FAME 2 – The best initial strategy for patients with stable coronary artery disease: Do we have an answer at last?

Results of the Fractional flow reserve versus Angiography for Multivessel Evaluation 2 (FAME 2) trial were recently presented at the European Society of Cardiology (ESC) meeting in Munich and published concurrently in the New England Journal of Medicine1. Interpretation of the results and clinical significance of the study continue to be topics of considerable controversy. FAME 2 is a randomized “all-comers” multicenter trial, designed to test the hypothesis that in patients with stable ischemic heart disease (IHD), stenting ischemia-producing stenoses – defined as fractional flow reserve (FFR) < 0.80 – plus optimal medical treatment (OMT), would reduce the composite end-point of death, nonfatal myocardial infarction (MI) and urgent revascularization, compared to OMT alone. Secondary endpoints included individual components of the primary endpoint, cardiac death, non-urgent revascularization and angina class. The trial was funded by St. Jude Medical, Inc.