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Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study by Haude, Michael (author);Wlodarczak, Adrian (author);van der Schaaf, René J. (author);Torzewski, Jan (author);Ferdinande, Bert (author);Escaned, Javier (author);Iglesias, Juan F. (author);Bennett, Johan (author);Toth, Gabor (author);Joner, Michael (author);Toelg, Ralph (author);Wiemer, Marcus (author);Olivecrona, Göran (author);Vermeersch, Paul (author);Garcia-Garcia, Hector M. (author);Waksman, Ron (author) is a Medicine article available to read on EtoBox.

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## Summary ## Background A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. ## Methods This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). ## Findings Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preserv

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Author

Haude, Michael (author);Wlodarczak, Adrian (author);van der Schaaf, René J. (author);Torzewski, Jan (author);Ferdinande, Bert (author);Escaned, Javier (author);Iglesias, Juan F. (author);Bennett, Johan (author);Toth, Gabor (author);Joner, Michael (author);Toelg, Ralph (author);Wiemer, Marcus (author);Olivecrona, Göran (author);Vermeersch, Paul (author);Garcia-Garcia, Hector M. (author);Waksman, Ron (author)

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)