Biofreedom France registry: A prospective evaluation of clinical outcomes in real-world patients treated by coronary angioplasty with Biolimus A9 polymer-free Biofreedom stents

The Biolimus A9 polymer-free Biofreedom stent was shown to be superior to bare metal stents in terms of efficacy and safety in the randomized controlled clinical trial LEADERS FREE in high bleeding risk (HBR) patients treated by one-month DAPT. To assess prospectively the two-year clinical outcomes in a real-world population treated by coronary angioplasty with Biofreedom stents. 1502 patients (74% men, mean age 72 years) were enrolled in 26 French centers. 756 (50.33%) patients presented at least one criterion of HBR. Multi-lesion procedure was performed in 30% of patients with implantation of 1.56 stent/patient. Patients were followed by phone contact at 3, 12 and 24 months. The primary endpoint (device-oriented) was composed of cardiovascular death, myocardial infarction or clinically driven target lesion revascularization at 12 months. The secondary patient-oriented end point was a composite of all-cause death, any stroke, any myocardial infarction and any revascularization at 12 and 24 months. Further secondary endpoints were BARC 3 to 5 bleeding, or stent thrombosis. At 3-month and 12-month follow-up the primary composite end point was observed in 32 (2.14%) and 84 (6.2%) patients, respectively, including cardiovascular death in 17 (1.14%) and 24 (1.69%), myocardial infarction in 8 (0.54%) and 12 (0.85%), and clinical driven target lesion revascularization in 12 (0.85%) and 59 (4.51%) patients. Stent thrombosis occurred in 6 (0.4%) and 14 (1.02%) patients at three months and one year, and stroke was observed in 8 (0.54%) and in 13 (0.93%). Bleeding BARC 3 to 5 was observed in 17 (1.14%) and 32 (2.31%) at 3 and 12 months. Two-year follow up is currently ongoing. This prospective registry confirms the excellent safety and efficacy profile of the Biolimus A9 polymer-free Biofreedom stent in a real-world population of patients with ischemic heart disease treated by angioplasty.