PCSK9i reduces MACE and coronary revascularization in patients with prior PCI
Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention
Introduction and methods
Background
There is a need to improve outcomes for patients who have undergone percutaneous coronary intervention (PCI), because these patients remain at high risk of subsequent myocardial infarction (MI) and coronary revascularization [1-3].
The PCSK9 inhibitor evolocumab reduced major adverse events (MACE) by 15% compared to placebo in patients with clinically overt stable ASCVD and additional high-risk features in the FOURIER trial [4].
In this prespecified analysis was investigated whether patients with prior PCI identified a subset of patients who in particular benefitted from PCSK9 inhibition, whether effects of evolocumab were similar across a range of procedures types and whether these findings varied based on time from most recent PCI.
Methods
Patients in the FOURIER trial had established, but stable ASCVD and had to have baseline LDL-c ≥70 mg/dL or non-HDL-c ≥100 mg/dL on stable treatment with statin, with or without ezetimibe. Patients were also required to have at least one additional high-risk criterion. Median follow-up in FOURIER was 2.2 years.
17,073 Patients (61.9%) in the FOURIER trial had a documented history of prior PCI at baseline and 10,455 (37.9%) had not.
Outcomes
Primary endpoint was time to MACE, a composite of CV death, MI, stroke, unstable angina or coronary revascularization.
Main results
- Risk reduction of MACE with evolocumab was similar in patient with prior PCI (HR 0.84, 95%CI: 0.77-0.91) and without (HR 0.88, 95%CI:0.77-1.01, Pinteraction=0.51).
- In patients with prior PCI, evolocumab reduced the risk of overall coronary revascularization procedures (HR 0.76, 95%CI:0.69-0.85) with consistent effects for PCI and CABG.
- Also, consistent effects for several types of revascularization procedures were observed, including revascularization for in-stent restenosis (ISR), PCI for de novo coronary lesions, PCI for not de novo lesions, PCI for ISR, PCI for stent thrombosis and PCI for graft failure. And there were also reductions with evolocumab in ischemia-driven, urgent and complex coronary revascularizations.
- There was no heterogeneity for reductions in MACE with evolocumab according to time for most recent PCI.
Conclusion
This prespecified subgroup analysis of FOURIER showed that risk reduction for MACE with evolocumab was similar in patients with and without prior PCI. Moreover, in patients with prior PCI, evolocumab treatment resulted in risk reduction of coronary revascularization which extended to a broad range of lesion types.
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