FAME 2 Primary End-Point Data Analysis: FFR-Guided PCI vs. Medical Treatment in Stable Coronary Disease
Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents improved outcomes in patients with stable coronary artery disease, compared to medical therapy alone, according to results of the FAME 2 Trial presented Sept. 1 as part of ESC Congress 2014 and published simultaneously in the New England Journal of Medicine.
The study of 1,220 patients assessed the FFR in all stenosis that were visible on angiography. Patients with at least one stenosis with an FFR of 0.80 or less were randomly assigned to FFR-guided PCI plus medical therapy or medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone.
Overall, patients undergoing FFR-guided PCI had a 44 percent relative risk reduction in death from any cause, nonfatal myocardial infarction or urgent revascularization within two years, compared to those receiving medical therapy alone. According to study investigators, this reduction was largely driven by a significantly lower rate of urgent revascularization triggered by myocardial infarction or ischemic changes on electrocardiography in the PCI group. Urgent revascularizations for PCI patients were half as frequent as those for patients receiving medical therapy alone.
Study investigators noted, however, that medical therapy alone was associated with "an excellent two-year clinical outcome" in patients without hemodynamically significant stenosis. These findings were regardless of the angiographic appearance of the stenosis.
In a corresponding editorial, Jeffrey Rade, MD, FACC, writes that "the results from the FAME 2 trial show that early FFR-guided PCI in patients with stable coronary disease sustainably reduced the need for urgent revascularization, a viable hard end point." He notes that as the safety of both stents and the procedure used to implant them improve, "it is entirely possible that PCI may eventually be shown to have a favorable effect on other hard end points as well."
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