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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)

Citation

Carrington, MJ and Ball, J and Horowitz, JD and Marwick, TH and Mahadevan, G and Wong, C and Abhayaratna, WP and Haluska, B and Thompson, DR and Scuffham, PA and Stewart, S, 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) pp. 359-365. ISSN 0167-5273 (2013) [Refereed Article]

DOI: doi:10.1016/j.ijcard.2011.10.065

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.

Item Details

Item Type:Refereed Article
Keywords:Atrial fibrillation; Disease management; Anti-coagulation
Research Division:Medical and Health Sciences
Research Group:Cardiorespiratory Medicine and Haematology
Research Field:Cardiology (incl. Cardiovascular Diseases)
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Cardiovascular System and Diseases
Author:Marwick, TH (Professor Tom Marwick)
ID Code:87838
Year Published:2013
Web of Science® Times Cited:15
Deposited By:Menzies Institute for Medical Research
Deposited On:2013-12-10
Last Modified:2014-12-17
Downloads:0

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