Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial

Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.

This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.

The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.

Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; P_interaction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; P_interaction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; P_interaction = 0.071).

In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).