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

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Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3Trial. JACC. Cardiovascular interventions Takahashi, K., Otsuki, H., Zimmermann, F. M., Ding, V. Y., Oldroyd, K. G., Wendler, O., Reardon, M. J., Woo, Y. J., Yeung, A. C., Pijls, N. H., De Bruyne, B., Fearon, W. F., FAME 3 Trial Investigators 2024

Abstract

BACKGROUND: 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.OBJECTIVES: This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.METHODS: The FAME 3 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.RESULTS: 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; Pinteraction=0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95%CI: 1.26-3.56; Pinteraction=0.102) and repeat revascularization (adjusted HR: 2.26; 95%CI: 1.47-3.47; Pinteraction=0.071).CONCLUSIONS: 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).

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