Author + information
- Received August 14, 2018
- Revision received September 9, 2018
- Accepted September 10, 2018
- Published online September 23, 2018.
- Yundai Chen, MDa,∗ (, )
- Lei Gao, MDa,
- Qin Qin, MDb,
- Shaoliang Chen, MDc,
- Jun Zhang, MDd,
- Hui Chen, MDe,
- Lefeng Wang, MDf,
- Zening Jin, MDg,
- Yang Zheng, MDh,
- Zheng Zhang, MDi,
- Hui Li, MDj,
- Xue Li, MDk,
- Guosheng Fu, MDl,
- Lian Chen, MDa,
- Zhijun Sun, MDa,
- Yu Wang, MDa,
- Qinhua Jin, MDa,
- Feng Cao, MDa,
- Jun Guo, MDa,
- Yanyan Zhao, BSm,
- Changdong Guan, MScn,
- Wei Li, PhDm,
- Bo Xu, MBBSn,∗∗ (, )
- for the RESTORE ISR China Investigators
- aDepartment of Cardiology, Chinese PLA General Hospital, Beijing, China
- bDepartment of Cardiology, Tianjin Chest Hospital, Tianjin, China
- cDepartment of Cardiology, Nanjing First Hospital, Nanjing, China
- dDepartment of Cardiology, Cangzhou Central Hospital, Cangzhou, China
- eDepartment of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
- fDepartment of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
- gDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
- hDepartment of Cardiology, The First Hospital of Jilin University, Jinlin, China
- iDepartment of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China
- jDepartment of Cardiology, Daqing Oilfield General Hospital, Daqing, China
- kDepartment of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi’an, China
- lDepartment of Cardiology, Sir Run Run Shaw, Zhejiang University School of Medicine, Zhejiang, 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: Yundai Chen, MD Department of Cardiology Chinese PLA General Hospital No. 28, Fuxing Road, Haidian District Beijing, 100853, China Telephone: +86-10-5549-9009, Fax: +86-10-5549-9009
- ↵∗∗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 The present study sought to evaluate the angiographic efficacy, clinical safety and effectiveness of the Restore paclitaxel-coated balloon (Cardionovum, Germany) 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 (ISR). 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 trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to Restore DCB or SeQuent Please DCB (B Braun, Germany) 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 (LL).
Results Between May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either Restore group (n=120) or SeQuent Please group (n=120). The 9-month in-segment LL was 0.38±0.50 mm for Restore vs. 0.35±0.47 mm for 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 (pnoninferiority=0.02). Both DCBs had similar 1-year rate of target lesion failure (13.3% vs. 12.6%, p=0.87).
Conclusions In this head-to-head randomized trial, Restore DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment LL.
The first two authors (YC and LG) 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 ISR China clinical 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 9, 2018.
- Accepted September 10, 2018.