Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation
Sergio Raposeiras‐Roubín, Ignacio J. Amat‐Santos, Xavier Rosselló, Rocío González-Ferreiro, Inmaculada González Bermúdez, Diego López‐Otero, Luis Nombela‐Franco, Livia Gheorghe, Jose L. Diez, Carlos Baladrón, José Antonio Baz, Antonio J. Muñoz-García, Victòria Vilalta, Soledad Ojeda, José M. de la Torre Hernández, Juan Gabriel Córdoba Soriano, Ander Regueiro, P. Bordes Siscar, Jorge Salgado Fernández, Bruno García del Blanco, Roberto Martín-Reyes, Rafael Romaguera, César Morı́s, Sergio García Blas, Juan Antonio Franco Peláez, Ignacio Cruz‐González, Dabit Arzamendi, Nieves Romero-Rodríguez, Felipe Díez‐Delhoyo, Santiago Jesús Camacho Freire, Francisco Bosa Ojeda, Juan Carlos Astorga Burgo, Eduardo Molina Navarro, Juan Caballero Borrego, Valeriano Ruíz Quevedo, Ángel Sánchez‐Recalde, Vicente Peral Disdier, Eduardo Alegría‐Barrero, Javier Torres-Llergo, Gisela Feltes, José Díaz, Carlos Cuellas, Gustavo Jiménez Brítez, Juan Sánchez-Rubio Lezcano, Cristina Barreiro-Pardal, Iván J. Núñez‐Gil, Emad Abu‐Assi, Andrés Íñiguez, Valentı́n Fuster, Borja Ibáñez
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.).