Yundai Chen1, Lei Gao2, Qin Qin3, Shaoliang Chen4, Jun Zhang5, Hui Chen6, Lefeng Wang7, Zening Jin8, Yang Zheng9, Zheng Zhang10, Hui Li11, Xue Li12, Guosheng Fu13, Lian Chen2, Zhijun Sun2, Yu Wang2, Qinhua Jin2, Feng Cao2, Jun Guo2, Yanyan Zhao14, Changdong Guan15, Wei Li14, Bo Xu16. 1. Department of Cardiology, Chinese PLA General Hospital, Beijing, China. Electronic address: cyundai@vip.163.com. 2. Department of Cardiology, Chinese PLA General Hospital, Beijing, China. 3. Department of Cardiology, Tianjin Chest Hospital, Tianjin, China. 4. Department of Cardiology, Nanjing First Hospital, Nanjing, China. 5. Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China. 6. Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. 7. Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. 8. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. 9. Department of Cardiology, The First Hospital of Jilin University, Jinlin, China. 10. Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China. 11. Department of Cardiology, Daqing Oilfield General Hospital, Daqing, China. 12. Department of Cardiology, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China. 13. Department of Cardiology, Sir Run Run Shaw, Zhejiang University School of Medicine, Zhejiang, China. 14. Medical Research and Biometrics Center, National Center for Cardiovascular Diseases of China, Beijing, China. 15. Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. 16. Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. Electronic address: bxu@citmd.com.
Abstract
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).
RCT Entities:
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).