The EXPAND study: Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation

Hiroaki Shimokawa, Takeshi Yamashita, Shinichiro Uchiyama, Takanari Kitazono, Wataru Shimizu, Takanori Ikeda, Masahiro Kamouchi, Koichi Kaikita, Koji Fukuda, Hideki Origasa, Ichiro Sakuma, Keijiro Saku, Yasuo Okumura, Yuichiro Nakamura, Hideo Morimoto, Naoki Matsumoto, Akihito Tsuchida, Junya Ako, Nobuyoshi Sugishita, Shogo ShimizuHirotsugu Atarashi, Hiroshi Inoue

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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.

Original languageEnglish
Pages (from-to)126-132
Number of pages7
JournalInternational Journal of Cardiology
Volume258
DOIs
Publication statusPublished - May 1 2018

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Atrial Fibrillation
Embolism
Hemorrhage
Safety
Stroke
Incidence
Warfarin
Marketing
Observational Studies
Japan
Cohort Studies
Rivaroxaban

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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The EXPAND study : Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation. / Shimokawa, Hiroaki; Yamashita, Takeshi; Uchiyama, Shinichiro; Kitazono, Takanari; Shimizu, Wataru; Ikeda, Takanori; Kamouchi, Masahiro; Kaikita, Koichi; Fukuda, Koji; Origasa, Hideki; Sakuma, Ichiro; Saku, Keijiro; Okumura, Yasuo; Nakamura, Yuichiro; Morimoto, Hideo; Matsumoto, Naoki; Tsuchida, Akihito; Ako, Junya; Sugishita, Nobuyoshi; Shimizu, Shogo; Atarashi, Hirotsugu; Inoue, Hiroshi.

In: International Journal of Cardiology, Vol. 258, 01.05.2018, p. 126-132.

Research output: Contribution to journalArticle

Shimokawa, H, Yamashita, T, Uchiyama, S, Kitazono, T, Shimizu, W, Ikeda, T, Kamouchi, M, Kaikita, K, Fukuda, K, Origasa, H, Sakuma, I, Saku, K, Okumura, Y, Nakamura, Y, Morimoto, H, Matsumoto, N, Tsuchida, A, Ako, J, Sugishita, N, Shimizu, S, Atarashi, H & Inoue, H 2018, 'The EXPAND study: Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation', International Journal of Cardiology, vol. 258, pp. 126-132. https://doi.org/10.1016/j.ijcard.2018.01.141
Shimokawa, Hiroaki ; Yamashita, Takeshi ; Uchiyama, Shinichiro ; Kitazono, Takanari ; Shimizu, Wataru ; Ikeda, Takanori ; Kamouchi, Masahiro ; Kaikita, Koichi ; Fukuda, Koji ; Origasa, Hideki ; Sakuma, Ichiro ; Saku, Keijiro ; Okumura, Yasuo ; Nakamura, Yuichiro ; Morimoto, Hideo ; Matsumoto, Naoki ; Tsuchida, Akihito ; Ako, Junya ; Sugishita, Nobuyoshi ; Shimizu, Shogo ; Atarashi, Hirotsugu ; Inoue, Hiroshi. / The EXPAND study : Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation. In: International Journal of Cardiology. 2018 ; Vol. 258. pp. 126-132.
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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.",
author = "Hiroaki Shimokawa and Takeshi Yamashita and Shinichiro Uchiyama and Takanari Kitazono and Wataru Shimizu and Takanori Ikeda and Masahiro Kamouchi and Koichi Kaikita and Koji Fukuda and Hideki Origasa and Ichiro Sakuma and Keijiro Saku and Yasuo Okumura and Yuichiro Nakamura and Hideo Morimoto and Naoki Matsumoto and Akihito Tsuchida and Junya Ako and Nobuyoshi Sugishita and Shogo Shimizu and Hirotsugu Atarashi and Hiroshi Inoue",
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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

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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