J Cardiovasc Interv.  2023 Jan;2(1):19-30. 10.54912/jci.2022.0021.

Three-Year Clinical Outcomes of a Thin-Strut Biodegradable-Polymer Everolimus-Eluting Stent in Patients With Acute Coronary Syndrome

• Sim DS
• Hyun DY
• Cho KH
• Kim MC
• Hong YJ
• Kim JH
• Ahn Y
• Jeong MH
• Chun KJ
• Ahn TH
• Jeong YH
• Hwang KK
• Lee HC
• Park KH
• Hwang JY
• Lee SU
• Cho YK
• Park JS
• Kim DI
• Cho JM
• Cho JH
• Kim HY
• Hwang BH
• Kim SH
• Yoon MH
• Heo JH
• Kim SJ
• Joo SJ
• Bae JH

• KMID: 2561260
• DOI: http://doi.org/10.54912/jci.2022.0021

Abstract

Background
This study aimed to investigate safety and efficacy of a thin-strut biodegradable polymer everolimus-eluting stent (BP-EES) (SYNERGY TM ; Boston Scientific) in Korean patients with acute coronary syndrome (ACS).
Methods
From 2016 to 2018, 922 patients with ACS undergoing percutaneous coronary intervention with SYNERGY were enrolled from 22 hospitals in this single-arm, multicenter, observational study. The primary end point was a patient-oriented composite outcome (POCO), a composite of all-cause death, myocardial infarction (MI), stroke, and any repeat revascularization at 3 years. The key secondary end point was a device-oriented composite outcome (DOCO), a composite of cardiovascular death, target-vessel MI, and target lesion revascularization at 3 years.
Results
A total of 788 patients who completed 3-year follow-up were analyzed. The mean age was 63 ± 11 years, 75% were men, 60% had acute MI, 52% hypertension and 31% diabetes. Transradial PCI was performed in 68%; multivessel PCI in 21%; and intravascular ultrasound imaging in 34%. The number of stents, stent diameter, and stent length per patient were 1.4 ± 0.7, 3.1 ± 0.5 mm, and 36.5 ± 22.8 mm, respectively. All-cause mortality was 1.1% at 1 year and 3.8% at 3 years. POCO occurred in 6.2% at 1 year and in 9.9% at 3 years. DOCO occurred in 2.8% at 1 year and in 3.6% at 3 years. Definite or probable stent thrombosis (ST) developed in 2 patients (0.3%, 1 subacute ST, 1 very late ST).
Conclusions
The thin-strut BP-EES showed excellent safety and efficacy in real-world Korean patients with ACS at 3-year follow-up.

Keyword

Acute coronary syndrome; Drug-eluting stents; Percutaneous coronary intervention