This randomized trial with an initial plan to include 1832 patients, compared stent implantation guided by fractional flow reserve (FFR) versus optimal medical treatment. In this study, we invasively evaluated the severity of lesion by FFR. Of this population, only patients who had lesions with significant translesional gradient (FFR <0.9) were included in the study (1219 patients from 28 centers in Europe, USA and Canada). These were randomized to angioplasty versus medical treatment. In an interim analysis, the angioplasty group showed a significantly lower rate of hospitalization and emergency revascularization than the medical treatment group. Because of these findings, the Data Monitoring Safety Committee decided to terminate the enrollment considering it unethical to continue the study due to excessive group difference in favor of angioplasty.
Dr. De Bruyne said that FFR use embodies a complementary analysis of coronary angiography diagnostic and should be performed in case of doubt. If it were a study of arteries without lesions, FFR is not indicated. For scenarios with more than one injury, it is essential to specify the hemodynamic impact of each lesion separately. This study differs from the Courage study for several reasons. First, the selection of patients: FAME II patients were treated only with one or more hemodynamically significant stenosis, while the Courage and other studies comparing percutaneous treatment with medical treatment included patients with stenosis were probably not hemodynamically significant. Second, angioplasty consisted of implanting a FFR guided drug stent, i.e., only stenosis with FFR <0.8 were treated. These differences are comprehensible as the Courage was conceived 20 years ago.
For Dr. Ron Waksman endpoint urgent revascularization, i.e., hospitalization due to chest pain resulting in angioplasty is a subjective concept, especially if the study was not blind, and this might be a bias. Dr. David Holmes of the Mayo Clinic, for his part, says these results are strong drivers of change in our clinical practice. This technology helps us to select candidates for angioplasty and optimize results, and teaches us to treat ischemia and not stenosis.
Bernhard de Bruyne