title: [Drug-coated balloons in the treatment of peripheral artery disease (PAD). History and current level of evidence].
abstract: BACKGROUND
  Despite initially encouraging technical success after femoropopliteal PTA, restenosis remains the major challenge in patients with peripheral artery disease (PAD). The main cause of restenosis is neointimal hyperplasia which can be suppressed by antiproliferative drugs. Drug-coated balloons (DCB) or drug-eluting stents (DES) are used for the inhibition of restenosis.
  
  
  OBJECTIVE
  The present article gives an overview of DCB development, actual DCB systems for femoro- and infrapopliteal use, displays the outcomes of randomized clinical trials and the discusses the evidence for the DCB treatment in PAD.
  
  
  METHODS
  A systematic literature search was performed in i) medical journals (i. e. MEDLINE), ii) in international registers for clinical studies (i. e. www.clinicaltrials.gov ) and in iii) scientific session abstracts.
  
  
  RESULTS
  The clinical evidence of the PTX-DCB of the first and following generation has been shown in several controlled randomized trials.
  
  
  CONCLUSIONS
  Major advantages of the DCBs lie in leaving no stent scaffold behind, the immediate release of high drug concentrations with a single dosage, their efficacy in areas, where stents have been contra-indicated until now and its use for secondary interventions. As their effect seems to be limited in severely calcified lesions, prior plaque preconditioning or removal could be advantageous. First positive results data supporting this hypothesis do exist.
authors.affiliation: Klinik für Vaskuläre und Endovaskuläre Chirurgie, Universitätsklinikum Münster, Münster, Deutschland. Monika.Herten@ukmuenster.de.
authors.forename: M
authors.initials: M
authors.lastname: Herten
authors.affiliation: Gefäßchirurgie, St. Franziskus-Hospital Münster, Münster, Deutschland.
authors.forename: S
authors.initials: S
authors.lastname: Stahlhoff
authors.affiliation: Klinik für Vaskuläre und Endovaskuläre Chirurgie, Universitätsklinikum Münster, Münster, Deutschland.
authors.forename: B
authors.initials: B
authors.lastname: Imm
authors.affiliation: Institut für Ausbildung und Studienangelegenheiten (IfAS), Medizinischen Fakultät, Westfälischen Wilhelms-Universität Münster, Münster, Deutschland.
authors.forename: E
authors.initials: E
authors.lastname: Schönefeld
authors.affiliation: Gefäßchirurgie, St. Franziskus-Hospital Münster, Münster, Deutschland.
authors.forename: A
authors.initials: A
authors.lastname: Schwindt
authors.affiliation: Klinik für Vaskuläre und Endovaskuläre Chirurgie, Universitätsklinikum Münster, Münster, Deutschland.|Gefäßchirurgie, St. Franziskus-Hospital Münster, Münster, Deutschland.
authors.forename: G B
authors.initials: GB
authors.lastname: Torsello
mesh_terms: D000800:Angioplasty, Balloon / Q000706:statistics & numerical data*; D054855:Drug-Eluting Stents; D019317:Evidence-Based Medicine; D005263:Femoral Artery / Q000601:surgery*; D006801:Humans; D058729:Peripheral Arterial Disease / Q000453:epidemiology* / Q000628:therapy*; D011150:Popliteal Artery / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000517:prevention & control; D015995:Prevalence; D012307:Risk Factors; D016896:Treatment Outcome
keywords: Drug-coated balloon (DCB); Drug-eluting balloon (DEB); Paclitaxel (PTX); Peripheral artery disease (PAD); Restenosis