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Randomized Controlled Trial
. 2022 Jan 13;386(2):128-137.
doi: 10.1056/NEJMoa2112299. Epub 2021 Nov 4.

Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery

William F Fearon  1 , Frederik M Zimmermann  1 , Bernard De Bruyne  1 , Zsolt Piroth  1 , Albert H M van Straten  1 , Laszlo Szekely  1 , Giedrius Davidavičius  1 , Gintaras Kalinauskas  1 , Samer Mansour  1 , Rajesh Kharbanda  1 , Nikolaos Östlund-Papadogeorgos  1 , Adel Aminian  1 , Keith G Oldroyd  1 , Nawwar Al-Attar  1 , Nikola Jagic  1 , Jan-Henk E Dambrink  1 , Petr Kala  1 , Oskar Angerås  1 , Philip MacCarthy  1 , Olaf Wendler  1 , Filip Casselman  1 , Nils Witt  1 , Kreton Mavromatis  1 , Steven E S Miner  1 , Jaydeep Sarma  1 , Thomas Engstrøm  1 , Evald H Christiansen  1 , Pim A L Tonino  1 , Michael J Reardon  1 , Di Lu  1 , Victoria Y Ding  1 , Yuhei Kobayashi  1 , Mark A Hlatky  1 , Kenneth W Mahaffey  1 , Manisha Desai  1 , Y Joseph Woo  1 , Alan C Yeung  1 , Nico H J Pijls  1 ; FAME 3 Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery

William F Fearon et al. N Engl J Med. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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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