Prevention & lipidsSecondary analysis
Effects of Evolocumab on Mortality Outcomes in Patients Without Previous Myocardial Infarction or Stroke: A Prespecified Analysis of the VESALIUS-CV Randomized Clinical Trial
- Prespecified analysis of the VESALIUS-CV randomised trial
- double-blind
Study context
- Population
- Patients with qualifying atherosclerosis or high-risk diabetes without previous MI or stroke, and LDL-C ≥90 mg/dL (or non-HDL-C ≥120 mg/dL or apolipoprotein B ≥80 mg/dL)
- Participants
- 12,257 patients
- Comparison
- Evolocumab vs placebo
- Primary endpoint
- All-cause mortality (prespecified mortality outcome)
- Follow-up
- Median 4.6 years
Primary result
All-cause mortality · 5-year Kaplan-Meier rate
Hazard ratio
0.80
95% CI 0.70–0.91
P = 0.0005
Events by treatment group
Evolocumab vs Placebo
HR 0.80 (95% CI 0.70–0.91); P = 0.0005
As reported in the abstract
Further findings
CV death · median 4.6 years
- CV death, evolocumab vs placebo: 156 deaths [2.8%] vs 195 [3.6%]
- HR 0.79 (95% CI 0.64-0.98)
Non-CV death · median 4.6 years
- Non-CV death, evolocumab vs placebo: 229 [4.2%] vs 268 [5.0%]
- HR 0.85 (95% CI 0.71-1.01)
Death of undetermined cause · median 4.6 years
- Undetermined-cause death, evolocumab vs placebo: 49 [1.1%] vs 76 [1.4%]
- HR 0.64 (95% CI 0.45-0.92)
All-cause mortality by subgroup
- Results consistent regardless of age, sex, region, race, qualifying atherosclerosis or high-risk diabetes, baseline LDL-C or background lipid therapy
Non-CV death: contribution of prevented nonfatal CV events (multistate modeling)
- Share of the non-CV death observation driven by prevention of antecedent nonfatal CV events
- 78%; bootstrap IQR 71-92%
Original publication
Effects of Evolocumab on Mortality Outcomes in Patients Without Previous Myocardial Infarction or Stroke: A Prespecified Analysis of the VESALIUS-CV Randomized Clinical Trial. Circulation. Published 31 August 2026. doi:10.1161/circulationaha.126.082436
Summarised from the published abstract; every number is checked against it