Benjamin A Steinberg1, Rosalia G Blanco2, Donna Ollis2, Sunghee Kim2, DaJuanicia N Holmes2, Peter R Kowey3, Gregg C Fonarow4, Jack Ansell5, Bernard Gersh6, Alan S Go7, Elaine Hylek8, Kenneth W Mahaffey9, Laine Thomas2, Paul Chang10, Eric D Peterson1, Jonathan P Piccini11. 1. Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. 2. Duke Clinical Research Institute, Durham, NC. 3. Lankenau Institute for Medical Research, Wynnewood, PA. 4. UCLA Division of Cardiology, Los Angeles, CA. 5. New York University School of Medicine, Lenox Hill Hospital, New York, NY. 6. Mayo Clinic, Rochester, MN. 7. Kaiser Permanente, Oakland, CA. 8. Boston University School of Medicine, Boston, MA. 9. Department of Medicine, Stanford University School of Medicine, Palo Alto, CA. 10. Janssen Scientific Affairs, Raritan, NJ. 11. Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: jonathan.piccini@duke.edu.
Abstract
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.
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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