Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT)
Authors: Rossello Xavier , Raposeiras-Roubin Sergio , Latini Roberto , Dominguez-Rodriguez Alberto , Barrabés José A , Sánchez Pedro L , Anguita Manuel , Fernández-Vázquez Felipe , Pascual-Figal Domingo , De la Torre Hernandez José M , Ferraro Stefano , Vetrano Alfredo , Pérez-Rivera José A , Prada-Delgado Oscar , Escalera Noemí , Staszewsky Lidia , Pizarro Gonzalo , Agüero Jaume , Pocock Stuart , Ottani Filippo , Fuster Valentín , Ibáñez Borja ,   REBOOT-CNIC investigators, Andres Abel , Autieri Adriano , Ariza Albert , Cordero Alberto , Costalunga Alessandra , Navazio Alessandro , Sionis Alessandro , Torres Alfonso , Valle Alfonso , Bardaji Alfredo , Renilla Alfredo , Olaru Alina , García-Alvarez Ana , Campos Ana Maria , Perez-Rivera Angel , Aloisi Annalisa , Bayes-Genis Antonio , Ortiz Antonio Ignacio Fernández , Rizzo Antonio , Coutsoumbas Barbara , Mariottoni Beatrice , Zawaideh Camilla Renèe , Gonzalez-Juanatey Carlos , Querol Carlos Tomás , Rus Carmen , Vimercati Claudio , Vetrano Danilo Saverio , Gentille Delicia , Alegría Eduardo , Arroyo Eduardo , Escobar Eduardo Moreno , Martínez-Quintana Efrén , Martinoli Elena , Marco Elvira , Vitale Enrica , Nicolis Enrico , Gazzola Erika , Mesolella Ezio , Navarro Felipe , Manca Francesco , Fernández-Aviles Francisco , Marin-Ortuño Francisco , Torres Francisco , Vázquez-Oliva Gabriel , Perna Gian Piero , Casella Gianni , Sirianni Giovanni , Grigis Giuletta , Bugani Giulia , Pongetti Giulia , Di Tano Giuseppe , Navarrete Gonzalo , Bueno Hector , Paris Hugo , Moeller Ines , Hernandez Isidro , Pariggiano Ivana , Román J Alberto San , Botas Javier , Palet Jordi , Sanchez Jorge , Ramirez Jose A , Cabrera José Angel , Díaz José , Ruiz José Manuel García , Gonzalez-Juanatey Jose R , Rozado Jose , Alegret Josep Maria , García Rubira Juan C , Bonilla Juan Luis , Ruiz-García Juan , Sanchis Juan , Hernandez Julio , Calò Lorenzo , Rollan Mª Jesus , de Mora Manuel , Solari Marco , Perrelli Maria Giulia , de Iacono Maria Rosa , Buffa Mariachiara , Lombardi Mario , Bianco Matteo , Rondi Mauro , Brunetti Natale , De Cesare Nicoletta , De Santis Nicoletta , Diaz Oscar , Fabregat-Andres Oscar , Bazal Pablo , Morillas Pedro , Sanz Petra , Basso Pierangelo , Ieva Ricardo , Carletti Roberto , Martin Roberto , Freixa Roman , Fernandez Rosa , Ortas Rosario , Meloni Sabina , Tondi Stefano , Regazzoni Valentina , Mora Vicente , García Agustín Martín , Cervero Alba , Martin Alba , Cambra Albert Duran , Massó-van Roessel Albert , Pérez Alberto , Pullara Alberto , Aldomà Albina , Amador Alejandro , Junco Alejandro , Pascual Alejandro , Rodriguez Alejandro , Grande-Flecha Alejandro Sanchez , Villanueva Alejandro , Vitagliano Alice , Pavés Alicia Bautista , Gainza Alicia , Moreno Alicia , Aceña Alvaro , Vicedo Alvaro , Laffond Ana Elvira , Santos Ana Isabel , Moralejo Ana María , Merino Ana , Pello-Lázaro Ana M , Portoles Ana , Roman Ana , Testa Ana , Ayesta Ana , Cafro Andrea , Chiampan Andrea , Finzi Andrea , Kallmeyer Andrea , Lopez Andrea , Rubboli Andrea , Veliz Andrea , Iñiguez Andrés , Morist Andres , Aboitiz Ane , Franch Angel , Alonso Angela , Juez Angela , Romero Angelica , Carrasquer Anna , Vasamì Antonella , Perelló-Bordoy Antoni , Sambola Antonia , Gamez Antonio , Martín Antonio Jesus , Lara-Padrón Antonio , Miñano Antonio , Piñero Antonio , Quesada Antonio , Tello Antonio , Gil Aritz , Perez Armando , Lanaspa Arturo , Diaz Aurora , Majado Beatriz de Tapia , Saiz Beatriz , Samaniego Beatriz , Sampedro Beatriz , Alvarez Belen , Prado Belen , Caneiro Berenice , Borges Bernardo Ayala , Vega Berta , Olaizola Betel , Olivares Blanca , Jimenez Carla , Baladrón Carlos , Galán Carlos , Miguito Carlos , Rodriguez Carlos Millan , Ortiz Carlos , Guerrero Carmen , Palacios Carmen , Hernández-Luis Carolina , Redondo Carolina , Sorto Carolina , Corros Cecilia , Lopez Cecilia , Cortina Charo , Angeletti Chiara , Santos Claudia , Gonzalez Clea , Oliva Conchita , García Cosme , Cambeiro Cristina , Sanchez-Enrique Cristina , Tapia Cristina , de Sousa Damaris , Grosseto Daniele , Nassiacos Daniele , Gomez David , Rutigliano David , Vivas David , Cosmi Deborah , Arroyo Diego , Fernández Dolores Ruiz , Caballero Eduardo , Zatarain Eduardo , Barbaresi Elena , Batlle Elena , España Elena , Lopez Elena , Tundidor Elena , de Buruaga Elene Saez , Fernandez Elisabeth , David Eliu , Eirín Elizabet Méndez , Assi Emad Abu , Bertolino Emanuela Clara , Blanco Emilia , Cerrato Enrico , Gotti Enrico , Río Enrique Iglesias , Leon Enrique , Sanchez Enrique , del Amo Ernesto , Hernandez Ernesto , Capin Esmeralda , Sánchez-Corral Ester , Vilei Eugenio , Gonzalez Eva , Santamaria Eva , Santamaria Eva , Poletti Fabrizio , del Giudice Federica , Achilli Felice , Arribas Fernando , di Dona Filippo Maria , Baeza Flor , Pietrucci Francesca , Pastor Francisco José , Burillo Francisco Manuel , Rivera Francisco , Gonzalez Fco Jesus , Hurtado Gabriel , Sanchez Gabriel , Foresti Gabriella , Melis Gaspar , Oristrell Gerard , Danzi Gian Battista , Piovaccari Giancarlo , Pistis Gianfranco , Bonet Gil , Tortorella Giovanni , de Oliverira Gislaine Castilho , Martin Gonzalo , Moreno Guillermo , García Hector , Tajes Hernan , García Iciar , Piedra Iciar , Hernandez-Baldomero Idaira Famara , Sanchez Ignacio , Lunar Inés García , Fernandez Inmaculada , Buera Irene , Sempere Irene , Toribio Irene , Martinez Iria , Silva Iria , Garrido Iris , Hernández Isabel , Larrabide Itsaso , Olavarri Ivan , Monedero Jairo , Pons Jaume , Borrego Javier , Castrodeza Javier , Díaz Javier López , Maillo Javier , Mendoza Javier , Rekondo Javier , Simón Javier , Tobar Javier , Zueco Javier , Tschischke Jean Paul Vilchez , Roa Jessica , Vaquero Jessica , Gonzalez Jessika , Carmona Jesus , Molina Jesús , Zarauza Jesus , Fernández José Ángel Rodríguez , Romero Jose Enrique , Sanchez Jose Javier , Jimenez Jose Juan , Vazquez Jose Manuel , Rivera-Caravaca Jose Miguel , Amigo Jose Seijas , Tuñón Jose , García Josefa , Muñoz Juan Carlos , Escudero Juan , Franco Juan , Milla Juan Martínez , Miguez Juan Ocampo , Gonzalez Julia , Echarte Julio , Alvarez Laura , de la Fuente Blanco Laura , García Laura , Montagna Laura , Pertejo Laura , Sotelo Laura Rodríguez , Goikolea Leire , Goñi Leire , Martinez Lidia , Riesco Lorena Garcia , Matute-Blanco Lucía , Cebey Lucía Pérez , Leston Lucia Rioboo , Cerdán Luis , de la Fuente-Galán Luis , Martinez Luis , Guerrero Luis Ruiz , Carrillo Luna , Carrillo Luna , Esteve Mª Asun , Carrillo Magdalena , Sabate Manel , Iglesias Manuel , Gómez Manuel Jesús , Lobo Manuel , Lopez Manuel , Ruozzi Marco , Farrais Marcos , Puteo Maria Alessandra , Rubín María del Carmen Gómez , Facenda Maria , García Maria , Garrido María , Pallotti Maria Giovanna , Ezpeleta Maria Isabel , García Maria Jesus , Antolinos Maria Jose , Lasala Maria , Alvarez María López , Benito María López , Rodriguez Maria Luisa , Mariscal María Martín , Melendo Maria , Molina María , Ramos Maria , Rivadeneira Maria , Perez Maria Teresa , Matassini Maria Vittoria , Quintanilla Mariam , Gonzalez Maribel , Oliver Marina , Revilla Marina , Alonso-Fernández-de-Gatta Marta , Fernández Marta , Lopez Marta , Martin-Cabeza Marta , Monteagudo Marta , Santisteban Marta , Torres Marta , Torres Marta , Piepoli Massimo , Azzarone Matteo , Lisi Matteo , Mangiavacchi Maurizio , Ezzitoun Meryem , Arnau Arnau Miguel Angel , Lapeña Miguel , Molina Miguel , Puentes Miguel , Soroa Miguel , Martinez Mikel , Vives Miquel , Salim Miriam , Hernandez Nacho , Mollichelli Nadia , Sosa Nelva , Simonelli Niccolò , Locuratolo Nicola , Romero Nieves , Rojo-Prieto Noelia , Barja Noemi , Gómez Norberto Herrera , Sánchez Nuria , Zaldua Olatz , Caldes Onofre , De Diego Oriol , Rodriguez Oriol , González Oscar , Peiró Oscar M , Vedia Oscar , Gil Pablo , Jorge-Pérez Pablo , Fernández Pablo Manuel , Jover-Pastor Pablo , Martinez Pablo , Pastor Pablo , Avila Paloma , Sganzerla Paolo , Baratta Pasquale , Caldarola Pasquale , Arenas Patricia , Rello Pau , García Paula , Menendez Paula , Dorado Pedro Luis , Martin Pedro , Vigil Pedro , Bourio Rafa , Cobas Rafael , Hidalgo Rafael , Moscicki Rafael , Andion Ramon , Rios Ramon , Muñoz Raquel Díaz , Marzoa Raquel , Ocaranza Raymundo , Martin Roberto , Barquero Rocío , Ruiz Rocio , Fernandez Rodrigo , Bangueses Roi , Navarri Romina , Agra Rosa , Sanchez Rosa , Bergel Ruben , Sanchez Ruth , Talavera Sandra Gómez , García-Mancebo Santiago , Cardenas Sergio , Huertas Sergio , Huertas Sergio , Bayona Silvia , Gopar Silvia , Lozado-Edo Silvia , Mera Silvia , Prieto Silvia , Stabellini Silvia , D'Orazio Simona , Santos Sonia , Huertas Susana Martinez , Fernández Tamara , García Tamara , Seoane Tania , García Tania Seoane , Simón Teresa , Soriano Toni , Limbruno Ugo , Pelizzoni Valentina , Epureanue Valerio , Alonso Vanesa , Artiaga Verónica , Bertomeu-Gonzalez Vicente , Peral Vicente , Donoso Víctor , Perez Víctor , Rojo Víctor Puebla , Espejo Victoria , Platero Victoria , Mass Virginia , Bragagnini Walter , Martinez Xurxo , Gallego Yolanda , Persia Yvan 
Published: August 2021

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 &gt;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.