Dapagliflozin after TAVI reduces HF in elderly patients

Elderly patients with aortic stenosis at high risk for heart failure (HF) who underwent transcatheter aortic valve implantation (TAVI) benefitted from dapagliflozin in terms of reducing all-cause mortality or worsening HF, compared with placebo.

“Although TAVI has changed the way aortic stenosis is managed, patients still face high rates of HF,” explained Dr Sergio Raposeiras-Roubín (Hospital Universitario Álvaro Cunqueiro de Vigo, Spain) [1]. “In the past, patients with HF secondary to valvular heart disease-related interventions had been excluded from clinical trials testing SGLT2 inhibitors.”

The current randomised study (n=1,257; median age 83 years) assessed the SGLT2 inhibitor dapagliflozin in participants with aortic stenosis undergoing TAVI who had an indication for an SGLT2 inhibitor based on prior trials showing benefit, including a prior HF admission and 1 of the following criteria: left ventricular ejection fraction ≤40%, diabetes mellitus, or an estimated glomerular filtrate rate (eGFR) between 25 and 75 mL/min/1.73m². “The study aimed to test the efficacy of dapagliflozin in this population and evaluate the safety of this agent in patients >80 years of age,” added Dr Raposeiras-Roubín. The participants received either dapagliflozin or placebo. The primary endpoint was a composite of all-cause mortality or worsening HF.

At 1 year of follow-up, dapagliflozin was superior to placebo with respect to the incidence of all-cause mortality or worsening HF (15.0% vs 20.1%; HR 0.72; 95% CI 0.55–0.95; P=0.018; see Figure). The secondary endpoint of all-cause mortality did not show a significant difference between the study arms (7.8% vs 9.1%; HR 0.87; 95% CI 0.59–1.28), but the outcomes for worsening HF were significantly different between participants on dapagliflozin and those on placebo (9.4% vs 14.4%; HR 0.63; 95% CI 0.45–0.88). Results thus confirmed those of prior trials showing benefits in patients with diabetes and patients with HF. Finally, Dr Raposeiras-Roubín mentioned that genital infections (1.8% vs 0.5%) and symptomatic hypotension (6.6% vs 3.6%) were more common in the dapagliflozin arm but that the safety profiles of dapagliflozin and placebo were otherwise similar.

Figure: Primary endpoint in the intention-to-treat population [1]



CI, confidence interval; HR, hazard ratio.

“Dapagliflozin was efficacious and safe in elderly patients with aortic stenosis at risk for HF who underwent TAVI,” concluded Dr Raposeiras-Roubín.

1. Raposeiras-Roubín S, et al. Dapagliflozin after transcatheter aortic valve implantation. Late-breaking Clinical Trials III, ACC 2025 Scientific Session, 29–31 March, Chicago, USA.

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Posted on 22 May 202522 May 2025