A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.

IF 7.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2024-11-04 DOI:10.4244/EIJ-D-23-00868

Bruno Scheller, Norman Mangner, Raban V Jeger, Samuel Afan, Felix Mahfoud, Felix J Woitek, Gregor Fahrni, Carsten Schwenke, Beatrix Schnorr, Franz Kleber

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引用次数: 0

Abstract

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive.

Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions.

Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints.

Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths).

Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

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西罗莫司与紫杉醇涂层球囊治疗新发冠状动脉病变的随机试验。

背景：紫杉醇涂层球囊（PCB）是治疗新发冠状动脉病变的药物洗脱支架的可行替代品。目的：这项随机、对照、多中心、非劣效试验研究了一种新型西罗莫司结晶涂层球囊（SCB）与一种PCB球囊在新发冠状动脉病变中的对比：为了比较新型SCB与临床验证的PCB，德国和瑞士的4个中心共招募了70名新发冠状动脉病变患者。主要终点是6个月时血管造影晚期管腔缺损（LLL）的非劣效性，预定差值为δ=0.35毫米。次要终点包括手术成功率、主要心脏不良事件和个别临床终点：结果：定量冠状动脉造影显示基线参数无差异。6 个月时，PCB 组的段内 LLL 分别为 0.04±0.39 mm，而 SCB 组为 0.11±0.37 mm（不显著）。SCB和PCB之间的平均差异为0.07毫米（95%置信区间：-0.12至0.26）。在 0.35 的预定差值下显示出非劣效性。12个月内的临床事件发生率在两组之间没有差异（PCB组3例靶病变血管再通，SCB组2例，无心肌梗死，无死亡）：结论：在治疗新发冠状动脉疾病方面，新型 SCB 与临床验证的 PCB（ClinicalTrials.gov：NCT03908450）显示出相似的血管造影结果。

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

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

期刊介绍： EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.