Vincent Roolvink1, Saman Rasoul2, Jan Paul Ottervanger2, Jan-Henk E Dambrink2, Erik Lipsic3, Iwan C C van der Horst4, Bart de Smet5, Elvin Kedhi2, A T Marcel Gosselink2, Jan J Piek6, Vicente Sanchez-Brunete7, Borja Ibanez8, Valentin Fuster9, Arnoud W J Van't Hof2. 1. Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands. Electronic address: v.r.c.derks@isala.nl. 2. Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands. 3. University of Groningen, University Medical Center Groningen, Department of Cardiology, Groningen, The Netherlands. 4. University of Groningen, University Medical Center Groningen, Department of Critical Care, Groningen, The Netherlands. 5. Meander Medisch Centrum, Department of Cardiology, Amersfoort, The Netherlands. 6. Academic Medical Center, Department of Cardiology, Amersfoort, The Netherlands. 7. Servicio de Urgencia Medica de Madrid (SUMMA 112), Madrid, Spain. 8. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain. 9. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain; The Zena and Michael A Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, NY.
Abstract
BACKGROUND: β-Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions (STEMIs), as they are associated with a reduced mortality, recurrent myocardial infarction, life-threatening arrhythmias, and with prevention of unfavorable left ventricular remodeling. Whether early administration before primary percutaneous coronary intervention (PCI) of intravenous β-blockers reduces the infarct size in the current era is unknown. HYPOTHESIS: We postulate that the early administration of β-blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging (MRI) at 30 days. DESIGN: In a multinational, multicenter, double-blind, placebo-controlled, randomized trial, patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol (5 mg twice daily) administration or placebo. Before admission, study treatment will be started as soon as possible after the diagnosis of STEMI. After admission, primary PCI will be performed as per standard of care. After primary PCI, medical treatment will occur as per current guidelines in all patients, including the use of oral β-blockers. The primary end point is the myocardial infarct size as assessed by MRI at 30 days. Based on a superiority design and assuming an 18% relative infarct size reduction (from 28% to 23.5%), 408 patients are required to be enrolled, accounting for 20% drop-out (α = .05 and power = 80%). SUMMARY: The EARLY-BAMI trial is a multinational, multicenter, double-blind, placebo-controlled, randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days.
RCT Entities:
BACKGROUND: β-Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions (STEMIs), as they are associated with a reduced mortality, recurrent myocardial infarction, life-threatening arrhythmias, and with prevention of unfavorable left ventricular remodeling. Whether early administration before primary percutaneous coronary intervention (PCI) of intravenous β-blockers reduces the infarct size in the current era is unknown. HYPOTHESIS: We postulate that the early administration of β-blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging (MRI) at 30 days. DESIGN: In a multinational, multicenter, double-blind, placebo-controlled, randomized trial, patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol (5 mg twice daily) administration or placebo. Before admission, study treatment will be started as soon as possible after the diagnosis of STEMI. After admission, primary PCI will be performed as per standard of care. After primary PCI, medical treatment will occur as per current guidelines in all patients, including the use of oral β-blockers. The primary end point is the myocardial infarct size as assessed by MRI at 30 days. Based on a superiority design and assuming an 18% relative infarct size reduction (from 28% to 23.5%), 408 patients are required to be enrolled, accounting for 20% drop-out (α = .05 and power = 80%). SUMMARY: The EARLY-BAMI trial is a multinational, multicenter, double-blind, placebo-controlled, randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days.
Authors: Juan Carlos Garcia-Rubira; Manuel Almendro-Delia; Manuel Calvo-Taracido; Emilia Blanco-Ponce; Pablo Bastos-Amador; Antonio Reina-Toral; Roman Calvo-Jambrina; José Maria Cruz-Fernández; Angel Garcia-Alcántara; Rafael Hidalgo-Urbano Journal: Intern Emerg Med Date: 2015-05-20 Impact factor: 3.397
Authors: Enrico Fabris; Renicus Hermanides; Vincent Roolvink; Borja Ibanez; Jan Paul Ottervanger; Gonzalo Pizarro; Niels van Royen; Alonso Mateos-Rodriguez; Jan Henk Dambrink; Agustin Albarran; Francisco Fernández-Avilés; Javier Botas; Wouter Remkes; Victoria Hernandez-Jaras; Elvin Kedhi; Jose Zamorano; Fernando Alfonso; Alberto García-Lledó; Maarten van Leeuwen; Robin Nijveldt; Sonja Postma; Evelien Kolkman; Marcel Gosselink; Bart de Smet; Saman Rasoul; Erik Lipsic; Jan J Piek; Valentin Fuster; Arnoud Wj van 't Hof Journal: Open Heart Date: 2020-12
Authors: Derek J Hausenloy; Hans Erik Botker; Thomas Engstrom; David Erlinge; Gerd Heusch; Borja Ibanez; Robert A Kloner; Michel Ovize; Derek M Yellon; David Garcia-Dorado Journal: Eur Heart J Date: 2017-04-01 Impact factor: 29.983