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植入依维莫司洗脱支架后 3 个月双联抗血小板治疗:DATE(依维莫司洗脱支架置入后双联抗血小板治疗时间)注册研究。

Three-month dual antiplatelet therapy after implantation of zotarolimus-eluting stents: the DATE (Duration of Dual Antiplatelet Therapy AfterImplantation of Endeavor Stent) registry.

机构信息

Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.

出版信息

Circ J. 2010 Nov;74(11):2314-21. doi: 10.1253/circj.cj-10-0347. Epub 2010 Oct 2.

Abstract

BACKGROUND

The optimal duration of dual antiplatelet therapy remains controversial.

METHODS AND RESULTS

Between December 2006 and March 2008, 823 patients were enrolled in a prospective multicenter registry for 3-month dual antiplatelet therapy (aspirin 100-200mg+clopidogrel 75 mg daily) followed by aspirin mono-therapy after zotarolimus-eluting stents (ZES). Major exclusion criteria were: cardiogenic shock, stent thrombosis (ST)-segment elevation myocardial infarction (MI) within 48h, previous drug-eluting stent implantation, severe left ventricular dysfunction, bifurcation lesions requiring 2-stenting, left main and graft lesions. The primary outcome was a composite of cardiac death, MI, or ST at 1 year. The median duration of dual antiplatelet therapy was 95 days (interquartile range 90-101). At 1 year, 3 patients (0.4%) had cardiac deaths, 3 patients (0.4%) had MI, and 4 patients (0.5%) had definite or probable ST, leading to the primary outcome in 5 patients (0.6%). Death, MI, or any revascularization occurred in 68 patients (8.3%). Among patients who were event-free at 3 months (n=812), clopidogrel was discontinued at 3 months in 661 patients and was continued for longer than 3 months in 151 patients. Discontinuation of clopidogrel at 3 months did not increase the primary outcome (HR 0.90; 95%CI, 0.09-9.02), death, MI, or any revascularization (HR 0.89; 95%CI, 0.48-1.67) after adjustment for the propensity score.

CONCLUSIONS

Three-month dual antiplatelet therapy seems to be feasible after ZES implantation in relatively low-risk patients.

摘要

背景

双联抗血小板治疗的最佳持续时间仍存在争议。

方法和结果

2006 年 12 月至 2008 年 3 月,823 例患者入选了一项前瞻性多中心注册研究,接受 3 个月双联抗血小板治疗(阿司匹林 100-200mg+氯吡格雷 75mg 每日),随后在紫杉醇洗脱支架(ZES)后采用阿司匹林单药治疗。主要排除标准为:心源性休克、支架内血栓形成(ST 段抬高型心肌梗死)在 48 小时内、以前植入药物洗脱支架、严重左心室功能障碍、需要 2 个支架的分叉病变、左主干和移植病变。主要终点是 1 年内的心脏死亡、心肌梗死或 ST 复合终点。双联抗血小板治疗的中位时间为 95 天(四分位距 90-101)。1 年后,3 例(0.4%)患者发生心脏死亡,3 例(0.4%)患者发生心肌梗死,4 例(0.5%)患者发生明确或可能的 ST,导致 5 例(0.6%)患者出现主要终点事件。68 例(8.3%)患者发生死亡、心肌梗死或任何血运重建。在 3 个月时无事件的患者(n=812)中,661 例患者在 3 个月时停用氯吡格雷,151 例患者继续使用氯吡格雷超过 3 个月。在调整倾向评分后,3 个月时停用氯吡格雷并未增加主要终点事件(HR 0.90;95%CI,0.09-9.02)、死亡、心肌梗死或任何血运重建(HR 0.89;95%CI,0.48-1.67)。

结论

在相对低危患者中,ZES 植入后 3 个月的双联抗血小板治疗似乎是可行的。

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