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目的探讨真实世界(real-world)中药物洗脱支架(drug-eluting stents,DES)置入后血栓的发生率。方法研究为单中心 DES 注册,在入选标准上无特殊限制。自2001年12月至2007年4月共计8190例冠心病患者接受了 DES 的治疗,其中使用雷帕霉素 DES(Cypher 支架,美国 Cordis 公司)2986例,使用紫杉醇 DES(TAXUS 支架,美国波士顿科技公司)1587例,使用国产雷帕霉素 DES(Firebird,中国微创医疗器械有限公司)3617例。5412例完成了1年的临床随访,其中 Cypher DES2210例,TAXUS DES 1238例和 Firebird DES 1964例。完成2年临床随访的2176例包括 Cypher DES1245例,TAXUS DES 558例和 Firebird DES 373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。结果在8190例患者中,17例发生急性血栓(0.21%),7例发生在 Cypher DES 组,4例发生在 TAXUS DES 组,6例在 Firebird DES 组;23例发生亚急性血栓(0.28%),包括8例在 CypherDES 组,6例发生在 TAXUS DES 组和9例在 Firebird DES 组。急性和亚急性血栓的发生率为0.49%,其中 Cypher DES 组为0.50%,TAXUS DES 组为0.63%和 Firebird DES 组为0.41%。三组之间在急性和亚急性血栓发生率方面差异无统计学意义。1年随访结果显示晚期血栓发生率为0.61%,包括Cypher DES 组为0.63%,TAXUS DES 组为0.88%和 Firehird DES 组为0.46%,三组之间比较在晚期血栓发生率方面差异无统计学意义。2年随访结果显示,晚期血栓发生率为0.74%,其中 Cypher DES组为0.72%,TAXUS DES 组为0.90%,Firebird DES 组为0.54%,三组之间差异无统计学意义。结论研究结果提示在加强抗血小板治疗情况下,应用第一代 DES 治疗复杂性冠状动脉病变是安全和有效的,与早期选择性的病变研究相比,晚期血栓发生率无明显增加的趋势。
Objective To investigate the incidence of thrombus in real-world drug-eluting stents (DES). Methodological studies are single-center DES registries and there are no specific restrictions on inclusion criteria. From December 2001 to April 2007 a total of 8190 patients with coronary heart disease received DES treatment, which used rapamycin DES (Cypher stent, the United States Cordis) 2986 cases, the use of paclitaxel DES (TAXUS stent, the United States Boston Science and Technology Company) 1587 cases, the use of domestic rapamycin DES (Firebird, China Minimally Invasive Medical Devices Co., Ltd.) 3617 cases. 5412 cases completed a one-year clinical follow-up, including Cypher DES2210 cases, TAXUS DES 1238 cases and Firebird DES 1964 cases. 2176 patients who completed 2 years of clinical follow-up included 1245 cases of Cypher DES, 558 cases of TAXUS DES and 373 cases of Firebird DES. All patients received aspirin plus clopidogrel for at least 9 months after PCI. Results Among the 8,190 patients, 17 developed acute thromboembolism (0.21%), 7 occurred in the Cypher DES group, 4 in the TAXUS DES group, 6 in the Firebird DES group, and 23 in the subacute thrombus (0.28%) Including 8 in the CypherDES group, 6 in the TAXUS DES group and 9 in the Firebird DES group. The incidence of acute and subacute thrombi was 0.49%, with Cypher DES 0.50%, TAXUS DES 0.63% and Firebird DES 0.41%. The difference between the three groups in the incidence of acute and subacute thrombosis was not statistically significant. The 1-year follow-up results showed that the rate of late thrombosis was 0.61%, including 0.63% in the Cypher DES group, 0.88% in the TAXUS DES group and 0.46% in the Firehird DES group. There was no significant difference in the incidence of late thrombosis among the three groups significance. The 2-year follow-up results showed that the incidence of late thrombosis was 0.74%, which was 0.72% in Cypher DES group, 0.90% in TAXUS DES group and 0.54% in Firebird DES group. There was no significant difference between the three groups. Conclusions The results suggest that first-generation DES in the treatment of complex coronary lesions is safe and effective in the context of enhanced anti-platelet therapy, with no significant increase in the incidence of late thrombosis compared with early-selective lesions.