Heart failure & cardiomyopathiesRandomised controlled trial
Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation
- Randomised controlled trial
Authors' conclusion
Among older adults with aortic stenosis undergoing TAVI who were at high risk for heart-failure events, dapagliflozin resulted in a significantly lower incidence of death from any cause or worsening of heart failure than standard care alone.
Study context
- Population
- Patients with AS undergoing transcatheter aortic-valve implantation (TAVI) with a history of HF plus renal insufficiency, DM or LV systolic dysfunction, Spain1,222 in primary analysis
- Participants
- 620 vs 637
- Comparison
- Dapagliflozin vs standard care alone
- Dapagliflozinn = 620
- Standard caren = 637reference
- Primary endpoint
- Composite of:
- Death from any cause
- Worsening HF (hospitalization or urgent visit)
- Follow-up
- 1 year
Primary result
As reported in the abstract
Hazard ratio
0.72
95% CI 0.55–0.95
P = 0.02
Events by treatment group
Dapagliflozin vs Standard care
HR 0.72 (95% CI 0.55–0.95); P = 0.02
Further findings
| Outcome | Dapagliflozin | Standard care | HR (95% CI) | |
|---|---|---|---|---|
| Death from any cause | 7.8% | 8.9% | 0.87 (0.59–1.28) | |
| 0.512Hazard ratio (log scale) |
Worsening HF
subhazard ratio 0.63 (0.45–0.88)
Safety
Genital infection and hypotension
- Significantly more common with dapagliflozin
Original publication
Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. Published 29 March 2025. doi:10.1056/nejmoa2500366
Summarised from the published abstract; every number is checked against it