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

ABSTRACT:

Objectives

We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population.

Background

Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance.

Methods

BIOSOLVE-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.

Results

A 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

SUBMITTER: Verheye S 

PROVIDER: S-EPMC8359313 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature