Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism- the J-EINSTEIN DVT and PE program

N. Yamada*, A. Hirayama, H. Maeda, S. Sakagami, H. Shikata, M.H. Prins, A.W.A. Lensing, M. Kato, J. Onuma, Y. Miyamoto, K. Iekushi, M. Kajikawa

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background: 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. 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.

Methods: We 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.

Results: Eighty-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.

Conclusions: The 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.

Original languageEnglish
Article number2
Number of pages8
JournalThrombosis Journal
Publication statusPublished - 1 Jan 2015


  • Deep vein thrombosis
  • Japan
  • Pulmonary embolism
  • Randomized trial
  • Rivaroxaban
  • Unfractionated heparin
  • Venous thromboembolism
  • Warfarin

Cite this