Abstract
BackgroundNo scores presently exist to predict bleeding in atrial fibrillation (AF) populations using direct oral anticoagulants (DOACs). We used data from two independent healthcare claims databases to develop and validate a predictive model of major bleeding in a contemporary AF population.MethodsPatients with non-valvular AF initiating oral anticoagulation were identified in the MarketScan databases from 2007–2014. Using Cox regression models in 1000 bootstrapped samples, we developed a model that selected variables predicting major bleeding in the first year after anticoagulant initiation. The final model was validated in patients with non-valvular AF in the Optum Clinformatics database in the period 2009–2015. The discriminative ability of existing bleeding scores were individually evaluated and compared with the new bleeding model termed Anticoagulation-specific Bleeding Score (ABS) in both MarketScan and Optum.ResultsAmong 119,083 patients with AF initiating oral anticoagulation in the derivation cohort, 4,030 experienced a bleeding event. The variable selection model identified 15 variables (including individual type of oral anticoagulant) associated with major bleeding. Discrimination of the model was modest [c-statistic 0.68, 95% confidence interval (CI) 0.67–0.69]. The model was subsequently applied to 81,285 AF patients in the validation data set (3,238 bleeding events), showing similar discrimination (c-statistic 0.68, 95% CI 0.67–0.69). In both cohorts, the predictive performance of the ABS was better than the existing models for bleeding prediction in AF.ConclusionsWe developed a model that uses administrative healthcare data for the identification of AF patients at higher risk of bleeding after initiation of oral anticoagulation, taking into account the lower bleeding risk in DOAC compared to warfarin users.
Highlights
Atrial fibrillation (AF), a common cardiac arrhythmia, profoundly increases the risk of morbidity and mortality from stroke and several other cardiovascular diseases.[1, 2] Anticoagulation therapy reduces the risk of stroke,[3] the American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline for the Management of Patients With Atrial Fibrillation recommends oral anticoagulants (OACs) for patients with a moderate to high risk of stroke.[4]
We developed a model that uses administrative healthcare data for the identification of atrial fibrillation (AF) patients at higher risk of bleeding after initiation of oral anticoagulation, taking into account the lower bleeding risk in direct oral anticoagulants (DOACs) compared to warfarin users
Using data from large healthcare utilization databases in the US, we developed a model for the prediction of major bleeding in AF patients who initiated OAC therapy with either vitamin K antagonists (VKA) or non-VKA anticoagulants
Summary
Atrial fibrillation (AF), a common cardiac arrhythmia, profoundly increases the risk of morbidity and mortality from stroke and several other cardiovascular diseases.[1, 2] Anticoagulation therapy reduces the risk of stroke,[3] the American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline for the Management of Patients With Atrial Fibrillation recommends oral anticoagulants (OACs) for patients with a moderate to high risk of stroke.[4]. There are several risk stratification schemes available to quantify bleeding risk in AF patients,[6,7,8,9] all were developed in individuals on warfarin. Recently the Food and Drug Administration approved four direct oral anticoagulants (DOACs) for the prevention of ischemic stroke and cardioembolic complications. There is a need for a contemporary classification system to guide the decision between specific OACs based on the individual patient characteristics associated with bleeding risk. No scores presently exist to predict bleeding in atrial fibrillation (AF) populations using direct oral anticoagulants (DOACs). We used data from two independent healthcare claims databases to develop and validate a predictive model of major bleeding in a contemporary AF population
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