Abstract 12626: A Novel Drug-Coated Scoring Balloon for the Treatment of Coronary In-Stent Restenosis: One Year Results of the PATENT-C First-in-Human Trial
Introduction: Scoring balloons are useful in the acute treatment of in-stent restenosis, fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate as compared to conventional balloons.
Hypothesis: A novel paclitaxel-coated scoring balloon (SB) was developed to overcome these limitations. Prior studies in a coronary swine model demonstrated a marked reduction in restenosis using these SB and no evidence of local or systemic adverse effects.
Methods: SB were coated with paclitaxel admixed with a specific excipient. Patients at 5 sites (4 in Germany and one in Brazil) with bare metal stent in-stent restenosis (ISR) were randomized 1:1 to treatment with either a drug-coated or bare SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients were evaluated clinically at 30 days, 6 and 12 months. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included clinically driven target lesion revascularization (TLR), major adverse cardiovascular events (MACE), stent thrombosis (ST) and other clinical and angiographic variables. Patients will be followed clinically for 2 years.
Results: A total of 61 patients were randomized (28 uncoated and 33 coated SB); mean age 63.3 yrs, males 72%, and presence of diabetes 38%. At 6-month angiography, late lumen loss in-segment was 0.48±0.51 mm in the uncoated SB group versus 0.09±0.43 mm in the drug-coated SB group (p=0.002; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 6.5% in the drug-coated SB group (p<0.05). At one year, the MACE rate was 32% with the uncoated SB vs. 6.7% with the drug-coated SB (p<0.05).
Conclusions: A novel paclitaxel-coated coronary SB has been developed and achieved successful results in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533].
Author Disclosures: B. Scheller: None.
- © 2014 by American Heart Association, Inc.