MADIT II
Multicenter Automatic Defibrillator Implantation Trial II
Hypothesis:
To study whether, in patients with a previous MI and LV dysfunction, ICD therapy is able to reduce overall mortality
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
Published: New England Journal of Medicine, March 2002
Results:
For post-MI patients with LVEF ≤ 30%
- ICD therapy significantly reduced the incidence of overall mortality by 31%
- ICD therapy reduced arrhythmic death by 61%
- ICD therapy provided significant benefit among patients who were on optimal drug therapies
References
- Klein H, et al. New primary prevention trails of sudden cardiac death in patients with left ventricular dysfunction: SCD-HEFT and MADIT-II. Am J Cardiol. 1999;83(5B):91D-97D.
- 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.
- 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.
- Moss AJ. Presented before ACC 51st Annual Scientific Sessions, late-breaking clinical trials. March 19, 2002
