Vincent Roolvink1, Borja Ibáñez2, Jan Paul Ottervanger1, Gonzalo Pizarro3, Niels van Royen4, Alonso Mateos5, Jan-Henk E Dambrink1, Noemi Escalera6, Erik Lipsic7, Agustín Albarran8, Antonio Fernández-Ortiz9, Francisco Fernández-Avilés10, Javier Goicolea11, Javier Botas12, Wouter Remkes1, Victoria Hernandez-Jaras5, Elvin Kedhi1, José L Zamorano13, Felipe Navarro14, Fernando Alfonso15, Alberto García-Lledó16, Joaquin Alonso17, Maarten van Leeuwen4, Robin Nijveldt4, Sonja Postma18, Evelien Kolkman18, Marcel Gosselink1, Bart de Smet19, Saman Rasoul20, Jan J Piek21, Valentin Fuster22, Arnoud W J van 't Hof23. 1. Department of Cardiology, Isala Hospital, Zwolle, the Netherlands. 2. Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Department of Cardiology, IIS-Fundacion Jimenez Díaz Hospital, Madrid, Spain. 3. Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Department of Cardiology, Hospital Universitario Quirón, Universidad Europea de Madrid & Hospital Ruber-Quirónsalud, Madrid, Spain. 4. Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands. 5. Department of Cardiology, Servicio de Urgencia Medica de Madrid (SUMMA 112), Madrid, Spain. 6. Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain. 7. Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands. 8. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain. 9. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Clínico San Carlos, Madrid, Spain. 10. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Gregorio Marañón, Madrid, Spain. 11. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Puerta de Hierro, Madrid, Spain. 12. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Fundación Alcorcón, Madrid, Spain. 13. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Ramón y Cajal, Madrid, Spain. 14. Department of Cardiology, IIS-Fundacion Jimenez Díaz Hospital, Madrid, Spain; Department of Cardiology, Codigo Infarto, Madrid, Spain. 15. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital de La Princesa, Madrid, Spain. 16. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain. 17. Department of Cardiology, Codigo Infarto, Madrid, Spain; Department of Cardiology, Hospital de Getafe, Madrid, Spain. 18. Diagram, Diagnostic Research and Management, Zwolle, the Netherlands. 19. Department of Cardiology, Meander Medisch Centrum, Amersfoort, the Netherlands. 20. Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands. 21. Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands. 22. Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 23. Department of Cardiology, Isala Hospital, Zwolle, the Netherlands. Electronic address: v.r.c.derks@isala.nl.
Abstract
BACKGROUND: The impact of intravenous (IV) beta-blockers before primary percutaneous coronary intervention (PPCI) on infarct size and clinical outcomes is not well established. OBJECTIVES: This study sought to conduct the first double-blind, placebo-controlled international multicenter study testing the effect of early IV beta-blockers before PPCI in a general ST-segment elevation myocardial infarction (STEMI) population. METHODS:STEMI patients presenting <12 h from symptom onset in Killip class I to II without atrioventricular block were randomized 1:1 to IV metoprolol (2 × 5-mg bolus) or matched placebo before PPCI. Primary endpoint was myocardial infarct size as assessed by cardiac magnetic resonance imaging (CMR) at 30 days. Secondary endpoints were enzymatic infarct size and incidence of ventricular arrhythmias. Safety endpoints included symptomatic bradycardia, symptomatic hypotension, and cardiogenic shock. RESULTS: A total of 683 patients (mean age 62 ± 12 years; 75% male) were randomized to metoprolol (n = 336) or placebo (n = 346). CMR was performed in 342 patients (54.8%). Infarct size (percent of left ventricle [LV]) by CMR did not differ between the metoprolol (15.3 ± 11.0%) and placebo groups (14.9 ± 11.5%; p = 0.616). Peak and area under the creatine kinase curve did not differ between both groups. LV ejection fraction by CMR was 51.0 ± 10.9% in the metoprolol group and 51.6 ± 10.8% in the placebo group (p = 0.68). The incidence of malignant arrhythmias was 3.6% in the metoprolol group versus 6.9% in placebo (p = 0.050). The incidence of adverse events was not different between groups. CONCLUSIONS: In a nonrestricted STEMI population, early intravenous metoprolol before PPCI was not associated with a reduction in infarct size. Metoprolol reduced the incidence of malignant arrhythmias in the acute phase and was not associated with an increase in adverse events. (Early-Beta blocker Administration before reperfusion primary PCI in patients with ST-elevation Myocardial Infarction [EARLY-BAMI]; EudraCT no: 2010-023394-19).
RCT Entities:
BACKGROUND: The impact of intravenous (IV) beta-blockers before primary percutaneous coronary intervention (PPCI) on infarct size and clinical outcomes is not well established. OBJECTIVES: This study sought to conduct the first double-blind, placebo-controlled international multicenter study testing the effect of early IV beta-blockers before PPCI in a general ST-segment elevation myocardial infarction (STEMI) population. METHODS: STEMI patients presenting <12 h from symptom onset in Killip class I to II without atrioventricular block were randomized 1:1 to IV metoprolol (2 × 5-mg bolus) or matched placebo before PPCI. Primary endpoint was myocardial infarct size as assessed by cardiac magnetic resonance imaging (CMR) at 30 days. Secondary endpoints were enzymatic infarct size and incidence of ventricular arrhythmias. Safety endpoints included symptomatic bradycardia, symptomatic hypotension, and cardiogenic shock. RESULTS: A total of 683 patients (mean age 62 ± 12 years; 75% male) were randomized to metoprolol (n = 336) or placebo (n = 346). CMR was performed in 342 patients (54.8%). Infarct size (percent of left ventricle [LV]) by CMR did not differ between the metoprolol (15.3 ± 11.0%) and placebo groups (14.9 ± 11.5%; p = 0.616). Peak and area under the creatine kinase curve did not differ between both groups. LV ejection fraction by CMR was 51.0 ± 10.9% in the metoprolol group and 51.6 ± 10.8% in the placebo group (p = 0.68). The incidence of malignant arrhythmias was 3.6% in the metoprolol group versus 6.9% in placebo (p = 0.050). The incidence of adverse events was not different between groups. CONCLUSIONS: In a nonrestricted STEMI population, early intravenous metoprolol before PPCI was not associated with a reduction in infarct size. Metoprolol reduced the incidence of malignant arrhythmias in the acute phase and was not associated with an increase in adverse events. (Early-Beta blocker Administration before reperfusion primary PCI in patients with ST-elevation Myocardial Infarction [EARLY-BAMI]; EudraCT no: 2010-023394-19).
Authors: Maarit J Korhonen; Jennifer G Robinson; Izabela E Annis; Ryan P Hickson; J Simon Bell; Juha Hartikainen; Gang Fang Journal: J Am Coll Cardiol Date: 2017-09-26 Impact factor: 24.094
Authors: Nina W van der Hoeven; Gladys N Janssens; Guus A de Waard; Henk Everaars; Christopher J Broyd; Casper W H Beijnink; Peter M van de Ven; Robin Nijveldt; Christopher M Cook; Ricardo Petraco; Tim Ten Cate; Clemens von Birgelen; Javier Escaned; Justin E Davies; Maarten A H van Leeuwen; Niels van Royen Journal: JAMA Cardiol Date: 2019-08-01 Impact factor: 14.676