Impact of Renal Function on Effectiveness and Safety Associated With Low Dose Dabigatran in Non-valve Atrial Fibrillation Patients After Catheter Ablation.

Qianzhou Lv,Zi Wang,Chengchun Zuo,Qiuyi Ji,Xiaoye Li

doi:10.3389/fcvm.2021.762872

Abstract

Aim: The purpose of this study is to compare the effectiveness and safety of 110 mg dabigatran in non-valve atrial fibrillation (NVAF) patients with different eGFRs.Methods: We conducted a single-center retrospective cohort study to investigate the effectiveness and safety of 110 mg dabigatran for NVAF patients between January 2017 and December 2018 based on the eGFR category.Results: A total of 560 NVAF patients who treated with 110 mg dabigatran were included for analysis. In 12 months, the Kaplan-Meier survival curves indicated that the lower eGFR subgroups were more likely to experience thrombosis, bleeding, and cumulative events earlier (P = 0.021 for thrombosis; P = 0.026 for bleeding; P = 0.001 for cumulative events). Gastrointestinal bleeding occurred more frequently in the moderate group than in other groups (6.94% in the moderate group vs. 1.54% in the mild group vs. 1.22% in the normal group, P = 0.028). By multivariate analysis, chronic kidney disease (P = 0.043; OR = 4.273, 95% CI 1.043–17.543) and diabetes mellitus (P = 0.023; OR = 2.194, 95% CI 1.114–4.323) were independent predictors of the composite endpoints. A positive linear relationship was observed between eGFR levels and occurrence rate of thrombosis and bleeding under anticoagulation patients with 110 mg dabigatran (R2 = 0.432 and R2 = 0.784, respectively).Conclusions: Impaired renal function was associated with decreased safety and increased thrombosis risks in NVAF patients taking low dose dabigatran.

Highlights

Non-valve atrial fibrillation (NVAF) is one class of supra ventricular tachyarrhythmia with uncoordinated atrial electrical activation and causes ineffective atrial contraction which can result in hemodynamic abnormalities and thromboembolic events contributing to severe morbidity and mortality [1]
According to the KDOQI guidelines [9], participants were stratified into three groups: [1] the normal renal function group defined as estimated glomerular filtration rate (eGFR) beyond 90 mL/min/1.73m2; [2] the mildly decreased renal function group defined as eGFR ranging from 60 to 89 mL/min/1.73m2; [3] the moderately impaired renal function group defined as eGFR between 30 and 59 mL/min/1.73m2
There were no significant differences in the three renal function subgroups regarding sex, age, comorbidities, laboratory indicators, concomitant medications, predetermined stroke risk [CHA2DS2-VASC (P=0.430)] or predetermined major bleeding risk [HAS-BLED (P = 0.590)]

Summary

Introduction

Non-valve atrial fibrillation (NVAF) is one class of supra ventricular tachyarrhythmia with uncoordinated atrial electrical activation and causes ineffective atrial contraction which can result in hemodynamic abnormalities and thromboembolic events contributing to severe morbidity and mortality [1]. The guidelines recommend the use of dabigatran for the prevention of thrombosis in NVAF patients, and it is usually not necessary to monitor the coagulation function during the medication. Patients who need direct oral anticoagulation (DOAC) for thrombosis prevention are considered to be at high risk of adverse events related to renal dysfunction [4]. Since large proportion of dabigatran (∼80%) is excreted by the kidneys [6], renal dysfunction may lead to drug accumulation, which increases the risk of bleeding events. It should be mentioned that previous studies [7, 8] focused on the comparison of efficacy and safety of warfarin and dabigatran in NVAF patients with different renal functions. A few studies [5] compared the clinical outcomes of dabigatran itself with different eGFRs

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