Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy

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; P interaction =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.