Clinical outcomes associated with kidney function changes in anticoagulated atrial fibrillation patients: An ancillary analysis from the BOREALIS trial

Ying Bai; Alena Shantsila; Gregory Y H Lip

doi:10.1002/joa3.12306

Clinical outcomes associated with kidney function changes in anticoagulated atrial fibrillation patients: An ancillary analysis from the BOREALIS trial

J Arrhythm. 2020 Feb 6;36(2):282-288. doi: 10.1002/joa3.12306. eCollection 2020 Apr.

Authors

Ying Bai^{1

2}, Alena Shantsila¹, Gregory Y H Lip^{1

3}

Affiliations

¹ Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.
² Cardiovascular Center Beijing Tongren Hospital Capital Medical University Beijing China.
³ Aalborg Thrombosis Research Unit Department of Clinical Medicine Aalborg University Aalborg Denmark.

Abstract

Background: Patients with atrial fibrillation (AF) and chronic kidney disease represent a high-risk group for thromboembolism and bleeding.

Aims: To explore the relationship between kidney function changes and outcomes of stroke/systemic embolism (SE), major bleeding and all-cause death in anticoagulated AF patients participating in the BOREALIS trial comparing efficacy and safety of once-weekly s.c. idrabiotaparinux to that of warfarin.

Methods: Changes in kidney function by estimated glomerular filtration rate (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation in 2765 AF patients. Trial adjudicated outcomes were determined.

Results: After a mean follow-up of 394 days, in 94.4% of the included patients kidney function changed ranging from -30 mL/min to 30 mL/min. The incidence of stroke/SE and major bleeding was similar between patients with deteriorated (reduction in eGFR from baseline over follow-up) and preserved kidney function change (increase or no change in eGFR from baseline over follow-up) [stroke/SE: incidence rate (IR): 1.33%/year vs 1.80%/year; hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.41-1.32, P = .30; major bleeding: IR 1.63%/year vs 1.49%/year, HR 1.10, 95% CI 0.61-1.97, P = .76]. On Cox regression analysis, patients with deteriorated kidney function were at higher risk for all-cause death, compared to patients with preserved kidney function (HR: 1.64, 95% CI: 1.02-2.63, P = .04).

Conclusion: In the BOREALIS trial, the risk of adjudicated stroke/SE, major bleedings, and all-cause death was not related to mild-moderate follow-up changes in kidney function (±30 mL/min). The risk of all-cause death was significantly increased in AF patients with abruptly deteriorating kidney function.

Keywords: all‐cause death; deteriorated CKD‐EPI eGFR change; major bleeding; preserved CKD‐EPI eGFR change; stroke/systemic embolism.