Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.
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Zimmermann Frederik M, Ding Victoria Y, Pijls Nico H J, Piroth Zsolt, van Straten Albert H M, Szekely Laszlo, Davidavicius Giedrius, Kalinauskas Gintaras, Mansour Samer, Kharbanda Rajesh, Östlund-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, Engstrøm Thomas, Christiansen Evald H, Tonino Pim A L, Reardon Michael J, Otsuki Hisao, Kobayashi Yuhei, Hlatky Mark A, Mahaffey Kenneth W, Desai Manisha, Woo Y Joseph, Yeung Alan C, De Bruyne Bernard, Fearon William F, FAME 3 Investigators
Аннотация
METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke.
RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02).
CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifier: NCT02100722.