Journal Article

Drug-coated balloon therapy in coronary and peripheral artery disease

Alfonso, Fernando, Joner, Michael, Byrne, Robert A., Kastrati, Adnan

2014

Overview

Key Points Nonstent-based local drug delivery with drug-coated balloons (DCBs) can achieve rapid transfer of a drug to surrounding tissue, and durable antirestenotic efficacy Theoretical advantages of DCBs over drug-eluting stents (DESs) include broad surface contact, homogenous drug distribution, absence of stent footprint or polymer residue, and restoration of normal vessel anatomy and function Preclinical studies have shown that DCB delivery of paclitaxel combined with a hydrophilic spacer (excipient) results in clinically effective local tissue drug concentrations and sustained inhibition of neointimal growth Among patients with coronary bare-metal or drug-eluting stent restenosis, DCBs show similar results to standard-of-care treatment (repeat stenting with a DES) and obviate the need for further stent implants Among patients with de novo coronary artery disease, convincing data from randomized trials to support DCB therapy is lacking, and the use of DCBs for this indication requires further investigation In peripheral artery disease, DCB therapy has proven superior to balloon angioplasty for treatment of de novo femoropopliteal and below-the-knee disease De novo stenosis of coronary or peripheral arteries as well as restenosis of previously stented vessels are increasingly prevalent clinical problems. In this Review, Byrne and colleagues summarize the evidence for the use of novel balloon catheters covered with antiproliferative drug both to restore vessel patency and to provide long-lasting inhibition of cell regrowth. Nonstent-based local drug delivery during percutaneous intervention offers potential for sustained antirestenotic efficacy without the limitations of permanent vascular implants. Preclinical studies have shown that effective local tissue concentrations of drugs can be achieved using drug-coated balloon (DCB) catheters. Matrix coatings consisting of a mixture of lipophilic paclitaxel and hydrophilic spacer (excipient) are most effective. Clinical applications most suited to DCB therapy are those for which stent implantation is not desirable or less effective, such as in-stent restenosis, bifurcation lesions, or peripheral artery stenoses. Randomized trials have shown superiority of DCBs over plain-balloon angioplasty for both bare-metal and drug-eluting coronary in-stent restenosis, and similar efficacy as repeat stenting with a drug-eluting stent (DES). Bycontrast, randomized trials of DCBs in de novo coronary stenosis have, to date, not shown similar efficacy to standard-of-care DES therapy. In peripheral artery disease, DCB therapy has proven superior to plain-balloon angioplasty for treatment of de novo femoropoliteal and below-the-knee disease, and shown promising results for in-stent restenosis. Overall, however, despite many years of clinical experience with DCBs, the number of large, high-quality, randomized clinical trials is low, and further data are urgently needed across the spectrum of clinical indications.

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: 692/699/75/593/15 / 692/699/75/593/1920 / 692/700/565/2773 / 692/700/565/2776 / Angioplasty, Balloon - instrumentation / Cardiac Imaging / Cardiac Surgery / Cardiology / Care and treatment / Coated Materials, Biocompatible / Coronary Artery Disease - therapy / Health aspects / Humans / Medicine & Public Health / Patient outcomes / Peripheral Arterial Disease - therapy / review-article / Risk factors / Stenosis / Transluminal angioplasty / Treatment Outcome