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

生物可降解聚合物涂层依维莫司洗脱支架在多支冠状动脉疾病常规临床实践中的有效性和安全性:一项韩国多中心前瞻性观察研究

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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 (SYNERGY™, 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.

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