基于血管内超声指导的切割球囊血管成形术联合新型生物可吸收聚合物涂层依维莫司洗脱支架治疗钙化冠状动脉病变的疗效评估（CUPID 试验）：研究设计与方案。
Assessment of Cutting-Balloon Angioplasty with Novel Bioabsorbable Polymer-Coated Everolimus-Eluting Stent in Treating Calcified Coronary Lesions Guided by Intravascular Ultrasound (CUPID Trial): study design and protocol.
机构信息
Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea.
Department of Nursing, College of Medicine, Soonchunhyang University, Asan, Korea.
出版信息
Trials. 2024 Oct 29;25(1):727. doi: 10.1186/s13063-024-08484-0.
BACKGROUND
Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions.
METHODS
We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used.
DISCUSSION
In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06177808. Registered on January 1, 2024.
背景
在治疗严重冠状动脉钙化时，已经使用了各种设备和技术来进行斑块修饰。本前瞻性、多中心、随机、开放标签研究旨在评估使用新型可生物吸收聚合物涂层依维莫司洗脱冠状动脉支架进行切割球囊血管成形术治疗各种程度钙化冠状动脉病变的安全性和疗效。
方法
我们概述了旨在评估切割球囊（Wolverine™）在治疗钙化病变患者时是否不劣于顺应性差的球囊的试验设计，包括新发和支架内再狭窄（ISR）病变。我们计划招募 250 名接受生物可吸收聚合物涂层依维莫司洗脱冠状动脉支架（Synergy™）植入的患者。主要终点是血管内超声确定的钙部位最小支架横截面积。次要终点包括 12 个月时的主要不良心脏事件和靶病变血运重建，以及操作方便性和以术者为中心的参数，如使用的球囊数量、操作时间和总造影剂用量。
讨论
在这项研究中，我们将评估 Wolverine™和顺应性差的球囊在钙化性冠状动脉病变患者中的疗效和安全性，并为哪种类型的球囊最优化修饰钙病变提供依据。此外，我们将尝试扩大切割球囊治疗轻度至重度钙化性冠状动脉病变的适应证。由于在一些国家，切割球囊的保险覆盖范围仍然有限，因此这项研究可能为将其用于治疗新发钙化和 ISR 病变提供证据，从而扩大保险覆盖范围。
试验注册
ClinicalTrials.gov NCT06177808。于 2024 年 1 月 1 日注册。
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