1. Performance of HAS-BLED and DOAC scores to predict major bleeding events in atrial fibrillation patients treated with direct oral anticoagulants: A report from a prospective European observational registry.
- Author
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Mei DA, Imberti JF, Bonini N, Romiti GF, Corica B, Proietti M, Vitolo M, Lip GYH, and Boriani G
- Subjects
- Humans, Female, Aged, Male, Prospective Studies, Middle Aged, Europe, Risk Assessment, Administration, Oral, Rivaroxaban adverse effects, Rivaroxaban therapeutic use, Anticoagulants adverse effects, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors therapeutic use, Dabigatran adverse effects, Dabigatran therapeutic use, Dabigatran administration & dosage, Pyridones adverse effects, Pyridones therapeutic use, Stroke epidemiology, Risk Factors, Pyrazoles adverse effects, Pyrazoles therapeutic use, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Registries, Hemorrhage chemically induced, Hemorrhage epidemiology, ROC Curve
- Abstract
Background: The DOAC score has been recently proposed for bleeding risk stratification of patients with atrial fibrillation treated with direct oral anticoagulants (DOAC)., Objective: To compare the performance of HAS-BLED and DOAC score in predicting major bleeding events in a contemporary cohort of European AF patients treated with DOAC., Methods: We included patients derived from a prospective observational registry of European AF patients. HAS-BLED and DOAC scores were calculated as per the original schemes. Our primary endpoint was major bleeding events. Receiver operating characteristic (ROC) curves were used to compare the predictive ability of the scores., Results: A total of 2834 AF patients (median age [IQR] 69 [62-77] years; 39.6 % female) treated with DOAC were included in the analysis. According to the HAS-BLED score, 577 patients (20.4 %) were categorized as very low risk of bleeding, as compared to 1276 (45.0 %) according to DOAC score. A total of 55 major bleeding events occurred with an overall incidence of 1.04 per 100 patient-years. Both scores showed only a modest ability for the prediction of bleeding events (HAS-BLED area under the curve [AUC], 0.65, 95 % confidence interval [CI] 0.55-0.70; DOAC score AUC 0.62, 95 % CI 0.59-0.71, p for difference = 0.332]. At calibration analysis, the DOAC score showed modest calibration, especially for patients at high risk, when compared to HAS-BLED., Conclusion: In a contemporary cohort of DOAC-treated AF patients, both HAS-BLED and DOAC scores only modestly predicted the occurrence of major bleeding events. Our results do not support the preferential use of DOAC score over HAS-BLED., Competing Interests: Declaration of competing interest GB: reports small speaker fees from Bayer, Boehringer Ingelheim, Boston, BMS, Daiichi, Sanofi and Janssen outside the submitted work. GYHL: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Anthos. No fees are received personally. He is a National Institute for Health and Care Research (NIHR) Senior Investigator and co-PI of the AFFIRMO project on multimorbidity in AF (grant agreement No 899871), TARGET project on digital twins for personalised management of atrial fibrillation and stroke (grant agreement No 101136244) and ARISTOTELES project on artificial intelligence for management of chronic long term conditions (grant agreement No 101080189), which are all funded by the EU's Horizon Europe Research & Innovation programme. MP: Italian national Principal Investigator of the AFFIRMO project on multimorbidity in atrial fibrillation, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 899871. GFR: GFR reports consultancy for Boehringer Ingelheim and an educational grant from Anthos, outside the submitted work. No fees are directly received personally. The other authors do not have conflict of interests to report., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
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