Dapagliflozin after TAVI improves outcomes in elderly patients with aortic stenosis

Elderly patients with aortic stenosis who received dapagliflozin after transcatheter aortic-valve implantation (TAVI) had better outcomes than those who did not receive the drug, according to the DapaTAVI* trial presented at ACC.25.

“TAVI has changed how aortic stenosis is managed. However, despite TAVI, patients still face high rates of heart failure (HF), especially during the first year after the procedure,” said lead author Dr Sergio Raposeiras‑Roubin from Hospital Álvaro Cunqueiro, Pontevedra, Spain.

“Previous trials have provided evidence for SGLT2 inhibitors in patients with a variety of other conditions but excluded patients with valvular heart disease,” he noted.

Hence, given the limited evidence of SGLT2 inhibitors in older patients with aortic stenosis undergoing TAVI, Raposeiras-Roubin and his team sought to investigate the efficacy and safety of adding dapagliflozin to standard care in this patient population.

The trial enrolled 1,257 patients (mean age 82.4 years, 49.4 percent female) with aortic stenosis who underwent TAVI at 39 centres in Spain. At baseline, 43.9 percent of the participants had diabetes, 17 percent had a left ventricular ejection fraction (LVEF) of <40 percent, and 88.6 percent had an estimated glomerular filtrate rate (eGFR) of 25−70 mL/min/1.73m².

Upon hospital discharge or within 14 days after TAVI, they were randomized in a 1:1 ratio to receive either dapagliflozin 10 mg once daily and standard care (n=605) or standard care alone (n=617).

At 1-year follow-up, the rate of the primary composite endpoint of all-cause death or worsening HF (defined as any hospitalization for HF or urgent HF visit requiring intravenous diuretics) was significantly lower in the dapagliflozin arm than the standard care alone arm (15 percent vs 20.1 percent; hazard ratio [HR], 0.72; p=0.018). [Raposeiras‑Roubin, et al, ACC.25]

Furthermore, when the individual components were analysed separately, there was a 37-percent reduction in worsening HF which occurred in 9.4 percent of patients treated with dapagliflozin compared with 14.4 percent of those treated with standard care alone (HR, 0.63). However, there was no significant difference in the rate of all-cause death, which occurred in 7.8 percent vs 8.9 percent (HR, 0.87) of patients, respectively.

Of note, the effect of dapagliflozin on the primary outcome appeared to be consistent across prespecified subgroups, including patients with or without diabetes, LVEF of >40 or ≤40 percent, or eGFR ≥60 or <60 ml/min/1.73 m², Raposeiras-Roubin noted.

As for the secondary endpoints, the incidence of hospitalization for HF, urgent HF visit, and the composite of CV death or hospitalization for HF was lower with dapagliflozin compared with standard care alone (HRs, 0.68, 0.46, and 0.71, respectively), but not all-cause death (HR, 0.81).

However, in terms of safety endpoints, genital infection and symptomatic hypotension occurred more frequently in the dapagliflozin group than the control group (1.8 percent vs 0.5 percent and 6.6 percent vs 3.6 percent).

All other adverse events were similar in both groups, noted Raposeiras-Roubin.

“Our results appear to confirm that SGLT2 inhibitors were safe in older patients and associated with clinical benefits, which is important given the low frequency of prescriptions for SGLT2 inhibitors among older patients,” said the researchers. [N Engl J Med 2025;doi:10.1056/NEJMoa2500366]

“Overall, among elderly patients with aortic stenosis undergoing TAVI and at high risk for future HF events, SGLT2 inhibition with dapagliflozin … reduced the incidence of all-cause death or worsening HF compared with standard care alone,” Raposeiras-Roubin concluded.