Department of Neurology, Brown University, Providence, RI (S.Y., B.Z., A.S., K.J., B.P., L.S., E.D.G., K.F.).
Center for Evidence Synthesis in Health, Department of Health Services, Policy, & Practice, and Department of Epidemiology, Brown University School of Public Health, Providence, RI (I.J.S.).
Stroke. 2022 Oct;53(10):3014-3024. doi: 10.1161/STROKEAHA.122.039579. Epub 2022 Aug 8.
High level evidence for direct oral anticoagulants (DOACs) in patients with cerebral venous thrombosis is lacking. We performed a systematic review and meta-analysis to assess the efficacy and safety of DOACs versus vitamin K antagonists in patients with cerebral venous thrombosis.
This systematic review was registered in PROSPERO (CRD42021228800). We searched MEDLINE (via Ovid), EMBASE, CINAHL, and the Web of Science Core Collection between January 1, 2007 and Feb 22, 2022. Search terms included a combination of keywords and controlled vocabulary terms for cerebral venous thrombosis, vitamin K antagonists/warfarin, and DOACs. We included both randomized and nonrandomized studies that compared vitamin K antagonists and DOACs in 5 or more patients with cerebral venous thrombosis. Where studies were sufficiently similar, we performed meta-analyses for efficacy (recurrent venous thromboembolism and complete recanalization) and safety (major hemorrhage) outcomes, using relative risks (RRs).
Out of 10 665 records identified, we screened 254 as potentially eligible. Nineteen studies (16 observational studies [n=1735] and 3 randomized controlled trials [n=215]) met the inclusion criteria. All 3 randomized controlled trials had some concerns, and all 16 observational studies had at least moderate risk of bias. When compared with vitamin K antagonist treatment, DOAC had comparable risks of recurrent venous thromboembolism (relative risk [RR], 0.85 [95% CI, 0.52-1.37], I=0%), major hemorrhage (RR, 0.70 [95% CI, 0.40-1.21], I=0%), intracranial hemorrhage (RR, 0.58 [95% CI, 0.30-1.12]; I=0%), death (RR, 1.14 [95% CI, 0.54-2.43], I=1%), and complete venous recanalization (RR, 0.98 [95% CI, 0.87-1.11]; I=0%).
This systematic review and meta-analysis suggest that in patients with cerebral venous thrombosis, DOACs, and warfarin may have comparable efficacy and safety. Given the limitations of the studies included (low number of randomized controlled trials, modest total sample size, rare outcome events), our findings should be interpreted with caution pending confirmation by ongoing randomized controlled trials and large, prospective, observational studies.
缺乏直接口服抗凝剂（DOACs）治疗颅内静脉血栓形成患者的高级别证据。我们进行了一项系统评价和荟萃分析，以评估 DOACs 与维生素 K 拮抗剂（VKA）在颅内静脉血栓形成患者中的疗效和安全性。
本系统评价已在 PROSPERO（CRD42021228800）中注册。我们检索了 MEDLINE（通过 Ovid）、EMBASE、CINAHL 和 Web of Science 核心合集，检索时间为 2007 年 1 月 1 日至 2022 年 2 月 22 日。检索词包括颅内静脉血栓形成、维生素 K 拮抗剂/华法林和 DOACs 的关键词和受控词汇的组合。我们纳入了比较 5 例或 5 例以上颅内静脉血栓形成患者中维生素 K 拮抗剂和 DOACs 的随机和非随机研究。对于足够相似的研究，我们使用相对风险（RR）对疗效（复发性静脉血栓栓塞和完全再通）和安全性（大出血）结局进行荟萃分析。
在 10665 条记录中，我们筛选了 254 条作为可能符合条件的记录。19 项研究（16 项观察性研究[ n = 1735]和 3 项随机对照试验[ n = 215]）符合纳入标准。所有 3 项随机对照试验都存在一些问题，而所有 16 项观察性研究都至少存在中度偏倚风险。与维生素 K 拮抗剂治疗相比，DOAC 具有相似的复发性静脉血栓栓塞风险（RR，0.85 [95%CI，0.52-1.37]，I = 0%）、大出血风险（RR，0.70 [95%CI，0.40-1.21]，I = 0%）、颅内出血风险（RR，0.58 [95%CI，0.30-1.12]；I = 0%）、死亡率（RR，1.14 [95%CI，0.54-2.43]，I = 1%）和完全静脉再通率（RR，0.98 [95%CI，0.87-1.11]；I = 0%）。
本系统评价和荟萃分析表明，在颅内静脉血栓形成患者中，DOAC 和华法林可能具有相似的疗效和安全性。鉴于纳入研究的局限性（随机对照试验数量较少、总样本量适中、结局事件罕见），我们的发现应谨慎解释，等待正在进行的随机对照试验和大型前瞻性观察性研究的证实。
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