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Www. Clinical trial results.org The MADIT II Trial Multicenter Autonomic Defibrillator Implantation Trial II Presented at the American College of Cardiology.

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Presentation on theme: "Www. Clinical trial results.org The MADIT II Trial Multicenter Autonomic Defibrillator Implantation Trial II Presented at the American College of Cardiology."— Presentation transcript:

1 www. Clinical trial results.org The MADIT II Trial Multicenter Autonomic Defibrillator Implantation Trial II Presented at the American College of Cardiology 51st Annual Scientific Session Atlanta, GA Arthur J. Moss, M.D. for the MADIT II investigators Multicenter Autonomic Defibrillator Implantation Trial II Presented at the American College of Cardiology 51st Annual Scientific Session Atlanta, GA Arthur J. Moss, M.D. for the MADIT II investigators

2 www. Clinical trial results.org MADIT & Multicenter Unsustained Tachycardia Trial (MUSTT): Demonstrated a benefit from ICD implantation in patients with CAD, reduced ventricular function, unsustained ventricular tachycardia, and inducible ventricular tachycardia on EP testing. In MADIT II: No EP study required, inclusion criteria included a prior MI at least 30 days previous to implantation, and EF of 30% or less. MADITT randomized 1232 patients from 71 US centers and 5 European centers to receive either an ICD, or to continue on conventional medical therapy 3 to 4 million patients fit the entry criteria 400,000 new cases annually MADIT & Multicenter Unsustained Tachycardia Trial (MUSTT): Demonstrated a benefit from ICD implantation in patients with CAD, reduced ventricular function, unsustained ventricular tachycardia, and inducible ventricular tachycardia on EP testing. In MADIT II: No EP study required, inclusion criteria included a prior MI at least 30 days previous to implantation, and EF of 30% or less. MADITT randomized 1232 patients from 71 US centers and 5 European centers to receive either an ICD, or to continue on conventional medical therapy 3 to 4 million patients fit the entry criteria 400,000 new cases annually Multicenter Autonomic Defibrillator Implantation Trial II (MADIT II): Background

3 www. Clinical trial results.org Patients with prior MI within 30 days and LVEF < 30% randomized in a 3:2 ratio 71 US centers and 5 European centers Patients with prior MI within 30 days and LVEF < 30% randomized in a 3:2 ratio 71 US centers and 5 European centers Conventional medical therapy (n=490) Conventional medical therapy (n=490) Implantable defibrillator (n=742) Implantable defibrillator (n=742) All Cause Mortality - Average follow-up of 20 months Stopped early by Data Safety Monitoring Board MADIT II: Study Design

4 www. Clinical trial results.org Conventional Therapy Conventional Therapy ICD P=0.016 Death Avg. follow-up=20 months Death Avg. follow-up=20 months MADIT II: All-Cause Mortality Hazard Ratio = 0.65

5 www. Clinical trial results.org Non Cardiac MADIT II: Mortality Events Conv Therapy Conv Therapy ICD Cardiac Conv Therapy Conv Therapy ICD Arrhythmic Non Arrhythmic Conv Therapy Conv Therapy ICD Conv Therapy Conv Therapy ICD

6 www. Clinical trial results.org Conventional Therapy Conventional Therapy ICD P=0.09 New or Worsening Heart Failure MADIT II: CHF


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