The impact of sex differences on fractional flow reserve-guided percutaneous coronary intervention: a FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) substudy.

Objectives: This study sought to evaluate the impact of sex differences on fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI).

Background: The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study demonstrated that FFR-guided PCI improves outcomes compared with an angiography-guided strategy. The role of FFR-guided PCI in women versus men has not been evaluated.

Methods: We analyzed 2-year data from the FAME study in the 744 men and 261 women with multivessel coronary disease, who were randomized to angiography- or FFR-guided PCI. Statistical comparisons based on sex were stratified by treatment method.

Results: Although women were older and had significantly higher rates of hypertension than men did, there were no differences in the rates of major adverse cardiac events (20.3% vs. 20.2%, p = 0.923) and its individual components at 2 years. FFR values were significantly higher in women than in men (0.75 ± 0.18 vs. 0.71 ± 0.17, p = 0.001). The proportion of functionally significant lesions (FFR ≤ 0.80) was lower in women than in men for lesions with 50% to 70% stenosis (21.1% vs. 39.5%, p < 0.001) and for lesions with 70% to 90% stenosis (71.9% vs. 82.0%, p = 0.019). An FFR-guided strategy resulted in similar relative risk reductions for death, myocardial infarction, and repeat revascularization in men and in women. There were no interactions between sex and treatment method for any outcome variables.

Conclusions: In comparison with men, angiographic lesions of similar severity are less likely to be ischemia-producing in women. An FFR-guided PCI strategy is equally beneficial in women as it is in men.