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Sex Differences in FFR-Guided PCI vs. CABG in the FAME 3 Trial
Quick Takes
- Compared with men, women had similar outcomes at 3 years through FFR guidance after PCI, whereas they had a higher adjusted risk of MACCE at 3 years compared to men.
- Women had similar outcomes after FFR-guided PCI compared to CABG.
- Men had better outcomes with CABG compared with PCI, although the interaction term did not show statistical significance.
- For PCI, women had a similar risk of MACCE at 3 years compared with men.
Study Questions:
Do outcomes differ by sex after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG)?
Methods:
Data from FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3), an investigator-initiated, multicenter, randomized controlled trial, were used for the present analysis. This trial compared FFR-guided PCI with current-generation DES versus CABG among patients with three-vessel coronary artery disease (CAD) (≥50% diameter stenosis based on visual estimation) and deemed amenable to both FFR-guided PCI and CABG through clinical judgment. Patients with involvement of the left main coronary artery were not included. 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 (MI), stroke, or repeat revascularization at 3 years.
Results:
A total of 1,500 patients were randomized to either FFR-guided PCI (n = 757) or to CABG (n = 743), of which 17.7% (n = 265) were women. Women participants were older and more likely to have hypertension and a family history of CAD, while men were more likely to be smokers. Women had fewer lesions and less complex CAD (via anatomical SYNTAX score) compared to men. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs. 11.7%; adjusted hazard ratio [aHR], 2.07; 95% confidence interval [CI], 1.19-3.60). For PCI, women had a similar risk of MACCE at 3 years compared with men (18.2% vs. 19.1%; aHR, 1.27; 95% CI, 0.79-2.03). Women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (aHR, 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 (aHR, 1.68; 95% CI, 1.25-2.25; p for interaction = 0.142), which was mainly driven by a higher risk of MI (aHR, 2.11; 95% CI, 1.26-3.56; p for interaction = 0.102) and repeat revascularization (aHR, 2.26; 95% CI, 1.47-3.47; p for interaction = 0.071).
Conclusions:
The authors conclude that in the FAME 3 trial, at 3 years, women have similar outcomes with FFR-guided PCI compared with CABG, whereas men have improved outcomes with CABG.
Perspective:
These data may assist clinicians in revascularization management of CAD (i.e., PCI vs. CABG); however, it should be noted that the number of women included was relatively small and the study population was predominantly White race. Furthermore, as noted by the investigators, longer-term outcomes may assist in more nuanced understanding of gender differences in revascularization management.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery
Keywords: Coronary Artery Bypass, Fractional Flow Reserve, Myocardial, Percutaneous Coronary Intervention, Sex Factors
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