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目的:评估非选择性冠心病患者置入TAXUS系列的新型支架-TAXUS-LiberteTM-SR的安全性和有效性。方法:作为一个前瞻性的、双中心、观察性的研究,时间从2006-12-2007-07,符合冠心病诊断的患者共入选240例,获得伦理委员会的同意,并签署知情同意书。以新发冠状动脉病变为主要研究病变,血管直径2.25～3.5mm之间的作为靶血管进行冠状动脉介入治疗术。主要研究终点TAXUS-LiberteTM-SR支架置入后6个月主要心脏不良事件的发生率及靶病变血管重建率,支架血栓发生率。结果:入选的240例患者,平均年龄(65.61±10.87)岁,靶血管长度(>20mm)占到29%,参考血管直径(<2.5mm)有17%,新发血管病变为82%;平均狭窄直径百分数(89.02±8.14)%。有支架置入指针为93%,共224例患者置入支架,6个月随访主要心脏事件5%,其中死亡0.83%,再次心肌梗死1.7%。90.6%的患者进行冠状动脉造影随访,其中靶病变血管重建率2.6%,发生支架内血栓2例,其中死亡1例。结论:TAXUS-LiberteTM-SR支架作为新一代的TAXUS紫杉醇药物支架系统,是TAXUS-EXPRESS支架系统优秀平台的延续,对各类冠心病患者具有相当的安全性和良好的临床疗效。
Objective: To evaluate the safety and efficacy of TAXUS-Liberte ™-SR, a new type of TAXUS stent, in patients with non-selective coronary heart disease. Methods: As a prospective, bi-center and observational study, 240 patients with coronary heart disease were enrolled in the study from December 2006 to July 2007, with the consent of ethics committee and signed informed consent. The newly developed coronary artery disease as the main study lesions, vascular diameter 2.25 ~ 3.5mm between the target vessel for coronary intervention. MAIN OUTCOME MEASURES Six months after TAXUS-LiberteTM-SR stent implantation, the incidence of major adverse cardiac events, rates of target vessel revascularization and stent thrombosis were recorded. Results: The average age of the 240 patients (65.61 ± 10.87 years), 29% of target vessel length (> 20mm), 17% of reference vessel diameter (<2.5mm) and 82% of new vessel disease The percentage of stenosis diameter (89.02 ± 8.14)%. There were 93% of patients with a stent placement, a total of 224 patients were placed in stents, 5% of the major cardiac events were followed up for 6 months, of which 0.83% died and 1.7% had another myocardial infarction. Follow-up coronary angiography was performed in 90.6% of the patients, of which the target lesion revascularization rate was 2.6%. Two cases of stent thrombosis occurred, of which 1 died. Conclusion: As a new generation of TAXUS paclitaxel drug scaffold system, TAXUS-LiberteTM-SR stent is a continuation of the excellent platform of TAXUS-EXPRESS scaffold system and has considerable safety and good clinical efficacy in patients with various types of coronary heart disease.