摘要
目的观察急性心肌梗死(AMI)患者经皮冠脉介入(PCI)时应用药物洗脱支架的疗效及安全性。方法采用前瞻性随机对照方法,将AMI患者随机分为普通支架组(CrofelexTheca支架组,C组),进口药物洗脱支架组(Taxus组,T组),国产药物洗脱支架组(Firebird组,F组),每组计划入选各20例,急诊PCI术时仅处理梗死相关动脉。观察住院期间、6个月心血管疾病死亡,再梗死,再住院,靶血管再血管化等情况。结果最终C组、T组、F组各入选15,18,16例,发病至手术时间:C组(6.67±3.26)h,T组(6.22±3.77)h,F组(6.44±3.69)h;靶血管特征为:C组血管直径≥3.0mm占80%,T组≥3.0mm占72.2%,F组≥3.0mm占81.3%;C组植入支架15枚,T组21枚,F组16枚,手术成功率均为100%。三组住院其间均无心血管性疾病死亡,再梗死、靶血管再血管化;6个月随访中亦无心血管性疾病死亡、再梗死、靶血管再血管化,C组、F组各有1例因为心功能不全再入院。结论急诊PCI中应用药物洗脱支架,包括国产药物洗脱支架Firebird安全可靠,疗效明确;但样本量小,还有待进一步大样本,多中心的临床研究来证实。
Objective To observe the efficacy and safety of applying drug eluting stent in AMI. Methods All patients with AMI were enrolled in this randomized contral trail from July, 2003 to Jan, 2004 in Shanghai sixth people's hospital. They were divided into Crofelex Theca group (Group C ), Taxus group (Group T) and Firebird group (Group F), with 20 patients for each. Only the infarction related artery was treated by PCI. The cardiovascular mortality, AMI rehospitalized and target vessel revasculization (TVR) were observed in hospital and 6 months post-PCI. Results 15, 18, 16 cases were enrolled finally and 15, 21, 16 stents were implanted in Group C, Group T, Group F respectively. All procedures of each group were successful. The average ages were 68 ± 11, 66 ± 9 and 62 ± 14 years old, the times from onset to operation were(6.67 ± 3.26)h, (6.22 ± 3.77)h and(6.44 ± 3.69)h; for Group C, Group T and Group F respectively. The rate of target vessels' diameters more than 3.0 mm in Group C, Group T and Group F were 80%, 72.2% and 81.3% respectively. There was no cardiovascular mortality of AMI, TVR during in-hospital and at 6 months follow-up, except group C and group F having each of one case re-inhospilized with heart failure. Conclusion The application of drug-eluting stent in AMI is safe and reliable. However, a further large-scale and muhicenter trial is still needed. (J Intervent Radiol, 2006, 15: 518-520)
出处
《介入放射学杂志》
CSCD
2006年第9期518-520,共3页
Journal of Interventional Radiology
关键词
急性心肌梗死
药物洗脱支架
经皮冠状动脉介入
Acute myocardial infarction
Pereutaneous coronary intervention
Drug eluting stent