VESALIUS-CV
Evolocumab in Patients at High Cardiovascular Risk without Prior Myocardial Infarction or Stroke
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 12,257 patients at high cardiovascular risk without prior myocardial infarction or stroke, evolocumab reduced major adverse cardiovascular events compared with placebo.
N
12.257
Disegno
Randomized, double-blind, placebo-controlled trial; evolocumab 140 mg subcutaneously every 2 weeks vs placebo added to background lipid-lowering therapy in patients with atherosclerosis or high-risk diabetes and LDL-C ≥ 90 mg/dL but no prior myocardial infarction or stroke; median follow-up 4.6 years; median age 66 years, 43% women, 93% White.
Esito
Two primary endpoints: coronary death, myocardial infarction or ischemic stroke (3-point MACE), and the same composite plus ischemia-driven arterial revascularization (4-point MACE).
Rilevanza
1
Risultato3-point MACE 6.2% vs 8.0% (HR 0.75; 95% CI 0.65-0.86), 4-point MACE 13.4% vs 16.2% (HR 0.81; 95% CI 0.73-0.89); median LDL-C at week 48 45 mg/dL vs 109 mg/dL; no new safety signals.
Bohula EA, Marston NA, Bhatia AK, et al. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. N Engl J Med. 2026;394(2):117-127. 10.1056/nejmoa2514428