Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial.

AIMS: Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospi...

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Autores: Amat-Santos, Ignacio J, Sanchez-Luna, Juan P, Abu-Assi, Emad, Melendo Viu, Maria, Cruz-Gonzalez, Ignacio, Nombela-Franco, Luis, Munoz Garcia, Antonio Jesus, Garcia Blas, Sergio, de la Torre Hernandez, Jose Maria, Romaguera, Rafael, Sanchez-Recalde, Angel, Diez Gil, Jose Luis, Lopez Otero, Diego, Gheorge, Livia, Ibanez, Borja, Iniguez Romo, Andres, Raposeiras-Roubin, Sergio, Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI), Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investiga
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p16090
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/16090
Access Level:acceso abierto
Palabra clave:Dapagliflozin
Heart failure
Sodium-glucose co-transporter 2 inhibitor
Trial design
Descripción
Sumario:AIMS: Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus, reduced left ventricular ejection fraction and chronic kidney disease. However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. METHODS: DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicentre trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing TAVI. Candidate patients should have prior history of HF admission plus =1 of the following criteria: (i) diabetes mellitus, (ii) left ventricular ejection fraction =40%, or (iii) estimated glomerular filtration rate between 25 and 75 ml/min/1.73 m(2) . A total of 1020 patients will be randomized (1:1) to dapagliflozin vs. no dapagliflozin. Key secondary outcomes include: (i) incidence rate of individual components of the primary outcome; (ii) cardiovascular mortality; (iii) the composite of HF hospitalization or cardiovascular death; and (iv) total number of HF rehospitalizations. CONCLUSION: DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI.

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