PCSK9i reduces complex coronary disease that requires revascularization
Reduction with Evolocumab in Complex Coronary Revascularization: Insights from the FOURIER trial
Presented at the AHA Scientific Sessions 2020 by Kazuma Oyama (Boston, MA, USA)
Introduction and methods
PCSK9 inhibitors reduce coronary artery atherosclerotic plaque volume, thereby lowering the risk of coronary revascularization.
This study assessed the anatomical complexity during coronary revascularization and evaluated the effect of the PCSK9 inhibitor evolocumab on the risk of complex coronary revascularization procedures, compared to placebo using data of the FOURIER trial.
FOURIER was a randomized, placebo-controlled trial that enrolled 27,564 patients with stable atherosclerosis treated with high or moderate intensity statin-therapy, who were randomized to evolocumab or placebo. Revascularization events were blindly reviewed to investigate coronary anatomy and procedural characteristics. The primary endpoint was complex coronary revascularization, which was defined as coronary artery bypass-graft (CABG) surgery or complex percutaneous coronary intervention (PCI) according to the GLOBAL LEADERS definition of: 1) multivessel PCI, 2) ≥3 stents implanted, 3) ≥3 lesions treated, 4) bifurcation PCI with ≥2 stents, and 5) total stent length >60 mm. 296 Patients underwent CABG, 336 patients complex PCI and 1092 patients simple PCI. Median follow-up was 2.2 years.
- The angiographic characteristics of the coronary arteries of patients at the time of coronary revascularization were anatomically complex: 12% of patients had left main coronary artery (LMCA) stenosis ≥50%, 36% had proximal left anterior descending (LAD) artery stenosis >50%, 48% had multivessel disease, 19% had bypass graft stenosis ≥50%, 36% had chronic total occlusion (CTO), and 17% had in-stent restenosis (ISR) ≥50%.
- Evolocumab significantly reduced the risk of complex coronary revascularization (HR 0.71, 95% CI: 0.61-0.84, P<0.001), as well as CABG (HR 0.76, 95% CI: 0.60-0.96, P=0.0019), and complex PCI (HR 0.67, 95% CI: 0.54-0.84, P<0.001), compared to placebo.
- Evolocumab reduced all complex PCI components: 1) multivessel PCI (HR 0.67, 95% CI:0.51-0.87) , 2) ≥3 stents implanted (HR 0.70, 95% CI: 0.49-0.98), 3) ≥3 lesions treated (HR 0.59, 95% CI: 0.40-0.87), 4) bifurcation PCI with ≥2 stents (HR 0.55, 95% CI: 0.30-0.99), and 5) total stent length >60 mm(HR 0.70, 95% CI: 0.46-1.06).
- The relative risk reduction for complex revascularization in the evolocumab group, compared to placebo group, steadily increased over time: 20% in the first 12 months (HR 0.80, 95% CI: 0.64-0.99), 36% between 12- 24 months (HR 0.64, 95% CI: 0.49-0.84), and 41% after 24 months (HR 0.59, 95% CI: 0.37-0.96).
Evolocumab additionally given to statins in ASCVD patients significantly reduced the risk of developing complex coronary disease that needs revascularization.
- Our reporting is based on the information provided during AHA Scientific Sessions 2020 –