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Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Topic:

Theme Issue
Platelets, inflammation and anti-inflammatory drugs in ACS and CAD

DOI: https://doi.org/10.1160/TH15-02-0131
Issue: 2015: 114/3 (Sep) pp. 445–656
Pages: 645-650
Ahead of Print: 2015-05-21

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism

Rationale for and design of the EINSTEIN CHOICE study

Online Supplementary Material

J. I. Weitz (1), R. Bauersachs (2), J. Beyer-Westendorf (3), H. Bounameaux (4), T. A. Brighton (5), A. T. Cohen (6), B. L. Davidson (7), G. Holberg (8), A. Kakkar (9), A. W. A. Lensing (8), M. Prins (10), L. Haskell (11), B. van Bellen (12), P. Verhamme (13), P. S. Wells (14), P. Prandoni (15), on behalf of the EINSTEIN CHOICE Investigators

(1) Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada; (2) Vascular Medicine, Klinikum Darmstadt, Darmstadt, Germany; (3) University Hospital “Carl-Gustav Carus”, Department of Vascular Medicine, Technische Universität Dresden, Germany; (4) Division of Angiology and Hemostasis, University Hospitals of Geneva and Faculty of Medicine, Geneva, Switzerland; (5) Department of Haematology, Prince of Wales Hospital, Sydney, New South Wales, Australia; (6) Department of Haematological Medicine, Guys and St Thomas’ Hospitals, King’s College Hospital, London, UK; (7) University of Washington School of Medicine, Seattle, Washington, USA; (8) Bayer HealthCare AG, Leverkusen, Germany; (9) Thrombosis Research Institute, London and University College London, UK; (10) Maastricht University Medical Center, Maastricht, The Netherlands; (11) Janssen Research & Development, Raritan, New Jersey, USA; (12) Hospital Beneficência Portuguesa, São Paulo, Brazil; (13) Vascular Medicine and Hemostasis, University of Leuven, Belgium; (14) Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ontario, Canada; (15) Department of Cardiothoracic & Vascular Sciences, Thromboembolism Unit, University of Padua, Italy

Keywords

prevention, pulmonary embolism, Deep-vein thrombosis, Venous thrombosis, Antiplatelet agents

Summary

Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6–12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

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