The Centre of Research Excellence (CRE) to Reduce Inequality in Heart Disease focuses on improving the heart health and outcomes of groups and communities i.e. Regional Australians, Indigenous Australians and International Health

SAFETY

Research Stream: Older individuals with chronic heart Ddsease

 

SAFETY (Standard versus Atrial Fibrillation-spEcific managemenT studY) is a secondary prevention, multi-centre randomised controlled trial that aims to optimise the management of patients with atrial fibrillation (AF) by improving delineation of individual risk factors over and above conventional risk profiling, led by the Baker IDI. In collaboration with Co-Investigators from the University of Adelaide, University of Queensland, Griffith University, Menzies Research Institute (Tasmania), Australian National University and Australian Catholic University, we will utilise the outcomes of this profiling in combination with an AF-specific disease management program (DMP) involving advanced echocardiographic imaging, Holter monitoring and advanced platelet and endothelial function studies to direct and optimise the health status of a cohort of AF patients who have been hospitalised as a result of AF.

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Full Study Title

Standard versus Atrial Fibrillation-spEcific managemenT studY (SAFETY).

 

Trial Registration

Australian New Zealand Clinical Trials Registry number: 12610000221055 (http://www.anzctr.org.au).

 

Funding Source

SAFETY is supported by a National Health and Medical Research Council (NHMRC) Program Grant (519823) awarded to the project investigators from 2009 to 2014.

 

Rationale for the Study

Chronic AF is the most common sustained cardiac arrhythmia observed in medical practice and one of the most common cardiovascular disorders overall. The most serious consequences of AF are stroke and heart failure. Recent studies have suggested that both the primary care and hospital burden attributable to AF is increasing in parallel with ageing populations in the developed world, with cases expected to double by the year 2050. In addition, key pathways to AF (e.g. advancing age, hypertension, obesity etc) are also reaching historically high levels, further contributing to increases in prevalence. Health outcomes associated with AF continue to be sub-optimal within the context of predominantly older patients who require complex therapeutic regimes and for whom blanket management often does not provide clinical stability. AF has a significant impact on morbidity, mortality and quality of life and exerts an evolving public health, social and economic burden worldwide.

 

Study Aims

To improve the delineation of underlying risk of thrombo-embolic events, progressive cardiac dysfunction and poorly controlled clinical status via enhanced evaluation of haemodynamic risk, embolic risk and psychosocial adaptation to pharmacological/non-pharmacological management. Additionally, the aim is also to create a more individualised approach to managing AF patients by minimising a patient’s risk of thrombo-embolic events coupled with minimising the risk of bleeding events, maximising cardio-protection to optimise and maintain underlying cardiac structure and function and minimising AF-related symptoms and clinical instability.

 

Study Design

SAFETY is a multi-centre, randomised controlled trial of a nurse-led, AF-specific management intervention compared to usual post-discharge care. Participants included were those >45 years of age with documented chronic AF which was the cause of at least one hospitalisation. Patients scheduled for ablation, with valvular disease or pre-existing chronic heart failure (NYHA Class III-IV with a left ventricular ejection fraction were excluded.

 

Primary Outcomes

The composite primary endpoint of SAFETY is event-free survival from all-cause death or unplanned re-hospitalisation during 18 to 36 months follow-up. This endpoint will be examined with respect to both the absolute number and timing of events and “days out of hospital alive”. Additional endpoints are: cardiovascular related morbidity and mortality, duration and rate of hospital stay; all-cause hospital stay; cost of health care; change in health-related quality of life and function; changes in left ventricular systolic and diastolic function; and failure to maintain treatment targets.

 

You can view the 'Statistical Analysis Plan' here.

 

Study Conclusions & Translational Potential

SAFETY will conclude in March 2014 with the completion of all 24-month follow-up clinic visits. Given that the prevalence of AF is increasing exponentially, SAFETY has the potential to deliver significant clinical benefits from an individual to a health care system perspective. The innovative integration of risk delineation, management, a community-based trial and reporting of cost-effectiveness will make a substantial contribution to new knowledge of AF-specific disease management at an international level.

 

Ongoing Research

There is significant potential for the findings of SAFETY to direct future research into optimal disease management of patients with AF and for further improving or enhancing risk delineation strategies.

 

For a copy of our study booklet "Living with Atrial Fibrillation" please click here.

 

Key Collaborators

  • Professor Simon Stewart: Australian Catholic University, Australia
  • Professor Paul Scuffham:Griffith University, Population and Social Health Research Unit
  • Professor Thomas Marwick: Director, Menzies Research Institute, Tasmania
  • Professor John Horowitz: The University of Adelaide
  • Professor David Thompson: Australian Catholic University, Cardiovascular Research Centre
  • Associate Professor Melinda Carrington: Australian Catholic University, Australia
  • Dr Brian Haluska:The University of Queensland
  • Associate Professor Chiew Wong: Western Hospital, Cardiology Unit
  • Professor Walter Abhayaratna: Australian National University, Clinical Trials Unit Canberra Hospital
  • Dr Gnanadevan Mahadevan: The Queen Elizabeth Hospital

 

Study Publications

  1. Stewart S., Ball J, Horowitz JD, Marwick TH, Mahadevan G, Wong C, Abhayaratna WP, Chan, YK, Esterman, A, Thompson DR, Scuffham PA, Carrington MJ. Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial. Lancet, 2015. 385(9970): p. 775-84.

  2. Carrington MJ, Ball J, Horowitz JD, Marwick TH, Mahadevan G, Wong C, Abhayaratna WP, Haluska B, Thompson DR, Scuffham PA, 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). Int J Cardiol 2013; 166: 359-65.
  3. Ball J, Carrington MJ, Stewart S. Reply: diagnosing vascular mild cognitive impairment with atrial fibrillation remains a challenge. Heart 2013; 99: 819-20.
  4. Ball J, Carrington MJ, Wood KA, Stewart S. Women versus men with chronic atrial fibrillation: insights from the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY). PLoS ONE 2013; 8: e65795.
  5. Ball J, Carrington MJ, Stewart S. A new or old solution to an old problem? Eur Heart J 2013; E-letter: published online 11 April, 2013.
  6. Ball J, Carrington MJ, Stewart S. Mild cognitive impairment in high-risk patients with chronic atrial fibrillation: a forgotten component of clinical management? Heart 2013; 99: 542-7.
  7. Ball J, Carrington MJ, McMurray JJV, Stewart S. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Cardiol 2013; [E-pub ahead of print] PMID 167:1807-24