title: Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.
abstract: BACKGROUND
  The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis.
  
  
  RESULTS
  On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 microg/mm2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9+/-26.7% in controls (n=34) and 14.2+/-16.6% in the 2.7-microg/mm2 group (n=31; P=0.006). Late loss decreased from 0.73+/-0.73 to 0.11+/-0.50 mm (P=0.002). Binary restenosis (> or =50% at follow-up) decreased from 20.6% to 3.2% (P=0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P=NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only.
  
  
  CONCLUSIONS
  Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 microg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.
authors.affiliation: Department of Cardiology, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Gershlick
authors.forename: Ivan
authors.initials: I
authors.lastname: De Scheerder
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Amanda
authors.initials: A
authors.lastname: Stephens-Lloyd
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.forename: Christian
authors.initials: C
authors.lastname: Vrints
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Reifart
authors.forename: Luc
authors.initials: L
authors.lastname: Missault
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Goy
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Brinker
authors.forename: Albert E
authors.initials: AE
authors.lastname: Raizner
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
authors.forename: Alan W
authors.initials: AW
authors.lastname: Heldman
mesh_terms: D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D016503:Drug Delivery Systems; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015607:Stents
chemical_list: D017239:Paclitaxel