进口与国产雷帕霉素洗脱支架一年临床疗效比较Comparison of one-year clinical outcomes of domestic sirolimus-eluting stents versus imported sirolimus-eluting stents for the treatment of coronary artery disease
于淼,周玉杰,阎赢,王志坚,史冬梅,刘宇扬,赵迎新,成万钧,郭永和
摘要(Abstract):
目的对因冠状动脉粥样硬化性心脏病接受择期经皮冠状动脉介入治疗(PCI)的患者,对比接受国产雷帕霉素药物洗脱支架(Firebird)和进口雷帕霉素药物洗脱支架(CypherSelect)治疗后1年的临床疗效。方法连续入选2004年1月至2006年12月于北京安贞医院接受介入治疗置入国产和进口雷帕霉素药物洗脱支架(SES)的冠心病患者2000例,根据置入支架类型,分为国产Firebird组(Firebird;1004例)和进口Cypher组(Cypher;996例)。随访1年的临床疗效。初级终点为两组患者支架术后主要心血管不良事件(MACE)的发生率,包括全因死亡、非致死性心肌梗死及靶血管重建。次级终点为1年内的支架内血栓发生率。结果 1年的随访结果显示,国产和进口雷帕霉素药物洗脱支架(SES)组的MACE发生率差异无统计学意义(17.8%比18.6%,P=0.666)。两组患者的死亡(4.7%比5.1%,P=0.649)、心肌梗死(4.2%比4.8%,P=0.493)和靶血管重建率(9.0%比8.6%,P=0.795)均相近。两组患者12个月确定/可能性支架内血栓的发生率亦差异未见统计学意义(1.1%比1.0%,P=0.841)。多因素回归分析表明,DES类型不是1年内MACE的独立预测因素。结论国产FirebirdSES和进口CypherSES在术后1年内具有相同的临床疗效和安全性。
关键词(KeyWords): 药物洗脱支架;治疗结果;预后
基金项目(Foundation):
作者(Author): 于淼,周玉杰,阎赢,王志坚,史冬梅,刘宇扬,赵迎新,成万钧,郭永和
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