TY - JOUR
T1 - Prognostic significance of nuisance bleeding in anticoagulated patients with atrial fibrillation
AU - O'Brien, Emily C.
AU - Holmes, Da Juanicia N.
AU - Thomas, Laine E.
AU - Fonarow, Gregg C.
AU - Allen, Larry A.
AU - Gersh, Bernard J.
AU - Kowey, Peter R.
AU - Singer, Daniel E.
AU - Ezekowitz, Michael D.
AU - Naccarelli, Gerald V.
AU - Ansell, Jack E.
AU - Chan, Paul S.
AU - Mahaffey, Kenneth W.
AU - Go, Alan S.
AU - Freeman, James V.
AU - Reiffel, James A.
AU - Peterson, Eric D.
AU - Piccini, Jonathan P.
AU - Hylek, Elaine M.
N1 - Funding Information:
Dr O’Brien had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. This analysis was conceptualized by Drs Hylek and O’Brien. Dr Thomas and D.N. Holmes conducted the statistical analysis. Drs O’Brien and Hylek wrote the article. The decision to publish was entirely that of the authors. D.N. Holmes and Dr Thomas have no disclosures. Dr O’Brien reports significant research grant from BMS, No-vartis, and Pfizer. Dr Fonarow is a consultant for Janssen (significant). Dr Kowey is a consultant for Johnson & Johnson (significant). Dr Ansell reports consulting and being on the advisory board for Bristol Myers Squibb, Pfizer, Janssen, Boehringer Ingelheim, and Daiichi Sankyo; and equity interest in Perospher. Dr Allen reports consultancy from Novartis (significant) and Janssen. Dr Singer reports a research grant (significant) from Johnson & Johnson; consultant/advisory board (modest) for Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Johnson and Johnson, and Pfizer; and consultant/advisory noard (significant) for Daiichi Sankyo. Dr Ezekowitz reports speakers bureau (significant) for Boehringer Ingelheim; consultant/advisory board (modest) for Pozen Inc, Eisai, and AstraZeneca; consultant/advisory board (significant) for Boehringer Ingelheim, ARYx Therapeutics, Pfizer, Sanofi, Bristol Myers Squibb, PORTOLA, Diachi Sanko, Medtronics, MERCK, Gilead, and Janssen Scientific Affairs. Dr Nacca-relli reports consultant/advisory board for Janssen, Daiichi Sankyo, GlaxoSmith-Kline, and AstraZeneca; and research support from Janssen. Dr Chan receives funding from the National Heart Lung & Blood Institute (1R01HL123980). Dr Go reports no disclosures. Dr Freeman reports being a consultant for Janssen (modest) and receiving salary support from the American College of Cardiology National Cardiovascular Data Registry. Dr Reiffel reports consultant and/or speaker’s bureau for Boehringer-Ingelheim, Janssen (significant), Pfizer, BMS, Portola (modest), and Daiichi Sankyo. Dr Mahaffey reports research support from AstraZeneca, Amgen, Bayer, Boehringer-Ingleheim, Bristol-Myers-Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Portola, POZEN, Schering-Plough, and The Medicines Company; and consulting agreements with Amgen, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, and Merck. Dr Gersh reports consultancies to Janssen Scientific Affairs (significant) and Cipla Limited Data Safety Monitoring Board (modest) for Mount Sinai St Luke’s, Boston Scientific Corporation, Teva Pharmaceutical Industries, St Jude Medical, Janssen Research & Development, Baxter Healthcare Corporation, Thrombosis Research Institute, Duke Clinical Research Institute, Duke University, Kowa Research Institute, and Cardiovascular Research Foundation. Dr Peterson reports significant research support from Eli Lilly & Company, Dai-ichi Sankyo, and Janssen. Dr Piccini reports significant research support from Boston Scientific, ResMed, ARCA Biopharma, St. Jude Medical Center, Gilead Sciences, Johnson & Johnson, Spectranetics, and Janssen; and consultancies to Janssen (significant), Spectranetics (significant), Medtronic (significant), Forest Laboratories (modest), Pfizer (Modest), and GlaxoSmithKline (modest). Dr Hylek reports consultant/advisory board for Bayer, Boehringer Ingelheim, BMS, Dai-ichi Sankyo, Johnson & Johnson, and Pfizer; research grants from Bristol-Myers Squibb and Ortho-McNeil-Janssen; and speaker’s fees for Boehringer Ingelheim and Bristol-Myers Squibb.
Funding Information:
The ORBIT-AF registry is sponsored by Janssen Scientific Affairs, LLC, Rari-tan, NJ. This project was supported (in part) by funding from the Agency of Healthcare Research and Quality through cooperative agreement number 1U19 HS021092. Dr Chan is supported by funding (R01HL123980) from the National Heart Lung and Blood Institute. Janssen Scientific Affairs, LLC, funds the coordinating center.
Publisher Copyright:
© 2018 American Heart Association, Inc.
PY - 2018
Y1 - 2018
N2 - BACKGROUND: Bleeding is commonly cited as a reason for stopping oral anticoagulants (OACs). Whether minor bleeding events (nuisance bleeding, NB) in patients with atrial fibrillation on OACs are associated with OAC discontinuation, major bleeding, and stroke/systemic embolism (SSE) is unknown. METHODS: Within the ORBIT-AF prospective, outpatient registry (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation), we identified 6771 patients ≥18 years of age at 172 sites with atrial fibrillation and eligible follow-up visits. NB was ascertained from the medical record and was defined as minor bleeding that did not require medical attention (eg, bruising, hemorrhoidal bleeding). We used multivariable pooled logistic regression modeling to evaluate the associations between NB and major bleeding and SSE in the 180 days after documentation of NB. Our unit of analysis was the patient visit, occurring at ≈6-month intervals for a median of 1.5 years following enrollment. Changes in anticoagulation treatment satisfaction after NB were examined descriptively in a subset of patients. RESULTS: The median age of the overall population was 75.0 (interquartile range, 67.0-81.0); 90.0% were white and 42.5% were female. Among 6771 patients (18 560 visits), n=1357 (20.0%) had documented NB, for an incidence rate of 14.8 events per 100 person-years. Over 96.4% of patients remained on OAC therapy after the NB event. Overall, 287 (4.3%) patients experienced major bleeding and 64 (0.96%) had a SSE event during follow-up. NB was not associated with a significant increased risk of major bleeding over 6 months in models adjusting for the ATRIA bleeding score (Anticoagulation and Risk Factors in Atrial Fibrillation) (odds ratio, 1.04; 95% confidence interval, 0.68-1.60; P=0.86). NB was also not associated with increased SSE risk over 6 months in models adjusting for the CHA2DS2-VASc risk score (odds ratio, 1.24; 95% confidence interval, 0.53-2.91; P=0.62). CONCLUSIONS: NB is common among patients with atrial fibrillation on OACs. However, NB was not associated with a higher risk of major bleeding or SSE over the next 6 months, suggesting its occurrence should not lead to changes in anticoagulation treatment strategies in OAC-treated patients.
AB - BACKGROUND: Bleeding is commonly cited as a reason for stopping oral anticoagulants (OACs). Whether minor bleeding events (nuisance bleeding, NB) in patients with atrial fibrillation on OACs are associated with OAC discontinuation, major bleeding, and stroke/systemic embolism (SSE) is unknown. METHODS: Within the ORBIT-AF prospective, outpatient registry (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation), we identified 6771 patients ≥18 years of age at 172 sites with atrial fibrillation and eligible follow-up visits. NB was ascertained from the medical record and was defined as minor bleeding that did not require medical attention (eg, bruising, hemorrhoidal bleeding). We used multivariable pooled logistic regression modeling to evaluate the associations between NB and major bleeding and SSE in the 180 days after documentation of NB. Our unit of analysis was the patient visit, occurring at ≈6-month intervals for a median of 1.5 years following enrollment. Changes in anticoagulation treatment satisfaction after NB were examined descriptively in a subset of patients. RESULTS: The median age of the overall population was 75.0 (interquartile range, 67.0-81.0); 90.0% were white and 42.5% were female. Among 6771 patients (18 560 visits), n=1357 (20.0%) had documented NB, for an incidence rate of 14.8 events per 100 person-years. Over 96.4% of patients remained on OAC therapy after the NB event. Overall, 287 (4.3%) patients experienced major bleeding and 64 (0.96%) had a SSE event during follow-up. NB was not associated with a significant increased risk of major bleeding over 6 months in models adjusting for the ATRIA bleeding score (Anticoagulation and Risk Factors in Atrial Fibrillation) (odds ratio, 1.04; 95% confidence interval, 0.68-1.60; P=0.86). NB was also not associated with increased SSE risk over 6 months in models adjusting for the CHA2DS2-VASc risk score (odds ratio, 1.24; 95% confidence interval, 0.53-2.91; P=0.62). CONCLUSIONS: NB is common among patients with atrial fibrillation on OACs. However, NB was not associated with a higher risk of major bleeding or SSE over the next 6 months, suggesting its occurrence should not lead to changes in anticoagulation treatment strategies in OAC-treated patients.
KW - Anticoagulants
KW - Atrial fibrillation
KW - Hemorrhage
KW - Risk assessment
KW - Stroke
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UR - http://www.scopus.com/inward/citedby.url?scp=85053859408&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.117.031354
DO - 10.1161/CIRCULATIONAHA.117.031354
M3 - Article
C2 - 29678813
AN - SCOPUS:85053859408
VL - 138
SP - 889
EP - 897
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 9
ER -