Dapagliflozin does not improve QoL after TAVI in elderly with aortic stenosis

ESC Heart Failure 2025 – In a prespecified analysis of DapaTAVI among elderly patients with severe aortic stenosis undergoing TAVI, dapagliflozin resulted in more participants achieving NYHA class I at 12 months compared with standard care only but there was no effect on quality of life (QoL).

This summary is based on the presentation of Clara Bonanad Lozano, MD, PhD (Valencia, Spain) at the ESC Heart Failure Congress 2025 - Impact of dapagliflozin on quality of life in patients with aortic stenosis undergoing transcatheter aortic valve implantation.

Introduction and methods

Patients with severe valvular heart disease, those undergoing TAVI, and elderly people have been systematically excluded from RCTs with SGLT2 inhibitors. The DapaTAVI (Dapagliflozin After Transcatheter Aortic Valve Implantation) trial was the first RCT in which the efficacy and safety of SGLT2 inhibitors were assessed in TAVI patients, specifically in those aged >80 years. It showed dapagliflozin reduced the risk of the composite outcome of all-cause mortality or worsening HF at 12 months by 28% compared with standard care alone.

In a prespecified analysis of the DapaTAVI trial, the effects of dapagliflozin on NYHA functional class and quality of life (QoL) as assessed with the KCCQ-12 were examined, as well as its effects on the composite outcome according to baseline NYHA class and KCCQ-12 score. The DapaTAVI trial was a multicenter, independent, pragmatic, open-label, blinded-endpoint, phase 4 RCT conducted in Spain in which 1222 patients with severe aortic stenosis, history of HF, and ≥1 risk factors (renal insufficiency, diabetes, or LVEF ≤40%) undergoing TAVI were randomized to dapagliflozin 10 mg once daily in addition to standard care or standard care only. Mean age was 82.4 years, and 7.4% of the participants were >90 years old. NYHA class and KCCQ-12 score data at 12 months were available for 862 patients (70.5%).

Main results

• In both patients treated with dapagliflozin and those receiving standard care only, the mean KCCQ-12 score improved rapidly and this was sustained through 12 months, with no difference between the 2 groups (–0.10; 95%CI: –3.13 to 2.93; P=0.948).
• There were also no differences between the treatment groups when the patients were stratified by the change in the KCCQ-12 score from baseline to 12 months.
• Subgroup analysis demonstrated consistent treatment effects of dapagliflozin versus standard care only on the KCCQ-12 score across prespecified subgroups stratified by, among others, age, sex, LVEF, or medication use at baseline.
• At 12 months, greater reductions in NYHA class were observed in the dapagliflozin group compared with the standard-care only group and more patients in the dapagliflozin group achieved NYHA class I at 12 months than those in the control group (OR: 0.76; 95%CI: 0.61–0.94; P=0.013).
• The beneficial effects of dapagliflozin on the composite outcome of all-cause mortality or worsening HF at 12 months were not influenced by baseline KCCQ-12 score (P for interaction=0.356) or baseline NYHA class (P for interaction=0.769).

Conclusion

In this prespecified analysis of the DapaTAVI trial among elderly patients (mean age: >80 years) with severe aortic stenosis undergoing TAVI, 12-month treatment with dapagliflozin in addition to standard care resulted in more participants achieving NYHA class I compared with standard care only but there was no effect on QoL as assessed with the KCCQ-12. Dapagliflozin also reduced the risk of all-cause mortality or worsening HF regardless of NYHA class or KCCQ-12 score at baseline.

- Our reporting is based on the information provided at the ESC Heart Failure Congress 2025 and publication of the study design at ClinicalTrials.gov -