Dapagliflozin reduced mortality risk in aortic stenosis patients undergoing TAVI: Study
A new study published in The New England Journal of Medicine showed that daily dapagliflozin dramatically reduced the risk of death or deteriorating illness among patients with heart failure (HF) at one year following transcatheter aortic valve implantation (TAVI).
Since patients with valvular heart disease have been mostly excluded from randomized studies of the medicine, dapagliflozin (Farxiga; AstraZeneca), an SGLT2 inhibitor, has not yet been explicitly evaluated in TAVI. It is advised in heart failure regardless of ejection fraction. Additionally, TAVI patients are often older, and studies prefer to exclude this demographic. Thus, this study by Sergio Raposeiras-Roubin and colleagues to evaluate the function of dapagliflozin in TAVI.
This randomized, controlled study was carried out in Spain to assess the effectiveness of dapagliflozin (10 mg once day) in comparison to standard treatment alone for aortic stenosis patients receiving TAVI. Each patient had a history of heart failure along with at least one of the following conditions: diabetes, left ventricular systolic dysfunction, or renal insufficiency. At one year of follow-up, the main outcome was a composite of mortality from any cause and worsening heart failure, which was defined as hospitalization or an urgent visit.
Following TAVI, a total of 637 patients were randomly allocated to receive standard therapy alone, and 620 patients were randomly assigned to take dapagliflozin; 1222 patients were included in the primary analysis after exclusions.
Nearly, 91 patients (15.0%) in the dapagliflozin group and 124 patients (20.1%) in the standard-care group experienced a primary-outcome event. 55 patients (8.9%) in the standard-care group and 47 patients (7.8%) in the dapagliflozin group died from any cause. In 9.4% and 14.4% of the patients, respectively, heart failure worsened. The dapagliflozin group experienced a substantially higher incidence of genital infection and hypotension.
Overall, the effectiveness of dapagliflozin in the TAVI group emphasizes that these patients do not have a normal heart even when the outflow blockage has been relieved. When compared to conventional treatment alone, dapagliflozin significantly reduced the incidence of mortality from any cause and worsening of heart failure in older persons with aortic stenosis receiving TAVI who were at high risk for heart-failure events.
Source:
Raposeiras-Roubin, S., Amat-Santos, I. J., Rossello, X., González Ferreiro, R., González Bermúdez, I., Lopez Otero, D., Nombela-Franco, L., Gheorghe, L., Diez, J. L., Baladrón Zorita, C., Baz, J. A., Muñoz García, A. J., Vilalta, V., Ojeda-Pineda, S., de la Torre Hernández, J. M., Cordoba Soriano, J. G., Regueiro, A., Bordes Siscar, P., Salgado Fernández, J., … Ibáñez, B. (2025). Dapagliflozin in patients undergoing transcatheter aortic-valve implantation. The New England Journal of Medicine. https://doi.org/10.1056/nejmoa2500366
