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Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial

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资源类型：
作者：
Yida Tang[a] * ; Shubin Qiao[a] * ; Xi Su[b] ; Yundai Chen[c] ; Zening Jin[d] ; Hui Chen[e] ; Biao Xu[f] ; Xiangqing Kong[g] ; Wenyue Pang[h] ; Yong Liu[i] ; Zaixin Yu[j] ; Xue Li[k] ; Hui Li[l] ; Yanyan Zhao[m] ; Yang Wang[m] ; Wei Li[m] ; Jian Tian[a] ; Changdong Guan[n] ; Bo Xu[n,*1] ; Runlin Gao[a,*1] ;
机构： [a]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [b]Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China [c]Department of Cardiology, Chinese PLA General Hospital, Beijing, China [d]Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China [e]Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [f]Department of Cardiology, Affiliated Nanjing Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China [g]Department of Cardiology, Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China [h]Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China [i]Department of Cardiology, the Fourth Central Hospital of Tianjin, Tianjin, China [j]Department of Cardiology, Xiangya Hospital of Central South University, Changsha, China [k]Department of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi’an, China [l]Department of Cardiology, Daqing Oilfield General Hospital, Daqing, 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.2018.09.009
ISSN：

关键词： drug-coated balloon drug-eluting stent(s) percentage diameter stenosis small-vessel disease

摘要：
OBJECTIVES The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BACKGROUND Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established. METHODS In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter >= 2.25 and <= 2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1: 1 ratio stratified by diabetes and number of lesions treated. Patients with RVD >= 2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. RESULTS Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 +/- 2.0% with the DCB versus 24.1 +/- 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority <0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). CONCLUSIONS In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307) (J Am Coll Cardiol Intv 2018;11:2381-92) (c) 2018 by the 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[2023]版：
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
第一作者：
第一作者机构： [a]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
共同第一作者：
通讯作者：
通讯机构： [a]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [n]Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [*1]Department of Cardiology or 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)：
Yida Tang,Shubin Qiao,Xi Su,et al.Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial[J].JACC-CARDIOVASCULAR INTERVENTIONS.2018,11(23):2381-2392.doi:10.1016/j.jcin.2018.09.009.
APA：
Yida Tang,Shubin Qiao,Xi Su,Yundai Chen,Zening Jin...&Runlin Gao.(2018).Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial.JACC-CARDIOVASCULAR INTERVENTIONS,11,(23)
MLA：
Yida Tang,et al."Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial".JACC-CARDIOVASCULAR INTERVENTIONS 11..23(2018):2381-2392

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