The medication dapagliflozin, indicated in type 2 diabetes, is associated with a better clinical outcome in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI, for its initials in English). This benefit is observed regardless of the degree of cardiac function, as confirmed by an expanded analysis of the "DapaTAVI" study, led by specialists from the Carlos III National Center for Cardiovascular Research (CNIC) and the Spanish Society of Cardiology.
"Until now we knew that dapagliflozin improved the prognosis of patients undergoing TAVI. Now we have seen that this benefit is maintained both in people with reduced ventricular function and in those with preserved function," explained the scientific director of the CNIC, cardiologist at the Jiménez Díaz Foundation University Hospital and group leader at the CIBER of cardiovascular diseases (CIBERCV), Borja Ibáñez.
The work, published in the "European Journal of Heart Failure," analyzed 1,223 people with severe aortic stenosis treated with TAVI in 39 Spanish hospital centers. Of this cohort, 17.4 percent had reduced ejection fraction (less than or equal to 40%), while the rest maintained a ventricular function above 40 percent.
After a one-year follow-up, the research team found that dapagliflozin uniformly decreased the combined risk of death from any cause or worsening heart failure in all evaluated subgroups, as indicated by the CNIC.
Statistical models confirmed that the protective effect of the drug was maintained across the entire spectrum of ventricular function, with no significant differences between those with reduced ejection fraction and those who preserved it.
"One of the most relevant findings is that the benefit appears very soon after the intervention. During the first months, we observed a significant reduction in episodes of heart failure, precisely the period of greatest vulnerability for these patients," specified the researcher from the Valladolid University Clinical Hospital and the CNIC Ignacio Amat-Santos, co-author of the work.
The study also confirmed that the treatment is safe in very elderly patients: the average age was 82 years, clearly higher than that of most previous trials with SGLT2 inhibitors. "Demonstrating efficacy and safety in this group has enormous clinical relevance," highlighted the general director of the CNIC, Valentín Fuster, co-author of the study.
According to the authors, these data support that the favorable cardiovascular effects of dapagliflozin go beyond the classic categories based on ejection fraction and are related to key cardiorenal mechanisms in the progression of heart failure.
A very common valvulopathy in older people
Aortic stenosis is among the most common valvulopathies in the elderly population. The TAVI procedure, which allows for the implantation of a new valve via catheterization and avoids open surgery, has transformed the approach to this disease. However, a considerable number of patients continue to suffer from heart failure, repeated hospital admissions, and a high risk of mortality after the implant.
In this scenario, sodium-glucose cotransporter type 2 inhibitors (iSGLT2), such as dapagliflozin, have shown cardiovascular and renal benefits in numerous clinical trials. However, patients with advanced valvulopathies had been systematically excluded from these studies, creating a significant lack of specific evidence.
"DapaTAVI' is helping to close an important knowledge gap in clinical cardiology," noted the researcher from the Álvaro Cunqueiro University Hospital in Vigo, from the CNIC and coordinator of the study, Sergio Raposeiras-Roubín.
For his part, Borja Ibáñez emphasized that dapagliflozin "emerges as a simple, safe, and potentially applicable option for a wide majority of these patients."