Sustained safety and performance of the second-generation sirolimus-eluting absorbable metal scaffold: Pooled outcomes of the BIOSOLVE-II and -III trials at 3 years.

Haude, Michael; Ince, Hüseyin; Kische, Stephan; Toelg, Ralph; Van Mieghem, Nicolas M; Verheye, Stefan; von Birgelen, Clemens; Christiansen, Evald Høj; Barbato, Emanuele; Garcia-Garcia, Hector M; Waksman, Ron

BACKGROUND/PURPOSE To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption. METHODS/MATERIALS BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6-months. RESULTS Patients were 65.5 ± 10.8 years old, and lesions were 12.1 ± 4.5 mm long and located in vessels with a diameter of 2.7 ± 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically-driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis. CONCLUSION In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis. ANNOTATED TABLE OF CONTENTS BIOSOLVE-II- and III are prospective international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically-driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.