Fractional Flow Reserve–Guided PCI Versus Medical Therapy in Stable Coronary Disease
What is the comparative efficacy of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with drug-eluting stents plus the best available medical therapy, to the best available medical therapy alone in reducing the rate of death, myocardial infarction, or unplanned hospitalization leading to urgent revascularization among patients with stable coronary artery disease?
In patients with stable coronary artery disease for whom PCI was being considered, the FAME 2 trial investigators assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group), or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary endpoint was a composite of death, myocardial infarction, or urgent revascularization.
Recruitment was halted prematurely after enrollment of 1,220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary endpoint event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio [HR] with PCI, 0.32; 95% confidence interval [CI], 0.19-0.53; p < 0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; HR, 0.13; 95% CI, 0.06-0.30; p < 0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (HR, 0.13; 95% CI, 0.04-0.43; p< 0.001). Among patients in the registry, 3.0% had a primary endpoint event.
The authors concluded that in patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization.
This study reports that FFR-guided PCI with drug-eluting stents plus the best available medical therapy, as compared with the best available medical therapy alone, resulted in significantly improved clinical outcomes among patients with functionally significant stenoses and stable coronary artery disease. The difference between the two strategies was driven by an increase in the need for urgent revascularization in the medical-therapy group. 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 6 months leaves many unanswered questions. The ongoing ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial should provide additional insight on this issue.
Keywords: Constriction, Myocardial Infarction, Coronary Artery Disease, Follow-Up Studies, Drug-Eluting Stents, Coronary Circulation, Electrocardiography, Angioplasty, Percutaneous Coronary Intervention, Coronary Angiography, Ischemia, Cardiology
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