Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials
Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials
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DOI：
10.1016/s0140-6736(13)62343-0
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发表时间：
2014-03-15
期刊：
影响因子：
168.9
通讯作者：
Antman, Elliott M.
中科院分区：
文献类型：
--
作者：
Ruff, Christian T.;Giugliano, Robert P.;Antman, Elliott M.
背景：四种新型口服抗凝剂在房颤患者卒中预防方面优于华法林；然而，亚组的疗效和安全性之间的平衡需要更好的定义。我们的目的是评估新型口服抗凝剂在关键亚组中的相对获益，以及对重要次要结局的影响。方法：我们从2009年1月1日至2013年11月19日检索Medline，将检索限制在房颤患者随机接受新的口服抗凝剂或华法林的3期随机试验，以及疗效和安全性结果均有报道的试验。我们对RE-LY、ROCKET AF、ARISTOTLE和ENGAGE AF- timi 48项试验中纳入的所有71 683名受试者进行了预先指定的荟萃分析。主要结局为脑卒中和全身性栓塞事件、缺血性脑卒中、出血性脑卒中、全因死亡率、心肌梗死、大出血、颅内出血和胃肠道出血。我们计算了每个结果的相对危险度（RRs）和95% ci。我们进行了亚组分析，以评估患者和试验特征的差异是否会影响结果。我们使用随机效应模型来比较合并结果并检验异质性。结果42 411名参与者接受了新的口服抗凝剂治疗，29 272名参与者接受了华法林治疗。与华法林相比，新型口服抗凝剂可显著减少19%的卒中或全身性栓塞事件(RR 0.81, 95% CI 0.73-0.91; p
Background Four new oral anticoagulants compare favourably with warfarin for stroke prevention in patients with atrial fibrillation; however, the balance between efficacy and safety in subgroups needs better definition. We aimed to assess the relative benefit of new oral anticoagulants in key subgroups, and the effects on important secondary outcomes.Methods We searched Medline from Jan 1, 2009, to Nov 19, 2013, limiting searches to phase 3, randomised trials of patients with atrial fibrillation who were randomised to receive new oral anticoagulants or warfarin, and trials in which both efficacy and safety outcomes were reported. We did a prespecified meta-analysis of all 71 683 participants included in the RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48 trials. The main outcomes were stroke and systemic embolic events, ischaemic stroke, haemorrhagic stroke, all-cause mortality, myocardial infarction, major bleeding, intracranial haemorrhage, and gastrointestinal bleeding. We calculated relative risks (RRs) and 95% CIs for each outcome. We did subgroup analyses to assess whether differences in patient and trial characteristics affected outcomes. We used a random-effects model to compare pooled outcomes and tested for heterogeneity.Findings 42 411 participants received a new oral anticoagulant and 29 272 participants received warfarin. New oral anticoagulants significantly reduced stroke or systemic embolic events by 19% compared with warfarin (RR 0.81, 95% CI 0.73-0.91; p