Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy
Language English Country United States Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Multicenter Study, Comparative Study
- Keywords
- cardiovascular surgery, chronic total occlusion, fractional flow reserve, percutaneous coronary intervention, three-vessel coronary artery disease,
- MeSH
- Time Factors MeSH
- Chronic Disease MeSH
- Fractional Flow Reserve, Myocardial * MeSH
- Coronary Angiography * MeSH
- Percutaneous Coronary Intervention * adverse effects mortality MeSH
- Coronary Artery Bypass * adverse effects mortality MeSH
- Coronary Occlusion * diagnostic imaging mortality therapy physiopathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Coronary Artery Disease therapy mortality diagnostic imaging physiopathology MeSH
- Predictive Value of Tests MeSH
- Risk Factors MeSH
- Aged 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
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
BACKGROUND: The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear. METHODS: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO. RESULTS: Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; P=0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; P=0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; P<0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; P=0.56; Pinteraction=0.31). CONCLUSIONS: The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.
Atlanta VA Healthcare System Decatur GA
Cardiovascular Center Aalst Belgium
Cardiovascular Medicine and Stanford Cardiovascular Institute Stanford University CA
Catharina Hospital Eindhoven the Netherlands
Cedars Sinai Medical Center Los Angeles CA
Centre Hospitalier Universitaire de Charleroi Belgium
Clinical Hospital Centre Zemun University of Belgrade Serbia
Department of Cardiothoracic Surgery and Stanford Cardiovascular Institute Stanford University CA
Emory University School of Medicine Atlanta GA
Isala Hospital Zwolle the Netherlands
King's College Hospital London United Kingdom
New York Presbyterian Brooklyn Methodist Hospital Weill Cornell Medical College Brooklyn
St Antonius Hospital Nieuwegein the Netherlands
University Hospital Brno and Masaryk University Brno Bruno Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT02100722
