Which strategy is 'best' after myocardial infarction? The beta-blocker strategy plus implantable cardioverter defibrillator trial: Rationale and study design

Antonio Raviele, Maria Grazia Bongiorni, Michele Brignole, Riccardo Cappato, Alessandro Capucci, Fiorenzo Gaita, Salvatore Mangiameli, Alessandro Montenero, Roberto Pedretti, Jorge Salerno, Sergio Sermasi

Research output: Contribution to journalArticle

Abstract

The Beta-blocker Strategy plus Implantable Cardioverter Defibrillator (BEST-ICD) Trial is a multicenter prospective randomized trial that started in June 1998, in 95 centers in Italy and Germany. The trial will test the hypothesis whether, in high-risk post myocardial infarction (MI) patients already treated with β blockers, electrophysiologic study (EPS)-guided therapy (including the prophylactic implantation of implantable cardioverter defibrillator [ICD] in inducible patients) will improve survival compared with conventional therapy. Patients eligible for the study are survivors of recent MI (≥5 and ≤21 days), aged ≤80 years, with left ventricular ejection fraction ≤35% and ≥ 1 of the following additional risk factors: (1) ventricular premature beats ≥10/hour; (2) decreased heart rate variability (standard deviation of unusual RR intervals 25% of which 50% is anticipated to be from sudden death. The main criteria of exclusion from the study are (1) a history of sustained ventricular arrhythmia; (2) documentation of nonsustained ventricular tachycardia during the screening phase; and (3) the need for myocardial revascularization and contraindications or intolerance to β- blocker therapy. Eligible patients will be randomized to 2 different therapeutic strategies: conventional strategy or EPS/ICD strategy. Patients allocated to the EPS/ICD strategy will undergo further risk stratification, and electrophysiologically inducible patients (~35%) will receive prophylactic ICDs, in addition to the conventional therapy, whereas noninducible patients will be only conventionally treated. The primary endpoint of the study will be death from all causes. By hypothesizing a 30% reduction in the 2-year mortality (from 20% to 14%) in the EPS/ICD group compared with conventionally treated patients, 1,200 patients will have to be included. A triangular, 2-sided sequential design with preset boundaries, for a 5% significance level and 90% power to detect a reduction in 2-year mortality from 20% to 14%, will be used to permit early termination of the trial if the strategy is found to be efficacious, no difference, or inefficacious.

Original languageEnglish
JournalThe American Journal of Cardiology
Volume83
Issue number5 B
Publication statusPublished - Mar 11 1999

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Raviele, A., Bongiorni, M. G., Brignole, M., Cappato, R., Capucci, A., Gaita, F., Mangiameli, S., Montenero, A., Pedretti, R., Salerno, J., & Sermasi, S. (1999). Which strategy is 'best' after myocardial infarction? The beta-blocker strategy plus implantable cardioverter defibrillator trial: Rationale and study design. The American Journal of Cardiology, 83(5 B).