TY - JOUR
T1 - How well does physician risk assessment predict stroke and bleeding in atrial fibrillation? Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
AU - ORBIT-AF Investigators and Patients
AU - Steinberg, Benjamin A.
AU - Shrader, Peter
AU - Kim, Sunghee
AU - Thomas, Laine
AU - Fonarow, Gregg C.
AU - Ansell, Jack
AU - Kowey, Peter R.
AU - Singer, Daniel E.
AU - Gersh, Bernard J.
AU - Mahaffey, Kenneth W.
AU - Peterson, Eric D.
AU - Piccini, Jonathan P.
N1 - Funding Information:
Dr Steinberg reports modest educational support from Medtronic. Mr Shrader, Dr Kim, and Dr Thomas report no disclosures. Dr Fonarow reports modest consultant/advisory board support from Ortho McNeil. Dr Ansell reports modest consultant/advisory board from Bristol Myers Squibb, Pfizer, Janssen, Daiichi, Boehringer Ingelheim, and Alere. Dr Kowey reports modest consultant/advisory board support from Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Portola, Merck, Sanofi, and Daiichi Sankyo. Dr Singer reports significant research grant support from Johnson and Johnson; modest consultant/advisory board support from Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Johnson and Johnson, and Pfizer; and significant consultant/advisory board support from Daiichi Sankyo. Dr Gersh reports modest DSMB/advisory board support from Medtronic, Baxter Healthcare Corporation, InspireMD, Cardiovascular Research Foundation, PPD Development, LP, Boston Scientific, and St Jude. Dr Mahaffey's financial disclosures before August 1, 2013 can be viewed at https://www.dcri.org/about-us/conflict-of-interest/Mahaffey-COI_2011-2013.pdf ; disclosures after August 1, 2013 can be viewed at http://med.stanford.edu/profiles/kenneth_mahaffey . Dr Peterson reports significant research grant support from Eli Lilly & Company, Janssen Pharmaceuticals, and the American Heart Association, and modest consultant/advisory board support from Boehringer Ingelheim, Bristol-Myers Squibb, Janssen Pharmaceuticals, Pfizer, and Genentech. Dr Piccini reports significant research grant support from Johnson & Johnson/Janssen Pharmaceuticals; significant other research support from Bayer HealthCare Pharmaceuticals (formerly Berlex Labs), Boston Scientific Corporation, Johnson & Johnson Pharmaceutical Research & Development; modest consultant/advisory board support from Forest Laboratories and Medtronic; and significant consultant/advisory board support from Johnson & Johnson/Janssen Pharmaceuticals.
Publisher Copyright:
© 2016 The Authors
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Background Assessments of stroke and bleeding risks are essential to selecting oral anticoagulation in patients with atrial fibrillation (AF). We aimed to assess outcomes according to physician assessed risk, with comparison to empirical risk scores. Methods This was a prospective, observational study of 9,715 outpatients with AF enrolled in ORBIT-AF, a US national registry. Stroke and bleeding risks were quantified by physician assignment, CHADS2 and CHA2DS2-VASc stroke scores, and ATRIA and HAS-BLED bleeding scores. Outcomes were stroke or systemic embolism and major bleeding during a median follow-up of 28 months. Results Physician-assigned risk was associated with thromboembolic events: low risk (0.71 per 100 patient-years [95% CI 0.56-0.91], n = 3,991), intermediate risk (0.98 [95% CI 0.79-1.20], n = 4,148), and high risk (1.84 [95% CI 1.43-2.37], n = 1,576, P < .0001), and major bleeding: low (3.43 [95% CI 3.07-3.82], n = 4,250), intermediate (4.55 [95% CI 4.03-5.15], n = 2,702), and high (5.76 [95% CI 4.42-7.50], n = 468; P < .0001). Discrimination of stroke risk was similar with CHADS2 (c = 0.59, 95% CI 0.57-0.61) vs physician assessment (c = 0.58, 95% CI 0.55-0.62). Among patients on oral anticoagulation, bleeding risk discrimination was higher with ATRIA (c = 0.63, 95% CI 0.61-0.65) and HAS-BLED (c = 0.60, 95% CI 0.59-0.62) than with physician assessment (0.55, 95% CI 0.53-0.57). Physician-assessed risk categories did not add significantly to empirical risk scores, in Cox models for outcomes (Padjusted > .05 for all physician assessments vs Padjusted < .05 for empirical scores). Conclusion Physician-assigned risk showed a graded relationship with outcomes, and both physician-based and empirical scores yielded only moderate discrimination. Although empirical scores provided valuable risk stratification information (with or without physician judgment), physician assessment added little to existing scores. These data support the use of empirical scores for stroke and bleeding risk stratification, and the need for novel approaches to risk stratification in this population.
AB - Background Assessments of stroke and bleeding risks are essential to selecting oral anticoagulation in patients with atrial fibrillation (AF). We aimed to assess outcomes according to physician assessed risk, with comparison to empirical risk scores. Methods This was a prospective, observational study of 9,715 outpatients with AF enrolled in ORBIT-AF, a US national registry. Stroke and bleeding risks were quantified by physician assignment, CHADS2 and CHA2DS2-VASc stroke scores, and ATRIA and HAS-BLED bleeding scores. Outcomes were stroke or systemic embolism and major bleeding during a median follow-up of 28 months. Results Physician-assigned risk was associated with thromboembolic events: low risk (0.71 per 100 patient-years [95% CI 0.56-0.91], n = 3,991), intermediate risk (0.98 [95% CI 0.79-1.20], n = 4,148), and high risk (1.84 [95% CI 1.43-2.37], n = 1,576, P < .0001), and major bleeding: low (3.43 [95% CI 3.07-3.82], n = 4,250), intermediate (4.55 [95% CI 4.03-5.15], n = 2,702), and high (5.76 [95% CI 4.42-7.50], n = 468; P < .0001). Discrimination of stroke risk was similar with CHADS2 (c = 0.59, 95% CI 0.57-0.61) vs physician assessment (c = 0.58, 95% CI 0.55-0.62). Among patients on oral anticoagulation, bleeding risk discrimination was higher with ATRIA (c = 0.63, 95% CI 0.61-0.65) and HAS-BLED (c = 0.60, 95% CI 0.59-0.62) than with physician assessment (0.55, 95% CI 0.53-0.57). Physician-assessed risk categories did not add significantly to empirical risk scores, in Cox models for outcomes (Padjusted > .05 for all physician assessments vs Padjusted < .05 for empirical scores). Conclusion Physician-assigned risk showed a graded relationship with outcomes, and both physician-based and empirical scores yielded only moderate discrimination. Although empirical scores provided valuable risk stratification information (with or without physician judgment), physician assessment added little to existing scores. These data support the use of empirical scores for stroke and bleeding risk stratification, and the need for novel approaches to risk stratification in this population.
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U2 - 10.1016/j.ahj.2016.07.026
DO - 10.1016/j.ahj.2016.07.026
M3 - Article
C2 - 27823686
AN - SCOPUS:84988969674
VL - 181
SP - 145
EP - 152
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -