(SLB-030) Risk of Acute Kidney Injury with Non-vitamin K Antagonist Oral Anticoagulants Use: A Retrospective Cohort Study

Background: A potential signal from the FDA Adverse Event Reporting System (FAERS) suggests a safety concern regarding acute kidney injury (AKI) associated with non-vitamin K antagonist oral anticoagulants (NOACs). However, it remains still unclear whether NOACs are associated with an increased risk of AKI.

Objectives: To evaluate the risk of AKI in patients treated with NOACs, compared to those who have never used NOACs.

Methods: We conducted a retrospective cohort study using the hospital electronic health record (EHR)-based Common Data Model (CDM) database from 14 univercity hospitals in Korea. The study cohort included patients aged 18 and older, diagnosed with conditions including atrial fibrillation, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebral infarction between January 2016 and June 2022. We compared individuals who initiated NOACs (dabigatran, rivaroxaban, apixaban, or edoxaban) with those who never received the oral anticoagulants. The primary outcomes were AKI and increased serum creatinine levels. To adjust for measured confounders, we implemented 1:1 propensity score matching and used a Cox proportional hazards regression model to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Additionally, we conducted subgroup analyses based on sex, age, specific NOACs ingredient, and chronic disease status.

Results: A total of 375,205 patients were included in the cohort. After matching based on propensity scores, 63,667 patients were selected for both the NOACs users and the NOACs non-users. The NOACs users had a significantly higher risk of acute kidney injury (AKI) compared to the NOACs non-users (adjusted HR = 1.41; 95% CI: 1.27–1.57).
According to subgroup analyses, the risk of AKI among NOACs users was significantly higher than in the NOACs non-users (adjusted HR = 1.94; 95% CI: 1.61–2.34) among women, whereas no statistically significant difference was found among men. In the age-specific analysis, patients aged 60 years and older had a higher risk of AKI with NOACs use compared to younger age groups.
All NOACs were associated with an increased risk of AKI compared to the NOACs non-users, with apixaban showing the highest risk (adjusted HR = 1.62; 95% CI: 1.45–1.81).

Conclusions: Our findings suggest that NOACs may increase the risk of AKI, particularly in patients over 60 years old and in women. These findings highlight the importance of monitoring the risk of acute kidney injury in these patient populations. Therefore, it is crucial to regularly assess kidney function indicators, such as serum creatinine levels and eGFR, to enable early detection and timely intervention.