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Randomized Controlled Trial
. 2025 Oct 14;86(15):1128-1138.
doi: 10.1016/j.jacc.2025.07.051.

Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Clara Bonanad-Lozano  1 , Sergio García Blas  2 , Ignacio Amat-Santos  3 , Rafael Gonzalez-Manzanares  4 , Juan Sanchís  5 , Diego López Otero  6 , Luis Nombela Franco  7 , Livia Gheorge  8 , Jorge Sanz-Sánchez  9 , Carlos Baladrón Zorita  3 , Andrés Iñiguez Romo  10 , Antonio Jesús Muñoz García  11 , Victoria Vilalta  12 , Soledad Ojeda  13 , Gabriela Veiga Fernández  14 , Juan Gabriel Córdoba Soriano  15 , Pedro Cepas  16 , Miriam Sandín Rollán  17 , Xacobe Flores Ríos  18 , Ricardo Palma-Carbajal  19 , Roberto Martín Reyes  20 , Rafael Romaguera  21 , Pablo Avanzas  22 , Juan A Franco-Peláez  23 , Javier Martín Moreiras  24 , José Ramón Gonzalez Juanatey  25 , Gabriela Tirado  7 , German Calle  8 , José Luis Díez  9 , Sandra Santos-Martínez  26 , Pablo Domínguez Erquicia  10 , Erika Muños García  11 , Eduard Fernandez-Nofrerias  12 , Javier López País  27 , Nieves Gonzalo  7 , Alejandro Gutierrez Barri  8 , Lluis Asmarats  28 , Manuel López Pérez  29 , Luis Manuel Domínguez Rodríguez  30 , Marta Cobo  31 , Inmaculada González Bermúdez  10 , Ana García Álvarez  16 , Pablo García Pavía  31 , Valentín Fuster  32 , Borja Ibáñez  33 , Sergio Raposeiras-Roubín  34
Affiliations
Randomized Controlled Trial

Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Clara Bonanad-Lozano et al. J Am Coll Cardiol. .

Abstract

Background: Patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) experience a great improvement in health status. Dapagliflozin has been shown to reduce death and heart failure (HF) in these patients. However, the impact of dapagliflozin on improving health status after TAVI is unknown.

Objectives: In this prespecified analysis of the DapaTAVI (Dapagliflozin After Transcatheter Aortic Valve Implantation) trial, we examined the effects of dapagliflozin on health status by using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Methods: The DapaTAVI trial randomized patients undergoing TAVI to receive or not receive dapagliflozin. We assessed the change in KCCQ score from baseline to 3 and 12 months by using an ordinal logistic regression model. Additionally, we analyzed the effect of dapagliflozin on the composite of death or worsening HF by baseline KCCQ score.

Results: A total of 964 patients had baseline KCCQ scores (mean 39.5 ± 22.2). Patients in both arms of the study exhibited improvements in KCCQ score, without significant differences between groups in the change in KCCQ score at 3 or 12 months (3-month OR for improvement: 0.96; 95% CI: 0.72-1.26; P = 0.745; 12-month OR: 1.03; 95% CI: 0.83-1.27; P = 0.819). At 12 months, similar proportions of patients in the dapagliflozin and control groups showed clinically meaningful improvements, with 43.4% vs 45.4%, respectively, improving by >50 points. The clinical benefits of dapagliflozin after TAVI appeared to be similar across the full range of baseline KCCQ scores.

Conclusions: TAVI was associated with a substantial improvement in KCCQ scores. However, the addition of dapagliflozin following the procedure did not confer an additional benefit in health status compared with standard care. (Dapagliflozin After Transcatheter Aortic Valve Implantation [DapaTAVI]; NCT04696185).

Keywords: NYHA functional class; aortic stenosis; dapagliflozin; quality of life; transcatheter aortic valve implantation (TAVI).

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Conflict of interest statement

Funding Support and Author Disclosures This study has received support from by a grant (FIS PI19/01882) from the Institute of Health Carlos III, a grant (GRS 2459/A/21, 2022) from the Gerenzia Regional de Salud de la Junta de Castilla y Leon y Fondos, a grant (SEC/FEC-INV-CLI 21/004) from the Spanish Society of Cardiology, a grant (SOGACAR 2022) from the Galician Society of Cardiology, a grant (SGLT2-HYPE 101156555, to Dr Ibáñez) from the European Commission, and by the Spanish National Center for Cardiovascular Research (CNIC), which is supported by the Institute of Health Carlos III; the Ministry of Science, Innovation, and Universities; the Pro CNIC Foundation; and a grant (CEX2020-001041-S funded by MICIU/AEI/10.13039/501100011033) from the Severo Ochoa Center of Excellence. Dr Gonzalez-Manzanares has received research contracts (CM22/00259, JR24/00064) and an international mobility grant (MV24/00106) from the Carlos III Health Institute. Dr Ibáñez has received grant support from the European Commission. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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