The Sant Pau Research Institute (IR Sant Pau), together with the Hospital de Sant Pau, has participated in the DapaTAVI clinical trial, which has shown that the use of the drug dapagliflozin significantly reduces the risk of death or worsening heart failure in older patients who have undergone transcatheter aortic valve implantation (TAVI) due to severe aortic stenosis. The study was published in the New England Journal of Medicine and presented this past weekend at the annual American College of Cardiology (ACC) congress, confirming its relevance in the international scientific community.
The trial, promoted by the Spanish Society of Cardiology and the Spanish National Center for Cardiovascular Research (CNIC), was conducted across 39 Spanish hospitals, including the Hospital de Sant Pau. It enrolled 1,222 elderly patients, with an average age of 82, all of whom had already undergone TAVI for aortic stenosis and had at least one additional risk factor such as heart failure, diabetes, ventricular dysfunction, or kidney disease. These types of patients are often excluded from large clinical trials due to their clinical complexity, despite being very common in real-world practice.
According to Dr. Dabit Arzamendi, cardiologist at Hospital de Sant Pau and investigator in the study, “These older patients with valvular disease and comorbidities had, until now, no specific evidence to support the use of treatments like dapagliflozin. With this study, we show that not only can they benefit from this drug, but its clinical impact is clear and consistent in reducing adverse events.”
The DapaTAVI results show that patients treated with dapagliflozin experienced a 28% reduction in the combined risk of death from any cause or worsening heart failure during the first year after TAVI, compared to those receiving standard treatment. This difference was mainly due to a decrease in hospital readmissions and urgent visits related to heart failure. Moreover, the benefits were consistent across all patient subgroups, regardless of whether they had diabetes, reduced ventricular function, or kidney failure.
“TAVI is an excellent treatment for resolving aortic stenosis, but many patients still experience heart failure decompensation. With dapagliflozin, we can reduce these events, which translates into fewer hospitalizations, longer survival, and better quality of life,” adds Dr. Arzamendi.
Another important aspect of the study is that the drug proved to be safe even in very elderly patients. “Dapagliflozin is a simple oral medication, easy to administer, and very well tolerated in this population. Side effects were minimal—mainly mild urinary infections or some hypotension—which are well-known and easily manageable,” notes Dr. Arzamendi. “This facilitates its implementation in everyday clinical practice, especially in such frail patients as those included in the study.”
The study design was particularly meticulous. After receiving the valve implant via TAVI, all patients were randomized to receive or not receive dapagliflozin, and were followed for twelve months. Clinical events were assessed in a centralized and blinded manner to ensure objective results.
Dapagliflozin was originally developed for the treatment of type 2 diabetes, but recently, it has taken a leading role in the management of heart failure, thanks to its multiple cardiovascular benefits. In addition to its glucose-lowering effect, it promotes diuresis and vasodilation, reduces left ventricular overload, and improves myocardial metabolic efficiency, all of which contribute to better heart function in patients with heart failure.
According to Dr. Arzamendi, “Dapagliflozin started as an antidiabetic drug, but today we use it more for its heart benefits than its glucose-lowering effects. It has a very favorable safety profile, and its mechanism of action fits perfectly with the needs of these patients after a TAVI.” The fact that it’s easy to administer and well tolerated, even in very elderly individuals, makes it a particularly valuable tool in this clinical setting.
Aortic stenosis is a common degenerative disease in older adults, in which the aortic valve narrows and impedes the flow of blood from the heart to the body. This can cause symptoms such as fatigue, shortness of breath, chest pain, or fainting, and if left untreated, can lead to heart failure and death.
The current treatment of choice for elderly patients or those at high surgical risk is transcatheter aortic valve implantation, known as TAVI—a minimally invasive technique that allows a new valve to be implanted through a catheter inserted via the leg, without the need for open-heart surgery. While TAVI resolves the mechanical problem of the valve, many patients still face a high risk of heart failure events due to cumulative damage to the heart. It is in this context that dapagliflozin may play a fundamental role as a complementary treatment.
“The key finding of DapaTAVI is that we can significantly improve outcomes for these patients with a safe, well-known, easy-to-use medication that had not previously been applied in this setting due to lack of evidence. This will undoubtedly change the way we manage older patients after TAVI, and we hope its results will soon be reflected in updates to international clinical guidelines,” concludes Dr. Arzamendi.
Raposeiras-Roubin S, Amat-Santos IJ, Rossello X, González Ferreiro R, González Bermúdez I, Lopez Otero D, Nombela-Franco L, Gheorghe L, Diez JL, Baladrón Zorita C, Baz JA, Muñoz García AJ, Vilalta V, Ojeda-Pineda S, de la Torre Hernández JM, Cordoba Soriano JG, Regueiro A, Bordes Siscar P, Salgado Fernández J, Garcia del Blanco B, Martín-Reyes R, Romaguera R, Moris C, García Blas S, Franco-Peláez JA, Cruz-González I, Arzamendi D, Romero Rodríguez N, Díez-del Hoyo F, Camacho Freire S, Bosa Ojeda F, Astorga Burgo JC, Molina Navarro E, Caballero Borrego J, Ruiz Quevedo V, Sánchez-Recalde Á, Peral Disdier V, Alegría-Barrero E, Torres-Llergo J, Feltes G, Fernández Díaz JA, Cuellas C, Jiménez Britez G, Sánchez-Rubio Lezcano J, Barreiro-Pardal C, Núñez-Gil I, Abu-Assi E, Iñiguez-Romo A, Fuster V, Ibáñez B. Dapagliflozin in patients undergoing transcatheter aortic-valve implantation. N Engl J Med 2025. https://doi.org/10.1056/nejmoa2500366
