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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-term and long-term effects of domestic-made sirolimus-eluting stent (Firebird) in patients with coronary heart disease. Methods From November 2003 to January 2005 a total of 410 patients with coronary heart disease (460 lesions) placed Firebird stent 501. All patients were given adequate antiplatelet drugs preoperatively and postoperatively. Some patients underwent coronary angiography to evaluate the clinical efficacy of Firebird stent in the treatment of coronary heart disease in China. Results The successful rate of operation was 99.5%. One case had intra-arterial thrombosis during operation. One case of sudden death occurred after hospitalization. The incidence of major adverse cardiac events (including death, non-fatal myocardial infarction and target lesion revascularization) was 0.2 % (1/410); 376 patients were followed up, the follow-up rate was 91.7%, mean follow-up time was 12.8 ± 3.2 months, 3 died, 4 non fatal myocardial infarction and 11 re-target lesion reconstruction , The incidence of major adverse cardiac events was 4.3% (16/376) and the rate of stent thrombosis was 1.1% (4/376). Coronary angiography was performed in 102 patients (122 lesions). The rate of in-stent restenosis was 2.9% (12/418) in all follow-up patients, accounting for 9.8% (12/122) of all angiograms. Conclusion Firebird stent is safe and effective in the interventional treatment of coronary heart disease in China, but large-scale randomized controlled trials are still needed to evaluate.