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Randomized Controlled Trial
. 2022 Mar;24(3):581-588.
doi: 10.1002/ejhf.2370. Epub 2021 Nov 9.

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

Ignacio J Amat-Santos  1   2 , Juan P Sánchez-Luna  1   2 , Emad Abu-Assi  3 , María Melendo-Viu  3 , Ignacio Cruz-Gonzalez  4 , Luis Nombela-Franco  5 , Antonio J Muñoz-Garcí  1   6 , Sergio G Blas  7 , Jose M de la Torre Hernandez  8 , Rafael Romaguera  9 , Ángel Sánchez-Recalde  10 , José L Diez-Gil  11 , Diego Lopez-Otero  1   12 , Livia Gheorge  13 , Borja Ibáñez  1   14   15 , Andrés Iñiguez-Romo  3 , Sergio Raposeiras-Roubín  3   15 ; Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

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

Ignacio J Amat-Santos et al. Eur J Heart Fail. 2022 Mar.
Free article

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 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.

Keywords: Dapagliflozin; Heart failure; Sodium-glucose co-transporter 2 inhibitor; Trial design.

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References

    1. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-8.
    1. Nombela-Franco L, del Trigo M, Morrison-Polo G, Veiga G, Jimenez-Quevedo P, Abdul-Jawad Altisent O, et al. Incidence, causes, and predictors of early (≤30 days) and late unplanned hospital readmissions after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2015;8(13):1748-57.
    1. Durand E, Doutriaux M, Bettinger N, Tron C, Fauvel C, Bauer F, et al. Incidence, prognostic impact, and predictive factors of readmission for heart failure after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2017;10(23):2426-36.
    1. Cid-Menéndez A, López-Otero D, González-Ferreiro R, Iglesias-Álvarez D, Álvarez-Rodríguez L, Antúnez-Muiños PJ, et al. Predictors and outcomes of heart failure after transcatheter aortic valve implantation using a self-expanding prosthesis. Rev Esp Cardiol (Engl Ed). 2020;73(5):383-92.
    1. Kaewkes D, Ochiai T, Flint N, Patel V, Mahani S, Kim I, et al. Optimal medical therapy following transcatheter aortic valve implantation. Am J Cardiol. 2021;141:62-71.

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