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

Shinichiro Uchiyama,Koichi Kaikita,Hiroaki Shimokawa,Hideki Origasa,Takanori Ikeda,Masahiro Kamouchi,Hirotsugu Atarashi,Takanari Kitazono,Takeshi Yamashita,Koji Fukuda,Wataru Shimizu,Hiroshi Inoue

doi:10.1007/s00380-018-1219-0

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

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