Dapagliflozin Improves Outcomes in Heart Failure After TAVI Procedure

Daily dapagliflozin significantly lowered the incidence of mortality or worsening disease among patients with heart failure (HF) at 1 year after transcatheter aortic valve implantation (TAVI), according to new data presented at the American College of Cardiology (ACC) 2025 Annual Scientific Sessions.1

DapaTAVI was the first trial to evaluate sodium-glucose co-transporter 2 (SGLT2) inhibition compared with standard care alone, recruiting more than 1200 patients with HF and severe aortic stenosis undergoing the procedure in Spain, with an average age of 82 years and more than half women.

“Previous trials have provided evidence for SGLT2 inhibitors in patients with a variety of other conditions but have excluded patients with valvular heart disease,” said Sergio Raposeiras-Roubin, MD, a clinical cardiologist at Alvaro Cunqueiro Hospital and professor of medicine at the University of Santiago de Compostela.2 “Based on our study, if you have a patient undergoing TAVI who is at risk of HF, it is important to treat them with dapagliflozin or another SGLT2 inhibitor. These are safe drugs and have a lot of benefit.”

Across a spectrum of patients, SGLT2 inhibitors have been proven effective for reducing HF-related admissions—clinical guidelines from both the US and Europe recommend their use, irrespective of left ventricular ejection fraction (LVEF) or diabetes status. Supporting evidence has not confirmed its benefit for patients with HF attributed to reversible conditions, including aortic stenosis.3,4

As patients undergoing the procedure are often elderly, Raposeiras-Roubin and colleagues noted that those ≥80 years are typically excluded from clinical trials assessing SGLT2 inhibitors, limiting the frequency of prescriptions for this population. DapaTAVI was conducted at 39 centers in Spain to test the efficacy and safety of daily oral dapagliflozin 10 mg for those with aortic stenosis undergoing TAVI.1

All patients had a history of hospitalization for HF and ≥1 condition putting them at high risk for adverse outcomes, including renal insufficiency, diabetes, and a low LVEF. Among the patients, 620 were randomly assigned to dapagliflozin starting within two weeks after TAVI and 637 to standard care alone after TAVI—exclusions left 1222 patients in the primary analysis.

Upon analysis, the rate of the study’s primary endpoint at one year, a composite of all-cause death or worsening HF was 28% lower in those taking dapagliflozin (15.0%), compared with standard care (20.1%) (hazard ratio [HR], 0.72; 95% CI, 0.55–0.95; P =.02). Raposeiras-Roubin and colleagues attributed this significant improvement to a 37% lowering in worsening HF with dapagliflozin.

Further analysis showed death from any cause occurred in 47 (7.8%) patients in the dapagliflozin group and 55 (8.9%) in the standard care group (HR, 0.87; 95% CI, 0.59–1.28), but the difference was not statistically significant. Worsening of HF occurred in 57 (9.4%) and 89 (14.4%) patients in the dapagliflozin and standard care groups, respectively (subhazard ratio, 0.63; 95% CI, 0.45–0.88).

Safety analysis revealed no difference between study groups in the rate of urinary tract infections, but dapagliflozin was linked to a significantly higher rate of genital infection (P =.03) and hypotension (P =.01). Adverse events led to discontinuation of dapagliflozin in 37 (6.1%) patients.

As results were consistent across age, sex, kidney function, and diabetes status, Raposeiras-Roubin and colleagues announced plans to evaluate further differences by LVEF status and quality of life outcomes for this HF population undergoing TAVI.

“We found that these drugs are safe even in our elderly population, who are usually excluded from clinical trials,” Raposeiras-Roubin added.2 “It is important to have evidence in this group of patients; it is good for science and good for physicians to have an independent trial to demonstrate that the [beneficial] effect of SGLT2 inhibitors is also consistent in subgroups of patients in whom we didn’t have evidence until now.” dapagliflozin

References

1. Raposeiras-Roubin S, Amat-Santos I, Rossello X, Ferreiro R. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. The New England Journal of Medicine. March 29, 2025. Accessed March 30, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2500366.

2. Dapagliflozin safe and effective in elderly patients with heart failure undergoing valve replacement. American College of Cardiology. March 29, 2025. Accessed March 30, 2025. https://www.acc.org/About-ACC/Press-Releases/2025/03/29/17/17/Dapagliflozin-Safe-and-Effective-in-Elderly.

3. McDonagh TA, Metra M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2024;26(1):5-17. doi:10.1002/ejhf.3024

4. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2022 May 3;145(18):e1033. doi: 10.1161/CIR.0000000000001073.] [published correction appears in Circulation. 2022 Sep 27;146(13):e185. doi: 10.1161/CIR.0000000000001097.] [published correction appears in Circulation. 2023 Apr 4;147(14):e674. doi: 10.1161/CIR.0000000000001142.]. Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063