Long-Term Clinical Outcomes of Polymer-Free Sirolimus-Eluting Stent and Polymer-Coated Sirolimus-Eluting Stent in Patients with Type 2 Diabetes.

Abstract

Introduction: Polymer-free sirolimus-eluting stent (PF-SES) possess multiple properties improving targeted drug elution and in-stent reendothelialization without the presence of polymers. The long-term clinical performance comparison between PF-SES and the latest generation polymer-coated sirolimus-eluting stents (SES), particularly regarding intravascular imaging assessment and in the type 2 diabetes mellitus (DM) population, remains unexplored.

Methods: We conducted a retrospective study involving 2646 diabetes patients meeting coronary artery disease (CAD) criteria underwent coronary stents in the real-world. All patients were divided into the PF-SES group and the SES group. Optical coherence tomography (OCT) was used to evaluate the imaging characteristics of in-stent reendothelialization. Patient information between the two groups was systematically compared in hospital and at 5-year follow-up.

Results: In terms of basic characteristics, the proportion of current smoker and stable angina patients in the PF-SES group was significantly higher than that in the SES group. The PF-SES group exhibited significantly higher rate of left anterior descending (LAD) lesion and more stents per patients compared to the SES group. The value of minimum lumen area (MLA), neointimal area (NA) and neointimal thickness (NT) were higher in the PF-SES group. Additionally, the occurrence rates of heterogeneous, lipid layer, intimal tears, thrombi, and micro-vessels were notably lower in the PF-SES group compared to the SES group. A higher all-cause mortality was observed in the SES cohort.

Discussion: PF-SES could effectively improve in-stent reendothelialization in patients with type 2 DM, with positive effects on survival rate and may, therefore, be considered as an alternative treatment option for improving clinical long-term outcomes.