title: Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention: early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis.
abstract: OBJECTIVE
  The efficacy of paclitaxel-coated balloons (PCB) for the treatment of superficial femoral artery (SFA) disease has been demonstrated in the clinical setting. Due to the high frequency of arterial calcification found in this vascular territory, the adjunctive use of atherectomy plus PCB has been proposed. In this study, we aimed to evaluate the biological effect on vascular healing and drug retention of this combination approach in the familial hypercholesterolaemic swine (FHS) model of femoral artery stenosis.
  
  
  RESULTS
  Eleven femoral arteries (six superficial and five profunda arteries) were included. Vessels were injured (x2) over a 28-day period and all animals were maintained on a high cholesterol diet for 60 days following initial injury. Vessels were randomised to PCB (n=5) or orbital atherectomy system (OAS) plus PCB (n=6). At 28 days following therapy, vessels were followed with angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Vessels were harvested for histological and pharmacokinetic analysis. Angiographic findings were comparable at termination between both groups. The OCT findings were comparable at termination. There were no differences in the vascular healing profile between both groups. The paclitaxel levels at termination were comparable between both groups (PCB=5.16 vs. OAS+PCB=3.03 ng/mg).
  
  
  CONCLUSIONS
  In the experimental setting, the combination of OAS+PCB appears to be safe by demonstrating a vascular healing profile and drug tissue levels comparable to PCB only. The vascular effect of PCB may be enhanced by the use of OAS by decreasing plaque burden and cholesterol crystals.
authors.affiliation: Skirball Center for Innovation, Cardiovascular Research Foundation, Orangeburg, NY, USA.
authors.forename: Armando
authors.initials: A
authors.lastname: Tellez
authors.forename: Raymond
authors.initials: R
authors.lastname: Dattilo
authors.forename: Jihad A
authors.initials: JA
authors.lastname: Mustapha
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Gongora
authors.forename: Chelsea M
authors.initials: CM
authors.lastname: Hyon
authors.forename: Taylor
authors.initials: T
authors.lastname: Palmieri
authors.forename: Serge
authors.initials: S
authors.lastname: Rousselle
authors.forename: Greg L
authors.initials: GL
authors.lastname: Kaluza
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D000800:Angioplasty, Balloon / Q000379:methods*; D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000493:pharmacokinetics* / Q000494:pharmacology; D017073:Atherectomy / Q000379:methods*; D003131:Combined Modality Therapy; D003251:Constriction, Pathologic / Q000209:etiology / Q000601:surgery; D004195:Disease Models, Animal; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000187:drug effects / Q000601:surgery*; D006938:Hyperlipoproteinemia Type II / Q000150:complications; D017239:Paclitaxel / Q000493:pharmacokinetics* / Q000494:pharmacology; D058729:Peripheral Arterial Disease / Q000209:etiology / Q000601:surgery*; D013552:Swine; D041623:Tomography, Optical Coherence; D018084:Ultrasonography, Interventional; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel