Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Status:
Not yet recruiting
Trial end date:
2027-01-31
Target enrollment:
Participant gender:
Summary
Patients who have survived a myocardial infarction (MI) are at increased risk for sudden
cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A
severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of
impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this
observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between
end of the 1990s and early 2000s. These trials compared the survival of patients with
severely reduced LVEF who received an implantable cardioverter-defibrillator with the
survival of patients being on medical therapy alone. They reported a significantly better
survival of patients in the defibrillator arm and led to international guideline
recommendations for routine implantation of defibrillators in survivors of MI with severely
impaired LVEF as a means for primary prevention of SCD. Since then, the management of these
patients has changed dramatically with the advent of a series of novel drug classes that
reduce not only mortality but specifically SCD leading to a substantial decrease of the
sudden death rates as well as of the rates of appropriate defibrillator therapies implanted
for primary prevention of SCD. At the same time, the complication rates associated with the
defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of
routine defibrillator implantation for primary prevention of SCD in patients with severely
reduced LVEF has substantially changed since the conduction of the landmark trials that
established this therapy. Due to the inherent risks and considerable costs of the
defibrillator, a novel randomised adequately powered assessment of the potential benefit or
harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal
medical treatment (OMT) appears imperative.
OBJECTIVE:
To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for
this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is
not inferior to OMT with ICD implantation (control group) with respect to all-cause
mortality.