December 24, 2025
1 min read
The VESALIUS-CV trial evaluated the impact of the PCSK9 inhibitor evolocumab on risk for major adverse cardiovascular events in patients with atherosclerosis and/or diabetes and no prior myocardial infarction or stroke.
Read Healio’s in-depth coverage of the VESALIUS-CV trial.
VESALIUS-CV included 12,257 patients who were randomly assigned evolocumab (Repatha, Amgen) 140 mg or placebo every 2 weeks on top of optimal lipid-lowering therapy.
During a median follow-up of 4.6 years, the addition of evolocumab conferred a 25% relative reduction in risk for the primary endpoint of coronary heart disease death, MI or ischemic stroke and a 19% reduction in a broader coprimary endpoint that also included any ischemia-driven arterial revascularization compared with placebo.
Researchers reported evolocumab also lowered risk for a majority of secondary endpoints, with no difference between groups in safety.
Evolocumab is the first PCSK9 inhibitor to demonstrate effectiveness in both primary and secondary prevention populations, according to the researchers.
Results of VESALIUS-CV were presented at the American Heart Association Scientific Sessions and simultaneously published in The New England Journal of Medicine.