BACKGROUND Previous meta-analyses of randomized controlled trials of oral anticoagulation in patients with heart failure and sinus rhythm reported reduced stroke risk and increased bleeding risk compared to antiplatelets or placebo. However, the effect estimates may be subject to imprecision, as all included trials were prematurely terminated; stroke was not the primary outcome and overall results were primarily driven by a single trial. Recently, new trial data became available. AIM To provide more accurate estimates of the effect of oral anticoagulation on stroke risk in heart failure patients with sinus rhythm by systematic review and meta-analysis of available randomized controlled trials including recently published evidence. METHODS We searched PubMed and Scopus for full-text articles of randomized controlled trials of oral anticoagulation versus antiplatelet or placebo in heart failure patients with sinus rhythm published between inception and 28 August 2018. The outcomes assessed were any stroke, major bleeding, and death. RESULTS In five trials (9490 patients; 21,067 patient-years), oral anticoagulation-treated patients had lower stroke risk (odds ratio (OR) 0.60, 95%CI: 0.46-0.78, absolute-risk-reduction: 1.3%, number-needed-to-treat: 77), higher major bleeding risk (OR: 1.92, 95%CI: 1.51-2.45, absolute-risk-increase: 2.0%, number-needed-to-harm: 50), and no significant difference in death rates (OR: 0.90, 95%CI: 0.73-1.11) compared to antiplatelets or placebo. CONCLUSIONS In the largest meta-analysis to date, oral anticoagulation is associated with a considerable reduction of stroke risk, which is offset by a significant increase in major bleeding risk. For every 1000 patients treated with oral anticoagulation rather than antiplatelet or no antithrombotic treatment for 2.21 years, 13 strokes are prevented but 20 additional major hemorrhages occur, without significant difference in death rates.

中文翻译：

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口服抗凝药物与抗血小板药物或安慰剂预防心力衰竭和窦性心律的中风：随机对照试验的系统评价和荟萃分析。

背景技术先前对患有心力衰竭和窦性心律的患者进行口服抗凝治疗的随机对照试验的荟萃分析报告，与抗血小板或安慰剂相比，卒中风险降低，出血风险升高。但是，由于所有纳入的试验都提前终止，因此效果评估可能不准确。中风不是主要结局，总体结果主要由一项试验决定。最近，新的试验数据可用。目的通过对现有随机对照试验（包括最近发表的证据）进行系统回顾和荟萃分析，以更准确地评估口服抗凝剂对窦性心律性心力衰竭患者中风风险的影响。方法我们在PubMed和Scopus上搜索了从开始到2018年8月28日发表的针对窦性心律的心力衰竭患者口服抗凝药物，抗血小板药物或安慰剂的随机对照试验的全文研究。评估的结果为任何中风，大出血和死亡。结果在五项试验（9490例患者； 21,067病人-年）中，口服抗凝治疗的患者发生中风的风险更低（优势比（OR）0.60，95％CI：0.46-0.78，绝对风险降低：1.3％，数字-需要治疗：77），重大出血风险更高（OR：1.92，95％CI：1.51-2.45，绝对风险增加：2.0％，需要伤害的数字：50），无显着差异与抗血小板药物或安慰剂相比，死亡率（OR：0.90、95％CI：0.73-1.11）更高。结论在迄今为止最大的荟萃分析中，口服抗凝治疗与中风风险的显着降低有关，但可以被主要出血风险的显着提高所抵消。对于每1000例接受口服抗凝治疗而非抗血小板治疗或未进行抗凝治疗的患者，在过去的2.21年中，预防了13例中风，但又发生了20例重大出血，死亡率没有显着差异。