Cassese Salvatore, Simonetti Fiorenzo, Covarrubias Hector Alfonso Alvarez, Janisch Marion, Joner Michael, Kufner Sebastian, Lenz Tobias, Pellegrini Costanza, Rheude Tobias, Sager Hendrik, Schunkert Heribert, Starnecker Fabian, Voll Felix, Xhepa Erion, Kastrati Adnan, Kessler Thorsten
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20.
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.
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.
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.
ClilicalTrial.gov, NCT06369142.
严重钙化病变的经皮冠状动脉介入治疗受到支架扩张不充分和临床预后不佳的限制。在过去十年中，已开发出多种用于钙化修饰和病变预处理的器械和技术。血管内冲击波碎石术（IVL）就是其中一种新工具。尽管已有大量关于该技术的观察性研究报道，但缺乏针对严重钙化病变患者中IVL相对优点的以临床预后为指标的随机试验。
ISAR-WAVE试验是一项多中心、前瞻性、随机、单盲对照试验。目的是检验在初发严重钙化冠状动脉病变中，IVL是否优于其他钙化修饰技术（改良或超高压球囊以及斑块消融器械）。该研究计划招募666名患者。主要终点是12个月时主要心脑血管不良事件的复合终点，定义为死亡、非致死性心肌梗死、非致死性卒中以及临床指征的靶血管血运重建。除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指标。
ISAR-WAVE是一项多中心随机试验，旨在验证以下假设：对于初发严重钙化冠状动脉病变接受经皮介入治疗的患者，与其他钙化修饰技术相比，IVL策略具有更优的临床性能。
ClinicalTrial.gov，NCT06369142。
