Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents
Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents
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DOI：
10.1001/jama.293.17.2126
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发表时间：
2005-05-04
影响因子：
120.7
通讯作者：
Colombo, A
中科院分区：
文献类型：
--
作者：
Iakovou, I;Schmidt, T;Colombo, A
背景传统上，支架血栓形成一直被认为是术后30天内经皮冠状动脉介入治疗的并发症。然而，与植入药物洗脱支架相关的延迟内皮化可能会延长血栓形成的风险超过30天。关于这一现象的风险和影响的临床试验数据有限。目的评估常规临床实践中西罗莫司和紫杉醇洗脱支架植入后支架血栓的发生率、预测因素和临床结果。设计、设置和患者前瞻性观察队列研究在德国和意大利的1所学术医院和2家社区医院进行。2002年4月至2004年1月，2229例患者成功地植入了西罗莫司洗脱支架(1062例，1996个病变，2272个支架)或紫杉醇洗脱支架(1167例，1801个病变，2223个支架)。所有患者均给予噻氯匹定或氯吡格雷联合阿司匹林治疗。阿司匹林无限期继续服用，氯吡格雷或。西罗莫司洗脱后至少3个月，紫杉醇洗脱支架置入后至少6个月。主要指标亚急性血栓形成(从手术结束到30天)、晚期血栓形成(30天)和累积支架血栓形成。结果9个月随访时，29例患者(1.3%)发生支架血栓，西罗莫司组9例(0.8%)，紫杉醇组20例[1.7%]；P=.09)。亚急性血栓形成14例(0.6%)，晚期血栓形成15例(0.7%)。在这29名患者中，13人死亡(病死率为45%)。支架血栓形成的独立预测因素是过早停止抗血小板治疗(风险比[HR]，89.78；95%CI，29.90-269.60；P
Context Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials.Objective To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice.Design, Setting, and Patients Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting (1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting (1167 patients, 1801 lesions, 2223 Stents) stents between April 2002 and January 2004.Interventions implantation of a drug-eluting stent (sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or. ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxel-eluting stent implantation.Main Outcome Measures Subacute thrombosis (from procedure end through 30 days), late thrombosis (>30 days), and cumulative stent thrombosis.Results At 9-month follow-up, 29 patients (1.3%) had stent thrombosis (9 [0.8%] with sirolimus and 20 [1.7%] with paclitaxel; P=.09). Fourteen patients had subacute thrombosis (0.6%) and 15 patients had late thrombosis (0.7%). Among these 29 patients, 13 died (case fatality rate, 45%). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation (hazard ratio [HR], 89.78; 95% Cl, 29.90-269.60; P