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

• Authors: FEARON William F; ZIMMERMANN Frederik M; BERNARD De Bruyne; PIROTH Zsolt; VAN STRATEN ALBERT H M.; SZEKELY Laszlo; DAVIDAVICIUS Giedrius; KALINAUSKAS Gintaras; MANSOUR Samer; KHARBANDA Rajesh; OSTLUND-PAPADOGEORGOS Nikolaos; AMINIAN Adel; OLDROYD Keith G; AL-ATTAR Nawwar; JAGIC Nikola; DAMBRINK Jan-Henk E; KALA Petr; ANGERAS Oskar; MACCARTHY Philip; WENDLER Olaf; CASSELMAN Filip; WITT Nils; MAVROMATIS Kreton; MINER Steven E S; SARMA Jaydeep; ENGSTROM Thomas; CHRISTIANSEN Evald H; TONINO Pim A L; REARDON Michael J; LU Di; DING Victoria Y; KOBAYASHI Yuhei; HLATKY Mark A; MAHAFFEY Kenneth W; DESAI Manisha; WOO Y Joseph; YEUNG Alan C; PIJLS Nico H J
• Year of publication: 2022
• Type: Article in Periodical
• Magazine / Source: New England Journal of Medicine
• MU Faculty or unit: Faculty of Medicine
• web: https://www.nejm.org/doi/10.1056/NEJMoa2112299
• Doi: http://dx.doi.org/10.1056/NEJMoa2112299
• Keywords: Fractional Flow Reserve-Guided PCI; Coronary Bypass Surgery
• Description: 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.