Review: Stable coronary disease remains a scenario where percutaneous coronary intervention, (PCI), has not cleared the edges. In a study conducted in 28 centers in Europe and the United States, a design model was created where all patients enrolled consecutively, (all comers trial in order to avoid selection bias), received an invasive functional assessment using the Fractional Flow Reserve, (FFR) technique. In the presence of at least one lesion with FFR <0.8 the inclusion criteria was met for randomization and imperative PCI versus optimal medical therapy, (OMT).
Initially designed to include 1,632 patients (p) with a 2-year follow-up, the study had to be suspended with 888 p because of a greater occurrence of events in the OMT group, (12.7% versus. 4.3%, HR 0.32, CI 95% 0, 19 – 0.53, p <0.001), mainly due to a higher rate of revascularization in the OMT group, (1.6% vs. 11.1%, P = 0.001), due to myocardial infarction and unstable angina signs. It also followed patients with FFR> 0.8 in a 332 p register where both strategies yielded no significant differences.
Obviously their findings reinforce the importance of a functional assessment of anatomically defined lesions. The intervention in these patients has reduced the presentation of acute coronary syndromes, (approximately one fifth of them being a heart attack).
Bernard De Bruyne
Original title: FAME II: Fractional Flow Reserve-Guided Percutaneous Coronary Intervention plus Optimal Medical Treatment versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease.