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

Xavier Rossello, Sergio Raposeiras-Roubin, Roberto Latini, Alberto Dominguez-Rodriguez, Jose A. Barrabes, Pedro L. Sánchez, Manuel Anguita, Felipe Fernández-Vázquez, Domingo Pascual-Figal, Jose M. De La Torre Hernandez, Stefano Ferraro, Alfredo Vetrano, Jose A. Perez-Rivera, Oscar Prada-Delgado, Noemí Escalera, Lidia Staszewsky, Gonzalo Pizarro, Jaume Agüero, Stuart Pocock, Filippo OttaniValentín Fuster, Borja Ibáñez

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

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.

Original languageEnglish
Pages (from-to)291-301
Number of pages11
JournalEuropean Heart Journal - Cardiovascular Pharmacotherapy
Volume8
Issue number3
DOIs
StatePublished - 1 May 2022
Externally publishedYes

Keywords

  • Acute myocardial infarction
  • Left ventricular ejection fraction
  • Randomized clinical trial
  • β-Blockers

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