title: Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries.
abstract: OBJECTIVE
  Paclitaxel-coated balloon catheters inhibit restenosis after coronary and peripheral angioplasty (PCI,PTA). The aim of this study was to investigate paclitaxel plasma levels and laboratory parameters following PTA with paclitaxel-coated balloons (PCB) in peripheral arteries.
  
  
  METHODS
  This single treatment arm, multicenter study included 14 patients with Rutherford stage 1 - 5 with occlusions of up to 5 cm or ≥ 70 % diameter stenosis of the superficial femoral or popliteal arteries (SFA, PA). PTA was performed using up to three PCB catheters. The paclitaxel plasma levels and safety laboratory parameters were determined by collecting blood samples pre-intervention, immediately post-intervention, at 0.5, 1, 2, 4, 8, 24 hours and 1 and 4 weeks post-intervention (p. i.). Vital signs were monitored to assess clinical safety.
  
  
  RESULTS
  PTA was performed successfully in all patients. Paclitaxel plasma levels were always below a level and duration known to cause systemic side effects. A mean peak paclitaxel plasma level (40 ng/ml) was reached immediately p. i. and decreased rapidly below detectable levels in more than half of the patients already 2 hours p. i. The paclitaxel plasma concentrations returned to values below detectable levels at 24 hours p. i. in all patients. Laboratory parameters and vital signs did not give any reason for safety concerns. No adverse events associated with balloon coating were observed.
  
  
  CONCLUSIONS
  The results of 14 patients with peripheral arterial occlusive disease show no systemic bioavailability of paclitaxel > 24 hours after PTA with one or more PCB catheters, indicating that the PCB catheter is safe with regard to possible systemic effects.
authors.affiliation: Klinik für Strahlenheilkunde, Charité Universitätsmedizin, Berlin. patrick.freyhardt@charite.de
authors.forename: P
authors.initials: P
authors.lastname: Freyhardt
authors.forename: T
authors.initials: T
authors.lastname: Zeller
authors.forename: T J
authors.initials: TJ
authors.lastname: Kröncke
authors.forename: U
authors.initials: U
authors.lastname: Schwarzwaelder
authors.forename: N F
authors.initials: NF
authors.lastname: Schreiter
authors.forename: H
authors.initials: H
authors.lastname: Stiepani
authors.forename: S
authors.initials: S
authors.lastname: Sixt
authors.forename: A
authors.initials: A
authors.lastname: Rastan
authors.forename: M
authors.initials: M
authors.lastname: Werk
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D001157:Arterial Occlusive Diseases / Q000097:blood* / Q000628:therapy*; D001682:Biological Availability; D002404:Catheterization / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D004305:Dose-Response Relationship, Drug; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods*; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D011150:Popliteal Artery
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel