OCT对无载体纳米药物洗脱支架抑制再狭窄和促进内皮化的动物观察研究

Observation study on the inhibition of restenosis and promote endothelialization of carrier-free nanodrug-eluting stents by OCT

目的评价新型无聚合物涂层雷帕霉素药物洗脱支架在抑制内膜增生、降低炎性反应等方面的安全性和有效性。方法随机选择猪冠状动脉前降支、右冠状动脉或回旋支置入金属裸支架、聚合物载体雷帕霉素洗脱支架(Partner支架)和无聚合物载体雷帕霉素洗脱支架。置入后1个月和3个月行冠脉造影,光学相干断层成像和定量冠脉狭窄分析,测量新生内膜面积、面积狭窄百分比、新生内膜覆盖率等,而后处死动物,进行组织形态学检查和病理积分分析。结果置入后1个月光学相干断层成像、定量冠脉狭窄分析以及组织形态学分析提示,相比金属裸支架、Partner药物洗脱支架和无聚合物载体雷帕霉素洗脱支架明显减少新生内膜面积及管腔丢失。术后3个月,相比金属裸支架和Partner药物洗脱支架,无聚合物载体雷帕霉素洗脱支架明显减少新生内膜面积、管腔丢失。随访期间,BMS组和PFSES组炎症反应及损伤积分之间差异无显著性,但术后3个月PSES组的炎症积分显著升高。结论无聚合物载体雷帕霉素洗脱支架在小型猪模型中,炎性反应程度更轻,无支架内血栓形成,可以有效抑制新生内膜增殖,表现出良好的组织相容性。

Objective To evaluate the efficacy and safety of Polymer-free sirolimus eluting-stents （PFSES） ,three stents of BMS ,Polymer-based sirolimus-eluting stent （PSES） ,and PFSES were ran-domized implanted in porcine coronary model ,and optical cohehence tomography （OCT ） ,quantitative coronary narrow analysis （QCA） ,and histopathological methods were used to evaluate the inhibiting of neointimal hyperplasia ,inflammation ,and etc .after stent implantation .Methods Anterior descend-ing coronary artery ,right coronary artery or the circumflex artery were randomly selected to implant BMS ,PSES and PFSES .After 1 month ,3 months and 6 months ,coronary angiography ,optical co-herence tomography and QCA were used to measure neointimal area ,area stenosis percentage ,neoint-imal coverage of stent thrombosis ,and luminal loss ,etc .And then the animals were sacrificed and pathological examination conducted histological analysis points .Results The 1 month outcome after im-plantation by OCT ,QCA ,and histomorphomeric analysis showed significant reduction in ,luminal loss （LL） in PFSES compared with BMS .After 3 months ,compared with BMS and PSES ,neointima area and lumen loss were significantly reduced .6 months later ,neointimal proliferation still can be seen in PFSES ,but there was no significant difference among three groups .There was no significant difference between BMS group and PFSES group in inflammation and damage points .But after three and six months ,the inflammation scores of PSES were significantly higher .Conclusion In porcine cor-onary model ,The PFSES has lower degree of inflammatory response and no stent thrombosis ,and can effectively inhibit neointimal proliferation ,showing good tissue compatibility .