Perreault S, Boivin Proulx LA, Lenglet A, Massy ZA, Dorais M. Effectiveness and safety of apixaban and rivaroxaban vs warfarin in patients with atrial fibrillation and chronic kidney disease. World J Nephrol 2023; 12(5): 132-146 [PMID: 38230301 DOI: 10.5527/wjn.v12.i5.132]
Corresponding Author of This Article
Sylvie Perreault, BPharm, MSc, PhD, Professor, Faculty of Pharmacy, University of Montreal, No. 2940 Chemin de Polytechnique, Quebec, Montreal H3C3J7, Canada. sylvie.perreault@umontreal.ca
Research Domain of This Article
Pharmacology & Pharmacy
Article-Type of This Article
Retrospective Cohort Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Nephrol. Dec 25, 2023; 12(5): 132-146 Published online Dec 25, 2023. doi: 10.5527/wjn.v12.i5.132
Effectiveness and safety of apixaban and rivaroxaban vs warfarin in patients with atrial fibrillation and chronic kidney disease
Sylvie Perreault, Laurie-Anne Boivin Proulx, Aurélie Lenglet, Ziad A Massy, Marc Dorais
Sylvie Perreault, Faculty of Pharmacy, University of Montreal, Quebec, Montreal H3C3J7, Canada
Laurie-Anne Boivin Proulx, Department of Cardiology, Faculty of Medicine, University of Ottawa Heart Institute, Ontario, Ottawa K1Y4W7, Canada
Aurélie Lenglet, Department of Pharmacy, Amiens-Picardie Hospital University Center, Amiens 80000, France
Aurélie Lenglet, Faculty of Pharmacy, MP3CV Laboratory, UR7545, University of Picardie Jules Verne, Amiens 80000, France
Ziad A Massy, Division of Nephrology, University of Paris Ouest -Versailles-Saint-Quentin-en-Yvelines (UVSQ), Villejuif, France., AP-HP Ambroise-Paré Hospital, Boulogne Billancourt/Paris 92104, France
Marc Dorais, StatSciences Inc., Notre-Dame-de-l’Île-Perrot, Quebec, Montreal J7W 3K8, Canada
Author contributions: Perreault S, Boivin-Proulx LA, Lenglet A and Massy ZA contributed equally to concept, writing, and revising of the manuscript; Dorais M contributed to data analysis, figures, and reviewed the manuscript.
Institutional review board statement: The study was reviewed and approved for publication by our Institutional Reviewer.
Informed consent statement: As the study used anonymous and pre-existing data, the requirement for the informed consent from patients was waived.
Conflict-of-interest statement: All the Authors have no conflict of interest related to the manuscript.
Data sharing statement: No data sharing is authorized according to the agreement of the Commission d’accès à l’information that authorizing the study.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sylvie Perreault, BPharm, MSc, PhD, Professor, Faculty of Pharmacy, University of Montreal, No. 2940 Chemin de Polytechnique, Quebec, Montreal H3C3J7, Canada. sylvie.perreault@umontreal.ca
Received: May 19, 2023 Peer-review started: May 19, 2023 First decision: July 19, 2023 Revised: July 26, 2023 Accepted: September 26, 2023 Article in press: September 26, 2023 Published online: December 25, 2023 Processing time: 216 Days and 21.2 Hours
ARTICLE HIGHLIGHTS
Research background
The effectiveness and safety of apixaban and rivaroxaban in patients with atrial fibrillation (AF) and stage III chronic kidney disease (CKD) are not well established.
Research motivation
Few studies have evaluated the safety and efficacy of individual direct oral anticoagulants vs warfarin, nor have they established how dose selection impacts patients with AF and stage III CKD with respect to the incidence of stroke/systemic embolism (SE), major bleeding, and death.
Research objectives
We assessed and compared the effectiveness and safety of standard-dose rivaroxaban, low-dose rivaroxaban, standard-dose apixaban, and low-dose apixaban vs warfarin in a representative group of patients with AF and stage III CKD.
Research methods
A cohort of new users of apixaban, rivaroxaban or warfarin in AF patients and stage III CKD was created using administrative databases. We defined the effectiveness as a composite of stroke, SE or death; safety was defined as a composite of major bleeding within 1-year of follow-up. Comparisons were under treatment analysis using inverse probability of treatment weighting and Cox models.
Research results
Rivaroxaban 15 mg and 20 mg were associated with a similar efficacy and safety composite risk vs warfarin. Apixaban 5.0 mg was linked with decreased effectiveness composite risk [hazard ratio (HR) 0.76; 0.65-0.88] and a similar safety risk (HR 0.94; 0.66-1.35), compared with apixaban 2.5 mg, which was associated with a similar effectiveness composite (HR 1.00; 0.79-1.26) and a lower safety risk (HR 0.65; 0.43-0.99).
Research conclusions
This observational study of new users of rivaroxaban and apixaban find that both appear to be safe and effective compared to warfarin in patients with AF and stage III CKD. Apixaban 2.5 mg might even have a better safety profile than warfarin, while apixaban 5.0 mg might have a better effectiveness profile than warfarin, to a reduction in deaths.
Research perspectives
The research perspective should be an appropriately sized randomized controlled trials to confirm these findings in AF patients with stage III CKD.