Risk scores for major bleeding from direct oral anticoagulants: comparing predictive performance in patients with atrial fibrillation

Alessandra M Campos-Staffico; Juliet P Jacoby; Michael P Dorsch; Nita A Limdi; Geoffrey D Barnes; Jasmine A Luzum

doi:10.1016/j.rpth.2023.102285

Risk scores for major bleeding from direct oral anticoagulants: comparing predictive performance in patients with atrial fibrillation

Res Pract Thromb Haemost. 2023 Nov 30;8(1):102285. doi: 10.1016/j.rpth.2023.102285. eCollection 2024 Jan.

Authors

Alessandra M Campos-Staffico¹, Juliet P Jacoby¹, Michael P Dorsch¹, Nita A Limdi², Geoffrey D Barnes³, Jasmine A Luzum¹

Affiliations

¹ Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.
² Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
³ Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.

Abstract

Background: Despite direct oral anticoagulants (DOACs) being safer than warfarin for stroke prevention in atrial fibrillation (AF), major bleeding concerns persist. Most bleeding risk scores predate DOAC approval.

Objectives: This study aimed to compare the Age, history of Bleeding, and non-bleeding related Hospitalisation [ABH] score's performance-derived for DOAC-treated patients-with those of 5 other scores (Anticoagulation and Risk Factors in Atrial Fibrillation [ATRIA], Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs/alcohol concomitantly [HAS-BLED], Hepatic, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke [HEMORR₂HAGES], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF], and Congestive heart failure, Hypertension, Age ≥75 [doubled], Diabetes, Stroke [doubled]-Vascular disease, Age 65-74, Sex category [CHA₂DS₂-VASc]) in predicting DOAC-related major bleeding in patients with AF.

Methods: In this retrospective study of 2364 patients with nonvalvular AF on rivaroxaban or apixaban (median age, 68.3 years; 32.1% women), International Society on Thrombosis and Haemostasis-defined major bleeding (incidence, 4.1%; n = 97) was analyzed. C-statistics from time-dependent receiver operating characteristic (ROC) curves for continuous risk scores were the primary comparison metric, but other metrics, such as decision curves, were also compared.

Results: At 100 days, C-statistics were highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60); some significant differences favored ORBIT-AF. At 1100 days, C-statistics remained highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60 again), and ORBIT-AF had significantly higher C-statistics than those for all other risk scores (P < .05), except for ATRIA. At 2100 days, all C-statistics were <0.60 with no significant differences. Decision curves showed the greatest net benefit for ORBIT-AF and ATRIA at 100 days and for ATRIA at 1100 days, with no discernible net benefit for any of the scores at 2100 days.

Conclusion: ORBIT-AF and ATRIA provided the best bleeding risk prediction within the first 1100 days. None of the 6 bleeding risk scores provided predictive benefit over 2100 days of DOAC treatment.

Keywords: anticoagulants; atrial fibrillation; blood coagulation; factor Xa inhibitors; hemorrhage.

Abstract

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