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 hospit...

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Published in:European journal of heart failure 2022-03, Vol.24 (3), p.581-588
Main Authors: Amat‐Santos, Ignacio J., Sánchez‐Luna, Juan P., Melendo‐Viu, María, Cruz‐Gonzalez, Ignacio, Blas, Sergio G., Romaguera, Rafael, Sánchez‐Recalde, Ángel, Diez‐Gil, José L., Lopez‐Otero, Diego, Gheorge, Livia, Raposeiras‐Roubín, Sergio, Sanz‐Sánchez, Jorge, Pereiro‐Montes, Diana, Gutierrez‐Barri, Alejandro, Salgado‐Fernández, Jorge, Veiga‐Fernández, Gabriela, Tirado, Gabriela, Baladrón‐Zorita, Carlos, Córdoba‐Soriano, Juan Gabriel, Vilalta, Victoria, Peral‐Disdier, Vicente, Alonso, José Antonio Baz, Abellas, María, Moris, César, Díaz‐Fernández, José Francisco, Blanco‐Mata, Roberto, Regueiro, Ander, Lezcano, Juan Sánchez‐Rubio, García, Bruno, Arzamendi‐Aizpurua, Dabit, Feltes, Gisela, Cuellas, Carlos, Bordes, Pascual, Sarnago‐Cebada, Fernando, Gil‐Ortega, Manuel Villa, Borrero, Juan Caballero, Reyes, Roberto Martín, Alonso Briales, Juan H, Alcaide, Javier, López‐Ledesma, Bernabé, Ten Morro, Francisco, SanMartín‐Pena, Juan Carlos, López‐Pais, Javier, Calle, German, Flores‐Rios, Xacobe, Núñez, María Soto, Álvarez, Manuel Pan, Lezo, Javier Suarez, Nuñez‐Gil, Iván, Bonanad‐Lozano, Clara, Núñez‐Villota, Julio, Valero‐Picher, Ernesto, González‐D'Gregorio, Jesskika, Fernández‐Cisnal, Agustín, Santos, Sandra, Arana, José Raúl Delgado, Barrero, Alejandro, Sanz‐Patiño, Esther, Gallardo‐López, Arsenio, Carrillo‐Suarez, Xavier, Grau, Edgar Fadeuilhe, Fernandez‐Nofrerias, Eduard, Álvarez, María López, Franco‐Peláez, Juan Antonio, Talavera, Sandra Gómez, Molina‐Jiménez, María, Morcuende‐González, Antonio, Ramallal‐Martínez, Raul, Sanchez‐Elvira, Guillermo, Bazal‐Chacon, Pablo, Bowden, Geoffrey Yanes, González‐Ferreiro, Rocío, Ocampo‐Míguez, Juan, Riobóo‐Lestón, Lucía, Cespón‐Fernández, María, Ledo‐Piñeiro, Ana, Camacho‐Freire, Santiago, Astorga‐Burgo, Juan Carlos, Cepas, Pedro Luic, Gracia, María Cruz Ferrer, Ferreira, Ignacio, Calago, Álvaro, Palma, Ricardo, Asmarats‐Serra, Lluis, Garcia‐Fernandez, Angeles Gelines, Fernández‐Vázquez, Felipe, Prado, Armando Pérez, Mainar, Vicente, Ruiz‐Nodar, Juan Miguel, Valencia‐Martín, José, Quiles‐Granado, Juan Manuel, Lozano‐Palencia, Teresa, Sandín‐Rollán, Miriam, Ajo‐Ferrer, Raquel, Ajo‐Ferrer, María, Gonzalez‐Trevilla, Agustín Albarrán, Gómez‐Blázquez, Iván Tomás, Huertas‐Nieto, Sergio, Maneiro‐Melón, Nicolás Manuel, Alfonso, Fernando
Format: Article
Language:English
Subjects:
Aortic Valve
Aortic Valve Stenosis - complications
Aortic Valve Stenosis - surgery
Benzhydryl Compounds
Dapagliflozin
Glucosides
Heart Failure
Humans
Prospective Studies
Sodium–glucose co‐transporter 2 inhibitor
Stroke Volume
Transcatheter Aortic Valve Replacement
Treatment Outcome
Trial design
Ventricular Function, Left
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Summary: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 m2. 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.
ISSN:1388-9842
1879-0844
DOI:10.1002/ejhf.2370