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MedWire News: Using fractional flow reserve (FFR) to guide stent placement in multivessel coronary artery disease (CAD) reduces adverse events at 1 year, a large clinical trial has shown.
Traditionally, the decision to stent a lesion during percutaneous coronary intervention (PCI) depends on the degree of stenosis as seen on angiography. However, angiography often overestimates or underestimates a lesion’s functional severity, and in patients with multivessel disease it can be difficult to determine which lesions are causing ischemia and thereby warrant stenting.
The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) study was therefore conducted to clarify whether percutaneous coronary intervention (PCI) performed on the basis of FFR might improve outcomes in patients with multivessel disease as compared with the standard angiographic approach. The trial randomized 1005 patients with multivessel CAD to undergo either angiography-guided PCI with stenting of all indicated lesions or to FFR-guided PCI with stenting of angiographically-indicated lesions only if the FFR was <0.80. Drug-eluting stents were used in all cases.
The mean number of indicated lesions per patient was comparable in the angiography and FFR groups (2.7 vs 2.8). However, the number of stents used per patient was significantly lower in the FFR group (1.9 vs 2.7, p<0.001), thereby offering potential cost-savings.
Most importantly, the incidence of major adverse events (a composite of death, nonfatal myocardial infarction, and repeat revascularization) at 1 year was 13.2% in the FFR group versus 18.3% in the angiography group, a highly significant reduction (p=0.02).
Commenting on their study, which appears in the New England Journal of Medicine, Pim Tonino (Catharina Hospital, Eindhoven, The Netherlands) and fellow investigators say the results “support the evolving strategy of revascularization of ischemic lesions and medical treatment of nonischemic lesions.”
Author of an accompanying editorial Stephen Ellis (Cleveland Clinic, Ohio, USA) says the FAME trial investigators “are on to something” but calls for a validation study. In the meantime he urges interventional cardiologists “to recognize the limitations of coronary angiography and PCI, while of course not forgetting their benefits.”
