The Spanish essay changes a medical practice after 40 years

An international clinical trial coordinated by the National Cardiovascular Research Center (CNIC) in collaboration with the Mario Negri Institute from Milan (Italy), whose main researcher is the Spanish doctor Borja Ibáñezhas shown that beta blockers, drugs used to treat various cardiac pathologies, do not provide any benefit to patients who have suffered an uncomplicated myocardium infarction, that is, with a contractile function of the intact heart.

Ibáñez is a scientific director of the CNIC, cardiologist at the Jiménez Díaz Foundation University HospitalResearcher of his Health Research Institute (IIS-FJD) and Group Chief at the Biomedical Research Center of Cardiovascular Diseases (CIBERCV).

The results, published simultaneously in two works in the magazines ‘The New England Journal of Medicine’ and ‘The Lancet’, were presented last Friday at the “Hot Line” session of the Congress of the European Society of Cardiology (ESC), which is held until today in Madrid, and represent a paradigm shift in the treatment of these patients, modifying a Medical practice in force for more than 40 years.

This essay ‘REBOOT‘(Treatment with Beta-Blockers After Myocardial Infarcion Without Reduced Execion Fraction) has included 8,505 patients in 109 hospitals in Spain and Italy, who were randomly assigned to receiving or not beta blockers after hospital discharge. All participants received the current standard treatment and were followed during an average period of almost four years. The results did not show significant differences in mortality, reinfaro rates or heart failure income between both groups.

Although these are generally safe medications, beta blockers can cause side effects such as fatigue, bradycardia (low heart rate) or sexual dysfunction. “Reboot is going to change the treatment in these cases worldwide, since until now more than 80 percent of patients with this type of uncomplicated infarction are discharged with treatment with beta blockers,” said Dr. Ibáñez. “Reboot results represent one of the most significant advances in the therapeutic strategy of acute myocardial infarction in recent decades.”

After a heart attack, the contractile function of the heart can deteriorate significantly (ejection fraction of the left ventricle of less than 40%), moderately reduced (between 40%and 50%) or stay preserved (above 50%). Currently, most patients (approximately 70%) survive the heart attack with preserved cardiac function; About 20% have a moderately reduced function and 10%, a clearly marked dysfunction.

The Reboot study included the first two groups, since there were no clear evidence about the benefits of beta blockers in this type of patients. Although the results of the trial did not show significant benefits of treatment in the general population of the study, a possible positive effect in the subgroup with moderately reduced contractile function was observed. However, this subgroup constituted a relatively small proportion of the study population, and the reduced sample size prevented the team from drawing firm conclusions about this subgroup.

To address this issue, the researchers carried out a Metaanalysis joint with other clinical trials smaller ones who also included patients with these characteristics. The results, published in The Lancet, confirmed that beta blockers significantly reduce the risk of death, recurrent infarction or heart failure only in post -infarction patients with moderately reduced cardiac contractile function.

After a myocardial infarction, patients usually receive multiple drugs, which makes adherence to treatment difficult. “The beta blockers were incorporated from the beginning to the standard treatment of the infarction because, at the time, mortality significantly decreased. Their benefit was attributed to their ability to reduce the consumption of oxygen of the heart and prevent arrhythmias. However, current therapies have radically evolved: now the opening of the coronary arteries occluded during the infarction, which has considerably minimized the infarction, which has considerably minimized considerably. serious complications such as arrhythmias.

More than 500 researchers distributed throughout the Spanish and Italian geography have participated in the Reboot essay. A total of 109 hospitals (74 in Spain and 35 in Italy) recruited 8,505 patients. The Italian participation was coordinated by the Mario Negri Institute in Milan, led by cardiologist Roberto Latini, thanks to a collaboration agreement with the CNIC.

The CNIC, through its Clinical Test Coordination Unit (UCEC), He led the logistics and essay management, thus demonstrating the capacity of the Spanish scientific system to promote clinical studies with international impact. This CNIC unit has been consolidated as a key entity in the Coordination of Clinical Megaessayos in Cardiology with merely scientific objectives. The collaboration between CNIC, the Spanish Society of Cardiology (SEC) and the CIBERCV has been key to the success of the project.

For the president of the SEC, the doctor Luis Rodríguez Padial, “Reboot not only changes the treatment of infarction, but also the way of designing and executing clinical trials in Spain.” For his part, Dr. Valentín Fuster, General Director of the CNIC and president of the Mount Sinai Fuster Heart Hospital and one of the Senior Reboot researchers, indicated that “this trial will change all international clinical guides and joins other large trials led by the CNIC such as the study Secure with the polypíldora and the DAPATAVI, which implies the inhibition of SGR2 Tavi, who have already transformed the approach to cardiovascular diseases worldwide. ”

The essay has been funded by the National Center for Cardiovascular Research Carlos III (CNIC), a center affiliated with the Carlos III Health Institute (ISCIII), agency under the Ministry of Science, Innovation and Universities.