title: Navigating the fine line between benefit and risk in chronic atrial fibrillation: rationale and design of the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY).
abstract: BACKGROUND
  Health outcomes associated with atrial fibrillation (AF) continue to be poor and standard management often does not provide clinical stability. The Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY) compares the efficacy of a post-discharge, nurse-led, multi-disciplinary programme to optimise AF management with usual care.
  
  
  METHODS
  SAFETY is a prospective, multi-centre, randomised controlled trial with blinded-endpoint adjudication. A target of 320 hospitalised patients with a chronic form of AF will be randomised (stratified by "rate" versus "rhythm" control) to usual post-discharge care or the SAFETY Intervention (SI). The SI involves home-based assessment, extensive clinical profiling and the application of optimal gold-standard pharmacology which is individually tailored according to a "traffic light" framework based on clinical stability, risk profile and therapeutic management. The primary endpoint is event-free survival from all-cause death or unplanned readmission during 18-36 months follow-up. Secondary endpoints include rate of recurrent hospital stay, treatment success (i.e. maintenance of rhythm or rate control and/or application of anti-thrombotic therapy without a bleeding event) and cost-efficacy.
  
  
  RESULTS
  With study recruitment to be completed in early 2012, the results of this study will be available in early 2014.
  
  
  CONCLUSIONS
  If positive, SAFETY will represent a potentially cost-effective and readily applicable strategy to improve health outcomes in high risk individuals discharged from hospital with chronic AF.
authors.affiliation: Preventative Health, Baker IDI Heart and Diabetes Institute, Melbourne, Australia.
authors.forename: Melinda J
authors.initials: MJ
authors.lastname: Carrington
authors.forename: Jocasta
authors.initials: J
authors.lastname: Ball
authors.forename: John D
authors.initials: JD
authors.lastname: Horowitz
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Marwick
authors.forename: Gnanadevan
authors.initials: G
authors.lastname: Mahadevan
authors.forename: Chiew
authors.initials: C
authors.lastname: Wong
authors.forename: Walter P
authors.initials: WP
authors.lastname: Abhayaratna
authors.forename: Brian
authors.initials: B
authors.lastname: Haluska
authors.forename: David R
authors.initials: DR
authors.lastname: Thompson
authors.forename: Paul A
authors.initials: PA
authors.lastname: Scuffham
authors.forename: Simon
authors.initials: S
authors.lastname: Stewart
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D002908:Chronic Disease; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment