Key result
Dapagliflozin reduces death or worsening HF in elderly TAVI patients regardless of baseline LVEF.
Why the study?
SGLT2 inhibitors improve outcomes in HF across the LVEF spectrum, but patients with severe valvular heart disease have been excluded from pivotal trials.
Does dapagliflozin reduce all-cause death or worsening heart failure in elderly patients with severe aortic stenosis undergoing TAVI?
RCT (n=1,223)
Open-label
randomized
Yes
Does dapagliflozin reduce all-cause death or worsening heart failure in elderly patients with severe aortic stenosis undergoing TAVI?
Dapagliflozin safely reduces the risk of all-cause death or worsening heart failure in elderly patients undergoing TAVI, extending the benefits of SGLT2 inhibitors to this population regardless of baseline LVEF.
Supports dapagliflozin post-TAVI regardless of LVEF; extends SGLT2 inhibitor benefits to elderly patients with severe aortic stenosis.
AIMS: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve outcomes in heart failure (HF) across the left ventricular ejection fraction (LVEF) spectrum, but patients with severe valvular heart disease have been excluded from pivotal trials. We investigated the efficacy and safety of dapagliflozin across the full range of baseline LVEF in elderly patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: DapaTAVI was a pragmatic, multicentre, randomized, open-label trial with blinded endpoint adjudication conducted at 39 Spanish centres. Patients with severe aortic stenosis undergoing TAVI were randomized after the procedure to dapagliflozin 10 mg once daily or standard of care. The primary endpoint was a composite of all-cause death or worsening HF. Among 1223 patients with available baseline LVEF, 213 (17.4%) had LVEF ≤40% and 1010 (82.6%) had LVEF >40%. During 1-year follow-up, the primary endpoint occurred in 20.2% of patients with LVEF ≤40% and 17.0% of those with LVEF >40% (adjusted HR 1.28, 95% CI 0.91-1.80; P = .15). Dapagliflozin reduced the risk of the primary endpoint consistently across LVEF subgroups, with no significant interaction between treatment effect and baseline LVEF (P for interaction = .41). Analyses modelling LVEF as a continuous variable confirmed a homogeneous treatment effect across the entire LVEF spectrum. Dapagliflozin was well tolerated, with a safety profile comparable to control across all LVEF categories, although genitourinary infections were more frequent with dapagliflozin. CONCLUSION: In elderly patients undergoing TAVI, dapagliflozin reduced the risk of all-cause death or worsening HF irrespective of baseline LVEF and was safe across the full LVEF spectrum. These findings extend the benefits of SGLT2 inhibition to patients with severe aortic stenosis treated with TAVI, independent of systolic function.
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Raposeiras‐Roubín et al. (2026) conducted an RCT in Severe aortic stenosis (n=1,223). Dapagliflozin vs. Standard of care was evaluated on Composite of all-cause death or worsening HF. Dapagliflozin reduced the risk of all-cause death or worsening heart failure consistently across baseline LVEF subgroups (P for interaction = 0.41) in elderly patients undergoing TAVI.
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