达比加群酯逆转剂依达鲁单抗：适应证和结局的系统评价和荟萃分析。

Idarucizumab for dabigatran reversal: A systematic review and meta-analysis of indications and outcomes.

机构信息

Department of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Thromb Res. 2023 Aug;228:21-32. doi: 10.1016/j.thromres.2023.05.020. Epub 2023 May 29.

DOI:10.1016/j.thromres.2023.05.020

PMID:37267671

Abstract

BACKGROUND

Idarucizumab has been approved to reverse the anticoagulant effect of dabigatran. However, there is little knowledge of the effectiveness and safety of idarucizumab in daily practice.

AIMS

This systematic review and meta-analysis aims to evaluate the use, effectiveness and outcomes of idarucizumab.

METHODS

A systematic literature search was performed up to September 8th 2022. Original studies including patients prescribed idarucizumab, evaluating prescription indications, prescription appropriateness, haemostatic efficacy and/or the occurrence of adverse events were eligible. Case-reports and studies performed in patients ≤18 years or in healthy volunteers were excluded. Study selection and data extraction were performed by two independent reviewers. Pooled estimates were calculated using the random-effects model, after Freeman-Tukey double-arcsine transformation.

RESULTS

Thirty studies comprising 3602 patients were included. Idarucizumab was prescribed for bleeding (63.1 %, 95%CI 57.0 %-69.0 %), invasive procedures (30.5 %, 95%CI: 24.1 %-37.2 %), to enable thrombolysis (range: 2.0 %-27.3 %), dabigatran intoxication without bleeding (range: 3.6 %-7.0 %) or unspecified reasons (range: 0.4 %-18.8 %). Overall, 2.8 % (95%CI 0.5 %-6.2 %) of prescription indications were reported to be inappropriate upon post-hoc evaluation. Hemostatic effectiveness was achieved in 77.7 % (95%CI 66.7 %-87.2 %) and peri-procedural haemostasis was normal in 98.5 % (95%CI 86.6 %-100 %) of patients. The pooled incidences of all-cause mortality and thromboembolic events at any follow-up duration were 13.6 % (95%CI 9.6 %-17.9 %) and 2.0 % (95%CI 0.8 %-3.4 %), respectively.

CONCLUSION

Idarucizumab was mainly prescribed in the setting of bleeding. The reported hemostatic effectiveness was good, especially perioperatively, and the incidence of thromboembolic events was low. Patients with dabigatran-associated bleeding or requiring an urgent procedure nonetheless face a high mortality risk.

摘要

背景

依达鲁单抗已被批准用于逆转达比加群的抗凝作用。然而，在日常实践中，人们对依达鲁单抗的有效性和安全性知之甚少。

目的

本系统评价和荟萃分析旨在评估依达鲁单抗的使用、疗效和结局。

方法

系统检索截至 2022 年 9 月 8 日的文献。纳入评估依达鲁单抗处方适应证、处方适宜性、止血效果和/或不良事件发生情况的患者的原始研究。排除了在≤18 岁患者或健康志愿者中进行的病例报告和研究。两名独立审查员进行研究选择和数据提取。采用随机效应模型计算汇总估计值，在 Freeman-Tukey 双反正弦变换后进行。

结果

共纳入 30 项研究，包含 3602 例患者。依达鲁单抗用于出血（63.1%，95%CI：57.0%-69.0%）、侵入性操作（30.5%，95%CI：24.1%-37.2%）、促进溶栓（范围：2.0%-27.3%）、无出血性达比加群中毒（范围：3.6%-7.0%）或不明原因（范围：0.4%-18.8%）。总体而言，2.8%（95%CI：0.5%-6.2%）的处方适应证被认为是不适当的。77.7%（95%CI：66.7%-87.2%）的患者达到止血效果，98.5%（95%CI：86.6%-100%）的患者围手术期止血正常。任何随访期间全因死亡率和血栓栓塞事件的汇总发生率分别为 13.6%（95%CI：9.6%-17.9%）和 2.0%（95%CI：0.8%-3.4%）。