The Warfarin/Aspirin Study in Heart failure (WASH): A randomized trial comparing antithrombotic strategies for patients with heart failure

The Warfarin/Aspirin Study in Heart failure (WASH): A randomized trial comparing antithrombotic strategies for patients with heart failure
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DOI:
10.1016/j.ahj.2004.03.010
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发表时间:
2004-07-01
影响因子:
4.8
通讯作者:
Poole-Wilson, PA
Poole-Wilson, PA
中科院分区:
医学2区
文献类型:
--
作者:
Cleland, JGF;Findlay, I;Poole-Wilson, PA

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背景心力衰竭通常与血管疾病和高发生率的动脉粥样硬化血栓形成事件有关,但抗血栓治疗的风险和益处尚不清楚。方法本研究是一项开放标签、随机、对照试验,比较无抗血栓治疗、阿司匹林(300 mg/天),和华法林(目标国际标准化比值2.5)在需要利尿剂治疗的心力衰竭和左心室收缩功能障碍患者中的应用。主要目的是证明可行性,并为更大规模结局研究的设计提供信息。主要临床结局为死亡、非致命性心肌梗死或非致命性中风。结果279例患者随机分组,平均随访时间为27 +/- 1个月,累积暴露627患者年。分别有26例(26%)、29例(32%)和23例(26%)随机分配至无抗血栓治疗组、阿司匹林组和华法林组的患者达到主要结局(ns)。在随机分配到阿司匹林组的患者中,一些次要结局有更差的趋势。显着(P = 0.044)更多的患者随机分配到阿司匹林住院的心血管原因,特别是恶化的heartfailure.Conclusions Warcraft/阿司匹林研究心力衰竭(WASH)提供没有证据表明,阿司匹林是有效的或安全的心力衰竭患者。华法林对窦性心律心力衰竭患者的益处尚未确定。心力衰竭患者的抗血栓治疗并非基于证据,但通常会导致多种药物治疗。
Background Heart failure is commonly associated with vascular disease and a high rate of athero-thrombotic events, but the risks and benefits of antithrombotic therapy are unknown.Methods The current study was an open-label, randomized, controlled trial comparing no antithrombotic therapy, aspirin (300 mg/day), and warfarin (target international normalized ratio 2.5) in patients with heart failure and left ventricular systolic dysfunction requiring diuretic therapy. The primary objective was to demonstrate the feasibility and inform the design of a larger outcome study. The primary clinical outcome was death, nonfatal myocardial infarction, or nonfatal stroke.Results Two hundred seventy-nine patients were randomized and 627 patient-years exposure were accumulated over a mean follow-up time of 27 +/- 1 months. Twenty-six (26%), 29 (32%), and 23 (26%) patients randomized to no antithrombotic treatment, aspirin, and warfarin, respectively, reached the primary outcome (ns). There were trends to a worse outcome among those randomized to aspirin for a number of secondary outcomes. Significantly (P = .044) more patients randomized to aspirin were hospitalized for cardiovascular reasons, especially worsening heart failure.Conclusions The Warfarin/Aspirin Study in Heart failure (WASH) provides no evidence that aspirin is effective or safe in patients with heart failure. The benefits of warfarin for patients with heart failure in sinus rhythm have not been established. Antithrombotic therapy in patients with heart failure is not evidence based but commonly contributes to polypharmacy.