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

NEW ENGLAND JOURNAL OF MEDICINE  MASSACHUSETTS MEDICAL SOC

Tipo:
Article
Páginas:
1396-1405
PubMed:
40162639
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
24,907 SCImago ℠
Cuartil:
Q1 SCImago ℠

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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

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