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

Kuniaki Takahashi; Hisao Otsuki; Frederik M Zimmermann; Victoria Y Ding; Keith G Oldroyd; Olaf Wendler; Michael J Reardon; Y Joseph Woo; Alan C Yeung; Nico H J Pijls; Bernard De Bruyne; William F Fearon; FAME 3 Trial Investigators

doi:10.1016/j.jcin.2024.09.030

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

JACC Cardiovasc Interv. 2024 Nov 11:S1936-8798(24)01217-2. doi: 10.1016/j.jcin.2024.09.030. Online ahead of print.

Affiliations

¹ Stanford University School of Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford, California, USA.
² Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands; St. Antonius Hospital, Nieuwegein, The Netherlands.
³ Golden Jubilee National Hospital, Glasgow, United Kingdom.
⁴ Cleveland Clinic London, London, United Kingdom.
⁵ Houston Methodist Debakey Heart & Vascular Center, Houston, Texas, USA.
⁶ Department of Cardiothoracic Surgery, Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford, California, USA.
⁷ Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
⁸ Cardiovascular Center Aalst, Belgium.
⁹ Stanford University School of Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford, California, USA; VA Palo Alto Medical Systems, Palo Alto, California, USA. Electronic address: wfearon@stanford.edu.

PMID: 39641725
DOI: 10.1016/j.jcin.2024.09.030

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; 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).

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).

Keywords: coronary artery bypass grafting; fractional flow reserve; percutaneous coronary intervention; three-vessel coronary artery disease.

Associated data

ClinicalTrials.gov/NCT02100722