Effectiveness and Safety of Extended Treatment Apixaban Versus Low-Molecular-Weight Heparin in Cancer-Associated Venous Thromboembolism
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Background: Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months. Methods: A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB). Results: A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34–0.53), MB (HR, 0.50; 95% CI, 0.41–0.61), and CRNMB (HR, 0.76; 95% CI, 0.68–0.85) versus LMWH. Conclusions: Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.
Submitted October 10, 2023; final revision received January 31, 2024; accepted for publication February 1, 2024.
Previous presentation: Data from this analysis were presented at the ESC Congress 2023; August 25–29, 2023; Amsterdam, the Netherlands.
Author contributions: Study concept & design: Cohen, Dhamane, Liu, Singh, Luo. Data acquisition & analysis: Singh, Wang. Data interpretation: All authors. Manuscript preparation & critical revision: All authors. Final approval of manuscript: All authors.
Disclosures: A.T. Cohen has disclosed receiving grant/research support from Bristol Myers Squibb Company and Pfizer Inc. A.D. Dhamane has disclosed being employed by and a shareholder of Bristol Myers Squibb Company. R. Singh has disclosed being employed by Cencora. S. Han has disclosed being employed by and owning stock in Bristol Myers Squibb Company. R. Stellhorn has disclosed being employed by and is a shareholder of Bristol Myers Squibb Company. J. Wang has disclosed being employed by Cencora. X. Luo has disclosed being employed by and a shareholder of Pfizer Inc. X. Liu has disclosed not receiving any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was sponsored by Pfizer Inc. and Bristol Myers Squibb Company.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7016. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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