Kulyassa Péter Márton, Németh Balázs Tamás, Hizoh István, Jankó Laura Krisztina, Ruzsa Zoltán, Jambrik Zoltán, Balázs Brúnó Bánk, Becker Dávid, Merkely Béla, Édes István Ferenc
Heart and Vascular Centre, Semmelweis University, 1122 Budapest, Hungary.
Invasive Cardiology Division, Department of Internal Medicine, University of Szeged, 6720 Szeged, Hungary.
J Pers Med. 2025 Feb 2;15(2):60. doi: 10.3390/jpm15020060.
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a cornerstone of the management of ischemic heart disease. However, in-stent restenosis (ISR) remains a significant clinical challenge, occurring in approximately 5-10% of patients undergoing PCI. This study is designed to compare the efficacy and safety of the primary therapeutic approaches for DES-ISR, specifically drug-coated balloons (DCBs)-paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs)-with a new-generation everolimus-eluting stent (EES), contributing to the evolving field of personalized medicine. This prospective, multicentre, randomised, non-inferiority trial aims to enroll 150 patients with DES-ISR, who will be randomised into one of the following: SCB, PCB, or EES. The primary endpoint comparing DCB and EES is late lumen loss (LLL) at 6 months, as measured by quantitative coronary angiography (QCA). Secondary endpoints comparing the three arms include a device-oriented composite endpoint, intraluminal gain, optical coherence tomography (OCT) measured LLL, and correlations between LLL and quantitative flow ratio (QFR). The primary endpoint will be analysed using a non-inferiority design, with a margin set at 0.25 mm, for which the sample size was calculated. Statistical analysis of the primary endpoint will be conducted on an intention-to-treat basis with a one-tailed Mann-Whitney U test with a significance level of 95. Secondary endpoints will be analysed via superiority testing using ANOVA, the Kruskal-Wallis test, logistic regression, or Fisher's exact test, as appropriate. The study protocol has been approved by the Medical Devices Department of the Hungarian National Institute of Pharmacy and Nutrition, ensuring compliance with ethical standards as outlined in the Declaration of Helsinki. All investigators declare no conflicts of interest related to this study. The trial is registered in ClinicalTrials.gov under the ID: NCT04862052.
药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）是缺血性心脏病治疗的基石。然而，支架内再狭窄（ISR）仍然是一项重大的临床挑战，约5-10%接受PCI的患者会出现这种情况。本研究旨在比较DES-ISR主要治疗方法的疗效和安全性，具体为药物涂层球囊（DCB）——紫杉醇涂层球囊（PCB）和西罗莫司涂层球囊（SCB）——与新一代依维莫司洗脱支架（EES），为不断发展的个性化医学领域提供参考。这项前瞻性、多中心、随机、非劣效性试验旨在招募150例DES-ISR患者，他们将被随机分为以下组之一：SCB组、PCB组或EES组。比较DCB和EES的主要终点是6个月时的晚期管腔丢失（LLL），通过定量冠状动脉造影（QCA）测量。比较三组的次要终点包括器械导向复合终点、管腔内增益、光学相干断层扫描（OCT）测量的LLL，以及LLL与定量血流比（QFR）之间的相关性。主要终点将采用非劣效性设计进行分析，设定的非劣效界值为0.25毫米，并据此计算样本量。主要终点的统计分析将在意向性治疗基础上进行，采用单尾曼-惠特尼U检验，显著性水平为95%。次要终点将根据情况通过使用方差分析（ANOVA）、克鲁斯卡尔-沃利斯检验、逻辑回归或费舍尔精确检验的优效性检验进行分析。该研究方案已获得匈牙利国家药学与营养研究所医疗器械部的批准，确保符合《赫尔辛基宣言》中概述的伦理标准。所有研究者均声明与本研究无利益冲突。该试验已在ClinicalTrials.gov上注册，注册号为：NCT04862052。
