Idarucizumab is the first Food and Drugs Administration (FDA) approved reversal agent for anticoagulant dabigatran, a direct thrombin inhibitor. Emerging evidence suggests idarucizumab can improve clinical outcome following dabigatran-associated hemorrhage, however, its specific use in intracranial hemorrhage has been poorly described. The aim of this study was to systematically review the available literature of idarucizumab in the setting of dabigatran-associated ICH to evaluate its efficacy in the stabilizing/resolving of the primary hemorrhage. A systematic search of 7 electronic databases from their earliest records to August 2018 was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. There were 864 articles identified for screening against selection criteria. The search identified 9 articles to be included in our analysis, describing hemorrhage outcomes in 23 dabigatran-associated cases of ICH managed by idarucizumab. Mean overall age was 76.2 years, with 43% females, and bleeding was subdural, subarachnoid and intracerebral in 43%, 13% and 43% cases respectively. Surgical intervention was pursued in 48% of cases. During the course of the hospitalization, the hemorrhages stabilized/resolved in 87% of patients, and worsened in 13%. In-hospital complications occurred in 4% of cases, and mortality occurred in 4% of cases as well. The available literature suggests that idarucizumab can be applied in the setting of ICH, for its therapeutic effect in patients presenting with dabigatran-associated ICH appears acceptable with no compromise to clinical safety. However, currently there is a paucity of data about various aspects that are involved in other aspects of ICH treatment, including recovery, that limits the significance of the current literature. As more evidence is published relating specifically to long-term ICH outcomes that have been treated by idarucizumab, we will be better placed to establish the optimal role of idarucizumab in the setting of dabigatran-associated ICH.

译文

Idarucizumab是第一个食品和药物管理局 (FDA) 批准的抗凝剂达比加群 (一种直接凝血酶抑制剂) 逆转剂。新的证据表明,idarucizumab可以改善达比加群相关出血后的临床结局,然而,其在颅内出血中的具体应用还没有得到很好的描述。这项研究的目的是系统地回顾idarucizumab在达比加群相关ICH的背景下的可用文献,以评估其在稳定/解决原发性出血中的功效。按照系统评价和荟萃分析 (PRISMA) 指南的首选报告项目,对7个电子数据库从最早记录到2018年8月进行了系统搜索。有864篇文章被确定用于根据选择标准进行筛选。搜索确定了9篇文章纳入我们的分析,描述了由idarucizumab管理的23例达比加群相关ICH病例的出血结果。平均年龄76.2岁,女性43% 例,硬膜下、蛛网膜下腔和脑内出血分别为43% 例、13% 例和43% 例。在48% 病例中进行了手术干预。在住院期间,87% 患者出血稳定/缓解,13% 恶化。4% 病例发生院内并发症,4% 病例也发生死亡率。现有文献表明,idarucizumab可用于ICH的治疗,因为其在出现达比加群相关ICH的患者中的治疗效果似乎可以接受,而不会损害临床安全性。但是,目前缺乏有关ICH治疗其他方面 (包括恢复) 的各个方面的数据,这限制了当前文献的重要性。随着更多的证据被公布,特别是与经过idarucizumab治疗的长期ICH结局有关,我们将更好地确定idarucizumab在dabigatran相关ICH中的最佳作用。

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