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The defibrillator in acute myocardial infarction trial (DINAMIT): study protocol
S H Hohnloser1, S J Connolly, K H Kuck
1Department of Medicine, Division of Cardiology, J.W. Goethe University, Frankfurt, Germany. Hohnloser@em.uni-frankfurt.de
Insights
The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) investigated implantable cardioverter/defibribrillators (ICDs) for primary prevention of sudden cardiac death. This study evaluated ICDs in high-risk myocardial infarction survivors, but did not find a mortality benefit.
Area of Science:
- Cardiology
- Clinical Trials
- Sudden Cardiac Death Prevention
Background:
- Implantable cardioverter/defibrillators (ICDs) are effective for secondary prevention of sudden cardiac death.
- The role of ICDs in primary prevention after myocardial infarction (MI) was previously unknown.
- High-risk MI survivors with reduced left ventricular function and impaired autonomic function are candidates for primary prevention strategies.
Purpose of the Study:
- To evaluate the efficacy of ICD therapy in reducing overall mortality in high-risk MI survivors.
- To test the hypothesis that ICDs reduce sudden arrhythmogenic death, thereby lowering overall mortality.
- To assess the benefit of ICDs for primary prevention of sudden cardiac death in post-MI patients.
Main Methods:
- The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) was a randomized, open-label, international multicenter study.
- Patients were enrolled 6-40 days post-MI with ejection fraction ≤0.35 and impaired heart rate variability or elevated 24-hour heart rate.
- Participants were randomized to ICD therapy or no ICD therapy and followed for approximately 3 years, with all-cause death as the primary outcome.
Main Results:
- The study enrolled patients with specific criteria for reduced left ventricular function and autonomic dysfunction post-MI.
- Patients were followed for an average of 3 years to assess the primary outcome of all-cause mortality.
- Data analysis followed the intent-to-treat principle.
Conclusions:
- DINAMIT was the first prospective study to assess ICDs for primary prevention of sudden cardiac death in high-risk post-MI patients.
- The study did not demonstrate a mortality benefit for ICD therapy in this patient population.
- Further research may be needed to refine patient selection for primary prevention strategies.
Background:
The implantable cardioverter/defibrillator (ICD) has been shown to be superior to antiarrhythmic drug therapy for the secondary prevention of sudden cardiac death. Its role in the primary prevention of sudden death after myocardial infarction is unknown. Methods and Results The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) is a randomized, open-label, parallel-group comparison of ICD therapy versus no ICD therapy in selected survivors of acute myocardial infarction. It will test the hypothesis that reduction of sudden arrhythmogenic death by means of the ICD will result in reduction of overall mortality rates in patients at high risk after acute myocardial infarction. Accordingly, this international multicenter study aims to enroll patients shortly after their infarction (day 6 to day 40) who have reduced left ventricular function (left ventricular ejection fraction
Conclusions:
DINAMIT is the first prospective study to evaluate the benefit of ICD therapy for the primary prevention of sudden cardiac death in patients at high risk after acute myocardial infarction.