Key result
In Japanese patients with non-valvular atrial fibrillation taking rivaroxaban, the incidence of stroke or systemic embolism was 2.2%/year in those with prior stroke or TIA compared to 0.7%/year in those without.
Cohort (n=7,141)
Yes
In real-world Japanese patients with non-valvular atrial fibrillation, Japan-specific dosages of rivaroxaban demonstrated low rates of stroke and major bleeding, though patients with prior stroke had higher risks of recurrent events and intracranial hemorrhage.
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Rivaroxaban showed comparable real-world outcomes with or without prior stroke/TIA; leaves open generalizability beyond this Japanese cohort.
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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Uchiyama et al. (2018) conducted a cohort in Non-valvular atrial fibrillation (n=7,141). History of stroke or TIA (Secondary prevention) vs. No history of stroke or TIA (Primary prevention) was evaluated on Composite of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism (p=<0.001). In Japanese patients with non-valvular atrial fibrillation taking rivaroxaban, the incidence of stroke or systemic embolism was 2.2%/year in those with prior stroke or TIA compared to 0.7%/year in those without.
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