TY - JOUR

T1 - Fractional flow reserve–guided PCI as compared with coronary bypass surgery

AU - Fearon, William F.

AU - Zimmermann, Frederik M.

AU - de Bruyne, Bernard

AU - Piroth, Zsolt

AU - van Straten, Albert H.M.

AU - Szekely, Laszlo

AU - Davidavičius, Giedrius

AU - Kalinauskas, Gintaras

AU - Mansour, Samer

AU - Kharbanda, Rajesh

AU - Östlund-Papadogeorgos, Nikolaos

AU - Aminian, Adel

AU - Oldroyd, Keith G.

AU - Al-Attar, Nawwar

AU - Jagic, Nikola

AU - Jan-Henk, E. Dambrink

AU - Kala, Petr

AU - Angerås, Oskar

AU - MacCarthy, Philip

AU - Wendler, Olaf

AU - Casselman, Filip

AU - Witt, Nils

AU - Mavromatis, Kreton

AU - Miner, Steven E.S.

AU - Sarma, Jaydeep

AU - Engstrøm, Thomas

AU - Christiansen, Evald H.

AU - Tonino, Pim A.L.

AU - Reardon, Michael J.

AU - Lu, Di

AU - Ding, Victoria Y.

AU - Kobayashi, Yuhei

AU - Hlatky, Mark A.

AU - Mahaffey, Kenneth W.

AU - Desai, Manisha

AU - Woo, Y. Joseph

AU - Yeung, Alan C.

AU - Pijls, Nico H.J.

AU - for the FAME 3 Investigators

N1 - Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.

PY - 2022

Y1 - 2022

N2 - 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 byMedtronicandAbbottVascular;FAME3ClinicalTrials.govnumber,NCT02100722.)

AB - 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 byMedtronicandAbbottVascular;FAME3ClinicalTrials.govnumber,NCT02100722.)

U2 - 10.1056/NEJMoa2112299

DO - 10.1056/NEJMoa2112299

M3 - Journal article

C2 - 34735046

AN - SCOPUS:85120324234

VL - 386

SP - 128

EP - 137

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 2

ER -