{"id":"f76be3653ed9","type":"article","url":"https://hartvaat.nl/2026/03/28/vesalius-cv-evolocumab-verlaagt-risico-op-eerste-cardiovasculair-event-met-31-bi/","title":"VESALIUS-CV: evolocumab verlaagt risico op eerste cardiovasculair event met 31% bij patiënten zonder significant atherosclerose","title_en":"","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog","huisarts","internist"],"tags":["acc-2026","biomarkers-cardiovasculair","diabetes-en-hart","diabetes-type-2","ezetimibe","farmaco-economie","figaro-dkd","obesitas","ouderen","perifeer-vaatlijden","soul-trial"],"journal":"JAMA","doi":"https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2026.4521","source_url":"https://doi.org/https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2026.4521","authors":["Nicholas Marston, Erin Ann Bohula, Ajay Bhatia et al."],"significance":9,"published":"2026-03-28","source_date":"2026-03-28","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"acc-2026","summary_en":"In a subgroup analysis of VESALIUS-CV, 3,655 patients with diabetes but no known significant atherosclerosis were followed for a median of 4.8 years. Evolocumab reduced 3-P MACE by 31% (HR 0.69; P=0.009) and 4-P MACE by 31% (HR 0.69; P=0.001). The effect appeared after 1 year and grew to ~40% reduction thereafter. CV death was reduced by 32% and all-cause mortality by 24%. This supports the use of PCSK9 inhibitors for primary prevention in high-risk diabetes patients.","created":"2026-07-03T10:32:15Z","updated":"2026-07-03T13:31:12Z","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":"In een subgroepanalyse van de VESALIUS-CV-trial werden 3.655 patiënten met diabetes maar zonder bekende significante atherosclerose gevolgd gedurende mediaan 4,8 jaar. Evolocumab verlaagde het risico op 3-punts MACE met 31% (HR 0,69; P=0,009) en 4-punts MACE eveneens met 31% (HR 0,69; P=0,001). Het effect werd zichtbaar na 1 jaar en nam toe tot ~40% reductie nadien. Cardiovasculaire sterfte daalde met 32% en totale sterfte met 24%. Dit ondersteunt de inzet van PCSK9-remmers voor primaire preventie bij diabetespatiënten met hoog risico.","abstract_original":"Background: Intensive LDL-C lowering with PCSK9 inhibitors has largely been reserved for patients with significant atherosclerosis. We investigated whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without significant atherosclerosis. Methods: VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab in 12,257 patients with qualifying atherosclerosis or diabetes, no prior MI or stroke, and LDL-C >=90 mg/dL. In this subgroup analysis, we examined outcomes in patients without known significant atherosclerosis (eg, any arterial stenosis >=50% or CAC >=100). The dual primary endpoints were composites of coronary heart disease death, MI, or ischemic stroke (3-P MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4-P MACE). Results: This cohort included 3,655 patients (median age 65 yrs, 57% female) followed for a median of 4.8 yrs. Among those in the lipid substudy, LDL-C at 48 wks was 52 vs. 111 mg/dL in the evolocumab vs. placebo arms (p<0.0001). Evolocumab significantly reduced the risk of 3-P MACE and 4-P MACE each by 31% (HR 0.69 [0.52-0.91], p=0.009; HR 0.69 [0.55-0.86], p=0.001). The effect became apparent after 1 year, with 41% and 39% reductions in the risk of 3-P MACE and 4-P MACE thereafter. The HR for CV death was 0.68 (0.46-0.99) and the HR for all-cause mortality was 0.76 (0.61-0.95). Conclusion: In patients without significant atherosclerosis, evolocumab substantially reduced the risk of a first major CV event."}