Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT)
Xavier Rosselló, Sergio Raposeiras‐Roubín, Roberto Latini, Alberto Domínguez‐Rodríguez, José A. Barrabés, Pedro L. Sánchez, Manuel Anguita, Felipe Fernández‐Vázquez, Domingo A. Pascual‐Figal, José M. de la Torre Hernández, Stefano Ferraro, Alfredo Vetrano, Jose-Ángel Pérez-Rivera, Óscar Prada‐Delgado, Noemí Escalera, Lidia Staszewsky, Gonzalo Pizarro, Jaume Agüero, Stuart Pocock, Filippo Ottani, Valentı́n Fuster, Borja Ibáñez, REBOOT-CNIC investigators, A. Gómez-Caro Andrés, Adriano Autieri, Albert Ariza, Alberto Cordero, Alessandra Costalunga, Alessandro Navazio, Alessandro Sionís, Alfonso Torres, Alfonso Serrano del Valle, Alfredo Bardajı́, Alfredo Renilla, Alina Olaru, Ana García‐Álvarez, A.M. Villanueva Campos, Jose-Ángel Pérez-Rivera, Annalisa Aloisi, Antoni Bayés‐Genís, Antonio Ignacio Fernández Ortiz, A Rizzo, Barbara Coutsoumbas, Beatrice Mariottoni, Camilla Zawaideh, Carlos González‐Juanatey, Carlos Tomás Querol, Carmen Rus, C Vimercati, Danilo Saverio Vetrano, Delicia Gentille, Eduardo Alegría, Eduardo Arroyo, Eduardo Moreno Escobar, Efrén Martínez‐Quintana, E Martinoli, Elvira Marco, Enrica Vitale, Enrico Nicolis, Erika Gazzola, Ezio Mesolella, Felipe Navarro, Francesco Manca, Francisco Fernández‐Avilés, Francisco Marín‐Ortuño, Francisco Torres, Gabriel Vázquez-Oliva, Gian Piero Perna, Gianni Casella, Giovanni Sirianni, Giuletta Grigis, Giulia Bugani, Giulia Pongetti, Giuseppe Di Tano, Gonzalo Navarrete, Héctor Bueno, Hugo París, I Moeller, Isidro Hernandez, Ivana Pariggiano, J. Alberto San Román, Javier Botas, Jordi Palet, Jorge Sanz‐Sánchez, José A. Ramírez, José Ángel Cabrera, José Díaz, José Manuel García Ruiz, José Ramón González‐Juanatey, José Rozado, Josep M. Alegret, Juan C. Garcı́a-Rubira, J L Bonilla, Juan Ruiz-García, Juan Sanchís, Julio Hernandez, Lorenzo Calò, Ma Jesus Rollan, Manuel de Mora, Marco Solari
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.