Lip Gregory Yh, Wrigley Benjamin J, Pisters Ron
University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK.
Cochrane Database Syst Rev. 2012 Jun 13(6):CD003336. doi: 10.1002/14651858.CD003336.pub2.
Patients with chronic heart failure (heart failure) are at risk of thromboembolic events, including stroke, pulmonary embolism and peripheral arterial embolism, whilst coronary ischaemic events also contribute to the progression of heart failure. Long-term oral anticoagulation is established in certain groups, including patients with heart failure and atrial fibrillation, but there is wide variation in the indications and use of oral anticoagulation in the broader heart failure population.
To determine whether long-term oral anticoagulation reduces total deaths and/or major thromboembolic events in patients with heart failure.
We updated the searches in February 2010 on CENTRAL on The Cochrane Library (Issue 1, 2010), MEDLINE (2000 to February 2010) and EMBASE (1998 to February 2010). Reference lists of papers and abstracts from national and international cardiovascular meetings were studied to identify unpublished studies. Relevant authors were contacted to obtain further data. No language restrictions were applied.
Randomised controlled trials (RCTs) comparing oral anticoagulants with placebo in adults with heart failure, and with treatment duration at least one month. Non-randomised studies were also included for assessing side-effects. Inclusion decisions were duplicated, disagreement resolved by discussion or a third party.
Four review authors independently assessed trials for inclusion and assessed the risks and benefits from antithrombotic therapy using relative measures of effects, such as odds ratio, accompanied with 95% confidence intervals.
Two RCTs were identified. One compared warfarin, aspirin and no antithrombotic therapy and the second compared warfarin with placebo in patients with idiopathic dilated cardiomyopathy. Three small prospective controlled studies of warfarin in heart failure were also identified, but were over 50 years old with methods not considered reliable by modern standards. In both WASH 2004 and HELAS 2006, there were no significant differences in the incidence of myocardial infarction, non-fatal stroke and death between patients taking oral anticoagulation and placebo. Four retrospective non-randomised cohort analyses and four observational studies of oral anticoagulation in heart failure included differing populations of heart failure patients and reported contradictory results.
AUTHORS' CONCLUSIONS: Based on the two major randomised trials (HELAS 2006; WASH 2004), there is no convincing evidence that oral anticoagulant therapy modifies mortality or vascular events in patients with heart failure and sinus rhythm. Although oral anticoagulation is indicated in certain groups of patients with heart failure (for example atrial fibrillation), the data available does not support its routine use in heart failure patients who remain in sinus rhythm. A large randomised trial of warfarin in heart failure patients in sinus rhythm is currently in progress and data from this trial will be a useful addition to this topic.
慢性心力衰竭患者有发生血栓栓塞事件的风险，包括中风、肺栓塞和外周动脉栓塞，而冠状动脉缺血事件也会促使心力衰竭病情进展。在某些人群中，包括心力衰竭合并房颤患者，长期口服抗凝治疗已得到确立，但在更广泛的心力衰竭人群中，口服抗凝治疗的适应证和使用情况存在很大差异。
确定长期口服抗凝治疗是否能降低心力衰竭患者的全因死亡和/或主要血栓栓塞事件发生率。
我们于2010年2月更新了对Cochrane图书馆CENTRAL（2010年第1期）、MEDLINE（2000年至2010年2月）和EMBASE（1998年至2010年2月）的检索。研究了国内和国际心血管会议论文及摘要的参考文献列表，以识别未发表的研究。联系了相关作者以获取更多数据。未设语言限制。
比较口服抗凝剂与安慰剂用于成年心力衰竭患者且治疗持续时间至少1个月的随机对照试验（RCT）。还纳入了非随机研究以评估副作用。纳入决策进行了重复，分歧通过讨论或第三方解决。
四位综述作者独立评估试验是否纳入，并使用效应的相对测量指标（如比值比）及95%置信区间评估抗栓治疗的风险和益处。
识别出两项RCT。一项比较了华法林、阿司匹林和不进行抗栓治疗，另一项比较了华法林与安慰剂用于特发性扩张型心肌病患者。还识别出三项关于华法林用于心力衰竭的小型前瞻性对照研究，但这些研究已有50多年历史，其方法按现代标准不被认为可靠。在WASH 2004和HELAS 2006中，口服抗凝治疗组与安慰剂组患者在心肌梗死、非致命性中风和死亡发生率方面均无显著差异。四项回顾性非随机队列分析和四项关于心力衰竭患者口服抗凝治疗的观察性研究纳入了不同的心力衰竭患者群体，报告结果相互矛盾。
基于两项主要随机试验（HELAS 2006；WASH 2004），没有令人信服的证据表明口服抗凝治疗能改变窦性心律心力衰竭患者的死亡率或血管事件。虽然在某些心力衰竭患者群体（如房颤患者）中需要口服抗凝治疗，但现有数据不支持在窦性心律的心力衰竭患者中常规使用。一项关于华法林用于窦性心律心力衰竭患者的大型随机试验正在进行中，该试验的数据将为这一主题增添有用信息。
