Comparison of HAS-BLED and ORBIT bleeding risk scores in atrial fibrillation patients treated with non-vitamin K antagonist oral anticoagulants: a report from the ESC-EHRA EORP-AF General Long-Term Registry
Marco Proietti, Giulio Francesco Romiti, Marco Vitolo, Tatjana Potpara, Giuseppe Boriani, Gregory Y.H. Lip, ESC-EHRA EORP-AF Long-Term General Registry Investigators, Giuseppe Boriani, Gregory Y.H. Lip, Luigi Tavazzi, Aldo P. Maggioni, G-A Dan, T Potpara, M Nabauer, Francisco Marı́n, Zbigniew Kalarus, Laurent Fauchier, Roberto Ferrari, Alena Shantsila, Artan Goda, Georges H. Mairesse, T Shalganov, Loizos Antoniades, Miloš Táborský, Sam Riahi, Piibe Muda, Ignacio García Bolao, Olivier Piot, M Nabauer, Kakhaber Etsadashvili, Εmmanuel Simantirakis, Moti Haim, Amirhossein Azhari, Jamshid Najafian, Massimo Santini, E Mirrakhimov, K a Kulzida, Andrejs Ērglis, L Poposka, M Burg, Harry J.G.M. Crijns, Ömer Erküner, D Atar, Radosław Lenarczyk, Mário Oliveira, Dipen Shah, G-A Dan, E Serdechnaya, T Potpara, E Diker, Gregory Y.H. Lip, Deirdre A. Lane, E Zëra, U Ekmekçiu, Vilma Paparisto, Mihal Tase, H Gjergo, J Dragoti, Artan Goda, M Ciutea, N. Ahadi, Ziad El Husseini, M. Raepers, J. Leroy, P Haushan, A Jourdan, Caroline Lepièce, Lien Desteghe, Johan Vijgen, Pieter Koopman, G. Van Genechten, Hein Heidbüchel, Tim Boussy, M De Coninck, Hannelore Van Eeckhoutte, N Bouckaert, Alain Friart, J. Boreux, C Arend, P Evrard, L Stefan, E Hoffer, J. Herzet, M Massoz, C. Celentano, Muriel Sprynger, Luc Piérard, P Mélon, B Van Hauwaert, C. Kuppens, Dirk Faes, Dirk van Lier, A. Van Dorpe, A. Gerardy, Olivier Deceuninck, Olivier Xhaët, Fabien Dormal, Elisabeth Ballant, Dominique Blommaert, D. Yakova
Abstract
AIMS: Bleeding risk assessment is recommended in guidelines for the management of atrial fibrillation (AF). The HAS-BLED score was proposed prior to non-vitamin K antagonist oral anticoagulants (NOACs) and it has been suggested that the ORBIT score may be superior in predicting bleeds in NOAC users. We aimed to compare the HAS-BLED and ORBIT scores in contemporary AF patients treated with NOACs. METHODS AND RESULTS: We analysed patients enrolled in the ESC-EHRA EORP-AF (EURObservational Research Programme in AF) General Long-Term Registry. HAS-BLED and ORBIT scores were computed based on original schemes. The primary outcome was the occurrence of major bleeding (MB). A total of 3018 patients (median age 70; 39.6% females) were included: median [interquartile range (IQR)] HAS-BLED and ORBIT scores were 1 [1-2] and 1 [0-2], respectively; 356 (11.8%) patients were at high risk for MB using HAS-BLED (≥3) and 123 (4.1%) using ORBIT (≥4). Overall, 60 (2.0%) MB events were recorded, with an incidence of 1.1 per 100 patient-years. Both HAS-BLED and ORBIT were associated with outcome, modestly predicting MB [area under the curve (AUC) 0.653, 95% confidence interval (CI) 0.593-0.714 and AUC 0.601, 95% CI 0.526-0.677, respectively]. Calibration plots showed that both scores were poorly calibrated, particularly the ORBIT score, which showed consistent poorer calibration. Time-dependent reclassification analysis showed a trend towards incorrect lower risk reclassification using ORBIT compared with HAS-BLED. CONCLUSION: In this real-life contemporary cohort of AF patients treated with NOACs, the ORBIT score did not provide reclassification improvement, showing even poorer calibration compared with HAS-BLED. Our findings do not support the preferential use of ORBIT in NOAC-treated AF patients.