国产生物可降解聚合物支架与进口永久聚合物支架在冠状动脉血运重建中的对比  

Comparison of biodegradable polygmer stents and durable polymer stents in coronary revascularization

作　　者：孙奡燕[1] 张景轩[1] 葛华[1] 于安石[1] 富萍[1] 

机构地区：[1]沈阳医学院奉天医院心内科,辽宁省沈阳市110024

出　　处：《中国组织工程研究与临床康复》2011年第42期7965-7968,共4页Journal of Clinical Rehabilitative Tissue Engineering Research

摘　　要：背景:雷帕霉素洗脱支架是冠状动脉支架置入后再狭窄的有效防治措施,是国产和进口支架材料会有什么区别吗?目的:比较新型国产EXCEL生物可降解聚合物雷帕霉素洗脱支架与进口Cypher永久聚合物雷帕霉素洗脱支架的疗效和安全性。方法:回顾性分析259例冠状动脉心病患者临床资料,根据置入支架的不同分为两组进行比较观察:EXCEL支架组(n=130):置入新型国产生物可降解聚合物雷帕霉素洗脱支架;Cypher支架组(n=129):置入进口永久聚合物雷帕霉素洗脱支架。结果与结论:256例患者完成随访,失访者3例,其中EXCEL支架组1例,Cypher支架组2例,失访率为1%。两组患者各有2例发生急性和亚急性血栓,Cypher支架组患者有3例发生晚期血栓。两组之间比较差异无显著性意义(P>0.05)。随访期间未发生支架内再狭窄。置入后18个月无主要不良心脏事件生存率为98.8%,置入后亚急性血栓发生率1.56%。提示,EXCEL生物可降解聚合物雷帕霉素洗脱支架与Cypher永久聚合物雷帕霉素洗脱支架在冠状动脉血运重建方面的近期及远期各项指标差异无显著性意义,两者均是安全可靠的。BACKGROUND： Sirolimus-eluting stent is an effective prevention measure for restenosis after coronary stent implantation. It is unclear whether there is a difference between domestic and imported scaffolds. OBJECTIVE： To compare the effect and safety of biodegradable polygmer stents （EXCEL） made in China and imported durable polymer stents （Cypher） in coronary revascularization. METHODS： A cohort of 259 consecutive patients with coronary arterial disease was registered. The patients were categorized into EXCEL group （n=130） and Cypher group （n=129）. RESULTS AND CONCLUSION： 256 of 259 patients completed a follow-up visit, and 3 patients lost including 1 in the EXCEL group and 2 in the Cypher group with a lost rate of 1%. There were 2 cases of adverse cardiovascular events in the EXCEL group and 3 in the Cypher group. But there was no significant difference between the two groups （P 0.05）. No restenosis occurred during the follow-up. It was observed that the survival rate without main adverse cardiovascular events was 98.8% and the incidence of sub-acute thrombosis was 1.56% at 18 months after stent implantation. Both of EXCEL and Cypher stents are safe and reliable in coronary revascularization.

关 键 词：雷帕霉素 药物洗脱支架 药物涂层 冠状动脉支架 再狭窄 

分 类 号：R318[医药卫生—生物医学工程]