MADIT-II
Trial question
Is implantable defibrillator superior to conventional medical therapy in patients with MI and reduced ejection fraction?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 1232
1232 patients (192 female, 1040 male).
Inclusion criteria: patients with MI and reduced ejection fraction.
Key exclusion criteria: indication for an implantable defibrillator, NYHA functional class IV at enrollment, coronary revascularization within the preceding three months, MI within the past month, advanced cerebrovascular disease.
Interventions
N=742 ICD implantation (with standard techniques, plus medical therapy).
N=490 conventional medical therapy (β-blockers, ACE inhibitors, and lipid lowering drugs).
Primary outcome
Rate of death at an average follow-up of 20 months
14.2%
19.8%
19.8 %
14.9 %
9.9 %
5.0 %
0.0 %
ICD
implantation
Conventional medical
therapy
Significant
decrease ▼
NNT = 17
Significant decrease in the rate of death at an average follow-up of 20 months (14.2% vs. 19.8%; HR 0.69, 95% CI 0.51 to 0.93).
Secondary outcomes
No significant difference in hospitalized with HF (19.9% vs. 14.9%; RR 1.36, 95% CI -0.21 to 2.93).
Safety outcomes
Significant difference in hospitalization with HF (19.9% vs. 14.9%).
Conclusion
In patients with MI and reduced ejection fraction, ICD implantation was superior to conventional medical therapy with respect to the rate of death at an average follow-up of 20 months.
Reference
Moss AJ, Zareba W, Hall WJ et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83.
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