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 language | English |
|---|---|
| Pages (from-to) | 126-132 |
| Number of pages | 7 |
| Journal | International Journal of Cardiology |
| Volume | 258 |
| DOIs | |
| Publication status | Published - May 1 2018 |
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All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
Cite this
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 journal › Article
}
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
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.
UR - http://www.scopus.com/inward/record.url?scp=85041645770&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85041645770&partnerID=8YFLogxK
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 -