Dinc Rasit, Yerebakan Halit
INVAMED Medical Innovation Institute, Ankara, Turkey.
Department of Cardiovascular Surgery, Yeditepe University, Istanbul, Turkey.
Acta Cardiol Sin. 2024 Sep;40(5):585-594. doi: 10.6515/ACS.202409_40(5).20240618A.
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.
冠状动脉疾病（CAD）是全球范围内导致死亡和发病的主要原因之一。许多CAD患者需要进行机械血运重建。然而，微创干预后的再狭窄是这些患者面临的一个主要问题。幸运的是，药物洗脱支架的可控药物递送特性似乎能够克服这一问题。在本研究中，评估了涂覆聚乳酸-乙醇酸共聚物（PLGA）的阿特拉斯药物洗脱冠状动脉支架的药效学和药代动力学特性。
本研究纳入20只非动脉粥样硬化的雌性绵羊，随机分为4组，每组包括4只研究动物和1只对照动物。研究组的动物植入阿特拉斯药物洗脱冠状动脉支架，并评估其药效学和药代动力学特性。
西罗莫司对血管内皮显示出具有统计学意义的重要作用。随着时间的推移，血样中西罗莫司的减少具有统计学意义。植入后有2只动物死亡；然而，其他动物未观察到具有临床意义的副作用。
本研究结果表明，植入涂覆PLGA聚合物的阿特拉斯药物洗脱冠状动脉支架后，内膜增生显著减少。药代动力学研究还表明，28天后该支架未释放大量西罗莫司。
