Physiology vs angiography-guided percutaneous coronary intervention in transcatheter aortic valve implantation: the FAITAVI trial
Flavio Ribichini, Roberto Scarsini, Gabriele Pesarini, Tommaso Fabris, Marco Barbierato, Gianpiero D’Amico, Chiara Zanchettin, Darío Gregori, Giulia Lorenzoni, Tommaso Piva, Elisa Nicolini, Caterina Gandolfo, Ketty La Spina, Massimo Fineschi, Francesco Gallo, Bernardo Baccani, Anna Sonia Petronio, Marco De Carlo, Sergio Berti, Andrea Drago, Francesco Saia, Rocco Sclafani, Giovanni Esposito, Fabrizio D’Ascenzo, Giuseppe Tarantini, for the FAITAVI Trial investigators, Flavio Ribichini, Gabriele Pesarini, Michele Pighi, Roberto Scarsini, Mattia Lunardi, Simone Fezzi, Paolo Alberto Del Sole, Luigi Iossa, Concetta Mammone, Francesca Rubino, Federico Vigo, J Rojas, Giovanni Esposito, Anna Franzone, Domenico Simone Castiello, Fabrizio D’Ascenzo, Francesco Bruno, Federico Conrotto, Giuseppe Tarantini, Tommaso Fabris, Massimo Napodano, Luca Nai Fovino, Chiara Fraccaro, Giulia Masiero, Chiara Zanchettin, Francesco Bedogni, Francesco Caprioglio, Andrea Drago, Ester Cabianca, Tommaso Piva, Elisa Nicolini, Massimo Fineschi, Bernardo Bccani, Marco Barbierato, Gianpiero D’Amico, Francesco Saia, Mateusz Orzałkiewicz, Sergio Berti, Rocco Sclafani, Claudio Cavallini, Caterina Gandolfo, Ketty La Spina, Anna Sonia Petronio, Marco De Carlo, Carlo Di Mario
Abstract
BACKGROUND AND AIMS: The optimal approach to coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI) remains debated. Fractional flow reserve (FFR) may improve the identification of ischaemia-producing lesions compared to angiographic assessment alone, but data in the TAVI population are lacking. METHODS: In this multicentric, open-label, randomized, superiority trial with blind adjudication of adverse events, patients with aortic stenosis and intermediate coronary lesions undergoing TAVI were randomized 1:1 to FFR-guided or angiography-guided percutaneous coronary intervention (PCI). The trial was registered at ClinicalTrials.gov (NCT03360591). All randomized patients were included in the primary analysis according to the intention-to-treat principle. The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE) at 12 months of follow-up, defined as a composite of all-cause death, myocardial infarction, ischaemia-driven target vessel revascularization, disabling stroke, or major bleeding. RESULTS: A total of 320 patients were enrolled across 15 Italian centres. The median age of the patients was 86 years [interquartile range (IQR) 83-90], and the median STS score was 3% (IQR 2-5). The median SYNTAX score was 7 (IQR 5-11). FFR-guided PCI was associated with a significantly lower rate of MACCE at 12 months compared with angiography-guided PCI (8.5% vs 16.0%; hazard ratio .52; 95% confidence interval .27-.99; P = .047). The difference in the primary endpoint was primarily driven by a reduction in all-cause mortality (hazard ratio .31; 95% confidence interval .10-.96). Other components of the composite were numerically lower but not statistically significant. CONCLUSIONS: In patients undergoing TAVI with intermediate coronary lesions, FFR-guided PCI was associated with a reduced risk of MACCE at 12 months. These findings support a physiology-based revascularization strategy in this frail, elderly population.