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

OBJECTIVES The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BACKGROUND Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a 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 >= 2.25 and <= 2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1: 1 ratio stratified by diabetes and number of lesions treated. Patients with RVD >= 2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. RESULTS Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 +/- 2.0% with the DCB versus 24.1 +/- 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority <0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). CONCLUSIONS In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307) (J Am Coll Cardiol Intv 2018;11:2381-92) (c) 2018 by the American College of Cardiology Foundation.