Abstract

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.

Highlights

  • The morbidity of stroke has been reported as 2.6% for adult population and 15.1% for elderly aged 65 years and above [1]

  • Demographics of subjects enrolled by prevention group

  • The following factors were noted more frequently in the secondary prevention group compared with the primary prevention group; male sex, mean age, elderly (75 years old and above), C­ HADS2, ­CHA2DS2-VASc and HAS-BLED scores, peripheral artery disease, diabetes mellitus, dyslipidemia, history of bleeding/ bleeding tendency, non-paroxysmal atrial fibrillation (AF), and use of concomitant antiplatelet drugs

Read more

Summary

Introduction

The morbidity of stroke has been reported as 2.6% for adult population and 15.1% for elderly aged 65 years and above [1]. The elderly patients aged 75 years or above with atrial fibrillation (AF) have relatively higher risk of stroke and death [2, 3]. The risk factors for stroke in patients with AF include those used to calculate the ­CHA2DS2-VASc score proposed in the European Society of Cardiology Guidelines in 2010 [4]. Among these risk factors, stroke/transient ischemic attack (TIA)/thromboembolism and elderly age (> 75 years) are associated with the highest risk [4]. In the previous study for secondary prevention of stroke, recurrent stroke continued to account for 25–30% of all stroke [6]

Methods
Results
Discussion
Conclusion

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.