TY - JOUR
T1 - The EXPAND study
T2 - Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation
AU - Shimokawa, Hiroaki
AU - Yamashita, Takeshi
AU - Uchiyama, Shinichiro
AU - Kitazono, Takanari
AU - Shimizu, Wataru
AU - Ikeda, Takanori
AU - Kamouchi, Masahiro
AU - Kaikita, Koichi
AU - Fukuda, Koji
AU - Origasa, Hideki
AU - Sakuma, Ichiro
AU - Saku, Keijiro
AU - Okumura, Yasuo
AU - Nakamura, Yuichiro
AU - Morimoto, Hideo
AU - Matsumoto, Naoki
AU - Tsuchida, Akihito
AU - Ako, Junya
AU - Sugishita, Nobuyoshi
AU - Shimizu, Shogo
AU - Atarashi, Hirotsugu
AU - Inoue, Hiroshi
N1 - Funding Information:
H.S. has received lecture fees from Bayer Yakuhin, Ltd., and Daiichi Sankyo Co., Ltd. T.Y. has received grants and personal fees from Bayer, Daiichi Sankyo, BMS, and Mitsubishi Tanabe; and personal fees from Pfizer, Eisai, Ono Pharmaceutical, Toa Eiyo, and Nippon Boehringer, outside the submitted work. S.U. has received personal fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Sanofi, Dainippon Sumitomo, Otsuka, Takeda Astellas, AstraZeneka, Sanwa Kagaku, Shionogi, Mitsubishi Tanabe, and Pfizer, outside the submitted work. T.K. has received grants and personal fees from Daiichi Sankyo Co., Ltd., Bayer Yakuhin, Ltd., Pfizer, Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim, Mitsubishi Tanabe Pharma Corporation, Shionogi & Co., Ltd., Astellas Pharma Inc., and MSD; personal fees from Bristol-Myers Squibb, Sanofi K.K., and AstraZeneca K.K.; and grants from Takeda Pharmaceutical Co., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., EA Pharma Co., Ltd., Asahi Kasei Medical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Torii Pharmaceutical Co., Ltd., Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd., and Sumitomo Dainippon Pharma Co., Ltd., outside the submitted work. W.S. has received personal fees from Bayer Yakuhin, Ltd., outside the submitted work. T.I. has received grants and personal fees from Daiichi-Sankyo, and Bristol-Myers Squibb; personal fees from Bayer Healthcare, and Pfizer; and grants from Boehringer Ingelheim, outside the submitted work. M.K. has received personal fees from Tohoku University, during the conduct of the study; and personal fees from Bayer Yakuhin, Ltd., outside the submitted work. K.F. has received personal fees from Bayer Yakuhin Ltd., outside the submitted work. H.O. has received personal fees from Daiichi-Sankyo, and Bayer Japan, outside the submitted work. I.S. has received personal fees from Bayer Yakuhin Ltd., and Takeda Pharmaceutical Co., Ltd., outside the submitted work. K.S. has an Endowed Department of Molecular Cardiovascular Therapeutics, Fukuoka University, which is supported by MSD, an Endowed Department of Advanced Therapeutics for Cardiovascular Disease, Fukuoka University, which is supported by Boston Scientific Japan Co., Japan, Medtronic Co., Japan Lifeline Co., Biotronik Japan, and St Jude Medical Japan Co., and an Endowed Department of Future Medicine for Cardiovascular Disease, Fukuoka University, supported by Nihon Kohden Corp. Ltd., Japan. H.M. has received personal fees from Daiichi Sankyo Co., Ltd., Bayer Yakuhin, Ltd., Bristol-Myers Squibb, Boehringer Ingelheim, Otsuka Pharmaceutical Co., Ltd., Eisai Co., Ltd., Novo Nordisk Pharma Ltd., and Kowa Pharmaceutical Co., Ltd., outside the submitted work. N.M. has received personal fees from Bayer, Daiichi-Sankyo, and Boehringer Ingelheim; and grants and personal fees from Bristol-Myers, and Pfizer, outside the submitted work. J.A. has received grants and personal fees from Bayer Yakuhin, outside the submitted work. H.A. has received personal fees from Daiichi Sankyo, outside the submitted work. H.I. has received personal fees from Bayer Healthcare, Boehringer Ingelheim, Daiichi-Sankyo, and Bristol-Myers Squibb, outside the submitted work. K.K., Y.O., Y.N., N.S., S.S., and A.T. have nothing to disclose.
Publisher Copyright:
© 2018 The Authors
PY - 2018/5/1
Y1 - 2018/5/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ijcard.2018.01.141
DO - 10.1016/j.ijcard.2018.01.141
M3 - Article
C2 - 29429636
AN - SCOPUS:85041645770
VL - 258
SP - 126
EP - 132
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -