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常规临床实践中的药物洗脱支架血栓形成:来自 TAXUS ARRIVE 注册研究的两年结果和预测因素。

Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries.

机构信息

Washington University School of Medicine, St. Louis, MO 63110, USA.

出版信息

Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. doi: 10.1161/CIRCINTERVENTIONS.109.852178.109.852178. Epub 2009 Jul 22.

DOI:10.1161/CIRCINTERVENTIONS.109.852178.109.852178
PMID:20031730
Abstract

BACKGROUND

Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.

METHODS AND RESULTS

Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.

CONCLUSIONS

The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

摘要

背景

支架血栓形成(ST)是药物洗脱支架和裸金属支架的一种罕见但严重的并发症。为了评估当代药物洗脱支架 ST 的情况,我们分析了来自 7492 例患者的 ARRIVE 登记处的 2 年数据。

方法和结果

患者在接受经皮冠状动脉介入治疗时入组,除使用紫杉醇洗脱 TAXUS 支架外,无其他纳入/排除标准。2 年随访率为 94%,主要心脏不良事件的独立评估。第二个独立的委员会裁定学术研究联合会(ARC)确定/可能的 ST。2 年累积 ARC 定义的 ST 为 2.6%(1.0%早期 ST[<30 天],0.7%晚期 ST[31-365 天]和 0.8%非常晚期 ST[>1 年])。单纯使用(单血管和单支架)病例的发生率低于广泛使用(更广泛的患者/病变特征,2 年累积:1.4%比 3.3%,P<0.001;早期 ST:0.4%比 1.4%,P<0.001;晚期 ST:0.5%比 0.8%,P=0.14;非常晚期 ST:0.4%比 1.0%,P=0.008)。ST 发生后 7 天内,23%的患者死亡;28%发生 Q 波心肌梗死。早期 ST(39%)的死亡率高于晚期 ST(12%,P<0.001)或非常晚期 ST(13%,P<0.001)。多变量分析显示解剖因素增加了早期 ST(病变>28mm,病变钙化)和晚期 ST(血管<3.0mm);生物因素增加了非常晚期 ST(肾病,先前的放射治疗)。尽管早期 ST(71.4%)和非常晚期 ST(23.1%)患者在 ST 发生时均接受双重抗血小板治疗,但噻吩吡啶过早停药是两者的独立强预测因素。

结论

早期和晚期 ST 的相对风险不同。对特定亚组 ST 风险的了解可能有助于指导血运重建选择,直到这些广泛人群的随机试验完成。

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