Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism
- PMID: 29231094
- DOI: 10.1056/NEJMoa1711948
Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism
Abstract
Background: Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear.
Methods: In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration.
Results: Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P=0.006 for noninferiority; P=0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6).
Conclusions: Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials.gov number, NCT02073682 .).
Comment in
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Edoxaban for the Treatment of Venous Thromboembolism in Patients with Cancer.N Engl J Med. 2018 Feb 15;378(7):673-674. doi: 10.1056/NEJMe1800041. N Engl J Med. 2018. PMID: 29443673 No abstract available.
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Edoxaban for the treatment of cancer associated venous thromboembolism as an alternative to low-molecular-weight-heparin.Intern Emerg Med. 2018 Oct;13(7):1089-1091. doi: 10.1007/s11739-018-1886-y. Epub 2018 Jun 12. Intern Emerg Med. 2018. PMID: 29948831 No abstract available.
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Edoxaban is non-inferior to low-molecular-weight heparin for treating cancer-associated venous thromboembolism.BMJ Evid Based Med. 2018 Dec;23(6):230. doi: 10.1136/bmjebm-2018-111007. Epub 2018 Jun 29. BMJ Evid Based Med. 2018. PMID: 29959155 Review. No abstract available.
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Edoxaban for Cancer-Associated Venous Thromboembolism.N Engl J Med. 2018 Jul 5;379(1):93. doi: 10.1056/NEJMc1806646. N Engl J Med. 2018. PMID: 29975029 No abstract available.
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Edoxaban for Cancer-Associated Venous Thromboembolism.N Engl J Med. 2018 Jul 5;379(1):93-4. doi: 10.1056/NEJMc1806646. N Engl J Med. 2018. PMID: 29975031 No abstract available.
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Edoxaban for Cancer-Associated Venous Thromboembolism.N Engl J Med. 2018 Jul 5;379(1):94. doi: 10.1056/NEJMc1806646. N Engl J Med. 2018. PMID: 29975032 No abstract available.
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Edoxaban for Cancer-Associated Venous Thromboembolism.N Engl J Med. 2018 Jul 5;379(1):94-5. doi: 10.1056/NEJMc1806646. N Engl J Med. 2018. PMID: 29975033 No abstract available.
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Was ist die beste antithrombotische Therapie?MMW Fortschr Med. 2021 Dec;163(21-22):82. doi: 10.1007/s15006-021-0608-y. MMW Fortschr Med. 2021. PMID: 34888823 German. No abstract available.
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