WOMEN undergoing fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents (DES) had similar three-year outcomes compared with coronary artery bypass grafting (CABG), while men had better outcomes with CABG.
The FAME 3 trial investigated sex-based differences in clinical outcomes for patients with three-vessel coronary artery disease undergoing either FFR-guided PCI or CABG. Understanding these differences is essential for improving treatment strategies and personalising clinical decision-making. This prespecified subgroup analysis aimed to assess whether men and women experienced different risks of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, myocardial infarction, stroke, or repeat revascularization, at three years.
A total of 1,500 patients were enrolled in the trial, of whom 265 (17.7%) were women. The analysis revealed that women had a significantly higher risk of MACCE at three years following CABG compared with men (18.1% vs 11.7%; adjusted hazard ratio [HR]: 2.07; 95% confidence interval [CI]: 1.19-3.60). However, the risk of MACCE for women undergoing PCI was similar to that of men (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). When comparing PCI with CABG, women had similar MACCE rates at three years (adjusted HR: 1.15; 95% CI: 0.62-2.11), whereas men experienced a higher MACCE risk with PCI than with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25). This difference was largely due to an increased risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47) among men undergoing PCI.
These findings suggest that CABG remains the superior option for men with three-vessel disease, while for women, FFR-guided PCI may be a viable alternative to surgery. Given the observed differences in outcomes, a tailored approach to revascularization should be considered, incorporating both clinical and patient-specific factors. Future research should explore underlying biological and procedural factors contributing to these sex-based disparities, ensuring optimal, evidence-based treatment strategies for both men and women in clinical practice.
Katrina Thornber, EMJ
Reference
Takahashi K et al. Sex differences in patients undergoing FFR-guided PCI or CABG in the FAME 3 trial. Cardiovascular Interventions. 2025;18(2):157-67.