Drug-Coated Balloon Versus Drug-Eluting Stent for Small Vessel Disease: The RESTORE SVD China Randomized Trial

Abstract Objectives To evaluate the angiographic efficacy and clinical outcomes of Restore paclitaxel-coated balloon (Cardionovum, Germany) in a randomized trial designed to enable its approval with small vessel disease (SVD) indication. Background Higher rates of restenosis and stent thrombosis limit effectiveness of drug-eluting stents (DES) treatment of SVD. Whether drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established. Methods In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter (RVD) ≥2.25 mm and ≤2.75 mm were randomized to Restore DCB or RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 mm and Results Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to DCB group (n=116) or DES group (n=114); 32 patients were treated with DCB in the VSV cohort. The 9-month in-segment %DS was 29.6±2.0% with DCB vs. 24.1±2.0% with DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of DCB compared with DES (p noninferiority Conclusions In this multicenter randomized trial, Restore DCB was noninferior to RESOLUTE DES for 9-month in-segment %DS.