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. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

Abstract

Background: Patients with reduced left ventricular function after myocardial infarction are at risk for life-threatening ventricular arrhythmias. This randomized trial was designed to evaluate the effect of an implantable defibrillator on survival in such patients.

Methods: Over the course of four years, we enrolled 1232 patients with a prior myocardial infarction and a left ventricular ejection fraction of 0.30 or less. Patients were randomly assigned in a 3:2 ratio to receive an implantable defibrillator (742 patients) or conventional medical therapy (490 patients). Invasive electrophysiological testing for risk stratification was not required. Death from any cause was the end point.

Results: The clinical characteristics at base line and the prevalence of medication use at the time of the last follow-up visit were similar in the two treatment groups. During an average follow-up of 20 months, the mortality rates were 19.8 percent in the conventional-therapy group and 14.2 percent in the defibrillator group. The hazard ratio for the risk of death from any cause in the defibrillator group as compared with the conventional-therapy group was 0.69 (95 percent confidence interval, 0.51 to 0.93; P=0.016). The effect of defibrillator therapy on survival was similar in subgroup analyses stratified according to age, sex, ejection fraction, New York Heart Association class, and the QRS interval.

Conclusions: In patients with a prior myocardial infarction and advanced left ventricular dysfunction, prophylactic implantation of a defibrillator improves survival and should be considered as a recommended therapy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-Antagonists / therapeutic use
  • Aged
  • Amiodarone / therapeutic use
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Anti-Arrhythmia Agents / therapeutic use
  • Arrhythmias, Cardiac / etiology
  • Arrhythmias, Cardiac / prevention & control*
  • Combined Modality Therapy
  • Defibrillators, Implantable* / adverse effects
  • Female
  • Humans
  • Hypolipidemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Myocardial Infarction / complications
  • Myocardial Infarction / mortality
  • Myocardial Infarction / physiopathology
  • Myocardial Infarction / therapy*
  • Proportional Hazards Models
  • Stroke Volume
  • Survival Analysis
  • Ventricular Dysfunction, Left / etiology
  • Ventricular Dysfunction, Left / mortality
  • Ventricular Dysfunction, Left / therapy*

Substances

  • Adrenergic beta-Antagonists
  • Angiotensin-Converting Enzyme Inhibitors
  • Anti-Arrhythmia Agents
  • Hypolipidemic Agents
  • Amiodarone