Comparison of apixaban 5 mg vs 2.5 mg for the prevention of cancer-associated venous thromboembolism: A pooled analysis of two studies

European Heart Journal Supplements

1 August 2025
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ESC Journals

Abstract

AbstractIntroduction

Cancer-associated venous thromboembolism (VTE) management is complex, requiring a balance between thrombosis prevention and minimizing bleeding risk. While patients with cancer remain in a hypercoagulable state, extended anticoagulation is reasonable to reduce the risk of recurrent VTE. However, it remains uncertain whether there is an optimal timing for dose de-escalation after six months to maintain efficacy while reducing bleeding risk. This meta-analysis aims to compare the efficacy and safety of reduced-dose (2.5 mg) versus standard-dose (5 mg) apixaban in preventing VTE recurrence and major bleeding in cancer patients.

Methods

A systematic literature search was conducted in PubMed and EMBASE, identifying one randomized controlled trial (RCT) and one observational study (Larsen et al., 2022). Data were extracted for two primary outcomes: recurrent VTE and major bleeding. A total of 477 patients received apixaban 2.5 mg, and 377 received apixaban 5 mg across both studies.

Results

Recurrent venous thromboembolism occurred with RR 0.73 (95% CI: 0.32–1.66; p = 0.45), indicating no statistically significant difference between the dosing regimens. Major bleeding occurred with RR 0.39 (95% CI: 0.04–3.89; p = 0.42), also showing no statistically significant difference.

Discussion/Conclusion

This meta-analysis indicates no significant difference between apixaban 2.5 mg and 5 mg in terms of VTE recurrence or major bleeding risk in cancer patients. While the findings suggest that dose reduction may be safe, the current evidence remains limited by the small number of studies and sample size. Further research, particularly randomized controlled trials, is warranted to explore potential subgroup benefits. The upcoming API-CAT trial, expected in March 2025, will provide additional insights and enhance the power of these findings. These results suggest that a reduced dose may be a viable option for long-term anticoagulation in cancer patients; however, additional trials are needed to confirm these results and refine patient-specific anticoagulation strategies.

Forest plot: VTE

 

Forest plot: Major Bleeding

Contributors

M Sabina
M Sabina

Author

Lakeland Regional Health System Lakeland , United States of America

S Patel
S Patel

Author

J Trube
J Trube

Author