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Medtronic reveals series of SCA risk stratification trial results

Medtronic : 15 May, 2008  (Company News)
Medtronic, together with several partners, has announced details of several major clinical trials aimed at developing and validating new and innovative risk stratification tools to predict which post-myocardial infarction (MI, or heart attack) patients are at greatest risk of Sudden Cardiac Arrest (SCA).
Medtronic’s industry-leading research efforts aim to further advance the base of clinical evidence for implanted cardiac device therapies to ensure those patients at greatest risk of SCA are protected.

“We are on the cusp of new discoveries in clinical cardiology. These trials will utilise advanced innovations in technology and research, spanning novel diagnostics to genomics,” said David M Steinhaus, MD, vice president and medical director of the Cardiac Rhythm Disease Management business at Medtronic. “Medtronic is proud to have partnered with leading researchers worldwide to apply these scientific innovations in an effort to better understand which patients may benefit from implantable medical therapies.”

VEST/PREDICTS (The Vest Prevention of Early Sudden Death Trial / The Prediction of ICD Therapies Study), is a multicentre, randomised controlled trial designed to test a strategy to reduce the early post-MI sudden cardiac arrest risk, followed by an observational cohort study to develop and validate a tool to determine which patients will benefit most from an ICD two months post-MI.

The VEST portion of the study will test the hypothesis that a non-invasive, wearable automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in patients with LVEF less than and equal to 35 percent.

The PREDICTS portion of the study aims to develop and validate a tool that predicts the occurrence of spontaneous treatable’ ventricular arrhythmias up to five years post-MI, and identify high-risk patients in whom an ICD would be most cost-effective. Study participants will receive either an ICD or Medtronic Reveal DX insertable cardiac monitor (ICM) to ascertain data on ICD-treatable arrhythmic events.

VEST/PREDICTS is part of a National Institutes of Health (NIH) grant awarded to the University of California-San Francisco (UCSF) and is co-funded by Medtronic, GE Healthcare, and Zoll. It will involve up to 60 centres and more than 4,500 patients in the USA, Canada and Europe.

“The VEST / PREDICTS study is intended to address the two key deficiencies in our current post-MI treatment strategy, which include 1) the untreated high sudden death rate in the early post-MI period and 2) the non-specific nature of ejection fraction to predict spontaneous ventricular arrhythmias and ICD shocks,” said Jeff Olgin, MD, principal investigator for VEST / PREDICTS, and chief of cardiac electrophysiology and professor of medicine at UCSF. “This important study will define a clear pathway to identify those patients who benefit most from ICDs.”

The objective of Medtronic’s GAME (Genetic Arrhythmia Markers for Early Detection) trial is to determine if genetic markers can be used to identify individuals with an increased susceptibility to SCA. Involving 1,000 patients at more than 30 sites in the 48 contiguous United States, GAME will study cardiac events retrospectively to potentially develop a genetic risk scoring system to determine which patients would benefit from an ICD.

The first patient enrollment in GAME recently took place at Arkansas CardiologyClinic in Little Rock, Arkansas.

“We are about to enter a new era of medicine, one in which so much will eventually be individualized, including prevention and therapy,” said Eric Topol, MD, principal investigator of the GAME trial and chief academic officer at Scripps Health in San Diego. “Genomics has already had a major impact on the treatment of cancer and many other diseases. Now we’re looking at genomics of patients with arrhythmias as a way to more precisely treat this important type of heart disease.”

Also underway is the Medtronic-supported DISCOVERY (Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Ventricular Tachyarrhythmias in ICD Patients) trial, involving nearly 1,300 patients at approximately 80 centres in Europe.

DISCOVERY is a non-randomised, prospective, multicenter study and is composed of two parts. The first is double-blinded and collects data on genetic polymorphisms and potential prognostic of ventricular and atrial tachyarrhythmias. The second part evaluates the influence of dual chamber ICD-based diagnostic information on long-term patient management and treatment.

Medtronic is also committed to ongoing study of Microvolt T-Wave Alternans (MTWA) and other risk markers that will further advance the understanding of how to better identify patients at risk for SCA. MTWA is being studied in the MASTER trial, of which data has previously been presented at the American Heart Association’s Scientific Sessions 2007 and American College of Cardiology’s Scientific Sessions 2008, and will be presented at Heart Rhythm 2008, the Heart Rhythm Society’s 29thAnnual Scientific Sessions. Medtronic will continue to explore the potential of MTWA, as evidenced in these aforementioned risk stratification studies.
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