Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377. doi: 10.1016/j.jcin.2018.09.010.
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).
本研究旨在评估在一项旨在使新型器械在中国获批的随机试验中，Restore 紫杉醇涂层球囊的血管造影疗效、临床安全性和有效性。
药物涂层球囊（DCB）血管成形术为支架内再狭窄提供了一种有效的治疗方法。Restore 是一种新型 DCB，其采用 SAFEPAX 紫胶-铵盐赋形剂，可避免药物在输送至靶病变部位的导管过程中洗脱。
在非劣效性 RESTORE ISR China（比较 RESTORE DEB 和 SeQuent Please 在有或无糖尿病的中国冠状动脉支架内再狭窄患者中的疗效和安全性）试验中，符合条件的首次发生药物洗脱支架内再狭窄的患者按 1:1 比例随机分配至 Restore DCB 或 SeQuent Please DCB 组，分层因素为糖尿病。所有患者分别计划在 9 个月和 1 年进行血管造影和临床随访。该研究的主要终点为 9 个月时的节段内晚期丢失。
2016 年 5 月至 2017 年 7 月，共在 12 个中心随机分配了 240 例患者至 Restore 组（n=120）或 SeQuent Please 组（n=120）。Restore 组 9 个月时的节段内晚期丢失为 0.38±0.50mm，而 SeQuent Please 组为 0.35±0.47mm；差值的单侧 97.5%置信上限为 0.17mm，Restore 组与 SeQuent Please 组相比具有非劣效性（p非劣效性=0.02）。两种 DCB 组 1 年时的靶病变失败率相似（13.3% vs. 12.6%；p=0.87）。
在这项头对头的随机试验中，与 SeQuent Please DCB 相比，Restore DCB 在 9 个月时的节段内晚期丢失主要终点上非劣效。（比较 RESTORE DEB 和 SeQuent Please 在有或无糖尿病的中国冠状动脉支架内再狭窄患者中的疗效和安全性；NCT02944890）。
