Key result
Fractional flow reserve-guided PCI failed to demonstrate non-inferiority compared with CABG with respect to hard cardiovascular outcomes at 1-year follow-up in patients with three-vessel CAD.
Why the study?
Does FFR-guided PCI reduce hard cardiovascular outcomes compared to CABG in patients with three-vessel CAD?
Does FFR-guided PCI reduce hard cardiovascular outcomes compared to CABG in patients with three-vessel CAD?
This commentary highlights that FFR-guided PCI failed to show non-inferiority to CABG for hard cardiovascular outcomes in patients with three-vessel CAD.
This comment refers to ‘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’, published in The Lancet, https://doi.org/10.1016/S0140-6736(25)00505-7. Prior seminal randomized controlled trials (RCTs) have demonstrated that myocardial revascularization with coronary artery bypass grafting (CABG) is associated with a prognostic advantage compared with percutaneous coronary intervention (PCI) in patients with three-vessel coronary artery disease (CAD), particularly in patients with higher disease burden and lesion complexity, and in the presence of diabetes.3 However, these studies were based on angiographic guidance only, and were conducted using revascularization techniques and materials that are no longer contemporary. Yet, PCI has demonstrated non-inferiority to surgery in patients with low anatomical complexity (SYNTAX score < 22).4 Based on the available evidence that a PCI strategy guided by functional assessment with fractional flow reserve (FFR) is associated with better clinical outcomes as compared with an angiography-guided PCI strategy, the FAME 3 trial tested the hypothesis that FFR-guided PCI might be non-inferior to CABG with respect to hard cardiovascular outcomes in patients with three-vessel CAD.1 At 1-year follow-up, the FAME 3 trial failed to demonstrate the non-inferiority of FFR-guided PCI compared with CABG.1
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Leone et al. (2025) conducted an editorial in Three-vessel coronary artery disease. Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) vs. Coronary artery bypass grafting (CABG) was evaluated on Hard cardiovascular outcomes. Fractional flow reserve-guided PCI failed to demonstrate non-inferiority compared with CABG with respect to hard cardiovascular outcomes at 1-year follow-up in patients with three-vessel CAD.
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