Comparison of Sirolimus-Versus Paclitaxel-Coated Balloons in Coronary Artery Disease: One-Year Results of Two Real-World Prospective Registries.

IF 2.1 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Catheterization and Cardiovascular Interventions Pub Date : 2025-05-19 DOI:10.1002/ccd.31587

Selina Vlieger, Jin M Cheng, Filippo Luca Gurgoglione, Tay M Heang, Alexander J J Ijsselmuiden, Alfonso Ielasi, Eric Boersma, Lee C Yan, Alessandro Sciahbasi, Ramesh Singh, George Karavolias, Dario Gattuso, Rohit M Oemrawsingh, Bernardo Cortese

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引用次数: 0

Abstract

Background: Paclitaxel-(PCB) and sirolimus-coated balloons (SCB) are used for treatment of in-stent restenosis (ISR) and de novo (DN) lesions. Studies comparing major adverse cardiac events (MACE) after PCB versus SCB are limited.

Aims: This study aims to contribute to this knowledge gap and enhance the understanding of optimal strategies for treating ISR and DN lesions.

Methods: EASTBOURNE and PEARL are large-scale, prospective clinical registries, evaluating the performance of drug-coated balloons. PEARL included patients who underwent percutaneous coronary intervention using Protege PCB and EASTBOURNE included patients treated with MagicTouch SCB in study centers in Europe and Asia. We combined these registries and used logistic regression analysis to assess the association between SCB/PCB and the likelihood of experiencing MACE, a composite of all-cause mortality, myocardial infarction (MI) and target-lesion revascularisation (TLR) at 1-year follow-up.

Results: Out of 2596 patients, MACE was observed more frequently in ISR lesions (n = 1292 patients, SCB:17.8% vs. PCB:14.1%, p = 0.12) versus DN lesions (n = 1304 patients, SCB:6.4% vs. PCB:6.1%, p = 1.00). The adjusted hazards ratio (HR) for MACE was 1.17 (95% CI: 0.59-1.23, p = 0.40). As regards DN lesions, no significant difference was found in MACE (SCB: 6.4% vs. PCB 6.1%, p = 1.00). The adjusted HR for MACE was 1.24 (95% CI: 0.20-2.01, p = 0.13). There were no differences in the individual components of the primary endpoint.

Conclusions: This real-world comparison demonstrated comparable outcomes between new-generation PCB and SCB in terms of MACE at 1-year follow-up, across different lesion settings.

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西罗莫司与紫杉醇包覆球囊在冠状动脉疾病中的比较：两个真实世界前瞻性注册的一年结果

背景：紫杉醇（PCB）和西罗莫司涂层球囊（SCB）用于治疗支架内再狭窄（ISR）和新生（DN）病变。比较PCB和SCB后主要不良心脏事件（MACE）的研究是有限的。目的：本研究旨在弥补这一知识缺口，提高对治疗ISR和DN病变最佳策略的理解。方法：EASTBOURNE和PEARL是大规模的前瞻性临床登记，评估药物包被气球的性能。PEARL纳入了在欧洲和亚洲的研究中心接受Protege PCB经皮冠状动脉介入治疗的患者，EASTBOURNE纳入了使用MagicTouch SCB治疗的患者。我们结合这些登记并使用逻辑回归分析来评估SCB/PCB与经历MACE(全因死亡率、心肌梗死（MI）和靶病变血运重建（TLR）的复合1年随访的可能性之间的关系。结果：在2596例患者中，MACE在ISR病变（n = 1292例患者，SCB:17.8% vs PCB:14.1%, p = 0.12）中比在DN病变（n = 1304例患者，SCB:6.4% vs PCB:6.1%, p = 1.00）中更常见。MACE的校正危险比（HR）为1.17 （95% CI: 0.59-1.23, p = 0.40）。对于DN病变，MACE无显著差异（SCB: 6.4% vs. PCB: 6.1%, p = 1.00）。MACE校正后的HR为1.24 （95% CI: 0.20-2.01, p = 0.13）。主要终点的各个组成部分没有差异。结论：这一现实世界的比较表明，在不同的病变环境下，新一代PCB和SCB在1年随访时的MACE结果具有可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.