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随机研究评估新型评分气球在穿皮冠状动脉干预中的有效性和安全性:Wedge NC试验

Haibo Chen^1,2,3, Jian Xu¹, Delong Chen^1,2,3

¹Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

Journal of thoracic disease

|May 22, 2025

概括

韦奇NC评分气球导管在经皮冠状动脉干预 (PCI) 治疗冠状动脉损伤方面证明与ScoreFlex导管无劣. 两种器件都显示出相似的,较低的程序并发症率.

科学领域:

心脏病学心脏病学
干预心脏病学干预心脏病学
医疗器械医疗器械

背景情况:

计分气球血管整形导管的目的是通过在低膨胀压力下通过高焦点应力改善病变的修饰.
冠状动脉病变在心血管干预中构成了重大挑战.

研究的目的:

评估新型Wedge NC评分气球导管的有效性和安全性.
为了将Wedge NC导管与ScoreFlex冠状动脉扩张导管进行比较,用于治疗冠状动脉病变.

主要方法:

进行了一项前性,多中心,随机控制的非劣势性试验 (Wedge NC试验).
198名接受皮肤冠状动脉干预 (PCI) 的患者被随机分配到接受Wedge NC或ScoreFlex气球治疗.
程序的成功,定义为残留狭窄 ≤30%没有重大并发症,是主要的终点.

主要成果:

程序的成功率很高,在各组之间可比 (98/99年两组).
形NC组在手术后立即显示出显著更大的最小光线直径 (P=0.02).
在Wedge NC组 (P=0.004和P=0.02分别) 观察到更低的直径百分比狭窄和更高的急性光度增加.

结论:

形NC评分气球导管对PCI的ScoreFlex导管没有劣势.
这两种器械的过程并发症率相似且较低.
形NC导管在实现更好的急性光度增长和较低的残留狭窄方面提供了潜在的优势.

关键词:

皮肤穿透冠状动脉干预 (PCI)损伤的修改损伤的改变评分气球球的成绩

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