Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation

被引：6

作者：

Raposeiras-Roubin, Sergio ^{[1
,2
,3
,4
]}

Amat-Santos, Ignacio J. ^{[5
,6
]}

Rossello, Xavier ^{[1
,5
,7
,8
,9
]}

Ferreiro, Rocio Gonzalez ^{[2
,3
]}

Bermudez, Inmaculada Gonzalez ^{[2
,3
]}

Otero, Diego Lopez ^{[5
,10
]}

Nombela-Franco, Luis ^{[11
]}

Gheorghe, Livia ^{[12
]}

Diez, Jose L.

Zorita, Carlos Baladron ^{[5
,6
]}

Baz, Jose A. ^{[2
,3
,5
]}

Garcia, Antonio J. Munoz

Vilalta, Victoria ^{[13
]}

Ojeda-Pineda, Soledad ^{[5
,14
]}

Hernandez, Jose M. de la Torre ^{[15
,16
]}

Soriano, Juan G. Cordoba ^{[17
]}

Regueiro, Ander ^{[18
]}

Siscar, Pascual Bordes ^{[19
]}

Fernandez, Jorge Salgado ^{[20
]}

del Blanco, Bruno Garcia ^{[5
,21
]}

Martin-Reyes, Roberto

Romaguera, Rafael ^{[22
]}

Moris, Cesar ^{[23
]}

Blas, Sergio Garcia ^{[5
,24
]}

Franco-Pelaez, Juan A. ^{[25
,26
]}

Cruz-Gonzalez, Ignacio ^{[5
,27
]}

Arzamendi, Dabit ^{[28
]}

Rodriguez, Nieves Romero ^{[29
]}

Diez-del Hoyo, Felipe ^{[30
]}

Freire, Santiago Camacho ^{[31
]}

Ojeda, Francisco Bosa

Burgo, Juan C. Astorga ^{[32
]}

Navarro, Eduardo Molina ^{[33
]}

Borrego, Juan Caballero ^{[34
]}

Quevedo, Valeriano Ruiz ^{[35
]}

Sanchez-Recalde, Angel ^{[36
]}

Disdier, Vicente Peral ^{[7
,8
]}

Alegria-Barrero, Eduardo ^{[37
,38
]}

Torres-Llergo, Javier ^{[39
]}

Feltes, Gisela ^{[40
,41
]}

Diaz, Jose A. Fernandez ^{[42
]}

Cuellas, Carlos ^{[43
]}

Britez, Gustavo Jimenez ^{[44
]}

Lezcano, Juan Sanchez-Rubio ^{[45
]}

Barreiro-Pardal, Cristina ^{[46
]}

Nunez-Gil, Ivan ^{[11
,41
,47
]}

Abu-Assi, Emad ^{[48
]}

Iniguez-Romo, Andres ^{[2
,3
,5
]}

Fuster, Valentin ^{[1
,49
]}

Ibanez, Borja ^{[1
,5
,25
,26
]}

机构：

[1] Ctr Nacl Invest Cardiovasc Carlos III, Melchor Fernandez Almagro 3, Madrid 28029, Spain

[2] Univ Hosp Alvaro Cunqueiro, Cardiol Dept, Vigo, Spain

[3] Inst Invest Sanitaria Galicia Sur, Vigo, Spain

[4] Univ Santiago de Compostela, Santiago De Compostela, Spain

[5] Ctr Invest Biomed Red Enfermedades Cardiovasc, Madrid, Spain

[6] Univ Clin Hosp Valladolid, Cardiol Dept, Valladolid, Spain

[7] Univ Hosp Son Espases, Cardiol Dept, Palma De Mallorca, Spain

[8] Inst Invest Sanitaria Islas Baleares, Palma De Mallorca, Spain

[9] Univ Illes Balears, Palma De Mallorca, Spain

[10] Univ Hosp Montecelo, Cardiol Dept, Pontevedra, Spain

[11] Univ Clin Hosp San Carlos, Cardiol Dept, Madrid, Spain

[12] Univ Hosp Puerta del Mar, Cardiol Dept, Cadiz, Spain

[13] Univ Hosp German Trias i Pujol, Cardiol Dept, Badalona, Spain

[14] Univ Hosp Reina Sofia, Cardiol Dept, Cordoba, Spain

[15] Univ Hosp Marques de Valdecilla, Cardiol Dept, Santander, Spain

[16] Inst Invest Sanitaria Valdecilla, Santander, Spain

[17] Univ Hosp Albacete, Cardiol Dept, Albacete, Spain

[18] Univ Clin Hosp, Cardiol Dept, Barcelona, Spain

[19] Univ Gen Hosp Alicante, Cardiol Dept, Alicante, Spain

[20] Univ Hosp Juan Canalejo, Cardiol Dept, La Coruna, Spain

[21] Univ Hosp Vall dHebron, Cardiol Dept, Barcelona, Spain

[22] Univ Hosp Bellvitge, Cardiol Dept, Barcelona, Spain

[23] Univ Hosp Cent Asturias, Cardiol Dept, Oviedo, Spain

[24] Univ Clin Hosp Valencia, Cardiol Dept, Valencia, Spain

[25] Univ Autonoma Madrid, Univ Hosp Fdn Jimenez Diaz, Cardiol Dept, Madrid, Spain

[26] Univ Autonoma Madrid, Fdn Jimenez Diaz, Inst Invest Sanitaria, Madrid, Spain

[27] Univ Clin Hosp Salamanca, Cardiol Dept, Salamanca, Spain

[28] Univ Hosp Santa Creu & St Pau, Biomed Res Inst IIB St Pau, Cardiol Dept, Pediat Cardiol Unit, Barcelona, Spain

[29] Univ Hosp Virgen del Rocio, Cardiol Dept, Seville, Spain

[30] Univ Hosp 12 Octubre, Cardiol Dept, Madrid, Spain

[31] Univ Hosp Juan Ramon Jimenez, Cardiol Dept, Huelva, Spain

[32] Univ Hosp Cruces, Cardiol Dept, Baracaldo, Spain

[33] Univ Hosp Virgen de las Nieves, Cardiol Dept, Granada, Spain

[34] Univ Hosp San Cecilio, Cardiol Dept, Granada, Spain

[35] Univ Hosp Navarra, Cardiol Dept, Pamplona, Spain

[36] Univ Hosp Ramon y Cajal, Cardiol Dept, Madrid, Spain

[37] Univ Hosp Torrejon, Cardiol Dept, Madrid, Spain

[38] Univ Francisco de Vitoria, Madrid, Spain

[39] Univ Hosp Jaen, Cardiol Dept, Jaen, Spain

[40] Univ Hosp Vithas Arturo Soria, Cardiol Dept, Madrid, Spain

[41] Univ Europea Madrid, Madrid, Spain

[42] Univ Hosp Puerta del Hierro, Cardiol Dept, Madrid, Spain

[43] Univ Hosp Leon, Cardiol Dept, Leon, Spain

[44] Clin Teknon, Cardiol Dept, Barcelona, Spain

[45] Univ Hosp Miguel Servet, Cardiol Dept, Zaragoza, Spain

[46] Univ Hosp Montecelo, Anesthesiol Dept, Pontevedra, Spain

[47] Univ Hosp Torrejon, Cardiol Dept, Ribera Salud Grp, Madrid, Spain

[48] Univ Hosp Povisa, Cardiol Dept, Ribera Salud Grp, Vigo, Spain

[49] Icahn Sch Med Mt Sinai, Cardiovasc Inst, New York, NY USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2025年 / 392卷 / 14期

关键词：

HEART-FAILURE; OLDER-ADULTS; OUTCOMES;

D O I：

10.1056/NEJMoa2500366

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of heart-failure admission among high-risk patients. However, most patients with valvular heart disease, including those undergoing transcatheter aortic-valve implantation (TAVI), have been excluded from randomized trials. METHODS We conducted this randomized, controlled trial in Spain to evaluate the efficacy of dapagliflozin (at a dose of 10 mg once daily) as compared with standard care alone in patients with aortic stenosis who were undergoing TAVI. All the patients had a history of heart failure plus at least one of the following: renal insufficiency, diabetes, or left ventricular systolic dysfunction. The primary outcome was a composite of death from any cause or worsening of heart failure, defined as hospitalization or an urgent visit, at 1 year of follow-up. RESULTS A total of 620 patients were randomly assigned to receive dapagliflozin and 637 to receive standard care alone after TAVI; after exclusions, a total of 1222 patients were included in the primary analysis. A primary-outcome event occurred in 91 patients (15.0%) in the dapagliflozin group and in 124 patients (20.1%) in the standard-care group (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P = 0.02). Death from any cause occurred in 47 patients (7.8%) in the dapagliflozin group and in 55 (8.9%) in the standard-care group (hazard ratio, 0.87; 95% CI, 0.59 to 1.28). Worsening of heart failure occurred in 9.4% and 14.4% of the patients, respectively (subhazard ratio, 0.63; 95% CI, 0.45 to 0.88). Genital infection and hypotension were significantly more common in the dapagliflozin group. CONCLUSIONS 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.

引用

页码：1396 / 1405

页数：10

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