ORIGINAL ARTICLE
Apixaban and dalteparin in active malignancy‐associated venous thromboembolism: The ADAM VTE trial

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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.

Keywords

apixaban
bleeding
cancer
dalteparin
venous thromboembolism

Cited by (0)

Abstract Presentation: American Society of Hematology Annual Meeting, December 2018

Trial registration number: NCT02585713

Manuscript handled by: Marc Carrier

Final decision: Marc Carrier 14 October 2019

Funding informationThe funding support for this trial was Bristol Myers Squibb/Pfizer Alliance.