Efficacy and Safety of the Novel Oral Anticoagulants in Atrial Fibrillation A Systematic Review and Meta-Analysis of the Literature
Efficacy and Safety of the Novel Oral Anticoagulants in Atrial Fibrillation A Systematic Review and Meta-Analysis of the Literature
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DOI：
10.1161/circulationaha.112.115410
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发表时间：
2012-11-13
期刊：
影响因子：
37.8
通讯作者：
Ageno, Walter
中科院分区：
文献类型：
--
作者：
Dentali, Francesco;Riva, Nicoletta;Ageno, Walter
背景-新型口服抗凝剂（NOAC）已被提议作为维生素K拮抗剂的替代品，用于预防房颤患者的卒中和全身性栓塞。个别而言，NOAC至少非劣于维生素K拮抗剂，但在整体和血管死亡率的明显优势并不一致promised.Methods和Results-We进行了荟萃分析的第二阶段和第三阶段的随机对照试验比较NOAC与维生素K拮抗剂在房颤患者。检索MEDLINE和EMBASE数据库，补充会议摘要书籍和www.clinicaltrials.gov，检索时间截止至2012年7月的第一周，无语言限制。两名评审员进行了独立的文章评审和研究质量评估。收集了总体和心血管死亡率、卒中或全身性栓塞、缺血性卒中、大出血和颅内出血以及心肌梗死的数据。合并NOAC以与维生素K拮抗剂进行比较，计算合并相对风险（RR）和相关95%置信区间（CI）。我们检索了12项研究（3项达比加群给药、4项利伐沙班给药、2项阿哌沙班给药和3项依度沙班给药），共招募了54875例患者。NOAC显著降低了总死亡率（5.61% vs 6.02%; RR，0.89; 95% CI，0.83-0.96），心血管死亡率（3.45% vs 3.65%; RR，0.89; 95% CI，0.82-0.98）和卒中/全身性栓塞（2.40% vs 3.13%; RR，0.77; 95% CI，0.70-0.86）。有大出血减少的趋势（RR，0.86; 95% CI，0.72-1.02），颅内出血显著减少（RR，0.46; 95% CI，0.39-0.56）。心肌梗死无差异observed.Conclusions-NOACs与整体临床效益相比，维生素K拮抗剂。需要在随机试验之外进行更多的研究来证实这些发现。（循环。2012; 126：2381-2391）。
Background-Novel oral anticoagulants (NOACs) have been proposed as alternatives to vitamin K antagonists for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Individually, NOACs were at least noninferior to vitamin K antagonists, but a clear superiority in overall and vascular mortality was not consistently proven.Methods and Results-We performed a meta-analysis of phase II and phase III randomized, controlled trials comparing NOACs with vitamin K antagonists in patients with atrial fibrillation. The MEDLINE and EMBASE databases, supplemented with conference abstract books and www.clinicaltrials.gov, were searched up to the first week of July 2012 with no language restriction. Two reviewers performed independent article review and study quality assessment. Data on overall and cardiovascular mortality, stroke or systemic embolism, ischemic stroke, major and intracranial bleeding, and myocardial infarction were collected. NOACs were pooled to perform a comparison with vitamin K antagonists, calculating pooled relative risks (RRs) and associated 95% confidence intervals (CIs). We retrieved 12 studies (3 administering dabigatran, 4 administering rivaroxaban, 2 administering apixaban, and 3 administering edoxaban) enrolling a total of 54 875 patients. NOACs significantly reduced total mortality (5.61% versus 6.02%; RR, 0.89; 95% CI, 0.83-0.96), cardiovascular mortality (3.45% versus 3.65%; RR, 0.89; 95% CI, 0.82-0.98), and stroke/systemic embolism (2.40% versus 3.13%; RR, 0.77; 95% CI, 0.70-0.86). There was a trend toward reduced major bleeding (RR, 0.86; 95% CI, 0.72-1.02) with a significant reduction of intracranial hemorrhage (RR, 0.46; 95% CI, 0.39-0.56). No difference in myocardial infarction was observed.Conclusions-NOACs are associated with an overall clinical benefit compared with vitamin K antagonists. Additional research is required to confirm these findings outside the context of randomized trials. (Circulation. 2012; 126: 2381-2391.)