BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

Abstract

ObjectivesWe aimed to assess the safety and performance of the Magmaris sirolimus‐eluting bioresorbable magnesium scaffold in a large patient population.BackgroundMagmaris has shown good outcomes in small‐sized controlled trials, but further data are needed to confirm its usability, safety, and performance.MethodsBIOSOLVE‐IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow‐up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months.ResultsA total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non‐ST‐elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan–Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target‐vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy.ConclusionBIOSOLVE‐IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low‐risk population.