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Published on: May 14, 2013
Atlas Drug-Eluting Coronary Stents Inhibit Neointimal Hyperplasia in Sheep Modeling
1INVAMED Medical Innovation Institute, Ankara, Turkey.
Insights
Atlas Drug-eluting Coronary Stents coated with PLGA effectively reduced neointimal hyperplasia. Pharmacokinetic studies confirmed minimal sirolimus release after 28 days, indicating a promising treatment for coronary artery disease restenosis.
Area of Science:
- Cardiovascular Medicine
- Biomaterials Science
- Pharmacology
Background:
- Coronary artery disease (CAD) is a major global health concern.
- Restenosis after coronary interventions remains a significant clinical challenge.
- Drug-eluting stents offer a solution for controlled drug delivery to prevent restenosis.
Purpose of the Study:
- To evaluate the pharmacodynamic and pharmacokinetic properties of Atlas Drug-eluting Coronary Stents.
- To assess the efficacy of poly (lactic acid-co-glycolic acid) (PLGA) coating in drug delivery.
- To investigate the potential of these stents in managing CAD restenosis.
Main Methods:
- Utilized a sheep model with 20 non-atherosclerotic female sheep.
- Randomly assigned animals into 4 study groups and 1 control group.
- Implanted Atlas Drug-eluting Coronary Stents and monitored pharmacodynamic and pharmacokinetic parameters.
Main Results:
- Demonstrated a statistically significant reduction in neointimal hyperplasia post-stent implantation.
- Observed a statistically significant decrease in sirolimus levels in blood samples over time.
- Two animals experienced mortality post-implantation; other animals showed no significant adverse effects.
Conclusions:
- Atlas Drug-eluting Coronary Stents coated with PLGA significantly reduce neointimal hyperplasia.
- Pharmacokinetic analysis indicated no significant sirolimus release from the stent after 28 days.
- These findings suggest the potential of PLGA-coated stents for managing CAD restenosis.
Background:
Coronary artery disease (CAD) is one of the leading causes of mortality and morbidity worldwide. Many patients with CAD require mechanical revascularization. However, restenosis after minimally invasive interventions is a major problem for these patients. Fortunately, the controlled drug delivery properties of drug-eluting stents seem to be able to overcome this problem. In this study, the pharmacodynamic and pharmacokinetic properties of Atlas Drug-eluting Coronary Stents coated with poly (lactic acid-coglycolic acid) (PLGA) were evaluated.
Materials And Methods:
This study included 20 non-atherosclerotic female sheep divided into 4 groups that included 4 study and 1 control animal randomly assigned to each group. Animals in the study groups were stented with Atlas Drug-eluting Coronary Stents, and the pharmacodynamic and pharmacokinetic properties were evaluated.
Results:
Sirolimus was shown to have a statistically important effect on the vascular endothelium. With time, the decrease in sirolimus in blood samples was statistically significant. Two animals died after implantation; however no clinically significant side effects were observed in the others.
Conclusions:
The results in this study showed a significant reduction in neointimal hyperplasia after experimental implantation of Atlas Drug-eluting Coronary Stents coated with PLGA polymer. Pharmacokinetic studies also showed that the stent did not release a significant amount of sirolimus after 28 days.
