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

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 out...

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Published in:Journal of thrombosis and haemostasis Vol. 18; no. 2; pp. 411 - 421
Main Authors: McBane, Robert D., Wysokinski, Waldemar E., Le‐Rademacher, Jennifer G., Zemla, Tyler, Ashrani, Aneel, Tafur, Alfonso, Perepu, Usha, Anderson, Daniel, Gundabolu, Krishna, Kuzma, Charles, Perez Botero, Juliana, Leon Ferre, Roberto A., Henkin, Stanislav, Lenz, Charles J., Houghton, Damon E., Vishnu, Prakash, Loprinzi, Charles L.
Format: Journal Article
Language:English
Published: England Elsevier Limited 01.02.2020
Subjects:
Anticoagulants
Anticoagulants - adverse effects
apixaban
Bleeding
Cancer
Chemotherapy
dalteparin
Dalteparin - adverse effects
Heparin
Humans
Malignancy
Metastases
Neoplasm Recurrence, Local
Pyrazoles
Pyridones
Thromboembolism
Treatment Outcome
venous thromboembolism
Venous Thromboembolism - diagnosis
Venous Thromboembolism - drug therapy
cancer
bleeding
apixaban
venous thromboembolism
dalteparin
ISSN:1538-7933, 1538-7836, 1538-7836
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Summary: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.
Bibliography:Funding information
The funding support for this trial was Bristol Myers Squibb/Pfizer Alliance.
Abstract Presentation: American Society of Hematology Annual Meeting, December 2018
Final decision: Marc Carrier 14 October 2019
Trial registration number: NCT02585713
Manuscript handled by: Marc Carrier
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ISSN:1538-7933
1538-7836
1538-7836
DOI:10.1111/jth.14662