Atlas Drug-Eluting Coronary Stents Inhibit Neointimal Hyperplasia in Sheep Modeling.

Abstract

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. 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. 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. 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.