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SHR Neuro Cancer Cardio Lipid Metab Microb

Haude, M; Wlodarczak, A; van, der, Schaaf, RJ; Torzewski, J; Ferdinande, B; Escaned, J; Iglesias, JF; Bennett, J; Toth, GG; Joner, M; Toelg, R; Wiemer, M; Olivecrano, G; Vermeersch, P; Garcia-Garcia, HM; Waksman, R.
A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-1 first-in-human study.
EuroIntervention. 2023; Doi: 10.4244/EIJ-D-23-00326 [OPEN ACCESS]
Web of Science PubMed FullText FullText_MUG

Co-authors Med Uni Graz: Toth-Gayor Gabor
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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 alternative to DES. CLINICALTRIALS: gov: NCT04157153.
Find related publications in this database (Keywords): bioresorbable scaffolds; drug-eluting stent; NSTEMI; stable angina