MADIT Trial

Tachycardia

MADIT Trial

Multi-center Automatic Defibrillator Implantation Trial

Protocol

Hypothesis

To study whether prophylactic therapy with an ICD as compared with conventional medical therapy (e.g., amiodarone, beta-blockers/sotalol and class I antiarrhythmics) will improve survival in this high-risk group.

Study Population

Target/actual number of subjects in the trial: 196 patients (95 received defibrillator and 101 received medical therapy). Age and age range: 62 + 9 years (defibrillator group), 64 + 9 years (medical therapy group). Gender: 92 male, 8 female (medical therapy group).

Inclusion Criteria

Previous (> 3 weeks) Q wave of enzyme-positive MI; had an episode of asymptomatic, documented unsustained ventricular tachycardia (a run of 3 to 30 ventricular ectopic beats at a rate of > 120 beats/min) unrelated to an acute MI; ejection fraction = 0.35 on angiography, radionuclide scanning or echocardiography; were in New York Heart Association functional class I, II or III; and had no indications for coronary bypass operation or coronary angioplasty within the past 3 months.

Exclusion Criteria

Previous cardiac arrest or ventricular tachycardia causing syncope that was not associated with an acute MI; symptomatic hypotension while in a stable rhythm; MI within the past 3 weeks; recent coronary bypass operation in the past 2 months or coronary angioplasty in the past 3 months; women of childbearing age who were not using medically prescribed contraceptives; patients with advanced cerebrovascular disease.

Primary Outcome

All-cause mortality.

Results

There were 15 deaths in the defibrillator group (11 from cardiac causes) and 39 deaths in the conventional-therapy group (27 from cardiac causes). There was a reduction of 54% mortality rate in the defibrillator group as compared to conventional therapy group. There was no evidence that amiodarone, beta-blockers, or any other antiarrhythmic therapy had a significant influence on the mortality curves.

References

• Multicenter Automatic Defibrillator Implantation Trial (MADIT): design and clinical protocol. PACE 1991, 14:920-927.
• Moss AJ, et al: Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996, 335:1933-1940.