Effectiveness and safety of reduced-dose rivaroxaban for elderly patients with non-valvular atrial fibrillation: A subanalysis of the EXPAND study.

Anticoagulation Elderly Ischemic heart disease Non-valvular atrial fibrillation Rivaroxaban Stroke

Journal

International journal of cardiology
ISSN: 1874-1754
Titre abrégé: Int J Cardiol
Pays: Netherlands
ID NLM: 8200291

Informations de publication

Date de publication:
15 Nov 2023
Historique:
received: 15 03 2023
revised: 11 08 2023
accepted: 20 08 2023
pubmed: 25 8 2023
medline: 25 8 2023
entrez: 24 8 2023
Statut: ppublish

Résumé

Establishing the appropriate rivaroxaban dose in older patients with non-valvular atrial fibrillation (NVAF) is important because of the high risk of adverse events. In this EXPAND study subanalysis, we examined the safety and efficacy of standard-dose (15 mg/day) and non-recommended reduced-dose (10 mg/day) rivaroxaban in patients aged ≥65 years with NVAF and preserved renal function. The entire analysis population (ALL cohort [n = 3982]; ≥65 years) was divided into early elderly (ELD) (65-74 years [n = 1444]) and late ELD (≥75 years [n = 2386]) sub-cohorts. Each sub-cohort was divided into reduced-dose and standard-dose groups. Kaplan-Meier survival curves with adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were used to assess efficacy (thromboembolic events) and safety (hemorrhagic events) outcomes. The aHR for major bleeding did not differ between the dosages in any of the cohorts (aHRs: 0.86-0.93). There were no significant differences in the occurrence of stroke + systemic embolism (SE) or stroke + SE + myocardial infarction (MI) + cardiovascular (CV) death among the cohorts. The aHR for MI/unstable angina + interventional/CV surgery + CV death was higher with 10-mg/day rivaroxaban than 15-mg/day rivaroxaban in the ALL cohort (aHR: 1.56 [95% CI 1.02-2.37], p = 0.039) and the late ELD sub-cohort (aHR: 1.86 [95% CI 1.01-3.42], p = 0.045). Reduced-dose rivaroxaban may increase the risk of coronary artery events. The use of rivaroxaban 15 mg/day in patients with NVAF aged ≥75 years with preserved renal function was supported.

Sections du résumé

BACKGROUND BACKGROUND
Establishing the appropriate rivaroxaban dose in older patients with non-valvular atrial fibrillation (NVAF) is important because of the high risk of adverse events. In this EXPAND study subanalysis, we examined the safety and efficacy of standard-dose (15 mg/day) and non-recommended reduced-dose (10 mg/day) rivaroxaban in patients aged ≥65 years with NVAF and preserved renal function.
METHODS METHODS
The entire analysis population (ALL cohort [n = 3982]; ≥65 years) was divided into early elderly (ELD) (65-74 years [n = 1444]) and late ELD (≥75 years [n = 2386]) sub-cohorts. Each sub-cohort was divided into reduced-dose and standard-dose groups. Kaplan-Meier survival curves with adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were used to assess efficacy (thromboembolic events) and safety (hemorrhagic events) outcomes.
RESULTS RESULTS
The aHR for major bleeding did not differ between the dosages in any of the cohorts (aHRs: 0.86-0.93). There were no significant differences in the occurrence of stroke + systemic embolism (SE) or stroke + SE + myocardial infarction (MI) + cardiovascular (CV) death among the cohorts. The aHR for MI/unstable angina + interventional/CV surgery + CV death was higher with 10-mg/day rivaroxaban than 15-mg/day rivaroxaban in the ALL cohort (aHR: 1.56 [95% CI 1.02-2.37], p = 0.039) and the late ELD sub-cohort (aHR: 1.86 [95% CI 1.01-3.42], p = 0.045).
CONCLUSIONS CONCLUSIONS
Reduced-dose rivaroxaban may increase the risk of coronary artery events. The use of rivaroxaban 15 mg/day in patients with NVAF aged ≥75 years with preserved renal function was supported.

Identifiants

DOI: 10.1016/j.ijcard.2023.131290 PMID: 37619876
pubmed: 37619876
pii: S0167-5273(23)01169-5
doi: 10.1016/j.ijcard.2023.131290
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

131290

Informations de copyright

Copyright © 2023 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest All authors have received funding support from Bayer Yakuhin Ltd. throughout the implementation of the EXPAND Study, including reporting of this sub-analysis. Other disclosures are as follows; WS has received honoraria from Daiichi-Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co. Ltd., Bayer Yakuhin Ltd., Pfizer Co. Ltd., and Bristol-Myers Squibb K. K.; TU has received consulting fees from LSI Medience, Inc.; HA has received honoraria from Daiichi-Sankyo Co. Ltd.; HI has received honoraria from Daiichi-Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co. Ltd., Bayer Yakuhin Ltd., and Bristol-Myers Squibb K. K.; TK has received honoraria from Daiichi-Sankyo Co. Ltd. and Bayer Yakuhin, Ltd., and scholarship from Takeda Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Asahi Kasei Medical Co., Ltd., Shionogi & Co., Ltd., Taisho Pharmaceutical Holdings Co., Ltd., Teijin Pharma, Ltd., Kowa Co. Ltd., Bayer Yakuhin, Ltd., Eisai Co., Ltd., Sumitomo Pharma Co., Ltd., Daiichi-Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Torii Pharmaceutical Co., Ltd., AbbVie GK, EA Pharma Co.,Ltd., Kyowa Kirin Co., Ltd., Zeria Pharmceutical Co., Ltd., Eli Lilly Japan K.K., Sanwa Kagaku Kenkyusho Co., Ltd., Mochida Pharmaceutical Co.,Ltd., Ono Pharmaceutical Co., Ltd., and Novo Nordisk Pharma Ltd.; TY has received consulting fees from Daiichi-Sankyo Co. Ltd., Novartis Pharma K. K., and Toa Eiyo Ltd., and honoraria from Daiichi-Sankyo Co., Ltd., Bayer Yakuhin Ltd., and Bristol-Myers Squibb K. K., and Novartis Pharma K. K.; TI has received grants from Daiichi-Sankyo Co. Ltd., and honoraria from Bayer Yakuhin Ltd., Daiichi-Sankyo Co. Ltd., and Pfizer Japan Inc.; MK has received honoraria from Daiichi-Sankyo Co. Ltd. and had board participations on a trial sponsored by Daiichi-Sankyo Co. Ltd.; KK has grants from Bayer Yakuhin Ltd., Daiichi-Sankyo Co. Ltd., Abbott Medical Co. Ltd. and honoraria from Bayer Yakuhin Ltd., Daiichi-Sankyo Co. Ltd., Novartis Pharma AG., and Otsuka Pharmaceutical Co. Ltd.

Auteurs

Wataru Shimizu (W)

Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. Electronic address: wshimizu@nms.ac.jp.

Shinichiro Uchiyama (S)

Clinical Research Center for Medicine, Center for Brain and Cerebral Vessels, Sanno Medical Center, Tokyo, Japan.

Hirotsugu Atarashi (H)

AOI Hachioji Hospital, Tokyo, Japan.

Hiroshi Inoue (H)

Saiseikai Toyama Hospital, Toyama, Japan.

Takanari Kitazono (T)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Takeshi Yamashita (T)

Cardiovascular Institute Hospital, Tokyo, Japan.

Takanori Ikeda (T)

Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan.

Masahiro Kamouchi (M)

Department of Health Care Administration and Management, Center for Cohort Study, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.

Koichi Kaikita (K)

Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.

Koji Fukuda (K)

Division of Heart Rhythm, International University of Health and Welfare Hospital, International University of Health and Welfare, Tochigi, Japan.

Hideki Origasa (H)

The Institute of Statistical Mathematics, Tokyo, Japan.

Hiroaki Shimokawa (H)

Graduate School, International University of Health and Welfare, Chiba, Japan; Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.

Classifications MeSH