冠心病真实世界中药物洗脱支架置入术后血栓形成的发生率

The incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease in the real world:a single center registry study

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 observe the incidence rate of stent thrombosis after implantation of drug- eluting stents （DES） in patients with coronary artery disease （CAD） in the real world. Methods A total of 8190 consecutive CAD patients underwent implantation with Cypher or Cypher Select stents（ Cordis, USA, n =2986）, TAXUS stents（ Boston Scientific Corp. , USA, n = 1587） and Chinese Rapamycin eluting stentts （Firebird, Microport Medical Company, China, n = 3617） for enrolled in this single center registry study from Dec. 2001 to April 2007. One-year follow-up was completed in 5412 patients （2210 Cypher or Cypher select stents, 1238 TAXUS stents and 1964 Firebird stents）. Two-year follow-up was finished in 2176 patients （1245 Cypher or Cypher Select stents, 558 TAXUS stents and 373 Firebird stentts）. 80. 1% of all the lesions were the type B2 and type C lesions. All patients were treated with aspirin plus clopidogrel for at least 9 months post DES. Results Among 8190 patients, 17 patients had acute stent thrombosis （0. 21% ） ：7 in the Cypher group, 4 in the TAXUS group, 6 in the Firebird group; 23 patients had subacute stent thrombosis （0. 28% ） ： 8 in Cypher group, 6 in TAXUS group and 9 in Firebird group. The incidence rate of acute and subacute thrombosis was 0. 49% （40/8190） and incidence of thrombosis was similar among the three groups （0. 50% in Cypher group, 0.63% in TAXUS group and 0.41% in Firebird group, P 〉 0. 05）. One-year follow-up showed that late thrombosis rate was 0. 63 % （34/5412） and similar among the groups （0.63% in Cypher group, 0. 89% in TAXUS group and 0. 46% in Firebird group, P 〉0. 05）. Two- year follow-up showed that late thrombosis rate was 0. 74 % （16/2176） and was similar among the 3 groups （0.72% in Cypher group, 0. 90% in TAXUS group and 0. 54% in Firebird group, P 〉 0. 05 ）. Condtmion This study indicates that using the first-generation DES to treat complex coronary lesions is safe and effective and the incidence of late thrombosis remains low （ 〈 1% ） under double antiplatelet treatment.