A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
Bruno SchellerAlexandre Abizaid

Abstract

Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group ...Continue Reading

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Citations

Jan 20, 2016·Current Treatment Options in Cardiovascular Medicine·Patrick M LooserDmitriy N Feldman
Oct 30, 2016·International Journal of Cardiology·Damon JacksonJamie Layland
Jan 25, 2017·Expert Review of Cardiovascular Therapy·Damianos G KokkinidisEhrin J Armstrong
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Jan 11, 2020·Expert Opinion on Drug Delivery·Thomas NestelbergerRaban Jeger
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Jun 20, 2020·Coronary Artery Disease·Fernando AlfonsoUNKNOWN Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment with Scoring Balloon Pre-dilatation (RIBS VI ‘Scoring’) St
Mar 7, 2020·Journal of the American College of Cardiology·Bruno SchellerFelix Mahfoud

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