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. 2024 Jan 5;3(2):100813.
doi: 10.1016/j.jacadv.2023.100813. eCollection 2024 Feb.

Rivaroxaban vs Vitamin K Antagonist in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease

Collaborators, Affiliations

Rivaroxaban vs Vitamin K Antagonist in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease

Reinhold Kreutz et al. JACC Adv. .

Abstract

Background: Treatment with vitamin K antagonists (VKAs) has been linked to worsening of kidney function in patients with atrial fibrillation (AF).

Objectives: XARENO (Factor XA-inhibition in RENal patients with non-valvular atrial fibrillation Observational registry; NCT02663076) is a prospective observational study comparing adverse kidney outcomes in patients with AF and advanced chronic kidney disease receiving rivaroxaban or VKA.

Methods: Patients with AF and an estimated glomerular filtration rate (eGFR) of 15 to 49 mL/min/1.73 m2 were included. Blinded adjudicated outcome analysis evaluated adverse kidney outcomes (a composite of eGFR decline to <15 mL/min/1.73 m2, need for chronic kidney replacement therapy, or development of acute kidney injury). A composite net clinical benefit outcome (stroke or systemic embolism, major bleeding, myocardial infarction, acute coronary syndrome, or cardiovascular death) was also analyzed. HRs with 95% CIs were calculated using propensity score overlap weighting Cox regression.

Results: There were 1,455 patients (764 rivaroxaban; 691 VKA; mean age 78 years; 44% females). The mean eGFR was 37.1 ± 9.0 in those receiving rivaroxaban and 36.4 ± 10.1 mL/min/1.73 m2 in those receiving VKA. After a median follow-up of 2.1 years, rivaroxaban was associated with less adverse kidney outcomes (HR: 0.62; 95% CI: 0.43-0.88) and all-cause death (HR: 0.76, 95% CI: 0.59-0.98). No significant differences were observed in net clinical benefit.

Conclusions: In patients with AF and advanced chronic kidney disease, those receiving rivaroxaban had less adverse kidney events and lower all-cause mortality compared to those receiving VKA, supporting the use of rivaroxaban in this high-risk group of patients.

Keywords: bleeding; elderly; kidney failure; oral anticoagulation.

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Conflict of interest statement

Funded by 10.13039/100004326Bayer AG as an investigator-initiated study. Dr Kreutz has received support for research by 10.13039/100004326Bayer AG and personal honoraria from Bayer AG, Berlin-Chemie Menarini, Daiichi Sankyo, Ferrer, Merck, Sanofi, and Servier. Dr Deray has received support for research by 10.13039/100004326Bayer AG and personal honoraria from Bayer AG. Dr Floege has received personal honoraria from AstraZeneca, Bayer AG, Boehringer, Fresenius, Novartis, and Vifor. Dr Gwechenberger has received personal honoraria from Boehringer Ingelheim, Bayer AG, and Daiichi Sankyo. Dr Hahn has received personal honoraria from Bayer AG, Daiichi Sankyo, Berlin Chemie, Vifor Pharma, AstraZeneca and financial support by AMGEN. Dr Luft has received personal honoraria from Bayer AG, Amgen, and Moleac. He has received research funding from the P&K Pühringer Foundation, The LOOP Zurich, the University of Zurich, and the Swiss National Science Foundation. Dr Persson has received personal honoraria from Bayer AG (regarding renal safety); and has received support for research on contrast media and the kidney by Bayer AG. Dr Axthelm has received institutional research support and personal honoraria from Abbott, Amgen, Astra, Bayer AG, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Esperion, Microport, Novartis, Novo Nordisk, Pfizer, Sanofi Sythelabo, and SmithKline Beecham. Dr Beer has received grant support from the Swiss National Foundation of Science, the Swiss Heart Foundation and the Stiftung Kardio; grant support, speaker and consultation fees to the institution from Bayer, Sanofi, and Daiichi Sankyo. Dr Lellouche was a speaker for and has received consulting fees from Bayer, Bristol-Myers Squibb and Pfizer. Dr Coleman has received support for research by Bayer AG, Janssen Scientific Affairs LLC, and AstraZeneca; and consulting fees from Bayer AG, Janssen Scientific Affairs LLC, and AstraZeneca. Dr Beyer-Westendorf has received institutional research support and personal honoraria from Bayer AG, Daiichi Sankyo, Pfizer, and Portola/Alexion. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Flow Diagram With Patient Disposition in the XARENO Registry The flow of patients who participated in the registry is shown, including the number originally enrolled, and eligible participants included into the intention-to-treat population. The small group of 89 patients that were not treated with anticoagulation at the discretion of participating physicians were according to the study protocol not included in the propensity score overlap weighting outcome analysis. XARENO = Factor XA-inhibition in RENal patients with non-valvular atrial fibrillation Observational registry.
Figure 2
Figure 2
Main Outcomes Annual event rates, and adjusted HR (95% CI) for the comparison between rivaroxaban and vitamin K antagonist (VKA) after propensity score overlap weighting outcome analysis. ∗Event rates per 100 patient-years. eGFR = estimated glomerular filtration rate; KRT = kidney replacement therapy.
Central Illustration
Central Illustration
Rivaroxaban vs Vitamin K Antagonist in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease Annual event rates and adjusted HRs (95% CI) for the comparison between rivaroxaban and vitamin K antagonist (VKA) after propensity score overlap-weighted outcome analysis. CKD = chronic kidney disease; XARENO = Factor XA-inhibition in RENal patients with non-valvular atrial fibrillation Observational registry.

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