AHA 2025: Evolocumab lowers CV event risk in high-risk patients without prior MI or stroke

Evolocumab provides substantial CV risk reduction in high-risk patients without prior MI or stroke, expanding the population who may benefit from PCSK9 inhibition beyond secondary prevention. These results, reported at the American Heart Association (AHA) Scientific Sessions, support consideration of evolocumab for primary prevention in select high-risk individuals inadequately controlled on standard lipid-lowering therapy.

Study details: The international, double-blind, randomized, placebo-controlled VESALIUS-CV trial (NCT03872401) enrolled 12,257 adults with atherosclerosis or diabetes, LDL-C ≥90 mg/dL, and no prior MI or stroke. Participants received evolocumab 140 mg every 2 weeks or placebo, with a median follow-up of 4.6 years. Primary endpoints: composite of death from coronary heart disease, MI, or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE).

Results: Evolocumab significantly reduced the risk of first major CV events:

• 3-point MACE: 6.2% in evolocumab group vs. 8.0% in placebo group (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.65–0.86; P<0.001)
• 4-point MACE: 13.4% in evolocumab group vs. 16.2% in placebo group (HR, 0.81; 95% CI, 0.73–0.89; P<0.001)

Safety profiles were similar between groups, with no excess adverse events.

Source:

Bohula EA, et al; VESALIUS-CV Investigators. (2025, November 8). N Engl J Med. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. https://pubmed.ncbi.nlm.nih.gov/41211925/