Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).

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). The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial...

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Detalhes bibliográficos
Autores: Rosselló, Xavier, Raposeiras-Roubin, Sergio, Latini, Roberto, Dominguez-Rodriguez, Alberto, Barrabés, José A., Sanchez, Pedro Luis, Anguita, Manuel, Fernández-Vázquez, Felipe, Pascual-Figal, Domingo, de la Torre Hernández, 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
Tipo de documento: artigo
Data de publicação:2022
País:España
Recursos:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositório:Docusalut
Idioma:inglês
OAI Identifier:oai:docusalut.com:20.500.13003/20159
Acesso em linha:https://hdl.handle.net/20.500.13003/20159
Access Level:Acceso aberto
Palavra-chave:Prospective Studies
Adrenergic beta-Antagonists
Stroke Volume
Humans
Ventricular Dysfunction, Left
Ventricular Function, Left
Myocardial Infarction
Función Ventricular Izquierda
Humanos
Estudios Prospectivos
Infarto del Miocardio
Volumen Sistólico
Disfunción Ventricular Izquierda
Antagonistas Adrenérgicos beta
Descrição
Resumo: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). 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. The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.

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