Author + information
- Received August 14, 2018
- Revision received September 5, 2018
- Accepted September 10, 2018
- Published online September 23, 2018.
- Yida Tang, MDa,
- Shubin Qiao, MDa,
- Xi Su, MDb,
- Yundai Chen, MDc,
- Zening Jin, MDd,
- Hui Chen, MDe,
- Biao Xu, MDf,
- Xiangqing Kong, MDg,
- Wenyue Pang, MDh,
- Yong Liu, MDi,
- Zaixin Yu, MDj,
- Xue Li, MDk,
- Hui Li, MDl,
- Yanyan Zhao, BSm,
- Yang Wang, MScm,
- Wei Li, PhDm,
- Jian Tian, MDa,
- Changdong Guan, MScn,
- Bo Xu, MBBSn,∗∗ (, )
- Runlin Gao, MDa,∗ (, )
- for the RESTORE SVD China Investigators
- aDepartment of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- bDepartment of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
- cDepartment of Cardiology, Chinese PLA General Hospital, Beijing, China
- dDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
- eDepartment of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
- fDepartment of Cardiology, Affiliated Nanjing Drum Tower Hospital of Nanjing University School of Medicine, Nanjing, China
- gDepartment of Cardiology, Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
- hDepartment of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China
- iDepartment of Cardiology, the Fourth Central Hospital of Tianjin, Tianjin, China
- jDepartment of Cardiology, Xiangya Hospital of Central South University, Changsha, China
- kDepartment of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi’an, China
- lDepartment of Cardiology, Daqing Oilfield General Hospital, Daqing, China
- mMedical Research and Biometrics Center, National Center for Cardiovascular Diseases of China, Beijing, China
- nCatheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- ↵∗Address for Correspondence: Runlin Gao, MD Department of Cardiology Fu Wai Hospital National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences A 167, Beilishi Road, Xicheng District Beijing, 100037, China Telephone: +86-10-6833-1622 Fax: +86-10-6833-3879
- ↵∗∗Bo Xu, MBBS, Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Xicheng District, Beijing, 100037, China, Telephone: +86-10-8832-2562 Fax: +86-10-6831-3012.
Objectives To evaluate the angiographic efficacy and clinical outcomes of Restore paclitaxel-coated balloon (Cardionovum, Germany) in a randomized trial designed to enable its approval with small vessel disease (SVD) indication.
Background Higher rates of restenosis and stent thrombosis limit effectiveness of drug-eluting stents (DES) treatment of SVD. Whether 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 (RVD) ≥2.25 mm and ≤2.75 mm were randomized to Restore DCB or RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 mm and <2.25 mm were enrolled in a nested very small vessel (VSV) 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 percent diameter stenosis (%DS).
Results Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to DCB group (n=116) or DES group (n=114); 32 patients were treated with DCB in the VSV cohort. The 9-month in-segment %DS was 29.6±2.0% with DCB vs. 24.1±2.0% with DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of DCB compared with DES (pnoninferiority<0.001). DCB and DES had comparable 1-year rate of target lesion failure (4.4% vs. 2.6%, p=0.72).
Conclusions In this multicenter randomized trial, Restore DCB was noninferior to RESOLUTE DES for 9-month in-segment %DS.
The first two authors (YT and SQ) contributed equally to this work.
The study was sponsored by Cardionovum, Germany through an institutional research grant. The executive committee, together with the sponsor, designed the RESTORE SVD China trial. The sponsor had no role in data collection, data analysis, data interpretation, writing the manuscript, or the decision to submit the manuscript for publication.
- Received August 14, 2018.
- Revision received September 5, 2018.
- Accepted September 10, 2018.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.