Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

OBJECTIVES: Based on outcomes of the BIOSOLVE‐II study, a novel second generation drug‐eluting absorbable metal scaffold gained CE‐mark in 2016. The BIOSOLVE‐III study aimed to confirm these outcomes and to obtain additional 12‐month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long‐term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE‐II and BIOSOLVE‐III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE‐II and 61 patients in BIOSOLVE‐III). Primary endpoints were in‐segment late lumen loss at 6 months (BIOSOLVE‐II) and procedural success (BIOSOLVE‐III). RESULTS: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE‐III, there were significantly more type B2/C lesions than in BIOSOLVE‐II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate‐to‐severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in‐segment and 0.39 ± 0.34 mm in‐scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target‐vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE‐II and BIOSOLVE‐III provide further evidence on the safety and performance of a novel drug‐eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.