Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease.
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, www.clinicaltrials.gov), 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.
Department of Vascular and Endovascular Surgery, University Hospital Münster.
Monika
M
Herten
Department of Vascular and Endovascular Surgery, University Hospital Münster; Department of Vascular Surgery, St Franziskus Hospital, Münster.
Giovanni B
GB
Torsello
Institute for Education and Student Affairs, University Hospital Münster, Münster, Germany.
Eva
E
Schönefeld
Department of Vascular Surgery, St Franziskus Hospital, Münster.
Stefan
S
Stahlhoff
D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016638:Critical Illness; D004867:Equipment Design; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
atherectomy; critical limb ischemia; drug-coated balloon; peripheral artery disease; restenosis; stent restenosis