Clinical question: How does fractional flow reserve (FFR)-guided percutaneous intervention (PCI) with second-generation drug-eluting stents compare with coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease (CAD)?
Background: Randomized trials show that CABG improves outcomes when compared to PCI in patients with three-vessel CAD. However, these studies rarely used second-generation drug-eluting stents or FFR-guided PCI. Second-generation stents and FFR-guided PCI both improve cardiovascular outcomes compared with angiography-guided PCI or medical therapy.
Study design: Multi-center, international, randomized, controlled trial using intention-to-treat analysis.
Setting: International multi-center trial with 48 sites.
Synopsis: 1,500 patients with angiographically identified three-vessel CAD not involving left main disease were randomly assigned to undergo CABG or FFR-guided PCI. Only stenoses with an FFR of 0.80 or less were treated with PCI. Patients with recent ST-elevation myocardial infarction, cardiogenic shock, and an ejection fraction less than 30% were excluded. The primary composite endpoint was the occurrence of death from any cause, myocardial infarction, stroke, or repeat revascularization within one year.
At one year, the composite primary endpoint occurred in 10.6% versus 6.9% (hazard ratio, 1.5; 95% CI, 1.1-2.2; P=0.35) in the FFR-guided PCI group versus the group who underwent CAGB. This did not meet the prespecified cutoff for non-inferiority.
Bottom line: CABG resulted in a lower incidence of the composite of death, myocardial infarction, stroke, and repeat revascularization at one year compared to FFR-guided PCI in patients with three-vessel CAD.
Citation: Fearon WF, et al. Fractional flow reserve-guided PCI as compared with coronary bypass surgery. N Engl J Med. 2022 Jan 12;386(2):128-137. doi: 10.1056/NEJMoa2112299.
Dr. Cunningham is a hospitalist at Denver Health, Denver, and an assistant professor in the division of internal medicine, at the University of Colorado School of Medicine.