A groundbreaking study known as the REBOOT Trial, led by senior investigator Valentin Fuster, MD, PhD, President of Mount Sinai Fuster Heart Hospital and General Director of Spain’s Centro Nacional de Investigaciones Cardiovasculares (CNIC), has the potential to revolutionize standard treatment practices for patients after a heart attack. The findings were unveiled on Saturday, August 30, during a prestigious "Hot Line" session at the European Society of Cardiology Congress in Madrid and were simultaneously published in The New England Journal of Medicine.
In addition to the primary findings, a substudy from the REBOOT Trial, published in the European Heart Journal, revealed concerning results for women treated with beta blockers. This subgroup analysis indicated that women experienced a higher risk of death, heart attack, or hospitalization for heart failure compared to those who did not receive the medication. Interestingly, this increased risk was not observed in men. Dr. Fuster emphasized, “This trial will reshape all international clinical guidelines,” highlighting the significance of these results.
The REBOOT Trial joins a series of influential studies led by CNIC and Mount Sinai, such as the SECURE trial, which demonstrated that a polypill combining three medications—aspirin, ramipril, and atorvastatin—can reduce cardiovascular events by an impressive 33 percent in patients recovering from a heart attack. Additionally, the DapaTAVI trial found that medications like dapagliflozin and empagliflozin, used primarily for diabetes treatment, significantly improve the prognosis for patients with aortic stenosis undergoing transcatheter aortic valve implantation.
“REBOOT will change clinical practice worldwide,” stated Borja Ibáñez, MD, CNIC’s Scientific Director and Principal Investigator of the trial. Currently, over 80 percent of patients with uncomplicated myocardial infarction are discharged on beta blockers. The REBOOT findings represent one of the most significant advancements in heart attack treatment in decades, potentially altering the way healthcare professionals approach post-heart attack care.
While beta blockers have been regarded as generally safe, they can lead to side effects such as fatigue, bradycardia (low heart rate), and sexual dysfunction. For over 40 years, these medications have been a standard treatment following a heart attack. However, the benefits of beta blockers in the context of modern treatments were previously unverified. The REBOOT Trial stands as the largest clinical trial addressing this issue.
The international study was coordinated by CNIC in collaboration with the Mario Negri Institute for Pharmacological Research in Milan. A total of 8,505 patients were enrolled across 109 hospitals in Spain and Italy. Participants were randomly assigned to receive either beta blockers or standard care without the medication. All patients were monitored for a median duration of nearly four years.
The trial results revealed no significant differences between the two groups concerning rates of death, recurrent heart attacks, or hospitalization for heart failure. However, the subgroup analysis highlighted that women on beta blockers faced a 2.7 percent higher absolute risk of mortality compared to their counterparts who did not receive the medication during the 3.7 years of follow-up. Notably, this elevated risk was confined to women with normal cardiac function following a heart attack.
Dr. Ibáñez explained, “After a heart attack, patients are typically prescribed multiple medications, which can complicate adherence.” While beta blockers were historically added to treatment regimens to reduce mortality, advancements in medical technology have significantly improved patient outcomes. As coronary arteries are now reopened more effectively, the necessity for beta blockers in many cases remains uncertain.
The motivation behind the REBOOT Trial was to optimize heart attack care based on robust scientific evidence and without commercial interests. “These results will help streamline treatment, reduce side effects, and improve the quality of life for thousands of patients every year,” said Dr. Ibáñez, emphasizing the trial's potential to change the landscape of heart attack treatment.
As the medical community absorbs these findings, the implications for the treatment of heart attack patients could lead to a significant shift in how healthcare providers approach post-event care, ultimately improving patient outcomes worldwide.
