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T h e n e w e ng l a n d j o u r na l o f m e dic i n e
original article
Oral Rivaroxaban for Symptomatic Venous
Thromboembolism
The EINSTEIN Investigators*
A BS T R AC T
Background
Rivaroxaban, an oral factor Xa inhibitor, may provide a simple, fixed-dose regimen
for treating acute deep-vein thrombosis (DVT) and for continued treatment, without the need for laboratory monitoring.
Methods
We conducted an open-label, randomized, event-driven, noninferiority study that
compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg
once daily) with subcutaneous enoxaparin followed by a vitamin K antagonist (either warfarin or acenocoumarol) for 3, 6, or 12 months in patients with acute, symptomatic DVT. In parallel, we carried out a double-blind, randomized, event-driven
superiority study that compared rivaroxaban alone (20 mg once daily) with placebo
for an additional 6 or 12 months in patients who had completed 6 to 12 months of
treatment for venous thromboembolism. The primary efficacy outcome for both
studies was recurrent venous thromboembolism. The principal safety outcome was
major bleeding or clinically relevant nonmajor bleeding in the initial-treatment
study and major bleeding in the continued-treatment study.
Results
The study of rivaroxaban for acute DVT included 3449 patients: 1731 given rivaroxaban and 1718 given enoxaparin plus a vitamin K antagonist. Rivaroxaban had noninferior efficacy with respect to the primary outcome (36 events [2.1%], vs. 51 events
with enoxaparin–vitamin K antagonist [3.0%]; hazard ratio, 0.68; 95% confidence
interval [CI], 0.44 to 1.04; P100 kg
245 (14.2)‡
246 (14.3)‡
85 (14.1)‡
87 (14.6)‡
6 (0.3)
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