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.
RCT Entities:
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.
Authors: Nathan E K Procter; Jocasta Ball; Doan T M Ngo; Yuliy Y Chirkov; Jeffrey S Isenberg; Elaine M Hylek; Simon Stewart; John D Horowitz Journal: Herz Date: 2015-07-02 Impact factor: 1.443
Authors: Nathan Ek Procter; Jocasta Ball; Tamila Heresztyn; Vivek B Nooney; Saifei Liu; Cher-Rin Chong; Doan Tm Ngo; Jeffrey S Isenberg; Yuliy Y Chirkov; Simon Stewart; John D Horowitz Journal: Am J Cardiovasc Dis Date: 2015-08-01
Authors: Nathan Ek Procter; Jocasta Ball; Doan Tm Ngo; Jeffrey S Isenberg; Elaine M Hylek; Yuliy Y Chirkov; Simon Stewart; John D Horowitz Journal: J Geriatr Cardiol Date: 2016-03 Impact factor: 3.327
Authors: Adam D DeVore; Anne S Hellkamp; Richard C Becker; Scott D Berkowitz; Guenter Breithardt; Werner Hacke; Jonathan L Halperin; Graeme J Hankey; Kenneth W Mahaffey; Christopher C Nessel; Daniel E Singer; Keith A A Fox; Manesh R Patel; Jonathan P Piccini Journal: Europace Date: 2016-05-12 Impact factor: 5.214