Yundai Chen, Lei Gao, Qin Qin, Jun Zhang, Shaobin Jia, Mingxing Wu, Yong He, Guosheng Fu, Jinghua Liu, Hui Chen, Qian Tong, Zaixin Yu, Jian An, Chunguang Qiu, Biao Xu, Yu Cao, Changqian Wang, Genshan Ma
{"title":"治疗冠状动脉支架内再狭窄的Biolimus涂层球囊与紫杉醇涂层球囊（BIO ASCEND ISR）：随机、非劣效试验。","authors":"Yundai Chen, Lei Gao, Qin Qin, Jun Zhang, Shaobin Jia, Mingxing Wu, Yong He, Guosheng Fu, Jinghua Liu, Hui Chen, Qian Tong, Zaixin Yu, Jian An, Chunguang Qiu, Biao Xu, Yu Cao, Changqian Wang, Genshan Ma","doi":"10.4244/EIJ-D-24-00295","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.</p><p><strong>Aims: </strong>The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).</p><p><strong>Methods: </strong>This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.</p><p><strong>Results: </strong>A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm<sup>2</sup> in the BCB group compared to 2.37±0.93 mm<sup>2</sup> in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm<sup>2</sup>; p=non-significant.</p><p><strong>Conclusions: </strong>This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"e806-e817"},"PeriodicalIF":7.6000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11200665/pdf/","citationCount":"0","resultStr":"{\"title\":\"Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.\",\"authors\":\"Yundai Chen, Lei Gao, Qin Qin, Jun Zhang, Shaobin Jia, Mingxing Wu, Yong He, Guosheng Fu, Jinghua Liu, Hui Chen, Qian Tong, Zaixin Yu, Jian An, Chunguang Qiu, Biao Xu, Yu Cao, Changqian Wang, Genshan Ma\",\"doi\":\"10.4244/EIJ-D-24-00295\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.</p><p><strong>Aims: </strong>The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).</p><p><strong>Methods: </strong>This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.</p><p><strong>Results: </strong>A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm<sup>2</sup> in the BCB group compared to 2.37±0.93 mm<sup>2</sup> in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm<sup>2</sup>; p=non-significant.</p><p><strong>Conclusions: </strong>This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).</p>\",\"PeriodicalId\":54378,\"journal\":{\"name\":\"Eurointervention\",\"volume\":\" \",\"pages\":\"e806-e817\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11200665/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eurointervention\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4244/EIJ-D-24-00295\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00295","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.
Background: The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.
Aims: The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).
Methods: This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.
Results: A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant.
Conclusions: This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).
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.
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