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oai:repisalud.isciii.es:20.500.12105/266392025-12-18T12:56:04Zcom_20.500.12105_19586com_20.500.12105_2202col_20.500.12105_19587
Repisalud author Raposeiras-Roubin, Sergio author Amat-Santos, Ignacio J author Rossello, Xavier author González Ferreiro, Rocío author González Bermúdez, Inmaculada author Lopez Otero, Diego author Nombela-Franco, Luis author Gheorghe, Livia author Diez, Jose L author Baladrón Zorita, Carlos author Baz, José A author Muñoz García, Antonio J author Vilalta, Victoria author Ojeda-Pineda, Soledad author de la Torre Hernández, José M author Cordoba Soriano, Juan G author Regueiro, Ander author Bordes Siscar, Pascual author Salgado Fernández, Jorge author Garcia Del Blanco, Bruno author Martín-Reyes, Roberto author Romaguera, Rafael author Moris, César author García Blas, Sergio author Franco-Peláez, Juan A author Cruz-González, Ignacio author Arzamendi, Dabit author Romero Rodríguez, Nieves author Díez-Del Hoyo, Felipe author Camacho Freire, Santiago author Bosa Ojeda, Francisco author Astorga Burgo, Juan C author Molina Navarro, Eduardo author Caballero Borrego, Juan author Ruiz Quevedo, Valeriano author Sánchez-Recalde, Ángel author Peral Disdier, Vicente author Alegría-Barrero, Eduardo author Torres-Llergo, Javier author Feltes, Gisela author Fernández Díaz, José A author Cuellas, Carlos author Jiménez Britez, Gustavo author Sánchez-Rubio Lezcano, Juan author Barreiro-Pardal, Cristina author Núñez-Gil, Iván author Abu-Assi, Emad author Iñiguez-Romo, Andrés author Fuster, Valentín author Ibáñez, Borja 2025-05-05T08:57:40Z 2025-05-05T08:57:40Z 2025-04-10 N Engl J Med. 2025 Apr 10;392(14):1396-1405. New England Journal of Medicine 40162639 https://hdl.handle.net/20.500.12105/26639 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. 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. 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. 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.). eng Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. research article 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 URL https://repisalud.isciii.es/bitstreams/09e165b7-02ba-4daa-8e05-cca6f4b758cd/download File MD5 c9b7a791b43c51122af5a63d3b8df81c 1104717 application/pdf Dapagliflozin In Patients Undergoing Transcatheter_NEJM_2025.pdf