학술논문
Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myocardial infarction withOut reduced ejection fracTion (REBOOT)
Document Type
Academic Journal
Author
Rossello, Xavier; Raposeiras-Roubin, Sergio; Latini, Roberto; Dominguez-Rodriguez, Alberto; Barrabes, Jose A.; Sanchez, Pedro L.; Anguita, Manuel; Fernandez-Vazquez, Felipe; Pascual-Figal, Domingo; Hernandez, Jose M. De la Torre; Ferraro, Stefano; Vetrano, Alfredo; Perez-Rivera, Jose A.; Prada-Delgado, Oscar; Escalera, Noemi; Staszewsky, Lidia; Pizarro, Gonzalo; Aguero, Jaume; Pocock, Stuart; Ottani, Filippo; Fuster, Valentin; Ibanez, Borja
Source
European Heart Journal: Cardiovascular Pharmacotherapy. May 2022, Vol. 8 Issue 3, p291, 11 p.
Subject
Language
English
ISSN
2055-6837
Abstract
Introduction The clinical benefit of [beta]-blockers after a myocardial infarction (Ml) in patients with reduced left ventricular ejection fraction (LVEF) is supported by solid evidence from modern trials. (1-3) However, [...]
Aims There is a lack of evidence regarding the benefits of [beta]-blocker treatment after invasively managed acute myocardial infarction (Ml) 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 [beta]-blocker maintenance therapy in patients discharged after Ml 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 [beta]-blocker therapy (agent and dose according to treating physician) or no [beta]-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 [beta]-blockers to patients discharged after Ml without reduced LVEF. Keywords [beta]-Blockers * Acute myocardial infarction * Left ventricular ejection fraction * Randomized clinical trial
Aims There is a lack of evidence regarding the benefits of [beta]-blocker treatment after invasively managed acute myocardial infarction (Ml) 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 [beta]-blocker maintenance therapy in patients discharged after Ml 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 [beta]-blocker therapy (agent and dose according to treating physician) or no [beta]-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 [beta]-blockers to patients discharged after Ml without reduced LVEF. Keywords [beta]-Blockers * Acute myocardial infarction * Left ventricular ejection fraction * Randomized clinical trial