Paclitaxel-Eluting Balloon: From Bench to Bed

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in-stent restenosis. Brachytherapy and drug-eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in-stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non-stent based local drug delivery and particularly the use of paclitaxel-eluting balloons could be one of these strategies. We aimed to review the concept, preclinical-, and clinical data available with non-stent based local drug delivery and, in particular, with paclitaxel-eluting balloons. (C) 2009 Wiley-Liss, Inc.