Korean Circ J.  2024 Jun;54(6):339-350. 10.4070/kcj.2024.0023.

Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer Ultimaster™ in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry

• Park S
• Rha SW
• Choi BG
• Seo JB
• Choi IJ
• Woo SI
• Kim SH
• Ahn TH
• Kim JS
• Her AY
• Ahn JH
• Lee HC
• Choi J
• Byon JS
• Sinurat MR
• Choi SY
• Cha J
• Hyun SJ
• Choi CU
• Park CG

• KMID: 2556532
• DOI: http://doi.org/10.4070/kcj.2024.0023

Abstract

Background and Objectives
Ultimaster™, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of Ultimaster™ stents in Korean patients with coronary artery disease.
Methods
This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up.
Results
A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint.
Conclusions
The present registry shows that Ultimaster™ stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

Keyword

Drug-eluting stent; Coronary artery disease; Percutaneous coronary intervention

Figure

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  Figure 1 Flowchart of the study population.

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  Figure 2 Event-free survival from clinical outcomes.Kaplan–Meier curves of freedom from the primary and secondary endpoint; (A) shows TLF (blue line) and MACE (red line). (B) illustrates total death (red solid line), cardiac death (red dashed line), MI (blue solid line), RR (green solid line), TLR (green dotted line), and ST (black dotted line). TLF is defined as the composite of cardiac death, target vessel MI, and TLR. MACE is defined as the composite of total death, MI, and RR.MACE = major adverse cardiac events; MI = myocardial infarction; RR = repeat revascularization; ST = stent thrombosis; TLF = target lesion failure; TLR = target lesion revascularization.

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  Figure 3 Prespecified subgroup analysis for risk of TLF.This figure illustrates the cumulative risk of TLF at 1 year in patients with ACS, DM, HTN, dyslipidemia and bifurcation. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.ACS = acute coronary syndrome; DM = diabetes mellitus; HTN = hypertension; TLF = target lesion failure.

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