SCD-HeFT Trial Follow-Up Period Ends, Data Being Analyzed; NHLBI-Sponsored Trial Could Report Results in First Quarter of 2004.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Nov. 3, 2003

One of the most anticipated clinical trials in cardiology has moved one step closer to completion, as the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) has closed its patient follow-up period. SCD-HeFT is the largest implantable defibrillator study (ICD) ever, and is evaluating the use of ICDs and amiodarone hydrochloride for the prevention of sudden death in 2,521 heart failure patients. Results of this clinical study, sponsored by the National Heart Lung and Blood Institute of the National Institutes of Health, are expected to be announced in the first quarter of 2004.

"By observing the data from all patients over a minimum follow-up of 30 months and an average follow-up of approximately 40 months, we will be able to provide important evidence about the effectiveness of implantable defibrillators, an anti-arrhythmic drug, or placebo in patients with moderate heart failure who are at high risk for sudden cardiac arrest," said study director and principal investigator, Gust H. Bardy, M.D., Seattle Institute for Cardiac Research. "Following all patients over relatively long periods of time strengthens the power of the study and ensures that the data will be meaningful for the public health."

SCD-HeFT is a placebo-controlled, three-arm trial examining the use of ICD therapy and/or anti-arrhythmic drug therapy in patients who have mild or moderate congestive heart failure (New York Heart Association Class II or III) and impaired pumping function of the left ventricle. Such individuals are at risk of developing dangerously fast heart rhythms, such as ventricular fibrillation or ventricular tachycardia, that can lead to sudden cardiac arrest (SCA) and death. All patients in the study had heart failure. In some cases, this was associated with coronary artery disease or heart attacks. The primary endpoint of the trial is all cause mortality.

One-third of the patients enrolled in the study received a single-chamber ICD (provided by Medtronic). Another third received amiodarone (provided by Wyeth Pharmaceuticals), a medication used to manage fast heart rhythms, and one-third received a placebo. All patients in the trial received optimal conventional heart failure therapy when appropriate and tolerated, including medications such as ACE inhibitors, beta-blockers, diuretics, statins, and aspirin.

The results of the SCD-HeFT study will be closely watched to see how they relate to the findings of other recent clinical trials such as MADIT II, in which ICD recipients showed a 31 percent reduction in deaths compared to those who received only optimal medical therapy. Recent additional data on MADIT II also showed that 40 percent of the ICD patients in the trial received appropriate ICD therapy within 4 years of receiving their implant, reinforcing the value of ICD therapy in this group.

Patients in the MADIT II trial are heart attack survivors who have poor pumping function. SCD-HeFT patients have not necessarily had heart attacks, but they do uniformly have poor pumping function. Unlike MADIT II, all SCD-HeFT patients have congestive heart failure, and amiodarone and placebo were not used in MADIT II.

Sponsored by the NHLBI, with additional funding from Medtronic (NYSE:MDT) and Wyeth Pharmaceuticals, patient enrollment began on September 16, 1997 and continued through October 18, 2001. In addition to Dr. Bardy, Dr. Kerry L. Lee is the co-principal investigator and study biostatistician, and Dr. Daniel B. Mark is the principal study investigator for economic and quality-of-life analysis, a critically important part of the study. Dr. Lee and Dr. Mark both are from Duke University's College of Medicine.

Heart failure is a progressive condition affecting at least five million Americans that causes the lower chambers of the heart to lose their ability to pump sufficient blood to meet the needs of the circulatory system. Approximately 1 million Americans suffer from the potentially lethal combination of heart failure and high risk of sudden cardiac arrest. In addition, sudden cardiac arrest occurs six to nine times more frequently in people with heart failure than in the general population. SCA kills approximately 450,000 people in the United States each year, and many of these deaths can be prevented with proper evaluation and treatment by a heart rhythm specialist.

Study organizers say completion of the long follow-up period for SCD-HeFT was essential to capture the required arrhythmia event rates; compare data about death rates, quality of life and cost of therapy; and determine the most effective treatment options.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its website is www.medtronic.com.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.