• Melinda J. Carrington Melinda J. Carrington
  • Jocasta Ball Jocasta Ball
  • John D. Horowitz John D. Horowitz
  • Thomas H. Marwick Thomas H. Marwick
  • Gnanadevan Mahadevan Gnanadevan Mahadevan
  • Chiew Wong Chiew Wong
  • Walter P. Abhayaratna Walter P. Abhayaratna
  • Brian Haluska Brian Haluska
  • David R. Thompson David R. Thompson
  • Paul Scuffham Paul Scuffham
  • Simon Stewart Simon Stewart

Background Health outcomes associated with atrial fibrillation (AF) continue to be poor and standard magement often does not provide clinical stability. The Standard versus Atrial Fibrillation spEcific magemenT studY (SAFETY) compares the efficacy of a post-discharge, nurse-led, multi-discipliry programme to optimise AF magement 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 magement. 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. maintence 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.