国产Firebird 2^(TM)与进口Endeavor-Sprint药物洗脱支架临床应用比较

Comparison of home-made Firebird 2^(TM) drug-eluting stent and imported Endeavor-Sprint drug-eluting stent

目的对比研究国产Firebird 2TM雷帕霉素药物洗脱钴基合金支架与进口Endeavor-Sprint药物洗脱支架临床应用的安全性及疗效。方法对100例冠心病患者进行介入治疗,随机分为Firebird组和Endeavor组,每组50例,比较两组支架植入后效果。结果两组患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数比较差异无统计学意义(P>0.05),平均血管直径和平均靶病变长度比较差异无统计学意义(P>0.05);两组手术成功率为100%。Firebird组无血栓形成事件发生,Endeavor组发生1例亚急性血栓形成事件,且进行血运重建。Firebird组28例复查冠状动脉造影,1例再狭窄;Endeavor组19例复查冠状动脉造影,2例有再狭窄,两组比较差异无统计学意义(P>0.05)。结论 Firebird 2TM雷帕霉素药物洗脱钴基合金支架具有良好的安全性和满意的近、中期疗效。其与进口Endeavor-Sprint药物洗脱支架比较无明显差别。

Objective To compare the safety and efficacy between home - made Firebird 2TM sirolimus drug - e- luting Co - based alloy stent and imported Endeavor - Sprint drug - eluting stent. Methods One hundred patients with coronary artery disease, who were to received percutaneous coronary intervention therapy, were randomly divided into Fire- bird Group （50 cases） and Endeavor Group（50 cases）. The efficacy and safety were compared. Results There was no significant difference was revealed in age, sex ratio, hypertension, diabetes mellitus, or myocardial infarction history be- tween the two groups ; neither was the number or location of the affected vessels, nor the vascular diameter or target lesion length. The operation success rates were 100% in both groups. No thrombosis was reported in Firebird Group, while re- vascularization was performed for one sub - acute thrombosis event in Endeavor Group. In 28 and 19 cases received coro- nary angiography in Firebird Group and Endeavor Group, respectively, 1 and 2 cases of re - stenosis were reported, re- spectively, though there was no significant difference revealed （ P 〉 0. 05 ）. Conclusion We can obtain favorable safety and efficacy in short and medium - term of the home - made Firebird 2TM sirolimus drug - eluting Co - based alloy stents in coronary artery cases, with no significant difference when compared with the imported Endeavor - Sprint drug - eluting stent.