clinical Summary Score 71.3 (interquartile range: 53.4 to 86.5) versus 81.3 (interquartile range: 65.1 to 92.7; p < 0.0001)-despite similar left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide. However, women had lower mortality (adjusted hazard ratio: 0.68; 95% confidence interval: 0.62 to 0.74; p < 0.001) and risk of HF hospitalization (hazard ratio: 0.80; 95% confidence interval: 0.72 to 0.89; p < 0.001). Diuretics and anticoagulants were underutilized in women. Device therapy was underused in both men and women, but more so in women (e.g., defibrillator 8.6% vs. 16.6%; p < 0.0001). CONCLUSIONS: Although women with HFrEF live longer than men, their additional years of life are of poorer quality, with greater self-reported psychological and physical disability. The explanation for this different sex-related experience of HFrEF is unknown as is whether physicians recognize it. Women continue to receive suboptimal treatment, compared with men, with no obvious explanation for this shortfall."},{"id":"4d80d103cd01","type":"article","url":"https://hartvaat.nl/2019/01/08/cva-analyse-in-momentum-3-langetermijncohort/","title":"CVA-analyse in MOMENTUM 3 langetermijncohort","title_en":"Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037231","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037231","authors":["Paolo C Colombo","Mandeep R Mehra","Daniel J Goldstein","Jerry D Estep","Christopher Salerno","Ulrich P Jorde","Jennifer A Cowger","Joseph C Cleveland","Nir Uriel","Gabriel Sayer","Eric R Skipper","Francis X Downey","Masahiro Ono","Robert Hooker","Anelechi C Anyanwu","Michael M Givertz","Claudius Mahr","Ia Topuria","Sami I Somo","Daniel L Crandall","Douglas A Horstmanshof"],"significance":6,"published":"2019-01-08","source_date":"2019-01-08","image":"","kennis":[],"congress":"","summary_en":"This comprehensive MOMENTUM 3 analysis characterized stroke incidence and risk factors in the HeartMate 3 long-term cohort, informing the prevention and management of cerebrovascular events during LVAD support.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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 van CVA-incidentie en risicofactoren in het MOMENTUM 3 langetermijncohort met de HeartMate 3 LVAD.","abstract_original":"BACKGROUND: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. METHODS: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. RESULTS: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1-733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181-730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08-0.63; P=0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). CONCLUSIONS: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755."},{"id":"42d577a7bf8d","type":"article","url":"https://hartvaat.nl/2019/01/07/ffr-geleide-pci-versus-medicamenteuze-therapie-bij-stabiele-coronairlaesies-meta/","title":"FFR-geleide PCI versus medicamenteuze therapie bij stabiele coronairlaesies: meta-analyse","title_en":"Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["stabiel-coronairlijden"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy812","source_url":"https://doi.org/10.1093/eurheartj/ehy812","authors":["Frederik M Zimmermann","Elmir Omerovic","Stephane Fournier","Henning Kelbæk","Nils P Johnson","Martina Rothenbühler","Panagiotis Xaplanteris","Mohamed Abdel-Wahab","Emanuele Barbato","Dan Eik Høfsten","Pim A L Tonino","Bianca M Boxma-de Klerk","William F Fearon","Lars Køber","Pieter C Smits","Bernard De Bruyne","Nico H J Pijls","Peter Jüni","Thomas Engstrøm"],"significance":7,"published":"2019-01-07","source_date":"2019-01-07","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/"],"congress":"","summary_en":"This meta-analysis confirmed that FFR-guided PCI with contemporary drug-eluting stents reduces cardiovascular events compared with medical therapy alone in patients with stable coronary lesions, consolidating the evidence for physiologically guided revascularization.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"Meta-analyse die FFR-geleide PCI vergeleek met medicamenteuze therapie bij stabiele coronairlaesies. Consolideert het FFR-evidence.","abstract_original":"AIMS: To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions. METHODS AND RESULTS: We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI. CONCLUSION: In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI."},{"id":"7dd490082170","type":"article","url":"https://hartvaat.nl/2019/01/07/bioresorbeerbare-scaffold-versus-ees-bij-stabiel-coronairlijden-prospectieve-tri/","title":"Bioresorbeerbare scaffold versus EES bij stabiel coronairlijden: prospectieve trial","title_en":"Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy710","source_url":"https://doi.org/10.1093/eurheartj/ehy710","authors":["Robert A Byrne","Fernando Alfonso","Simon Schneider","Michael Maeng","Jens Wiebe","Evgeny Kretov","Christian Bradaric","Himanshu Rai","Javier Cuesta","Fernando Rivero","Petra Hoppmann","Jana Schlichtenmaier","Evald H Christiansen","Salvatore Cassese","Michael Joner","Heribert Schunkert","Karl-Ludwig Laugwitz","Adnan Kastrati"],"significance":6,"published":"2019-01-07","source_date":"2019-01-07","image":"","kennis":[],"congress":"","summary_en":"This randomized trial of bioresorbable scaffolds versus everolimus-eluting stents in stable coronary disease added further negative evidence for BRS technology, with higher rates of target lesion failure.","created":"2026-07-03T10:27:43Z","updated":"2026-07-03T13:26:56Z","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":"Prospectieve gerandomiseerde trial van BRS versus EES bij stabiel coronairlijden. Aanvullend negatief bewijs voor bioresorbeerbare scaffolds.","abstract_original":"AIMS: Bioresorbable scaffolds (BRS) provide short-term coronary artery scaffolding and drug delivery. Although prior trials showed a higher rate of device failure compared with conventional drug-eluting stents (DES), only a single trial investigated patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). We aimed to compare outcomes with BRS vs. DES in patients undergoing PCI for MI. METHODS AND RESULTS: We did a prospective, randomized, multicentre, non-inferiority, clinical trial of everolimus-eluting BRS vs. durable polymer everolimus-eluting stents (EES) in patients with acute MI. Patients were eligible for enrolment if they presented with ST-elevation MI, or non-ST-elevation MI with thrombosis visual at angiography and were randomly allocated to treatment with BRS or EES in 2:1 proportion. Angiographic follow-up was scheduled at 6-8 months and clinical follow-up was done at 12 months. The primary endpoint was percentage diameter stenosis in-segment at follow-up. A total of 262 patients were enrolled and were allocated to BRS (n = 173) or EES (n = 89). Angiographic follow-up was available for 213 (81.3%) patients. Mean diameter stenosis was 24.6 ± 12.2% with BRS vs. 27.3 ± 11.7% with EES (mean difference -2.7%, upper limit of one-sided 97.5% confidence limit 0.7%, pre-specified margin of non-inferiority 5%, Pnon-inferiority <0.001). The rate of the device-oriented composite of cardiac death/target vessel MI/target lesion revascularization [BRS: 12 (7.0%) vs. EES: 6 (6.7%), hazard ratio (HR) 1.04, 95% confidence interval (CI) 0.39-2.78] and definite/probable stent thrombosis [3 (1.7%) vs. 2 (2.3%), HR 0.76, 95% CI 0.13-4.56] were comparable in both groups. CONCLUSION: In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up. Rates of clinical events were comparable between the treatment groups, although the study was not powered to detect differences in clinical outcomes. CLINICAL TRIAL REGISTRATION: The trial was registered at www.clinicaltrials.gov (NCT01942070)."},{"id":"8a59b02edd42","type":"article","url":"https://hartvaat.nl/2019/01/05/staken-van-hf-medicatie-bij-herstelde-dilaterende-cardiomyopathie-lancet-tred-hf/","title":"Staken van HF-medicatie bij herstelde dilaterende cardiomyopathie: Lancet TRED-HF","title_en":"Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["answer-hf","gedilateerde-cardiomyopathie","hypertrofische-cardiomyopathie","laminopathie","pathfinder-trial"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)32484-X","source_url":"https://doi.org/10.1016/S0140-6736(18)32484-X","authors":["Brian P Halliday","Rebecca Wassall","Amrit S Lota","Zohya Khalique","John Gregson","Simon Newsome","Robert Jackson","Tsveta Rahneva","Rick Wage","Gillian Smith","Lucia Venneri","Upasana Tayal","Dominique Auger","William Midwinter","Nicola Whiffin","Ronak Rajani","Jason N Dungu","Antonis Pantazis","Stuart A Cook","James S Ware","A John Baksi","Dudley J Pennell","Stuart D Rosen","Martin R Cowie","John G F Cleland","Sanjay K Prasad"],"significance":8,"published":"2019-01-05","source_date":"2019-01-05","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hartfalen-en-zwangerschap/"],"congress":"","summary_en":"The TRED-HF trial showed that withdrawal of heart failure medications in patients with recovered dilated cardiomyopathy led to relapse of ventricular dysfunction within 6 months in 40% of patients. The results established that heart failure therapy should be continued indefinitely even after apparent cardiac recovery.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:56Z","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 TRED-HF trial die aantoonde dat staken van hartfalenmedicatie bij herstelde dilaterende cardiomyopathie leidt tot recidief. Bepalend voor levenslange behandeling.","abstract_original":"BACKGROUND: Patients with dilated cardiomyopathy whose symptoms and cardiac function have recovered often ask whether their medications can be stopped. The safety of withdrawing treatment in this situation is unknown. METHODS: We did an open-label, pilot, randomised trial to examine the effect of phased withdrawal of heart failure medications in patients with previous dilated cardiomyopathy who were now asymptomatic, whose left ventricular ejection fraction (LVEF) had improved from less than 40% to 50% or greater, whose left ventricular end-diastolic volume (LVEDV) had normalised, and who had an N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) concentration less than 250 ng/L. Patients were recruited from a network of hospitals in the UK, assessed at one centre (Royal Brompton and Harefield NHS Foundation Trust, London, UK), and randomly assigned (1:1) to phased withdrawal or continuation of treatment. After 6 months, patients in the continued treatment group had treatment withdrawn by the same method. The primary endpoint was a relapse of dilated cardiomyopathy within 6 months, defined by a reduction in LVEF of more than 10% and to less than 50%, an increase in LVEDV by more than 10% and to higher than the normal range, a two-fold rise in NT-pro-BNP concentration and to more than 400 ng/L, or clinical evidence of heart failure, at which point treatments were re-established. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02859311. FINDINGS: Between April 21, 2016, and Aug 22, 2017, 51 patients were enrolled. 25 were randomly assigned to the treatment withdrawal group and 26 to continue treatment. Over the first 6 months, 11 (44%) patients randomly assigned to treatment withdrawal met the primary endpoint of relapse compared with none of those assigned to continue treatment (Kaplan-Meier estimate of event rate 45·7% [95% CI 28·5-67·2]; p=0·0001). After 6 months, 25 (96%) of 26 patients assigned initially to continue treatment attempted its withdrawal. During the following 6 months, nine patients met the primary endpoint of relapse (Kaplan-Meier estimate of event rate 36·0% [95% CI 20·6-57·8]). No deaths were reported in either group and three serious adverse events were reported in the treatment withdrawal group: hospital admissions for non-cardiac chest pain, sepsis, and an elective procedure. INTERPRETATION: Many patients deemed to have recovered from dilated cardiomyopathy will relapse following treatment withdrawal. Until robust predictors of relapse are defined, treatment should continue indefinitely. FUNDING: British Heart Foundation, Alexander Jansons Foundation, Royal Brompton Hospital and Imperial College London, Imperial College Biomedical Research Centre, Wellcome Trust, and Rosetrees Trust."},{"id":"a55acd2870e7","type":"article","url":"https://hartvaat.nl/2019/01/05/sglt2-remmers-voor-primaire-en-secundaire-cv-en-renale-preventie-bij-diabetes-la/","title":"SGLT2-remmers voor primaire en secundaire CV- en renale preventie bij diabetes: Lancet meta-analyse","title_en":"SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["fidelio-dkd","figaro-dkd","sglt2-remmers"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)32590-X","source_url":"https://doi.org/10.1016/S0140-6736(18)32590-X","authors":["Thomas A Zelniker","Stephen D Wiviott","Itamar Raz","Kyungah Im","Erica L Goodrich","Marc P Bonaca","Ofri Mosenzon","Eri T Kato","Avivit Cahn","Remo H M Furtado","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","John P H Wilding","Marc S Sabatine"],"significance":9,"published":"2019-01-05","source_date":"2019-01-05","image":"","kennis":["https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"This Lancet meta-analysis of SGLT2 inhibitor trials confirmed class-wide reductions in cardiovascular death, heart failure hospitalization, and kidney disease progression in patients with type 2 diabetes. The analysis demonstrated that heart failure and renal benefits were consistent regardless of baseline atherosclerotic disease or cardiovascular risk.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:56Z","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 systematische review en meta-analyse van alle SGLT2-remmers voor cardiovasculaire en renale preventie bij diabetes type 2. Definitieve klasse-effectanalyse.","abstract_original":"BACKGROUND: The magnitude of effect of sodium-glucose cotransporter-2 inhibitors (SGLT2i) on specific cardiovascular and renal outcomes and whether heterogeneity is based on key baseline characteristics remains undefined. METHODS: We did a systematic review and meta-analysis of randomised, placebo-controlled, cardiovascular outcome trials of SGLT2i in patients with type 2 diabetes. We searched PubMed and Embase for trials published up to Sept 24, 2018. Data search and extraction were completed with a standardised data form and any discrepancies were resolved by consensus. Efficacy outcomes included major adverse cardiovascular events (myocardial infarction, stroke, or cardiovascular death), the composite of cardiovascular death or hospitalisation for heart failure, and progression of renal disease. Hazard ratios (HRs) with 95% CIs were pooled across trials, and efficacy outcomes were stratified by baseline presence of atherosclerotic cardiovascular disease, heart failure, and degree of renal function. FINDINGS: We included data from three identified trials and 34 322 patients (60·2% with established atherosclerotic cardiovascular disease), with 3342 major adverse cardiovascular events, 2028 cardiovascular deaths or hospitalisation sfor heart failure events, and 766 renal composite outcomes. SGLT2i reduced major adverse cardiovascular events by 11% (HR 0·89 [95% CI 0·83-0·96], p=0·0014), with benefit only seen in patients with atherosclerotic cardiovascular disease (0·86 [0·80-0·93]) and not in those without (1·00 [0·87-1·16], p for interaction=0·0501). SGLT2i reduced the risk of cardiovascular death or hospitalisation for heart failure by 23% (0·77 [0·71-0·84], p<0·0001), with a similar benefit in patients with and without atherosclerotic cardiovascular disease and with and without a history of heart failure. SGLT2i reduced the risk of progression of renal disease by 45% (0·55 [0·48-0·64], p<0·0001), with a similar benefit in those with and without atherosclerotic cardiovascular disease. The magnitude of benefit of SGLT2i varied with baseline renal function, with greater reductions in hospitalisations for heart failure (p for interaction=0·0073) and lesser reductions in progression of renal disease (p for interaction=0·0258) in patients with more severe kidney disease at baseline. INTERPRETATION: SGLT2i have moderate benefits on atherosclerotic major adverse cardiovascular events that seem confined to patients with established atherosclerotic cardiovascular disease. However, they have robust benefits on reducing hospitalisation for heart failure and progression of renal disease regardless of existing atherosclerotic cardiovascular disease or a history of heart failure. FUNDING: None."},{"id":"70a00144cdac","type":"article","url":"https://hartvaat.nl/2019/01/03/icosapent-ethyl-en-cardiovasculaire-uitkomsten-bij-hypertriglyceridemie-nejm-red/","title":"Icosapent-ethyl en cardiovasculaire uitkomsten bij hypertriglyceridemie: NEJM REDUCE-IT","title_en":"Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["ezetimibe","farmaco-economie","lipidenverlaging","niet-statine-therapie"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1812792","source_url":"https://doi.org/10.1056/NEJMoa1812792","authors":["Deepak L Bhatt","P Gabriel Steg","Michael Miller","Eliot A Brinton","Terry A Jacobson","Steven B Ketchum","Ralph T Doyle","Rebecca A Juliano","Lixia Jiao","Craig Granowitz","Jean-Claude Tardif","Christie M Ballantyne"],"significance":10,"published":"2019-01-03","source_date":"2019-01-03","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/omega3-vetzuren-cardiologie/","https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"The REDUCE-IT trial demonstrated that icosapent ethyl (purified EPA) reduced cardiovascular events by 25% in statin-treated patients with elevated triglycerides and established cardiovascular disease or diabetes. This landmark result established a role for triglyceride-lowering therapy in residual cardiovascular risk reduction.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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":"Landmark NEJM REDUCE-IT-trial die aantoonde dat icosapent-ethyl (gezuiverd EPA) cardiovasculaire events significant vermindert bij statinebehandelde patiënten met hypertriglyceridemie. Paradigmashift voor triglyceridebehandeling.","abstract_original":"BACKGROUND: Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06). CONCLUSIONS: Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361 .)."},{"id":"239796f432a4","type":"article","url":"https://hartvaat.nl/2019/01/02/duurzaamheid-van-bloeddrukeffect-van-kapper-interventie/","title":"Duurzaamheid van bloeddrukeffect van kapper-interventie","title_en":"Sustainability of Blood Pressure Reduction in Black Barbershops.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.038165","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.038165","authors":["Ronald G Victor","Ciantel A Blyler","Ning Li","Kathleen Lynch","Norma B Moy","Mohamad Rashid","L Cindy Chang","Joel Handler","Jeffrey Brettler","Florian Rader","Robert M Elashoff"],"significance":6,"published":"2019-01-02","source_date":"2019-01-02","image":"","kennis":[],"congress":"","summary_en":"This follow-up study showed that the blood pressure reduction achieved through the barber-pharmacist collaborative model is sustained over time, demonstrating the durability of community-based hypertension interventions.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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":"Follow-up van de NEJM barbershop-trial die de duurzaamheid van het bloeddrukverlagend effect evalueerde.","abstract_original":"BACKGROUND: We developed a new model of hypertension care for non-Hispanic black men that links health promotion by barbers to medication management by American Society of Hypertension-certified pharmacists and demonstrated efficacy in a 6-month cluster-randomized trial. The marked reduction in systolic blood pressure (BP) seen at 6 months warranted continuing the trial through 12 months to test sustainability, a necessary precondition for implementation research. METHODS: We enrolled a cohort of 319 black male patrons with systolic BP ≥140 mm Hg at baseline. Fifty-two Los Angeles County barbershops were assigned to either a pharmacist-led intervention or an active control group. In the intervention group, barbers promoted follow-up with pharmacists who prescribed BP medication under a collaborative practice agreement with patrons' primary care providers. In the control group, barbers promoted follow-up with primary care providers and lifestyle modification. After BP assessment at 6 months, the intervention continued with fewer in-person pharmacist visits to test whether the intervention effect could be sustained safely for 1 year while reducing pharmacist travel time. Final BP and safety outcomes were assessed in both groups at 12 months. RESULTS: At baseline, mean systolic BP was 152.4 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 12 months, mean systolic BP fell by 28.6 mm Hg (to 123.8 mm Hg) in the intervention group and by 7.2 mm Hg (to 147.4 mm Hg) in the control group. The mean reduction was 20.8 mm Hg greater in the intervention (95% CI, 13.9-27.7; P<0.0001). A BP <130/80 mm Hg was achieved by 68.0% of the intervention group versus 11.0% of the control group ( P<0.02). These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data. No treatment-related serious adverse events occurred in either group over 12 months. Cohort retention at 12 months was 90% in both groups. CONCLUSIONS: Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in large and sustained BP reduction over 12 months when coupled with medication management by American Society of Hypertension-certified pharmacists. Broad-scale implementation research is both justified and warranted. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 02321618."},{"id":"f98266488536","type":"article","url":"https://hartvaat.nl/2019/01/02/permanente-versus-polymeervrije-des-all-comers-gerandomiseerde-trial/","title":"Permanente versus polymeervrije DES: all-comers gerandomiseerde trial","title_en":"Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.037707","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.037707","authors":["Rik Rozemeijer","Mera Stein","Michiel Voskuil","Rutger van den Bor","Peter Frambach","Bruno Pereira","Stefan Koudstaal","Geert E Leenders","Leo Timmers","Saskia Z Rittersma","Adriaan O Kraaijeveld","Pierfrancesco Agostoni","Kit C Roes","Pieter A Doevendans","Pieter R Stella"],"significance":5,"published":"2019-01-02","source_date":"2019-01-02","image":"","kennis":[],"congress":"","summary_en":"This all-comers randomized trial compared a durable polymer zotarolimus-eluting stent with a novel polymer-free amphilimus-eluting stent, evaluating the newest drug delivery technology in a broad PCI population.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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":"All-comers gerandomiseerde trial die een permanente polymer zotarolimus-eluting stent vergeleek met een polymeervrije amphilimus-eluting stent.","abstract_original":"BACKGROUND: Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial. METHODS: In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin). RESULTS: In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; Pnoninferiority=0.0086). Cardiac death occurred in 10 (1.3%) versus 10 patients (1.3%; P value for difference, 1.00), target-vessel myocardial infarction occurred in 18 (2.4%) versus 17 patients (2.3%; P value for difference, 0.87), and target-lesion revascularization occurred in 22 (2.9%) versus 20 patients (2.6%; P value for difference, 0.75) for PF-AES as compared with PP-ZES. Overall, definite or probable stent thrombosis occurred in 1.0%. CONCLUSIONS: PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898."},{"id":"bdec9496bc3d","type":"article","url":"https://hartvaat.nl/2019/01/02/macitentan-bij-eisenmenger-syndroom/","title":"Macitentan bij Eisenmenger-syndroom","title_en":"Evaluation of Macitentan in Patients With Eisenmenger Syndrome.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog"],"tags":[],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.033575","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.033575","authors":["Michael A Gatzoulis","Michael Landzberg","Maurice Beghetti","Rolf M Berger","Michela Efficace","Sophie Gesang","Jian'guo He","Kelly Papadakis","Tomás Pulido","Nazzareno Galiè"],"significance":6,"published":"2019-01-02","source_date":"2019-01-02","image":"","kennis":["https://hartvaat.nl/kennis/nierziekte/contrastmiddel-en-nierfunctie/"],"congress":"","summary_en":"This multicenter study evaluated macitentan in patients with Eisenmenger syndrome, testing whether the dual endothelin receptor antagonist improves hemodynamics and exercise capacity in this complex congenital heart disease population.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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 die macitentan evalueerde bij patiënten met het Eisenmenger-syndroom — een ernstige vorm van pulmonale hypertensie bij aangeboren hartafwijkingen.","abstract_original":"BACKGROUND: Eisenmenger syndrome describes congenital heart disease-associated severe pulmonary hypertension accompanied by right-to-left shunting. The multicenter, double-blind, randomized, placebo-controlled, 16-week, phase III MAESTRO study (Macitentan in Eisenmenger Syndrome to Restore Exercise Capacity) evaluated the efficacy and safety of the endothelin receptor antagonist macitentan in patients with Eisenmenger syndrome. METHODS: Patients with Eisenmenger syndrome aged ≥12 years and in World Health Organization functional class II-III were randomized 1:1 to placebo or macitentan 10 mg once daily for 16 weeks. Patients with complex cardiac defects, Down syndrome and background PAH therapy were eligible. The primary end point was change from baseline to week 16 in 6-minute walk distance. Secondary end points included change from baseline to week 16 in World Health Organization functional class. Exploratory end points included NT-proBNP (N-terminal pro-B-type natriuretic peptide) at end of treatment expressed as a percentage of baseline. In a hemodynamic substudy, exploratory end points included pulmonary vascular resistance index (PVRi) at week 16 as a percentage of baseline. RESULTS: Two hundred twenty six patients (macitentan n=114; placebo n=112) were randomized. At baseline, 60% of patients were in World Health Organization functional class II and 27% were receiving phosphodiesterase type-5 inhibitors. At week 16, the mean change from baseline in 6-minute walk distance was 18.3 m and 19.7 m in the macitentan and placebo groups (least-squares mean difference, -4.7 m; 95% confidence limit (CL), -22.8, 13.5; P=0.612). World Health Organization functional class improved from baseline to week 16 in 8.8% and 14.3% of patients in the macitentan and placebo groups (odds ratio, 0.53; 95% CL, 0.23, 1.24). NT-proBNP levels decreased with macitentan versus placebo (ratio of geometric means, 0.80; 95% CL, 0.68, 0.94). In the hemodynamic substudy (n=39 patients), macitentan decreased PVRi compared with placebo (ratio of geometric means, 0.87; 95% CL, 0.73, 1.03). The most common adverse events with macitentan versus placebo were headache (11.4 versus 4.5%) and upper respiratory tract infection (9.6 versus 6.3%); a hemoglobin decrease from baseline of ≥2 g/dL occurred in 36.0% versus 8.9% of patients. Five patients (3 macitentan; 2 placebo) prematurely discontinued treatment and 1 patient died (macitentan group). CONCLUSIONS: Macitentan did not show superiority over placebo on the primary end point of change from baseline to week 16 in exercise capacity in patients with Eisenmenger syndrome. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01743001."},{"id":"3bc1b3f83da4","type":"article","url":"https://hartvaat.nl/2019/01/02/preventie-van-cardiogene-shock-na-acuut-mi/","title":"Preventie van cardiogene shock na acuut MI","title_en":"Prevention of Cardiogenic Shock After Acute Myocardial Infarction.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":["cardiogene-shock","myocardinfarct"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.118.036536","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.118.036536","authors":["Maarten Vanhaverbeke","Kris Bogaerts","Peter R Sinnaeve","Luc Janssens","Paul W Armstrong","Frans Van de Werf"],"significance":6,"published":"2019-01-02","source_date":"2019-01-02","image":"","kennis":[],"congress":"","summary_en":"This review discussed strategies for preventing cardiogenic shock after acute MI, covering early risk identification, hemodynamic monitoring, and preventive mechanical circulatory support before hemodynamic collapse.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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":"Review over strategieën voor preventie van cardiogene shock na acuut myocardinfarct. Vroege risico-identificatie en preventieve maatregelen.","abstract_original":""},{"id":"8762f9b70ddf","type":"article","url":"https://hartvaat.nl/2019/01/01/laaggedoseerd-intracoronair-alteplase-bij-primaire-pci-jama-t-time/","title":"Laaggedoseerd intracoronair alteplase bij primaire PCI: JAMA T-TIME","title_en":"Effect of Low-Dose Intracoronary Alteplase During Primary Percutaneous Coronary Intervention on Microvascular Obstruction in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2018.19802","source_url":"https://doi.org/10.1001/jama.2018.19802","authors":["Peter J McCartney","Hany Eteiba","Annette M Maznyczka","Margaret McEntegart","John P Greenwood","Douglas F Muir","Saqib Chowdhary","Anthony H Gershlick","Clare Appleby","James M Cotton","Andrew Wragg","Nick Curzen","Keith G Oldroyd","Mitchell Lindsay","J Paul Rocchiccioli","Aadil Shaukat","Richard Good","Stuart Watkins","Keith Robertson","Christopher Malkin","Lynn Martin","Lynsey Gillespie","Thomas J Ford","Mark C Petrie","Peter W Macfarlane","R Campbell Tait","Paul Welsh","Naveed Sattar","Robin A Weir","Keith A Fox","Ian Ford","Alex McConnachie","Colin Berry"],"significance":7,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The T-TIME trial showed that low-dose intracoronary alteplase during primary PCI did not reduce microvascular obstruction in STEMI patients. The negative result dampened enthusiasm for adjunctive intracoronary fibrinolysis during primary PCI.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","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":"JAMA T-TIME gerandomiseerde trial naar laaggedoseerd intracoronair alteplase tijdens primaire PCI voor vermindering van microvasculaire obstructie bij STEMI.","abstract_original":"IMPORTANCE: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction (STEMI) and is associated with adverse outcomes. OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with alteplase infused early after coronary reperfusion will reduce microvascular obstruction. DESIGN, SETTING, AND PARTICIPANTS: Between March 17, 2016, and December 21, 2017, 440 patients presenting at 11 hospitals in the United Kingdom within 6 hours of STEMI due to a proximal-mid-vessel occlusion of a major coronary artery were randomized in a 1:1:1 dose-ranging trial design. Patient follow-up to 3 months was completed on April 12, 2018. INTERVENTIONS: Participants were randomly assigned to treatment with placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n = 145) by manual infusion over 5 to 10 minutes. The intervention was scheduled to occur early during the primary PCI procedure, after reperfusion of the infarct-related coronary artery and before stent implant. MAIN OUTCOMES AND MEASURES: The primary outcome was the amount of microvascular obstruction (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment. The primary comparison was the alteplase 20-mg group vs the placebo group; if not significant, the alteplase 10-mg group vs the placebo group was considered a secondary analysis. RESULTS: Recruitment stopped on December 21, 2017, because conditional power for the primary outcome based on a prespecified analysis of the first 267 randomized participants was less than 30% in both treatment groups (futility criterion). Among the 440 patients randomized (mean age, 60.5 years; 15% women), the primary end point was achieved in 396 patients (90%), 17 (3.9%) withdrew, and all others were followed up to 3 months. In the primary analysis, the mean microvascular obstruction did not differ between the 20-mg alteplase and placebo groups (3.5% vs 2.3%; estimated difference, 1.16%; 95% CI, -0.08% to 2.41%; P = .32) nor in the analysis of 10-mg alteplase vs placebo groups (2.6% vs 2.3%; estimated difference, 0.29%; 95% CI, -0.76% to 1.35%; P = .74). Major adverse cardiac events (cardiac death, nonfatal MI, unplanned hospitalization for heart failure) occurred in 15 patients (10.1%) in the placebo group, 18 (12.9%) in the 10-mg alteplase group, and 12 (8.2%) in the 20-mg alteplase group. CONCLUSIONS AND RELEVANCE: Among patients with acute STEMI presenting within 6 hours of symptoms, adjunctive low-dose intracoronary alteplase given during the primary percutaneous intervention did not reduce microvascular obstruction. The study findings do not support this treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02257294."},{"id":"9bbcc7e02505","type":"article","url":"https://hartvaat.nl/2019/01/01/medicatie-copay-vouchers-en-p2y12-gebruik-en-cv-events-na-mi-jama/","title":"Medicatie-copay vouchers en P2Y12-gebruik en CV-events na MI: JAMA","title_en":"Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","huisarts"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2018.19791","source_url":"https://doi.org/10.1001/jama.2018.19791","authors":["Tracy Y Wang","Lisa A Kaltenbach","Christopher P Cannon","Gregg C Fonarow","Niteesh K Choudhry","Timothy D Henry","David J Cohen","Durgesh Bhandary","Naeem D Khan","Kevin J Anstrom","Eric D Peterson"],"significance":6,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/"],"congress":"","summary_en":"This JAMA trial tested whether medication copayment vouchers for P2Y12 inhibitors improve adherence and cardiovascular outcomes after MI, addressing the financial barrier to guideline-recommended antiplatelet therapy.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:55Z","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":"JAMA trial die onderzocht of copay vouchers voor P2Y12-remmers het medicatiegebruik en cardiovasculaire events verbeteren na MI. Financiële barrières en therapietrouw.","abstract_original":"IMPORTANCE: Despite guideline recommendations, many patients discontinue P2Y12 inhibitor therapy earlier than the recommended 1 year after myocardial infarction (MI), and higher-potency P2Y12 inhibitors are underutilized. Cost is frequently cited as an explanation for both of these observations. OBJECTIVE: To determine whether removing co-payment barriers increases P2Y12 inhibitor persistence and lowers risk of major adverse cardiovascular events (MACE). DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized clinical trial among 301 hospitals enrolling adult patients with acute MI (June 5, 2015, through September 30, 2016); patients were followed up for 1 year after discharge (final date of follow-up was October 23, 2017), with blinded adjudication of MACE; choice of P2Y12 inhibitor was per clinician discretion. INTERVENTIONS: Hospitals randomized to the intervention (n = 131 [6436 patients]) provided patients with co-payment vouchers for clopidogrel or ticagrelor for 1 year (median voucher value for a 30-day supply, $137 [25th-75th percentile, $20-$339]). Hospitals randomized to usual care (n = 156 [4565 patients]) did not provide study vouchers. MAIN OUTCOMES AND MEASURES: Independent coprimary outcomes were patient-reported persistence with P2Y12 inhibitor (defined as continued treatment without gap in use ≥30 days) and MACE (death, recurrent MI, or stroke) at 1 year among patients discharged with a prescription for clopidogrel or ticagrelor. RESULTS: Among 11 001 enrolled patients (median age, 62 years; 3459 [31%] women), 10 102 patients were discharged with prescriptions for clopidogrel or ticagrelor (clopidogrel prescribed to 2317 [36.0%] in the intervention group and 2497 [54.7%] in the usual care group), 4393 of 6135 patients (72%) in the intervention group used the voucher, and follow-up data at 1 year were available for 10 802 patients (98.2%). Patient-reported persistence with P2Y12 inhibitors at 1 year was higher in the intervention group than in the control group (unadjusted rates, 5340/6135 [87.0%] vs 3324/3967 [83.8%], respectively; P < .001; adjusted difference, 2.3% [95% CI, 0.4% to 4.1%]; adjusted odds ratio, 1.19 [95% CI, 1.02 to 1.40]). There was no significant difference in MACE at 1 year between intervention and usual care groups (unadjusted cumulative incidence, 10.2% vs 10.6%; P = .65; adjusted difference, 0.66% [95% CI, -0.73% to 2.06%]; adjusted hazard ratio, 1.07 [95% CI, 0.93 to 1.25]). CONCLUSIONS AND RELEVANCE: Among patients with MI, provision of vouchers to offset medication co-payments for P2Y12 inhibitors, compared with no vouchers, resulted in a 3.3% absolute increase in patient-reported persistence with P2Y12 inhibitors and no significant reduction in 1-year MACE outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02406677."},{"id":"9f2181703e43","type":"article","url":"https://hartvaat.nl/2019/01/01/mi-bij-pav-patienten-incidentie-en-uitkomsten-euclid/","title":"MI bij PAV-patiënten: incidentie en uitkomsten — EUCLID","title_en":"Incidence, Characteristics, and Outcomes of Myocardial Infarction in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","internist"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2018.4171","source_url":"https://doi.org/10.1001/jamacardio.2018.4171","authors":["Christoph B Olivier","Hillary Mulder","William R Hiatt","W Schuyler Jones","F Gerry R Fowkes","Frank W Rockhold","Jeffrey S Berger","Iris Baumgartner","Peter Held","Brian G Katona","Lars Norgren","Juuso Blomster","Manesh R Patel","Kenneth W Mahaffey"],"significance":5,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/vasculair/perifeer-arterieel-vaatlijden/","https://hartvaat.nl/kennis/vasculair/claudicatio-intermittens/"],"congress":"","summary_en":"This EUCLID analysis characterized the incidence, types, and outcomes of myocardial infarction in patients with peripheral artery disease, documenting the high cross-territory ischemic event rate in the PAD population.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:55Z","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":"EUCLID-analyse naar incidentie, kenmerken en uitkomsten van myocardinfarct bij patiënten met perifeer arterieel vaatlijden.","abstract_original":"IMPORTANCE: Patients with peripheral artery disease (PAD) are at high risk for myocardial infarction (MI). OBJECTIVE: To characterize the incidence and types of MI in a PAD population, identify factors associated with MI, and determine the association of MI with cardiovascular mortality and acute limb ischemia. DESIGN, SETTING, AND PARTICIPANTS: The Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (EUCLID) was a double-blind randomized clinical trial conducted at 811 sites in 28 countries that randomized 13 885 patients with symptomatic PAD to monotherapy with ticagrelor or clopidogrel. Participants had an ankle-brachial index (ABI) of 0.80 or less or previous lower extremity revascularization. Median follow-up was 30 months. For these analyses, patients were evaluated for MI occurrence during follow-up irrespective of treatment. Data were analyzed from June 2017 to September 2018. MAIN OUTCOMES AND MEASURES: An adjudication clinical events committee classified MI as type 1 (spontaneous), type 2 (secondary), type 3 (sudden cardiac death), type 4a (less than 48 hours after percutaneous coronary intervention), type 4b (definite stent thrombosis), or type 5 (less than 72 hours after coronary artery bypass graft). A multivariate regression model was developed by stepwise selection to identify factors associated with MI, and a time-dependent multivariate Cox regression analysis was performed to determine the association of MI with cardiovascular death and acute limb ischemia requiring hospitalization. RESULTS: Of the 13 885 patients included in this analysis, 9997 (72.0%) were male, and the median (interquartile range) age was 66 (60-73) years. Myocardial infarction occurred in 683 patients (4.9%; 2.4 events per 100 patient-years) during a median follow-up of 30 months. Patients experiencing MI were older (median [interquartile range] age, 69 [62-75] vs 66 [60-72] years), more likely to have diabetes (349 of 683 [51.1%] vs 4996 of 13 202 [37.8%]) or a previous lower extremity revascularization (466 of 683 [68.2%] vs 7409 of 13 202 [56.1%]), and had a lower ABI (if included by ABI) compared with censored patients. Of the 683 patients with MI during follow-up, the most common MI type was type 1 (405 [59.3%]), followed by type 2 (236 [34.6%]), type 4a (14 [2.0%]), type 3 (12 [1.8%]), type 4b (11 [1.6%]), and type 5 (5 [0.7%]). Postrandomization MI was independently associated with cardiovascular death (adjusted hazard ratio, 9.0; 95% CI, 7.3-11.2; P < .001) and acute limb ischemia requiring hospitalization (adjusted hazard ratio, 2.5; 95% CI, 1.3-5.0; P = .008). CONCLUSIONS AND RELEVANCE: Approximately 5% of patients with symptomatic PAD had an MI during a median follow-up of 30 months. Type 1 MI (spontaneous) was the most common MI type; however, one-third of MIs were type 2 MI (secondary). More research is needed to identify therapies to reduce the risk of MI in patients with PAD and to improve management of type 2 MI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01732822."},{"id":"d0b7af02d88e","type":"article","url":"https://hartvaat.nl/2019/01/01/interindividuele-variatie-in-ldl-verlaging-met-evolocumab-fourier-analyse/","title":"Interindividuele variatie in LDL-verlaging met evolocumab: FOURIER-analyse","title_en":"Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","ldl-cholesterol","pcsk9-remmers"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2018.4178","source_url":"https://doi.org/10.1001/jamacardio.2018.4178","authors":["Arman Qamar","Robert P Giugliano","Anthony C Keech","Julia F Kuder","Sabina A Murphy","Christopher E Kurtz","Scott M Wasserman","Peter S Sever","Terje R Pedersen","Marc S Sabatine"],"significance":6,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/","https://hartvaat.nl/kennis/lipiden/pcsk9-remmers-evolocumab-alirocumab/"],"congress":"","summary_en":"This FOURIER analysis of interindividual variation in LDL cholesterol response to evolocumab showed that most patients achieve substantial LDL lowering, with clinical factors explaining some but not all of the response variability.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:55Z","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":"JAMA Cardiology analyse van interindividuele variatie in LDL-respons op evolocumab in de FOURIER-trial. Relevant voor verwachtingsmanagement bij PCSK9-remming.","abstract_original":"IMPORTANCE: Little is known about the heterogeneity in low-density lipoprotein cholesterol levels (LDL-C) lowering with proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor medications. OBJECTIVE: To evaluate the interindividual variability in LDL-C reduction with the PCSK9 inhibitor drug evolocumab. DESIGN, SETTING, AND PARTICIPANTS: We examined the percentage change in LDL-C levels from baseline in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, a placebo-controlled randomized clinical trial of the PCSK9 inhibitor evolocumab in patients with stable atherosclerotic cardiovascular disease who were taking statin medications. Patients in either treatment arm who had high baseline LDL-C variability during screening and either did not receive the study drug, altered their background lipid-lowering therapy regimen, or had no LDL-C level sample in week 4 were excluded from the primary analysis. Analyses in the patients were stratified by treatment arm. Data was collected from 2013 to 2016, and data were analyzed from January 2018 to November 2018. MAIN OUTCOMES AND MEASURES: Interindividual variation in percent reduction in LDL-C with evolocumab. RESULTS: There were 27 564 individuals in the cohort; after exclusions for baseline variability (n = 3524) or alterations in background lipid therapy and other causes (n = 2272), 21 768 patients remained. At week 4, the median percent reduction in LDL-C levels from baseline was 66% (interquartile range, 54%-76%; median [interquartile range] baseline value, 90 [79-105] mg/dL; postchange value, 31 [21-44] mg/dL) with evolocumab. During the first year, a total of 10 325 of 10902 patients in the evolocumab group (94.7%) had a reduction 50% or greater in LDL-C levels, 10 669 of 10 902 (97.9%) had a reduction 30% or more, and 10 849 of 10 902 (99.5%) had any reduction in LDL-C levels. Fifty-three patients (0.5%) had no apparent reduction in LDL-C levels. In the placebo arm, the median LDL-C reduction was 4% (interquartile range, 6% increase to 13% reduction; baseline median [IQR] value, 90 [79-106] mg/dL; postchange value, 87 [74-103] mg/dL) at 4 weeks. Waterfall plots showed notable variability in the top and bottom 5% of patients for both evolocumab and placebo groups, with large changes in LDL-C levels in the placebo group (increases of ≥25%, 531 patients [4.9%]; decreases of ≥25%, 985 patients [9.1%]). At 4 weeks, the placebo-adjusted reductions in LDL-C levels with evolocumab were 50% or greater in 9839 of 10 866 patients (90.5%) and 30% or greater in 10 846 of 10 866 patients (99.8%). Results were consistent across clinically relevant subgroups. CONCLUSIONS AND RELEVANCE: There appears to be a highly consistent robust reduction in LDL-C levels with evolocumab use. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01764633."},{"id":"31fcf289c888","type":"article","url":"https://hartvaat.nl/2019/01/01/linagliptine-versus-placebo-bij-diabetes-type-2-met-hoog-cv-en-renaal-risico-jam/","title":"Linagliptine versus placebo bij diabetes type 2 met hoog CV- en renaal risico: JAMA CARMELINA","title_en":"Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","internist"],"tags":["figaro-dkd","soul-trial"],"journal":"JAMA","doi":"10.1001/jama.2018.18269","source_url":"https://doi.org/10.1001/jama.2018.18269","authors":["Julio Rosenstock","Vlado Perkovic","Odd Erik Johansen","Mark E Cooper","Steven E Kahn","Nikolaus Marx","John H Alexander","Michael Pencina","Robert D Toto","Christoph Wanner","Bernard Zinman","Hans Juergen Woerle","David Baanstra","Egon Pfarr","Sven Schnaidt","Thomas Meinicke","Jyothis T George","Maximilian von Eynatten","Darren K McGuire"],"significance":8,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"The CARMELINA trial confirmed the cardiovascular and renal safety of linagliptin in patients with type 2 diabetes at high cardiovascular and renal risk. The neutral outcome positioned DPP-4 inhibitors as safe but without the cardiovascular or renal benefits demonstrated by SGLT2 inhibitors and GLP-1 agonists.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:54Z","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":"JAMA CARMELINA-trial die cardiovasculaire en renale veiligheid van linagliptine bevestigde bij hoogrisico diabetes type 2. Neutrale uitkomst voor de DPP-4-remmerklasse.","abstract_original":"IMPORTANCE: Type 2 diabetes is associated with increased cardiovascular (CV) risk. Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) inhibitors but have included limited numbers of patients with high CV risk and chronic kidney disease. OBJECTIVE: To evaluate the effect of linagliptin, a selective DPP-4 inhibitor, on CV outcomes and kidney outcomes in patients with type 2 diabetes at high risk of CV and kidney events. DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled, multicenter noninferiority trial conducted from August 2013 to August 2016 at 605 clinic sites in 27 countries among adults with type 2 diabetes, hemoglobin A1c of 6.5% to 10.0%, high CV risk (history of vascular disease and urine-albumin creatinine ratio [UACR] >200 mg/g), and high renal risk (reduced eGFR and micro- or macroalbuminuria). Participants with end-stage renal disease (ESRD) were excluded. Final follow-up occurred on January 18, 2018. INTERVENTIONS: Patients were randomized to receive linagliptin, 5 mg once daily (n = 3494), or placebo once daily (n = 3485) added to usual care. Other glucose-lowering medications or insulin could be added based on clinical need and local clinical guidelines. MAIN OUTCOMES AND MEASURES: Primary outcome was time to first occurrence of the composite of CV death, nonfatal myocardial infarction, or nonfatal stroke. Criteria for noninferiority of linagliptin vs placebo was defined by the upper limit of the 2-sided 95% CI for the hazard ratio (HR) of linagliptin relative to placebo being less than 1.3. Secondary outcome was time to first occurrence of adjudicated death due to renal failure, ESRD, or sustained 40% or higher decrease in eGFR from baseline. RESULTS: Of 6991 enrollees, 6979 (mean age, 65.9 years; eGFR, 54.6 mL/min/1.73 m2; 80.1% with UACR >30 mg/g) received at least 1 dose of study medication and 98.7% completed the study. During a median follow-up of 2.2 years, the primary outcome occurred in 434 of 3494 (12.4%) and 420 of 3485 (12.1%) in the linagliptin and placebo groups, respectively, (absolute incidence rate difference, 0.13 [95% CI, -0.63 to 0.90] per 100 person-years) (HR, 1.02; 95% CI, 0.89-1.17; P < .001 for noninferiority). The kidney outcome occurred in 327 of 3494 (9.4%) and 306 of 3485 (8.8%), respectively (absolute incidence rate difference, 0.22 [95% CI, -0.52 to 0.97] per 100 person-years) (HR, 1.04; 95% CI, 0.89-1.22; P = .62). Adverse events occurred in 2697 (77.2%) and 2723 (78.1%) patients in the linagliptin and placebo groups; 1036 (29.7%) and 1024 (29.4%) had 1 or more episodes of hypoglycemia; and there were 9 (0.3%) vs 5 (0.1%) events of adjudication-confirmed acute pancreatitis. CONCLUSIONS AND RELEVANCE: Among adults with type 2 diabetes and high CV and renal risk, linagliptin added to usual care compared with placebo added to usual care resulted in a noninferior risk of a composite CV outcome over a median 2.2 years. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01897532."},{"id":"7cd709d73dfd","type":"article","url":"https://hartvaat.nl/2019/01/01/slokdarmletsel-bij-af-ablatie-prevalentie-en-preventie-meta-analyse/","title":"Slokdarmletsel bij AF-ablatie: prevalentie en preventie — meta-analyse","title_en":"Prevalence and prevention of oesophageal injury during atrial fibrillation ablation: a systematic review and meta-analysis.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["aspirine","primaire-preventie","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/euy121","source_url":"https://doi.org/10.1093/europace/euy121","authors":["Francis J Ha","Hui-Chen Han","Prashanthan Sanders","Andrew W Teh","David O'Donnell","Omar Farouque","Han S Lim"],"significance":6,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":[],"congress":"","summary_en":"This systematic review and meta-analysis evaluated the prevalence and prevention strategies for esophageal injury during AF ablation, providing a comprehensive safety assessment for this uncommon but potentially fatal complication.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:54Z","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":"Systematische review en meta-analyse naar prevalentie en preventie van slokdarmletsel tijdens AF-ablatie. Veiligheidsoverzicht voor een potentieel fatale complicatie.","abstract_original":"AIMS: Atrio-oesophageal fistula (AOF) is a potentially lethal complication of atrial fibrillation (AF) ablation. Many studies have evaluated the presence and prevention of endoscopically-detected oesophageal lesions (EDOL) as a proxy measure for risk of AOF. This systematic review and meta-analysis sought to determine the prevalence of EDOL and effectiveness of general preventive measures during AF ablation. METHODS AND RESULTS: We searched electronic databases for studies reporting prevalence or prevention of EDOL post-AF ablation. Pooled prevalence were reported with 95% confidence intervals (CI) while studies evaluating preventive measures including oesophageal temperature monitoring (OTM), esophageal manipulation and type of anaesthesia were analyzed descriptively or by random-effects modeling. Twenty-five studies were included in the analysis. Any and ulcerated EDOL pooled prevalence was 11% (95%CI, 6-15%) and 5% (95%CI, 3-7%), respectively. In six studies, there was no difference in EDOL with or without OTM (pooled OR 1.65, 95%CI, 0.22-12.55). There was no difference using a multi-sensor versus single-sensor OTM (one study) nor when using a deflectable probe (two studies). Oesophageal displacement was associated with significant instrumentation injury in one study. Two studies evaluating Oesophageal cooling showed conflicting results. General anaesthesia was associated with more EDOL than conscious sedation in two studies. CONCLUSION: The pooled prevalence of any and ulcerated EDOL post-ablation was 11% and 5%, but varied between studies. Techniques such as OTM and oesophageal displacement or cooling have not conclusively demonstrated a reduction in EDEL, while general anaesthesia may be associated with higher EDOL risk. Further randomized data are critically needed to validate and develop measures to prevent EDOL and AOF."},{"id":"34eaf2fa18b4","type":"article","url":"https://hartvaat.nl/2019/01/01/hotspots-van-gefractioneerde-elektrogrammen-in-linker-en-rechter-atrium-bij-af/","title":"Hotspots van gefractioneerde elektrogrammen in linker en rechter atrium bij AF","title_en":"Anatomical hotspots of fractionated electrograms in the left and right atrium: do they exist?","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/euy059","source_url":"https://doi.org/10.1093/europace/euy059","authors":["Roeliene Starreveld","Lisette J M E van der Does","Natasja M S de Groot"],"significance":4,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/ritmecontrole-af/"],"congress":"","summary_en":"A structured literature review investigated anatomical hotspots of complex fractionated atrial electrograms during AF. The systematic mapping provides foundational data for understanding the rationale and limitations of CFAE-guided ablation strategies.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T18:38:41Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 die anatomische hotspots van gefractioneerde elektrogrammen onderzocht bij AF. Fundamenteel voor de CFAE-ablatiestrategie.","abstract_original":"AIMS: Targeting of complex fractionated electrograms (CFEs) in the atria is not yet beneficial in treating drug-refractory atrial fibrillation (AF). In order to gain insight into potential anatomical hotspots of fractionated electrograms, a structured literature search was performed. METHODS AND RESULTS: PubMed was searched for studies describing fractionation during human atrial electrophysiological measurements (n = 565), of which 36 articles described the pre-ablation distribution of fractionated electrograms for the left atrium and/or right atrium in at least four regions. Fractionation was commonly found in high proportions within all regions of both atria, without clear preference for specific regions. Furthermore, no differences in the fractionation distribution between paroxysmal AF and persistent AF patients were observed. CONCLUSION: Whereas atrial inhomogeneous conduction is widely believed to play a key role in AF initiation and perpetuation, different electrophysiological causes for fractionation and the influence of measurement properties complicate identification of the arrhythmogenic substrate. Thereby, simply targeting all CFEs would be short-sighted. Further research is warranted on how to distinguish 'physiologic CFEs' from 'pathologic CFEs', with only the latter reflecting potential targets for ablative therapy of AF."},{"id":"289b9780ff46","type":"article","url":"https://hartvaat.nl/2019/01/01/levenslangrisico-op-cva-en-coronairlijden-naar-bloeddrukniveau-epoch-japan/","title":"Levenslangrisico op CVA en coronairlijden naar bloeddrukniveau: EPOCH-JAPAN","title_en":"Lifetime Risk of Stroke and Coronary Heart Disease Deaths According to Blood Pressure Level: EPOCH-JAPAN (Evidence for Cardiovascular Prevention From Observational Cohorts in Japan).","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.11635","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.11635","authors":["Michihiro Satoh","Takayoshi Ohkubo","Kei Asayama","Yoshitaka Murakami","Daisuke Sugiyama","Michiko Yamada","Shigeyuki Saitoh","Kiyomi Sakata","Fujiko Irie","Toshimi Sairenchi","Shizukiyo Ishikawa","Masahiko Kiyama","Hirofumi Ohnishi","Katsuyuki Miura","Yutaka Imai","Hirotsugu Ueshima","Tomonori Okamura"],"significance":7,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":[],"congress":"","summary_en":"This EPOCH-JAPAN analysis estimated lifetime risk of stroke and coronary heart disease deaths according to blood pressure level, providing a lifespan perspective that strengthens the case for early and sustained blood pressure management.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:54Z","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":"EPOCH-JAPAN analyse naar het levenslange risico op beroerte en coronairlijden naar bloeddrukniveau. Levenslangperspectieven versterken het preventiemotief.","abstract_original":"Lifetime risk (LTR) provides an absolute risk assessment during the remainder of one’s life. Few studies have focused on the LTRs of stroke and coronary heart disease (CHD), categorized by fine blood pressure in Asian populations. We aimed to assess it using a large database of a meta-analysis with the individual participant data. The present metaanalysis included 107 737 Japanese (42.4% men; mean age, 55.1 years) from 13 cohorts. During the mean follow-up of 15.2±5.3 years (1 559 136 person-years), 1922 died from stroke and 913 from CHD. We estimated risks after adjusting for competing risk of death other than the outcome of interest. The 10-year risk of stroke and CHD deaths at index age of 35 years was ≤1.9% and ≤0.3%, respectively. The LTRs of stroke death at the index age of 35 years (men/women) were 6.1%/4.8% for optimal, 5.7%/6.3% for normal, and 6.6%/6.0% for high-normal blood pressure groups, and 9.1%/7.9% for grade 1, 14.5%/10.3% for grade 2, and 14.6%/14.3% for grade 3 hypertension groups. The LTRs of CHD death similarly elevated with an increase in blood pressure but were lower (≤7.2%) than those of stroke death. In conclusion, blood pressure was clearly associated with an elevated LTR of stroke or CHD death, although the LTR of CHD death was one-half of that of stroke death in an Asian population. These results would help young people with hypertension to adopt a healthy lifestyle or start antihypertensive therapy early."},{"id":"6185282546d5","type":"article","url":"https://hartvaat.nl/2019/01/01/acute-creatininestijging-bij-start-ace-remmer-en-effecten-van-voortzetting-analy/","title":"Acute creatininestijging bij start ACE-remmer en effecten van voortzetting: analyse","title_en":"Acute Increases in Serum Creatinine After Starting Angiotensin-Converting Enzyme Inhibitor-Based Therapy and Effects of its Continuation on Major Clinical Outcomes in Type 2 Diabetes Mellitus.","category":"preventie","category_label":"Preventie","professions":["cardioloog","huisarts","internist"],"tags":["ace-remmers","acuut-hartfalen","cardiorenal-behandelstrategie","ras-remmers"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.12060","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.12060","authors":["Toshiaki Ohkuma","Min Jun","Anthony Rodgers","Mark E Cooper","Paul Glasziou","Pavel Hamet","Stephen Harrap","Giuseppe Mancia","Michel Marre","Bruce Neal","Vlado Perkovic","Neil Poulter","Bryan Williams","Sophia Zoungas","John Chalmers","Mark Woodward"],"significance":7,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":[],"congress":"","summary_en":"This study showed that acute creatinine increases after starting ACE inhibitor therapy do not necessarily indicate kidney damage and that continuation of treatment leads to better long-term outcomes than discontinuation, challenging traditional concerns about RAAS inhibitor-related creatinine rises.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:54Z","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 naar acute creatininestijging bij start van ACE-remmerbehandeling en de effecten van voortzetting versus staken. Nuanceert de reactie op initiële nierfunctieverandering.","abstract_original":"Discontinuation of angiotensin-converting enzyme (ACE) inhibitor is recommended if patients experience ≥30% acute increase in serum creatinine after starting this therapy. However, the long-term effects of its continuation or discontinuation on major clinical outcomes after increases in serum creatinine are unclear. In the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation), 11 140 diabetes mellitus patients were randomly assigned to perindopril-indapamide or placebo after a 6-week active run-in period. The current study included 11 066 participants with 2 serum creatinine measurements recorded before and during the active run-in period (3 weeks apart). Acute increase in creatinine was determined using these 2 measurements and classified into 4 groups: increases in serum creatinine of <10%, 10% to 19%, 20% to 29%, and ≥30%. The primary study outcome was the composite of major macrovascular events, new or worsening nephropathy, and all-cause mortality. An acute increase in serum creatinine was associated with an elevated risk of the primary outcome ( P for trend <0.001). The hazard ratios were 1.11 (95% CI, 0.97-1.28) for those with an increase of 10% to 19%, 1.34 (1.07-1.66) for 20% to 29%, and 1.44 (1.15-1.81) for ≥30%, compared with <10%. However, there was no evidence of heterogeneity in the benefit of randomized treatment effects on the outcome across subgroups defined by acute serum creatinine increase ( P for heterogeneity=0.94). Acute increases in serum creatinine after starting perindopril-indapamide were associated with greater risks of subsequent major clinical outcomes. However, the continuation of angiotensin-converting enzyme inhibitor-based therapy reduced the long-term risk of major clinical outcomes, irrespective of acute increase in creatinine. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00145925."},{"id":"0fadabed023d","type":"article","url":"https://hartvaat.nl/2019/01/01/bloeddrukstijging-bij-jonge-vrouwen-met-turner-syndroom-ongeacht-oestradiol-dosi/","title":"Bloeddrukstijging bij jonge vrouwen met Turner syndroom ongeacht oestradiol dosis: 5-jaars RCT","title_en":"Five-Year Randomized Study Demonstrates Blood Pressure Increases in Young Women With Turner Syndrome Regardless of Estradiol Dose.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["vrouwen"],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.118.11742","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.118.11742","authors":["Sara Brun","Line Cleemann","Kirsten Holm","Gitte Salskov","Mogens Erlandsen","Agnethe Berglund","Niels H Andersen","Claus H Gravholt"],"significance":5,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":[],"congress":"","summary_en":"This 5-year randomized study in young women with Turner syndrome showed blood pressure increases regardless of estradiol replacement dose, highlighting the cardiovascular monitoring needs in this genetic condition.","created":"2026-07-03T10:27:41Z","updated":"2026-07-03T13:26:54Z","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":"5-jaars gerandomiseerde studie die bloeddrukstijging aantoonde bij jonge vrouwen met Turner syndroom, ongeacht de oestradiol-dosering.","abstract_original":"We evaluated the development in blood pressure (BP) and heart rate in young women with Turner syndrome (TS) and investigated potential influencing cofactors. Twenty TS women (mean±SD, 22.9±2.3 years of age) were investigated in a 5-year prospective setting. Data were derived from a randomized controlled clinical trial investigating 2 different doses of estradiol treatment (2 mg 17β-estradiol per day and placebo or 2+2 mg 17β-estradiol per day). A control group of 12 healthy age-matched young women (mean±SD, 23.11±2.2 years of age) was examined at the end of the study. BP and lipids were monitored yearly. At the end of the study, TS (n=15) and controls were examined by 24-hour ambulatory BP monitoring. Systolic and diastolic BPs increased regardless of estradiol dose ( P=0.005 and P=0.009) in TS patients, whereas heart rate decreased ( P=0.05). Neither body mass index, height, weight, nor lipids contributed significant to the changes. There was no difference in BP, heart rate, or lipids because of treatment. At the end of the study, diastolic BP and heart rate were significantly higher in TS during day, night, and over 24 hours. Systolic BP increased insignificantly. Lipids did not change during the study period, but body mass index determined individual levels. In conclusion, systolic and diastolic BPs increase significantly in late adolescence and early adulthood in TS. It remains an enigma why BP increases early in life in TS. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00134745."},{"id":"416ea6ba9e2f","type":"article","url":"https://hartvaat.nl/2019/01/01/implementatie-van-mi-zorgsystemen-in-lage-en-middeninkomenslanden/","title":"Implementatie van MI-zorgsystemen in lage- en middeninkomenslanden","title_en":"Implementing myocardial infarction systems of care in low/middle-income countries.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["acuut-hartfalen","farmaco-economie","hypertrofische-cardiomyopathie","laminopathie","myocardinfarct","ouderen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313398","source_url":"https://doi.org/10.1136/heartjnl-2018-313398","authors":["Bruno R Nascimento","Luisa C Caldeira Brant","Bárbara C A Marino","Luiz Guilherme Passaglia","Antonio Luiz P Ribeiro"],"significance":6,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/polypil-cardiovasculair/"],"congress":"","summary_en":"This review addressed the challenges and strategies for implementing acute MI care systems in low- and middle-income countries, where the majority of global ischemic heart disease deaths occur.","created":"2026-07-03T10:27:40Z","updated":"2026-07-03T18:38:41Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (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 over de implementatie van myocardinfarct-zorgsystemen in lage- en middeninkomenslanden. Uitdagingen en strategieën voor wereldwijde cardiovasculaire zorg.","abstract_original":"Ischaemic heart disease is the leading cause of death worldwide, with an increasing trend from 6.1 million deaths in 1990 to 9.5 million in 2016, markedly driven by rates observed in low/middle-income countries (LMIC). Improvements in myocardial infarction (MI) care are crucial for reducing premature mortality. We aimed to evaluate the main challenges for adequate MI care in LMIC, and possible strategies to overcome these existing barriers.Reperfusion is the cornerstone of MI treatment, but worldwide around 30% of patients are not reperfused, with even lower rates in LMIC. The main challenges are related to delays associated with patient education, late diagnosis and inadequate referral strategies, health infrastructure and insufficient funding. The implementation of regional MI systems of care in LMIC, systematising timely reperfusion strategies, access to intensive care, risk stratification and use of adjunctive medications have shown some successful strategies. Telemedicine support for remote ECG, diagnosis and organisation of referrals has proven to be useful, improving access to reperfusion even in prehospital settings. Organisation of transport and referral hubs based on anticipated delays and development of MI excellence centres have also resulted in better equality of care. Also, education of healthcare staff and task shifting may potentially widen access to optimal therapy.In conclusion, efforts have been made for the implementation of MI systems of care in LMIC, aiming to address particularities of the health systems. However, the increasing impact of MI in these countries urges the development of further strategies to improve reperfusion and reduce system delays."},{"id":"b0d5ea75009c","type":"article","url":"https://hartvaat.nl/2019/01/01/globale-prevalentie-van-therapieresistente-hypertensie-meta-analyse-van-3-2-milj/","title":"Globale prevalentie van therapieresistente hypertensie: meta-analyse van 3,2 miljoen patiënten","title_en":"Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","huisarts","internist"],"tags":["resistente-hypertensie","vrouwen"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313599","source_url":"https://doi.org/10.1136/heartjnl-2018-313599","authors":["Jean Jacques Noubiap","Jobert Richie Nansseu","Ulrich Flore Nyaga","Paule Sandra Sime","Innocent Francis","Jean Joel Bigna"],"significance":8,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/mineralocorticoid-antagonisten-hypertensie/"],"congress":"","summary_en":"This meta-analysis of 3.2 million patients provided the first comprehensive estimate of resistant hypertension prevalence, distinguishing between apparent, pseudo-resistant, and true resistant hypertension. The data quantified the scale of this challenging clinical problem.","created":"2026-07-03T10:27:40Z","updated":"2026-07-03T18:38:41Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Grootste meta-analyse ooit naar de prevalentie van therapieresistente hypertensie, gebaseerd op 3,2 miljoen patiënten. Kwantificeert de omvang van het probleem.","abstract_original":"OBJECTIVE: We conducted the first systematic review and meta-analysis to estimate the specific prevalence of apparent treatment-resistant, pseudo-resistant and true-resistant hypertension among treated patients with hypertension globally. METHODS: We conducted a search in PubMed, EMBASE, Web of Science and Global Index Medicus to identify articles published from inception to 30 September 2017, and searched the reference list of retrieved articles. We used a random-effects model to estimate the prevalence of resistant hypertension across studies and heterogeneity was assessed via the χ² test on Cochran's Q statistic. RESULTS: We included 91 studies published between 1991 and 2017 reporting data of a pooled sample of 3 207 911 patients with hypertension on antihypertensive drugs globally. Most of the studies (n=64, 70%) only used office blood pressure (BP) measurement. In the general, population of treated patients with hypertension, the prevalence of true-resistant, apparent treatment-resistant and pseudo-resistant hypertension were 10.3% (95% CI 7.6% to 13.2%), 14.7% (95% CI 13.1% to 16.3%) and 10.3% (95% CI 6.0% to 15.5%). The prevalence of true-resistant hypertension was 22.9% (95% CI 19.1% to 27.0%), 56.0% (95% CI 52.7% to 59.3%) and 12.3% (95% CI 1.7% to 30.5%) in chronic kidney disease, renal transplant and elderly patients, respectively. CONCLUSIONS: This study shows a high prevalence of true-resistant hypertension. This prevalence is lower than that of apparent treatment-resistant hypertension, demonstrating the importance to exclude causes of pseudo-resistant hypertension including white-coat hypertension with the use of ambulatory BP measurement. The burden of resistant hypertension is highest in patients with chronic kidney disease. New treatments for resistant hypertension are highly needed, considering the disastrous complications of the disease."},{"id":"77d68c420d72","type":"article","url":"https://hartvaat.nl/2019/01/01/polypil-en-cardiovasculaire-preventie-meta-analyse-van-gerandomiseerde-trials/","title":"Polypil en cardiovasculaire preventie: meta-analyse van gerandomiseerde trials","title_en":"Reaching cardiovascular prevention guideline targets with a polypill-based approach: a meta-analysis of randomised clinical trials.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts","internist"],"tags":["aspirine","bloeddrukbehandeling","farmaco-economie","fidelity","figaro-dkd","ouderen","richtlijnen-esc","roken","secundaire-preventie","statines"],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2018-313108","source_url":"https://doi.org/10.1136/heartjnl-2018-313108","authors":["Vanessa Selak","Ruth Webster","Sandrine Stepien","Chris Bullen","Anushka Patel","Simon Thom","Bruce Arroll","Michiel L Bots","Alex Brown","Sue Crengle","Prabhakaran Dorairaj","C Raina Elley","Diederick E Grobbee","Matire Harwood","Graham S Hillis","Tracey-Lea Laba","Bruce Neal","David Peiris","Natasha Rafter","Christopher Reid","Alice Stanton","Andrew Tonkin","Tim Usherwood","Angela Wadham","Anthony Rodgers"],"significance":7,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/polypil-cardiovasculair/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"This meta-analysis showed that a polypill-based approach significantly improves achievement of ESC cardiovascular prevention guideline targets for blood pressure and LDL cholesterol, supporting the polypill as a tool for overcoming treatment inertia.","created":"2026-07-03T10:27:40Z","updated":"2026-07-03T13:26:54Z","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":"Meta-analyse die aantoont dat een polypilstrategie (vaste combinatie antihypertensiva + statine) de cardiovasculaire richtlijndoelen beter bereikt. Praktische preventie.","abstract_original":"OBJECTIVE: The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy. METHODS: We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy. RESULTS: Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0-1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively. CONCLUSIONS: Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline."}]}