A decades-old standard treatment for heart attack survivors may soon be rewritten. The largest trial of its kind has found that beta blockers—widely prescribed to millions of patients after a myocardial infarction—offer no benefit for those with preserved heart function and may even be harmful for women.
The findings come from the international REBOOT Trial, led by Valentin Fuster, MD, PhD, President of Mount Sinai Fuster Heart Hospital and Director General of Spain’s Centro Nacional de Investigaciones Cardiovasculares (CNIC). Results were presented August 30 at the European Society of Cardiology (ESC) Congress in Madrid and published simultaneously in The New England Journal of Medicine.
No Benefit in Modern Care
Researchers followed 8,505 patients across 109 hospitals in Spain and Italy for nearly four years. Participants were randomly assigned to receive or not receive beta blockers after hospital discharge. All patients received current standard care, including rapid reopening of blocked arteries and guideline-directed medications.
The trial found no significant differences between groups in death, recurrent heart attack, or hospitalization for heart failure. “More than 80 percent of patients with uncomplicated myocardial infarction are discharged on beta blockers,” said principal investigator Borja Ibáñez, MD, Scientific Director at CNIC. “REBOOT represents one of the most significant advances in heart attack treatment in decades.”
Higher Risk for Women
A substudy, published the same day in the European Heart Journal, revealed concerning sex-based differences. Women prescribed beta blockers had a higher risk of death, recurrent heart attack, or heart failure hospitalization compared with women who did not take the drug. This elevated risk was not seen in men.
Specifically, women with fully preserved heart function (left ventricular ejection fraction of 50% or higher) experienced a 2.7% higher absolute risk of mortality over the 3.7-year follow-up period when treated with beta blockers.
A Shift in Guidelines Ahead
For more than 40 years, beta blockers have been prescribed after heart attacks to reduce oxygen demand and prevent dangerous arrhythmias. But therapies have changed dramatically. With rapid interventions now limiting heart damage, the relevance of beta blockers in uncomplicated cases is increasingly in question.
“This trial will reshape international clinical guidelines,” Dr. Fuster said. “Like other landmark trials led by CNIC and Mount Sinai, REBOOT will transform global cardiovascular care.”
Previous landmark studies include the SECURE trial, which showed that a single “polypill” combining aspirin, ramipril, and atorvastatin reduced cardiovascular events by 33% after a heart attack, and the DapaTAVI trial, which found that diabetes drugs dapagliflozin and empagliflozin improved outcomes in patients undergoing transcatheter aortic valve implantation.
Patient Impact
Although generally considered safe, beta blockers are associated with fatigue, low heart rate, and sexual dysfunction. Removing unnecessary prescriptions could simplify care, reduce side effects, and improve quality of life for thousands of patients each year.
“The REBOOT trial was designed independently, without pharmaceutical funding, to optimize heart attack care based on scientific evidence,” Dr. Ibáñez noted. “These results will streamline treatment and set a new global standard.”
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