冲击波冠状动脉碎石术在冠状动脉内支架植入和其他结果：ISAR-WAVE试验的设计和基本原理。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-12-20 DOI:10.1016/j.ahj.2024.12.008

Salvatore Cassese MD, PhD , Fiorenzo Simonetti MD , Hector Alfonso Alvarez Covarrubias MD , Marion Janisch MD , Michael Joner MD , Sebastian Kufner MD , Tobias Lenz MD , Costanza Pellegrini MD , Tobias Rheude MD , Hendrik Sager MD , Heribert Schunkert MD , Fabian Starnecker MD , Felix Voll MD , Erion Xhepa MD, PhD , Adnan Kastrati MD , Thorsten Kessler MD

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引用次数: 0

摘要

背景：经皮冠状动脉介入治疗严重钙化病变受到支架扩张不足和临床结果不佳的限制。在过去的十年中，已经开发了几种用于钙修饰和病变制备的设备和技术。在这种情况下，血管内碎石术（IVL）是一种新的工具。尽管有大量关于该技术的观察性研究报道，但缺乏关于IVL在严重钙化病变患者中相对优点的临床结果的随机试验。研究设计和目的：ISAR-WAVE试验是一项多中心、前瞻性、随机、单盲对照试验。目的是测试IVL在新发严重钙化冠状动脉病变中是否优于其他钙修饰技术（改良或超高压球囊和动脉粥样硬化装置）。该研究计划招募666名患者。主要终点是主要心脑血管不良事件的综合，定义为12个月时死亡、非致死性心肌梗死、非致死性卒中和临床指示的靶血管重建术。除了主要终点的各个组成部分外，次要终点还包括安全性，生活质量和成本效益措施。结论：ISAR-WAVE是一项多中心随机试验，旨在验证IVL策略与其他钙修饰技术相比，在接受经皮介入治疗新发严重钙化冠状动脉病变的患者中具有更好的临床表现。试验注册：clinicaltrial .gov, NCT06369142。

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Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial

Background

Percutaneous coronary intervention of severely calcified lesions is limited by inadequate stent expansion and poor clinical outcomes. Over the past decade, several devices and techniques have been developed for calcium modification and lesion preparation. Intravascular lithotripsy (IVL) is a novel tool in this context. Although numerous observational studies have been reported on this technique, randomized trials powered for clinical outcomes on the relative merits of IVL in patients with severely calcified lesions are lacking.

Study design and objectives

The ISAR-WAVE trial is a multicenter, prospective, randomized, single-blind controlled trial. The aim is to test whether IVL is superior to other calcium-modifying techniques (modified or super high-pressure balloon and atheroablative devices) in de novo severely calcified coronary lesions. The study is planned to enroll 666 patients. The primary endpoint is the composite of major cardiac and cerebrovascular adverse events defined as death, nonfatal myocardial infarction, nonfatal stroke and clinically indicated target vessel revascularization at 12 months. In addition to the individual components of the primary endpoint, secondary endpoints include also safety, quality of life and cost-effectiveness measures.

Conclusions

ISAR-WAVE is a multicenter, randomized trial designed to test the hypothesis that a strategy of IVL confers superior clinical performance compared to other calcium-modifying techniques in patients undergoing percutaneous intervention for a de novo severely calcified coronary artery lesion.

Trial registration

ClilicalTrial.gov, NCT06369142.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.