title: Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial.
abstract: BACKGROUND
  Patients are increasingly being admitted with chronic atrial fibrillation, and disease-specific management might reduce recurrent admissions and prolong survival. However, evidence is scant to support the application of this therapeutic approach. We aimed to assess SAFETY--a management strategy that is specific to atrial fibrillation.
  
  
  METHODS
  We did a pragmatic, multicentre, randomised controlled trial in patients admitted with chronic, non-valvular atrial fibrillation (but not heart failure). Patients were recruited from three tertiary referral hospitals in Australia. 335 participants were randomly assigned by computer-generated schedule (stratified for rhythm or rate control) to either standard management (n=167) or the SAFETY intervention (n=168). Standard management consisted of routine primary care and hospital outpatient follow-up. The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed. Clinical reviews were undertaken at 12 and 24 months (minimum follow-up). Coprimary outcomes were death or unplanned readmission (both all-cause), measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital. Analyses were done on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN 12610000221055).
  
  
  RESULTS
  During median follow-up of 905 days (IQR 773-1050), 49 people died and 987 unplanned admissions were recorded (totalling 5530 days in hospital). 127 (76%) patients assigned to the SAFETY intervention died or had an unplanned readmission (median event-free survival 183 days [IQR 116-409]) and 137 (82%) people allocated standard management achieved a coprimary outcome (199 days [116-249]; hazard ratio 0·97, 95% CI 0·76-1·23; p=0·851). Patients assigned to the SAFETY intervention had 99·5% maximum event-free days (95% CI 99·3-99·7), equating to a median of 900 (IQR 767-1025) of 937 maximum days alive and out of hospital. By comparison, those allocated to standard management had 99·2% (95% CI 98·8-99·4) maximum event-free days, equating to a median of 860 (IQR 752-1047) of 937 maximum days alive and out of hospital (effect size 0·22, 95% CI 0·21-0·23; p=0·039).
  
  
  CONCLUSIONS
  A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital (but not prolonged event-free survival) relative to standard management. Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation.
  
  
  BACKGROUND
  National Health and Medical Research Council of Australia.
authors.affiliation: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. Electronic address: simon.stewart@acu.edu.au.
authors.forename: Simon
authors.initials: S
authors.lastname: Stewart
authors.affiliation: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.
authors.forename: Jocasta
authors.initials: J
authors.lastname: Ball
authors.affiliation: The Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia.
authors.forename: John D
authors.initials: JD
authors.lastname: Horowitz
authors.affiliation: Menzies Research Institute Tasmania, Hobart, TAS, Australia.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Marwick
authors.affiliation: The Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia.
authors.forename: Gnanadevan
authors.initials: G
authors.lastname: Mahadevan
authors.affiliation: Department of Cardiology, Footscray Hospital, Melbourne, VIC, Australia.
authors.forename: Chiew
authors.initials: C
authors.lastname: Wong
authors.affiliation: Division of Medicine, Canberra Hospital and Australian National University, Canberra, ACT, Australia.
authors.forename: Walter P
authors.initials: WP
authors.lastname: Abhayaratna
authors.affiliation: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.
authors.forename: Yih K
authors.initials: YK
authors.lastname: Chan
authors.affiliation: Division of Health Sciences, University of South Australia, Adelaide, SA, Australia.
authors.forename: Adrian
authors.initials: A
authors.lastname: Esterman
authors.affiliation: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.
authors.forename: David R
authors.initials: DR
authors.lastname: Thompson
authors.affiliation: Centre for Applied Health Economics, Griffith University, Brisbane, QLD, Australia.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Scuffham
authors.affiliation: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.
authors.forename: Melinda J
authors.initials: MJ
authors.lastname: Carrington
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000401:mortality / Q000451:nursing*; D002908:Chronic Disease; D015716:Electrocardiography, Ambulatory / Q000401:mortality; D005260:Female; D006699:Home Care Services; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D010348:Patient Care Team / Q000458:organization & administration; D010359:Patient Readmission / Q000706:statistics & numerical data; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D055502:Secondary Prevention / Q000379:methods; D016896:Treatment Outcome