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

Autor: McBane RD 2nd; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.; Hematology Division, Mayo Clinic, Rochester, Minnesota.; Cardiovascular Department, Mayo Clinic, Rochester, Minnesota., Wysokinski WE; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.; Hematology Division, Mayo Clinic, Rochester, Minnesota.; Cardiovascular Department, Mayo Clinic, Rochester, Minnesota., Le-Rademacher JG; Health Science Research Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota., Zemla T; Health Science Research Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota., Ashrani A; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.; Hematology Division, Mayo Clinic, Rochester, Minnesota., Tafur A; NorthShore Medical Group, Evanston, Illinois., Perepu U; Medical Oncology, University of Iowa, Iowa City, Iowa., Anderson D; Department of Hematology, Oncology and Transplantation, University of Minnesota, Regions Hospital, St Paul, Minnesota., Gundabolu K; Department of Oncology and Hematology, University of Nebraska Medical Center, Omaha, Nebraska., Kuzma C; Department of Hematology and Oncology, First Health of the Carolinas, Pinehurst, North Carolina., Perez Botero J; Froedtert Cancer Center, Milwaukee, Wisconsin., Leon Ferre RA; Medical Oncology Department, Mayo Clinic, Rochester, Minnesota., Henkin S; Department of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire., Lenz CJ; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.; Cardiovascular Department, Mayo Clinic, Rochester, Minnesota., Houghton DE; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.; Hematology Division, Mayo Clinic, Rochester, Minnesota.; Cardiovascular Department, Mayo Clinic, Rochester, Minnesota., Vishnu P; Department of Oncology and Hematology, Mayo Clinic, Jacksonville, Florida., Loprinzi CL; Medical Oncology Department, Mayo Clinic, Rochester, Minnesota.
Jazyk: angličtina
Zdroj: Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2020 Feb; Vol. 18 (2), pp. 411-421. Date of Electronic Publication: 2019 Nov 28.
DOI: 10.1111/jth.14662
Abstrakt: 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.
(© 2019 International Society on Thrombosis and Haemostasis.)
Databáze: MEDLINE
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