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The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation
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 pred...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670965/ https://www.ncbi.nlm.nih.gov/pubmed/26424865 http://dx.doi.org/10.1093/eurheartj/ehv476 |
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author | O'Brien, Emily C. Simon, DaJuanicia N. Thomas, Laine E. Hylek, Elaine M. Gersh, Bernard J. Ansell, Jack E. Kowey, Peter R. Mahaffey, Kenneth W. Chang, Paul Fonarow, Gregg C. Pencina, Michael J. Piccini, Jonathan P. Peterson, Eric D. |
author_facet | O'Brien, Emily C. Simon, DaJuanicia N. Thomas, Laine E. Hylek, Elaine M. Gersh, Bernard J. Ansell, Jack E. Kowey, Peter R. Mahaffey, Kenneth W. Chang, Paul Fonarow, Gregg C. Pencina, Michael J. Piccini, Jonathan P. Peterson, Eric D. |
author_sort | O'Brien, Emily C. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4670965 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-46709652015-12-08 The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation O'Brien, Emily C. Simon, DaJuanicia N. Thomas, Laine E. Hylek, Elaine M. Gersh, Bernard J. Ansell, Jack E. Kowey, Peter R. Mahaffey, Kenneth W. Chang, Paul Fonarow, Gregg C. Pencina, Michael J. Piccini, Jonathan P. Peterson, Eric D. Eur Heart J Clinical Research 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. Oxford University Press 2015-12-07 2015-09-30 /pmc/articles/PMC4670965/ /pubmed/26424865 http://dx.doi.org/10.1093/eurheartj/ehv476 Text en © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Clinical Research O'Brien, Emily C. Simon, DaJuanicia N. Thomas, Laine E. Hylek, Elaine M. Gersh, Bernard J. Ansell, Jack E. Kowey, Peter R. Mahaffey, Kenneth W. Chang, Paul Fonarow, Gregg C. Pencina, Michael J. Piccini, Jonathan P. Peterson, Eric D. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title | The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title_full | The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title_fullStr | The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title_full_unstemmed | The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title_short | The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
title_sort | orbit bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670965/ https://www.ncbi.nlm.nih.gov/pubmed/26424865 http://dx.doi.org/10.1093/eurheartj/ehv476 |
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