Outcomes registry for better informed treatment of atrial fibrillation II: Rationale and design of the ORBIT-AF II registry - 25/07/14

Doi : 10.1016/j.ahj.2014.04.005

Benjamin A. Steinberg, MD, MHS ^a,^b, Rosalia G. Blanco, MBA ^b, Donna Ollis, MS ^b, Sunghee Kim, PhD ^b, DaJuanicia N. Holmes, MS ^b, Peter R. Kowey, MD ^c, Gregg C. Fonarow, MD ^d, Jack Ansell, MD ^e, Bernard Gersh, MB, ChB, DPhil ^f, Alan S. Go, MD ^g, Elaine Hylek, MD, MPH ^h, Kenneth W. Mahaffey, MD ⁱ, Laine Thomas, PhD ^b, Paul Chang, MD ^j, Eric D. Peterson, MD, MPH ^a,^b, Jonathan P. Piccini, MD, MHS ^a,^b,^{^⁎}
on behalf of the
ORBIT-AF Steering Committee Investigators
^a Duke University Medical Center, Durham, NC
^b Duke Clinical Research Institute, Durham, NC
^c Lankenau Institute for Medical Research, Wynnewood, PA
^d UCLA Division of Cardiology, Los Angeles, CA
^e New York University School of Medicine, Lenox Hill Hospital, New York, NY
^f Mayo Clinic, Rochester, MN
^g Kaiser Permanente, Oakland, CA
^h Boston University School of Medicine, Boston, MA
ⁱ Department of Medicine, Stanford University School of Medicine, Palo Alto, CA
^j Janssen Scientific Affairs, Raritan, NJ

^⁎Reprint requests: Jonathan Piccini, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27710.

Riassunto

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.

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Registry objectives

Design

Site selection

Patient enrollment criteria

Sample size and anticoagulation strategy

Registry organization

Oversight and leadership

Study sponsorship

Timeline

Reporting of potential severe adverse events

Initial ORBIT-AF II patient recruitment

	William G. Stevenson, MD, served as guest editor for this article.
	ClinicalTrials.gov NCT01701817

Esportazione

Vol 168 - N° 2

P. 160-167 - Agosto 2014 Ritorno al numero

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Outcomes registry for better informed treatment of atrial fibrillation II: Rationale and design of the ORBIT-AF II registry - 25/07/14

Riassunto

Background

Methods/Design

Conclusions

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