Bioresorbable drug-eluting magnesium-alloy scaffold: design and feasibility in a porcine coronary model.

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Citation: Eurointervention. 8(12):1441-50, 2013 Apr 22.PMID: 23680959Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Research Support, Non-U.S. Gov'tSubject headings: *Absorbable Implants | *Alloys/ch [Chemistry] | *Cardiovascular Agents/ad [Administration & Dosage] | *Drug-Eluting Stents | *Magnesium/ch [Chemistry] | *Paclitaxel/ad [Administration & Dosage] | *Percutaneous Coronary Intervention/is [Instrumentation] | Animals | Cardiovascular Agents/ch [Chemistry] | Cardiovascular Agents/me [Metabolism] | Coronary Angiography | Coronary Vessels/de [Drug Effects] | Coronary Vessels/ra [Radiography] | Feasibility Studies | Female | Fibrosis | Kinetics | Male | Materials Testing | Models, Animal | Molecular Weight | Neointima | Paclitaxel/ch [Chemistry] | Paclitaxel/me [Metabolism] | Polyglactin 910/ch [Chemistry] | Prosthesis Design | Swine | Swine, MiniatureYear: 2013ISSN:
  • 1774-024X
Name of journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of CardiologyAbstract: AIMS: Among three versions of bioresorbable magnesium scaffolds featuring different paclitaxel-elution kinetics, we determined the best-performing scaffold and compared it with established, paclitaxel-eluting, permanent stents TAXUS Liberte and eucaTAX.CONCLUSIONS: By selecting suitable paclitaxel-elution kinetics, it was feasible to develop a bioresorbable magnesium scaffold whose efficacy and healing characteristics in a porcine coronary model are comparable with those of established paclitaxel-eluting permanent metallic stents.METHODS AND RESULTS: Drug-elution kinetics in magnesium scaffolds were modulated by varying the composition of their bioresorbable poly(lactide-co-glycolide) coating loaded with paclitaxel. A 50:50 ratio of lactide to glycolide, or an 85:15 ratio and either high- or low-molecular-weight polymer was applied in the "50/50", "85/15H", and "85/15L" scaffolds, respectively. Seventy-three magnesium scaffolds (25 50/50, 24 85/15H, 24 85/15L) and 36 control stents (18 TAXUS Liberte, 18 eucaTAX) were implanted in coronary arteries of 50 Yucatan mini-pigs. Angiography, histomorphometry, and histopathology data were acquired at 28, 90 and 180 days. The best-performing magnesium scaffold, 85/15H, was equivalent to TAXUS Liberte and superior to eucaTAX regarding late luminal loss, intimal area, fibrin score, and endothelialisation. Intimal inflammation score was higher in 85/15H than in the control stents at 28 days, but this effect disappeared at later time points.All authors: Adden N, Braune M, Riedmuller J, Savard C, Waksman R, Wittchow EFiscal year: FY2013Digital Object Identifier: Date added to catalog: 2014-02-24
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Journal Article MedStar Authors Catalog Article 23680959 Available 23680959

AIMS: Among three versions of bioresorbable magnesium scaffolds featuring different paclitaxel-elution kinetics, we determined the best-performing scaffold and compared it with established, paclitaxel-eluting, permanent stents TAXUS Liberte and eucaTAX.

CONCLUSIONS: By selecting suitable paclitaxel-elution kinetics, it was feasible to develop a bioresorbable magnesium scaffold whose efficacy and healing characteristics in a porcine coronary model are comparable with those of established paclitaxel-eluting permanent metallic stents.

METHODS AND RESULTS: Drug-elution kinetics in magnesium scaffolds were modulated by varying the composition of their bioresorbable poly(lactide-co-glycolide) coating loaded with paclitaxel. A 50:50 ratio of lactide to glycolide, or an 85:15 ratio and either high- or low-molecular-weight polymer was applied in the "50/50", "85/15H", and "85/15L" scaffolds, respectively. Seventy-three magnesium scaffolds (25 50/50, 24 85/15H, 24 85/15L) and 36 control stents (18 TAXUS Liberte, 18 eucaTAX) were implanted in coronary arteries of 50 Yucatan mini-pigs. Angiography, histomorphometry, and histopathology data were acquired at 28, 90 and 180 days. The best-performing magnesium scaffold, 85/15H, was equivalent to TAXUS Liberte and superior to eucaTAX regarding late luminal loss, intimal area, fibrin score, and endothelialisation. Intimal inflammation score was higher in 85/15H than in the control stents at 28 days, but this effect disappeared at later time points.

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