Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve–Guided Revascularization Strategy

Chee Hae Kim, Bon-Kwon Koo, Hakim-Moulay Dehbi, Joo Myung Lee, Joon-Hyung Doh, Chang-Wook Nam, Eun-Seok Shin, Christopher M. Cook, Rasha Al-Lamee, Ricardo Petraco, Sayan Sen, Iqbal S. Malik, Sukhjinder S. Nijjer, Hernán Mejía-Rentería, Eduardo Alegria-Barrero, Ali Alghamdi, John Altman, S. rgio B. Baptista, Ravinay Bhindi, Waldemar BojaraSalvatore Brugaletta, Pedro Canas Silva, Carlo di Mario, Andrejs Erglis, Robert T. Gerber, Olaf Going, Tobias Härle, Farrel Hellig, Ciro Indolfi, Luc Janssens, Allen Jeremias, Rajesh K. Kharbanda, Ahmed Khashaba, Yuetsu Kikuta, Florian Krackhardt, Mika Laine, Sam J. Lehman, Hitoshi Matsuo, Martijin Meuwissen, Giampaolo Niccoli, Jan J. Piek, Flavo Ribichini, Habib Samady, James Sapontis, Arnold H. Seto, Murat Sezer, Andrew S. P. Sharp, Jasvindar Singh, Hiroaki Takashima, Suneel Talwar, Nobuhiro Tanaka, Kare Tang, Eric van Belle, Niels van Royen, Hugo Vinhas, Christiaan J. Vrints, Darren Walters, Hiroyoshi Yokoi, Bruce Samuels, Christopher Buller, Manesh R. Patel, Patrick W. Serruys, Javier Escaned, Justin E. Davies

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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)
Original languageEnglish
Pages (from-to)2035-2046
JournalJACC: Cardiovascular Interventions
Volume12
Issue number20
DOIs
Publication statusPublished - 28 Oct 2019

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