Clinical research

DOI: 10.4244/EIJ-D-23-00326

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

Michael Haude1, MD; Adrian Wlodarczak2, MD; René J. van der Schaaf3, MD; Jan Torzewski4, MD; Bert Ferdinande5, MD; Javier Escaned6, MD; Juan F Iglesias7, MD; Johan Bennett8, MD; Gabor G. Toth9, MD; Michael Joner10, MD; Ralph Toelg11, MD; Marcus Wiemer12, MD; Göran Olivecrano13, MD; Paul Vermeersch14, MD; Hector M. Garcia-Garcia15, MD; Ron Waksman15, MD

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 intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent.

Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible...

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Volume 19 Number 5
Aug 7, 2023
Volume 19 Number 5
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