Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial

Abstract 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 (p noninferiority =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.