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Minerva Cardioangiologica 2011 October;59(5):431-45


language: English

Review of clinical data with Paccocath™- Coated Balloon Catheters

Schnorr B. 1, Speck U. 1, Scheller B. 2, 3

1 Department of Radiology, Experimental Radiology, Charité, University Hospital, Berlin, Germany; 2 Department of Cardiology, Angiology and Intensive Care, Clinic for Internal Medicine III, University Hospital of Saarland, Homburg/Saar, Germany; 3 Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany


The use of drug-coated balloons (DCB) for preventing restenosis in both coronary and peripheral arteries has received increasing attention. The first successful clinical outcomes in inhibiting restenosis have been reported for paclitaxel-coated balloons. Paclitaxel is a lipophilic substance characterized by rapid intracellular uptake and irreversible binding to microtubules. In this way, paclitaxel alters the cell structure, ultimately reducing proliferation, migration, and signaling. These properties make paclitaxel a very potent antiproliferative drug. Paclitaxel admixed to a small amount of the hydrophilic X-ray contrast medium iopromide (Ultravist™) emerged as a very effective coating matrix from numerous in vitro and in vivo experiments and has been denoted as Paccocath™. The randomized controlled ISR I/II-, Thunder- and FEMPAC studies have been conducted using Paccocath™ balloons. Late lumen loss as the primary endpoint at 6 months proved to be statistically significantly reduced in the coated balloon groups in coronary and peripheral arteries. The slightly modified coating on the SeQuent™ Please balloons (B.Braun, Melsungen, Germany) has been clinically studied in the PEPCAD (Paclitaxel-Eluting PTCA-Catheter in Coronary Artery Disease) clinical trial program. Cotavance™ balloons (MEDRAD Inc, Minneapolis, USA) are also coated with the Paccocath™ formulation. In this review we first outline the development of Paccocath™ balloons to then provide an overview of the clinical results obtained with the modified coating. Furthermore we examine possible mechanism of action by which single administration of an antiproliferative drug dose using paclitaxel-coated balloons inhibits restenosis.

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