Ref: NICE 2000/014 Issued: 11 May 2000

NICE has issued its guidance on the use of coronary artery stents in Ischaemic Heart Disease (IHD) to the NHS in England and Wales.

NICE recommends that

  • patients with angina or who have had a heart attack, who will be having a balloon angioplasty/ PCI should now normally receive a coronary artery stent.
  • if a patient is suitable for both a PCI and a coronary artery bypass graft (CABG), then it may be considered preferable for these patients to undergo a PCI with a coronary artery stent, instead of a CABG.

Andrew Dillon, (Chief Executive of NICE) said, "The Institute’s guidance is based on a very careful consideration of the evidence and I believe that all those involved in cardiac services in the NHS will welcome it. This guidance is good news for patients with IHD, wherever they live in England & Wales."

Professor Sir Michael Rawlins (Chair of NICE) said "We feel positive that our guidance on coronary artery stents will help those working in this area meet the targets set out in the National Service Framework on Coronary Heart Disease; in turn this will be of enormous benefit to patients who are currently waiting to be treated for what is a very disabling condition."

ENDS

Notes for Editors:
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1. Media copies of the full Guidance and patient notes are available from the website or NICE. Public copies are published on the web site (www.nice.org.uk) and also available from the numbers below (quote reference number 21511).
Tel:
Fax:
Post:
Email:		 0541 555 455
01623 724 524
PO Box 777 London SE1 6XH
doh@prologistics.co.uk
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2. NICE was asked to look at coronary artery stents in the treatment of ischaemic heart disease and provide guidance to the NHS, which will help surgeons and cardiologists decide when coronary artery stents should be used. The guidance issued today is the result of that work. NICE has recommended that :

•        For patients with either stable or unstable angina, or acute myocardial infarction  (MI) and where percutaneous coronary intervention (PCI) is the clinically appropriate procedure, stents should be used routinely.

•        Where it is considered clinically appropriate to undertake either PCI or coronary artery bypass grafting (CABG), the availability of stents should push the balance of clinical decision-making towards PCI. 

•        Arteries with a diameter less than 2.5mm and greater than 3.5 mm should only normally be stented in the setting of a so called ‘bail out’ procedure (i.e. when acute closure of the vessel occurs following PCI), or if there has been a sub-optimal result following ballooning alone or as part of properly conducted trials. These criteria do not apply to saphenous vein grafts (SVG). The Institute is aware that new evidence on stenting in arteries with a diameter less than 2.5 mm is likely to become available soon. If necessary, this guidance will be amended to take account of the fully reported results.

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This guidance does not mean that a patient whose condition (e.g. angina) is currently managed with medication should necessarily have a PCI.  Most patients who take medication to control their angina will continue to do so.  Patients should continue with their current course of treatment until advised otherwise by their doctor

3. The use of PCI, with or without Stents, should be limited to those units with a level of expertise that has been accredited using the standards set by the British Cardiac Society and the British Cardiovascular Intervention Society.

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4. Ischaemic heart disease (IHD) is the largest cause of heart disease; it affects the ability of patients and their families to lead a normal life and is responsible for about 120,000 deaths each year in the UK.
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  IHD is caused by the narrowing of blood vessels in the heart (the coronary arteries), which is known as stenosis. These narrowed blood vessels are often treated with drugs. However, drugs don’t always control the symptoms of the disease and the patient may need further treatment. Two types of treatment can be provided:

  • an operation known as coronary artery bypass grafting (CABG). This is where the surgeon re-routes the blood flow around the narrowed or blocked part of the blood vessel using a new blood vessel. This requires a major operation.
  • non-surgical widening from inside the blood vessel by using a tube with an inflatable balloon attached to it (this is known as balloon angioplasty, or percutaneous coronary intervention – PCI).  This is a minimally invasive procedure.
  • Following this treatment, the blood vessel can sometimes narrow again.  To prevent this re-narrowing a small tube-like device, known as a coronary artery stent, can be placed inside the blood vessel at the time of the widening procedure.

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6. PCI has become commonplace in patients suffering from symptoms associated with coronary artery disease, which includes both stable and unstable angina as well as acute myocardial infarction (MI). The rate of PCIs in the UK in 1998 was 437 per million population. The European Community average exceeds 800 per million population.
7. Stents, may have significant advantage in overcoming the problems that limit the full potential of balloon angioplasty. In 1998, stents were used on average in 69% of PCIs performed in the UK, ranging from under 40% to over 90%..
8. Initial use of stents was associated with the problems of acute thrombosis leading to the need for emergency CABG and in the longer term, in-stent stenosis, due to progressive reaction to the presence of a foreign body within the artery. Recent advances in stent technology have reduced these problems, as well as lowering the cost of stents. In addition the use of antiplatelet drugs and other therapeutic strategies to prevent thrombosis have improved long term outcome..
9. Each piece of NICE guidance has a review date –the guidance on coronary artery stents will be reviewed in April 2003. However there is further research underway in this area.  The results of this will be reviewed by NICE to decide if the guidance needs to be updated before this date.

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10. The guidance represents the view of the Institute’s Appraisal Committee, which was arrived at after careful consideration of the available evidence. Health professionals are expected to take it fully into account when exercising their clinical judgement about the circumstances in which it is appropriate to use coronary artery stents in the treatment of ischaemic heart disease. This guidance does not, however, override the individual responsibility of health professionals to make the appropriate decisions in the circumstances of the individual patient, in consultation with the patient and their guardian or carer.
11. National Service Frameworks (NSF’s) set national standards for specific services or care groups, and provide programmes for implementation and establish performance measures.  NSF’s are part of the government’s initiative to promote equality in healthcare and to ensure patients receive consistent care.  They are developed by a group of experts and address whole systems of care, incorporating social services, NHS Trusts and Health Authorities, voluntary groups and industry.  More information on NSF’s can be found on the Department of Health web site, at www.doh.gov.uk/nsf/coronary.htm.
12. The National Institute for Clinical Excellence was set up as a Special Health Authority on the 1st April 1999 and as such it is a part of the National Health Service (NHS).
13. There are three main strands to the work of the Institute: appraisals of health technologies, the development of clinical guidelines and the promotion of clinical audit.

 

14. Responsibility for selecting the guideline topics referred to the Institute rests with the Secretary of State for Health and the National Assembly for Wales

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