Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio
Authors: Javier Escaned, Alejandro Travieso, Hakim-Moulay Dehbi, Sukhjinder S. Nijjer, Sayan Sen, Ricardo Petraco, Manesh Patel, Patrick W. Serruys, Justin Davies, Justin E Davies, Sayan Sen, Hakim-Moulay Dehbi, Rasha Al-Lamee, Ricardo Petraco, Sukhjinder S Nijjer, Ravinay Bhindi, Sam J Lehman, Darren Walters, James Sapontis, Luc Janssens, Christiaan J Vrints, Ahmed Khashaba, Mika Laine, Eric Van Belle, Florian Krackhardt, Waldemar Bojara, Olaf Going, Tobias Härle, Ciro Indolfi, Giampaolo Niccoli, Flavio Ribichini, Nobuhiro Tanaka, Hiroyoshi Yokoi, Hiroaki Takashima, Yuetsu Kikuta, Andrejs Erglis, Hugo Vinhas, Pedro Canas Silva, Sérgio B Baptista, Ali Alghamdi, Farrel Hellig, Bon-Kwon Koo, Chang-Wook Nam, Eun-Seok Shin, Joon-Hyung Doh, Salvatore Brugaletta, Eduardo Alegria-Barrero, Martijin Meuwissen, Jan J Piek, Niels van Royen, Murat Sezer, Carlo Di Mario, Robert T Gerber, Iqbal S Malik, Andrew S P Sharp, Suneel Talwar, Kare Tang, Habib Samady, John Altman, Arnold H Seto, Jasvindar Singh, Allen Jeremias, Hitoshi Matsuo, Rajesh K. Kharbanda, Manesh R. Patel, Patrick W Serruys, Alejandro Travieso, Javier Escaned
Journal: JAMA Cardiology (2024)

Importance The differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown. Objective To compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization. Design, Setting, and Participants The DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021. MAIN OUTCOME MEASURES Five-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point. Results At 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio [HR], 1.18; 95% CI, 0.99-1.42; P = .06). While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87). Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01). Conclusions and relevance At 5-year follow up, an iFR based–strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization. Trial Registration ClinicalTrials.gov Identifier: NCT02053038