Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF).

Abstract

BACKGROUND: Temporary interruption of oral anticoagulation for procedures is often required, and some propose using bridging anticoagulation. However, the use and outcomes of bridging during oral anticoagulation interruptions in clinical practice are unknown. METHODS AND RESULTS: The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry is a prospective, observational registry study of US outpatients with atrial fibrillation. We recorded incident temporary interruptions of oral anticoagulation for a procedure, including the use and type of bridging therapy. Outcomes included multivariable-adjusted rates of myocardial infarction, stroke or systemic embolism, major bleeding, cause-specific hospitalization, and death within 30 days. Of 7372 patients treated with oral anticoagulation, 2803 overall interruption events occurred in 2200 patients (30%) at a median follow-up of 2 years. Bridging anticoagulants were used in 24% (n=665), predominantly low-molecular-weight heparin (73%, n=487) and unfractionated heparin (15%, n=97). Bridged patients were more likely to have had prior cerebrovascular events (22% versus 15%; P=0.0003) and mechanical valve replacements (9.6% versus 2.4%; P<0.0001); however, there was no difference in CHA2DS2-VASc scores (scores ≥ 2 in 94% versus 95%; P=0.5). Bleeding events were more common in bridged than nonbridged patients (5.0% versus 1.3%; adjusted odds ratio, 3.84; P<0.0001). The incidence of myocardial infarction, stroke or systemic embolism, major bleeding, hospitalization, or death within 30 days was also significantly higher in patients receiving bridging (13% versus 6.3%; adjusted odds ratio, 1.94; P=0.0001). CONCLUSIONS: Bridging anticoagulation is used in one quarter of anticoagulation interruptions and is associated with higher risk for bleeding and adverse events. These data do not support the use of routine bridging, and additional data are needed to identify best practices concerning anticoagulation interruptions. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01165710.

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Published Version (Please cite this version)

10.1161/CIRCULATIONAHA.114.011777

Publication Info

Steinberg, Benjamin A, Eric D Peterson, Sunghee Kim, Laine Thomas, Bernard J Gersh, Gregg C Fonarow, Peter R Kowey, Kenneth W Mahaffey, et al. (2015). Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation, 131(5). pp. 488–494. 10.1161/CIRCULATIONAHA.114.011777 Retrieved from https://hdl.handle.net/10161/15007.

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Scholars@Duke

Thomas

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.      

Sherwood

Matthew William Sherwood

Adjunct Assistant Professor in the Department of Medicine

I am striving to become a clinical and research leader in structural heart disease and complex coronary disease, specifically in the use of antithrombotic agents after structural heart interventions.  I will also explore the significance of bleeding/vascular complications and stroke in these patients as well as potential therapies such as transfusion, and embolic protection devices.

Piccini

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.


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