Trial DesignOutcomes registry for better informed treatment of atrial fibrillation II: Rationale and design of the ORBIT-AF II registry
Section snippets
Registry objectives
The objectives of the ORBIT-AF II registry are as follows: (1) to evaluate the safety of non–vitamin K oral anticoagulants, including factor Xa inhibitors and direct thrombin inhibitors, in outpatients with AF; (2) to evaluate clinical outcomes in patients with AF treated with non–vitamin K oral anticoagulants; (3) to describe the management of patients with AF undergoing cardiac procedures and their outcomes; (4) to describe AF patient characteristics, with specific attention to the use of
Design
The ORBIT-AF II registry will be a prospective, observational study of outpatients with AF, followed up every 6 months to 2 years. By design, it will have a specific and unique focus on enrollment of patients with new-onset AF and those newly transitioned to non–vitamin K oral anticoagulants.
Oversight and leadership
The protocol of the ORBIT-AF II registry has been approved by the Duke University Institutional Review Board. In addition, enrollment centers will obtain site-specific institutional review board approval pursuant to local regulations. All patients will be required to sign written, informed consent prior to collection of any study data. The ORBIT-AF II registry is led by independent executive and steering committees comprising electrophysiologists, cardiologists, anticoagulation specialists, and
Initial ORBIT-AF II patient recruitment
Characteristics of the initial 1,000 patients enrolled in ORBIT-AF II, compared with other contemporary AF registries, as well as controlled trials, are shown in Table III. This population is very similar to ORBIT-AF, phase I: 40% of the patients are women, and cardiovascular disease and risk factors are common. Consistently, patients studied are in their 70s and at significant risk for stroke or systemic embolism (as assessed by CHADS2 scores).
Discussion
The ORBIT-AF II study will function as a postmarket surveillance study after the transition from clinical practice with a single available anticoagulant (ie, warfarin) to the era of widely available non–vitamin K, or target-specific, oral anticoagulants. This transition follows on the recent completion of several “mega-trials” of both direct thrombin and factor Xa inhibitors.6, 7, 8, 9, 10 These large, phase III trials were conducted to demonstrate safety and efficacy in specific populations,
Limitations
The ORBIT-AF II registry is designed as a large, prospective, observational, clinical study in an effort to address specific questions regarding the care of patients with AF in community practice. However, there are specific limitations inherent in such methods. Primarily, there is no random assignment of patients to any treatments, and thus, comparisons among groups will be limited by residual and unmeasured bias. They could provide descriptive and hypotheses-generating observations. Second,
Conclusions
The ORBIT-AF II registry will fill a significant gap in the dynamic landscape of AF care and research. It will provide unique and necessary data on the management and outcomes of outpatients treated with emerging therapies and, combined with ORBIT-AF I, will yield the largest, contemporary longitudinal cohort of patients with AF in the United States.
Disclosures
The ORBIT-AF II registry is sponsored by Janssen Scientific Affairs, LLC, Raritan, NJ. Dr Steinberg was funded by National Institutes of Health T-32 Training Grant No. 5 T32 HL 7101-38.
The following relationships related to this manuscript exist: B.S., R.B., D.O., S.K., D.H., A.G., and L.T. report no disclosures. Dr Kowey reports modest consultant/advisory board support from Boehringer Ingelheim, Bristol-Myers Squibb, Johnson & Johnson, Portola, Merck, Sanofi, and Daiichi Sankyo. Dr Fonarow
References (36)
- et al.
Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF
Am Heart J
(2011) - et al.
Use of evidence-based cardiac prevention therapy among outpatients with atrial fibrillation
Am J Med
(2013) - et al.
Rate versus rhythm control for management of atrial fibrillation in clinical practice: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry
Am Heart J
(2013) - et al.
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
J Thromb Haemost
(2005) - et al.
Linking inpatient clinical registry data to Medicare claims data using indirect identifiers
Am Heart J
(2009) - et al.
Relationships between emerging measures of heart failure processes of care and clinical outcomes
Am Heart J
(2010) - et al.
Evaluation of paradoxic beneficial effects of smoking in patients receiving thrombolytic therapy for acute myocardial infarction: mechanism of the “smoker's paradox” from the GUSTO-I trial, with angiographic insights. Global Utilization of Streptokinase and Tissue-Plasminogen Activator for Occluded Coronary Arteries
J Am Coll Cardiol
(1995) - et al.
Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation
J Am Coll Cardiol
(2012) - et al.
Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry
J Am Coll Cardiol
(2012) - et al.
Feasibility & safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry
J Am Coll Cardiol
(2014)
Efficacy and safety of dabigatran etexilate and warfarin in “real-world” patients with atrial fibrillation: a prospective nationwide cohort study
J Am Coll Cardiol
Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation
Am Heart J
Cardiac performance measure compliance in outpatients: the American College of Cardiology and National Cardiovascular Data Registry's PINNACLE (Practice Innovation And Clinical Excellence) program
J Am Coll Cardiol
Impact of atrial fibrillation on mortality, stroke, and medical costs
Arch Intern Med
Atrial fibrillation as an independent risk factor for stroke: the Framingham Study
Stroke
Preventing stroke in patients with atrial fibrillation
JAMA
Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis
Ann Intern Med
Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation
Ann Intern Med
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2022, Heart Rhythm O2Citation Excerpt :All subjects provided written, informed consent. Patient data collection has been previously described in depth and utilized a case report form that included an extensive list of patient demographics, comorbidities, and medications.8,9 All events were patient reported via questionnaire.
Residual stroke risk in atrial fibrillation: Our patients must be our partners
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2022, American Heart JournalCitation Excerpt :First, we used data from The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II), an outpatient registry that enrolled patients aged 21 years or older with ECG-confirmed AF that was not due to a reversible cause. The rationale and design of this study has been previously reported in detail.6 As part of the case report form for ORBIT-AF, enrolling sites were queried as to the availability of AECGs for patients (primarily Holter monitor tests).
William G. Stevenson, MD, served as guest editor for this article.
ClinicalTrials.gov NCT01701817