Actividad Investigadora
Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation.
Autores de IDIVAL
Autores ajenos al IDIVAL
- 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
- 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
- DapaTAVI Investigators
Unidades
Abstract
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of heart-failure admission among high-risk patients. However, most patients with valvular heart disease, including those undergoing transcatheter aortic-valve implantation (TAVI), have been excluded from randomized trials. METHODS: We conducted this randomized, controlled trial in Spain to evaluate the efficacy of dapagliflozin (at a dose of 10 mg once daily) as compared with standard care alone in patients with aortic stenosis who were undergoing TAVI. All the patients had a history of heart failure plus at least one of the following: renal insufficiency, diabetes, or left ventricular systolic dysfunction. The primary outcome was a composite of death from any cause or worsening of heart failure, defined as hospitalization or an urgent visit, at 1 year of follow-up. RESULTS: A total of 620 patients were randomly assigned to receive dapagliflozin and 637 to receive standard care alone after TAVI; after exclusions, a total of 1222 patients were included in the primary analysis. A primary-outcome event occurred in 91 patients (15.0%) in the dapagliflozin group and in 124 patients (20.1%) in the standard-care group (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P = 0.02). Death from any cause occurred in 47 patients (7.8%) in the dapagliflozin group and in 55 (8.9%) in the standard-care group (hazard ratio, 0.87; 95% CI, 0.59 to 1.28). Worsening of heart failure occurred in 9.4% and 14.4% of the patients, respectively (subhazard ratio, 0.63; 95% CI, 0.45 to 0.88). Genital infection and hypotension were significantly more common in the dapagliflozin group. CONCLUSIONS: Among older adults with aortic stenosis undergoing TAVI who were at high risk for heart-failure events, dapagliflozin resulted in a significantly lower incidence of death from any cause or worsening of heart failure than standard care alone. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT04696185.).
Copyright © 2025 Massachusetts Medical Society.
Datos de la publicación
- ISSN/ISSNe:
- 0028-4793, 1533-4406
- Tipo:
- Article
- Páginas:
- 1396-1405
- PubMed:
- 40162639
NEW ENGLAND JOURNAL OF MEDICINE MASSACHUSETTS MEDICAL SOC
Citas Recibidas en Web of Science: 57
Documentos
- No hay documentos
Filiaciones
Campos de Estudio
Cita
Raposeiras S, Amat IJ, Rossello X, González R, González I, Lopez D, Nombela L, Gheorghe L, Diez JL, Baladrón C, Baz JA, Muñoz AJ, Vilalta V, Ojeda S, de la Torre JM, Cordoba JG, Regueiro A, Bordes P, Salgado J, Garcia Del Blanco B, Martín R, Romaguera R, Moris C, García S, Franco JA, Cruz I, Arzamendi D, Romero N, Díez F, Camacho S, Bosa F, Astorga JC, Molina E, Caballero J, Ruiz V, Sánchez Á, Peral V, Alegría E, Torres J, Feltes G, Fernández JA, Cuellas C, Jiménez G, Sánchez J, Barreiro C, Núñez I, Abu E, Iñiguez A, Fuster V, Ibáñez B, DapaTAVI I. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025. 392. (14):p. 1396-1405. IF:78,500. (1).
