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Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings

Background  Rivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients wi...

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Autores principales: Arashi, Hiroyuki, Yamaguchi, Junichi, Hagiwara, Nobuhisa, Yasuda, Satoshi, Kaikita, Koichi, Akao, Masaharu, Ako, Junya, Matoba, Tetsuya, Nakamura, Masato, Miyauchi, Katsumi, Kimura, Kazuo, Hirayama, Atsushi, Matsui, Kunihiko, Ogawa, Hisao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag KG 2022
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420554/
https://www.ncbi.nlm.nih.gov/pubmed/35697255
http://dx.doi.org/10.1055/s-0042-1744543
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author Arashi, Hiroyuki
Yamaguchi, Junichi
Hagiwara, Nobuhisa
Yasuda, Satoshi
Kaikita, Koichi
Akao, Masaharu
Ako, Junya
Matoba, Tetsuya
Nakamura, Masato
Miyauchi, Katsumi
Kimura, Kazuo
Hirayama, Atsushi
Matsui, Kunihiko
Ogawa, Hisao
author_facet Arashi, Hiroyuki
Yamaguchi, Junichi
Hagiwara, Nobuhisa
Yasuda, Satoshi
Kaikita, Koichi
Akao, Masaharu
Ako, Junya
Matoba, Tetsuya
Nakamura, Masato
Miyauchi, Katsumi
Kimura, Kazuo
Hirayama, Atsushi
Matsui, Kunihiko
Ogawa, Hisao
author_sort Arashi, Hiroyuki
collection PubMed
description Background  Rivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50 mL/min and received 10 (underdose) or 15 mg/d (standard-dose) rivaroxaban. We aimed to assess the effects of rivaroxaban underdose on clinical outcomes. Methods  We assessed efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding in the subgroup of patients with preserved renal function in the AFIRE trial. Results  Age ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription. The underdose group had a similar incidence of the efficacy endpoint (3.62 vs. 3.51% per patient-year; p  = 0.871) and significantly lower incidence of major bleeding (0.82 vs. 2.17% per patient-year; p  = 0.022) than the standard-dose group. In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group. Conclusion  In patients with AF, stable CAD, and preserved renal function, rivaroxaban underdose was associated with similar rates of thrombotic events but a lower incidence of hemorrhagic events than the standard dose. Clinical Trial Registration  AFIRE UMIN Clinical Trials Registry ( https://www.umin.ac.jp/ctr/ ), number UMIN000016612, and ClinicalTrials.gov, number NCT02642419.
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spelling pubmed-94205542022-08-29 Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings Arashi, Hiroyuki Yamaguchi, Junichi Hagiwara, Nobuhisa Yasuda, Satoshi Kaikita, Koichi Akao, Masaharu Ako, Junya Matoba, Tetsuya Nakamura, Masato Miyauchi, Katsumi Kimura, Kazuo Hirayama, Atsushi Matsui, Kunihiko Ogawa, Hisao Thromb Haemost Background  Rivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50 mL/min and received 10 (underdose) or 15 mg/d (standard-dose) rivaroxaban. We aimed to assess the effects of rivaroxaban underdose on clinical outcomes. Methods  We assessed efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding in the subgroup of patients with preserved renal function in the AFIRE trial. Results  Age ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription. The underdose group had a similar incidence of the efficacy endpoint (3.62 vs. 3.51% per patient-year; p  = 0.871) and significantly lower incidence of major bleeding (0.82 vs. 2.17% per patient-year; p  = 0.022) than the standard-dose group. In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group. Conclusion  In patients with AF, stable CAD, and preserved renal function, rivaroxaban underdose was associated with similar rates of thrombotic events but a lower incidence of hemorrhagic events than the standard dose. Clinical Trial Registration  AFIRE UMIN Clinical Trials Registry ( https://www.umin.ac.jp/ctr/ ), number UMIN000016612, and ClinicalTrials.gov, number NCT02642419. Georg Thieme Verlag KG 2022-06-13 /pmc/articles/PMC9420554/ /pubmed/35697255 http://dx.doi.org/10.1055/s-0042-1744543 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Arashi, Hiroyuki
Yamaguchi, Junichi
Hagiwara, Nobuhisa
Yasuda, Satoshi
Kaikita, Koichi
Akao, Masaharu
Ako, Junya
Matoba, Tetsuya
Nakamura, Masato
Miyauchi, Katsumi
Kimura, Kazuo
Hirayama, Atsushi
Matsui, Kunihiko
Ogawa, Hisao
Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title_full Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title_fullStr Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title_full_unstemmed Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title_short Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings
title_sort rivaroxaban underdose for atrial fibrillation with stable coronary disease: the afire trial findings
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420554/
https://www.ncbi.nlm.nih.gov/pubmed/35697255
http://dx.doi.org/10.1055/s-0042-1744543
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