M Nakamura1, Y Q Wang2, C Wang3,4,5, D Oh6, W-H Yin7,8, T Kimura9, K Miyazaki10, K Abe11, M Mercuri12, L H Lee13, A Segers14, H Büller15. 1. Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Mie, Japan. 2. Zhongshan Hospital, Fudan University, Shanghai, China. 3. National Clinical Research Center of Respiratory Diseases, Capital Medical University, Beijing, China. 4. Department of Respiratory Medicine, Capital Medical University, Beijing, China. 5. China-Japan Friendship Hospital, Beijing, China. 6. CHA Bundang Medical Center, CHA University, Gyeongghi-do, South Korea. 7. Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan. 8. Faculty of Medicine, National Yang Ming University, Taipei, Taiwan. 9. Clinical Planning Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 10. Asia Development Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 11. Clinical Data & Biostatistics Department, Daiichi Sankyo Co. Ltd, Tokyo, Japan. 12. Clinical Development Department, Daiichi Sankyo Pharma Development, Edison, NJ, USA. 13. Department of Hematology, Singapore General Hospital, Singapore, Singapore. 14. ITREAS, Amsterdam, the Netherlands. 15. Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Abstract
BACKGROUND: Direct oral anticoagulants have been evaluated for their efficacy and safety in the treatment of venous thromboembolism (VTE), which comprises deep vein thrombosis and pulmonary embolism. The randomized, double-blind Hokusai-VTE trial demonstrated that 60 mg of edoxaban once daily following initial heparin treatment is non-inferior to heparin overlapped with and followed by warfarin for the treatment of VTE, and is associated with significantly fewer bleeding events. OBJECTIVES: To assess the efficacy and safety of edoxaban versus warfarin among East Asian patients enrolled in the Hokusai-VTE trial. PATIENTS/ METHODS: The Hokusai-VTE trial enrolled 8292 patients from 439 centers worldwide, including 1109 patients from Japan, China, Korea, and Taiwan. The primary efficacy and safety outcomes were symptomatic recurrent VTE and clinically relevant bleeding, respectively. RESULTS: In the overall East Asian population, the primary efficacy outcome of symptomatic recurrent VTE occurred in 16 of 563 (2.8%) patients in the edoxaban group versus 24 of 538 (4.5%) patients in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.34-1.19; P = 0.1601). The primary safety outcome of clinically relevant bleeding occurred in 56 of 563 (9.9%) patients in the edoxaban group versus 93 of 538 (17.3%) patients in the warfarin group (HR 0.56; 95% CI 0.40-0.78; P < 0.001). CONCLUSIONS:Edoxaban is an effective and safer alternative to warfarin in East Asian patients with acute VTE who require anticoagulant therapy, consistent with overall study findings from the Hokusai-VTE trial.
RCT Entities:
BACKGROUND: Direct oral anticoagulants have been evaluated for their efficacy and safety in the treatment of venous thromboembolism (VTE), which comprises deep vein thrombosis and pulmonary embolism. The randomized, double-blind Hokusai-VTE trial demonstrated that 60 mg of edoxaban once daily following initial heparin treatment is non-inferior to heparin overlapped with and followed by warfarin for the treatment of VTE, and is associated with significantly fewer bleeding events. OBJECTIVES: To assess the efficacy and safety of edoxaban versus warfarin among East Asian patients enrolled in the Hokusai-VTE trial. PATIENTS/ METHODS: The Hokusai-VTE trial enrolled 8292 patients from 439 centers worldwide, including 1109 patients from Japan, China, Korea, and Taiwan. The primary efficacy and safety outcomes were symptomatic recurrent VTE and clinically relevant bleeding, respectively. RESULTS: In the overall East Asian population, the primary efficacy outcome of symptomatic recurrent VTE occurred in 16 of 563 (2.8%) patients in the edoxaban group versus 24 of 538 (4.5%) patients in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.34-1.19; P = 0.1601). The primary safety outcome of clinically relevant bleeding occurred in 56 of 563 (9.9%) patients in the edoxaban group versus 93 of 538 (17.3%) patients in the warfarin group (HR 0.56; 95% CI 0.40-0.78; P < 0.001). CONCLUSIONS:Edoxaban is an effective and safer alternative to warfarin in East Asian patients with acute VTE who require anticoagulant therapy, consistent with overall study findings from the Hokusai-VTE trial.