进口与国产雷帕霉素洗脱支架一年临床疗效比较

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。

Comparison of one-year clinical outcomes of domestic sirolimus-eluting stents versus imported sirolimus-eluting stents for the treatment of coronary artery disease

Objective To compare the clinical outcomes between treatment with domestic sirolimus-eluting stents（SES）and imported SES.Methods Two thousand consecutive patients treated with SESs from January 2004 to December 2006 in Anzhen hospital were included in this study.Based on the difference of the stents,the patients were divided into 2 groups including the domestic SES（Firebird stent）group（n=1004）and the imported SES（Cypher stent）group（n=996）.Clinical outcomes were monitored for one year.The primary endpoint was the incidence of major adverse cardiac events（MACE）：a composite of death,nonfatal myocardial infarction（MI）,and target-vessel revascularization（TVR）.Secondary endpoint was definite/probable stent thrombosis.Results After one-year follow-up,there was no significant difference in MACE between domestic and imported DES groups（17.8% vs.18.6%,P=0.666）.The mortality（4.7% vs.5.1%,P=0.649）,MI（4.2% vs.4.8%,P=0.493）and TVR rate（9.0% vs.8.6%,P=0.795）were all similar between the two groups.The incidence of definite/probable stent thrombosis has no significant difference during one year of follow-up（1.1% vs.1.0%,P=0.841）.After adjustment for other variates,DES type was not an independent risk factor for one-year MACE.Conclusion Domestic Firebird SES and imported Cypher SES had similar effects and safety in terms of on one-year clinical outcomes.