Park Soohyung, Rha Seung-Woon, Choi Byoung Geol, Seo Jae-Bin, Choi Ik Jun, Woo Sung-Il, Kim Soo-Han, Ahn Tae Hoon, Kim Jae Sang, Her Ae-Young, Ahn Ji-Hun, Lee Han Cheol, Choi Jaewoong, Byon Jin Soo, Sinurat Markz Rmp, Choi Se Yeon, Cha Jinah, Hyun Su Jin, Choi Cheol Ung, Park Chang Gyu
Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.
Cardiovascular Research Institute, Korea University, Seoul, Korea.
Korean Circ J. 2024 Jun;54(6):339-350. doi: 10.4070/kcj.2024.0023. Epub 2024 Apr 22.
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.
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.
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.
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.
Ultimaster™是一种使用可生物降解聚合物的第三代西罗莫司洗脱支架，旨在克服诸如再狭窄或支架内血栓形成等长期不良血管事件。在本研究中，我们旨在评估Ultimaster™支架在韩国冠心病患者中的12个月临床结局。
本研究是一项在12家医院开展的多中心、前瞻性观察性注册研究。为反映真实世界的临床证据，本研究纳入了非选择性的患者和病变亚型。研究终点为12个月临床随访时的靶病变失败（TLF）（心脏死亡、靶血管心肌梗死[MI]和靶病变血运重建[TLR]的复合终点）。
2016年11月至2021年5月期间共纳入576例患者。大多数患者为男性（76.5%），平均年龄为66.0±11.2岁。在纳入的患者中，40.1%患有糖尿病（DM），67.9%患有急性冠状动脉综合征（ACS）。12个月时，TLF的发生率为4.1%。心脏死亡的发生率为1.5% , MI为1.0%，TLR为2.7%，支架内血栓形成的发生率为0.6%。在基于ACS、DM、高血压、血脂异常或分叉情况进行的亚组分析中，主要终点的发生率无显著差异。
本注册研究表明，Ultimaster™支架在非选择性韩国患者的常规真实世界临床实践中是安全有效的，至少在12个月内不良事件发生率较低。
