国产与进口西罗莫司药物洗脱支架治疗冠心病临床疗效对比One-year clinical outcomes of domestic sirolimus-eluting stent in treating unselected patients with coronary artery disease
张奇,张瑞岩,张建盛,胡健,杨震坤,倪钧,张宪,沈卫峰
摘要(Abstract):
目的评估国产西罗莫司药物洗脱冠状动脉(冠脉)支架在冠心病患者中应用的安全性及1年临床随访结果,并与同期应用进口药物洗脱支架(Cypher和Taxus)比较。方法与结果2003年5月至2004年6月,共计673例经冠脉造影证实的冠心病患者接受药物洗脱支架治疗,其中接受国产西罗莫司药物洗脱支架(Firebird,上海微创公司)224例,进口西罗莫司药物洗脱支架(Cypher,美国强生公司)246例,进口紫杉醇药物洗脱支架(Taxus,美国波士顿公司)203例。各组基础临床情况及造影特征均相似,尽管Firebird组患者平均每例置入支架数目较多且支架总长度较长,但其住院总费用仍显著低于其他两组。术后1年临床随访严重心脏不良事件(包括心源性死亡、非致命性心肌梗死和靶血管再次血运重建)发生率在Firebird组为9·0%、Cypher组为8·4%、Taxus组为11·2%,相互比较差异无统计学意义。造影证实Firebird组2例(0·9%)、Cypher组2例(0·9%)和Taxus组3例(1·6%)发生支架内血栓形成。结论国产西罗莫司药物洗脱冠脉支架治疗冠心病安全,其1年临床疗效与进口西罗莫司及紫杉醇药物洗脱冠脉支架相似。
关键词(KeyWords): 冠状动脉疾病;支架;西罗莫司
基金项目(Foundation):
作者(Author): 张奇,张瑞岩,张建盛,胡健,杨震坤,倪钧,张宪,沈卫峰
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