6/28/23, 10:34 PM FAME 3 Pathway Feedback Search Clinical Topics Home Studies FAME 3 FAME 3 Disease Coronary artery disease Trial question Is fractional flow reserve guided PCI noninferior to CABG in patients with three-vessel coronary artery disease? Study design Multi-center Open label RCT Population Characteristics of study participants 18.0% female N = 1500 82.0% male 1500 patients (270 female, 1230 male) Inclusion criteria: patients with three-vessel coronary artery disease Key exclusion criteria: cardiogenic shock; STEMI within 5 days; LVEF < 30%; life expectancy < 2 years; previous CABG Interventions N=757 PCI (fractional flow reserve guided PCI with current-generation zotarolimus-eluting stents) N=743 CABG (surgery performed as per standard practice with complete arterial revascularization) Primary outcome Death from any cause, myocardial infarction, stroke, or repeat revascularization at 1 year 10.6 % 10.6 https://web.pathway.md/studies/recb7fyneTYGXI9sT 1/2 6/28/23, 10:34 PM FAME 3 Pathway 7.9 % 6.9 5.3 % Difference exceeding nonferiority margin 2.6 % 0.0 % Percutaneous coronary intervention Coronary artery bypass graft Difference exceeding nonferiority margin in death from any cause, myocardial infarction, stroke, or repeat revascularization at 1 year (10.6% vs. 6.9%; HR 1.5, 95% CI 1.1 to 2.2) Secondary outcomes No significant difference in death, myocardial infarction, or stroke (7.3% vs. 5.2%; HR 1.4, 95% CI 0.9 to 2.1) No significant difference in death (1.6% vs. 0.9%; HR 1.7, 95% CI 0.7 to 4.3) No significant difference in the percentage of patients with myocardial infarction (5.2% vs. 3.5%; HR 1.5, 95% CI 0.9 to 2.5) Safety outcomes No significant differences in definite stent thrombosis, symptomatic graft occlusion. Significant differences in severe bleeding (1.6% vs. 3.8%), AKI (0.1% vs. 0.9%), arrhythmia or AF (2.4% vs. 14.1%). Conclusion In patients with three-vessel coronary artery disease, PCI was not noninferior to CABG with respect to death from any cause, myocardial infarction, stroke, or repeat revascularization at 1 year. Reference William F Fearon, Frederik M Zimmermann, Bernard De Bruyne et al. Fractional Flow Reserve- Guided PCI as Compared with Coronary Bypass Surgery. N Engl J Med. 2022 Jan 13;386(2):128-137. Open reference URL https://web.pathway.md/studies/recb7fyneTYGXI9sT 2/2