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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
WF. Fearon, FM. Zimmermann, VY. Ding, K. Takahashi, Z. Piroth, AHM. van Straten, L. Szekely, G. Davidavičius, G. Kalinauskas, S. Mansour, R. Kharbanda, N. Östlund-Papadogeorgos, A. Aminian, KG. Oldroyd, N. Al-Attar, N. Jagic, JE. Dambrink, P....
Language English Country England, Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Comparative Study, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Fractional Flow Reserve, Myocardial * MeSH
- Myocardial Infarction epidemiology MeSH
- Coronary Angiography MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Coronary Artery Bypass * methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Coronary Artery Disease * surgery mortality MeSH
- Aged MeSH
- Sirolimus analogs & derivatives administration & dosage MeSH
- Drug-Eluting Stents MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
BACKGROUND: Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years. 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.
Aarhus University Hospital Aarhus Denmark
Atlanta VA Healthcare System Decatur GA USA
Cardiovascular Center Aalst Aalst Belgium
Catharina Hospital Eindhoven Netherlands
Centre Hospitalier de l'Université de Montréal Montreal QC Canada
Centre Hospitalier Universitaire de Charleroi Charleroi Belgium
Cleveland Clinic London London UK
Clinical Hospital Centre Zemun University of Belgrade Belgrade Serbia
Danderyd University Hospital and Karolinska Institutet Solna Sweden
Department of Cardiothoracic Surgery Stanford University Stanford CA USA
Department of Health Policy Stanford University Stanford CA USA
Department of Medicine Stanford University Stanford CA USA
Emory University School of Medicine Atlanta GA USA
Golden Jubilee National Hospital Glasgow UK
Gottsegen National Cardiovascular Center Budapest Hungary
Houston Methodist Hospital Houston TX USA
Isala Hospital Zwolle Netherlands
Karolinska Institutet Solna Sweden
Kings College Hospital London UK
Lausanne University Centre Hospital Lausanne Switzerland
Medical Faculty of Masaryk University Brno Czech Republic
NY Presbyterian Brooklyn Methodist Hospital New York NY USA
Oxford University Hospital NHS Trust Oxford UK
Quantitative Sciences Unit Stanford University Stanford CA USA
Rigshospitalet Copenhagen Denmark
Sahlgrenska University Hospital Gothenburg Sweden
Södersjukhuset Hospital Stockholm Sweden
Southlake Regional Health Centre Newmarket ON Canada
St Antonius Hospital Nieuwegein Netherlands
Stanford Cardiovascular Institute Stanford University Stanford CA USA
Stanford Center for Clinical Research Department of Medicine Stanford University Stanford CA USA
University Hospital Brno Brno Czech Republic
VA Palo Alto Health Care System Palo Alto CA USA
Vilnius University Hospital Santaros Klinikos Vilnius Lithuania
References provided by Crossref.org
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