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News Release
Embargoed until: 10.00pm BST, Wednesday 19th May 2004

New hope for UK heart failure patients

A cardiac device could reduce the risk of death by up to 36 percent1 for many of the estimated 900,000 people living with heart failure in the UK2, according to the results of a landmark trial published today in the New England Journal of Medicine (NEJM).

The COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure) Trial, sponsored solely by an independent research grant from Guidant, is the first to evaluate whether cardiac resynchronisation therapy (CRT) devices reduce mortality or first hospitalisation in advanced heart failure patients.

The results demonstrate that CRT devices - implanted under the skin much like conventional pacemakers - used in combination with optimal drug therapy can significantly improve treatment outcomes in advanced heart failure patients.

Dr Michael Bristow, lead COMPANION Trial investigator, University of Colorado Health Sciences Center, US said: “Heart failure is a major public health problem in all industrialised countries. Despite improvements in drug therapy, heart failure continues to be a disease with high rates of hospitalisation and mortality, and poor patient quality of life.

“The results of COMPANION indicate that a substantial group of patients with advanced heart failure receive major benefit from CRT. These devices allow very ill, compromised patients not only to feel better and be more active, which was known previously, but to avoid hospital and live longer. COMPANION Trial results are fundamental because they demonstrate for the first time the significant improvement in patient outcome achieved with CRT, which is over and above and incremental to optimal drug therapy.”

Cardiac Resynchronisation Therapy (CRT) in the UK
The UK has been slow to adopt CRT compared to other countries. In 2003, around 11 devices were implanted in the UK per million of the population compared to 29 in Italy.3 Health economic studies reveal that CRT could potentially save the National Health Service (NHS) money.4-6 One study estimates cost savings could be up to £15 million per year due to reductions in patient management costs, hospitalisations and length of hospital stay.6

Professor John Camm, Professor of Clinical Cardiology, St. George’s Hospital Medical School, London, UK said: “The COMPANION Trial results clearly demonstrate that CRT has the potential to bring about very substantial health and economic benefits to patients and the NHS. However, the UK lags behind other countries in widely adopting this therapy. Clearly, it has an important role to play in the management of heart failure. Steps need to be taken to ensure better and more widespread use of this technology.”

About the COMPANION Trial:
The COMPANION Trial compared patients treated with CRT devices (with or without defibrillator back up) plus optimal drug therapy, to those treated with the drug therapy alone. A prospective, randomised study involving 1,520 advanced heart failure (NYHA Class III or IV) patients from 128 hospitals around the United States, the results at one year revealed:

· A 36 percent reduction in the risk of all-cause mortality* for heart failure patients who received Guidant’s CRT defibrillator device
· A 20 percent reduction in the risk of combined all-cause mortality or first all-cause hospitalisation** for heart failure patients implanted with Guidant’s CRT defibrillators
· A 19 percent reduction in the risk of combined all-cause mortality or first all-cause hospitalisation for heart failure patients implanted with Guidant’s CRT pacemakers

What is cardiac resynchronisation therapy?
CRT is delivered by a small device implanted under the skin in the shoulder area - a procedure performed in nearly all pacemaker centres in the UK. CRT devices use electrical stimulation to synchronise the contractions of the right and left ventricles of the heart, which pump blood around the body. CRT defibrillator devices function in the same way as CRT devices, but also include a defibrillation function, which sends an electrical shock to the heart to stop dangerously rapid rhythms that can result in sudden cardiac death.

What is heart failure?
Heart failure is a debilitating condition where the heart weakens and gradually loses the ability to pump blood effectively. Most cases of heart failure in the UK are caused by coronary heart disease (CHD) and about a third result from hypertensive heart disease.7,8 Heart failure has a poor prognosis, with survival rates worse than breast or prostate cancer.9

About Guidant:
Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 11,000 employees, Guidant develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life’s most threatening medical conditions. For more information visit www.guidant.com.

*All-cause mortality refers to the rate of death for any reason, not necessarily related to heart failure
**All-cause hospitalisation refers to the rate of hospitalisation for any reason, not necessarily related to heart failure

# ENDS #
Notes to Editors:
· For more information about COMPANION, CRT and to arrange an interview with Dr Bristow (COMPANION lead investigator), a UK Cardiovascular Specialist or to speak to a patient please contact:

Sara Williams, Claire Martin or Stephen Cull
Porter Novelli, Tel: 020 7853 2222

References:
1. Bristow MR et al. Effect of Cardiac Resynchronisation Therapy with and without an implantable Defribrillator on Morbidity and Mortality in Advanced Chronic Heart Failure: The COMPANION Trial. N Engl J Med 2004;350:pp
2. Peterson S, Rayner M, Wolstenholme J. Coronary heart disease statistics: heart failure supplement. London: British Heart Foundation, 2002.
3. Guidant Data on File.
4. Bocchiardo M, et al. Economic Evaluation of Biventricular Pacing in the Treatment of Heart Failure. Presented at the XXIV ANMCO Congress, 31st May – 4th June 2003, Florence, Italy.
5. Banz K et al. Cardiac Resynchronisation (CRT) in Heart Failure – A Model to Assess the Economic Value of the New Technology. Presented at the ESC Congress 30th August – 3rd September 2003, Vienna, Austria.
6. Making the Economic Case for Medical Technology. Derek Wanless, The Medical Technology Group. (HM Treasury 2002).
7. Cowie MR, Mosterd A, Wood D et al. The epidemiology of heart failure. European Heart Journal 1997; 18: 208-225.
8. SIGN Secretariat, Diagnosis and Treatment of Heart Failure due to Left Ventricular Systolic Dysfunction. Scottish Intercollegiate Guidelines Network. February 1999, SIGN Publication number 35, Royal College of Physicians, Edinburgh, Scotland.
9. Sanderson S. ACE Inhibitors in the treatment of chronic heart failure: effective and cost effective. Bandolier 1994; 1(8).

This press release was distributed by ResponseSource Press Release Wire on behalf of Porter Novelli Ltd in the following categories: Men's Interest, Health, Women's Interest & Beauty, Medical & Pharmaceutical, for more information visit https://pressreleasewire.responsesource.com/about.