Cardiovascular diseases are the leading cause of death and health expenditure worldwide.
MADRID (EUROPA PRESS) – A medication originally developed for diabetes treatment has shown promising results in improving outcomes for patients with aortic stenosis undergoing heart valve interventions, according to a clinical trial conducted by the National Center for Cardiovascular Research (CNIC) in collaboration with the Álvaro Cunqueiro Hospital in Vigo.
The drug, dapagliflozin, has been found to decrease the rate of death or hospitalization due to heart failure, as revealed in this trial involving 1,250 patients, and has been published in the ‘The New England Journal of Medicine’.
The CNIC points out that cardiovascular diseases remain the top cause of mortality and healthcare expenses globally.
Among these, heart valve diseases pose a significant challenge, particularly aortic valve stenosis, which becomes more prevalent as the population ages.
It is estimated that between 3 to 5 percent of people over the age of 75 in Europe and Spain suffer from this condition, translating to roughly 8 million individuals worldwide.
Aortic stenosis is a degenerative disease that gradually narrows the opening through which blood is pumped from the heart to the rest of the body.
This condition forces the heart muscle to work harder, which can lead to heart failure, chest pain (angina), or even sudden death due to malignant arrhythmias.
“Historically, the treatment for this condition has been valve replacement through heart surgery,” stated Sergio Raposeiras-Roubín, a cardiologist at the Álvaro Cunqueiro University Hospital in Vigo, researcher at CNIC, the Health Research Institute of Southern Galicia (IISGS), and the lead investigator of the clinical trial published in the NEJM.
“However, in older patients, the surgical risk is high, which has limited their access to this intervention,” the cardiologist noted, who presented the results at the American College of Cardiology (ACC) congress in Chicago, USA.
In recent years, a less invasive technique known as TAVI (transcatheter aortic valve implantation) has been developed, allowing for the implantation of a new valve via catheterization, avoiding major surgery, the researcher explained.
“Thanks to TAVI, many elderly patients have had their life expectancy extended. However, these individuals still face a high risk of heart failure due to the strain on their hearts,” he added.
SGLT2 inhibitors (such as dapagliflozin and empagliflozin), initially developed as antidiabetics, have proven effective in treating heart failure, making them a key treatment for this condition.
Yet, the exact mechanism by which SGLT2 inhibitors improve the prognosis of heart failure patients remains fully unknown.
“At CNIC, we have rigorously worked on this point due to its clinical relevance, and we have already shown that these drugs enhance the heart’s energy capacity by modulating the nutrients the myocardium uses to produce energy,” stated Borja Ibáñez, Scientific Director of CNIC, cardiologist at the Jiménez Díaz Foundation, group leader at CIBERCV, and scientific coordinator of the trial. This study was recently published in the ‘JACC: CardioOncology’ journal.
However, despite the fact that patients with aortic stenosis frequently develop heart failure, they have usually been excluded from clinical trials demonstrating the benefits of SGLT2 inhibitors. Moreover, Raposeiras notes, “the representation of elderly patients in these trials was merely anecdotal.”
For this reason, the research team, scientifically coordinated at CNIC by Ibáñez, decided to conduct a clinical trial specifically in this group of elderly patients undergoing TAVI.
‘DAPATAVI’ TRIAL
‘DapaTAVI’ is an independent trial conducted in Spain without pharmaceutical industry funding across 39 national hospitals, including 1,250 patients with severe aortic stenosis undergoing TAVI and at high risk of heart failure.
Half of the participants received dapagliflozin following the TAVI implant, while the other half received standard treatment. After one year of follow-up, the results showed a significant reduction in mortality and hospital admissions for heart failure in the group treated with dapagliflozin.
According to Ignacio Amat-Santos, interventional cardiologist at the University Hospital of Valladolid, also a scientist at CNIC, and co-principal investigator of the trial, “this study shows that we can further improve the prognosis for patients undergoing TAVI, a particularly vulnerable group.”
In this regard, Valentín Fuster, General Director of CNIC and co-investigator of the trial, emphasizes that “the results of ‘DapaTAVI’ will have a huge impact on a growing population of patients and will help extend their lifespan with better quality.”
The researchers indicate that ‘DapaTAVI’ marks a milestone in cardiovascular research and could change the treatment of aortic stenosis in elderly patients worldwide. The study received partial funding from the Carlos III Health Institute, the Spanish Society of Cardiology, the Galician Society of Cardiology, and the Regional Health Management of the Junta de Castilla y León.
