TY - JOUR
T1 - International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation
T2 - Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries
AU - For the GARFIELD-AF
AU - ORBIT-AF Investigators
AU - Steinberg, Benjamin A.
AU - Gao, Haiyan
AU - Shrader, Peter
AU - Pieper, Karen
AU - Thomas, Laine
AU - Camm, A. John
AU - Ezekowitz, Michael D.
AU - Fonarow, Gregg C.
AU - Gersh, Bernard J.
AU - Goldhaber, Samuel
AU - Haas, Sylvia
AU - Hacke, Werner
AU - Kowey, Peter R.
AU - Ansell, Jack
AU - Mahaffey, Kenneth W.
AU - Naccarelli, Gerald
AU - Reiffel, James A.
AU - Turpie, Alexander
AU - Verheugt, Freek
AU - Piccini, Jonathan P.
AU - Kakkar, Ajay
AU - Peterson, Eric D.
AU - Fox, Keith A.A.
N1 - Funding Information:
B. A. S. reports consulting for Janssen and BMS-Pfizer and research support from Janssen. H. G., P. S., K. P., and L. T. report no disclosures. A. J. C. has advised and conducted studies on behalf of Bayer, Boehringer Ingelheim, Pfizer/BMS, and Daiichi Sankyo. M. D. E. reports serving as a consultant for AstraZeneca, Eisai, Pozen Inc, Boehringer Ingelheim, ARYx Therapeutics, Pfizer, Sanofi, Bristol-Myers Squibb, Portola, Daiichi Sanko, Medtronic, Merck, Johnson & Johnson, Gilead, Janssen Scientific Affairs, and Armetheon and received grants from Boehringer Ingelheim, Bayer, Daiichi Sanko, Pfizer, and Bristol-Myers Squibb. G. C. F. reports consulting for Janssen, Medtronic, and St Jude Medical. B. J. G. reports Data Safety Monitoring Board–Mount Sinai St Luke’s, Boston Scientific Corporation, Teva Pharmaceutical Industries Ltd, St Jude Medical Inc, Janssen Research & Development LLC, Thrombosis Research Institute, Duke Clinical Research Institute, Duke University, Kowa Research Institute Inc, Cardiovascular Research Foundation, and Medtronic and general consulting for Janssen Scientific Affairs, Xenon Pharmaceuticals, and Sirtex Medical Limited. S. G. reports research support from BiO2 Medical, Boehringer-Ingelheim, BMS, BTG EKOS; Daiichi, Janssen, NHLBI, and Thrombosis Research Institute and serving as a consultant to Agile, Bayer, Boehringer-Ingelheim, BMS, Daiichi, Janssen, Portola, and Zafgen. S. H. reports personal fees from Aspen, personal fees from Bayer Healthcare, personal fees from BMS, personal fees from Daiichi-Sankyo, personal fees from Pfizer, and personal fees from Sanofi outside the submitted work. W. H. reports honoraria for serving on executive committees for Johnson & Johnson and Bayer. P. R. K. reports being a consultant for Johnson and Johnson. J. A. reports advisory activity and/or honoraria from Bristol Myers Squibb, Pfizer, Janssen, Daiichi Sankyo, and Boehringer Ingelheim. K. W. M.'s financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey . G. N. reports research support from Janssen and serving as consultant to Glaxo-Smith-Kline, Janssen, and Daiichi-Sankyo. J. A. R. reports research support from Janssen and Medtronic; consulting for Medtronic, Janssen, In Cardia Therapeutics, Acesion, and Portola; and being in the speaker's bureau for Janssen and Boehringer Ingelheim. A. T. reports being consultant to Bayer Pharma and speaker’s bureau for Janssen and Portola. F. V. reports honoraria for speaker fees and consultancy honoraria from AstraZeneca, Medtronic, Bayer Healthcare, Boehringer-Ingelheim, BMS/Pfizer, and Daiichi-Sankyo. J. P. P. reports funding for clinical research from Abbott Medical, ARCA biopharma, Boston Scientific, Gilead, Janssen Pharmaceuticals, and Spectranetics and serves as a consultant to Allergan, GlaxoSmithKline, Johnson & Johnson, Medtronic, and Spectranetics. A. K. reports grants and personal fees from Bayer Healthcare and personal fees from Boehringer-Ingelheim Pharma, Daiichi Sankyo Europe, Sanofi SA, and Janssen. E. D. P. reports significant Research Grant support from Eli Lilly & Company, Janssen Pharmaceuticals, Inc, and the American Heart Association, and modest Consultant/Advisory Board support from Boehringer Ingelheim, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc, Pfizer, and Genentech Inc. K. A. A. F. reports research grant and honoraria from Bayer and Janssen.
Funding Information:
Summary statistics of the baseline populations of GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II are described using percentages or means (95% CIs), as appropriate. These included baseline demographics, vital signs, medical history, laboratory and imaging data, as well as baseline medical therapies. Comparison statistical tests are not calculated because the large sample sizes are likely to yield statistically significant differences that may or may not be clinically relevant. For analyses of patients with new-onset AF, all cohorts were limited to patients diagnosed with AF within 6 weeks of enrollment. ORBIT-AF I included a small number of these patients, and so this cohort was excluded from this analysis of patients stratified by CHA 2 DS 2 -VASc. Analyses of the data from GARFIELD-AF were performed by the Thrombosis Research Institute using SAS software (version 9.4; SAS Institute, Cary, NC). Analyses of the deidentified data from ORBIT-AF were performed by the Duke Clinical Research Institute using SAS software (version 9.3; SAS Institute, Cary, NC). The Thrombosis Research Institute and the GARFIELD-AF registry are supported by an unrestricted research grant from Bayer AG, Berlin, Germany. The ORBIT-AF registry is sponsored by Janssen Scientific Affairs, LLC, Raritan, NJ. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Publisher Copyright:
© 2017 The Authors
PY - 2017/12
Y1 - 2017/12
N2 - Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. We aimed to provide comprehensive data on international patterns of AF stroke prevention treatment. Methods Demographics, comorbidities, and stroke risk of the patients in the GARFIELD-AF (n = 51,270), ORBIT-AF I (n = 10,132), and ORBIT-AF II (n = 11,602) registries were compared (overall N = 73,004 from 35 countries). Stroke prevention therapies were assessed among patients with new-onset AF (≤6 weeks). Results Patients from GARFIELD-AF were less likely to be white (63% vs 89% for ORBIT-AF I and 86% for ORBIT-AF II) or have coronary artery disease (19% vs 36% and 27%), but had similar stroke risk (85% CHA2DS2-VASc ≥2 vs 91% and 85%) and lower bleeding risk (11% with HAS-BLED ≥3 vs 24% and 15%). Oral anticoagulant use was 46% and 57% for patients with a CHA2DS2-VASc = 0 and 69% and 87% for CHA2DS2-VASc ≥2 in GARFIELD-AF and ORBIT-AF II, respectively, but with substantial geographic heterogeneity in use of oral anticoagulant (range: 31%-93% [GARFIELD-AF] and 66%-100% [ORBIT-AF II]). Among patients with new-onset AF, non–vitamin K antagonist oral anticoagulant use increased over time to 43% in 2016 for GARFIELD-AF and 71% for ORBIT-AF II, whereas use of antiplatelet monotherapy decreased from 36% to 17% (GARFIELD-AF) and 18% to 8% (ORBIT-AF I and II). Conclusions Among new-onset AF patients, non–vitamin K antagonist oral anticoagulant use has increased and antiplatelet monotherapy has decreased. However, anticoagulation is used frequently in low-risk patients and inconsistently in those at high risk of stroke. Significant geographic variability in anticoagulation persists and represents an opportunity for improvement.
AB - Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. We aimed to provide comprehensive data on international patterns of AF stroke prevention treatment. Methods Demographics, comorbidities, and stroke risk of the patients in the GARFIELD-AF (n = 51,270), ORBIT-AF I (n = 10,132), and ORBIT-AF II (n = 11,602) registries were compared (overall N = 73,004 from 35 countries). Stroke prevention therapies were assessed among patients with new-onset AF (≤6 weeks). Results Patients from GARFIELD-AF were less likely to be white (63% vs 89% for ORBIT-AF I and 86% for ORBIT-AF II) or have coronary artery disease (19% vs 36% and 27%), but had similar stroke risk (85% CHA2DS2-VASc ≥2 vs 91% and 85%) and lower bleeding risk (11% with HAS-BLED ≥3 vs 24% and 15%). Oral anticoagulant use was 46% and 57% for patients with a CHA2DS2-VASc = 0 and 69% and 87% for CHA2DS2-VASc ≥2 in GARFIELD-AF and ORBIT-AF II, respectively, but with substantial geographic heterogeneity in use of oral anticoagulant (range: 31%-93% [GARFIELD-AF] and 66%-100% [ORBIT-AF II]). Among patients with new-onset AF, non–vitamin K antagonist oral anticoagulant use increased over time to 43% in 2016 for GARFIELD-AF and 71% for ORBIT-AF II, whereas use of antiplatelet monotherapy decreased from 36% to 17% (GARFIELD-AF) and 18% to 8% (ORBIT-AF I and II). Conclusions Among new-onset AF patients, non–vitamin K antagonist oral anticoagulant use has increased and antiplatelet monotherapy has decreased. However, anticoagulation is used frequently in low-risk patients and inconsistently in those at high risk of stroke. Significant geographic variability in anticoagulation persists and represents an opportunity for improvement.
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U2 - 10.1016/j.ahj.2017.08.011
DO - 10.1016/j.ahj.2017.08.011
M3 - Article
C2 - 29223431
AN - SCOPUS:85031505789
SN - 0002-8703
VL - 194
SP - 132
EP - 140
JO - American Heart Journal
JF - American Heart Journal
ER -