The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) trial was a landmark study of the use of fractional flow reserve (FFR) to guide coronary revascularization through the identification of ischemia-inducing stenosis at the time of coronary angiography. The previously published 1- and 2-year results of the FAME trial demonstrated fewer major adverse cardiac events in the FFR arm as compared to patients undergoing revascularization guided by angiographic assessment alone. In the current study, the authors present the 5-year follow-up data from the FAME trial. The original trial enrolled 1005 patients across 20 centers from 2006 to 2007, with 496 randomized to angiography-guided revascularization and 506 to FFR-guided revascularization. Of these patients, 429 in the angiography-guided arm and 436 in the FFR-guided arm were included in the 5-year follow-up (86% overall). At 5 years, there was no difference between treatment arms for major adverse cardiac events (31% angiography vs. 28% FFR, relative risk 0.91 [95% CI 0.75-1.10]), or individual outcomes of all cause mortality, myocardial infarction, or coronary revascularization. Similarly, cardiac mortality was not significantly different between treatment arms (16% angiography vs. 13% FFR, p= 0.21). A sensitivity analysis in which death was assumed for lost-to-follow-up patients demonstrated similar findings.
Conclusions: At 5-years follow up, FFR-guided revascularization demonstrated similar outcomes when compared with revascularization guided by angiography alone. These findings provide reassurance that the early benefits of FFR targeted revascularization are not overwhelmed by late events.
Summarized by Javier A. Valle and Steven M. Bradley
van Nunen LX, Zimmermann FM, Tonino PAL, Barbato E, Baumbach A, Engstrøm T, et al. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet 2015; 386: 1853–60.