Cumulative Benefit With Evolocumab in Patients With No Prior Myocardial Infarction or Stroke in the VESALIUS-CV Study
Authors' conclusion
A substantial proportion of patients experiencing a cardiovascular event had more than 1 event. The addition of evolocumab reduced the total number of MACE
Study context
- Population
- Patients at high CV risk (qualifying atherosclerosis or high-risk diabetes) with no prior myocardial infarction (MI) or stroke and LDL-C ≥90 mg/dL on optimized lipid-lowering therapy
- Participants
- 12,257 patients
- Comparison
- Evolocumab vs placebo
- Primary endpoint
- Total (first and subsequent) dual primary endpoint events: 4-P MACE (CHD death, MI, ischemic stroke or ischemia-driven arterial revascularization) and 3-P MACE
- Follow-up
- Median 4.6 years
Methodological detailsprespecified analysis, negative binomial regression
- Prespecified analysis
- Negative binomial regression
Primary result
As reported in the abstract
Total 4-P and 3-P MACE
Evolocumab vs PlaceboIncidence rate ratio (95% CI)P value
Total 4-P MACE
0.80(0.71–0.90)
P = 0.0002Total 3-P MACE
0.73(0.63–0.86)
P = 0.0001- Total 4-P major adverse cardiovascular event (MACE) events (1,654 first, 1,107 subsequent)
- 2,761
- Total 3-P MACE events (779 first, 146 subsequent)
- 925
Further findings
| Outcome | Estimate | P value | |
|---|---|---|---|
| First and subsequent 4-P MACEEvolocumab vs Placebo · first events | HR 0.81 (95% CI 0.73–0.89) | P < 0.0001 | |
| First and subsequent 4-P MACEEvolocumab vs Placebo · subsequent events | IRR 0.75 (95% CI 0.61–0.91) | ||
| First and subsequent 3-P MACEEvolocumab vs Placebo · first events | HR 0.75 (95% CI 0.65–0.86) | P < 0.0001 | |
| First and subsequent 3-P MACEEvolocumab vs Placebo · subsequent events | IRR 0.63 (95% CI 0.42–0.94) | ||
| 0.512Ratio (log scale) |
| Outcome | Estimate | |
|---|---|---|
| Projected events prevented per 1,000 patients over 5 yearsEvolocumab vs Placebo | total-event difference, 4-P MACE (31 first, 24 subsequent) 55 events per 1,000 patients (95% CI 36–74) | |
| Projected events prevented per 1,000 patients over 5 yearsEvolocumab vs Placebo | total-event difference, 3-P MACE (20 first, 5 subsequent) 25 events per 1,000 patients (95% CI 15–37) | |
| −50050100Difference, events per 1,000 patients (linear scale) |
Key subgroups (statin intensity, qualifying atherosclerosis)
- Results consistent across key subgroups
Original publication
Cumulative Benefit With Evolocumab in Patients With No Prior Myocardial Infarction or Stroke in the VESALIUS-CV Study. J Am Coll Cardiol. Published 28 August 2026. doi:10.
Summarised from the published abstract; every number is checked against it