6/28/23, 10:33 PM FAME Pathway Feedback Search Clinical Topics Home Studies FAME FAME Disease Coronary artery disease Trial question What is the role of fractional flow reserve for guiding PCI in patients with multivessel coronary artery disease? Study design Multi-center Open label RCT Population Characteristics of study participants 26.0% female N = 1005 74.0% male 1005 patients (261 female, 744 male) Inclusion criteria: patients with multivessel coronary artery disease Key exclusion criteria: angiographically significant left main coronary artery disease, previous coronary artery bypass surgery, cardiogenic shock, extremely tortuous or calcified coronary arteries, a life expectancy < 2 years, or a contraindication to the placement of drug-eluting stents and pregnancy Interventions N=509 FFR-guided PCI (implantation of drug-eluting stents in indicated lesions if the FFR is 0.80 guided by FFR measurements in addition to angiography) N=496 angiography-guided PCI (implantation of drug-eluting stents in all indicated lesions guided by angiography alone) Primary outcome https://web.pathway.md/studies/recwyvir98yHqQszX 1/2 6/28/23, 10:33 PM FAME Pathway Death, nonfatal myocardial infarction, or repeat revascularization at 1 year 18.3 % 18.3 13.7 % 13.2 9.2 % Significant decrease 4.6 % NNT = 20 0.0 % FFR-guided percutaneous coronary intervention Angiography-guided percutaneous coronary intervention Significant decrease in death, nonfatal myocardial infarction, or repeat revascularization at 1 year (13.2% vs. 18.3%; RR 0.72, 95% CI 0.54 to 0.96) Secondary outcomes No significant difference in free from angina at 1 year (81.3% vs. 77.9%; RR 1.04, 95% CI -0.55 to 2.63) No significant difference in death from any cause (1.8% vs. 3%; RR 0.58, 95% CI 0.26 to 1.32) No significant difference in myocardial infarction (5.7% vs. 8.7%; RR 0.66, 95% CI 0.42 to 1.04) Conclusion In patients with multivessel coronary artery disease, FFR-guided PCI was superior to angiography-guided PCI with respect to death, nonfatal myocardial infarction, or repeat revascularization at 1 year. Reference Tonino PA, De Bruyne B, Pijls NH et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. Open reference URL https://web.pathway.md/studies/recwyvir98yHqQszX 2/2