Expanding indications for drug-coated balloons in coronary artery disease.

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI:10.1080/17434440.2025.2474179
Antonio Greco, Giacinto Di Leo, Marco Spagnolo, Daniele Giacoppo, Davide Capodanno
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Abstract

Introduction: Despite technical advances in percutaneous coronary intervention (PCI) and new iterations of drug-eluting stents (DES), complications still occur, including stent thrombosis and in-stent restenosis (ISR). Drug-coated balloons (DCBs) provide a promising option for the treatment of coronary lesions - particularly when DES are undesirable or contraindicated - allowing for PCI without the implantation of metallic devices, thus adhering to the 'leave nothing behind' principle.

Areas covered: A comprehensive literature search has been performed on PubMed, Web of Science and Cochrane, up to November 2024, with no significant restrictions. This article provides an overview of available DCB and summarizes the evidence supporting their use in different settings, including ISR, small-vessel disease, de novo large-vessel disease, and bifurcations.

Expert opinion: Trials of DCB are heterogeneous with respect to population, sample size, follow-up, anatomical pattern, and device used. Furthermore, they usually have limited statistical power for clinical endpoints. Based on current knowledge, DES may be preferrable for DES-ISR, de novo lesions in large vessels and for the treatment of the main branch in true bifurcations, with DCB approved for small-vessel disease and selected ISR lesions. Ongoing trials are expected to provide definitive insights into the efficacy and safety of DCB in different scenarios.

扩大药物包覆球囊在冠状动脉疾病中的适应症。
导读:尽管经皮冠状动脉介入治疗(PCI)技术取得了进步,药物洗脱支架(DES)也有了新的发展,但并发症仍然存在,包括支架血栓形成和支架内再狭窄(ISR)。药物包被球囊(DCB)为治疗冠状动脉病变提供了一个很有前途的选择——特别是当DES不受欢迎或有禁忌时——允许在不植入金属装置的情况下进行PCI,从而坚持“不留下任何东西”的原则。覆盖领域:-在PubMed, Web of Science和Cochrane上进行了全面的文献检索,截至2024年11月,没有重大限制。本文概述了现有的DCB,并总结了支持其在不同情况下使用的证据,包括ISR、小血管疾病、新生大血管疾病和分叉。专家意见:- DCB试验在人群、样本量、随访、解剖模式和使用的器械方面具有异质性。此外,它们通常对临床终点的统计能力有限。根据目前的知识,DES可能更适合于DES-ISR、大血管新生病变和真正分叉的主要分支的治疗,DCB被批准用于小血管疾病和选定的ISR病变。正在进行的试验有望对DCB在不同情况下的有效性和安全性提供明确的见解。
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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