Impact of diabetes on 1‐year clinical outcome in patients undergoing revascularization with the BioFreedom stents or the Orsiro stents from the SORT OUT IX trial. Issue 4 (18th January 2022) - Hansen, Kirstine Nørregaard
Abstract: This sub‐study of the SORT OUT IX trial sought to compare clinical outcomes between patients with diabetes randomized to implantation of either the polymer‐free biolimus A9‐coated BioFreedom stent (BF‐BES) or the ultra‐thin strut, biodegradable polymer sirolimus‐eluting Orsiro stent (O‐SES). Patients with diabetes have an increased risk of target lesion failure (TLF) after percutaneous coronary intervention (PCI). The impact of different stent types in patients with diabetes is still discussed. A total of 607 of the 3151 patients (19.3%) enrolled in the SORT OUT IX study had diabetes. Randomization was stratified by patients with/without diabetes; 304 received BF‐BES and 303 O‐SES. The primary endpoint was TLF, which was a composite of cardiac death, myocardial infarction (not related to other than the index lesion) and target lesion revascularization (TLR) within 1 year. After 1 year, patients with diabetes had higher TLF (7.2% vs. 3.7%, incidence rate ratio [IRR]: 1.65; 95% confidence interval [CI]: 1.08–2.50), than patients without diabetes. TLF did not differ significantly between BF‐BES and O‐SES in patients with diabetes (8.2% vs. 6.3%, IRR: 1.17; 95% CI: 0.63–2.20). In patients with diabetes, cardiac death occurred in 2.3% of BF‐BES and in 3.6% of O‐SES (IRR: 0.58; 95% CI: 0.23–1.45) and TLR occurred in 5.3% and 2.3% of BF‐BES and O‐SES, respectively (IRR: 2.12; 95% CI: 0.81–5.56). Definite stent thrombosis rates of 1.3% were found in both stent types. Patients with diabetes had higher 1‐year TLF rate after PCI compared to patients without diabetes, whereas TLF did not differ significantly between the two stent types BF‐BES and O‐SES in patients with diabetes.