The Multicenter Automatic Defibrillator Implantation Trial II (MADIT II)

ICD VS. Antiarrythmic Drug Treatment in Post-MI Patients

Protocol:

Hypothesis:

To study whether, in patients with a previous MI and LV dysfunction, ICD therapy is able to reduce overall mortality assuming:

• Mortality in control = 19%
• Mortality in ICD = 11.8%
• 38% reduction in mortality at 2 years

Primary endpoint:

• All-cause mortality (intention-to-treat analysis)

Secondary endpoints:

• Predictability of ICD discharge based on VT inducibility at EPS
• Usefulness of SAECG, HRV, TWA in predicting mortality or ICD discharge
• Cost–effectiveness
• Quality of life

Status:

Start: July 1997
Completion: November 2001
Sample size: 1232 patients

Results:

For post-MI patients with LVEF ≤ 30%

• ICD therapy significantly reduced the incidence of overall mortality by 31%
• ICD therapy provided significant benefit among patients who were on optimal drug therapies

References:

1. Klein H, et al. New primary prevention trails of sudden cardiac death in patients with left ventricular dysfunction: SCD-HEFT and MADIT-II. The American Journal of Cardiology. 1999;83(5B):91D-97D.
2. Moss A., Cannom D., Dubert J., Hall W., Higgins S., Klein H., Wilber D, Zareba W. and Brown M. Multicenter Automatic Defibrillator Implantation Trial II (MADIT II): design and clinical protocol, Ann Noninvasive Electrocardiol. 1999, 4:83-91.
3. Moss AJ, Zareba W, Hall WJ, et al., for the Multicenter Automatic Defibrillator Implantation Trial II Investigators, Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infraction and Reduced Ejection Fraction. N Engl J Med. 2002;346:877-83.

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