国产西罗莫司洗脱支架治疗冠心病的近远期疗效

Short and long-term therapeutic efficacy of drug-eluting stents (Firebird) for the treatment of coronary artery disease

目的评价国产西罗莫司洗脱支架(Firebird)在冠心病患者中应用的近、远期疗效。方法 2003年11月至2005年1月共410例冠心病患者(460处病变)置入 Firebird 支架501个。所有患者术前、术后均给予足量抗血小板药物,通过门诊或电话随访,部分患者进行了冠状动脉造影复查来评估 Firebird 支架在国人冠心病治疗中的临床疗效。结果手术成功率99.5%,术中有1例支架内血栓形成;术后住院期间有1例猝死,主要不良心脏事件(包括死亡、非致死性心肌梗死和靶病变血管重建术)发生率为0.2%(1/410);376例患者完成随访,随访率91.7%,平均随访时间(12.8±3.2)个月,死亡3例,非致死性心肌梗死4例,11例进行了再次靶病变重建术,主要不良心脏事件发生率为4.3%(16/376),支架内血栓发生率1.1%(4/376)。102例(122处病变)进行冠状动脉造影复查,支架内再狭窄率占所有随访患者的2.9%(12/418),占所有造影复查的9.8%(12/122)。结论Firebird 支架在国人冠心病介入治疗中的应用是安全和有效的,但尚需大规模的随机对照试验来评价。

Objective To evaluate the short and long-term therapeutic efticacy of drug-during stents （Firebird） for the treatment of coronary artery disease. Methods From Nov. 2003 to Jan. 2005, 501 Firebird stents were implanted in 410 patients with 460 lesions. All patients were administered with aspirin and clopidogrel before and after the procedures. Follow-up was made by telephone or interview, 102 out of 410 patients were followed up by angiography. Results The procedure success rate was 99.5%. Stent thrombosis occurred in one patient during the procedure and one sudden death developed 10 hours after the procedure in hospital. The major adverse cardiac event （MACE, including death, acute myocardial infarction and target lesion revascularization） rate during hospitalization was 0. 2% （1/410）. The MACE rate was 4. 3% （16/376） and the stent thrombosis rate was 1.1% （4/376） during clinical follow-up of 376 patients （ 12. 8 ±3.2 months）. The angiographic restenosis rate in 102 patients with 122 lesions was 9. 8% （12/122）. Conclusion Firebird drug-eluting stentt could be used safely and effectively in patient with coronary heart disease.