INTRODUCTION New oral anticoagulants (NOACs) are approved for use in nonvalvular atrial fibrillation (AF). OBJECTIVES This study aimed to evaluate the efficacy and safety of NOACs compared with warfarin in AF and valvular heart disease (VHD). METHODS We identified randomized controlled trials (RCTs) and post-hoc analyses comparing NOACs and warfarin in AF and VHD, including biological and mechanical heart valves (MHV). Through systematic review and meta-analysis, with the aid of the "Rev Man" program 5.3, the primary effectiveness endpoints were stroke and systemic embolism (SE). The primary safety outcome was major bleeding, and the secondary outcome included intracranial hemorrhage. Data were analyzed using risk ratios (RRs) and 95% confidence intervals (CIs), and heterogeneity was assessed using the I2 statistic. RESULTS Six RCTs were included, involving 13,850 patients with AF and VHD. NOACs significantly reduced the risk of stroke/SE (RR 0.78; 95% CI 0.66-0.91; P = 0.002) and intracranial hemorrhage (RR 0.51; 95% CI 0.33-0.79; P = 0.003) and lowered the risk of major bleeding (RR 0.77; 95% CI 0.58-1.02; P = 0.07) compared with warfarin. CONCLUSIONS The efficacy and safety of NOACs as thromboprophylaxis for AF and VHD are similar to those of warfarin.

中文翻译：

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房颤和瓣膜性心脏病患者新型口服抗凝药和华法林的比较：系统评价和荟萃分析。

引言新型口服抗凝剂（NOAC）被批准用于非瓣膜性房颤（AF）。目的本研究旨在评估与华法林相比，NOAC在房颤和瓣膜性心脏病（VHD）中的疗效和安全性。方法我们确定了随机对照试验（RCT）和事后分析，比较了AF和VHD中的NOAC和华法林，包括生物和机械心脏瓣膜（MHV）。通过系统的审查和荟萃分析，借助“ Rev Man”计划5.3，主要的有效性终点是中风和全身性栓塞（SE）。主要安全结果是大出血，次要结果包括颅内出血。使用风险比（RRs）和95％置信区间（CIs）分析数据，并使用I2统计量评估异质性。结果纳入了6个RCT，涉及13850例AF和VHD患者。NOACs显着降低了中风/ SE（RR 0.78; 95％CI 0.66-0.91; P = 0.002）和颅内出血的风险（RR 0.51; 95％CI 0.33-0.79; P = 0.003），并降低了大出血的风险（ RR 0.77； 95％CI 0.58-1.02； P = 0.07）。结论NOACs预防AF和VHD的血栓预防作用的有效性和安全性与华法林相似。