For over 40 years, beta-blockers have been prescribed to the survivors of the heart attack as a standard treatment. But the massive restart test revealed that they did not provide any advantage to patients with a preserved heart function – and can in fact increase the risks for women.
Standard treatment interviewed after 40 years
Beta-blockers, commonly prescribed for heart disease, including heart attacks, now offer no measurable advantage to patients who experience a simple myocardial infarction while maintaining a normal heart function. Although it is recommended for this group for four decades, their effectiveness in such cases is now questioned.
The conclusion comes from the restart test, a major study led by Valentin Fuster, MD, PHD, president of the Mount Sinai Fuster Heart Hospital and Director General of the Centro Nacional de Investigaciones Cardiovasculares (CNIC). The results, which question one of the oldest practices in cardiology, were presented on August 30, during a “hot line” session at the Congress of the European Cardiology Society in Madrid and published at the same time in The New England Journal of Medicine.
Higher risks for exposed women
A complementary restart, released the same day in the European Heart Journalrevealed an important difference between men and women. Women who were treated with beta-blockers after a heart attack have faced a greater probability of dying, suffering from another heart attack or to be hospitalized for heart failure compared to women who have not received the medication. This increased risk was not observed in men.
“This trial will reshape all international clinical directives. He joins other previous historical tests led by CNIC and Mount Sinai – like Secure with Polypill and Dapatavi, with the inhibition of SLT2 associated with TAVI – which have already transformed certain global approaches of cardiovascular disease“Explains Dr. Fuster.
The secure trial has shown a polypill, a single pill that combines three drugs – which contains aspirin, ramipril and atorvastatin – reduces 33% cardiovascular events in patients treated with this after a heart attack. The Dapatavi trial has shown that dapagliflozine and the associated medication empagliflozine – drugs used to treat diabetes – improve the prognosis of patients with aortic stenosis treated by implantation of Aortic Valve Transcatheter.
World impact on heart attack
“Restarting will change clinical practice worldwide,” explains the main investigator Borja Ibáñez, MD, scientific director of CNIC, who presented the results. “Currently, more than 80% of patients with uncomplicated myocardial infarction are released on beta-blockers. The results of the restart represent one of the most important progress in the treatment of heart attacks for decades. ”
Although generally considered safe, beta-blockers can cause side effects such as fatigue, bradycardia (low heart rate) and sexual dysfunction. For over 40 years, beta-blockers have been prescribed as a standard treatment after a heart attack, but their advantage in the context of modern treatments was not proven. The restart test is the largest clinical trial on this subject. The international study was coordinated by CNIC in collaboration with the Mario Negri for Pharmacological Institute Research in Milan.
The biggest beta-blocker study to date
Researchers have scored 8,505 patients in 109 hospitals in Spain and Italy. Participants were randomly assigned to receive or not receive beta-blockers after the hospital release. All patients have otherwise received the current care standard and were followed for a median of almost four years. The results have shown no significant difference between the two groups in death rates, the recurring heart attack or hospitalization for heart failure.
An analysis of the restart sub-group revealed that women treated with beta-blockers have experienced more unwanted events. The results show that women treated with beta-blockers presented an absolute risk of mortality of 2.7% higher than those not treated with beta-blockers during the 3.7 years of studying the study. The high risk when treated with beta-blockers was limited to women with a completely normal heart function after a heart attack (left ventricular ejection fraction of 50% or more). Those who have a slight deterioration of cardiac function had no excessive risk of unwanted results when treated with beta-blockers.
Why the old standard no longer corresponds
“After a heart attack, patients are generally prescribed multiple drugs, which can make adhesion difficult,” said Dr. Ibáñez. “Beta-blockers were added to the standard treatment from the start because they considerably reduced mortality at the time. Their advantages were linked to a reduction in the demand for cardiac oxygen and the prevention of arrhythmia. But is not clear.
Restart the motivation of the test
It was the motivation behind the restart.
“The trial was designed to optimize heart attack on the basis of solid scientific evidence and without commercial interests. These results will help rationalize treatment, reduce side effects and improve the quality of life of thousands of patients each year, ”adds Dr. Ibanez.
References:
“Beta-blockers after the myocardial infarction without fraction of reduced execution” by Borja Ibanez, Roberto Latini, Xavier Rossello, Alberto Dominguez-Rodriguez, Felipe Fernández-Vazquez, Valentina Pelizzoni, Pelipe Sánchez, Manuel Angetua, José A. Barrab, Serro L. Raostes-Rose. Stuart Pocock, Noemí Staircase, Lidia Staszewsky, Carlos Nicolás Pérez-García, Pablo Díez-Villanueva, Jose-Angel Pérezrara, Oscar Prada-Delgado, Ruth Owen, Gonzalo Pizarro, Onofre Tuñón, Matteo Bianco, Jesus Zaruza Vetrano, Ana Campos, Susana Martínez-Huertas, Héctor Bueno, Miguel Puentes, Giulietta Gris, Juan L. Bonilla-Palomas, Elvira Marco, José R. González-Junatey, King Bangutes, Carlos González-Junatey, Ana García-Alvarez, Juan RuiZ-García, Anna Carrasque, Juan C. García Pascual-Figal, Carlos Tomás-Querol, J. Alberto San Román, Pasquale Baratta, Jaume Agüero, Roberto Martín-Reyes, Furo Colivchi, Rosario, Roberto Martín-Reyes, Furo Colivchi, Rosario, Roberto Martín-Reyes, Furo Colivchi, Rosario, Rosario Ortas-Nadal, Pablo Bazal, Alberto Cordero, Antonio Fernández-Ortiz, Pierangelo Basso, Eva González, Fabrizio Poletti, Giulia Bugani, Marzia Deborah, Deborah, Deborah, Deborah, Deborah, Deborah, Deborah Bermejo, Giovanni Tortorella, Marco Marini, Javier Boots, José M. de la Torre-Hernández, Filippo Ottani and Valentín Fuster, August 29, 2025, New England Journal of Medicine.
DOI: 10.1056 / Nejmoa2504735
“Beta-blockers After a myocardial infarction: sex effects in the restart test” of Xavier Rossello, Alberto Dominguez-Rodriguez, Roberto Latini, Pedro L Sánchez, Sergio Roseiras-Roubín, Manuel Anguita, José a Barrabés, Giulitta Grigis, Ruth Owen, Stuar. Pocock, Sandra Gómez-Talavera, Ines García-Lunar, Noemí Ladder Ibanez, August 30, 2025, European Heart Journal.
DOI: 10.1093 / EURHEARTJ / EHAF673
Meeting: ESC Congress 2025
The restart was carried out without funding from the pharmaceutical industry.
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