TY - JOUR
T1 - Impact of diabetes mellitus on female subjects undergoing transcatheter aortic valve implantation
T2 - Insights from the WIN-TAVI international registry
AU - Goel, Ridhima
AU - Sartori, Samantha
AU - Cao, Davide
AU - Claessen, Bimmer E.
AU - Baber, Usman
AU - Chandiramani, Rishi
AU - Nicolas, Johny
AU - Roumeliotis, Anastasios
AU - Power, David
AU - Chandrasekhar, Jaya
AU - Tchetche, Didier
AU - Petronio, Anna Sonia
AU - Mehilli, Julinda
AU - Lefevre, Thierry
AU - Presbitero, Patrizia
AU - Capranzano, Piera
AU - Iadanza, Alessandro
AU - Sardella, Gennaro
AU - Van Mieghem, Nicolas M.
AU - Meliga, Emanuele
AU - Dumonteil, Nicolas
AU - Fraccaro, Chiara
AU - Trabattoni, Daniela
AU - Mikhail, Ghada W.
AU - Ferrer-Gracia, Maria Cruz
AU - Naber, Christoph
AU - Sharma, Samin
AU - Morice, Marie Claude
AU - Dangas, George D.
AU - Chieffo, Alaide
AU - Mehran, Roxana
N1 - Funding Information:
UB received institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific.
Funding Information:
JM received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific and Edwards Lifescience.
Funding Information:
NMVM received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic and research grant support from Edwards Lifesciences.
Funding Information:
GWM is the Director of Imperial Valve and Cardiovascular Course (IVCC) which is supported by a number of device and pharmaceutical companies.; has received educational grant from Abbott for an Interventional Fellowship.
Funding Information:
RM reports grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; personal fees: Abbott Laboratories, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, PLx Opco Inc./dba PLx Pharma Inc., Roivant Sciences, Sanofi, Medtelligence, Janssen Scientific Affairs; other: Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano Corp, Watermark Research Partners; non-financial support and other from Regeneron Pharmaceuticals, Idorsia Pharmaceuticals Ltd.
Publisher Copyright:
© 2020 Elsevier B.V.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Background: Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group. Method: WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis. Results: Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12–0.99; p =.047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes. Conclusions: Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.
AB - Background: Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group. Method: WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis. Results: Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12–0.99; p =.047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes. Conclusions: Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.
KW - Diabetes mellitus
KW - Female gender
KW - Transcatheter aortic valve implantation
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U2 - 10.1016/j.ijcard.2020.08.035
DO - 10.1016/j.ijcard.2020.08.035
M3 - Article
C2 - 32814108
AN - SCOPUS:85089964578
SN - 0167-5273
VL - 322
SP - 65
EP - 69
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -