成功置入FIREBIRD支架和CYPHER支架远期临床疗效比较:单中心注册研究分析结果

背景:近年来的数据显示,西罗莫司洗脱支架(SES)不仅可以减少再狭窄的发生率,同时也能减少靶血管血运重建率。CYPHER支架和FIREBIRD支架是目前中国使用最广泛的SES。然而,目前尚缺乏比较国人使用CYPHER支架和FIREBIRD支架远期有效性和安全性的数据资料。方法:自2004-04至2006-06我院共3 979例成功植入SES的患者入选本注册研究。入选患者根据支架类型分为FIREBIRD组2 274例,CYPHER组1 705例。随访指标包括术后24个月死亡、心肌梗死、血栓形成、靶病变血运重建、靶血管血运重建和主要心脏不良事件(死亡、心肌梗死和靶血管血运重建的复合终点)。采用Cox’s比例风险模型评估两组倾向性评分匹配后所有终点的相对风险。结果:经倾向性匹配后,术后24个月两组所有临床事件的发生率差异均无统计学意义(P>0.05)。两组间各终点发生的风险差异均无统计学意义(P>0.05)。两组间学术研究联合会(ARC)定义的所有血栓形成发生率均相似(P>0.05)。结论:使用国产FIREBIRD支架与进口CYPHER支架相比具有相同的有效性和安全性。

Comparison of Long-Term Clinical Outcome in Patients With Successfully Implanted FIREBIRD or CYPHER Sirolimus-Eluting Stents: A Single Center Registry Analysis

Objective:We found that sirolimus-eluting stents(SES) can reduce the incidences of re-stenosis and the target vessel revascularization(TVR) in recent year clinical practice.FIREBIRD and CYPHER stents are most frequently used SES in China.We compared the long-term efficacy and safety between domestic FIREBIRD SES and imported CYPHER SES in Chinese patients. Methods:A total of 3 979 consecutive patients who successfully underwent SES implantation from April 2004 to October 2006 in our hospital were retrospectively studied.The patients were divided as domestic FIREBIRD SES group,n=2 274,and imported CYPHER SES group,n=1 705.The patients were followed-up for 24 months for death,myocardial infarction(MI),thrombosis,target lesion revascularization,TVR,and major adverse cardiac events(MACE) which including the composite of death,MI,and TVR.Cox’s proportional-hazards models were used to assess the relative risk of all outcomes after the propensity match between two groups. Results:Propensity match analysis indicated that no significant difference for the above mentioned clinical events between two groups at 24 months follow-up time P>0.05,no difference in the risk for the composite of end events between two groups P>0.05.According to Academic Research Consortium definition,the thrombosis rate was similar between two groups P>0.05. Conclusion: Domestic FIREBIRD SES has almost the same efficacy and safety to imported CYPHER SES.FIREBIRD can be used alternatively in our clinical practice.