{"id":"a426c46925d7","type":"article","url":"https://hartvaat.nl/2025/04/10/dapagliflozine-bij-patienten-die-tavi-ondergaan-gerandomiseerde-trial-nejm/","title":"Dapagliflozine bij patiënten die TAVI ondergaan: gerandomiseerde trial — NEJM","title_en":"Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["dapa-hf","dapagliflozine","emperor-trials"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2500366","source_url":"https://doi.org/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"],"significance":8,"published":"2025-04-10","source_date":"2025-04-10","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/sglt2-remmers-farmacologie/"],"congress":"","summary_en":"This NEJM trial evaluated dapagliflozin in patients undergoing TAVI, exploring whether SGLT2 inhibition provides additional cardiac protection in this high-risk valvular heart disease population.","created":"2026-07-03T10:31:35Z","updated":"2026-07-03T13:30:35Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial onderzocht dapagliflozine bij patiënten die TAVI ondergaan. De SGLT2-remmer biedt potentieel aanvullende cardiale bescherming bij de groeiende TAVI-populatie.","abstract_original":"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.)."}