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

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).

Evolving Treatments for Arterial and Venous Thrombosis

“…The ongoing Reduced-Dose Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism (EINSTEIN CHOICE) trial is comparing 2 dosing regimens of rivaroxaban (10 and 20 mg OD) with aspirin to identify the optimal dose of rivaroxaban for extended VTE treatment and to determine whether rivaroxaban is superior to aspirin for this purpose. 74 In the RE-MEDY study, dabigatran was noninferior to warfarin (HR, 1.44; 95% CI, 0.78-2.64), but was associated with a 46% reduction in the composite of major or clinically relevant nonmajor bleeding (HR, 0.54; 95% CI, 0.41-0.71). 70 Therefore, the DOACs are an effective, safe, and convenient option for both the initial and the extended treatment of VTE.…”

Secondary prophylaxis decision‐making in venous thromboembolism: interviews on clinical practice in thirteen countries

“…From December 2015 to February 2016, we conducted 13 telephone‐based, semi‐structured interviews with an equal number of senior‐level physicians in the field of thrombosis, all of who were at the time affiliated with medical centers participating in the Einstein Choice study 10. We selected interviewee candidates on the basis of their considerable experience, stature, and organizational involvement in their respective local professional communities.…”

Secondary Prevention of Venous Thromboembolism

“…Further developments may also bring new alternatives to the drugs listed in the Figure and 16 This will be the first study to directly compare a new oral anticoagulant with aspirin in this setting. In addition, statins may be of potential interest for the secondary prevention of VTE.…”