Mortality outcomes in patients receiving direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trials

Mortality outcomes in patients receiving direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trials
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DOI:
10.1111/jth.13139
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发表时间:
2015-11-01
影响因子:
10.4
通讯作者:
Crowther, M.
Crowther, M.
中科院分区:
医学2区
文献类型:
--
作者:
Chai-Adisaksopha, C.;Hillis, C.;Crowther, M.

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背景:直接口服抗凝剂(DOAC)被广泛用作华法林的替代品。然而,与华法林相比,DOAC对死亡率结局的影响仍不清楚。目的:评估DOAC与华法林(或另一种维生素K拮抗剂)治疗患者的死亡率结局。方法:检索MEDLINE、EMBASE和CENTRAL数据库(开始至2014年9月)、会议摘要和,无语言限制。如果有在非瓣膜性房颤或静脉血栓栓塞患者中比较DOAC与华法林的III期随机试验,则选择研究。结果:13个随机对照试验,涉及102 707例成人患者纳入分析。服用DOAC的患者中大出血的病死率为7.57%(95% CI,6.53-8.68; I-2 = 0%),服用华法林的患者中为11.04%(95% CI,9.16-13.07; I-2 = 33.3%)。接受DOAC治疗的成人患者的致死性出血发生率为0.16/100患者-年(95% CI,0.12-0.20; I-2 = 36.5%)。与华法林相比,DOAC与致死性出血显著减少相关(RR,0.53; 95% CI,0.43-0.64; I-2 = 0%),心血管死亡率(RR,0.88; 95% CI,0.82-0.94; I-2 = 0%)和全因死亡率(RR,0.91; 95% CI,0.87-0.96; I-2 = 0%)。结论:与华法林相比,DOAC的使用与较低的致死性出血率、大出血病死率、心血管死亡率和全因死亡率相关。
Background: Direct oral anticoagulants (DOACs) are widely used as an alternative for warfarin. However, the impact of DOACs on mortality outcomes compared with warfarin remains unclear. Objective: To estimate the mortality outcomes in patients treated with DOACs vs. warfarin (or another vitamin K antagonist). Methods: MEDLINE, EMBASE and CENTRAL databases (inception to September 2014), conference abstracts and , were searched, without language restriction. Studies were selected if there were phase III, randomized trials comparing DOACs with warfarin in patients with non-valvular atrial fibrillation or venous thromboembolism. Results: Thirteen randomized controlled trials involving 102 707 adult patients were included in the analysis. The case-fatality rate of major bleeding was 7.57% (95% CI, 6.53-8.68; I-2 = 0%) in patients taking DOACs and 11.04% (95% CI, 9.16-13.07; I-2 = 33.3%) in patients taking warfarin. The rate of fatal bleeding in adult patients receiving DOACs was 0.16 per 100 patient-years (95% CI, 0.12-0.20; I-2 = 36.5%). When compared with warfarin, DOACs were associated with significant reductions in fatal bleeding (RR, 0.53; 95% CI, 0.43-0.64; I-2 = 0%), cardiovascular mortality (RR, 0.88; 95% CI, 0.82-0.94; I-2 = 0%) and all-cause mortality (RR, 0.91; 95% CI, 0.87-0.96; I-2 = 0%). Conclusions: The use of DOACs compared with warfarin is associated with a lower rate of fatal bleeding, case-fatality rate of major bleeding, cardiovascular mortality and all-cause mortality.