Impact of three major risk factors on clinical outcomes in patients with nonvalvular atrial fibrillation receiving rivaroxaban: Sub-analysis from the XAPASS study.
anticoagulant
atrial fibrillation
body weight
elderly
renal insufficiency
Journal
Journal of arrhythmia
ISSN: 1880-4276
Titre abrégé: J Arrhythm
Pays: Japan
ID NLM: 101263026
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
18
10
2021
revised:
20
02
2022
accepted:
04
03
2022
entrez:
5
7
2022
pubmed:
6
7
2022
medline:
6
7
2022
Statut:
epublish
Résumé
To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all-cause mortality, and stroke, non-central nervous system (non-CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real-world clinical setting. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single-arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors. Overall, 9823 patients were included: 4299 with low risk, 2816 with moderate risk, 1574 with high risk, and 1134 with very high risk. The hazard ratios (95% confidence interval) (reference: low risk) for the moderate-, high-, and very-high-risk groups were 1.62 (1.19, 2.21) ( Age ≥75 years and renal impairment, but not low body weight, were determinants for major bleeding. The accrual of three risk factors was associated with increased risk for major bleeding and stroke/non-CNS SE/MI in patients with NVAF receiving rivaroxaban; there was no increase in the cumulative risk for these with an increasing number of risk factors.
Sections du résumé
Background
UNASSIGNED
To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all-cause mortality, and stroke, non-central nervous system (non-CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real-world clinical setting.
Methods
UNASSIGNED
The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single-arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors.
Results
UNASSIGNED
Overall, 9823 patients were included: 4299 with low risk, 2816 with moderate risk, 1574 with high risk, and 1134 with very high risk. The hazard ratios (95% confidence interval) (reference: low risk) for the moderate-, high-, and very-high-risk groups were 1.62 (1.19, 2.21) (
Conclusions
UNASSIGNED
Age ≥75 years and renal impairment, but not low body weight, were determinants for major bleeding. The accrual of three risk factors was associated with increased risk for major bleeding and stroke/non-CNS SE/MI in patients with NVAF receiving rivaroxaban; there was no increase in the cumulative risk for these with an increasing number of risk factors.
Identifiants
pubmed: 35785372
doi: 10.1002/joa3.12700
pii: JOA312700
pmc: PMC9237294
doi:
Types de publication
Journal Article
Langues
eng
Pagination
369-379Informations de copyright
© 2022 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.
Déclaration de conflit d'intérêts
T. Ikeda, S. Ogawa, T. Kitazono, J. Nakagawara, K. Minematsu, S. Miyamoto, and Y. Murakawa were advisory board members for Bayer Yakuhin. T. Ikeda received research grants from Daiichi Sankyo, Medtronic, and Japan Lifeline, and lecture fees from Bayer Yakuhin, Bristol Myers Squibb, Ono, and Toa Eiyo. T. Kitazono received a research grant from Bayer Yakuhin. J. Nakagawara received a research grant from Nihon Medi‐Physics. K. Minematsu received lecture fees from Astellas, AstraZeneca, Bayer Yakuhin, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Japan Stryker, Kowa, Mitsubishi Tanabe, Nihon Medi‐Physics, Nippon Chemiphar, Otsuka, Pfizer, Sawai, and Sumitomo Dainippon, and was an advisory board member for CSL Behring and Medico's Hirata. S. Miyamoto received research grants from Astellas, Brainlab, Bristol Myers Squibb, Carl Zeiss Meditec, Chugai, CSL Behring, Daiichi Sankyo, Eisai, Medtronic, Meiji Seika, Mitsubishi Tanabe, Mizuho, Merck & Co., Pfizer, Nihon Medi‐Physics, Otsuka, Philips Electronics Japan, Sanofi, Siemens Healthcare, and Takeda. Y. Murakawa received research grants from Bayer Yakuhin, Boehringer Ingelheim, and Daiichi Sankyo, and lecture fees from Bayer Yakuhin, Boehringer Ingelheim, Bristol Myers Squibb, and Daiichi Sankyo. M. Tachiiri, Y. Okayama, T. Sunaya, K. Hirano, and T. Hayasaki are employees of Bayer Yakuhin.
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