Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial

Robert D McBane 2nd, Waldemar E Wysokinski, Jennifer G Le-Rademacher, Tyler Zemla, Aneel Ashrani, Alfonso Tafur, Usha Perepu, Daniel Anderson, Krishna Gundabolu, Charles Kuzma, Juliana Perez Botero, Roberto A Leon Ferre, Stanislav Henkin, Charles J Lenz, Damon E Houghton, Prakash Vishnu, Charles L Loprinzi, Robert D McBane 2nd, Waldemar E Wysokinski, Jennifer G Le-Rademacher, Tyler Zemla, Aneel Ashrani, Alfonso Tafur, Usha Perepu, Daniel Anderson, Krishna Gundabolu, Charles Kuzma, Juliana Perez Botero, Roberto A Leon Ferre, Stanislav Henkin, Charles J Lenz, Damon E Houghton, Prakash Vishnu, Charles L Loprinzi

Abstract

Background: Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancer patients.

Objectives: The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB).

Patients/methods: Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily).

Results: Of 300 patients randomized, 287 were included in the primary analysis. Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban, compared with 1.4% of 142 patients receiving dalteparin [P = .138; hazard ratio (HR) not estimable because of 0 bleeding event in apixaban group]. Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients [HR 0.099, 95% confidence interval [CI], 0.013-0.780, P = .0281). Major bleeding or CRNMB rates were 6% for both groups.

Conclusions: Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.

Trial registration: ClinicalTrials.gov NCT02585713.

Keywords: apixaban; bleeding; cancer; dalteparin; venous thromboembolism.

© 2019 International Society on Thrombosis and Haemostasis.

References

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