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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, G; Joner, M; Toelg, R; Wiemer, M; Olivecrona, G; Vermeersch, P; Garcia-Garcia, HM; Waksman, R.
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.
EClinicalMedicine. 2023; 59: 101940
Doi: 10.1016/j.eclinm.2023.101940
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- Co-authors Med Uni Graz
- Toth-Gayor Gabor
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- Abstract:
- 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 preservation of the scaffold area (mean 7.59 mm2 [SD 2.21] post-procedure vs 6.96 mm2 [SD 2.48]) at six months) with a low mean neointimal area (0.02 mm2 [SD 0.10]). Optical coherence tomography revealed that struts were embedded in the vessel wall and were already hardly discernible at six months. Target lesion failure occurred in one (0.9%) patient; a clinically driven target lesion revascularization was performed on post-procedure day 166. No definite or probable scaffold thrombosis or myocardial infarction was observed. INTERPRETATION: These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents. FUNDING: This study was funded by BIOTRONIK AG.
- Find related publications in this database (Keywords)
- Bioresobabe scaffolds
- Coronary artery disease
- Drug-eluting stents