Xavier Rossello1,2,3, Sergio Raposeiras-Roubin1,4, Roberto Latini5, Alberto Dominguez-Rodriguez3,6, José A Barrabés3,7, Pedro L Sánchez3,8, Manuel Anguita9, Felipe Fernández-Vázquez10, Domingo Pascual-Figal1,3,11, José M De la Torre Hernandez12, Stefano Ferraro13, Alfredo Vetrano14, José A Pérez-Rivera15, Oscar Prada-Delgado16, Noemí Escalera1, Lidia Staszewsky5, Gonzalo Pizarro1,3,17, Jaume Agüero3,18, Stuart Pocock19, Filippo Ottani20, Valentín Fuster1,21, Borja Ibáñez1,3,22. 1. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Melchor Fernández Almagro 3. 28029 Madrid, Spain. 2. Cardiology Department, Hospital Universitari Son Espases-IDISBA, Palma de Mallorca, Spain. 3. CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain. 4. Cardiology Department, University Hospital Álvaro Cunqueiro, Vigo, Spain. 5. Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy. 6. Servicio de Cardiología, Hospital Universitario de Canarias, Tenerife, Spain. 7. Department of Cardiology, Hospital Universitari Vall d'Hebron, Universitat Autònoma, Barcelona, Spain. 8. Cardiology Department, University Hospital of Salamanca, Biomedical Research Institute of Salamanca (IBSAL), Salamanca, Spain. 9. Department of Cardiology, Hospital Universitario Reina Sofía de Cordoba, Córdoba, Spain. 10. Cardiology Department, Hospital Universitario de León, León, Spain. 11. Cardiology Department, Hospital Virgen de la Arrixaca, IMIB-Arrixaca and University of Murcia, Murcia, Spain. 12. Cardiology Department, Hospital Marques de Valdecilla, IDIVAL, Santander, Spain. 13. Cardiology Department, Ospedale Guglielmo da Saliceto, Piacenza, Italy. 14. Cardiology Department, Ospedale S. Anna e S. Sebastiano, Caserta, Italy. 15. Department of Cardiology, Hospital Universitario de Burgos, Burgos, Spain. 16. Department of Cardiology, Hospital Universitario A Coruña, A Coruña, Spain. 17. Cardiology Department, Hospital Ruber Juan Bravo Quironsalud UEM, Madrid, Spain. 18. Cardiology Department, Hospital Universtitari i Politecnic La Fe, Valencia, Spain. 19. London School of Hygiene & Tropical Medicine, London, UK. 20. Cardiology Department, Ospedale Vizzolo Predabissi di Melegnano, Milan, Italy. 21. Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 22. IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Abstract
AIMS: There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. CONCLUSION: The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.
AIMS: There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. CONCLUSION: The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.
Authors: Sophia Humphries; John Wallert; Katarina Mars; Claes Held; Robin Hofmann; Erik M G Olsson Journal: Eur Heart J Acute Cardiovasc Care Date: 2022-06-22