FAME 2: Does FFR-Guided PCI Reduce Need for Urgent Revascularization?

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) plus optimal medical therapy decreases the need for urgent revascularization when compared to optimal medical therapy in patients with stable coronary artery disease and functionally significant stenosis, according to a study published on Aug. 28 in The New England Journal of Medicine and presented on Tuesday as part of the ESC Congress 2012 in Munich.


The study, called FAME 2, found that 4.3 percent of patients in the PCI group compared to 12.7 percent in the medical-therapy group (hazard ratio with PCI, 0.32; 95 percent CI, 0.19 to 0.53; P<0.001), had a primary end point event of death, myocardial infarction, or urgent revascularization. Due to this significant between-group difference, recruitment was halted prematurely after enrolment of 1,220 patients, note the authors. The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (0.7 percent vs. 9.5 percent; hazard ratio, 0.07; 95 percent CI, 0.02 to 0.22; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95 percent CI, 0.04 to 0.43; P<0.001), they add. Further, in patients without ischemia, optimal medical therapy alone appeared to be the best treatment "regardless of the angiographic appearance of the stenoses," the authors add.  


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Patients with at least one functionally significant stenosis (FFR, ≤0.08) were randomized to a FFR-guided PCI plus optimal medical therapy group, or to an optimal medical therapy alone group. Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received optimal medical therapy.


Comparing the FAME 2 and COURAGE trials in an editorial comment, William Boden, MD, FACC, from the Department of Medicine, Albany Medical Center in Albany, NY, notes that both trials are similar and show that PCI reduced only the need for revascularization. "Unfortunately, the early termination of the FAME 2 trial before full enrollment and follow-up were achieved, the neutral effects on the rate of death or myocardial infarction, and the lack of a significant, sustained treatment effect on the reduction of angina beyond six months leave more questions than answers," he adds. Boden notes that until results from studies currently in development become available, "the case for a more durable clinical benefit of PCI beyond relief of angina or a reduction in the rate of subsequent revascularization is likely to remain both elusive and illusory."

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