M Proietti1,2, Z Hijazi3,4, U Andersson4, S J Connolly5, J W Eikelboom5, M D Ezekowitz6, D A Lane7, J Oldgren3,4, V Roldan8,9, S Yusuf5, L Wallentin3,4. 1. Department of Internal Medicine and Medical Specialties, Sapienza-University of Rome, Rome, Italy. 2. Department of Neuroscience, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. 3. Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. 4. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 5. Population Health Research Institute, Hamilton, ON, Canada. 6. Sidney Kimmel Medical College, Thomas Jefferson University, Wynnewood, PA, USA. 7. University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK. 8. Department of Hematology and Clinical Oncology, Hospital Universitario Morales Meseguer, University of Murcia, Murcia, Spain. 9. Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca (IMIB), Murcia, Spain.
Abstract
BACKGROUND:Oral anticoagulation is the mainstay of stroke prevention in atrial fibrillation (AF), but must be balanced against the associated bleeding risk. Several risk scores have been proposed for prediction of bleeding events in patients with AF. OBJECTIVES: To compare the performance of contemporary clinical bleeding risk scores in 18 113 patients with AF randomized todabigatran 110 mg, 150 mg or warfarin in the RE-LY trial. METHODS:HAS-BLED, ORBIT, ATRIA and HEMORR2 HAGES bleeding risk scores were calculated based on clinical information at baseline. All major bleeding events were centrally adjudicated. RESULTS: There were 1182 (6.5%) major bleeding events during a median follow-up of 2.0 years. For all the four schemes, high-risk subgroups had higher risk of major bleeding (all P < 0.001). The ORBIT score showed the best discrimination with c-indices of 0.66, 0.66 and 0.62, respectively, for major, life-threatening and intracranial bleeding, which were significantly better than for the HAS-BLED score (difference in c-indices: 0.050, 0.053 and 0.048, respectively, all P < 0.05). The ORBIT score also showed the best calibration compared with previous data. Significant treatment interactions between the bleeding scores and the risk of major bleeding with dabigatran 150 mg BD versus warfarin were found for the ORBIT (P = 0.0019), ATRIA (P < 0.001) and HEMORR2 HAGES (P < 0.001) scores. HAS-BLED score showed a nonsignificant trend for interaction (P = 0.0607). CONCLUSIONS: Amongst the current clinical bleeding risk scores, the ORBIT score demonstrated the best discrimination and calibration. All the scores demonstrated, to a variable extent, an interaction with bleeding risk associated with dabigatran or warfarin.
RCT Entities:
BACKGROUND: Oral anticoagulation is the mainstay of stroke prevention in atrial fibrillation (AF), but must be balanced against the associated bleeding risk. Several risk scores have been proposed for prediction of bleeding events in patients with AF. OBJECTIVES: To compare the performance of contemporary clinical bleeding risk scores in 18 113 patients with AF randomized to dabigatran 110 mg, 150 mg or warfarin in the RE-LY trial. METHODS: HAS-BLED, ORBIT, ATRIA and HEMORR2 HAGES bleeding risk scores were calculated based on clinical information at baseline. All major bleeding events were centrally adjudicated. RESULTS: There were 1182 (6.5%) major bleeding events during a median follow-up of 2.0 years. For all the four schemes, high-risk subgroups had higher risk of major bleeding (all P < 0.001). The ORBIT score showed the best discrimination with c-indices of 0.66, 0.66 and 0.62, respectively, for major, life-threatening and intracranial bleeding, which were significantly better than for the HAS-BLED score (difference in c-indices: 0.050, 0.053 and 0.048, respectively, all P < 0.05). The ORBIT score also showed the best calibration compared with previous data. Significant treatment interactions between the bleeding scores and the risk of major bleeding with dabigatran 150 mg BD versus warfarin were found for the ORBIT (P = 0.0019), ATRIA (P < 0.001) and HEMORR2 HAGES (P < 0.001) scores. HAS-BLED score showed a nonsignificant trend for interaction (P = 0.0607). CONCLUSIONS: Amongst the current clinical bleeding risk scores, the ORBIT score demonstrated the best discrimination and calibration. All the scores demonstrated, to a variable extent, an interaction with bleeding risk associated with dabigatran or warfarin.
Authors: Ethan D Borre; Adam Goode; Giselle Raitz; Bimal Shah; Angela Lowenstern; Ranee Chatterjee; Lauren Sharan; Nancy M Allen LaPointe; Roshini Yapa; J Kelly Davis; Kathryn Lallinger; Robyn Schmidt; Andrzej Kosinski; Sana M Al-Khatib; Gillian D Sanders Journal: Thromb Haemost Date: 2018-10-30 Impact factor: 6.681
Authors: Alexander C Perino; Jun Fan; Krishna Pundi; Susan Schmitt; Mitra Kothari; Natasha Din; Paul A Heidenreich; Mintu P Turakhia Journal: Clin Cardiol Date: 2022-08-09 Impact factor: 3.287
Authors: Gordon Chu; Jaap Seelig; Emmy M Trinks-Roerdink; Anouk P van Alem; Marco Alings; Bart van den Bemt; Lucas Va Boersma; Marc A Brouwer; Suzanne C Cannegieter; Hugo Ten Cate; Charles Jhj Kirchhof; Harry Jgm Crijns; Ewoud J van Dijk; Arif Elvan; Isabelle C van Gelder; Joris R de Groot; Frank R den Hartog; Jonas Ssg de Jong; Sylvie de Jong; Frederikus A Klok; Timo Lenderink; Justin G Luermans; Joan G Meeder; Ron Pisters; Peter Polak; Michiel Rienstra; Frans Smeets; Giovanni Jm Tahapary; Luc Theunissen; Robert G Tieleman; Serge A Trines; Pepijn van der Voort; Geert-Jan Geersing; Frans H Rutten; Martin Ew Hemels; Menno V Huisman Journal: BMJ Open Date: 2020-08-24 Impact factor: 2.692