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
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
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)
Implantable defibrillator
(n=742)
All Cause Mortality - Average follow-up of 20 months
Stopped early by Data Safety Monitoring Board
MADIT II: Study Design
Conventional
Therapy
ICD
P=0.016
Death
Avg. follow-up=20 months
MADIT II: All-Cause Mortality
Hazard Ratio = 0.65
Non Cardiac
MADIT II: Mortality Events
Conv
Therapy
ICD
Cardiac
Conv
Therapy
ICD
Arrhythmic
Non Arrhythmic
Conv
Therapy
ICD
Conv
Therapy
ICD
Conventional
Therapy
ICD
P=0.09
New or Worsening Heart Failure
MADIT II: CHF