TY - JOUR
T1 - Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial
AU - Takahashi, Kuniaki
AU - Otsuki, Hisao
AU - Zimmermann, Frederik M.
AU - Ding, Victoria Y.
AU - Oldroyd, Keith G.
AU - Wendler, Olaf
AU - Reardon, Michael J.
AU - Woo, Y. Joseph
AU - Yeung, Alan C.
AU - Pijls, Nico H.J.
AU - De Bruyne, Bernard
AU - Fearon, William F.
N1 - Publisher Copyright:
© 2025 American College of Cardiology Foundation
PY - 2025/1/27
Y1 - 2025/1/27
N2 - 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 (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. 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.
AB - 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 (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. 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.
KW - coronary artery bypass grafting
KW - fractional flow reserve
KW - percutaneous coronary intervention
KW - three-vessel coronary artery disease
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U2 - 10.1016/j.jcin.2024.09.030
DO - 10.1016/j.jcin.2024.09.030
M3 - Article
C2 - 39641725
AN - SCOPUS:85213540653
SN - 1936-8798
VL - 18
SP - 157
EP - 167
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 2
ER -