The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation.
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BACKGROUND: Therapeutic decisions in atrial fibrillation (AF) are often influenced by assessment of bleeding risk. However, existing bleeding risk scores have limitations. OBJECTIVES: We sought to develop and validate a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large, community-based AF population. METHODS: We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a prospective registry that enrolled incident and prevalent AF patients at 176 US sites. Using Cox proportional hazards regression, we identified factors independently associated with major bleeding among patients taking oral anticoagulation (OAC) over a median follow-up of 2 years (interquartile range = 1.6-2.5). We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding. The predictive performance of the full model, the simple five-item score, and two existing risk scores (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly, HAS-BLED, and anticoagulation and risk factors in atrial fibrillation, ATRIA) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population, Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET-AF). RESULTS: Among 7411 ORBIT-AF patients taking OAC, the rate of major bleeding was 4.0/100 person-years. The full continuous model (12 variables) and five-factor ORBIT risk score (older age [75+ years], reduced haemoglobin/haematocrit/history of anaemia, bleeding history, insufficient kidney function, and treatment with antiplatelet) both had good ability to identify those who bled vs. not (C-index 0.69 and 0.67, respectively). These scores both had similar discrimination, but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial. CONCLUSIONS: The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores. The ORBIT risk score can provide a simple, easily remembered tool to support clinical decision making.
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Published Version (Please cite this version)10.1093/eurheartj/ehv476
Publication InfoAnsell, JE; Chang, P; Fonarow, GC; Gersh, Bernard John; Hylek, EM; Kowey, Peter R; ... Thomas, Laine Elliott (2015). The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J, 36(46). pp. 3258-3264. 10.1093/eurheartj/ehv476. Retrieved from http://hdl.handle.net/10161/15004.
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Adjunct Professor in the Department of Medicine
Assistant Professor in Population Health Sciences
I am an epidemiologist and health services researcher at the Duke Clinical Research Institute. My research focuses on comparative effectiveness, patient-centered outcomes, and pragmatic health services research in cardiovascular and pulmonary disease.Areas of expertise: Epidemiology, Health Services Research, and Clinical Decision Sciences
Fred Cobb, M.D. Professor of Medicine
Dr Peterson is the Fred Cobb Distinguished Professor of Medicine in the Division of Cardiology, a DukeMed Scholar, and the Past Executive Director of the Duke Clinical Research Institute (DCRI), Durham, NC, USA. Dr Peterson is the Principal Investigator of the National Institute of Health, Lung and Blood Institute (NHLBI) Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) Trial He is also the Principal I
Associate Professor of Medicine
Jonathan P. Piccini, MD, MHS is a clinical cardiac electrophysiologist and Associate Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute. His research interests include the conduct of clinical trials and the assessment of cardiovascular therapeutics for the care of patients with heart rhythm disorders. At present, he is the Director of the EP Clinical Trials Program and Arrhythmia Core Laboratory at Duke University. He also serves on the Clinical W
Associate Professor of Biostatistics and Bioinformatics
Measurement error, longitudinal data, joint modeling
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