A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.
Citation: Eurointervention. 19(5):e414-e422, 2023 Aug 07.PMID: 37334655Institution: MedStar Heart & Vascular Institute | MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Coronary Artery Disease | *Drug-Eluting Stents | *Percutaneous Coronary Intervention | Absorbable Implants | Coronary Angiography/mt [Methods] | Coronary Artery Disease/su [Surgery] | Humans | Magnesium/tu [Therapeutic Use] | Prospective Studies | Treatment OutcomeYear: 2023ISSN:- 1774-024X
AIMS: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.
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).
CLINICALTRIALS: gov: NCT04157153.
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.
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.
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