Defibrillator implantation early after myocardial infarction.
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Defibrillator implantation early after myocardial infarction. / Steinbeck, Gerhard; Andresen, Dietrich; Seidl, Karlheinz; Brachmann, Johannes; Hoffmann, Ellen; Wojciechowski, Dariusz; Kornacewicz-Jach, Zdzis Awa; Sredniawa, Beata; Lupkovics, Géza; Hofgärtner, Franz; Lubinski, Andrzej; Rosenqvist, Mårten; Habets, Alphonsus; Wegscheider, Karl; Senges, Jochen.
In: NEW ENGL J MED, Vol. 361, No. 15, 15, 2009, p. 1427-1436.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Defibrillator implantation early after myocardial infarction.
AU - Steinbeck, Gerhard
AU - Andresen, Dietrich
AU - Seidl, Karlheinz
AU - Brachmann, Johannes
AU - Hoffmann, Ellen
AU - Wojciechowski, Dariusz
AU - Kornacewicz-Jach, Zdzis Awa
AU - Sredniawa, Beata
AU - Lupkovics, Géza
AU - Hofgärtner, Franz
AU - Lubinski, Andrzej
AU - Rosenqvist, Mårten
AU - Habets, Alphonsus
AU - Wegscheider, Karl
AU - Senges, Jochen
PY - 2009
Y1 - 2009
N2 - 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 ( 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.)
AB - 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 ( 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.)
M3 - SCORING: Zeitschriftenaufsatz
VL - 361
SP - 1427
EP - 1436
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 15
M1 - 15
ER -