Fractional Flow Reserve–Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial-Reference-Cited by-同舟云学术

Fractional Flow Reserve–Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial

Published:2023-09-19 Issue:12 Volume:148 Page:950-958
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Zimmermann Frederik M.¹,Ding Victoria Y.²^ORCID,Pijls Nico H.J.¹,Piroth Zsolt³^ORCID,van Straten Albert H.M.¹^ORCID,Szekely Laszlo³^ORCID,Davidavicius Giedrius⁴⁵,Kalinauskas Gintaras⁴⁵,Mansour Samer⁶,Kharbanda Rajesh⁷^ORCID,Östlund-Papadogeorgos Nikolaos⁸,Aminian Adel⁹^ORCID,Oldroyd Keith G.¹⁰^ORCID,Al-Attar Nawwar¹⁰,Jagic Nikola¹¹,Dambrink Jan-Henk E.¹²,Kala Petr¹³^ORCID,Angeras Oskar¹⁴,MacCarthy Philip¹⁵,Wendler Olaf¹⁵,Casselman Filip¹⁶^ORCID,Witt Nils¹⁷¹⁸,Mavromatis Kreton¹⁹²⁰^ORCID,Miner Steven E.S.²¹^ORCID,Sarma Jaydeep²²,Engstrøm Thomas²³,Christiansen Evald H.²⁴^ORCID,Tonino Pim A.L.¹,Reardon Michael J.²⁵^ORCID,Otsuki Hisao²⁶,Kobayashi Yuhei²⁷^ORCID,Hlatky Mark A.²⁸^ORCID,Mahaffey Kenneth W.²⁹^ORCID,Desai Manisha²^ORCID,Woo Y. Joseph³⁰^ORCID,Yeung Alan C.²⁶,De Bruyne Bernard¹⁶³¹^ORCID,Fearon William F.²⁶³²^ORCID,

Affiliation:

1. Catharina Hospital, Eindhoven, the Netherlands (F.M.Z., N.H.J.P., A.H.M.v.S., P.A.L.T.).

2. Quantitative Sciences Unit (V.Y.D., M.D.), Stanford University, CA.

3. Gottsegen National Cardiovascular Center, Hungary (Z.P., L.S.).

4. Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Vilnius University, Lithuania (G.D., G.K.).

5. Vilnius University Hospital Santaros Klinikos, Lithuania (G.D., G.K.).

6. Centre Hospitalier de l’Université de Montréal, Canada (S.M.).

7. Oxford University Hospital NHS Trust, UK (R.K.).

8. Danderyd University Hospital and Karolinska Institutet, Solna, Sweden (N.Ö.-P.).

9. Centre Hospitalier Universitaire de Charleroi, Belgium (A.A.).

10. Golden Jubilee National Hospital, Glasgow, UK (K.G.O., N.A.-A.).

11. Clinical Hospital Centre Zemun, University of Belgrade, Serbia (N.J.).

12. Isala Hospital, Zwolle, the Netherlands (J.-H.E.D.).

13. Medical Faculty of Masaryk University and University Hospital Brno, Czech Republic (P.K.).

14. Sahlgrenska University Hospital, Sweden (O.A.).

15. Kings College Hospital, London, UK (P.M., O.W.).

16. Cardiovascular Center Aalst, Belgium (F.C., B.D.).

17. Södersjukhuset Hospital, Stockholm, Sweden (N.W.).

18. Karolinska Institutet, Solna, Sweden (N.W.).

19. Atlanta VA Healthcare System, Decatur, GA (K.M.).

20. Emory University School of Medicine, Atlanta, GA (K.M.).

21. Southlake Regional Health Centre, Newmarket, Canada (S.E.S.M.).

22. Wythenshawe Hospital, Manchester, UK (J.S.).

23. Rigshospitalet, Copenhagen, Denmark (T.E.).

24. Aarhus University Hospital, Denmark (E.H.C.).

25. Houston Methodist Hospital, TX (M.J.R.).

26. Division of Cardiovascular Medicine and Stanford Cardiovascular Institute (H.O., A.C.Y., W.F.F.), Stanford University, CA.

27. New York Presbyterian Brooklyn Methodist and Weill Cornell Medical College (Y.K.).

28. Departments of Health Policy and Medicine (M.A.H.), Stanford University, CA.

29. Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (K.W.M.).

30. Department of Cardiothoracic Surgery (Y.J.W.), Stanford University, CA.

31. Lausanne University Centre Hospital, Switzerland (B.D.).

32. VA Palo Alto Health Care System, CA (W.F.F.).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference25 articles.

1. Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease

2. Strategies for Multivessel Revascularization in Patients with Diabetes

3. Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease

4. Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease

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