N Engl J Med. 2025 Apr 10;392(14):1396-1405. doi: 10.1056/NEJMoa2500366. Epub 2025 Mar 29.
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.).
PMID:40162639 | DOI:10.1056/NEJMoa2500366
Authors: Sergio Raposeiras-Roubin, Ignacio J Amat-Santos, Xavier Rossello, Rocío González Ferreiro, Inmaculada González Bermúdez, Diego Lopez Otero, Luis Nombela-Franco, Livia Gheorghe, Jose L Diez, Carlos Baladrón Zorita, José A Baz, Antonio J Muñoz García, Victoria Vilalta, Soledad Ojeda-Pineda, José M de la Torre Hernández, Juan G Cordoba Soriano, Ander Regueiro, Pascual Bordes Siscar, Jorge Salgado Fernández, Bruno Garcia Del Blanco, Roberto Martín-Reyes, Rafael Romaguera, César Moris, Sergio García Blas, Juan A Franco-Peláez, Ignacio Cruz-González, Dabit Arzamendi, Nieves Romero Rodríguez, Felipe Díez-Del Hoyo, Santiago Camacho Freire, Francisco Bosa Ojeda, Juan C Astorga Burgo, Eduardo Molina Navarro, Juan Caballero Borrego, Valeriano Ruiz Quevedo, Ángel Sánchez-Recalde, Vicente Peral Disdier, Eduardo Alegría-Barrero, Javier Torres-Llergo, Gisela Feltes, José A Fernández Díaz, Carlos Cuellas, Gustavo Jiménez Britez, Juan Sánchez-Rubio Lezcano, Cristina Barreiro-Pardal, Iván Núñez-Gil, Emad Abu-Assi, Andrés Iñiguez-Romo, Valentín Fuster, Borja Ibáñez, DapaTAVI Investigators
Published: 2025-03-31 10:00:00
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