比较不同药物洗脱支架置入后晚期血栓形成的发生率

Comparison of Late Stent Thrombosis Rate After Different Drug-Eluting Stents Implantation in Patients With Coronary Artery Disease

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。

Objective ：To compare the late stent thrombosis rate after different drug-eluting stents （DES） implantation in patients with coronary artery disease （CAD） in real world practice. Methods： A total of 11352 consecutive CAD patients who underwent different DES implantation from December 2001 to December 2008 in our hospital were analyzed in 3 groups： Cypher or Cypher Select stents （Cypher group）, n = 3915 ,TAXUS or TAXUS Liberty stents （TAXUS group） ,n = 2202 and Firebird stent （Firebird group）, n = 5235. One year follow up was completed in 8626 patients,including 3012 in Cypher group, 1518 in TAXUS group, and 4096 in Firebird group. Two-year follow up were finished in 5993 patients including 2187 in Cypher group, 1159 in TAXUS group and 2647 in Firebird group. Three-year follow up had 3378 patients including 1596 in Cypher group ,860 in TAXUS group and 922 in Firebird group. All patients were treated with Aspirin plus Clopidogrel for at least 9 months after PCI. Results： One year follow up showed the rate of thrombosis was 1.20% in Cypher group, 1.25% in TAXUS group and 0. 81% in Firebird group; there was no significant difference among three groups. The rate of stent thrombosis for two-year and three-year follow up were 1.51% and 1.88% in Cypher group,1.70% and 1.86% in TAXUS group and 1.02% and 1.30% in Firebird group, respectively. There were no significant differences among three groups. Conclusion ： No significant difference was found in the rate of late thrombosis among three kinds of DES for three-year follow up. Prolonging dual anti-platelet therapy for more than one year might be recommended for reducing late thrombosis rate after DES implantation.