DapaTAVI Trial: Dapagliflozin in TAVR

dapatavi trial

The year 2025 brought several influential cardiovascular studies to light, and among the most promising was the DapaTAVI trial. This randomized, open-label trial explored the impact of dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, in a population often seen as high-risk but underrepresented—patients undergoing Transcatheter Aortic Valve Implantation (TAVI) with a background of heart failure or other comorbidities.

What Was the Goal of the DapaTAVI Trial?

The DapaTAVI trial set out to determine whether dapagliflozin 10 mg daily could improve outcomes in patients with severe aortic stenosis who had just undergone TAVI and were at high risk for heart failure events. The study enrolled 1,222 patients, assigning 620 to the dapagliflozin group and 637 to receive standard care alone.

Inclusion Criteria

Eligible patients had:

  • Severe aortic stenosis treated with TAVI
  • A history of prior heart failure admission
  • At least one of the following:
    • Left ventricular ejection fraction (LVEF) ≤ 40%
    • Diabetes mellitus
    • Moderate chronic kidney disease (eGFR 25–75 ml/min/1.73 m²)

Primary Outcome

The primary endpoint was a composite of death from any cause or worsening of heart failure.

  • Dapagliflozin group: 15%
  • Standard care group: 20.1%
  • Hazard Ratio (HR): 0.72
  • 95% Confidence Interval (CI): 0.55 to 0.95
  • P-value: 0.02

👉 The results were statistically significant, demonstrating a 28% relative risk reduction in the primary outcome for those receiving dapagliflozin.

Secondary Outcomes

While the overall death rate from any cause was not significantly different (7.8% vs. 8.9%, HR 0.87), there was a notable reduction in heart failure worsening:

  • Worsening of heart failure:
    • Dapagliflozin: 9.4%
    • Standard care: 14.4%
    • Subhazard Ratio: 0.63
    • 95% CI: 0.45 to 0.88

This secondary outcome reaffirms dapagliflozin’s role as a powerful agent in reducing heart failure events post-TAVI.

What Does the DapaTAVI Trial Tell Us?

The DapaTAVI trial supports expanding the use of SGLT2 inhibitors like dapagliflozin to post-TAVI patients who remain at risk for heart failure decompensation. These findings are especially relevant as the TAVI procedure continues to gain popularity among older adults with severe aortic stenosis, many of whom have overlapping comorbidities such as diabetes, heart failure, and chronic kidney disease.

Conclusion

The DapaTAVI trial offers promising data on improving outcomes in a vulnerable population. By significantly reducing the risk of death or heart failure progression, dapagliflozin has the potential to become standard adjunctive therapy post-TAVI in appropriately selected patients.

This study, published in NEJM and presented by Dr. Sergio Raposeiras-Roubin at ACC.25, is another step forward in optimizing long-term care after structural heart interventions.

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