# VESALIUS-CV-subgroep JAMA: evolocumab beschermt ook diabeten zonder vastgestelde atherosclerose

*geplaatst 2026-04-17 · Cholesterol · JAMA · doi 10.1001/jama.2026.3277 · https://hartvaat.nl/2026/03/28/vesalius-cv-subgroep-jama-evolocumab-beschermt-ook-diabeten-zonder-vastgestelde-/*

In deze vooraf gespecificeerde subgroepanalyse van de VESALIUS-CV-trial (n=3655 diabeten zonder manifeste atherosclerose, LDL-C ≥ 90 mg/dL) verlaagde evolocumab bovenop statines het risico op het eerste MACE significant ten opzichte van placebo, over een mediane follow-up van 4,8 jaar. De resultaten ondersteunen een eerdere PCSK9-remmerstart bij hoogrisico-diabeten voordat er sprake is van aangetoonde vaatschade. Voor de huisarts- en internistenpraktijk betekent dit dat intensieve LDL-verlaging ook zonder atherosclerotische manifestatie overweegbaar wordt bij type 2 diabetes met aanhoudend verhoogd LDL-C.

## English: 

This prespecified VESALIUS-CV subgroup (n=3655 diabetics with LDL-C ≥ 90 mg/dL and no established atherosclerosis) found that evolocumab on top of optimised statin therapy significantly reduced first MACE over a median 4.8 years of follow-up. The JAMA-published analysis pushes PCSK9 inhibition further upstream in high-risk diabetics without prior arterial disease, calcium score ≥ 100, or stenosis ≥ 50%. It strengthens the case for earlier intensive LDL-C lowering in primary prevention for diabetic patients.

## Abstract (original, from the publication)

IMPORTANCE: Intensive lowering of low-density lipoprotein cholesterol (LDL-C) levels with PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors for cardiovascular event reduction has largely been reserved for patients with significant atherosclerosis. OBJECTIVE: To investigate whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis. DESIGN, SETTING, AND PARTICIPANTS: VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab conducted across 774 sites in 33 countries and enrolling 12 257 patients with no prior myocardial infarction or stroke, LDL-C level 90 mg/dL or greater, and qualifying atherosclerosis or high-risk diabetes. This prespecified subgroup analysis examined outcomes in patients without known significant atherosclerosis (none of the following: prior arterial revascularization, arterial stenosis ≥50%, or coronary artery calcium score ≥100 Agatston units), all of whom had diabetes. Enrollment started in June 2019 and the last patient visit was July 2025, with a median follow-up of 4.8 years. INTERVENTION: Patients were randomized in a 1:1 ratio to subcutaneous administration of either evolocumab (140 mg every 2 weeks) or matching placebo added to optimally tolerated statin therapy. MAIN OUTCOMES AND MEASURES: The dual primary end points were composites of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4-P MACE). Secondary end points included all-cause mortality. RESULTS: This predefined subgroup included 3655 patients (1849 in the evolocumab group and 1806 in the placebo group) with a median age of 65 years (57% female). Among those in the lipid substudy, the median LDL-C level at 48 weeks was 52 mg/dL in the evolocumab group vs 111 mg/dL in the placebo group (P < .001). A 3-P MACE event occurred in 83 patients (5-year Kaplan-Meier estimate, 5.0%) in the evolocumab group compared with 117 patients (5-year Kaplan-Meier estimate, 7.1%) in the placebo group (hazard ratio [HR], 0.69 [95% CI, 0.52-0.91]; P = .009; between-group difference, 2.1% [95% CI, 0.4%-3.8%]). A 4-P MACE event occurred in 127 patients (5-year Kaplan-Meier estimate, 7.6%) in the evolocumab group compared with 178 patients (5-year Kaplan-Meier estimate, 10.5%) in the placebo group (HR, 0.69 [95% CI, 0.55-0.86]; P = .001; between-group difference, 2.9% [95% CI, 0.9%-4.9%]). There were 136 deaths (5-year Kaplan-Meier estimate, 7.8%) in the evolocumab group compared with 172 deaths (5-year Kaplan-Meier estimate, 10.1%) in the placebo group (HR, 0.76 [95% CI, 0.61-0.95]). CONCLUSIONS AND RELEVANCE: In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03872401.

Auteurs: Nicholas A Marston, Erin A Bohula, Ajay K Bhatia, Gaetano M De Ferrari, Lawrence A Leiter, Jose C Nicolau, Jeong-Gun Park, Sabina A Murphy, Emileigh Walsh, Lyrica Liu, Subodh Verma, Naveed Sattar, Stephen J Nicholls, Jose Lopez-Sendon, Ioanna Gouni-Berthold, Lale Tokgozoglu, Ron Blankstein, Marcoli Cyrille, Gabriel Paiva da Silva Lima, Robert P Giugliano, Marc S Sabatine

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Bron: JAMA, https://doi.org/10.1001/jama.2026.3277. Bijgewerkt 2026-07-03T13:31:41Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.