Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Raposeiras-Roubin S.
- Amat-Santos I.J.
- Rossello X.
- González Ferreiro R.
- González Bermúdez I.
- Lopez Otero D.
- Nombela-Franco L.
- Gheorghe 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.
- Garcia Del Blanco B.
- Martín-Reyes R.
- Romaguera R.
- Moris C.
- García Blas S.
- Franco-Peláez J.A.
- Cruz-González I.
- Arzamendi D.
- Romero Rodríguez N.
- Díez-Del Hoyo F.
- Camacho Freire S.
- Bosa Ojeda F.
- Astorga Burgo J.C.
- 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 J.A.
- 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.
Grupos
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. © 2025 Massachusetts Medical Society.
Datos de la publicación
- ISSN/ISSNe:
- 0028-4793, 1533-4406
- Tipo:
- Article
- Páginas:
- 1396-1405
- PubMed:
- 40162639
- Enlace a otro recurso:
- www.scopus.com
- Factor de Impacto:
- 24,907 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
NEW ENGLAND JOURNAL OF MEDICINE MASSACHUSETTS MEDICAL SOC
Documentos
- No hay documentos
Filiaciones
Keywords
- Aged; Aged, 80 and over; Aortic Valve Stenosis; Benzhydryl Compounds; Female; Glucosides; Heart Failure; Hospitalization; Humans; Kaplan-Meier Estimate; Male; Sodium-Glucose Transporter 2 Inhibitors; Transcatheter Aortic Valve Replacement; dapagliflozin; sodium glucose cotransporter 2 inhibitor; benzhydryl derivative; dapagliflozin; glucoside; sodium glucose cotransporter 2 inhibitor; aged; aortic stenosis; Article; atrial fibrillation; bacteremia; body surface; cerebrovascular accident; clinical outcome; controlled study; diabetes mellitus; diastolic blood pressure; echocardiography; estimated glomerular filtration rate; faintness; female; follow up; heart failure; hospitalization; human; hypoglycemia; hypotension; ketoacidosis; kidney failure; major clinical study; male; necrotizing fasciitis; neoplasm; randomized controlled trial; systolic blood pressure; transcatheter aortic valve implantation; urinary tract infection; urogenital tract infection; valvular heart disease; aortic valv
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. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025. 392. (14):p. 1396-1405. IF:84,500. (1).
Portal de investigación