TY - JOUR
T1 - Apixaban and dalteparin in active malignancy-associated venous thromboembolism
T2 - The ADAM VTE trial
AU - McBane, Robert D.
AU - Wysokinski, Waldemar E.
AU - Le-Rademacher, Jennifer G.
AU - Zemla, Tyler
AU - Ashrani, Aneel
AU - Tafur, Alfonso
AU - Perepu, Usha
AU - Anderson, Daniel
AU - Gundabolu, Krishna
AU - Kuzma, Charles
AU - Perez Botero, Juliana
AU - Leon Ferre, Roberto A.
AU - Henkin, Stanislav
AU - Lenz, Charles J.
AU - Houghton, Damon E.
AU - Vishnu, Prakash
AU - Loprinzi, Charles L.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - 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.
AB - 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.
KW - apixaban
KW - bleeding
KW - cancer
KW - dalteparin
KW - venous thromboembolism
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U2 - 10.1111/jth.14662
DO - 10.1111/jth.14662
M3 - Article
C2 - 31630479
AN - SCOPUS:85075059646
VL - 18
SP - 411
EP - 421
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
SN - 1538-7933
IS - 2
ER -