Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism (2010)


Treatment of acute symptomatic DVT 

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To compare rivaroxaban to enoxaparin/vitamin K antagonist (VKA) in the treatment of patients with acute symptomatic DVT

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Trial design

Randomized, open-label phase III non-inferiority study
Active treatment: rivaroxaban 15 mg p.o. twice daily for 3 weeks followed by rivaroxaban 20 mg once daily for 3, 6 or 12 months (n=1731)
Control treatment: enoxaparin 40 mg s.c. twice daily for at least 5 days in combination with VKA; enoxaparin discontinued, if INR ≥2, VKA continued for 3, 6 or 12 months (n=1718)

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Primary efficacy endpoint: symptomatic recurrent VTE – the composite of recurrent DVT or fatal or non-fatal PE 
Secondary efficacy endpoint: all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), and net clinical benefit (defined as the composite of the primary efficacy outcome or major bleeding), net clinical benefit (defined as the composite of the primary efficacy outcome or major bleeding)
Primary safety endpoint: major and clinically relevant non-major bleeding 
Secondary safety endpoint: adverse events

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Trial participants

3449 patients with objectively confirmed acute symptomatic DVT and without symptomatic PE

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Efficacy outcome: In the intent-to-treat population the primary efficacy endpoint occurred in 36 of 1731 patients (2.1%) given rivaroxaban and in 51 of 1718 patients (3.0%) given enoxaparin/VKA. The outcome of net clinical benefit occurred in 51 (2.9%) of the patients who received rivaroxaban and in 73 (4.2%) of the patients who received enoxaparin/VKA
Safety outcome: In the safety population, the primary safety endpoint occurred in 139 of 1718 patients of the patients given rivaroxaban (8.1%) and 138 of 1711 patients given enoxaparin/VKA (8.1%). The incidence of major bleeding was similar in the 2 groups: 0.8% and 1.2%, respectively

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Efficacy: Rivaroxaban was as effective as standard therapy with enoxaparin/VKA for the treatment of acute DVT
Safety:  There was no difference in the incidence of major and clinically relevant non-major bleeding in both treatment groups

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Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S for the EINSTEIN investigators. Oral rivaroxaban for symptomatic venous thromboembolism. New Engl J Med 2010;363(26):2499-2510

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Corresponding author

Harry R. Buller, MD, Department of Vascular Medicine, Academic Medical Center, F4-275, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands
e-mail: h.r.buller@amc.uva.nl

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