Baek Ju Yeol, Rha Seung Woon, Choi Byoung Geol, Choi Cheol Ung, Park Kyoung-Ha, Hwang Byung Hee, Lee Seung-Jin, Ahn Young Keun, Choi Jae Woong, Chae In-Ho, Choi Won Ho, Lim Young-Hyo, Ahn Ji Hoon, Choi Woong Gil
Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
Contemp Clin Trials Commun. 2020 Jan 14;17:100523. doi: 10.1016/j.conctc.2020.100523. eCollection 2020 Mar.
: Long-stenting, even with a second-generation drug-eluting stent (DES), is an independent predictor of restenosis and stent thrombosis in patients with long coronary lesions. Spot-stenting, i.e., selective stenting of only the most severe stenotic segments of a long lesion, may be an alternative to a DES. The purpose of this study is to compare the one-year clinical outcomes of patients with spot versus entire stenting in long coronary lesions using a second-generation DES.
This study is a randomized, prospective, multi-center trial comparing long-term clinical outcomes of angiography-guided spot versus entire stenting in patients with long coronary lesions (≥25 mm in length). The primary endpoint is target vessel failure (TVF) at 12 months, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization (TVR). A total of 470 patients are enrolled for this study according to sample size calculations. This study will be conducted to evaluate the non-inferiority of spot stenting compared to entire stenting with zotarolimus-eluting stents (ZES).
This study is designed to evaluate the clinical impact of spot-stenting with ZESs for TVF due to possible edge restenosis or non-target lesion revascularization. Theoretically, spot-stenting may decrease the risk of TVR and the extent of endothelial dysfunction.
This SPOT trial will provide clinical insight into spot-stenting with a current second-generation DES as a new strategy for long coronary lesions.
长病变支架置入术，即使使用第二代药物洗脱支架（DES），仍是长冠状动脉病变患者再狭窄和支架血栓形成的独立预测因素。局部支架置入术，即仅对长病变中最严重狭窄段进行选择性支架置入，可能是DES的一种替代方法。本研究的目的是比较使用第二代DES对长冠状动脉病变患者进行局部与全程支架置入的一年临床结局。
本研究是一项随机、前瞻性、多中心试验，比较在长冠状动脉病变（长度≥25mm）患者中，血管造影引导下局部与全程支架置入的长期临床结局。主要终点是12个月时的靶血管失败（TVF），它是心源性死亡、靶血管相关心肌梗死和靶血管血运重建（TVR）的复合终点。根据样本量计算，共有470例患者纳入本研究。本研究将评估与佐他莫司洗脱支架（ZES）全程支架置入相比，局部支架置入的非劣效性。
本研究旨在评估ZES局部支架置入术对因可能的边缘再狭窄或非靶病变血运重建导致的TVF的临床影响。理论上，局部支架置入术可能降低TVR风险和内皮功能障碍程度。
这项SPOT试验将为使用当前第二代DES进行局部支架置入作为长冠状动脉病变的一种新策略提供临床见解。
