Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation.

Autores de IDIVAL

• 

  José María De La Torre Hernández

  Autor

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

• INVESTIGACIÓN CARDIOVASCULAR

  

  Investigador Responsable

  José María De La Torre Hernández

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.).

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