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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. 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. 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. 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. Unlabelled Image • One fourth of female subjects undergoing transcatheter aortic valve implantation have diabetes mellitus at baseline. • DM female patients undergoing TAVI have higher comorbidities and lower transvalvular gradients. • DM in female subjects is associated with lower risk of VARC-2 life threatening bleeding up to 1 year after TAVI. [ABSTRACT FROM AUTHOR]

The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population. BRAVO-3 trial randomized 802 patients undergoing trans -femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE – death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p = 0.48) and acute kidney injury (19.7% vs. 15.1%, p = 0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p = 0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p = 0.03) and life-threatening bleeding both in-hospital (OR 1.50, p = 0.046) and at 30-days (OR 1.50, p = 0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients. Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR. • DM patients undergoing TAVR are at higher risk of life-threatening bleeding. • DM patients are also at higher risk of major vascular complication after TAVR. • Insulin dependent DM doesn't increase risk for short-term adverse events after TAVR. • DM does not increase risk of short-term mortality following trans -femoral TAVR. [ABSTRACT FROM AUTHOR]