Evidence map›Paper›PMID 43004293›Full record

Trial reportCardiovascular diabetology2026

Influence of diabetes mellitus on dapagliflozin response after transcatheter aortic valve replacement (TAVR): insights from the DAPA-TAVI trial.

Rocío Párraga, Carlos Real, Luis Nombela-Franco, Ignacio Amat-Santos, Pilar Jimenez-Quevedo, Diego López Otero, Livia Gheorghe, Jorge Sanz-Sánchez, Carlos Baladrón Zorita, Soledad Ojeda and 28 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors.

Rocío PárragaCardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Profesor Martin Lagos, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0003-2200-1824
Carlos RealCardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Profesor Martin Lagos, 28040, Madrid, Spain.
Luis Nombela-FrancoCardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Profesor Martin Lagos, 28040, Madrid, Spain. luisnombela@yahoo.com.
Ignacio Amat-SantosCardiology Department, University Clinical Hospital of Valladolid, Valladolid, Spain.
Pilar Jimenez-QuevedoCardiovascular Institute, Hospital Clinico San Carlos, IdISSC, Profesor Martin Lagos, 28040, Madrid, Spain.
Diego López OteroCardiology Department, University Hospital Montecelo, Pontevedra, Spain.
Livia GheorgheCardiology Department, University Hospital Puerta del Mar, Cádiz, Spain.
Jorge Sanz-SánchezCardiology Department, University Hospital La Fe, Valencia, Spain.
Carlos Baladrón ZoritaCardiology Department, University Clinical Hospital of Valladolid, Valladolid, Spain.
Soledad OjedaDepartment of Cardiology, Reina Sofia University Hospital, Córdoba, Spain.
Rocío González FerreiroCardiology Department, University Hospital Álvaro Cunqueiro, Estrada de Clara Campoamor 341, 36213, Vigo, Pontevedra, Spain.
Antonio Jesús Muñoz GarcíaCardiology Department, University Hospital Virgen de la Victoria, Málaga, Spain.
Victoria VilaltaCardiology Department, University Hospital German Trias i Pujol, Badalona, Spain.
Gabriela Veiga FernándezCardiology Department, University Hospital Marqués de Valdecilla, Santander, Spain.
Juan Gabriel Córdoba SorianoCardiology Department, University Hospital of Albacete, Albacete, Spain.
Pedro Cepas-GuillénCardiology Department, University Clinical Hospital. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Miriam Sandín RollánCardiology Department, Dr. Balmis University General Hospital, Alicante, Spain.
Xacobe Flores RíosCardiology Department, University Hospital Juan Canalejo, A Coruña, Spain.
Ricardo Palma-CarbajalCardiology Department, University Hospital Vall D'Hebron, Barcelona, Spain.
Roberto Martín ReyesCardiology Department, University Hospital Quiron Salud La Luz, Madrid, Spain.
Rafael RomagueraCardiology Department, Hospital Universitari de Bellvitge; Bioheart Group, Cardiovascular, Respiratory and Systemic Diseases and Cellular Aging Program, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.
Pablo AvanzasCentro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
Sergio García BlasCardiology Department, Clinic University Hospital of Valencia, Valencia, Spain.
Juan A Franco-PeláezCardiology Department, University Hospital Fundación Jiménez Díaz, Madrid, Spain.
Javier Martín MoreirasCardiology Department, University Clinical Hospital of Salamanca, Salamanca, Spain.
José R González-JuanateyCardiology Department, University Clinical Hospital of Santiago de Compostela, Compostela, Spain.
German CalleCardiology Department, University Hospital Puerta del Mar, Cádiz, Spain.
José Luis DíezCardiology Department, University Hospital La Fe, Valencia, Spain.
Sandra Santos-MartínezCardiology Department, University Clinical Hospital of Valladolid, Valladolid, Spain.
Pablo Domínguez ErquiciaCardiology Department, University Hospital Álvaro Cunqueiro, Estrada de Clara Campoamor 341, 36213, Vigo, Pontevedra, Spain.
Erika Muñoz GarcíaCardiology Department, University Hospital Virgen de la Victoria, Málaga, Spain.
Eduard Fernandez-NofreriasCardiology Department, University Hospital German Trias i Pujol, Badalona, Spain.
Xoan SanmartínCardiology Department, University Hospital Montecelo, Pontevedra, Spain.
Alejandro Gutiérrez BarriosCardiology Department, University Hospital Puerta del Mar, Cádiz, Spain.
Inmaculada González BermúdezCardiology Department, University Hospital Álvaro Cunqueiro, Estrada de Clara Campoamor 341, 36213, Vigo, Pontevedra, Spain.
Valentín FusterCentro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Borja IbáñezCentro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Sergio Raposeiras RoubínCentro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. raposeiras26@hotmail.com.

Funding

European Commission SGLT2-HYPE 101156555Galician Society of Cardiology SOGACAR 2022Gerencia Regional de Salud de la Junta de Castilla y León GRS 2459/A/21Instituto de Salud Carlos III FIS PI19/01882Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III) CM24/00142Spanish Society of Cardiology SEC/FEC-INV-CLI 21/004
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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.

resultsAmong 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.

conclusionsIn 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.

Indexed as

Aortic ValveAortic Valve StenosisBenzhydryl CompoundsDiabetes MellitusGlucosidesHeart FailureSodium-Glucose Transporter 2 InhibitorsTranscatheter Aortic Valve ReplacementAgedAged, 80 and overDisease ProgressionFemaleHumansMaleRisk AssessmentRisk FactorsBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 InhibitorsDiabetesHeart failureMortalitySGLT2iTAVI

Identifiers

PMID43004293
PMCPMC13746418

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