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Effectiveness and Safety of Biodegradable Polymer-Coated Everolimus-Eluting Stent in Multivessel Coronary Artery
Soohyung Park1, Woohyeun Kim2, Seung-Woon Rha1,3
1Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.
Insights
This study found that biodegradable polymer-coated everolimus-eluting stents showed favorable outcomes in Korean patients with multivessel coronary artery disease (MVD). The 1-year target lesion failure rate was low, comparable to previous studies.
Area of Science:
- Interventional Cardiology
- Cardiovascular Research
- Medical Device Technology
Background:
- Multivessel coronary artery disease (MVD) presents complex challenges in interventional cardiology.
- Limited real-world data exists on drug-eluting stent performance in Korean MVD patients.
- Biodegradable polymer-coated everolimus-eluting stents (SYNERGY™) offer a potential treatment option.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of SYNERGY™ stents in Korean patients with MVD.
- To assess the 1-year clinical performance of these stents in a diverse patient population.
- To provide data on the use of advanced stent technology in a specific ethnic group.
Main Methods:
- A prospective, observational registry study conducted across 22 hospitals in the Republic of Korea.
- Inclusion criteria: patients with ≥70% stenosis in at least two coronary vessels undergoing percutaneous coronary intervention (PCI).
- Primary endpoint: Target Lesion Failure (TLF) at 1 year, defined as cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR).
Main Results:
- 542 patients were enrolled between August 2016 and September 2018.
- The 1-year TLF rate was 2.1%, with low incidences of cardiac death (0.9%), MI (0.3%), TLR (0.9%), and stent thrombosis (0.3%).
- Independent predictors of TLF included in-stent restenosis and total stent length; no significant differences were observed between patients with or without acute coronary syndrome (ACS) or diabetes mellitus (DM).
Conclusions:
- The 1-year TLF rate of 2.1% is comparable to or lower than previously reported rates for drug-eluting stents in multivessel PCI.
- Biodegradable polymer-coated everolimus-eluting stents demonstrate favorable clinical outcomes in real-world practice for MVD patients.
- The study supports the use of SYNERGY™ stents for treating MVD in the Korean population.
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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