个人科研网厅 | | 帮助
首都医科大学宣武医院知识库
高级检索
当前位置： 首页 > 详情页

Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial

| 认领 | 导出 | |

文献详情

资源类型：

收录情况： ◇ SCIE

作者：
Yundai Chen[a,*1] * ; Lei Gao[a] * ; Qin Qin[b] ; Shaoliang Chen[c] ; Jun Zhang[d] ; Hui Chen[e] ; Lefeng Wang[f] ; Zening Jin[g] ; Yang Zheng[h] ; Zheng Zhang[i] ; Hui Li[j] ; Xue Li[k] ; Guosheng Fu[l] ; Lian Chen[a] ; Zhijun Sun[a] ; Yu Wang[a] ; Qinhua Jin[a] ; Feng Cao[a] ; Jun Guo[a] ; Yanyan Zhao[m] ; Changdong Guan[n] ; Wei Li[m] ; Bo Xu[n,*2] ;
机构： [a]Department of Cardiology, Chinese PLA General Hospital, Beijing, China [b]Department of Cardiology, Tianjin Chest Hospital, Tianjin, China [c]Department of Cardiology, Nanjing First Hospital, Nanjing, China [d]Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China [e]Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [f]Department of Cardiology, Beijing Chaoyang Hospital, and gDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China [h]Department of Cardiology, The First Hospital of Jilin University, Jinlin, China [i]Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China [j]Department of Cardiology, Daqing Oilfield General Hospital, Daqing, China [k]Department of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi’an, China [l]Department of Cardiology, Sir Run Run Shaw, Zhejiang University School of Medicine, Zhejiang, China [m]Medical Research and Biometrics Center, National Center for Cardiovascular Diseases of China, Beijing, China [n]Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
出处：
DOI： 10.1016/j.jcin.2018.09.010
ISSN：

关键词： drug-coated balloon drug-eluting stent(s) in-segment late loss in-stent restenosis

摘要：
Objectives: The aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China. Background: Drug-coated balloon (DCB) angioplasty offers an effective treatment for in-stent restenosis. Restore is a new DCB with a SAFEPAX shellac-ammonium salt excipient that can avoid drug washing off during catheter delivery to the target lesion site. Methods: In the noninferiority RESTORE ISR China (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis) trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to the Restore DCB or SeQuent Please DCB in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up was planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment late loss. Results: Between May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either the Restore group (n = 120) or the SeQuent Please group (n = 120). Nine-month in-segment late loss was 0.38 ± 0.50 mm with Restore versus 0.35 ± 0.47 mm with SeQuent Please; the 1-sided 97.5% upper confidence limit of the difference was 0.17 mm, achieving noninferiority of Restore compared with SeQuent Please (p for noninferiority = 0.02). Both DCBs had similar 1-year rates of target lesion failure (13.3% vs. 12.6%; p = 0.87). Conclusions: In this head-to-head randomized trial, the Restore DCB was noninferior to the SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis; NCT02944890) © 2018 American College of Cardiology Foundation

基金：
Cardionovum
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2017]版：
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
JCR分区：
出版当年[2016]版：
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版：
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子： 最新[2023版] 最新五年平均 出版当年[2016版] 出版当年五年平均 出版前一年[2015版] 出版后一年[2017版]

第一作者：
第一作者机构： [a]Department of Cardiology, Chinese PLA General Hospital, Beijing, China [*1]Department of Cardiology, Chinese PLA General Hospital, No. 28, Fuxing Road, Haidian District, Beijing 100853, China
共同第一作者：
通讯作者：
通讯机构： [a]Department of Cardiology, Chinese PLA General Hospital, Beijing, China [n]Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [*1]Department of Cardiology, Chinese PLA General Hospital, No. 28, Fuxing Road, Haidian District, Beijing 100853, China [*2]Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Xicheng District, Beijing 100037, China.
推荐引用方式(GB/T 7714)：
Yundai Chen,Lei Gao,Qin Qin,et al.Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial[J].JACC-CARDIOVASCULAR INTERVENTIONS.2018,11(23):2368-2377.doi:10.1016/j.jcin.2018.09.010.
APA：
Yundai Chen,Lei Gao,Qin Qin,Shaoliang Chen,Jun Zhang...&Bo Xu.(2018).Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial.JACC-CARDIOVASCULAR INTERVENTIONS,11,(23)
MLA：
Yundai Chen,et al."Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial".JACC-CARDIOVASCULAR INTERVENTIONS 11..23(2018):2368-2377

相关文献

[1]Debulking plus drug-coated balloon angioplasty versus drug-coated balloon angioplasty alone for femoropopliteal Tosaka III in-stent restenosis lesions [2]Clinical Study of Excimer Laser and Drug Coated Balloon Versus Excimer Laser and Plain Balloon Versus Plain Balloon and Drug Coated Balloon to Treat Femoropopliteal In-stent Restenosis [3]Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial [4]Real-World Performance of Excimer Laser Ablation Combined with Drug-Coated Balloon Versus Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis Disease [5]Rotarex®S rotational atherectomy combined with drug-coated balloon angioplasty for treating femoropopliteal artery in-stent restenosis [6]药物涂层球囊治疗肾动脉支架内再狭窄4例 [7]药物涂层球囊在冠状动脉小血管病变和支架内再狭窄中的临床应用 [8]Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis [9]A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated Balloon Versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis Results From the PEPCAD China ISR Trial [10]Drug-Coated Balloon Angioplasty and Debulking for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis(Open Access)

资源点击量：17069 今日访问量：0 总访问量：916 更新日期：2025-04-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持：重庆聚合科技有限公司 地址：北京市西城区长椿街45号宣武医院