title: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II: rationale and design of the ORBIT-AF II registry.
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
  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.
authors: Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors: Benjamin A
authors: BA
authors: Steinberg
authors: Duke Clinical Research Institute, Durham, NC.
authors: Rosalia G
authors: RG
authors: Blanco
authors: Duke Clinical Research Institute, Durham, NC.
authors: Donna
authors: D
authors: Ollis
authors: Duke Clinical Research Institute, Durham, NC.
authors: Sunghee
authors: S
authors: Kim
authors: Duke Clinical Research Institute, Durham, NC.
authors: DaJuanicia N
authors: DN
authors: Holmes
authors: Lankenau Institute for Medical Research, Wynnewood, PA.
authors: Peter R
authors: PR
authors: Kowey
authors: UCLA Division of Cardiology, Los Angeles, CA.
authors: Gregg C
authors: GC
authors: Fonarow
authors: New York University School of Medicine, Lenox Hill Hospital, New York, NY.
authors: Jack
authors: J
authors: Ansell
authors: Mayo Clinic, Rochester, MN.
authors: Bernard
authors: B
authors: Gersh
authors: Kaiser Permanente, Oakland, CA.
authors: Alan S
authors: AS
authors: Go
authors: Boston University School of Medicine, Boston, MA.
authors: Elaine
authors: E
authors: Hylek
authors: Department of Medicine, Stanford University School of Medicine, Palo Alto, CA.
authors: Kenneth W
authors: KW
authors: Mahaffey
authors: Duke Clinical Research Institute, Durham, NC.
authors: Laine
authors: L
authors: Thomas
authors: Janssen Scientific Affairs, Raritan, NJ.
authors: Paul
authors: P
authors: Chang
authors: Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors: Eric D
authors: ED
authors: Peterson
authors: Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: jonathan.piccini@duke.edu.
authors: Jonathan P
authors: JP
authors: Piccini
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy*; D065427:Factor Xa Inhibitors; D006801:Humans; D064887:Observational Studies as Topic; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012042:Registries; D020257:Ventricular Remodeling
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D065427:Factor Xa Inhibitors