Bioresorbable drug-eluting magnesium-alloy scaffold: design and feasibility in a porcine coronary model.
Bioresorbable drug-eluting magnesium-alloy scaffold: design and feasibility in a porcine coronary model.
- 2013
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.
English
1774-024X
*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, Miniature
MedStar Heart & Vascular Institute
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
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.
English
1774-024X
*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, Miniature
MedStar Heart & Vascular Institute
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't