Domestic rapamycin-eluting stent implantation for acute ST-segment elevation myocardial infarction: Comparison with foreign stent in safety and efficacy

Abstract

AIM：To compare the safety and efficacy of domestic (Firebird) rapamycin-eluting stent with foreign (CypherTM) stent in patients with acute ST-segment elevation myocardial infarction (STEMI).

METHODS：①All implantation were successful in 121 patients. 64 Firebird stents were implanted into 62 crime lesions of infarction-related artery and 61 CypherTM stents in 59 crime lesions.②One patient of Firebird group occurred subacute thrombosis on the fifth day after procedure, then he got successful second percutaneous coronary invention. In CypherTM stent group, one patient died of acute left ventricular function failure on the sixty-fourth day after procedure, one else patient occurred sudden death five months after procedure.③There were no significant differences between the two groups on instant angiographic and clinical outcomes.④At follow-ups of 117 patients, the mortality, target vessel revascularization ratio and major adverse cardiac events were 3.4%, 0%, 3.4% respectively in CypherTM group versus 3.2%, 1.6%, 4.8% respectively in Firebird group (P > 0.05).

RESULTS:The application of Firebird stents in patients with acute STEMI is safe. Compared with CypherTM stent, Firebird stent has no significant hemorheological or histiooytic side effect, and no special biocompatible problem or safety occurs.

Xie SF, Li ZH, Zhu HQ, Zhong YH, Liu WB, Xie Z, Li JM.Domestic rapamycin-eluting stent implantation for acute ST-segment elevation myocardial infarction: Comparison with foreign stent in safety and efficacy．Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(4):615-618(China) [www.zglckf.com/zglckf/ejournal/upfiles/08-4/4k-615(ps).pdf]

摘要
目的：比较国产雷帕霉素洗脱支架（Firebird支架）和进口雷帕霉素洗脱支架（CypherTM支架）置入治疗急性ST段抬高心肌梗死的安全性和有效性。
方法：选择2005-03/2007-02就诊于赣州市立医院心内科及深圳市孙逸仙心血管医院的急性ST段抬高心肌梗死患者121例，经患者及家属知情同意后进行临床观察，治疗过程经医院医学伦理委员会批准。其中CypherTM支架组59例，Firebird支架组62例。比较两组支架置入后冠状动脉造影结果、住院期间的临床结果；随访2~12个月，记录死亡率、靶血管重建率及主要心血管事件发生率。
结果：①121例患者支架置入均获得成功。62例梗死相关血管的62处病变置入64枚Firebird支架；另59支梗死相关血管的59处病变置入61枚CypherTM支架。②Firebird支架组1例术后第5天出现支架内亚急性血栓形成，再次行冠状动脉介入术获得成功。CypherTM支架组1例术后64 d发生急性左心衰竭而死亡，1例术后5个月在院外猝死。③两组比较支架置入后造影结果和临床结果差异无显著性意义。④对117例患者进行随访，CypherTM支架组死亡率、靶血管重建率和主要心血管事件发生率分别为3.4%、0%和3.4%；Firebird支架组死亡率、靶血管重建率和主要心血管事件发生率分别为3.2%、1.6%和4.8%，差异无显著性意义（P > 0.05）。
结论：国产雷帕霉素药物洗脱支架置入治疗急性ST段抬高心肌梗死患者是安全的,随访未发现管腔内出现血液及组织细胞的变化，无特殊生物相容性和安全性问题，与进口雷帕霉素药物涂层支架相比较各项指标差异不明显。
关键词：急性ST段抬高心肌梗死；雷帕霉素药物洗脱支架；急诊冠状动脉介入治疗；生物材料；生物相容性

谢绍峰，李忠红，朱恒青，钟湧辉，刘伟斌，谢正，李锦梅.国产雷帕霉素药物洗脱支架置入治疗急性ST段抬高心肌梗死：与进口药物支架比较其安全性和有效性[J].中国组织工程研究与临床康复，2008，12(4):615-618 [www.zglckf.com/zglckf/ejournal/upfiles/08-4/4k-615(ps).pdf]