国产Firebird支架与Cypher支架在急性心肌梗死患者中的临床对比研究

目的 通过对比研究的方法评价国产Firebird雷帕霉素涂层支架与进口Cypher雷帕霉素涂层支架在急性心肌梗死患者中应用的安全性和有效性.方法 选择我院2004年12月至2006年2月诊断为急性ST段抬高型心肌梗死且发病12小时以内患者中接受Firebird支架的患者38例(Firebird组),接受Cypher支架治疗的患者43例(Cypher组).观察两组住院期间和6个月随访期间的心血管事件及支架内再狭窄的发生情况.结果 住院期间Firebird组无急性、亚急性血栓形成及心绞痛事件发生,9例术后6个月复查冠状动脉造影(3例有心绞痛事件)均未见支架内再狭窄;Cypher组2例于术后复发胸痛,原ST段抬高导联再次抬高,急诊冠状动脉造影示亚急性血栓形成,再次开通.8例术后6个月复查冠状动脉造影(4例有心绞痛事件)1例显示支架内再狭窄,再次植入药物支架.两组各有3例患者心绞痛事件与非支架血管有关.结论 国产Firebird支架在急性心肌梗死患者中应用具有同Cypher支架一致的安全性和有效性.

Contrast study of domestic drug eluting stents (Firebird) to imported drug eluting stents(Cypher) :clinical application in patients with acute myocardial infarction

Objective To evaluate the safety and efficacy of domestic drug eluting stent(Firebird) in treatment of acute myocardial infarction patients by the way of contrast. Methods From Dec 2004 to Feb 2006,81 patients received emergency angioplasty within 12 hours from beginning of heart event,38 patients were implanted Firebird stents, and 43 patients were implanted Cypher stents. Both major cardiac events and restenosis were observed at 6 months' follow-up. Results Firebird group did not show acute and subacute thrombolic formation and angina events in hospital, 9 patients received angiography without restenosis in 6 months though 3 patients had angina occurrence. Two patients had angina after operation in Cypher group, and CAG showed subacute thrombolic formation and reopened.Eight patients were checked by angiography 6 months and 4 patients had angina and one was confirmed in-stent restenosis, implanted drug eluting stent again.Three patients respectively in two groups had events but correlated to other vessels. Conclusion Domestic drug eluting stents are safe and effective compared with imported drug eluting stents in the patients of acute myocardial infarction.