ABSTRACT
Background There is a lack of evidence regarding the benefits of maintenance β–blocker (BB) treatment in post–acute AMI patients (pts) without reduced LVEF in the era of invasive management. Design and Trial Status REBOOT is an independent multinational pragmatic, controlled, randomized, open–label, with blinded endpoint adjudication clinical trial testing the benefits of BB maintenance therapy in post–AMI pts (either with or without ST segment elevation) discharged with LVEF >40%. Patients ≥18 years (yr) old undergoing invasive management during admission and without history of heart failure (HF) are eligible to participate. At discharge, pts are 1:1 randomized to either receive BB (agent and dose chosen by the treating physician) or no BB therapy. The primary endpoint is a composite of "all–cause death, nonfatal reAMI, or HF hospitalization” over a minimum follow–up period of 2 yr. Key secondary endpoints are: a) the incidence rate of each individual component of the composite endpoint;b) cardiovascular death;c) admission for sustained ventricular tachycardia/ventricular fibrillation;and d) admission for atrial fibrillation. Events will be adjudicated by a blinded committee. A sample size of 8468 pts (728 events) was estimated to provide a power of 85% to detect a relative risk reduction of 20% (incidence of primary endpoint in control 10%) and assuming 5% withdrawals. Statistical analyses will be conducted according to the intention–to–treat principle, although a pre–specified per–protocol analysis will also be performed. The Spanish National Center for Cardiovascular Research (CNIC) is the sponsor of the trial, which has no external funding. CNIC coordinates ≥75 Spanish centers, while Istituto di Ricerche Farmacologiche Mario Negri IRCCS coordinate 33 Cardiology Centers distributed in 10 Italian regions. The first pt was included in Spain in October 2018, in Italy in January 2019. The end of enrollment is anticipated in December 2022. At 09 December 2021, 5669 pts had been enrolled from which 1263 in Italy (Figure). Pts baseline characteristics are described in the Table. Hospital admission data for COVID–19 pre and post randomization were also recorded since June 2020. Conclusions The REBOOT trial (NCT03596385) will fill the existing scientific gap on the efficacy of β–BB after AMI in pts with LVEF > 40% and no HF who are treated according to current standard–of–care. REBOOT trial results might have an impact on clinical practice guidelines.
ABSTRACT
Background: There is a lack of evidence regarding the benefits of maintenance β- blocker (BB) treatment in post-acute AMI patients (pts) without reduced LVEF in the era of invasive management. Design and Trial Status: REBOOT is an independent multinational pragmatic, controlled, randomized, open-label, with blinded endpoint adjudication clinical trial testing the benefits of BB maintenance therapy in post-AMI pts (either with or without ST segment elevation) discharged with LVEF >40%. Patients ≥18 years (yr) old undergoing invasive management during admission and without history of heart failure (HF) are eligible to participate. At discharge, pts are 1:1 randomized to either receive BB (agent and dose chosen by the treating physician) or no BB therapy. The primary endpoint is a composite of “all-cause death, nonfatal reAMI, or HF hospitalization” over a minimum follow-up period of 2 yr. Key secondary endpoints are: a) the incidence rate of each individual component of the composite endpoint;b) cardiovascular death;c) admission for sustained ventricular tachycardia/ventricular fibrillation;and d) admission for atrial fibrillation. Events will be adjudicated by a blinded committee. A sample size of 8468 pts (728 events) was estimated to provide a power of 85% to detect a relative risk reduction of 20% (incidence of primary endpoint in control 10%) and assuming 5% withdrawals. Statistical analyses will be conducted according to the intention-to-treat principle, although a pre-specified per-protocol analysis will also be performed. The Spanish National Center for Cardiovascular Research (CNIC) is the sponsor of the trial, which has no external funding. CNIC coordinates ≥75 Spanish centers, while Istituto di Ricerche Farmacologiche Mario Negri IRCCS coordinate 33 Cardiology Centers distributed in 10 Italian regions. The first pt was included in Spain in October 2018, in Italy in January 2019. The end of enrollment is anticipated in December 2022. At 09 December 2021, 5669 pts had been enrolled from which 1263 in Italy (Figure). Pts baseline characteristics are described in the Table. Hospital admission data for COVID-19 pre and post randomization were also recorded since June 2020. Conclusions: The REBOOT trial (NCT03596385) will fill the existing scientific gap on the efficacy of β-BB after AMI in pts with LVEF > 40% and no HF who are treated according to current standard-of-care. REBOOT trial results might have an impact on clinical practice guidelines. (Figure Presented).