title: Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.
abstract: 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).
authors.affiliation: Jeffrey I. Weitz, Thrombosis & Atherosclerosis Research Institute, and McMaster University, Hamilton, Ontario, Canada, E-mail: weitzj@taari.ca.
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Weitz
authors.forename: Rupert
authors.initials: R
authors.lastname: Bauersachs
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.forename: Henri
authors.initials: H
authors.lastname: Bounameaux
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Brighton
authors.forename: Alexander T
authors.initials: AT
authors.lastname: Cohen
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Davidson
authors.forename: Gerlind
authors.initials: G
authors.lastname: Holberg
authors.forename: Ajay
authors.initials: A
authors.lastname: Kakkar
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
authors.forename: Martin
authors.initials: M
authors.lastname: Prins
authors.forename: Lloyd
authors.initials: L
authors.lastname: Haskell
authors.forename: Bonno
authors.initials: B
authors.lastname: van Bellen
authors.forename: Peter
authors.initials: P
authors.lastname: Verhamme
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
authors.forename: Paolo
authors.initials: P
authors.lastname: Prandoni
mesh_terms: D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D012008:Recurrence; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000175:diagnosis / Q000517:prevention & control*
chemical_list: D005343:Fibrinolytic Agents; D000069552:Rivaroxaban; D001241:Aspirin
keywords: Venous thrombosis; antiplatelet agents; deep-vein thrombosis; prevention; pulmonary embolism