Apixaban and Dalteparin in Active Malignancy Associated Venous Thromboembolism: The ADAM VTE Trial.
J Thromb Haemost. 2019 Oct 20;:
Authors: McBane R, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL
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 10mg twice daily for 7 days followed by 5mg twice daily for 6 months or subcutaneous dalteparin (200 IU/kg for 1 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= 0.138; Hazard Ratio (HR) not estimable due to 0 bleeding events in apixaban group). Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients (HR 0.099, 95% CI, 0.013-0.780, p = 0.0281). 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.
PMID: 31630479 [PubMed – as supplied by publisher]