Transcript The MADIT 2 Trial - Clinical Trial Results

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
www. Clinical trial results.org
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
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MADIT II: Study Design
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
Conventional medical therapy
(n=742)
(n=490)
All Cause Mortality - Average follow-up of 20 months
Stopped early by Data Safety Monitoring Board
www. Clinical trial results.org
MADIT II: All-Cause Mortality
Death
25%
20%
Avg. follow-up=20 months
P=0.016
19.8%
15%
Hazard
Ratio =
0.65
14.2%
10%
5%
0%
Conventional
Therapy
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ICD
MADIT II: Mortality Events
Non Cardiac
15%
Cardiac
Arrhythmic
Non Arrhythmic
13.7%
10.0%
10%
9.4%
5.5%
5%
4.1%
3.6%
3.5%
3.7%
0%
Conv ICD
Therapy
Conv
ICD
Therapy
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Conv ICD
Therapy
Conv ICD
Therapy
MADIT II: CHF
New or Worsening Heart Failure
P=0.09
20%
15%
19.9%
14.9%
10%
5%
0%
Conventional
Therapy
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ICD