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awa Kornacewicz-Jach, M.D., Beata Sredniawa, M.D., Géza Lupkovics, M.D., Franz Hofgärtner, M.D., Andrzej Lubinski, M.D., Mårten Rosenqvist, M.D., Alphonsus Habets, Ph.D., Karl Wegscheider, Ph.D., Jochen Senges, M.D., for the IRIS Investigators
Background The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter–defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone.
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 (
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
[ClinicalTrials.gov]
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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 (
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.
Source Information
From Ludwig-Maximilians University, Munich (G.S.), Klinikum am Urban, Berlin (D.A.), Klinikum der Stadt Ludwigshafen, Ludwigshafen am Rhein (K.S., J.S.), Klinikum Coburg, Coburg (J.B.), Städtisches Krankenhaus München-Bogenhausen, Munich (E.H.), Klinik am Eichert, Göppingen (F.H.), and University Hospital, Hamburg-Eppendorf (K.W.) — all in Germany; Szpital Wolski, Warsaw (D.W.), Pomorska Akademia Medyczna, Szczecin (Z.K.-J.), Medical University of Silesia, Zabrze (B.S.), and Uniwersytecki Szpital, Lodz (A.L.) — all in Poland; Zala County Hospital, Zalaegerszeg, Hungary (G.L.); Karolinska Institute, South Hospital, Stockholm (M.R.); and Medtronic Bakken Research Center, Maastricht, the Netherlands (A.H.).
Drs. Steinbeck and Andresen contributed equally to this article.
Address reprint requests to Dr. Steinbeck at Department of Internal Medicine I, Ludwig-Maximilian Universität, Campus Grosshadern, Marchioninistr. 15, 81377 Munich, Germany, or at gerhard.steinbeck{at}med.uni-muenchen.de.
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