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目的:探讨冠心病患者非选择性病变中即真实世界中(real-world)不同药物洗脱支架(DES)置入后晚期血栓形成的发生率。方法:本研究为单中心DES注册研究,在病变的入选标准上无特殊限制,自2001-12至2008-12共计11352例冠心病患者接受了DES治疗,其中使用雷帕霉素DES(Cypher或Cypher Select支架,美国Cordis公司)3915例(Cypher组),使用紫杉醇DES(TAXUS或TAXUS liberty支架,美国波士顿科技公司)2202例(TAXUS组),使用国产雷帕霉素DES(Firebird,中国微创医疗器械有限公司)5235例(Firebird组)。在上述三种不同的DES中,完成1年临床随访总例数为8626例,其中Cypher组为3012例、TAXUS组为1518例、Firebird组为4096例,完成2年临床随访总例数为5993例,各组例数分别为2187例、1159例、2647例。完成3年临床随访总例数为3378例,各组例数分别为1596例、860例、922例。所有患者PCI术后联合应用阿司匹林与氯吡格雷至少9个月。结果:1年临床随访结果显示晚期血栓发生率在Cypher组、TAXUS组以及Firebird组各自为1.20%,1.25%和0.81%;2年临床随访显示晚期支架内血栓发生率三组分别为1.51%、1.70%、1.02%;3年临床随访显示晚期支架内血栓发生率三组分别1.88、1.86%、1.30%。3组之间各年度比较,其晚期血栓发生率差异均无统计学意义。然而在3组中均可发现,从第一年至第三年间,每年晚期血栓发生率呈递增现象。结论:本研究结果显示应用以上3种DES治疗冠心病无选择性病变均有良好的临床远期疗效,但每年晚期血栓发生率呈递增现象仍应引起高度的重视并提示对于复杂性冠状动脉病变或置入较多支架的患者,双联抗血小板治疗应延长至1年或更长时间为妥。
PURPOSE: To investigate the incidence of late thrombosis in non-selective lesions of patients with coronary heart disease, ie, real-world DES. METHODS: This study, a single-center DES registry, has no specific limitations on the criteria for inclusion of lesions. A total of 11,352 patients with coronary heart disease underwent DES from 2001-12 to 2008-12, using either rapamycin DES (Cypher or (Cypher Select Stent, Cordis Company, USA) 3915 cases (Cypher group) were treated with paclitaxel DES (TAXUS or TAXUS liberty stent, Boston Scientific) 2202 cases (TAXUS group) Medical Devices Co., Ltd.) 5235 cases (Firebird group). Among the above three different types of DES, the total number of clinical follow-up cases completed at 1 year was 8,626, including 3012 in the Cypher group, 1,518 in the TAXUS group and 4096 in the Firebird group. The total number of cases followed up for 2 years was 5,993 Cases, the number of cases were 2187 cases, 1159 cases, 2647 cases. The total number of clinical follow-up cases completed in 3 years was 3378 cases, with 1596 cases in each group, 860 cases and 922 cases. All patients received aspirin plus clopidogrel for at least 9 months after PCI. Results: The 1-year clinical follow-up results showed that the rates of late thrombosis were 1.20%, 1.25% and 0.81% respectively in Cypher group, TAXUS group and Firebird group. The 2-year clinical follow-up showed that the rate of late stent thrombosis was 1.51% 1.7% and 1.02% respectively. The 3-year clinical follow-up showed that the incidence of thrombosis in late stent was 1.88, 1.86% and 1.30% in three groups respectively. There was no significant difference in the incidence of thrombosis between the three groups in each year. However, in all three groups, the incidence of thrombosis increased from the first year to the third year. Conclusion: The results of this study show that the above three kinds of DES in the treatment of non-selective lesions of coronary heart disease have a good long-term clinical efficacy, but the annual thrombosis rate increased phenomenon should still be given a high degree of attention and prompted for complex coronary artery disease Or patients with more stents, double antiplatelet therapy should be extended to 1 year or longer.