Efficacy of Factor Xa Inhibitors Versus Placebo in Thromboprophylaxis for Cancer-Associated Thromboembolism: A Systematic Review and Meta-analysis.

Abstract

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, P = .24). However, there was a nearly twofold increased risk of major bleeding (RR = 1.90, 95% CI: 1.00-3.62, P = .05). No significant effect was found for clinically relevant non-major bleeding (CRNMB) (RR = 1.28, 95% CI: 0.73-2.22, P = .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.