Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.
(Journal Article;Multicenter Study)
OBJECTIVES: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies. BACKGROUND: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. METHODS: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. RESULTS: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). CONCLUSIONS: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).
Kim, CH; Koo, B-K; Dehbi, H-M; Lee, JM; Doh, J-H; Nam, C-W; Shin, E-S; Cook, CM; Al-Lamee, R; Petraco, R; Sen, S; Malik, IS; Nijjer, SS; Mejía-Rentería, H; Alegria-Barrero, E; Alghamdi, A; Altman, J; Baptista, SB; Bhindi, R; Bojara, W; Brugaletta, S; Silva, PC; Di Mario, C; Erglis, A; Gerber, RT; Going, O; Härle, T; Hellig, F; Indolfi, C; Janssens, L; Jeremias, A; Kharbanda, RK; Khashaba, A; Kikuta, Y; Krackhardt, F; Laine, M; Lehman, SJ; Matsuo, H; Meuwissen, M; Niccoli, G; Piek, JJ; Ribichini, F; Samady, H; Sapontis, J; Seto, AH; Sezer, M; Sharp, ASP; Singh, J; Takashima, H; Talwar, S; Tanaka, N; Tang, K; Van Belle, E; van Royen, N; Vinhas, H; Vrints, CJ; Walters, D; Yokoi, H; Samuels, B; Buller, C; Patel, MR; Serruys, PW; Escaned, J; Davies, JE
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