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

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。

Objective We investigated the safety and one-year clinical outcomes of Chinese sirolimus-eluting Firebird stents in the treatment of unselected patients with coronary artery disease, and compared to those receiving Cypher or Taxns stents. Methods and Results From May 1, 2003 to June 30, 2004, a total of 673 consecutive patients with de novo coronary lesions were randomized to Firebird （ n = 224, Firebird group）, Cypher （n= 246, Cypher group） and Taxns （n = 203, Taxus group） stent treatment. Major adverse cardiac events （MACE） including cardiac death, non-fatal myocardial infarction or target vessel revasctdarization were recorded. The baseline clinical and angiographic characteristics among the three groups were similar. Although the number of stents implanted per patient was greater and total stented length was longer in Firebird group compared with Cypher and Taxus groups, the cost of hospitalization was significantly lower. The incidence of MACE at one-year follow-up was 9.0% in Firebird group, 8.4% in Cypher group and 11.2% in Taxus group respectively （ P all 〉 0.05）. AngiographicaUy identified stent thrombosis occurred in 2 patients （0.9%） in Firebird group, 2 patients （0.9%） in Cypher group and 3 patients （1.6%） in Taxus group. Conclusion Implantation of the Firebird stent in unselected patients with coronary artery disease is safe and has shown no inferiority in one-year clinical outcomes compared to the Cypher or Taxns stents.