Chen Ji-lin, Yang Yue-jin, Gao Li-jian, Huang Jing-han, Qin Xue-wen, Qiao Shu-bin, Xu Bo, Yao Min, Liu Hai-bo, Wu Yong-jian, Yuan Jin-qing, Chen Jue, You Shi-jie, Dai Jun, Li Jian-jun, Gao Run-lin
Department of Cardiology, Chinese Academy of Medical Sciences, China.
Chin Med J (Engl). 2008 Nov 5;121(21):2144-7.
Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents (DES) implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease (CAD) in China.
From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up: 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird. After two years of follow-up, there were 2176 patients (1245 Cypher, 558 Taxus and 373 Firebird). All patients were treated with aspirin and clopidogrel over at least 9 months.
Among 8190 patients, 17 patients had acute stent thrombosis (0.24%): 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis: 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%: 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%: 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%: 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.
The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.
随机临床试验已证明药物洗脱支架（DES）植入术后与裸金属支架具有同等安全性。然而，随机试验中的DES血栓形成情况无法与临床实践中观察到的情况相比较，临床实践中常包括非适应证使用。本研究旨在评估在中国现实世界中冠状动脉疾病（CAD）患者植入DES后的血栓形成发生率。
2001年12月至2007年4月，8190例连续患者接受DES治疗，5412例患者完成一年随访：2210例使用西罗莫司洗脱支架Cypher，1238例使用紫杉醇洗脱支架Taxus，1964例使用国产西罗莫司洗脱支架Firebird。两年随访后，有2176例患者（1245例Cypher，558例Taxus，373例Firebird）。所有患者至少9个月接受阿司匹林和氯吡格雷治疗。
在8190例患者中，17例发生急性支架血栓形成（0.24%）：Cypher组7例，Taxus组4例，Firebird组6例；23例发生亚急性支架血栓形成：Cypher组8例，Taxus组6例，Firebird组9例。急性和亚急性血栓形成发生率为0.49%：Cypher组0.50%，Taxus组0.63%，Firebird组0.41%。一年随访时晚期血栓形成发生率为0.63%：Cypher组0.63%，Taxus组0.88%，Firebird组0.46%；两年随访时发生率为0.74%：Cypher组0.72%，Taxus组0.90%，Firebird组0.54%。三组在一年和两年随访时无显著差异。
如果患者积极接受双联抗血小板药物治疗，第一代DES治疗复杂病变是安全有效的。
