Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study

Andria Medina; Gary Raskob; Walter Ageno; Alexander T. Cohen; Marjolein P.A. Brekelmans; Cathy Z. Chen; Michael A. Grosso; Michele F. Mercuri; Annelise Segers; Peter Verhamme; Thomas Vanassche; Philip S. Wells; Min Lin; Shannon M. Winters; Jeffrey I. Weitz; Harry R. Büller

doi:10.1160/TH17-05-0523

Thrombosis and Haemostasis, Table of Contents

CC BY-NC-ND 4.0 · Thromb Haemost 2017; 117(12): 2406-2414
DOI: 10.1160/TH17-05-0523

Stroke, Systemic or Venous Thromboembolism

Schattauer GmbH Stuttgart

Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study

Andria Medina

¹Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

,

Gary Raskob

²College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

,

Walter Ageno

³Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy

,

Alexander T. Cohen

⁴Department of Haematological Medicine, Guy's and St Thomas' Hospitals, King's College London, Westminster, London, United Kingdom

,

Marjolein P.A. Brekelmans

⁵Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

,

Cathy Z. Chen

⁶Global Medical Affairs, Daiichi Sankyo Inc, Basking Ridge, New Jersey, United States

,

Michael A. Grosso

⁷Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, New Jersey, United States

,

Michele F. Mercuri

⁷Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, New Jersey, United States

,

Annelise Segers

⁸ITREAS Clinical Research, Amsterdam, The Netherlands

,

Peter Verhamme

⁹Vascular Medicine and Hemostasis, University of Leuven, Leuven, Belgium

,

Thomas Vanassche

⁹Vascular Medicine and Hemostasis, University of Leuven, Leuven, Belgium

,

Philip S. Wells

¹⁰Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada

,

Min Lin

⁷Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, New Jersey, United States

,

Shannon M. Winters

⁶Global Medical Affairs, Daiichi Sankyo Inc, Basking Ridge, New Jersey, United States

,

Jeffrey I. Weitz

¹¹Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada

,

Harry R. Büller

⁵Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

› Author Affiliations

Abstract

Direct oral anticoagulants (DOACs) facilitate the outpatient treatment of venous thromboembolism (VTE). However, the pivotal trials of DOACs have not reported outcomes separately for patients managed either as outpatients or in the hospital. We performed a subgroup analysis of the Hokusai-VTE study comparing efficacy and safety of edoxaban with warfarin in 8,292 patients with acute VTE. Patients received initial therapy with open-label enoxaparin or unfractionated heparin for ≥5 days in the hospital or as an outpatient at the discretion of the treating physician. Edoxaban or warfarin was then given for 3 to 12 months. The primary efficacy outcome was the cumulative incidence of symptomatic recurrent VTE at 12 months. The principal safety outcome was the incidence of clinically relevant bleeding (composite of major or clinically relevant non-major bleeding). Of the 5,223 consecutively enrolled patients with recorded hospital status and length of stay, 1,414 patients (27.1%) were managed as outpatients and 3,809 were managed in hospital. Among the outpatients, initial presentation was symptomatic deep-vein thrombosis (DVT) in 1,183 patients (83.7%) and pulmonary embolism (PE) in 231 patients (16.3%). Among the outpatients with DVT, recurrent VTE occurred in 18 (3.0%) given edoxaban and in 21 (3.6%) given warfarin (risk difference: −0.61, 95% confidence interval [CI]: −2.6 to 1.4). The principal safety outcome in outpatients occurred in 46 edoxaban patients (7.7%) and in 48 warfarin patients (8.3%; risk difference: −0.59, 95% CI: −3.7 to 2.5). Most outpatients had symptomatic DVT at presentation. In these patients, initial heparin followed by edoxaban had similar efficacy and safety to standard therapy with heparin and warfarin.

Keywords

deep-vein thrombosis - edoxaban - direct oral anticoagulants - pulmonary embolism - venous thromboembolism - vitamin K antagonists

Full Text

References

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