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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Georg Thieme Verlag KG
2022
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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. |
format | Online Article Text |
id | pubmed-9420554 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
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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