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Predicting performance of the HASBLED and ORBIT bleeding risk scores in patients with atrial fibrillation treated with Rivaroxaban: Observation from the prospective EMIR registry

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dc.contributor.authorEsteve Pastor, Maria Asunción
dc.contributor.authorRivera Caravaca, José Miguel
dc.contributor.authorRoldán Schilling, Vanessa
dc.contributor.authorSanmaritin Fernandez, Marcelo
dc.contributor.authorArribas, Fernando
dc.contributor.authorMasjuan, Jaime
dc.contributor.authorBarrios, Vivencio
dc.contributor.authorCosin Sales, Juan
dc.contributor.authorFreixa Pamies, Ramon
dc.contributor.authorRecalde, Esteban
dc.contributor.authorPerez-Cabeza, Alejandro
dc.contributor.authorVazquez Rodriguez, Manuel
dc.contributor.authorRafols, Carles
dc.contributor.authorAnguita, Manuel
dc.contributor.authorLip, Gregory Y
dc.contributor.authorMarin Ortuño, Francisco
dc.contributor.departmentMedicina
dc.date.accessioned2025-02-01T09:07:21Z
dc.date.available2025-02-01T09:07:21Z
dc.date.issued2022-11-01
dc.description© 2022 The authors. This document is the published version of a published work that appeared in final form in European Heart Journal - Cardiovascular Pharmacotherapy . To access the final edited and published work see: https://doi.org/10.1093/ehjcvp/pvac060
dc.description.abstractBackground Assessing bleeding risk during the decision-making process of starting oral anticoagulation (OAC) therapy in atrial fibrillation (AF) patients is essential. Several bleeding risk scores have been proposed for vitamin K antagonist users but, few studies have focused on validation of these bleeding risk scores in patients taking direct oral anticoagulants (DOACs). The aim was to compare the predictive ability of HAS-BLED and ORBIT bleeding risk scores in AF patients taking rivaroxaban in the EMIR (‘Estudio observacional para la identificación de los factores de riesgo asociados a eventos cardiovasculares mayores en pacientes con fibrilación auricular no valvular tratados con un anticoagulante oral directo [Rivaroxaban]) Study. Methods and results EMIR Study was an observational, multicenter, post-authorization, and prospective study that involved AF patients under OAC with rivaroxaban at least 6 months before enrolment. We analysed baseline clinical characteristics and adverse events after 2.5 years of follow-up and validated the predictive ability of HAS-BLED and ORBIT scores for major bleeding (MB) events. We analysed 1433 patients with mean age of 74.2 ± 9.7 (44.5% female). Mean HAS-BLED score was 1.6 ± 1.0 and ORBIT score was 1.1 ± 1.2. The ORBIT score categorised a higher proportion of patients as ‘low-risk’ (87.1%) compared with 53.5% using the HAS-BLED score. There were 33 MB events (1.04%/year) and 87 patients died (2.73%/year). Both HAS-BLED and ORBIT had a good predictive ability for MB{Area under the curve (AUC) 0.770, [95% confidence interval (CI) 0.693–0.847; P <0.001] and AUC 0.765 (95% CI 0.672–0.858; P <0.001), respectively}. There was a non-significant difference for discriminative ability of the two tested scores (P = 0.930) and risk reclassification in terms of net reclassification improvement (NRI) −5.7 (95% CI −42.4–31.1; P = 0.762). HAS-BLED score showed the best calibration and ORBIT score showed the largest mismatch in calibration, particularly in higher predicted risk patients. Conclusion In a prospective real-world AF population under rivaroxaban from EMIR registry, the HAS-BLED score had good predictive performance and calibration compared with ORBIT score for MB events. ORBIT score presented worse calibration than HAS-BLED in this DOAC treated population.
dc.formatapplication/pdfes
dc.format.extent9
dc.identifier.citationEur Heart J Cardiovasc Pharmacother. 2022 Dec 15 9(1):38-46.
dc.identifier.doihttps://doi.org/10.1093/ehjcvp/pvac060
dc.identifier.issnPrint.: 2055-6837
dc.identifier.issnElectronic.: 2055-6845
dc.identifier.urihttp://hdl.handle.net/10201/149922
dc.languageenges
dc.publisherOxford University Press
dc.relationBayer Hispania.es
dc.relation.publisherversionhttps://academic.oup.com/ehjcvp/article/9/1/38/6786271
dc.rights.accessRightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectAtrial fibrillation
dc.subjectHAS-BLED
dc.subjectORBIT
dc.subjectBleeding scores
dc.subjectBleeding risk
dc.titlePredicting performance of the HASBLED and ORBIT bleeding risk scores in patients with atrial fibrillation treated with Rivaroxaban: Observation from the prospective EMIR registryes
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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