Safety and Effectiveness of Direct Oral Anticoagulants Versus Low-Molecular-Weight Heparin for Cancer-Associated Thrombosis: A Systematic Review and Meta-analysis.

IF 5.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2026-10-01 Epub Date: 2026-06-15 DOI:10.1007/s40264-026-01684-4

Wei Kang, Bowie P Y Lam, Rinko Tsz Lam Lau, Silvia T H Li, Kangrui Wu, Yue Wei, Yu Yang, Kyung Jin Lee, Caige Huang, Vincent K C Yan, Hei Hang Edmund Yiu, Shing Fung Lee, Aya El Helali, Victor H F Lee, Stephen L Chan, Rina Y M Hui, Ka On Lam, Esther W Chan

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引用次数: 0

Abstract

Background: Cancer-associated thrombosis is a condition associated with high mortality rates, yet limited evidence exists regarding the safety and effectiveness of low-molecular-weight heparin (LMWH) and direct oral anticoagulants (DOACs), focusing on a fixed follow-up period based on clinical practice guideline recommendations.

Objective: This study aimed to compare the safety and effectiveness of DOACs versus LMWH in patients with cancer-associated thrombosis over a 6-month follow-up period.

Methods: PubMed, Embase, and Cochrane Library databases were systematically searched up to 30 June, 2025. Recurrent venous thromboembolism, major bleeding, and all-cause mortality were pooled using a random-effects meta-analysis.

Results: Seven randomized controlled trials and 28 cohort studies were included in our systematic review. After applying the criteria for a 6-month follow-up period, five randomized controlled trials and 16 cohort studies with 49,824 patients were analyzed in the meta-analysis. In randomized controlled trials, DOACs showed a lower incidence of venous thromboembolism recurrence (relative risk [RR] 0.66, 95% confidence interval [CI] 0.49-0.87) compared with LMWH, with a non-significant increase in major bleeding (RR 1.28, 95% CI 0.87-1.88) and no significant difference in all-cause mortality (RR 1.00, 95% CI 0.86-1.18). Cohort studies demonstrated a lower incidence of venous thromboembolism recurrence (RR 0.69, 95% CI 0.62-0.76) with DOACs, a non-significant reduction in major bleeding (RR 0.85, 95% CI 0.68-1.07), and a lower risk of all-cause mortality (RR 0.47, 95% CI 0.31-0.72).

Conclusions: In patients with cancer-associated thrombosis, DOACs demonstrated a decrease in recurrent venous thromboembolism without increasing the risk of all-cause mortality. A non-significant increase in the risk of major bleeding was recorded in randomized controlled trials, but not in cohort studies. DOACs may provide greater effectiveness for cancer-associated thrombosis compared with LMWH.

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直接口服抗凝剂与低分子肝素治疗癌症相关血栓的安全性和有效性：一项系统综述和荟萃分析

背景：癌症相关性血栓形成是一种与高死亡率相关的疾病，然而关于低分子肝素（LMWH）和直接口服抗凝剂（DOACs）的安全性和有效性的证据有限，主要是基于临床实践指南建议的固定随访期。目的：本研究旨在通过6个月的随访，比较DOACs与低分子肝素在癌症相关血栓患者中的安全性和有效性。方法：系统检索PubMed、Embase和Cochrane图书馆数据库，截止到2025年6月30日。静脉血栓栓塞复发、大出血和全因死亡率采用随机效应荟萃分析。结果：我们的系统综述纳入了7项随机对照试验和28项队列研究。应用该标准进行为期6个月的随访后，荟萃分析了5项随机对照试验和16项队列研究，共49,824例患者。在随机对照试验中，与低分子肝素相比，DOACs显示静脉血栓栓塞复发率较低（相对危险度[RR] 0.66, 95%可信区间[CI] 0.49-0.87），大出血无显著增加（RR 1.28, 95% CI 0.87-1.88），全因死亡率无显著差异（RR 1.00, 95% CI 0.86-1.18）。队列研究表明，DOACs的静脉血栓栓塞复发率较低（RR 0.69, 95% CI 0.62-0.76），大出血发生率无显著降低（RR 0.85, 95% CI 0.68-1.07），全因死亡率风险较低（RR 0.47, 95% CI 0.31-0.72）。结论：在癌症相关血栓患者中，DOACs可降低静脉血栓栓塞复发，但不增加全因死亡率。在随机对照试验中记录了大出血风险的非显著增加，但在队列研究中没有记录。与低分子肝素相比，DOACs可能对癌症相关血栓形成有更大的疗效。

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

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.