
VESALIUS-CV: Evolocumab Before a First Heart Attack or Stroke
Hormone Insight examines whether evolocumab reduces first major cardiovascular events in a selected high-risk population without previous myocardial infarction or stroke. This is an appraisal of the primary VESALIUS-CV randomised trial, not a new study announcement. We cover the two primary composites, absolute benefit, adverse events, the statistical boundary around mortality findings, and clinical applicability. Key findings: • 12,257 participants; median follow-up 4.6 years. • Coronary heart disease death, myocardial infarction or ischaemic stroke: five-year Kaplan–Meier estimates 6.2% versus 8.0%; hazard ratio 0.75 (95% CI 0.65–0.86). • The 1.8 percentage-point difference corresponds to approximately 18 fewer people per 1,000 experiencing the composite over five years, derived from rounded risk estimates. • Adding ischaemia-driven arterial revascularisation: 13.4% versus 16.2%; hazard ratio 0.81 (95% CI 0.73–0.89). • Serious adverse events: 28.2% versus 28.9%; adverse-event treatment discontinuation: 3.3% versus 3.7%. Safety collection did not comprehensively capture minor adverse effects. Around two thirds already had qualifying atherosclerosis. These results should not be applied indiscriminately to generally healthy adults or everyone with diabetes. Mortality analyses below the failed coronary-death test in the hierarchy remain exploratory. Funded by Amgen; 93% of participants were White. No direct comparison against an active alternative such as ezetimibe. Primary source Bohula EA et al. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. New England Journal of Medicine. 2026;394:117–127. Online 8 November 2025; issue 8 January 2026. Article and supplement: https://www.nejm.org/doi/full/10.1056/NEJMoa2514428 PubMed: https://pubmed.ncbi.nlm.nih.gov/41211925/ Trial registration: https://clinicaltrials.gov/study/NCT03872401 AI-generated narration using an authorised voice. Medical education only, not individual medical advice or accredited CME.


