Korean J Intern Med.
2021 Jul;36(4):906-913. 10.3904/kjim.2020.217.
A prospective, observational study of rivaroxaban for stroke prevention in atrial fibrillation: the XANAP Korea
- Shim J1
- On YK2
- Kwon SU3
- Nam GB4
- Lee MH5
- Park HW6
- Hong KS7
- Kim NH8
- Amarenco P9
- Rha SW10
- Shin DG11
- Rha JH12
- Kim YH
1
- Affiliations
-
- 1Department of Internal Medicine, Korea University Medical Center, Seoul, Korea
- 2Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 3Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 4Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 5Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
- 6Department of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea
- 7Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Korea
- 8Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea
- 9Department of Neurology and Stroke Center, Paris-Diderot-Sorbonne University, Paris, France
- 10Department of Cardiology, Korea University College of Medicine, Seoul, Korea
- 11Division of Cardiovascular Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
- 12Department of Neurology, Inha University School of Medicine, Incheon, Korea
- KMID: 2517807
- DOI: http://doi.org/10.3904/kjim.2020.217
Abstract
- Background/Aims
Atrial fibrillation (AF)-related stroke accounts for 20% of ischemic strokes. Rivaroxaban use in AF patients for preventing stroke and systemic embolism was approved in 2013 in Korea. This study was to investigate the safety and effectiveness of rivaroxaban use in Korean patients with non-valvular AF in a real-world setting.
Methods
This was an analysis of the Korean patients in Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific (XANAP), which was a prospective, observational cohort study including patients with non-valvular AF starting rivaroxaban treatment to prevent stroke or non-central nervous system systemic embolism (non-CNS SE), conducted in 10 Asian countries.
Results
A total of 844 patients were enrolled in the Korean portion of the XANAP study. In XANAP Korea, the mean age was 70.1 years and 62.6% were males. The mean CHADS2 score was 2.5 and the mean CHA2DS2-VASc score was 3.8. 47% of the patients had experienced prior stroke or non-CNS SE or transient ischemic attack. 73.6% of the patients had CHADS2 score ≥ 2. Incidence proportions of 0.8% of the patients (1.1 per 100 patient-years) developed adjudicated treatment-emergent major bleeding. Death was observed in 1.2% of the patients. The incidence of non-major bleeding as well as thromboembolic event were 8.4% (11.6 per 100 patient-years) and 1.5% (2.0 per 100 patient-years), respectively.
Conclusions
This study reaffirmed the consistent safety profile of rivaroxaban. We found consistent results with overall XANAP population for rivaroxaban in terms of safety in non-valvular AF patients for the prevention of stroke and non-CNS SE.
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