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

Robert D. McBane, 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

Research output: Contribution to journalArticle

47 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)411-421
Number of pages11
JournalJournal of Thrombosis and Haemostasis
Volume18
Issue number2
DOIs
StatePublished - Feb 1 2020

Keywords

  • apixaban
  • bleeding
  • cancer
  • dalteparin
  • venous thromboembolism

ASJC Scopus subject areas

  • Hematology

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