Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial.

IF 7.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2025-03-17 DOI:10.4244/EIJ-D-24-00742

You Zhou, Yiqing Hu, Xin Zhao, Zhangwei Chen, Chenguang Li, Likun Ma, Zongjun Liu, Hao Zhou, Xiwen Zang, Xingwei Zhang, Gaoxing Zhang, Zhanqian Cui, Yin Liu, Suxia Han, Lianpin Wu, Haiming Shi, Jianjun Jiang, Juying Qian, Hao Lu, Junbo Ge

{"title":"Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial.","authors":"You Zhou, Yiqing Hu, Xin Zhao, Zhangwei Chen, Chenguang Li, Likun Ma, Zongjun Liu, Hao Zhou, Xiwen Zang, Xingwei Zhang, Gaoxing Zhang, Zhanqian Cui, Yin Liu, Suxia Han, Lianpin Wu, Haiming Shi, Jianjun Jiang, Juying Qian, Hao Lu, Junbo Ge","doi":"10.4244/EIJ-D-24-00742","DOIUrl":null,"url":null,"abstract":"Background: The optimal strategy to treat coronary bifurcation lesions (CBL) has been a long-debated topic. The combination of a stent in the main vessel (MV) and a drug-coated balloon (DCB) in the side branch (SB) seems promising, but the evidence is limited.Aims: This study aims to investigate a novel sirolimus-coated balloon in the treatment of non-left main CBL compared with a paclitaxel-coated balloon.Methods: The SPACIOUS trial is a prospective, non-inferiority, multicentre trial. A total of 230 patients were randomised to the sirolimus DCB or the paclitaxel DCB group in a 1:1 ratio. Angiographic and clinical follow-ups were planned at 9 months and 1 year, respectively. The primary endpoint was diameter stenosis (DS) in the SB at 9 months.Results: At 9 months, DS in the sirolimus group was 30.5±16.1% compared with 33.5±16.2% in the paclitaxel group (difference -2.94%; 95% confidence interval: -7.62% to 1.74%; p for non-inferiority<0.01). The incidence of binary restenosis was significantly lower in the sirolimus group compared to the paclitaxel group (4.4% vs 12.8%; p=0.043). Secondary angiographic endpoints, including late lumen loss and net lumen gain, and 1-year clinical outcomes were not significantly different between groups.Conclusions: In de novo non-left main CBL treatment, MV stenting accompanied by SB dilation with the sirolimus DCB was non-inferior to the paclitaxel DCB.","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 6","pages":"e307-e317"},"PeriodicalIF":7.6000,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891925/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00742","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: The optimal strategy to treat coronary bifurcation lesions (CBL) has been a long-debated topic. The combination of a stent in the main vessel (MV) and a drug-coated balloon (DCB) in the side branch (SB) seems promising, but the evidence is limited.

Aims: This study aims to investigate a novel sirolimus-coated balloon in the treatment of non-left main CBL compared with a paclitaxel-coated balloon.

Methods: The SPACIOUS trial is a prospective, non-inferiority, multicentre trial. A total of 230 patients were randomised to the sirolimus DCB or the paclitaxel DCB group in a 1:1 ratio. Angiographic and clinical follow-ups were planned at 9 months and 1 year, respectively. The primary endpoint was diameter stenosis (DS) in the SB at 9 months.

Results: At 9 months, DS in the sirolimus group was 30.5±16.1% compared with 33.5±16.2% in the paclitaxel group (difference -2.94%; 95% confidence interval: -7.62% to 1.74%; p for non-inferiority<0.01). The incidence of binary restenosis was significantly lower in the sirolimus group compared to the paclitaxel group (4.4% vs 12.8%; p=0.043). Secondary angiographic endpoints, including late lumen loss and net lumen gain, and 1-year clinical outcomes were not significantly different between groups.

Conclusions: In de novo non-left main CBL treatment, MV stenting accompanied by SB dilation with the sirolimus DCB was non-inferior to the paclitaxel DCB.

查看原文本刊更多论文

西罗莫司包被与紫杉醇包被球囊治疗侧支冠状动脉分叉病变：宽敞试验

背景：治疗冠状动脉分叉病变（CBL）的最佳策略是一个长期争论的话题。主血管（MV）内支架和侧支（SB）内药物包覆球囊（DCB）的组合似乎很有希望，但证据有限。目的：本研究旨在研究一种新型西罗莫司包被球囊与紫杉醇包被球囊治疗非左主干CBL的比较。方法：宽敞试验是一项前瞻性、非劣效性、多中心试验。共有230名患者按1:1的比例随机分配到西罗莫司DCB组或紫杉醇DCB组。分别于9个月和1年进行血管造影和临床随访。主要终点是9个月时SB的直径狭窄（DS）。结果：9个月时，西罗莫司组DS为30.5±16.1%，紫杉醇组DS为33.5±16.2%(差异-2.94%；95%置信区间：-7.62% ~ 1.74%；结论：在新生非左主干CBL治疗中，西罗莫司DCB MV支架置入伴SB扩张的效果不逊色于紫杉醇DCB。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.