St. Jude Medical announces PAVE and DINAMIT clinical tri...( or the study included a heart attack wi...),Health

or the study included a heart attack within six to 40 days, a left ventricular ejection fraction (LVEF) of =35%, and signs of impaired cardiac autonomic modulation (i.e. depressed standard deviation of sinus RR intervals {=70 ms} or elevated heart rate {mean RR interval =750 ms}), and an age range of 18-80 years.

The DINAMIT study found that, in this patient population:

• ICD therapy did not decrease all-cause mortality.
• ICD therapy did significantly decrease arrhythmic mortality.

The study concluded, based on these findings, that ICD therapy is not beneficial in patients with a recent myocardial infarction, even if they have risk factors for arrhythmic death. Other therapeutic strategies need to be identified and investigated to reduce non-arrhythmic mortality in this patient cohort.

"The DINAMIT study showed that ICD therapy can significantly reduce the risk of sudden death in patients with a recent myocardial infarction who are at high risk of arrhythmic death due to extensive myocardial scarring and autonomic imbalance, but that this does not result in reduction in total mortality," said Stefan H. Hohnloser, M.D., Professor of Medicine, J.W. Goethe University, Frankfurt, Germany, one of the study's principal investigators.

"ICD therapy did not prove to be beneficial in patients early after acute myocardial infarction," said Stuart J. Connolly, M.D., Professor of Medicine, McMaster University, Hamilton, Ontario, Canada, also a principal investigator in the study. "This is most likely because their burden of myocardial ischemia puts them at risk of cardiac-related mortality from causes other than sudden cardiac death."

Previous large-scale clinical trials of patients with ischemic heart disease, low ejection fractions and a history of AMI demonstrated that this patient group will experience decreased mortality when ICD therapy is utilized. These clinica
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Contact: Mechal Weiss
mechal.weiss@edelman.com
212-642-7731
Edelman Public Relations
8-Mar-2004

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