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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)

    Author(s)
    Carrington, Melinda J
    Ball, Jocasta
    Horowitz, John D
    Marwick, Thomas H
    Mahadevan, Gnanadevan
    Wong, Chiew
    Abhayaratna, Walter P
    Haluska, Brian
    Thompson, David R
    Scuffham, Paul A
    Stewart, Simon
    Griffith University Author(s)
    Scuffham, Paul A.
    Year published
    2013
    Metadata
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    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 ...
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    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.
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    Journal Title
    International Journal of Cardiology
    Volume
    166
    Issue
    2
    DOI
    https://doi.org/10.1016/j.ijcard.2011.10.065
    Subject
    Cardiovascular medicine and haematology
    Cardiovascular medicine and haematology not elsewhere classified
    Publication URI
    http://hdl.handle.net/10072/45397
    Collection
    • Journal articles

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