Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis

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. Drug-coated balloon (DCB) angioplasty offers an effective treatment fo...

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Bibliographic Details
Published in:	JACC. Cardiovascular interventions 2018-12, Vol.11 (23), p.2368-2377
Main Authors:	Chen, Yundai, Gao, Lei, Qin, Qin, Chen, Shaoliang, Zhang, Jun, Chen, Hui, Wang, Lefeng, Jin, Zening, Zheng, Yang, Zhang, Zheng, Li, Hui, Li, Xue, Fu, Guosheng, Chen, Lian, Sun, Zhijun, Wang, Yu, Jin, Qinhua, Cao, Feng, Guo, Jun, Zhao, Yanyan, Guan, Changdong, Li, Wei, Xu, Bo, Zeng, Yong, Yang, Qing, Zhang, Jian, Yang, Jingyu, Li, Xiaobo, Zhang, Jun-jie, San, Shoujie, Ge, Zhen, Chen, Liang, You, Wei, Wu, Zhiming, Tian, Nailiang, Wang, Jun, Fu, Jinguo, Niu, Heping, Liang, Siwen, Zhao, Huiqiang, Li, Dongbao, Yang, Duo, Meng, Shuai, Zhang, Zhiyong, Hao, Shouyan, Bai, Ming, Zhao, Cunrui, Wang, Manqing, Wang, Jijia, Xue, Yusheng, Wang, Bin, Qiu, Fuyu, Zhao, Yanbo, Jin, Chongyin, Xu, Shengjie, Wu, Lili
Format:	Article
Language:	eng
Subjects:	drug-coated balloon drug-eluting stent(s) in-segment late loss in-stent restenosis
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Summary:	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. 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. 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. 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). 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) [Display omitted]
ISSN:	1936-8798 1876-7605