减少剂量与全剂量直接口服抗凝剂用于静脉血栓栓塞的延长治疗：随机对照试验的荟萃分析

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-07-01 DOI:10.1016/j.rpth.2025.102996

Mushood Ahmed , Eeshal Zulfiqar , Hadiah Ashraf , Tallal Mushtaq Hashmi , Raheel Ahmed , Jamal S. Rana , Stephen J. Greene , Robert J. Mentz , Marat Fudim , Gregg C. Fonarow

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引用次数: 0

摘要

背景静脉血栓栓塞（VTE）是全球心血管疾病发病率和死亡率的主要原因。虽然直接口服抗凝剂（DOACs）改善了静脉血栓栓塞的治疗，但平衡疗效和安全性的最佳剂量仍不清楚。目的：本系统综述和荟萃分析旨在评价在静脉血栓栓塞延长抗凝治疗期间，减少剂量DOACs与全剂量DOACs方案的有效性和安全性。方法检索PubMed、Embase和Cochrane图书馆截至2025年4月的文献，以确定随机对照试验（rct），比较减少剂量与全剂量DOACs对有或无癌症患者延长静脉血栓栓塞治疗的效果。使用随机效应模型估计风险比（RR）和95% ci。主要结局是静脉血栓栓塞复发和大出血或临床相关的非大出血。次要结局包括大出血、临床相关的非大出血、全因死亡率和静脉血栓栓塞相关死亡率。结果共纳入5项随机对照试验，共纳入8781例患者。患者平均±SD年龄为61.3±13.4岁，中位随访时间为12个月。在预防静脉血栓栓塞复发（RR, 0.94; 95% CI, 0.68-1.29）和全因死亡（RR, 0.86; 95% CI, 0.63-1.17）方面，减少剂量doac与全剂量方案相当。然而，与全剂量方案相比，减少剂量的DOACs显著降低了重大或临床相关的非重大出血（RR, 0.71; 95% CI, 0.61-0.82）、重大出血（RR, 0.62; 95% CI, 0.42-0.92）和临床相关的非重大出血（RR, 0.75; 95% CI, 0.63-0.88）的风险。在癌症相关人群和普通静脉血栓栓塞人群之间没有观察到显著的亚组差异。结论减少剂量doac与全剂量方案预防静脉血栓栓塞复发的效果相同，且出血风险明显降低。然而，需要更多的随机对照试验，延长随访时间，重点纳入癌症患者，以验证这些发现。

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Reduced-dose vs full-dose direct oral anticoagulants for extended treatment of venous thromboembolism: a meta-analysis of randomized controlled trials

Background

Venous thromboembolism (VTE) is a major cause of cardiovascular morbidity and mortality globally. Although direct oral anticoagulants (DOACs) have improved extended VTE treatment, the optimal dose for balancing efficacy and safety remains unclear.

Objectives

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of reduced-dose DOACs vs full-dose regimens during extended anticoagulation for VTE.

Methods

A literature search of PubMed, Embase, and Cochrane Library was performed up to April 2025 to identify randomized controlled trials (RCTs) comparing reduced-dose vs full-dose DOACs for extended VTE treatment in patients with or without cancer. Risk ratios (RR) and 95% CIs were estimated using a random-effects model. Primary outcomes were recurrent VTE and major or clinically relevant nonmajor bleeding. The secondary outcomes included major bleeding, clinically relevant nonmajor bleeding, all-cause mortality, and VTE-related mortality.

Results

Five RCTs involving 8781 patients were included in the meta-analysis. The mean ± SD age of patients was 61.3 ± 13.4 years, and median follow-up duration was 12 months. Reduced-dose DOACs were comparable with full-dose regimens in preventing recurrent VTE (RR, 0.94; 95% CI, 0.68-1.29) and all-cause death (RR, 0.86; 95% CI, 0.63-1.17). However, reduced-dose DOACs significantly lowered the risk of major or clinically relevant nonmajor bleeding (RR, 0.71; 95% CI, 0.61-0.82), major bleeding (RR, 0.62; 95% CI, 0.42-0.92), and clinically relevant nonmajor bleeding (RR, 0.75; 95% CI, 0.63-0.88) compared with full-dose regimens. No significant subgroup differences were observed between cancer-associated and general VTE populations.

Conclusion

Reduced-dose DOACs are as effective as full-dose regimens in preventing recurrent VTE and are associated with significantly lower bleeding risks. However, more RCTs with extended follow-up and focused inclusion of cancer patients are warranted to validate these findings.

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