Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial.
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Fearon William F, Zimmermann Frederik M, Ding Victoria Y, Takahashi Kuniaki, Piroth Zsolt, van Straten Albert H M, Szekely Laszlo, Davidavičius 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, Angerås 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, Pijls Nico H J, De Bruyne Bernard
Аннотация
METHODS: FAME 3 was a multicentre, randomised trial comparing FFR-guided PCI using current-generation zotarolimus-eluting stents versus CABG in patients with three-vessel coronary artery disease not involving the left main coronary artery. 48 hospitals in Europe, USA and Canada, Australia, and Asia participated in the trial. Patients (aged ≥21 years with no cardiogenic shock, no recent ST segment elevation myocardial infarction, no severe left ventricular dysfunction, and no previous CABG) were randomly assigned to either PCI or CABG using a web-based system. At 1 year, FFR-guided PCI did not meet the prespecified threshold for non-inferiority for the outcome of death, stroke, myocardial infarction, or repeat revascularisation versus CABG. The primary endpoint for this intention-to-treat analysis was the 5-year incidence of the prespecified composite outcome of death, stroke, or myocardial infarction. The trial was registered at ClinicalTrials.gov, NCT02100722, and is completed; this is the final report.
FINDINGS: Between Aug 25, 2014 and Nov 28, 2019, 757 of 1500 participants were assigned to PCI and 743 to CABG. 5-year follow-up was achieved in 724 (96%) patients assigned to PCI and 696 (94%) assigned to CABG. At 5 years, there was no significant difference in the composite of death, stroke, or myocardial infarction between the two groups, with 119 (16%) events in the PCI group and 101 (14%) in the CABG group (hazard ratio 1·16 [95% CI 0·89-1·52]; p=0·27). There were no differences in the rates of death (53 [7%] vs 51 [7%]; 0·99 [0·67-1·46]) or stroke (14 [2%] vs 21 [3%], 0·65 [0·33-1·28]), but myocardial infarction was higher in the PCI group than in the CABG group (60 [8%] vs 38 [5%], 1·57 [1·04-2·36]), as was repeat revascularisation (112 [16%] vs 55 [8%], 2·02 [1·46-2·79]).
INTERPRETATION: At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients.
FUNDING: Medtronic and Abbott Vascular.