Dapagliflozin After Transcatheter Aortic Valve Implantation According to Frailty in DapaTAVI Trial
Rafael González ManzanaresSoledad OjedaIgnacio J. Amat‐SantosAlbert Ariza‐SoléRafael RomagueraDiego López‐OteroLuis Nombela‐FrancoLivia GheorgheJorge Sanz‐SánchezCarlos Baladrón ZoritaIgnacio GalloRafael Cobas PazAntonio Jesús Muñoz GarcíaVictòria VilaltaGabriela Veiga FernándezJuan G. Córdoba‐SorianoPedro Cepas‐GuillénMiriam Sandín RollánXacobe Flores RíosRicardo Palma-CarbajalRoberto Martín ReyesPablo AvanzasSergio García‐BlasJuan A. Franco-PeláezJavier Martín MoreirasJosé Ramón Gonzalez JuanateyNieves GonzaloGermán CalleJosé Luis Díez GilSandra Santos‐MartínezRocío González-FerreiroErika Muñoz GarcíaEduard Fernández‐NofreríasXoán SanmartínGabriela Tirado‐ConteAlejandro Gutierrez BarriInmaculada González BermúdezXavier RossellóValentı́n FusterBorja IbáñezSergio Raposeiras‐Roubín
Key result
Dapagliflozin cuts death or worsening heart failure ~47% after TAVI, but only in frail patients.
- HR 0.53
- 95% CI 0.36-0.77
- P=0.021 for interaction
- n=1,222
Why the study?
Frailty is common in patients undergoing transcatheter aortic valve implantation and is associated with worse outcomes, but whether dapagliflozin's benefit differs by frailty status is uncertain.
Does dapagliflozin reduce the composite of all-cause death or worsening heart failure in patients undergoing transcatheter aortic valve implantation based on frailty status?
Key Points
- To assess whether the efficacy and safety of dapagliflozin after transcatheter aortic valve implantation vary according to patient frailty status.
- Conducted a post hoc analysis of 1222 patients with baseline frailty assessments enrolled in the DapaTAVI trial.
- Categorized baseline frailty using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale into robust (score 0), prefrail (1–2), and frail (3–5).
- Evaluated the primary composite endpoint of all-cause death or worsening heart failure over a 12-month follow-up period.
- At baseline, 47.2% of patients were frail, 40.3% prefrail, and 12.4% robust, with 215 patients (17.6%) reaching the primary endpoint over 12 months.
- Prefrail and frail patients had significantly elevated risks of the primary outcome compared to robust patients (prefrail adjusted HR, 1.88 [95% CI, 1.05–3.38]; frail adjusted HR, 2.29 [95% CI, 1.29–4.07]; P=0.004).
- Dapagliflozin lowered primary endpoint risk in frail patients (HR, 0.53 [95% CI, 0.36–0.77]), but showed no significant effect in prefrail (HR, 1.01 [95% CI, 0.66–1.55]) or robust patients (HR, 1.26 [95% CI, 0.42–3.75]; P for interaction=0.021), without modifying the safety profile.
Study Design
Type
RCT (n=1,222)
Structured PICO
Does dapagliflozin reduce the composite of all-cause death or worsening heart failure in patients undergoing transcatheter aortic valve implantation based on frailty status?
P
Population
1,222 patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with baseline frailty assessment, followed for 1 year.
I
Intervention
Dapagliflozin
O
Outcome
Composite of all-cause death or worsening heart failure at 1 yearcomposite
Main Result
Hazard Ratio: 0.53 (95% CI 0.36–0.77)
p-value: p=0.021 for interaction
In patients undergoing transcatheter aortic valve implantation, dapagliflozin appears to provide a targeted benefit in reducing death or worsening heart failure specifically among those with baseline frailty.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Previous trials have provided evidence for SGLT-2 inhibitors in patients with a variety of other conditions but have excluded patients with valvular heart disease. Based on our study, if you have a patient undergoing TAVI who is at risk of heart failure, it is important to treat them with dapagliflozin or another SGLT-2 inhibitor. These are safe drugs and have a lot of benefit.”
“Among elderly patients with aortic stenosis undergoing TAVI and at high risk for heart failure, dapagliflozin was safe and reduced the incidence of all-cause death or worsening heart failure compared with standard care.”
Implication
Dapagliflozin benefit post-TAVI appears consistent across frailty; supports consideration in frail patients but leaves open prospective confirmation.
Abstract
Background Frailty is common in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and portends worse outcomes. Whether the benefit of posttranscatheter aortic valve implantation dapagliflozin differs by frailty is uncertain. Methods In this post hoc analysis, we investigated the efficacy of dapagliflozin according to frailty status in the DapaTAVI (Dapagliflozin in Patients Undergoing Transcatheter Aortic Valve Implantation) trial. Frailty was assessed through the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight scale (robust=0, prefrail=1–2, frail=3–5). The primary outcome was the composite of all‐cause death or worsening heart failure at 1 year. Results Among 1222 patients with baseline frailty assessment, 47.2% were frail, 40.3% prefrail, and 12.4% robust. Over 12 months, 215 patients (17.6%) experienced the primary end point. Patients who were prefrail and frail had higher risk than robust patients (adjusted hazard ratios [HRs], 1.88 [95% CI, 1.05–3.38] and 2.29 [1.29–4.07], respectively; P =0.004). Dapagliflozin was associated with a lower risk of the primary end point in patients who were frail (HR, 0.53 [95% CI, 0.36–0.77]) but not in those who were prefrail (HR, 1.01 [95% CI, 0.66–1.55]) or robust patients (HR, 1.26 [95% CI, 0.42–3.75]); P for interaction=0.021. There was no evidence that frailty modified the safety profile of dapagliflozin. Conclusions Frailty was common and independently associated with worse outcomes after transcatheter aortic valve implantation. Dapagliflozin appeared to confer greater relative benefit in patients with frailty.
Discussion
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Cite This Study
Manzanares et al. (2026) conducted an RCT in Severe aortic stenosis (n=1,222). Dapagliflozin vs. Control was evaluated on Composite of all-cause death or worsening heart failure at 1 year (HR 0.53, 95% CI 0.36-0.77, p=0.021 for interaction). In patients undergoing TAVI, dapagliflozin reduced the risk of death or worsening heart failure in frail patients (HR 0.53; 95% CI 0.36-0.77), but not in prefrail or robust patients.