Abstract | BACKGROUND: METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)
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Authors | Gerhard Steinbeck, Dietrich Andresen, Karlheinz Seidl, Johannes Brachmann, Ellen Hoffmann, Dariusz Wojciechowski, Zdzisława Kornacewicz-Jach, Beata Sredniawa, Géza Lupkovics, Franz Hofgärtner, Andrzej Lubinski, Mårten Rosenqvist, Alphonsus Habets, Karl Wegscheider, Jochen Senges, IRIS Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 361
Issue 15
Pg. 1427-36
(Oct 08 2009)
ISSN: 1533-4406 [Electronic] United States |
PMID | 19812399
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2009 Massachusetts Medical Society |
Topics |
- Aged
- Cause of Death
- Death, Sudden, Cardiac
(prevention & control)
- Defibrillators, Implantable
(adverse effects)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(mortality, therapy)
- Proportional Hazards Models
- Registries
- Risk
- Survival Rate
- Time Factors
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