The medication, dapagliflozina, reduced the rate of death or hospitalization due to heart failure, as revealed in this trial conducted on 1,250 patients, which has been published in the journal ‘The New England Journal of Medicine.’
From the CNIC, it is noted that cardiovascular diseases are the leading cause of mortality and healthcare expenditure worldwide. Among them, diseases of the heart valves represent a significant problem, especially aortic valve stenosis, whose prevalence increases with population aging. It is estimated that between 3 and 5 percent of people over 75 years old in Europe and Spain suffer from this condition, equivalent to approximately 8 million people worldwide.
Aortic stenosis is a degenerative disease that progresses slowly, reducing the opening through which blood is pumped from the heart to the rest of the body. As a consequence, the heart muscle must work harder, which can lead to heart failure, angina, or even sudden death from malignant arrhythmias.
«Traditionally, the treatment for this condition has been valve replacement through cardiac surgery,» explained the cardiologist at the Álvaro Cunqueiro University Hospital in Vigo, a researcher at the CNIC, the Galicia Sur Health Research Institute (IISGS), and the lead researcher of the clinical trial published in the NEJM, Sergio Raposeiras-Roubín.
«However, in elderly patients, the surgical risk is high, limiting their access to this intervention,» noted the investigating cardiologist, who presented the results at the American College of Cardiology (ACC) congress held in Chicago (USA).
In recent years, a technique called TAVI (transcatheter aortic valve implantation) has been developed, a less invasive procedure that allows for a new valve to be implanted through catheterization, avoiding major surgery, as indicated by the researcher.
«Thanks to TAVI, many elderly patients have seen their life expectancy extended. However, these individuals still have a high risk of heart failure due to the wear and tear on their hearts,» he pointed out.
SGLT2 inhibitors (such as dapagliflozina and empagliflozina) were developed as antidiabetics, but their effectiveness in heart failure has made them a key treatment for this condition. However, the mechanism by which SGLT2 inhibitors improve the prognosis of patients with heart failure is still unknown.
«At CNIC, we are working extensively on this issue due to its clinical relevance, and we have already shown that these drugs improve the heart’s energy capacity by modulating the nutrients used by the myocardium 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 journal ‘JACC: CardioOncology.’
However, despite the fact that patients with aortic stenosis often develop heart failure, they have typically been excluded from clinical trials that demonstrated the benefit of SGLT2 inhibitors. Additionally, as Raposeiras points out, «the representation of elderly patients in these trials was minimal.»
For this reason, the research team, scientifically coordinated at CNIC by Ibáñez, decided to conduct a clinical trial in this specific population of elderly patients undergoing TAVI.
‘DapaTAVI’ is an independent trial conducted in Spain without funding from the pharmaceutical industry at 39 hospital centers nationwide, which included 1,250 patients with severe aortic stenosis undergoing TAVI and at high risk of heart failure.
Half of the participants received dapagliflozina after TAVI implantation, while the others received standard treatment. After one year of follow-up, the results showed a significant reduction in mortality and hospitalizations due to heart failure in the group treated with dapagliflozina.
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 demonstrates that the prognosis of patients undergoing TAVI, a particularly vulnerable group, can be further improved.»
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 contribute to prolonging their life expectancy with better quality.»
The researchers point out 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 Castilla y León region.
FUENTE