Impact of PCSK9 Inhibitors on Cardiometabolic Prevention in High-Risk Adults

In the VESALIUS-CV trial, adding the PCSK9 inhibitor evolocumab to standard lipid therapy reduced major adverse cardiovascular events by about 25% in high‑risk adults without prior myocardial infarction or stroke.

The study enrolled 12,257 adults at elevated cardiometabolic risk — people with atherosclerosis or diabetes and LDL‑C above 90 mg/dL — who had no prior myocardial infarction or stroke, creating a clear primary‑prevention cohort. Participants were randomized globally to evolocumab 140 mg every two weeks or matching placebo on top of standard lipid‑lowering therapy and were followed for a median of 4.6 years.

Patients randomized to evolocumab experienced 336 composite events (6.2%) versus 443 events (8.0%) with placebo over a median 4.6 years. Those figures translate to a 25% relative reduction in the composite of coronary death, myocardial infarction, or ischemic stroke.

Most prior PCSK9 evidence addressed secondary prevention in people with prior events; VESALIUS‑CV extends the clinical signal into an event‑free but high‑risk population.