M Herten1, S Stahlhoff2, B Imm3, E Schönefeld4, A Schwindt2, G B Torsello3,2. 1. Klinik für Vaskuläre und Endovaskuläre Chirurgie, Universitätsklinikum Münster, Münster, Deutschland. Monika.Herten@ukmuenster.de. 2. Gefäßchirurgie, St. Franziskus-Hospital Münster, Münster, Deutschland. 3. Klinik für Vaskuläre und Endovaskuläre Chirurgie, Universitätsklinikum Münster, Münster, Deutschland. 4. Institut für Ausbildung und Studienangelegenheiten (IfAS), Medizinischen Fakultät, Westfälischen Wilhelms-Universität Münster, Münster, Deutschland.
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. OBJECTIVES: 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.
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. OBJECTIVES: 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: Thomas Zeller; Iris Baumgartner; Dierk Scheinert; Marianne Brodmann; Marc Bosiers; Antonio Micari; Patrick Peeters; Frank Vermassen; Mario Landini; David B Snead; K Craig Kent; Krishna J Rocha-Singh Journal: J Am Coll Cardiol Date: 2014-10-14 Impact factor: 24.094
Authors: Gunnar Tepe; John Laird; Peter Schneider; Marianne Brodmann; Prakash Krishnan; Antonio Micari; Christopher Metzger; Dierk Scheinert; Thomas Zeller; David J Cohen; David B Snead; Beaux Alexander; Mario Landini; Michael R Jaff Journal: Circulation Date: 2014-12-03 Impact factor: 29.690