6/28/23, 10:33 PM FAME 2 Pathway Feedback Search Clinical Topics Home Studies FAME 2 FAME 2 Disease Coronary artery disease Trial question What is the role of fractional flow reserve-guided PCI in patients with stable coronary artery disease? Study design Multi-center Open label RCT Population Characteristics of study participants 22.0% female N = 888 78.0% male 888 patients (194 female, 694 male) Inclusion criteria: patients with stable coronary artery disease for whom PCI was being considered and in whom at least one stenosis was functionally significant, FFR 0.80 Key exclusion criteria: left main coronary artery disease requiring revascularization, recent < 1 week STEMI or non-STEMI, prior CABG, contraindication to dual antiplatelet therapy, LVEF < 30%, severe LV hypertrophy, age < 21 years, or pregnancy Interventions N=447 PCI (FFR-guided PCR plus best available medical therapy) N=441 medical therapy (best available medical therapy alone) Primary outcome Death, myocardial infarction, or urgent revascularization 12.7 % 12.7 https://web.pathway.md/studies/rec7w0QcBtEbqprPp 1/2 6/28/23, 10:33 PM FAME 2 Pathway 9.5 % 6.3 % Significant decrease 4.3 3.2 % NNT = 12 0.0 % Percutaneous coronary intervention Medical therapy Significant decrease in death, myocardial infarction, or urgent revascularization (4.3% vs. 12.7%; HR 0.32, 95% CI 0.19 to 0.53) Secondary outcomes Significant decrease in urgent revascularization (1.6% vs. 11.1%; HR 0.13, 95% CI 0.06 to 0.3) Significant decrease in urgent revascularization triggered by myocardial infarction or evidence of ischemia on electrocardiography (0.9% vs. 5.2%; HR 0.13, 95% CI 0.04 to 0.43) Conclusion In patients with stable coronary artery disease for whom PCI was being considered and in whom at least one stenosis was functionally significant, FFR 0.80, PCI was superior to medical therapy with respect to death, myocardial infarction, or urgent revascularization. Reference De Bruyne B, Pijls NH, Kalesan B et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. Open reference URL https://web.pathway.md/studies/rec7w0QcBtEbqprPp 2/2