In Japanese patients with acute DVT and/or PE, rivaroxaban resulted in a 1.4% rate of symptomatic recurrent VTE or asymptomatic deterioration compared to 5.3% with standard UFH/warfarin therapy (absolute risk difference 3.9%).
RCT (n=100)
Open-label
Central, interactive web response system, 4:1 ratio
Yes
Does oral rivaroxaban reduce the composite of symptomatic recurrent VTE or asymptomatic deterioration in Japanese patients with acute symptomatic DVT and/or PE compared to UFH/warfarin?
In Japanese patients with acute DVT and/or PE, a reduced-dose rivaroxaban regimen demonstrated a similar efficacy and safety profile to the Japanese standard of care (UFH/warfarin).
Absolute Risk Reduction: 3.9 (95% CI -3.4–23.8)
Absolute Event Rate: 1.4% vs 5.3%
Absolute Risk Reduction: 3.9%
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. 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. 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. 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. Clinicaltrials.gov: NCT01516840 and NCT01516814 .
Yamada et al. (Fri,) conducted a rct in Acute symptomatic deep vein thrombosis and/or pulmonary embolism (n=100). Rivaroxaban vs. Intravenous unfractionated heparin followed by warfarin (target INR 1.5-2.5) was evaluated on Composite of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration (ARR 3.9%, 95% CI -3.4-23.8). In Japanese patients with acute DVT and/or PE, rivaroxaban resulted in a 1.4% rate of symptomatic recurrent VTE or asymptomatic deterioration compared to 5.3% with standard UFH/warfarin therapy (absolute risk difference 3.9%).