公开了药物洗脱支架,所述药物洗脱支架的制造、使用和验证长期稳定性的方法,和在植入药物洗脱支架后预测长期支架功效和患者安全性的方法。在一个实施方案中,药物洗脱支架可以包括支架框架;含药层;包埋在含药层中的药物;和设置于支架框架上并支撑含药层的生物相容性基层。含药层可以具有不均匀的涂层厚度。此外或可替代地,可以配置含药层,以在支架植入后45天至60天显著溶解/消散/消失。支架可以减少、最小化或消除与植入支架相关的患者风险,包括例如再狭窄、血栓形成和/或MACE。
The present disclosure relates to drug eluting stents, methods of making, using, and verifying long-term stability of the drug eluting stents, and methods for predicting long term stent efficacy and patient safety after implantation of a drug eluting stent. In one embodiment, a drug eluting stent ma include a stent framework: a drug-containing layer, a drug embedded in the drug-containing layer; and a biocompatible base layer disposed over the stent framework and supporting the drug-containing layer. The drug-containing layer may have an uneven coating thickness. In addition or in alternative, the drug-containing layer may be configured to significantly dissolve/dissipate/disappear between 45 days and 60 days after stent implantation. Stents of the present disclosure may reduce, minimize, or eliminate patient risks associated with the implantation of a stent, including, for example, restenosis, thrombosis, and/or MACE.