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Influence of diabetes mellitus on dapagliflozin response after transcatheter aortic valve replacement (TAVR): insights from the DAPA-TAVI trial
Rocío PárragaCarlos RealLuis Nombela‐FrancoIgnacio Amat-SantosPilar Jiménez‐QuevedoDiego López OteroLivia GheorgheJorge Sanz-SánchezCarlos Baladron ZoritaSoledad OjedaRocío FerreiroAntonio Jesús Muñoz GarcíaVictòria VilaltaGabriela Veiga FernándezJuan Gabriel Córdoba SorianoPedro Cepas-GuillénMiriam Sandín RollánXacobe Flores‐RíosRicardo Palma-CarbajalRoberto Martín ReyesRafael RomagueraPablo AvanzasSergio García BlasJuan A. Franco-PeláezJavier Martín MoreirasJosé R. González-JuanateyGermán CalleJosé Luis DíezSandra Santos-MartínezPablo Domínguez ErquiciaErika Muñoz GarcíaEduard Fernandez-NofreriasXoan SanmartínAlejandro Gutiérrez BarriosInmaculada González BermúdezValentı́n FusterBorja IbáñezSergio Raposeiras Roubin
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Key result
Dapagliflozin cuts mortality or worsening heart failure ~42% vs standard care in diabetic TAVR patients.
- HR 0.580
- 95% CI 0.389-0.866
- P=0.008
- NNT 11
- n=1,222
Why the study?
Whether the magnitude of benefit of dapagliflozin in patients with prior heart failure undergoing TAVR differs according to diabetes mellitus status remains uncertain.
Does dapagliflozin reduce the composite of all-cause mortality or worsening heart failure in patients with severe aortic stenosis undergoing TAVR with prior heart failure, stratified by diabetes mellitus status?
Study Design
Type
RCT (n=1,222)
Blinding
Open-label
Randomization
1:1
Multicenter
Yes
Structured PICO
Does dapagliflozin reduce the composite of all-cause mortality or worsening heart failure in patients with severe aortic stenosis undergoing TAVR with prior heart failure, stratified by diabetes mellitus status?
P
Population
1,222 patients with severe aortic stenosis undergoing TAVR with prior heart failure and high-risk conditions, followed for 12 months to assess dapagliflozin efficacy stratified by diabetes status.
I
Intervention
Dapagliflozin 10 mg once daily, started within the first 7 days post-TAVR and continued for 12 months
C
Comparator
Standard care
O
Outcome
Composite of all-cause mortality or worsening heart failure (defined as either hospitalization for heart failure or an urgent heart-failure visit leading to the administration of intravenous diuretics) at 12 monthscomposite
Main Result
Hazard Ratio: 0.58 (95% CI 0.389–0.866)
Absolute Event Rate: 15.2% vs 22.7%
Number Needed to Treat: 11
p-value: p=0.008
Limitations
- Patients with and without diabetes mellitus were not directly comparable due to the trial's inclusion criteria.
- Limited statistical power inherent to subgroup analyses.
- No statistically significant interaction according to diabetes status was observed, meaning findings should be considered exploratory and hypothesis-generating.
- Patients with and without diabetes mellitus were not directly comparable because of the DAPA-TAVI trial inclusion criteria
- Limited statistical power inherent to subgroup analyses
- This is a subanalysis and the results should be interpreted with caution
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
DLDeepak L. BhattDirector, Mount Sinai Fuster Heart Hospital
“I know for me it will be practice changing when I go back to New York next week. I think I am pretty good about making sure that those without contraindications are discharged on an SGLT2 inhibitor. But I must say, in my TAVI or TAVR patients, that's not part of the checklist.”
WBWayne BatchelorInterventional cardiologist, Inova Health System
“Basically, if you've had a history of heart failure and you're already on decent guideline-directed medical therapy and you happen to have aortic stenosis, you'll benefit as much as a patient who we would actually treat normally anyway with [dapagliflozin]. To me this is almost just confirming that our normal treatment pattern is valid in patients with aortic stenosis.”
“Patients with severe aortic stenosis had consistently been excluded from the large SGLT2 inhibitor trials. DapaTAVI is helping to close an important gap in clinical cardiology.”
Implication
In a pre-specified subanalysis of the DAPA-TAVI trial, dapagliflozin significantly reduced the risk of death or worsening heart failure in diabetic patients undergoing TAVR, with a favorable benefit-risk profile.
Abstract
The DAPA-TAVI trial demonstrated that dapagliflozin reduced the composite of all-cause mortality or worsening heart failure (HF) at 1 year in patients undergoing transcatheter aortic valve replacement (TAVR) with prior HF. Whether the magnitude of this benefit differs according to diabetes mellitus (DM) status remains uncertain. This pre-specified subgroup analysis of the multicenter randomized DAPA-TAVI trial conducted at 39 centers in Spain, which enrolled 1222 patients with severe aortic stenosis undergoing TAVR with prior HF and at least one high-risk condition. Patients were stratified by the presence or absence of DM. The primary endpoint was a composite of all-cause mortality or worsening HF at 12 months. Secondary endpoints included the individual components of the primary endpoint, cardiovascular death, and safety outcomes. Cox proportional-hazards models adjusted for age, sex, coronary artery disease, baseline ejection fraction and baseline estimated glomerular filtration rate were used to estimate treatment effects. Among 1222 patients, 537 (43.9%) had DM. In patients with DM, dapagliflozin significantly reduced the primary endpoint compared with standard care (15.2% vs. 22.7%; HR 0.580; 95% CI 0.389–0.866; p = 0.008; number needed to treat [NNT] = 11), driven primarily by fewer worsening HF events. In patients without DM, the reduction was numerically lower and non-significant (15.0% vs. 18.0%; HR 0.814; 95% CI 0.560–1.183; p = 0.280; NNT = 32). Genital infections were more frequent with dapagliflozin in patients with DM, whereas symptomatic hypotension was more common in those without DM. No significant differences in serious adverse events were observed in either subgroup. No statistically significant interactions between DM status and treatment effect were observed for the primary or secondary endpoints. In this pre-specified subanalysis of the DAPA-TAVI trial, dapagliflozin significantly reduced the risk of death or worsening HF in patients with DM undergoing TAVR, with a favorable benefit–risk profile, whereas a more modest and non-significant effect was observed in non-DM patients. Although no statistically significant interaction according to diabetes status was observed, the apparently greater benefit among patients with DM warrants further investigation.
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Cite This Study
Párraga et al. (2026) conducted an RCT in Severe aortic stenosis with prior heart failure (n=1,222). Dapagliflozin vs. Standard care was evaluated on Composite of all-cause mortality or worsening heart failure at 12 months (in patients with diabetes mellitus) (HR 0.580, 95% CI 0.389-0.866, p=0.008). Dapagliflozin significantly reduced the composite of all-cause mortality or worsening heart failure (HR 0.580) compared to standard care in patients with diabetes mellitus undergoing TAVR.
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