1. 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

2. 3 to 4 million patients fit the entry criteria
Multicenter Autonomic Defibrillator Implantation Trial II (MADIT II): Background
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

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

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

5. MADIT II: Mortality Events
Non Cardiac
Cardiac
Arrhythmic
Non Arrhythmic
Conv
Therapy
ICD
Conv
Therapy
Conv
Therapy
Conv
Therapy
ICD
ICD
ICD

6. New or Worsening Heart Failure
MADIT II: CHF
New or Worsening Heart Failure
P=0.09
Conventional
Therapy
ICD