Dr Erich Minar, Medical University of Vienna, Austria, highlighted at the 2009 LINC conference, Leipzig, Germany, the limitations of drug-eluting balloons, and suggested that the current enthusiasm for drug-eluting balloons will settle down as the technique becomes established for a small number of procedures.
Minar’s assessment followed a presentation by Dr Gunnar Tepe, University of Tuebingen, Germany, on the latest clinical trials of the Paccocath paclitaxel-coated balloon catheter.
Tepe said that trials have taken place or are ongoing for the use of Paccocath in the treatment of coronary in-stent restenosis, de novo lesions (in which the catheter was inserted with a pre-mounted stent), and peripheral arterial disease. A trial is also underway, he said, with an alternative drug-eluting balloon in the treatment of peripheral venous disease.
Tepe described the THUNDER (Local Taxan with short-time exposure for reduction of restenosis in distal arteries) trial, which found that the Paccocath balloon catheter, which delivers the full dosage in just 60 seconds, is effective in preventing restenosis over a 24-month period, and compared favourably with uncoated-balloon angioplasty and balloon angioplasty with intra-arterial delivery of paclitaxel.
Minar, however, highlighted the limited data on the use of drug-eluting balloons, in terms of number of patients and variety of indications so far treated, and the duration of follow-up. He also expressed concern over the bulk release of drugs.