F I Mulder1, N van Es2, N Kraaijpoel2, M Di Nisio3, M Carrier4, A Duggal5, M Gaddh6, D Garcia7, M A Grosso5, A K Kakkar8, M F Mercuri5, S Middeldorp2, G Royle9, A Segers10, S Shivakumar11, P Verhamme12, T Wang13, J I Weitz14, G Zhang5, H R Büller2, G Raskob15. 1. Department of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: f.i.mulder@amsterdamumc.nl. 2. Department of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 3. Department of Medicine and Ageing Sciences, University G. D'Annunzio, Chieti, Italy. 4. Ottawa Hospital Research Institute, Ottawa, Canada. 5. Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA. 6. Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, USA. 7. Department of Medicine, Division of Hematology, University of Washington, Seattle, USA. 8. Thrombosis Research Institute, University College London, London, United Kingdom. 9. Department of Hematology, Middlemore Hospital, Auckland, New Zealand. 10. ITREAS, Academic Research Organization, Amsterdam, the Netherlands. 11. Department of Hematology, Queen Elizabeth II Health Sciences Centre, Halifax, Canada. 12. Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium. 13. Department of Internal Medicine, Division of Hematology, The Ohio State University Wexner Medical Center, Columbus, USA. 14. McMaster University, The Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada. 15. University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City, USA.
Abstract
BACKGROUND: The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups. METHODS: We evaluated the occurrence of the primary outcome in large cancer groups. The primary outcome was the composite of recurrent VTE or major bleeding over 12 months. RESULTS: In patients with gastrointestinal cancer, the primary outcome occurred in 19.4% patients given edoxaban and in 15.0% given dalteparin (risk difference [RD], 4.4%; 95%-CI, -4.1% to 12.8%). The corresponding rates for edoxaban and dalteparin were 10.4% and 10.7% for lung cancer (RD, -0.3%; 95%-CI, -10.0% to 9.5%), 13.6% and 12.5% for urogenital cancer (RD, 1.1; 95%-CI, -10.1-12.4), 3.1% and 11.7% for breast cancer (RD, -8.6; 95%-CI, -19.3-2.2), 8.9% and 10.9% for hematological malignancies (RD, -2.0; 95%-CI, -13.1-9.1), and 10.4% and 17.4% for gynecological cancer (RD, -7.0; 95%-CI, -19.8-5.7). In the subgroup of gastrointestinal cancer, edoxaban was associated with a 3.5% lower absolute risk of recurrent VTE and a 7.9% higher risk of major bleeding. CONCLUSION: Edoxaban has a similar risk-benefit ratio to dalteparin in most cancer groups. In those with gastrointestinal cancer, the lower risk of recurrent VTE and the advantages of oral therapy need to be balanced against the increased risk of major bleeding.
BACKGROUND: The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups. METHODS: We evaluated the occurrence of the primary outcome in large cancer groups. The primary outcome was the composite of recurrent VTE or major bleeding over 12 months. RESULTS: In patients with gastrointestinal cancer, the primary outcome occurred in 19.4% patients given edoxaban and in 15.0% given dalteparin (risk difference [RD], 4.4%; 95%-CI, -4.1% to 12.8%). The corresponding rates for edoxaban and dalteparin were 10.4% and 10.7% for lung cancer (RD, -0.3%; 95%-CI, -10.0% to 9.5%), 13.6% and 12.5% for urogenital cancer (RD, 1.1; 95%-CI, -10.1-12.4), 3.1% and 11.7% for breast cancer (RD, -8.6; 95%-CI, -19.3-2.2), 8.9% and 10.9% for hematological malignancies (RD, -2.0; 95%-CI, -13.1-9.1), and 10.4% and 17.4% for gynecological cancer (RD, -7.0; 95%-CI, -19.8-5.7). In the subgroup of gastrointestinal cancer, edoxaban was associated with a 3.5% lower absolute risk of recurrent VTE and a 7.9% higher risk of major bleeding. CONCLUSION:Edoxaban has a similar risk-benefit ratio to dalteparin in most cancer groups. In those with gastrointestinal cancer, the lower risk of recurrent VTE and the advantages of oral therapy need to be balanced against the increased risk of major bleeding.
Authors: Rachel P Rosovsky; Megan E Barra; Russel J Roberts; Alison Parmar; Jennifer Andonian; Larren Suh; Suzanne Algeri; Paul D Biddinger Journal: Oncologist Date: 2020-03-10
Authors: Mercedes Salgado; Elena Brozos-Vázquez; Begoña Campos; Paula González-Villarroel; María Eva Pérez; María Lidia Vázquez-Tuñas; David Arias Journal: Clin Appl Thromb Hemost Date: 2022 Jan-Dec Impact factor: 3.512
Authors: F I Mulder; A Hovenkamp; H W M van Laarhoven; H R Büller; P W Kamphuisen; M C C M Hulshof; M I van Berge Henegouwen; S Middeldorp; N van Es Journal: Br J Surg Date: 2020-05-19 Impact factor: 6.939
Authors: Michela Giustozzi; Jean M Connors; Ana Belen Ruperez Blanco; Sebastian Szmit; Nicolas Falvo; Alexander T Cohen; Menno Huisman; Rupert Bauersachs; Francesco Dentali; Cecilia Becattini; Giancarlo Agnelli Journal: J Thromb Haemost Date: 2021-07-29 Impact factor: 16.036