Outcomes After CABG Compared With FFR-Guided PCI in Patients Presenting With Acute Coronary Syndrome.
Background: There are limited data comparing coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in patients presenting with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Objective: The aim of this study was to evaluate differences in outcomes in patients presenting with or without NSTE-ACS after CABG compared with fractional flow reserve (FFR)-guided PCI using current generation drug-eluting stents.
Methods: The FAME 3 trial (Fractional flow reserve versus Angiography for Multivessel Evaluation; NCT02100722) was an investigator-initiated, randomized controlled trial to attest noninferiority of FFR-guided PCI using the current-generation drug-eluting stents to CABG with respect to the primary endpoint, defined as a composite of death, myocardial infarction (MI), stroke, or repeat revascularization at 1 year, in 1,500 patients with 3-vessel coronary artery disease. The prespecified key secondary endpoint was a composite of death, MI, or stroke at 3 years.
Results: Of 1,500 patients enrolled, 587 (39.2%) presented with NSTE-ACS. Patients were followed up for a median of 1,080 days (Q1-Q3: 1,080-1,080 days). At 3 years, the risk of the composite of death, MI, or stroke was similar between patients presenting with NSTE-ACS and with chronic coronary syndrome (CCS) (11.8% vs 10.0%; adjusted HR [aHR]: 1.20; 95% CI: 0.81-1.77; P = 0.37). Patients presenting with NSTE-ACS had a similar risk of death, MI, or stroke at 3 years after CABG as compared with PCI (aHR: 0.98; 95% CI: 0.60-1.60; P = 0.94), whereas patients presenting with CCS had a significantly reduced risk after CABG compared with PCI (aHR: 0.58; 95% CI: 0.38-0.90; P = 0.02; Pinteraction = 0.11), which was driven by a lower risk of MI (aHR: 0.32; 95% CI: 0.15-0.64; P = 0.002; Pinteraction = 0.01).
Conclusions: The risk of death, MI, or stroke at 3 years was similar after CABG compared with FFR-guided PCI in patients presenting with NSTE-ACS, but reduced by CABG in patients presenting with CCS. (Fractional flow reserve versus Angiography for Multivessel Evaluation [FAME 3]; NCT02100722).