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Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. 2022
William F Fearon, and
Frederik M Zimmermann, and
Bernard De Bruyne, and
Zsolt Piroth, and
Albert H M van Straten, and
Laszlo Szekely, and
Giedrius Davidavičius, and
Gintaras Kalinauskas, and
Samer Mansour, and
Rajesh Kharbanda, and
Nikolaos Östlund-Papadogeorgos, and
Adel Aminian, and
Keith G Oldroyd, and
Nawwar Al-Attar, and
Nikola Jagic, and
Jan-Henk E Dambrink, and
Petr Kala, and
Oskar Angerås, and
Philip MacCarthy, and
Olaf Wendler, and
Filip Casselman, and
Nils Witt, and
Kreton Mavromatis, and
Steven E S Miner, and
Jaydeep Sarma, and
Thomas Engstrøm, and
Evald H Christiansen, and
Pim A L Tonino, and
Michael J Reardon, and
Di Lu, and
Victoria Y Ding, and
Yuhei Kobayashi, and
Mark A Hlatky, and
Kenneth W Mahaffey, and
Manisha Desai, and
Y Joseph Woo, and
Alan C Yeung, and
Nico H J Pijls, and
From the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute (W.F.F., M.A.H., A.C.Y.), the Quantitative Sciences Unit (D.L., V.Y.D., M.D.), and the Departments of Health Policy (M.A.H.) and Cardiothoracic Surgery (Y.J.W.), Stanford University, and the Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine (K.W.M.), Stanford, and the VA Palo Alto Health Care System, Palo Alto (W.F.F.) - all in California; Catharina Hospital, Eindhoven (F.M.Z., A.H.M.S., P.A.L.T., N.H.J.P.), and Isala Hospital, Zwolle (J.-H.E.D.) - both in the Netherlands; Cardiovascular Center Aalst, Aalst (B.D.B., F.C.), and Centre Hospitalier Universitaire de Charleroi, Charleroi (A.A.) - both in Belgium; Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.); Gottsegen National Cardiovascular Center, Budapest, Hungary (Z.P., L.S.); the Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Vilnius University, and Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania (G.D., G.K.); Centre Hospitalier de l'Université de Montréal, Montreal (S.M.), and Southlake Regional Health Centre, Newmarket, ON (S.E.S.M.) - both in Canada; Oxford University Hospitals NHS Foundation Trust, Oxford (R.K.), Golden Jubilee National Hospital, Glasgow (K.G.O., N.A.-A.), and Wythenshawe Hospital, Manchester (J.S.) - all in the United Kingdom; Danderyd University Hospital (N.Ö.-P.) and Karolinska Institutet (N.Ö.-P., N.W.), Solna, and Sahlgrenska University Hospital, Gothenburg (O.A.) - all in Sweden; Clinical Hospital Centre Zemun, University of Belgrade, Belgrade, Serbia (N.J.); Medical Faculty of Masaryk University and University Hospital Brno, Brno, Czech Republic (P.K.); Kings College Hospital, London (P.M., O.W.); the Atlanta VA Healthcare System, Decatur, GA (K.M.); Rigshospitalet, Copenhagen (T.E.), and Aarhus University Hospital, Aarhus (E.H.C.) - both in Denmark; Houston Methodist Hospital, Houston (M.J.R.); and Montefiore Medical Center, New York (Y.K.).
Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking. In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed. A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group. In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).
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