Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists

Marjolein P. A. Brekelmans; Suzanne M. Bleker; Rupert Bauersachs; Zoltan Boda; Harry R. Büller; Youngsook Choi; Alex Gallus; Michael A. Grosso; Saskia Middeldorp; Doyeun Oh; Gary Raskob; Lee Schwocho; Alexander T. Cohen

doi:10.1160/TH15-11-0892

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2016; 116(01): 155-161
DOI: 10.1160/TH15-11-0892

Stroke, Systemic or Venous Thromboembolism

Schattauer GmbH

Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists

Authors

Marjolein P. A. Brekelmans

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
Suzanne M. Bleker

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
Rupert Bauersachs

²Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany
Zoltan Boda

³Thrombosis and Haemostasis Center, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary
Harry R. Büller

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
Youngsook Choi

⁴Daiichi Sankyo, Inc., Edison, New Jersey, USA
Alex Gallus

⁵SA Pathology at Flinders Medical Centre & Flinders University, Adelaide, Southern Australia, Australia
Michael A. Grosso

⁴Daiichi Sankyo, Inc., Edison, New Jersey, USA
Saskia Middeldorp

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
Doyeun Oh

⁶Division of Hematology-Oncology, Department of Internal Medicine, CHA University, Gyeonggi-do, Korea
Gary Raskob

⁷College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
Lee Schwocho

⁴Daiichi Sankyo, Inc., Edison, New Jersey, USA
Alexander T. Cohen

⁸Department of Haematological Medicine, Guy’s and St Thomas’ Hospitals, King’s College London, United Kingdom

Abstract

Summary

Edoxaban is a once-daily direct oral anticoagulant (DOAC). The Hokusai-VTE study revealed that, after initial treatment with heparin, edoxaban was non-inferior to and safer than vitamin K antagonists (VKA) in the prevention of recurrent deep-vein thrombosis and pulmonary embolism. This is the first report on the clinical relevance and management of bleeding events with edoxaban. All major bleeding events were classified blindly by three study-independent adjudicators. Predefined criteria were used to classify severity of clinical presentation and, separately, the clinical course and outcome into four categories. Major bleeding occurred in 56 patients treated with edoxaban and 65 patients treated with VKA. The severest categories (3 or 4) of the clinical presentation were assigned to 46 % of the major bleeding episodes in edoxaban recipients versus 58 % of the major bleeds in VKA recipients (odds ratio [OR] 0.62, 95 % confidence interval [CI] 0.30–1.27, p = 0.19). Clinical course was classified as severe (category 3 or 4) in 23 % of the edoxaban and 29 % of the VKA associated bleeds (OR 0.73, 95 % CI 0.32–1.66, p = 0.46). In conclusion, edoxaban associated major bleeding events have a comparable clinical presentation and course to major bleeds with VKA in patients treated for venous thromboembolism in the Hokusai-VTE study. These results may assure physicians that it is safe to prescribe this medication. If a major bleeding during edoxaban treatment occurs, its clinical presentation and clinical course are not worse than in VKA-treated patients.

Keywords

Anticoagulants - coumarins - edoxaban - venous thromboembolism - haemorrhage

Full Text

References

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