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Observational Study
. 2024 Nov 21;23(1):420.
doi: 10.1186/s12933-024-02504-8.

SGLT2-inhibitors in diabetic patients with severe aortic stenosis and cardiac damage undergoing transcatheter aortic valve implantation (TAVI)

Pasquale Paolisso #  1   2 , Marta Belmonte #  2   3 , Emanuele Gallinoro  1 , Roberto Scarsini  4 , Luca Bergamaschi  5 , Leonardo Portolan  4 , Matteo Armillotta  5 , Giuseppe Esposito  6 , Elisabetta Moscarella  7   8 , Giovanni Benfari  4 , Claudio Montalto  6 , Monika Shumkova  2 , Elayne Kelen de Oliveira  2   3 , Francesco Angeli  5 , Mateusz Orzalkiewicz  5 , Margherita Fabroni  4 , Nurcan Baydaroglu  6 , Andrea Raffaele Munafò  6 , Daniele Oreste D'Atri  9 , Matteo Casenghi  10 , Lucia Scisciola  11 , Michelangela Barbieri  11 , Raffaele Marfella  11 , Felice Gragnano  7   8 , Edoardo Conte  1   12 , Dario Pellegrini  9 , Alfonso Ielasi  9 , Daniele Andreini  1   12 , Martin Penicka  2 , Jacopo Andrea Oreglia  6 , Paolo Calabrò  7   8 , Antonio Bartorelli  1   12 , Carmine Pizzi  5 , Tullio Palmerini  5 , Marc Vanderheyden  2 , Francesco Saia  5 , Flavio Ribichini  4 , Emanuele Barbato  13   14
Affiliations
Observational Study

SGLT2-inhibitors in diabetic patients with severe aortic stenosis and cardiac damage undergoing transcatheter aortic valve implantation (TAVI)

Pasquale Paolisso et al. Cardiovasc Diabetol. .

Erratum in

  • Correction: SGLT2-inhibitors in diabetic patients with severe aortic stenosis and cardiac damage undergoing transcatheter aortic valve implantation (TAVI).
    Paolisso P, Belmonte M, Gallinoro E, Scarsini R, Bergamaschi L, Portolan L, Armillotta M, Esposito G, Moscarella E, Benfari G, Montalto C, Shumkova M, de Oliveira EK, Angeli F, Orzalkiewicz M, Fabroni M, Baydaroglu N, Munafò AR, D'Atri DO, Casenghi M, Scisciola L, Barbieri M, Marfella R, Gragnano F, Conte E, Pellegrini D, Ielasi A, Andreini D, Penicka M, Oreglia JA, Calabrò P, Bartorelli A, Pizzi C, Palmerini T, Vanderheyden M, Saia F, Ribichini F, Barbato E. Paolisso P, et al. Cardiovasc Diabetol. 2025 Jan 13;24(1):14. doi: 10.1186/s12933-024-02560-0. Cardiovasc Diabetol. 2025. PMID: 39806470 Free PMC article. No abstract available.

Abstract

Background: A substantial number of patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) experience adverse events after TAVI, with health care expenditure. We aimed to investigate cardiac remodeling and long-term outcomes in diabetic patients with severe AS, left ventricular ejection fraction (LVEF) < 50%, and extra-valvular cardiac damage (EVCD) undergoing TAVI treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) versus other glucose-lowering strategies (no-SGLT2i users).

Methods: Multicenter international registry of consecutive diabetic patients with severe AS, LVEF < 50%, and EVCD undergoing TAVI. Based on glucose-lowering therapy at hospital discharge, patients were stratified in SGLT2i versus no-SGLT2i users. The primary endpoint was a composite of all-cause death and heart failure (HF)-hospitalization (major adverse cardiovascular events, MACE) at 2-year follow-up. Secondary outcomes included all-cause death, cardiovascular death, and HF hospitalization.

Results: The study population included 311 patients, among which 24% were SGLT2i users. Within 1-year after TAVI, SGLT2i users experienced a higher rate of LV recovery (p = 0.032), especially those with baseline LVEF ≤ 30% (p = 0.026), despite the lower baseline LVEF. Patients not treated with SGLT2i were more likely to progress to a worse EVCD stage over time (p = 0.018). At 2-year follow-up, SGLT2i use was associated with a lower rate of MACE, all-cause death, and HF hospitalization (p < 0.01 for all). After adjusting for confounding factors, the use of SGLT2i emerged as an independent predictor of reduced MACE (HR = 0.45; 95% CI 0.17-0.75; p = 0.007), all-cause death (HR = 0.51; 95% CI 0.25-0.98; p = 0.042) and HF-hospitalization (HR = 0.40; 95% CI 0.27-0.62; p = 0.004).

Conclusions: In diabetic patients with severe AS, LVEF < 50%, and EVCD undergoing TAVI, the use of SGLT2i was associated with a more favorable cardiac remodeling and a reduced risk of MACE at 2-year follow-up.

Keywords: Aortic stenosis; Cardiac damage staging; Cardiac remodeling; Heart failure; LV recovery; Low-flow low-gradient; Outcomes; Prognosis; SGLT2i; TAVI.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Data were collected as part of an approved international multicenter observational study. The present study was conducted according to the principles of the Declaration of Helsinki; all patients were informed about their participation in the registry and provided informed consent for the anonymous publication of scientific data. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Hemodynamic phenotype, extra-valvular cardiac damage staging, and left ventricle ejection fraction distribution, stratified in SGLT2i versus no-SGLT2i users. Abbreviations: HG high gradient; LF–LG low flow low gradient, LVEF left ventricle ejection fraction, SGLT2i sodium/glucose cotransporter 2 inhibitors, S stage
Fig. 2
Fig. 2
Baseline versus follow-up changes in echocardiographic data (LVEF, LVEDV, LAV, TAPSE, PASP) in SGLT2i versus no-SGLT2i users. Abbreviations: SGLT2i sodium/glucose cotransporter 2 inhibitors, LV left ventricle, LVEDV left ventricular end-diastolic volume, LVEF left ventricular ejection fraction, LAVi left atrial volume indexed, PASP systolic pulmonary artery pressure, TAPSE tricuspid annular plane systolic excursion
Fig. 3
Fig. 3
Baseline versus follow-up LVEF distribution, stratified in SGLT2i versus no-SGLT2i users, in the overall study population and in the sub-groups of patients with LVEF ≤ 30%. Abbreviations: SGLT2i sodium/glucose cotransporter 2 inhibitors, LVEF left ventricular ejection fraction
Fig. 4
Fig. 4
Sankey diagram showing the transition of cardiac damage from baseline up to 1 year after TAVI in SGLT2i-treated versus no-SGLT2i-treated patients with comprehensive follow-up echocardiographic assessment (N = 224) (median time 8 [7–11] months, with no differences between groups) (Panel A). Rate of extra-valvular cardiac damage staging progression and LVEF recovery in SGLT2i versus no-SGLT2i users (Panel B) (median follow-up time 24 [14–35] months). Abbreviations: SGLT2i sodium/glucose cotransporter 2 inhibitors, LV left ventricle, LVEF left ventricular ejection fraction, EVCD extra-valvular cardiac damage
Fig. 5
Fig. 5
Kaplan–Meier survival curves of SGLT2i (red curve) versus no-SGLT2i users (blue curve). Panel A: MACE. Panel B: all-cause death; Panel C: hospitalization due to heart failure. Abbreviations: SGLT2i sodium-glucose co-transporter 2 inhibitors, MACE major adverse cardiovascular event, HF heart failure
See this image and copyright information in PMC

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