Insulin-treated diabetes mellitus was not identified as an independent risk factor for higher mortality at 3 years after transcatheter aortic valve implantation (HR 1.21, p=0.079).
Observational (n=2,000)
No
Does diabetes mellitus treated with insulin or oral antidiabetic drugs affect survival and clinical outcomes in patients with severe aortic stenosis undergoing TAVI?
Although insulin-dependent diabetes is a component of surgical risk assessment (EuroSCORE II), it is not an independent predictor of reduced survival after TAVI, suggesting it should have less influence on TAVI decision-making.
Hazard Ratio: 1.21 (95% CI 0.98–1.49)
Absolute Event Rate: 56.9% vs 67.9%
p-value: p=0.079
BACKGROUND: Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI. METHODS: This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276). RESULTS: There was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 95% confidence interval (CI) 0.64-1.91) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11-4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18-1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97-1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98-1.49; p = 0.079) after multivariable adjustment. CONCLUSIONS: Although insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.
Tzamalis et al. (Tue,) conducted a observational in Severe aortic stenosis (n=2,000). Insulin-treated diabetes mellitus vs. Without diabetes was evaluated on 3-year survival (HR 1.21, 95% CI 0.98-1.49, p=0.079). Insulin-treated diabetes mellitus was not identified as an independent risk factor for higher mortality at 3 years after transcatheter aortic valve implantation (HR 1.21, p=0.079).