TY - JOUR
T1 - Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease
T2 - 3-Year Follow-Up of the FAME 3 Trial
AU - Zimmermann, Frederik M.
AU - Ding, Victoria Y.
AU - Pijls, Nico H.J.
AU - Piroth, Zsolt
AU - Van Straten, Albert H.M.
AU - Szekely, Laszlo
AU - Davidavicius, 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 - Dambrink, Jan Henk E.
AU - Kala, Petr
AU - Angeras, 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 - Otsuki, Hisao
AU - Kobayashi, Yuhei
AU - Hlatky, Mark A.
AU - Mahaffey, Kenneth W.
AU - Desai, Manisha
AU - Woo, Y. Joseph
AU - Yeung, Alan C.
AU - De Bruyne, Bernard
AU - Fearon, William F.
N1 - Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/9/19
Y1 - 2023/9/19
N2 - BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. 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.
AB - BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. 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.
KW - coronary artery bypass
KW - drug-eluting stents
KW - percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85171806560&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85171806560&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.123.065770
DO - 10.1161/CIRCULATIONAHA.123.065770
M3 - Article
C2 - 37602376
AN - SCOPUS:85171806560
SN - 0009-7322
VL - 148
SP - 950
EP - 958
JO - Circulation
JF - Circulation
IS - 12
ER -