Elsevier

American Heart Journal

Volume 168, Issue 2, August 2014, Pages 160-167
American Heart Journal

Trial Design
Outcomes registry for better informed treatment of atrial fibrillation II: Rationale and design of the ORBIT-AF II registry

https://doi.org/10.1016/j.ahj.2014.04.005Get rights and content

Background

Recent clinical trials have demonstrated the safety and efficacy of several non–vitamin K oral anticoagulants (NOACs) for the treatment of atrial fibrillation (AF). However, there are limited data on their use and outcomes in routine clinical practice, particularly among patients newly diagnosed as having AF and patients with AF recently transitioned to a NOAC.

Methods/Design

ORBIT-AF II is a multicenter, national registry of patients with AF that is enrolling up to 15,000 newly diagnosed patients with AF and/or those with AF recently transitioned to a NOAC from 300 US outpatient practices. These patients will be followed for up to 2 years, including clinical status, outcomes (major adverse cardiovascular events, bleeding), and management of anticoagulation surrounding bleeding events. In addition, detailed data regarding the use of these agents in and around cardiac procedures, their complications, and management of such complications will be collected.

Conclusions

The ORBIT-AF II registry will provide valuable insights into the safety and effectiveness of NOACs used in AF in community practice settings.

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

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