Abstract
BackgroundThe global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. Owing to differences in targeted anticoagulant intensities in Japan, Japanese patients were not enrolled into the global studies. Instead, a separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in Japanese patients was conducted, which compared the Japanese standard of care with a reduced dose of rivaroxaban.MethodsWe conducted an open-label, randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) with activated partial thromboplastin time-adjusted intravenous unfractionated heparin (UFH) followed by warfarin (target international normalized ratio 2.0; range 1.5–2.5) in patients with acute, objectively confirmed symptomatic DVT and/or PE. Patients were assessed for the occurrence of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration and bleeding.ResultsEighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. Three patients were excluded because of serious non-compliance issues. The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, -3.4–23.8]). No major bleeding occurred during study treatment. Clinically relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban group and 1 (5.3%) patient in the UFH/warfarin group.ConclusionsThe findings of this study in Japanese patients with acute DVT and/or PE suggest a similar efficacy and safety profile with rivaroxaban and control treatment, consistent with that of the worldwide EINSTEIN DVT and PE program.Trial registrationClinicaltrials.gov: NCT01516840 and NCT01516814.Electronic supplementary materialThe online version of this article (doi:10.1186/s12959-015-0035-3) contains supplementary material, which is available to authorized users.
Highlights
The global EINSTEIN deep vein thrombosis (DVT) and pulmonary embolism (PE) studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding
Acute deep vein thrombosis (DVT) and pulmonary embolism (PE) are common disorders in the Western world [1,2,3], and treatment recommendations are based on the results of large randomized trials [4]
venous thromboembolism (VTE) management was characterized by a highly aggressive strategy in the acute phase, with frequent use of inferior vena cava filter insertion (40.6%) and thrombolysis (21.1%), whereas anticoagulation was characterized by targeting sub-therapeutic levels of unfractionated heparin (UFH) and warfarin
Summary
The global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. The recommended regimen of anticoagulant therapy for VTE in Japanese guidelines differs from that in other parts of the world, consisting of UFH infusion (instead of subcutaneous low molecular weight heparin [LMWH]) overlapping with and followed by warfarin, with a target international normalized ratio (INR) range of 1.5–2.5 instead of 2.0–3.0 [6]. This regimen is complex, owing to the need for intravenous administration of UFH and laboratory monitoring and dose adjustment for both UFH and warfarin [7,8]
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