EASY-AS: A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis
Principal Investigators: Professor Gerry McCann and Professor Graham Hillis
Aortic stenosis (AS) is a common life-threatening condition in which one of the four heart valves becomes narrowed over many years. Symptoms can include shortness of breath and chest pain, but these can take years to develop and some patients never develop symptoms at all. Patients who do have symptoms can have the valve replaced. This works really well, but as with any intervention, there is the chance of complications, and it often takes a long time to recover from.
Major heart surgery is a very good treatment for patients with symptoms but can cause complications and is often associated with prolonged recovery. The dilemma is therefore: should we operate in everyone when the AS is severe to avoid the risk of heart failure and death or wait until symptoms develop so that patients are spared unnecessary major surgery?
This multi-site international study (including sites in the UK, Australia and New Zealand) is investigating whether it is better for patients in the long run to have the aortic valve replacement (AVR) straight away, or to wait until the symptoms develop before this is done. The results will also tell us which is more cost effective for the NHS and will therefore directly impact on the management of tens of thousands of patients in the UK and hundreds of thousands worldwide.
The study design is a pragmatic, multi-centre, prospective, parallel group, open randomised controlled trial (RCT). We will randomise 2844 participants to either immediate aortic valve surgery or to continue monitoring with replacement of the narrowed valve only when symptoms develop. Participants must be over 18 years of age, have severe asymptomatic AS, be regarded by the treating cardiologist to be suitable for AVR, and willing to provide informed consent and be randomised. Apart from the possibility of receiving AVR before symptoms develop, everything about the surgery and the participants’ treatment will happen using standard models of care.
For more information about the EASY-AS study, please contact the central co-ordinating team via phone on 0116 229 7243 / 0116 229 7936 or email firstname.lastname@example.org
EASY-AS is funded by the British Heart Foundation (UK), Australian Government Medical Research Future Fund (Australia), Heart Foundation (New Zealand) and sponsored by the University of Leicester (UK), University of Western Australia (Australia) and University of Auckland (New Zealand)