Evolocumab reduces MACE risk in patients with prior PCI but no previous MI

In a pre-specified analysis of VESALIUS-CV, evolocumab reduced the risk of MACE in stable patients with prior PCI but no prior MI or stroke compared with placebo.

This summary is based on the publication of Bergmark BA, Bohula EA, Marston NA, et al. - Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior MI: Results From the VESALIUS-CV Trial. Circulation. 2026 May 19. [Online ahead of print]. doi: 10.1161/CIRCULATIONAHA.126.080616.

Introduction and methods

Background

In VESALIUS-CV, treatment with the PCSK9 inhibitor evolocumab reduced the risk of MACE in patients with established atherosclerosis or high-risk diabetes but with no prior MI or stroke compared with placebo [1]. Patients with prior PCI and no prior MI are common in clinical practice and these patients may have an increased risk for CV events. The clinical benefit of intensive LDL-c lowering with evolocumab in this population has not been well established.

Aim of the study

The aim of this pre-specified subgroup analysis of VESALIUS-CV was to evaluate the effects of evolocumab versus placebo in patients with prior PCI but without a prior MI.

Methods

The VESALIUS-CV trial was an international, double-blind, placebo-controlled, phase 3 RCT in which 12,257 stable patients with established atherosclerosis or high-risk diabetes but without prior MI or stroke were randomized to evolocumab 140 mg every 2 weeks or placebo, in addition to optimized lipid-lowering therapy (LLT). Patients had an LDL-c of ≥90 mg/dL, non-HDL-c of ≥120 mg/dL or apoB of ≥80 mg/dL. This pre-specified subgroup analysis included 3,627 patients (29.6%) who had undergone PCI before study enrollment. The median follow-up was 4.6 years.

Outcomes

The dual primary endpoints were 3-point MACE, a composite of CHD death, MI or ischemic stroke, and 4-point MACE, a composite of CHD death, MI, ischemic stroke or ischemia-driven arterial revascularization.

Main results

• In patients with prior PCI, evolocumab reduced the risk of 3-point MACE (HR: 0.70; 95%CI: 0.56-0.89; P=0.004) and 4-point MACE (HR: 0.82; 95%CI: 0.71-0.96; P=0.012) compared with placebo.
• Evolocumab also reduced the risk of MI (HR: 0.50; 95%CI: 0.36-0.70; P<0.001), coronary ischemia-driven revascularization (HR: 0.74; 95%CI: 0.61-0.89; P=0.002) and urgent coronary ischemia-driven revascularization (HR: 0.61; 95%CI: 0.46-0.80; P<0.001) compared with placebo.
• There was no significant effect on ischemic stroke (HR: 1.06; 95%CI: 0.69–1.64; P=0.79).
• Nominal reductions with evolocumab versus placebo were observed for CV death (2.6% vs. 3.7%; HR 0.66; 95%CI: 0.45-0.96; P=0.030) and all-cause mortality (8.2% vs. 10.2%; HR: 0.76; 95%CI: 0.60-0.95; P=0.016).

Conclusion

In this pre-specified subgroup analysis of the VESALIUS-CV trial, evolocumab substantially reduced the risk of MACE in stable patients with prior PCI but no previous MI or stroke. These findings support intensive LDL-c lowering with evolocumab in patients who have undergone PCI, even in the absence of a prior MI.

Find this article online at Circulation

References

1. Bohula EA, Marston NA, Bhatia AK, De Ferrari GM, Leiter LA, Nicolau JC, Park JG, Kuder JF, Murphy SA, Walsh E, et al. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. N Engl J Med. 2026;394:117-127.