国产可降解涂层雷帕霉素洗脱支架的中期有效性和安全性

目的:评估第二代国产生物可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)的中期有效性和安全性。方法:连续观察71例住院的冠心病患者,常规冠状动脉造影及支架植入。主要观察术后平均18个月的无主要不良心脏事件(MACE,包括心源性死亡、心肌梗死、靶血管再次介入治疗)生存率、术后急性、亚急性及晚发血栓的发生率。结果:71例患者90支血管的104处病变共植入了113枚支架。1例患者手术后3d死亡,70例患者完成了随访。随访期间未发生支架内再狭窄。术后18个月无MACE生存率为98.6%,术后亚急性血栓发生率1.4%。结论:国产第二代生物可降解涂层雷帕霉素洗脱支架有良好的中期效果和安全性。

Safety and efficacy of rapamycin-eluting stent coated with biodegradable polymer made in China

Objective:To evaluate the safety and efficacy of the second generation of rapamycin-eluting stent coated with biodegradable polymer(EXCEL) made in China.Methods:A cohort of 71 consecutive patients with coronary arterial disease was registered.The coronary angiographies were routinely performed and EXCELs were subsequently implanted to narrowed coronary arteries.In order to determine the survival rate without major adverse cardiac events(MACE) including cardiac death,myocardial infarction,and re-interventional therapy for target vessel,and the incidence of in-stent restenosis and stent thrombosis,the coronary angiography was carried out again in the subjects at sixteen to twenty-two months after initial coronary stenting.Results:A total of 113 stents were implanted in the 71 affected individualls,70 of whom underwent complete follow-up.It was observed that the survival rate of cases without MACE was 98.6%,the incidence of sub-acute thrombosis was 1.4%,and no in-stent restenosis occurred at an average of eighteen months following coronary stenting.Conclusion:Rapamycin-eluting stent coated with biodegradable polymer was safe and effective for the treatment of coronary artery disease.