Format

Send to

Choose Destination
Lancet. 2015 Feb 28;385(9970):775-84. doi: 10.1016/S0140-6736(14)61992-9. Epub 2014 Nov 17.

Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial.

Author information

1
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.
2
Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.
3
The Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia.
4
Menzies Research Institute Tasmania, Hobart, TAS, Australia.
5
Department of Cardiology, Footscray Hospital, Melbourne, VIC, Australia.
6
Division of Medicine, Canberra Hospital and Australian National University, Canberra, ACT, Australia.
7
Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.
8
Division of Health Sciences, University of South Australia, Adelaide, SA, Australia.
9
Centre for Applied Health Economics, Griffith University, Brisbane, QLD, Australia.

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).

FINDINGS:

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).

INTERPRETATION:

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.

FUNDING:

National Health and Medical Research Council of Australia.

PMID:
25467562
DOI:
10.1016/S0140-6736(14)61992-9
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center