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Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Authors Herten M, Torsello G, Schönefeld E, Stahlhoff S

Received 4 January 2016

Accepted for publication 15 March 2016

Published 29 August 2016 Volume 2016:12 Pages 341—356


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Daniel A. Duprez

Monika Herten,1 Giovanni B Torsello,1,2 Eva Schönefeld,3 Stefan Stahlhoff2

1Department of Vascular and Endovascular Surgery, University Hospital Münster, 2Department of Vascular Surgery, St Franziskus Hospital, Münster, 3Institute for Education and Student Affairs, University Hospital Münster, Münster, Germany

Abstract: Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie,, and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

Keywords: drug-coated balloon, critical limb ischemia, peripheral artery disease, restenosis, atherectomy, stent restenosis

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