© 2005 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.
Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment*
The BEta-blocker STrategy plus ICD trial
aCardiology Division, Ospedale Umberto I, Via Circonvallazione 50 30170 Mestre-Venezia, Italy; bCardiology Division, Ospedale Cisanello Pisa, Italy; cCardiology Division, Ospedale Civile Lavagna, Italy; dCardiology Division, Istituto Policlinico S Donato S Donato Milanese, Italy; eCardiology Division, Ospedale Civile Piacenza, Italy; fCardiology Division, Ospedale Civile Asti, Italy; gCardiology Division, Ospedale S Luigi-S Currò Catania, Italy; hCardiology Division, Ospedale Garibaldi Catania, Italy; iCardiology Division, Policlinico MultiMedica Sesto S Giovanni, Italy; jCardiology Division, IRCCS Fondazione S Maugeri Tradate, Italy; kCardiology Division, Università dell'Insubria, Ospedale di Circolo Varese, Italy; lCardiology Division, Ospedale degli Infermi Rimini, Italy; mGuidant Corporation Europe Brussels, Belgium
AIMS: This multicentre prospective randomised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)guided/implantable cardioverter defibrillator (ICD) strategy in patients at high risk of sudden death (SD) early after myocardial infarction (MI). Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI.
METHODS AND RESULTS: We enrolled 143 survivors of acute MI (<1 month) with left ventricular ejection fraction
35% and either frequent (
10/h) premature ventricular complexes (PVCs), or depressed heart rate variability (SDNN < 70 ms) or abnormal signal-averaged ECG, who were able to tolerate optimised beta-blocker therapy (68 ± 40 mg/day of metoprolol). Of these, 138 were randomised, in a 2:3 ratio, to two therapeutic strategies: conventional (CONV) strategy (n = 59) or EPS-guided/ICD strategy (n = 79). The latter resulted in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55. During a mean follow-up of 540 ± 378 days, 26 patients (19%) died: nine (6.5%) SD, nine (6.5%) non-SD, and four (3%) non-cardiac death; in four patients (3%) the cause of death was unknown. The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18% vs 14% after 1 year and 29.5% vs 20% after 2 years, respectively (P = 0.3 and 0.2).
CONCLUSIONS: Despite optimal therapy, mortality remains significant in high-risk patients following MI. Although there is a trend in favour of EPS-guided/ICD, our data are insufficient to demonstrate a survival benefit of this strategy early after MI.
Key Words: defibrillation, electrophysiology, myocardial infarction, sudden death, tachyarrhythmias
*Corresponding author. Tel.: +39 041 2607201; fax: +39 041 2607235. E-mail address: araviele{at}tin.it (A. Raviele).
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