DapaTAVI
Trial question
What is the effect of dapagliflozin in older patients with severe aortic stenosis undergoing TAVI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 1223
1223 patients (604 female, 619 male).
Inclusion criteria: older patients with severe aortic stenosis undergoing TAVI.
Key exclusion criteria: any contraindication to dapagliflozin; current therapy with a sulfonylurea or SGLT-2 inhibitor; SBP < 100 mmHg; DBP < 50 mmHg; eGFR < 25 mL/min/1.73 m²; chronic cystitis or recurrent UTI.
Interventions
N=605 dapagliflozin (oral dose of 10 mg once daily plus standard care).
N=618 standard care (standard care alone).
Primary outcome
Death or worsening of heart failure at 1 year
15%
20.1%
20.1 %
15.1 %
10.1 %
5.0 %
0.0 %
Dapagliflozin
Standard
care
Significant
decrease ▼
NNT = 19
Significant decrease in death or worsening of HF at 1 year (15% vs. 20.1%; HR 0.72, 95% CI 0.55 to 0.95).
Secondary outcomes
No significant difference in CV death (4.5% vs. 5.3%; sHR 0.81, 95% CI 0.49 to 1.35).
Significant decrease in hospitalization for HF or CV death (10.1% vs. 13.8%; sHR 0.71, 95% CI 0.51 to 0.98).
Significant decrease in worsening of HF (9.4% vs. 14.4%; sHR 0.63, 95% CI 0.45 to 0.88).
Safety outcomes
No significant differences in nontraumatic amputation, major hypoglycemia, cancer, UTI, bacteremia, syncope.
Significant differences in genital infection (1.8% vs. 0.5%), hypotension (6.6% vs. 3.6%).
Conclusion
In older patients with severe aortic stenosis undergoing TAVI, dapagliflozin was superior to standard care with respect to death or worsening of HF at 1 year.
Reference
Sergio Raposeiras-Roubin, Ignacio J Amat-Santos, Xavier Rossello et al. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405.
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