Effectiveness and Safety of Biodegradable Polymer-Coated Everolimus-Eluting Stent in Multivessel Coronary Artery Disease in Routine Clinical Practice: A Korean Multicenter, Prospective, and Observational Study

Abstract

Background: Multivessel coronary artery disease (CAD) poses a significant challenge in interventional cardiology due to its complexity and association with adverse clinical outcomes. Real-world data on the clinical performance of drug-eluting stents in Korean patients with multivessel disease (MVD) are limited. This study aimed to evaluate the efficacy and safety of the biodegradable polymer-coated everolimus-eluting stents (SYNERGYTM, Boston Scientific Corporation, Natick, MA, USA) in treating patients with MVD in real-world clinical setting. Methods: This multicenter, prospective, observational registry involved 22 hospitals in the Republic of Korea. Eligible patients presented with >= 70% stenosis in at least two vessels and were amenable for receiving percutaneous coronary intervention (PCI). The primary endpoint was target lesion failure ([TLF], the composite of cardiac death; target vessel myocardial infarction [MI]; and target lesion revascularization [TLR]) at 1 year. Results: Between August 2016 and September 2018, 542 patients were enrolled. The mean age of the patients was 66.2 +/- 10.4 years, and most of them were male (73.7%). Diabetes mellitus (DM) was present in 40.8% of patients, while 68.2% had acute coronary syndrome (ACS). The 1-year TLF was in 2.1%, with incidences of cardiac death 0.9%, MI 0.3%, TLR 0.9%, and stent thrombosis 0.3%. Subgroup analysis revealed no significant differences in the primary endpoint between patients with or without ACS, and DM. In-stent restenosis (hazard ratio [HR], 11.20; 95% confidence interval [CI], 2.20-56.91) and total stent length (HR, 1.02; 95% CI, 1.01-1.03) were identified as independent predictors of TLF. Conclusion: The 1-year TLF rate observed in our cohort (2.1%) was comparable to or lower than rates previously reported in studies evaluating drug-eluting stents in patients undergoing multivessel PCI. These results suggest that the biodegradable polymer-coated everolimus-eluting stents provide favorable clinical outcomes for this patient population in real-world clinical practice.