Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, NEJMoa2504735. https://doi.org/10.1056/NEJMoa2504735 Dr. Borja Ibanez et al.
Points
- A large randomized trial found that beta-blockers do not reduce death, reinfarction, or heart failure hospitalization after myocardial infarction in patients with a left ventricular ejection fraction above 40 percent.
- The study challenges a 40-year standard of care that was established before modern reperfusion therapies became routine, suggesting the longstanding treatment for an uncomplicated heart attack is no longer beneficial.
- A substudy revealed that women treated with beta-blockers, especially those with normal cardiac function, had a higher risk of adverse outcomes compared to women who did not receive the drug.
- These findings from the REBOOT trial are expected to reshape international clinical guidelines and streamline post-heart attack medication regimens, potentially reducing side effects and improving quality of life for patients.
- The trial’s conclusion supports discontinuing the routine prescription of beta-blockers for this specific patient population, highlighting the importance of re-evaluating established medical practices in light of evolving treatments.
Summary
A large, open-label, randomized trial (REBOOT) was conducted in Spain and Italy to re-evaluate the utility of beta-blocker therapy in the modern era of cardiac care. The study enrolled patients discharged after undergoing invasive treatment for acute myocardial infarction who had a left ventricular ejection fraction (LVEF) of 40% or higher. Current guidelines are based on trials conducted before the advent of contemporary pharmacotherapies, which have become the standard. The trial aimed to determine if beta-blockers, compared to no beta-blockers, reduced the primary composite outcome of death from any cause, reinfarction, or hospitalization for heart failure.
The primary analysis included 8,438 patients, with 4,243 assigned to receive beta-blockers and 4,262 to no beta-blocker therapy. Over a median follow-up of 3.7 years, no significant difference was observed in the primary outcome, which occurred in 316 patients in the beta-blocker group (22.5 events per 1000 patient-years) and 307 in the no-beta-blocker group (21.7 events per 1000 patient-years), yielding a hazard ratio of 1.04 (95% CI, 0.89 to 1.22; P=0.63). Component analyses showed no benefit for death from any cause (HR, 1.06; 95% CI, 0.85 to 1.33), reinfarction (HR, 1.01; 95% CI, 0.80 to 1.27), or hospitalization for heart failure (HR, 0.89; 95% CI, 0.58 to 1.38).
The trial concluded that beta-blocker therapy provided no clinical benefit for patients with myocardial infarction and an LVEF above 40% who received modern invasive care. Furthermore, a subgroup analysis found that women treated with beta-blockers, particularly those with a normal LVEF of 50% or higher, had a 2.7% higher absolute risk of mortality over the follow-up period compared to women not receiving the drug. These findings challenge the 40-year-old standard of care and are expected to inform the development of international clinical guidelines.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2504735
References Ibanez, B., Latini, R., Rossello, X., Dominguez-Rodriguez, A., Fernández-Vazquez, F., Pelizzoni, V., Sánchez, P. L., Anguita, M., Barrabés, J. A., Raposeiras-Roubín, S., Pocock, S., Escalera, N., Staszewsky, L., Pérez-García, C. N., Díez-Villanueva, P., Pérez-Rivera, J.-A., Prada-Delgado, O., Owen, R., Pizarro, G., … Fuster, V. (2025). Beta-blockers after myocardial infarction without reduced ejection fraction. New England Journal of Medicine, NEJMoa2504735. https://doi.org/10.1056/NEJMoa2504735
