Direct Oral Anticoagulants for Treating Acute Venous Thromboembolism in Children: Meta-Analysis of Randomized Controlled Trials.

IF 2.3 4区医学 Q2 HEMATOLOGY

Clinical and Applied Thrombosis/Hemostasis Pub Date : 2024-01-01 DOI:10.1177/10760296241271386

Xin Yu, Wengen Zhu, Chen Liu, Renrong Lu

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Abstract

Background: Acute venous thromboembolism (VTE) in children presents unique challenges due to the limitations of standard anticoagulation therapies. Herein, we aimed to systematically review randomized controlled trials (RCTs) evaluating the efficacy and safety of direct oral anticoagulants (DOACs) in pediatric patients with acute VTE.

Methods: PubMed and Embase databases were searched for RCTs comparing DOACs to standard anticoagulation in pediatric VTE patients. Efficacy outcomes included VTE recurrence and all-cause mortality, while safety outcomes comprised major bleeding and other adverse events.

Results: Three RCTs with 790 participants were included. When compared with standard anticoagulation, DOACs demonstrated a reduced risk of VTE recurrence (risk difference[RD] = -3%, 95% confidence interval[CI]: -6% to 0%, P = 0.04) and an increased risk of any adverse event (RD = 8%, 95% CI: 1% to 14%, P = 0.02). No significant differences were found in all-cause mortality, major bleeding, clinically relevant non-major bleeding, or total bleeding between the DOAC and control groups.

Conclusion: DOACs, primarily dabigatran and rivaroxaban, are non-inferior to standard anticoagulants in reducing VTE recurrence in pediatric patients, with comparable safety profiles. Further research is essential to confirm these findings.

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治疗儿童急性静脉血栓栓塞的直接口服抗凝剂：随机对照试验的 Meta 分析。

背景：由于标准抗凝疗法的局限性，儿童急性静脉血栓栓塞症（VTE）面临着独特的挑战。在此，我们旨在系统回顾评估直接口服抗凝剂（DOACs）对急性 VTE 儿童患者的疗效和安全性的随机对照试验（RCTs）：方法：在PubMed和Embase数据库中检索了对儿科VTE患者进行DOAC与标准抗凝治疗比较的RCT。疗效结果包括 VTE 复发率和全因死亡率，安全性结果包括大出血和其他不良事件：结果：共纳入了三项 RCT，790 名参与者。与标准抗凝相比，DOACs 可降低 VTE 复发风险（风险差异[RD] = -3%，95% 置信区间[CI]：-6% 至 0%，P = 0.04），增加任何不良事件的风险（风险差异[RD] = 8%，95% 置信区间[CI]：1% 至 14%，P = 0.02）。在全因死亡率、大出血、临床相关的非大出血或总出血量方面，DOAC组与对照组之间没有发现明显差异：结论：DOAC（主要是达比加群和利伐沙班）在减少儿科患者 VTE 复发方面的效果不优于标准抗凝药物，而且安全性相当。进一步的研究对证实这些发现至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Applied Thrombosis/Hemostasis 医学-外周血管病

CiteScore

4.40

自引率

3.40%

发文量

150

审稿时长

2 months

期刊介绍： CATH is a peer-reviewed bi-monthly journal that addresses the practical clinical and laboratory issues involved in managing bleeding and clotting disorders, especially those related to thrombosis, hemostasis, and vascular disorders. CATH covers clinical trials, studies on etiology, pathophysiology, diagnosis and treatment of thrombohemorrhagic disorders.