Trial DesignOutcomes registry for better informed treatment of atrial fibrillation: Rationale and design of ORBIT-AF
Section snippets
Registry objectives
The ORBIT-AF registry has 5 main objectives: (1) characterize and describe a large representative AF population in the United States, including demographics, comorbidities, and risk profiles; (2) define current practice patterns for the treatment of patients with AF, particularly stroke prevention therapies; (3) identify how patterns of care and subsequent outcomes vary by risk stratification (ie, low risk vs high risk), including existing and novel risk prediction schema; (4) assess adherence
Initial enrolling site characteristics
Given the adaptive design of the registry, the composition of the enrolling sites is continuously monitored to ensure adequate provider, demographic, and geographic diversity and representativeness. Across the United States, 161 of 181 active sites enrolled the first 7,294 patients: 58 (36%) primary care and internal medicine clinics, 86 (53%) cardiology clinics, and 17 (11%) electrophysiology clinics. At the time of this writing, 181 sites were IRB approved and activated to enroll patients. As
Discussion
The Institute of Medicine has identified the management of AF as a top priority for comparative effectiveness research.25 Atrial fibrillation increases the risk of stroke, cognitive impairment, and disability. Despite the presence of effective pharmacologic therapy for the prevention of stroke, anticoagulation prophylaxis in patients with AF is underused.26 Because many patients with AF do not receive anticoagulation therapy or discontinue therapy within 1 year,27 a key goal of ORBIT-AF will be
Conclusions
Although recent advances in the treatment of AF show promise for improved outcomes, no data exist to show how the results of these trials have influenced or will influence clinical practice. Prior studies have suggested that the application of evidence-based therapies remains suboptimal in patients with AF. The ORBIT-AF registry will examine current practice patterns, quality of care, and associated outcomes in the management of AF. These data will inform comparative effectiveness, comparative
Disclosures
The ORBIT-AF registry is sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ.
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Jeanne E. Poole, MD served as guest editor for this article.
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On behalf of the ORBIT-AF Steering Committee and Investigators.