Overview
- The VESALIUS-CV trial randomized 12,257 adults with atherosclerosis or high-risk diabetes but no prior heart attack or stroke to evolocumab or placebo on top of background therapy for a median 4.5 years.
- Evolocumab reduced the three-point primary endpoint of coronary heart disease death, myocardial infarction, or ischemic stroke by 25% and the four-point composite by 19% versus placebo.
- Key secondary outcomes showed a 36% reduction in myocardial infarction and a 27% reduction in cardiovascular death, myocardial infarction, or ischemic stroke.
- LDL cholesterol fell by about 55% to a median 45 mg/dL at 48 weeks with evolocumab, with benefits consistent across major subgroups including participants with high-risk diabetes.
- Safety matched placebo without new signals in this international, double-blind, Amgen-funded study, though the 93% White enrollment limits generalizability.