Hiroaki Shimokawa1, Takeshi Yamashita2, Shinichiro Uchiyama3, Takanari Kitazono4, Wataru Shimizu5, Takanori Ikeda6, Masahiro Kamouchi7, Koichi Kaikita8, Koji Fukuda9, Hideki Origasa10, Ichiro Sakuma11, Keijiro Saku12, Yasuo Okumura13, Yuichiro Nakamura14, Hideo Morimoto15, Naoki Matsumoto16, Akihito Tsuchida17, Junya Ako18, Nobuyoshi Sugishita19, Shogo Shimizu20, Hirotsugu Atarashi21, Hiroshi Inoue22. 1. Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan. Electronic address: shimo@cardio.med.tohoku.ac.jp. 2. Cardiovascular Institute Hospital, Tokyo, Japan. 3. International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan. 4. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan. 5. Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. 6. Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan. 7. Department of Health Care Administration and Management, Center for Cohort Study, Kyushu University Graduate School of Medical Sciences, Fukuoka, Fukuoka, Japan. 8. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan. 9. International University of Health and Welfare, Division of Heart Rhythm, International University of Health and Welfare Hospital, Nasushiobara, Tochigi, Japan. 10. Department of Biostatistics and Clinical Epidemiology, Toyama University, Toyama, Toyama, Japan. 11. Caress Sapporo Hokko Memorial Clinic, Sapporo, Hokkaido, Japan. 12. Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Fukuoka, Japan. 13. Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan. 14. Nakamura Cardiovascular Clinic, Itoshima, Fukuoka, Japan. 15. Department of Medicine, Fukagawa Municipal Hospital, Fukagawa, Hokkaido, Japan. 16. Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan. 17. Minami-Ichijo-Hospital, Sapporo, Hokkaido, Japan. 18. Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan. 19. Sugishita Clinic, Gujo, Gifu, Japan. 20. Mashiko Hospital, Kawaguchi, Saitama, Japan. 21. Minamihachioji Hospital, Tokyo, Japan. 22. Saiseikai Toyama Hospital, Toyama, Toyama, Japan.
Abstract
AIMS: The EXPAND study examined the real-world efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism (SE) in Japanese patients with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: This multicenter, prospective, non-interventional, observational, cohort study was conducted at 684 medical centers in Japan. A total of 7141 NVAF patients ≥20 years of age (mean, 71.6 ± 9.4 years) who were being or about to be treated with rivaroxaban (10 mg/day, 43.5%; 15 mg/day, 56.5%) were followed for an average of 897.1 (±206.8) days with a high follow-up rate (99.65%). The mean CHADS2 score at baseline was 2.1 (1.3) (0-1, 37%; 2, 29%; ≥3, 34%). The total incidence rate of symptomatic stroke and SE (primary efficacy endpoint) was 1.0%/year, and 0.5%, 0.9%, and 1.7%/year for those with CHADS2 scores of 0-1, 2, and ≥3, respectively. Cumulative incidence rates for major bleeding (primary safety endpoint) and non-major bleeding (secondary safety endpoint) were 1.2%/year and 4.9%/year, respectively. Differences were noted between new and current users only for major bleeding event rate (1.7% vs. 1.1%/year, P = 0.0024). Comparisons with previous studies suggested that rivaroxaban is effective and safe for low-risk patients (0-1 CHADS2), as shown for warfarin in the XANTUS international prospective post-marketing study. CONCLUSIONS: The EXPAND study demonstrated that low dosages of rivaroxaban for Japanese NVAF patients in real-world clinical practice, including those with CHADS2 scores 0-1, resulted in low rates of stroke and SE, and major and non-major bleeding.
AIMS: The EXPAND study examined the real-world efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism (SE) in Japanese patients with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: This multicenter, prospective, non-interventional, observational, cohort study was conducted at 684 medical centers in Japan. A total of 7141 NVAF patients ≥20 years of age (mean, 71.6 ± 9.4 years) who were being or about to be treated with rivaroxaban (10 mg/day, 43.5%; 15 mg/day, 56.5%) were followed for an average of 897.1 (±206.8) days with a high follow-up rate (99.65%). The mean CHADS2 score at baseline was 2.1 (1.3) (0-1, 37%; 2, 29%; ≥3, 34%). The total incidence rate of symptomatic stroke and SE (primary efficacy endpoint) was 1.0%/year, and 0.5%, 0.9%, and 1.7%/year for those with CHADS2 scores of 0-1, 2, and ≥3, respectively. Cumulative incidence rates for major bleeding (primary safety endpoint) and non-major bleeding (secondary safety endpoint) were 1.2%/year and 4.9%/year, respectively. Differences were noted between new and current users only for major bleeding event rate (1.7% vs. 1.1%/year, P = 0.0024). Comparisons with previous studies suggested that rivaroxaban is effective and safe for low-risk patients (0-1 CHADS2), as shown for warfarin in the XANTUS international prospective post-marketing study. CONCLUSIONS: The EXPAND study demonstrated that low dosages of rivaroxaban for Japanese NVAF patients in real-world clinical practice, including those with CHADS2 scores 0-1, resulted in low rates of stroke and SE, and major and non-major bleeding.
Authors: Jan Beyer-Westendorf; A John Camm; Keith A A Fox; Jean-Yves Le Heuzey; Sylvia Haas; Alexander G G Turpie; Saverio Virdone; Ajay K Kakkar Journal: Thromb J Date: 2019-04-25