Cardiovascular outcome trial · N Engl J Med 2026
VESALIUS-CV trial
Evolocumab in Patients without a Previous Myocardial Infarction or Stroke.
The bottom line
In patients with atherosclerosis or diabetes but no prior MI or stroke, adding evolocumab to therapy significantly lowered the risk of major cardiovascular events compared with placebo, with no apparent safety concerns.
BenefitUS status: US-approved
At a glance
- Medicine
- Evolocumab 140 mg every 2 weeks
- Compared with
- Placebo
- People
- 12,257
- Who took part
- Patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke who had an LDL-C level of at least 90 mg per deciliter
- Design
- international, double-blind, randomized, placebo-controlled trial
- Follow-up
- median follow-up was 4.6 years
- Main question
- Co-primary end points: (1) 3-point MACE (composite of death from coronary heart disease, myocardial infarction, or ischemic stroke) and (2) 4-point MACE (3-point MACE or ischemia-driven arterial revascularization)
Main result
3-point MACE: hazard ratio, 0.75; 95% CI, 0.65 to 0.86; P<0.001. 4-point MACE: hazard ratio, 0.81; 95% CI, 0.73 to 0.89; P<0.001.
Effect on LDL cholesterol
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Other results
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Safety
No evidence of a between-group difference was seen in the incidence of safety events.
In the trial's own words
“A 3-point MACE event occurred in 336 patients (5-year Kaplan-Meier estimate, 6.2%) in the evolocumab group, as compared with 443 (8.0%) in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). A 4-point MACE event occurred in 747 patients (5-year Kaplan-Meier estimate, 13.4%) in the evolocumab group, as compared with 907 (16.2%) in the placebo group (hazard ratio, 0.81; 95% CI, 0.73 to 0.89; P<0.001).”
Quoted from the abstract of N Engl J Med 2026, checked word for word against PubMed. PubMed 41211925 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the VESALIUS-CV trial find?
In patients with atherosclerosis or diabetes but no prior MI or stroke, adding evolocumab to therapy significantly lowered the risk of major cardiovascular events compared with placebo, with no apparent safety concerns.
Who was in VESALIUS-CV?
12,257 people. Patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke who had an LDL-C level of at least 90 mg per deciliter.
What was VESALIUS-CV's main result?
3-point MACE: hazard ratio, 0.75; 95% CI, 0.65 to 0.86; P<0.001. 4-point MACE: hazard ratio, 0.81; 95% CI, 0.73 to 0.89; P<0.001.
How much did LDL cholesterol change in VESALIUS-CV?
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