Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior Myocardial Infarction: Results From the VESALIUS-CV Trial
Authors' conclusion
Evolocumab reduced the risk of major cardiovascular events in stable patients with prior PCI but no MI.
Study context
- Population
- Patients with prior percutaneous coronary intervention (PCI) and no prior myocardial infarction (MI) or stroke (atherosclerosis or high-risk DM, LDL-C ≥90 mg/dL)prior PCI, of 12,257 randomized
- Participants
- 3,627 patients
- Comparison
- Evolocumab vs placebo
- Primary endpoint
- Dual primary: 3-point MACE (CHD death, MI or ischemic stroke) and 4-point MACE (plus ischemia-driven revascularization)
- Follow-up
- Median 4.6 years
Methodological detailsplacebo-controlled
- Placebo-controlled
Primary result
As reported in the abstract
3-point and 4-point MACE, prior PCI subgroup · 5-year Kaplan-Meier rates
Evolocumab
- 3-point MACE
- 7.0%
- 4-point MACE
- 17.9%
Placebo
- 3-point MACE
- 9.5%
- 4-point MACE
- 21.7%
3-point MACE
Evolocumab7.0%
Placebo9.5%
4-point MACE
Evolocumab17.9%
Placebo21.7%
Evolocumab vs PlaceboHazard ratio (95% CI)P value
3-point MACE
0.70(0.56–0.89)
P = 0.0044-point MACE
0.82(0.71–0.96)
P = 0.012Further findings
LDL-C (lipid substudy) · 48 weeks
P < 0.0001
| Outcome | Evolocumab | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| MIEffect apparent as soon as 6 months after randomization | 3.0% | 6.1% | 0.50 (0.36–0.70) | P < 0.001 | |
| Urgent coronary revascularization | 0.61 (0.46–0.80) | P < 0.001 | |||
| CV deathNominally lower | 2.6% | 3.7% | 0.66 (0.45–0.96) | P = 0.030 | |
| All-cause deathNominally lower | 8.2% | 10.2% | 0.76 (0.60–0.95) | P = 0.016 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior Myocardial Infarction: Results From the VESALIUS-CV Trial. Circulation. Published 19 May 2026. doi:10.
Summarised from the published abstract; every number is checked against it