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)

Carrington, Melinda J., Ball, Jocasta, Horowitz, John D., Marwick, Thomas H., Mahadevan, Gnanadevan, Wong, Chiew, Abhayaratna, Walter P., Haluska, Brian, Thompson, David, Scuffham, Paul A. and Stewart, Simon (2013) 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). International Journal of Cardiology, 166 2: 359-365. doi:10.1016/j.ijcard.2011.10.065

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Author Carrington, Melinda J.
Ball, Jocasta
Horowitz, John D.
Marwick, Thomas H.
Mahadevan, Gnanadevan
Wong, Chiew
Abhayaratna, Walter P.
Haluska, Brian
Thompson, David
Scuffham, Paul A.
Stewart, Simon
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)
Journal name International Journal of Cardiology   Check publisher's open access policy
ISSN 0167-5273
1874-1754
Publication date 2013-06-20
Year available 2011
Sub-type Article (original research)
DOI 10.1016/j.ijcard.2011.10.065
Volume 166
Issue 2
Start page 359
End page 365
Total pages 7
Place of publication Shannon, Co. Clare, Ireland
Publisher Elsevier Ireland
Collection year 2013
Language eng
Formatted 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.
Keyword Anti-coagulation
Atrial fibrillation
Disease management
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online: 12 November 2011.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
 
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Created: Tue, 11 Dec 2012, 14:55:53 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work