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.

Aarhus University Hospital Denmark

Atlanta VA Healthcare System Decatur GA

Cardiovascular Center Aalst Belgium

Catharina Hospital Eindhoven the Netherlands

Centre Hospitalier de l'Université de Montréal Canada

Centre Hospitalier Universitaire de Charleroi Belgium

Clinic of Cardiac and Vascular Diseases Institute of Clinical Medicine Vilnius University Lithuania

Clinical Hospital Centre Zemun University of Belgrade Serbia

Danderyd University Hospital and Karolinska Institutet Solna Sweden

Department of Cardiothoracic Surgery Stanford University CA

Departments of Health Policy and Medicine Stanford University CA

Division of Cardiovascular Medicine and Stanford Cardiovascular Institute Stanford University CA

Emory University School of Medicine Atlanta GA

Golden Jubilee National Hospital Glasgow UK

Gottsegen National Cardiovascular Center Hungary

Houston Methodist Hospital TX

Isala Hospital Zwolle the Netherlands

Karolinska Institutet Solna Sweden

Kings College Hospital London UK

Lausanne University Centre Hospital Switzerland

Medical Faculty of Masaryk University and University Hospital Brno Czech Republic

New York Presbyterian Brooklyn Methodist and Weill Cornell Medical College

Oxford University Hospital NHS Trust UK

Quantitative Sciences Unit Stanford University CA

Rigshospitalet Copenhagen Denmark

Sahlgrenska University Hospital Sweden

Södersjukhuset Hospital Stockholm Sweden

Southlake Regional Health Centre Newmarket Canada

Stanford Center for Clinical Research Department of Medicine Stanford University School of Medicine CA

VA Palo Alto Health Care System CA

Vilnius University Hospital Santaros Klinikos Lithuania

Wythenshawe Hospital Manchester UK

Circulation. 2024 Mar 12;149(11):894-895. doi: 10.1161/CIRCULATIONAHA.123.067446. PubMed

Circulation. 2024 Mar 12;149(11):892-893. doi: 10.1161/CIRCULATIONAHA.123.066934. PubMed

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ClinicalTrials.gov
NCT02100722