{"id":"45984","type":"article","url":"https://hartvaat.nl/2026/05/19/vesalius-cv-subgroep-prior-pci-zonder-eerder-mi-evolocumab-halveert-hartinfarct-/","title":"VESALIUS-CV subgroep prior PCI zonder eerder MI: evolocumab halveert hartinfarct-risico (n=3.627)","title_en":"Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior MI: Results From the VESALIUS-CV Trial","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Circulation","doi":"https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.126.080616","source_url":"https://doi.org/https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.126.080616","authors":[],"significance":8,"published":"2026-07-08","source_date":"2026-05-19","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"Prespecified subgroup analysis of VESALIUS-CV in 3,627 patients (29.6% of the total study population) with prior PCI but no prior myocardial infarction or stroke, randomised to evolocumab or placebo (median follow-up 4.6 years). Median age 66 years, 30.7% women, median time since PCI 4 years. At 48 weeks, median LDL-C was 41.5 versus 107.0 mg/dL with evolocumab versus placebo. Evolocumab reduced 3-point MACE by 30% (5-year KM 7.0% vs 9.5%; HR 0.70; 95% CI 0.56-0.89; p=0.004), 4-point MACE by 18%, MI risk by 50% (3.0% vs 6.1%; HR 0.50; p<0.001), and urgent coronary revascularisation by 39%. The effect was apparent within 6 months. Numerically lower cardiovascular mortality (HR 0.66) and all-cause mortality (HR 0.76). The findings support intensive LDL-C lowering with evolocumab in stable patients with prior PCI even without prior MI — a substantial practical expansion of the indication.","created":"2026-07-03T20:27:01Z","updated":"2026-07-04T19:27:16Z","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":"Vooraf gespecificeerde subgroep-analyse van VESALIUS-CV bij 3.627 patiënten (29,6% van de totale studiepopulatie) met eerdere PCI maar zonder eerder myocardinfarct of CVA, gerandomiseerd tussen evolocumab en placebo (mediane follow-up 4,6 jaar). Mediane leeftijd 66 jaar, 30,7% vrouw, mediane tijd sinds PCI 4 jaar. Op 48 weken was de mediane LDL-C 41,5 versus 107,0 mg/dL bij evolocumab versus placebo. Evolocumab verlaagde het 3-punts-MACE-risico met 30% (5-jaars KM 7,0% vs 9,5%; HR 0,70; 95%-BI 0,56-0,89; p=0,004), het 4-punts MACE met 18%, het MI-risico met 50% (3,0% vs 6,1%; HR 0,50; p<0,001) en spoed-coronairrevascularisatie met 39%. Effect zichtbaar al na 6 maanden. Numerisch lagere cardiovasculaire sterfte (HR 0,66) en totale sterfte (HR 0,76). De bevindingen ondersteunen intensieve LDL-verlaging met evolocumab bij stabiele patiënten met eerdere PCI ook zonder eerder MI — een grote praktische uitbreiding van de indicatie.","abstract_original":"Background: The clinical benefit of intensive LDL-C-lowering with evolocumab in patients with prior percutaneous coronary intervention (PCI) but without a prior myocardial infarction (MI) is not established.Methods: VESALIUS-CV randomized patients with atherosclerosis or high-risk diabetes but without prior MI or stroke and with LDL-C ≥90 mg≥dL to evolocumab vs placebo. The median follow-up was 4.6 years. The dual primary endpoints were: coronary heart disease death, MI, or ischemic stroke (3-point MACE); and the same composite plus ischemia-driven arterial revascularization (4-point MACE). For this pre-specified subgroup analysis, patients were categorized by whether they had undergone PCI at any time prior to trial enrollment.Results: Among 12,257 randomized patients, 3,627 (29.6≥) had undergone prior PCI with a median time between PCI and enrollment of 4 years. Their median age was 66 years and 30.7≥ were women. The median LDL-C at 48 weeks was 41.5 (26.0-67.0) mg/dL vs. 107.0 (84.0-135.0) mg/dL in the evolocumab vs. placebo arms (p&amp;lt;0.0001). Evolocumab reduced the risk of 3-point MACE by 30% (5yr KM 7.0% vs 9.5%; HR 0.70; 95%CI 0.56-0.89; P=0.004) and 4-point MACE by 18% (17.9% vs 21.7%HR 0.82; 95%CI 0.71-0.96; P=0.012), and reduced the risk of MI by 50% (3.0%vs 6.1%; HR 0.50; 95%CI 0.36-0.70; P&amp;lt;0.001), with the effect apparent as soon as 6 months after randomization, and of urgent coronary revascularization by 39% (HR 0.61; 95%CI 0.46-0.80; P&amp;lt;0.001). There were nominally lower rates of CV death (2.6% vs 3.7%; HR 0.66; 95%CI 0.45-0.96; P=0.030) and all-cause death (8.2% vs 10.2%; HR 0.76; 95%CI 0.60-0.95; P=0.016) with evolocumab.Conclusions: Evolocumab reduced the risk of major CV events in stable patients with prior PCI but no MI. These findings support intensive LDL-C-lowering in patients who have undergone PCI even in the absence of prior MI."}