Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. (9th November 2021)

• Record Type: Journal Article
• Authors: Amat‐Santos, Ignacio J.; Sánchez‐Luna, Juan P.; Abu‐Assi, Emad; Melendo‐Viu, María; Cruz‐Gonzalez, Ignacio; Nombela‐Franco, Luis; Muñoz‐Garcí, Antonio J.; Blas, Sergio G.; de la Torre Hernandez, Jose M.; Romaguera, Rafael; Sánchez‐Recalde, Ángel; Diez‐Gil, José L.; Lopez‐Otero, Diego; Gheorge, Livia; Ibáñez, Borja; Iñiguez‐Romo, Andrés; Raposeiras‐Roubín, Sergio
• Other Names: Muñoz‐García Erika investigator.; Sanz‐Sánchez Jorge investigator.; Pereiro‐Montes Diana investigator.; Gutierrez‐Barri Alejandro investigator.; Salgado‐Fernández Jorge investigator.; Veiga‐Fernández Gabriela investigator.; Ojeda Soledad investigator.; Tirado Gabriela investigator.; Sanchís Juan investigator.; Baladrón‐Zorita Carlos investigator.; Córdoba‐Soriano Juan Gabriel investigator.; Vilalta Victoria investigator.; del Amo Felipe Navarro investigator.; Molina‐Navarro Eduardo investigator.; Peral‐Disdier Vicente investigator.; Ruiz‐Quevedo Valeriano investigator.; Ojeda Francisco Bosa investigator.; Alonso José Antonio Baz investigator.; Abellas María investigator.; Moris César investigator.; Díaz‐Fernández José Francisco investigator.; Blanco‐Mata Roberto investigator.; Regueiro Ander investigator.; Fernández‐Díaz Jose Antonio investigator.; Lezcano Juan Sánchez‐Rubio investigator.; García Bruno investigator.; Arzamendi‐Aizpurua Dabit investigator.; Feltes Gisela investigator.; Cuellas Carlos investigator.; Bordes Pascual investigator.; Jiménez‐Brítez Gustavo David investigator.; Sarnago‐Cebada Fernando investigator.; Gil‐Ortega Manuel Villa investigator.; Borrero Juan Caballero investigator.; Reyes Roberto Martín investigator.; Alonso Briales Juan H investigator.; Alcaide Javier investigator.; López‐Ledesma Bernabé investigator.; Ten Morro Francisco investigator.; Sánchez‐Lacuesta Elena investigator.; SanMartín‐Pena Juan Carlos investigator.; López‐Pais Javier investigator.; Calle German investigator.; Flores‐Rios Xacobe investigator.; Méndez‐Eirín Elizabet investigator.; Núñez María Soto investigator.; Álvarez Manuel Pan investigator.; de Lezo Javier Suarez investigator.; Nuñez‐Gil Iván investigator.; Bonanad‐Lozano Clara investigator.; Núñez‐Villota Julio investigator.; Miñana‐Escriva Gema investigator.; Valero‐Picher Ernesto investigator.; González‐D'Gregorio Jesskika investigator.; Fernández‐Cisnal Agustín investigator.; Santos Sandra investigator.; Arana José Raúl Delgado investigator.; Barrero Alejandro investigator.; Sanz‐Patiño Esther investigator.; Mazuecos Jesús Jiménez investigator.; Gallardo‐López Arsenio investigator.; Carrillo‐Suarez Xavier investigator.; Grau Edgar Fadeuilhe investigator.; Fernandez‐Nofrerias Eduard investigator.; Lozano Antonio Piñeiro investigator.; Álvarez María López investigator.; Franco‐Peláez Juan Antonio investigator.; Talavera Sandra Gómez investigator.; Molina‐Jiménez María investigator.; Morcuende‐González Antonio investigator.; Millán‐Segovia Raul investigator.; Pascual‐Sastre Marcos investigator.; Maristany‐Daudert Jaume investigator.; Ramallal‐Martínez Raul investigator.; Sanchez‐Elvira Guillermo investigator.; Bazal‐Chacon Pablo investigator.; Bowden Geoffrey Yanes investigator.; de la Fuente Perdomo Belén investigator.; Loureiro Rodrigo Estévez investigator.; González‐Ferreiro Rocío investigator.; Melendo‐Viu María investigator.; Ocampo‐Míguez Juan investigator.; Cobas‐Paz Rafael investigator.; Queija Berenice Caneiro investigator.; Riobóo‐Lestón Lucía investigator.; Cespón‐Fernández María investigator.; Domínguez‐Erquicia Pablo investigator.; Ledo‐Piñeiro Ana investigator.; Camacho‐Freire Santiago investigator.; Astorga‐Burgo Juan Carlos investigator.; Cepas Pedro Luic investigator.; de Miguel José Antonio Diarte investigator.; Gracia María Cruz Ferrer investigator.; Ferreira Ignacio investigator.; Calago Álvaro investigator.; Palma Ricardo investigator.; Asmarats‐Serra Lluis investigator.; López‐Benito María investigator.; Garcia‐Fernandez Angeles Gelines investigator.; Fernández‐Vázquez Felipe investigator.; de Prado Armando Pérez investigator.; Mainar Vicente investigator.; Ruiz‐Nodar Juan Miguel investigator.; Valencia‐Martín José investigator.; Pineda‐Rocamora Javier investigator.; Torres‐Mezcua Fernando José investigator.; Quiles‐Granado Juan Manuel investigator.; Lozano‐Palencia Teresa investigator.; Sandín‐Rollán Miriam investigator.; Ajo‐Ferrer Raquel investigator.; Ajo‐Ferrer María investigator.; Gonzalez‐Trevilla Agustín Albarrán investigator.; Gómez‐Blázquez Iván Tomás investigator.; García‐Tejada Julio investigator.; Huertas‐Nieto Sergio investigator.; Maneiro‐Melón Nicolás Manuel investigator.; Olazabal‐Valiente Allende Pilar investigator.; Alfonso Fernando investigator.;
• Is Part Of: European journal of heart failure. Volume 24:Number 3(2022)
• Page Start: 581
• Page End: 588
• Publication Date: 2021-11-09
• Subjects: Dapagliflozin -- Sodium–glucose co‐transporter 2 inhibitor -- Heart failure -- Trial design; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.2370
• Languages: English
• ISSNs: 1388-9842

Abstract

Abstract: 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.