Oral anticoagulants and risk of acute liver injury in patients with nonvalvular atrial fibrillation: a propensity-weighted nationwide cohort study

Alain Weill,Jérôme Drouin,Anke Neumann,Cécile Billionnet,Marc Bardou,Géric Maura

doi:10.1038/s41598-020-68304-8

Abstract

Insufficient real-world data on acute liver injury (ALI) risk associated with oral anticoagulants (OACs) exist in patients with nonvalvular atrial fibrillation (NVAF). Using the French national healthcare databases, a propensity-weighted nationwide cohort study was performed in NVAF patients initiating OACs from 2011 to 2016, considering separately those (1) with no prior liver disease (PLD) as main population, (2) with PLD, (3) with a history of chronic alcoholism. A Cox proportional hazards model was used to estimate the hazard ratio with 95% confidence interval (HR [95% CI]) of serious ALI (hospitalised ALI or liver transplantation) during the first year of treatment, for each non-vitamin K antagonist (VKA) oral anticoagulant (NOAC: dabigatran, rivaroxaban, apixaban) versus VKA. In patients with no PLD (N = 434,015), only rivaroxaban new users were at increased risk of serious ALI compared to VKA initiation (adjusted HR: 1.41 [1.05–1.91]). In patients with chronic alcoholism history (N = 13,173), only those initiating dabigatran were at increased risk of serious ALI compared to VKA (2.88 [1.74–4.76]) but an ancillary outcome suggested that differential clinical follow-up between groups might partly explain this association. In conclusion, this study does not suggest an increase of the 1-year risk of ALI in NOAC versus VKA patients with AF.

Highlights

Insufficient real-world data on acute liver injury (ALI) risk associated with oral anticoagulants (OACs) exist in patients with nonvalvular atrial fibrillation (NVAF)
Due to the insufficient real-world data on liver injury risk associated with each type of oral anticoagulants to make informed choices in clinical practice, we investigated the risk of serious acute liver injury (ALI) associated with OAC use and compared this risk between each Non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonist (VKA) in AF patients, with no prior liver disease and in those with prior liver disease and those with a history of chronic alcoholism
Across all variables included in the propensity score (PS), the standardized differences ranged from − 0.54 to + 0.40 for the dabigatran/VKA cohort, − 0.55 to + 0.46 for the rivaroxaban/VKA cohort and − 0.59 to + 0.37 for the apixaban/VKA cohort

Summary

Introduction

Insufficient real-world data on acute liver injury (ALI) risk associated with oral anticoagulants (OACs) exist in patients with nonvalvular atrial fibrillation (NVAF). Two published cohort studies based on claims data have compared NOAC and VKA therapies in terms of liver injuries[16,17] Both studies defined liver injury as a mix of hospitalised acute and chronic (or unspecified) liver injuries and their estimates. Due to the insufficient real-world data on liver injury risk associated with each type of oral anticoagulants to make informed choices in clinical practice, we investigated the risk of serious acute liver injury (ALI) associated with OAC use and compared this risk between each NOAC (dabigatran, rivaroxaban, apixaban) and VKAs in AF patients, with no prior liver disease and in those with prior liver disease and those with a history of chronic alcoholism

Methods

Results

Discussion

Conclusion