Results from two studies showing the clinical non-inferiority of the Restore paclitaxel-coated balloon in treating in-stent restenosis (ISR) and small-vessel disease (SVD) indication could help enable the approval of the new device in China. The RESTORE ISR and RESTORE SVD findings were both presented Sept. 23 at TCT 2018 and published in JACC: Interventions.

In RESTORE ISR, 240 eligible patients from 12 sites in China were randomized to either Restore or SeQuent Please drug-coated balloon stents in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up took place at nine months and at one year, respectively, in all patients. The primary endpoint was nine-month in-segment late loss.

Overall results showed Restore to be non-inferior compared with SeQuent Please. The primary endpoint was 0.38±0.50 mm for Restore compared with 0.35±0.47 mm for SeQuent Please. Additionally, both stents had similar one-year rates of target lesion failure (13.3 percent vs. 12.6 percent; p=0.87).

In RESTORE SVD, 230 eligible patients with reference vessel diameter (RVD) ≥2.25 mm and ≤2.75 mm were randomized to Restore or RESOLUTE Integrity drug-eluting stent (DES) in a 1:1 ratio stratified by diabetes and number of lesions treated. All patients received angiographic and clinical follow-up at nine months and one year. The primary endpoint was nine-month in-segment percent diameter stenosis (%DS).

Results showed the nine-month in-segment %DS was 29.6±2.0 percent with drug-coated balloon (DCB) vs. 24.1±2.0 percent with DES (pnoninferiority<0.001). DCB and DES had comparable one-year rates of target lesion failure (4.4 percent vs. 2.6 percent; p=0.72).

In both cases given the very small sample sizes, researchers note that longer-term follow-up and large-scale studies are needed to further evaluate clinical outcomes with the new Restore DCB in the treatment of ISR and SVD.

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Angiography, Tricuspid Valve, Mitral Valve Insufficiency

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