Abstract

Introduction: Patients with chronic kidney disease (CKD) and non-valvular atrial fibrillation (NVAF) are at increased risk for both ischemic stroke and hemorrhage. In addition, treatment with vitamin K antagonists (VKA) has been associated with worsening of renal function compared to direct oral anticoagulants (DOACs). XARENO (Factor XA -inhibition in RENal patients with non-valvular atrial fibrillation Observational registry) is an ongoing prospective, non-interventional, observational study conducted in Europe. XARENO evaluates the effectiveness of rivaroxaban in preserving renal function and preventing thromboembolic events as compared to VKA in NVAF patients with CKD in clinical practice. Methods: XARENO included male and female NVAF patients ≥18 years old with an estimated glomerular filtration rate (eGFR) between 15 and 49 mL/min per 1.73 m 2 and an indication for anticoagulation. Enrolment took place from April 2016 until January 2020. Patients treated with either rivaroxaban or VKA were included, while patients in whom physicians were withholding any anticoagulation could be also enrolled. Minimal planned follow-up is one year. Primary observational outcomes include efficacy and safety outcomes (progression of CKD, stroke, other thromboembolic events, major cardiovascular events, major bleeding, and all-cause mortality). First results on outcomes in the full cohort are expected in 2021. Results: In this analysis of a first set of 1485 patients (56.1% males), 731 and 666 patients received rivaroxaban and VKA, while 88 patients did not receive any anticoagulation. Mean age at baseline was 77.3 years (67.5% older than 75 years) with a mean eGFR of 38.9 mL/min per 1.73 m 2 . Overall 74.7% of patients had eGFR values below 45 mL/min per 1.73 m 2 and 28.0% below 30 mL/min per 1.73 m 2 . In the latter group, use of a VKA was about twofold more frequent compared to rivaroxaban. Conclusions: This first analysis of XARENO patients reveals the very high age of NVAF patients with concomitant non-dialysis dependent advanced CKD and a preferential use of VKA in stage 4 CKD. XARENO aims to provide important information on the real-world effectiveness and safety of rivaroxaban compared with VKA for this vulnerable patient group.

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