Key result
PLGA-coated Atlas sirolimus-eluting stents reduce neointimal hyperplasia in a sheep model.
Why the study?
Restenosis after mechanical revascularization remains a major clinical problem in coronary artery disease, leading to this evaluation of the pharmacodynamic and pharmacokinetic properties of Atlas sirolimus-eluting coronary stents coated with PLGA.
Does the Atlas sirolimus-eluting coronary stent reduce neointimal hyperplasia in a sheep model?
RCT (n=20)
Randomly assigned
Does the Atlas sirolimus-eluting coronary stent reduce neointimal hyperplasia in a sheep model?
Atlas sirolimus-eluting stents coated with PLGA effectively reduce neointimal hyperplasia in a sheep model with favorable pharmacokinetic properties over 28 days.
Hypothesis-generating in sheep model; human trials needed before any clinical consideration.
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 intervention is a major problem for these patients. Fortunately, due to the controlled drug delivery properties of drug-eluting stents (DES), this problem seems to be significantly overcome. In this study, the pharmacodynamic and pharmacokinetic properties of Atlas sirolimus-eluting coronary stents coated with PLGA were evaluated. Materials and Methods This study was carried out in 20 non-atherosclerotic female sheep, divided into four groups that included 4 study and 1 control randomly assigned to each group. The animals in the study groups were stented with Atlas Drug-eluting coronary stents and the pharmacodynamic and pharmacokinetic properties were evaluated. Results A statistically important effectivity of sirolimus on the vascular endothelium was shown. With time, the decrease in sirolimus in blood samples was statistically significant. In the others, no clinically significant side effects were observed. Conclusions The results in this study showed a significant reduction in neointimal hyperplasia after experimental implantation of Atlas drug-eluting stents coated with PLGA polymer. Pharmacokinetic studies also showed that the stent did not release significant left sirolimus after 28 days.
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Dinç et al. (2023) conducted an RCT in Coronary artery disease (n=20). Atlas sirolimus-eluting coronary stents coated with PLGA vs. Control was evaluated on Pharmacodynamic and pharmacokinetic properties (neointimal hyperplasia). Atlas sirolimus-eluting coronary stents coated with PLGA significantly reduced neointimal hyperplasia in a sheep model, with no significant sirolimus release after 28 days.
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