Patients with stable coronary artery disease (CAD) and a fractional flow reserve (FFR) ≤0.80 benefit from revascularization plus medical therapy, whereas those with an FFR >0.80 have a favourable outcome with medical therapy only. These 5-year outcomes of the FAME 2 trial were presented at the EuroPCR conference in Paris, France, and simultaneously published in NEJM.

A total of 888 patients with an FFR ≤0.80 were randomly assigned to percutaneous coronary intervention (PCI) plus medical therapy or to medical therapy only. Patients with an FFR >0.80 received medical therapy only and were entered into a registry. After 5 years of follow-up, the rate of the primary end point (a composite of death, myocardial infarction, or urgent revascularization) was lower in the PCI group than in the medical-therapy group (13.9% versus 27.0%; HR 0.46, 95% CI 0.34–0.64). This difference was driven by a lower rate of urgent revascularization in the PCI group (6.3% versus 21.1%; HR 0.27, 95% CI 0.18–0.41). Of note, PCI was also associated with a lower rate of spontaneous myocardial infarction (6.5% versus 10.2%; HR 0.62, 95% CI 0.39–0.99). By contrast, mortality was similar in the two groups (5.1% versus 5.2%). The rate of the primary end point was not significantly different in the group undergoing PCI compared with the registry cohort (13.9% versus 15.7%).

“In patients with stable CAD, an initial FFR-guided PCI strategy resulted in a sustained clinical benefit,” conclude the investigators. “Our results contradict the general belief that abrupt coronary occlusions occur predominantly at sites of mild stenosis and hence that the treatment of severe lesions may not prevent myocardial infarction.” These 5-year data conclude the follow-up of the FAME 2 trial. Recruitment into the FAME 3 trial, designed to compare CABG surgery and FFR-guided PCI in patients with three-vessel CAD, is almost complete.