Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation.


BACKGROUND: Dabigatran is a novel oral anticoagulant approved for thromboprophylaxis in atrial fibrillation. Adoption patterns of this new agent in community practice are unknown. METHODS AND RESULTS: We studied patterns of dabigatran use among patients enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry between June 2010 and August 2011 and followed for 12 months. Among 9974 atrial fibrillation patients included, 1217 (12%) were treated with dabigatran during the study. Overall, patients receiving dabigatran were younger (median age 72 versus 75 years, P<0.0001), more likely to be white (92% versus 89%, P=0.005), more likely to have private insurance (33% versus 25%, P<0.0001), and less likely to have prior cardiovascular disease (4% versus 33%, P<0.0001). They had more new-onset atrial fibrillation (8.8% versus 4.1%, P<0.0001), lower CHADS2 scores (estimated risk based on the presence of congestive heart failure, hypertension, aged ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack; mean 2.0 versus 2.3, P<0.0001), and lower Anticoagulation and Risk Factors in Atrial Fibrillation scores (mean 2.4 versus 2.8, P<0.0001). More than half (n=14/25, 56%) of patients with severe kidney disease were not prescribed reduced dosing, whereas 10% (n=91/920) with preserved renal function received lower dosing. Among patients not on dabigatran at baseline, 8% had dabigatran initiated during follow-up. Patient education was significantly associated with switching from warfarin to dabigatran (adjusted odds ratio for postgraduate 1.73, P=0.007), whereas antiarrhythmic drug use significantly correlated with de novo adoption of dabigatran (adjusted odds ratio 2.4, P<0.0001). CONCLUSIONS: Patients receiving dabigatran were younger and at a lower risk of stroke and bleeding. Patients appeared to drive switching from warfarin, whereas clinical characteristics influenced de novo start of dabigatran. These data suggest cautious early uptake of dabigatran, and more careful attention to dosing adjustments is warranted. CLINICAL TRIAL REGISTRATION URL: Clinicaltrials.gov. Unique identifier: NCT01165710.





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Publication Info

Steinberg, Benjamin A, Dajuanicia N Holmes, Jonathan P Piccini, Jack Ansell, Paul Chang, Gregg C Fonarow, Bernard Gersh, Kenneth W Mahaffey, et al. (2013). Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation. J Am Heart Assoc, 2(6). p. e000535. 10.1161/JAHA.113.000535 Retrieved from https://hdl.handle.net/10161/15012.

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Jonathan Paul Piccini

Professor of Medicine

Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation and lead extraction. His research interests include the development and evaluation of innovative cardiovascular interventions for the treatment heart rhythm disorders. He has served as the chairman for several national and international clinical trials and registries, including the American Heart Association-Get with the Guidelines Atrial Fibrillation program. He is an Associate Editor at JACC: Clinical Electrophysiology and is an elected member of the American Society for Clinical Investigation. Dr. Piccini has more than 550 publications in the field of heart rhythm medicine and has been the recipient of several teaching and mentorship awards.


Laine Elliott Thomas

Professor of Biostatistics & Bioinformatics

Laine Thomas, PhD, joined the Department of Biostatistics and Bioinformatics and DCRI in 2009.  She serves as Associate Chair for Equity, Diversity and Inclusion within the Department of Biostatistics and Bioinformatics and Deputy Director of Data Science and Biostatistics at the Duke Clinical Research Institute.  She is a leader in study design and development of methods for observational and pragmatic studies, with over 240 peer reviewed clinical and methodological publications arising from scientific collaboration in the therapeutic areas of cardiovascular disease, diabetes, uterine fibroids and SARS-CoV-2 virus. She led the statistical teams on the HERO COVID-19, ORBIT-AF I & II, ACTION-CMS, CHAMP-HF, and COMPARE-UF clinical registries and secondary analyses of the NAVIGATOR and ARISTOTLE clinical trials. She has served as a primary investigator and co-investigator on numerous methodological studies with funding from NIH, AHRQ, PCORI and Burroughs Wellcome Fund, addressing observational treatment comparisons, time-varying treatments, heterogeneity of treatment effects, and randomized trials augmented by synthetic controls from real world data.      

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