MADIT II

Implantable Cardioverter Defibrillator (ICD) Trial History

The MADIT II study is the third major clinical trial with results that validate the efficacy of ICD therapy in patients with prior myocardial infarction (MI).1-3 The groundbreaking results of MADIT II expand upon prior evidence to definitively confirm that ICD therapy reduces mortality in coronary artery disease (CAD) patients with reduced ventricular function.1 Building upon the conclusions of earlier ICD trials, the design and results of MADIT II provide a model for the prevention of sudden cardiac death (SCD).

Patient Criteria in ICD Trials

As detailed in Table 1, MADIT II is the third major study in more than a decade with results that demonstrate a reduction in all-cause mortality among patients with advanced CAD and left ventricular (LV) dysfunction.1-3

Table 1. Patient Eligibility Criteria in ICD Trials

Eligibility Criteria	MADIT2	MUSTT3	MADIT II1

Coronary disease	MI > 3 weeks; NYHA Class I-III	MI, CABG, or PTCA > 96 hours	MI > 30 days

Left ventricular ejection fraction (LVEF)	< 35%	< 40%	< 30%

Ventricular tachycardia (VT)	NSVT; inducible, monomorphic VT	NSVT > 96 hours after MI, CABG, or PTCA	None

Required electrophysiology test	Yes	Yes	No

CABG = coronary artery bypass graft
NSVT = nonsustained ventricular tachycardia
PTCA = percutaneous transluminal coronary angioplasty

All three trials demonstrated the efficacy of ICD therapy in the reduction of SCD in coronary patients. With a 31% reduction in mortality in patients receiving ICD therapy, the results of MADIT II confirm previous evidence of ICD benefits.

The novel design of MADIT II increases the impact its groundbreaking results could have on ICD treatment practices. MADIT II did not include a patient requirement for nonsustained ventricular tachycardia (NSVT), and patients did not undergo electrophysiology testing to determine their risk of arrhythmia.1 Inclusion criteria for MADIT II were prior MI and an ejection fraction (EF) <30%.1

With no arrhythmia marker, prophylactic ICD therapy, in addition to conventional antiarrhythmic drug therapy, reduced the risk of death 31% in post-MI patients versus patients receiving conventional therapy alone.1 The patient inclusion criteria for MADIT II demonstrate that screening for an EF <30% in post-MI patients can determine eligibility for the benefits of Guidant ICD therapy.1

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References

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 infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
Moss AJ, Hall WJ, Cannom DS, et al, for the Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med. 1996;335:1933-1940.
Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G, for the Multicenter Unsustained Tachycardia Trial Investigators. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med. 1999;341:1882-1890.

ICD Instructions for Use Summary

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