Kamil Amna, Kumar Sandhiya Prem, Zulfiqar Rumaisa, Araib Eiman, Khan Bibi Samia, Khan Muhammad Saad, Khan Muhammad Mohsin, Naeem Umaimah, Waafira Aminath
Jinnah Sindh Medical University, Karachi, Pakistan.
People's University of Medical and Health Sciences for Women, Nawabshah, Sindh, Pakistan.
Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251372947. doi: 10.1177/10760296251372947. Epub 2025 Sep 5.
BackgroundCancer patients are at significantly increased risk of venous thromboembolism (VTE), a leading cause of morbidity and mortality in this population. While traditional anticoagulants like low-molecular-weight heparin (LMWH) and vitamin K antagonists (VKAs) are commonly used, their limitations have prompted growing interest in direct oral anticoagulants (DOACs), particularly Factor Xa inhibitors. However, concerns about bleeding risks persist. This meta-analysis aims to evaluate the efficacy of Factor Xa inhibitors versus placebo for thromboprophylaxis in cancer-associated VTE.MethodsThis systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024574869). A comprehensive search of PubMed, Cochrane Library, Scopus, Google Scholar, and ClinicalTrials.gov was conducted without language or demographic restrictions. Data were extracted independently by two reviewers and analyzed using a random-effects model.ResultsSix RCTs with a total of 2330 participants met the inclusion criteria. The pooled analysis showed a non-significant reduction in VTE incidence with Factor Xa inhibitors (RR = 0.33, 95% CI: 0.05-2.10, = .24). However, there was a nearly twofold increased risk of major bleeding (RR = 1.90, 95% CI: 1.00-3.62, = .05). No significant effect was found for clinically relevant non-major bleeding (CRNMB) (RR = 1.28, 95% CI: 0.73-2.22, = .39).ConclusionFactor Xa inhibitors may reduce the risk of VTE in cancer patients but appear to increase the risk of major bleeding. The evidence remains inconclusive due to limited event numbers and wide confidence intervals, highlighting the need for larger trials to better assess safety and efficacy.
背景
癌症患者发生静脉血栓栓塞（VTE）的风险显著增加，VTE是该人群发病和死亡的主要原因。虽然常用低分子量肝素（LMWH）和维生素K拮抗剂（VKA）等传统抗凝剂，但其局限性促使人们对直接口服抗凝剂（DOAC），尤其是Xa因子抑制剂的兴趣日益增加。然而，对出血风险的担忧依然存在。本荟萃分析旨在评估Xa因子抑制剂与安慰剂在癌症相关VTE血栓预防中的疗效。
方法
本系统评价和荟萃分析遵循PRISMA指南，并在PROSPERO（CRD42024574869）注册。对PubMed、Cochrane图书馆、Scopus、谷歌学术和ClinicalTrials.gov进行了全面检索，无语言或人口统计学限制。数据由两名审阅者独立提取，并使用随机效应模型进行分析。
结果
六项随机对照试验共2330名参与者符合纳入标准。汇总分析显示，Xa因子抑制剂使VTE发生率有非显著性降低（RR = 0.33，95%CI：0.05 - 2.10，P = 0.24）。然而，大出血风险增加了近两倍（RR = 1.90，95%CI：1.00 - 3.62，P = 0.05）。对于临床相关非大出血（CRNMB）未发现显著影响（RR = 1.28，95%CI：0.73 - 2.22，P = 0.39）。
结论
Xa因子抑制剂可能降低癌症患者VTE风险，但似乎会增加大出血风险。由于事件数量有限和置信区间较宽，证据仍不确凿，这突出表明需要进行更大规模的试验以更好地评估安全性和疗效。
