A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.

ABSTRACT:

Background

The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES).

Aims

The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.

Methods

This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years.

Results

A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravasc

SUBMITTER: Haude M 

PROVIDER: S-EPMC10397670 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature