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

doi:10.1016/j.ijcard.2018.01.141

Cited by 44 publications

(54 citation statements)

References 23 publications

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“…The target number of subjects was 7166, where 7141 patients were evaluated during the observation period up to March 31, 2016. The mean follow-up period was 897.1 ± 206.8 days (median 918.0), and 25 patients were lost to follow-up (follow-up rate 99.7%) [10, 11]. …”

Section: Resultsmentioning

confidence: 99%

“…The study design and the results of the main statistical analysis of the EXPAND Study were described previously [10, 11]. Briefly, the study was a multicenter, prospective, non-interventional, observational cohort study to demonstrate the efficacy and safety of rivaroxaban in patients with NVAF.…”

Section: Methodsmentioning

confidence: 99%

“…Briefly, the study was a multicenter, prospective, non-interventional, observational cohort study to demonstrate the efficacy and safety of rivaroxaban in patients with NVAF. Among patients aged ≥ 20 years with NVAF using or planned to use rivaroxaban who provided written consent, those not meeting the exclusion criteria were enrolled [10, 11]. Patients newly treated with rivaroxaban were defined as new users, and those already using rivaroxaban before providing informed consent were defined as current users [11].…”

Section: Methodsmentioning

confidence: 99%

“…The secondary safety endpoint was non-major bleeding events, including clinically relevant non-major bleeding. Events reported during the observation period were adjudicated for inclusion or exclusion by a clinical events in a committee independent of the research organization [10, 11]. …”

Section: Methodsmentioning

confidence: 99%

“…In the J-ROCKET AF Trial, evidence for the safety and efficacy in Japanese patients was not sufficiently accumulated because of the lack of data for patients with CHADS 2 scores of 0 or 1 [9]. However, the recent findings of our EXPAND Study reported in 2017 and 2018 showed the efficacy and safety of rivaroxaban in routine clinical practice including patients with such scores [10, 11]. The present report describes a sub-analysis of our EXPAND Study, addressing the primary and secondary prevention of stroke and systemic embolism (SE) with rivaroxaban in patients with non-valvular atrial fibrillation (NVAF).…”

Section: Introductionmentioning

confidence: 99%

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Primary and secondary prevention of stroke and systemic embolism with rivaroxaban in patients with non-valvular atrial fibrillation

Uchiyama

Atarashi²,

Inoue³

et al. 2018

Heart Vessels

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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). In this sub-analysis, we compared the differences in efficacy and safety between patients with and those without history of stroke or transient ischemic attack (TIA). This multicenter, prospective, non-interventional, observational, cohort study was conducted at 684 medical centers in Japan. A total of 7141 NVAF patients aged ≥ 20 years [mean age 71.6 ± 9.4 (SD) years] who were being or planned to be treated with rivaroxaban (10 mg/day, 43.5%; 15 mg/day, 56.5%) were followed for a mean period of 897.1 ± 206.8 days with a high follow-up rate (99.7%). The primary prevention group comprised patients without history of ischemic stroke or TIA (n = 5546, 77.7%), and the secondary prevention group comprised those with history of ischemic stroke or TIA (n = 1595, 22.3%). In the primary and secondary prevention groups, the incidence rate of stroke or SE (primary efficacy endpoint) was 0.7 and 2.2%/year, respectively (P < 0.001), and the incidence rate of major bleeding (primary safety endpoint) was 1.2 and 1.5%/year, respectively (P = 0.132). For major bleeding events, the incidence rate of intracranial bleeding was 0.4 and 0.8%/year (P = 0.002) in the primary and secondary prevention groups, respectively. This sub-analysis of the EXPAND Study showed that the Japan-specific dosages of rivaroxaban were effective and safe in Japanese NVAF patients with and those without ischemic stroke or TIA in routine clinical practice.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Primary and secondary prevention of stroke and systemic embolism with rivaroxaban in patients with non-valvular atrial fibrillation

Uchiyama

Atarashi²,

Inoue³

et al. 2018

Heart Vessels

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A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J‐ELD AF Registry)

Okumura

Yamashita

Suzuki

et al. 2019

Clinical Cardiology

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Background A global, randomized clinical trial indicated the efficacy and safety of apixaban in stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, data in the elderly NVAF patients ≥75 years, especially those on reduced dose, are limited. Hypothesis To confirm the current dose reduction criteria of apixaban in elderly NVAF patients. Method With a large‐scale, multicenter prospective observational study, one‐year outcomes after administration of on‐label doses of apixaban were analyzed in Japanese NVAF patients aged ≥75 years. Endpoints were stroke or systemic embolism, bleeding requiring hospitalization, total death, and cardiovascular death. Results A total of 3031 patients (average age, 81.7 years; female, 48.2%) taking standard (5 mg bid) or reduced dose (2.5 mg bid) of apixaban were enrolled from 110 facilities. Standard and reduced apixaban doses were administered in 1284 (42.4%) and 1747 (57.6%) patients, respectively. Event rates (/100 person‐years) in standard and reduced dose groups were 1.67 and 1.56, respectively, for stroke or systemic embolism, 1.42 and 2.25 for bleeding requiring hospitalization, 1.41 and 4.46 for total death, and 0.41 and 1.36 for cardiovascular death. Reduced apixaban dose was not significantly associated with stroke or systemic embolism and bleeding requiring hospitalization, but was independently associated with total and cardiovascular death. Conclusions Incidences of stroke or systemic embolism and bleeding requiring hospitalization were similar between standard and reduced apixaban doses in the elderly NVAF patients. The incidences of total and cardiovascular death were significantly higher in the reduced dose group due to the coexisting higher risks in this group.

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Effect of non‐recommended doses versus recommended doses of direct oral anticoagulants in atrial fibrillation patients: A meta‐analysis

Liu

Huang

et al. 2021

Clinical Cardiology

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Background Several observational studies have shown that the inappropriate dosing use of direct oral anticoagulants (DOACs) in atrial fibrillation (AF) that does not conform to recommendations is becoming a widespread phenomenon. Therefore, we performed a meta‐analysis and systematic review to assess the effect of non‐recommended doses versus recommended doses of DOACs on the effectiveness and safety outcomes among AF patients. Methods The PubMed and Ovid databases were systematically searched to identify the relevant studies until December 2020. The effect estimates were hazard ratios (HRs) and 95% confidence intervals (CIs), which were pooled using a fixed‐effects model (I2 ≤ 50%) or a random‐effects model (I2 > 50%). Results A total of 11 studies were included in this meta‐analysis. Compared with recommended dosing of DOACs, non‐recommended low dosing of DOACs was associated with increased risks of stroke or systemic embolism (SSE, HR = 1.29, 95% CI 1.12–1.49) and all‐cause death (HR = 1.37, 95% CI 1.15–1.62), but not the ischemic stroke, myocardial infarction, gastrointestinal bleeding, intracranial bleeding, and major bleeding. Compared with recommended dosing of DOACs, non‐recommended high dosing of DOACs was associated with increased risks of SSE (HR = 1.44, 95% CI 1.01–2.04), major bleeding (HR = 1.99, 95% CI 1.48–2.68), and all‐cause death(HR = 1.38, 95% CI 1.02–1.87). Conclusion Compared with recommended dosing of DOACs, non‐recommended low dosing of DOACs was associated with increased risks of SSE and all‐cause death. Further study should confirm the findings of non‐recommended high dosing versus recommended dosing of DOACs.

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

Abstract: The EXPAND study demonstrated that low dosages of rivaroxaban for Japanese NVAF patients in real-world clinical practice, including those with CHADS scores 0-1, resulted in low rates of stroke and SE, and major and non-major bleeding.

Cited by 44 publications

References 23 publications

Primary and secondary prevention of stroke and systemic embolism with rivaroxaban in patients with non-valvular atrial fibrillation

Primary and secondary prevention of stroke and systemic embolism with rivaroxaban in patients with non-valvular atrial fibrillation

A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J‐ELD AF Registry)

Effect of non‐recommended doses versus recommended doses of direct oral anticoagulants in atrial fibrillation patients: A meta‐analysis

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