title: The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES).
abstract: OBJECTIVE
  The aim of this study was to evaluate the effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia.
  
  
  BACKGROUND
  Conventional paclitaxel-eluting stents use a durable polymer coating as a vehicle for drug delivery. The Conor stent (Conor Medsystems, Menlo Park, California) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmacokinetics.
  
  
  METHODS
  Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent (n = 53) or one of six different release formulations that varied in dose (10 or 30 microg) and elution release kinetics (first order, zero order), direction (abluminal, luminal), and duration (5, 10, and 30 days). End points at six months (bare stent group) and at four months (eluting stent groups) were angiographic late loss and neointimal tissue volume by intravascular ultrasound and the rate of major adverse cardiac events (MACE).
  
  
  RESULTS
  The lowest in-stent late loss (0.38 mm, p <0.01, and 0.30 mm, p <0.01) and volume obstruction (8%, p <0.01, and 5%, p <0.01) were observed with the 10-microg and 30-microg doses in the 30-day release groups respectively, whereas the highest in-stent late loss (0.88 mm), volume obstruction (26%), and restenosis rate (11.6%) were observed in the bare stent group. The overall MACE rate of the eluting stent group was 8.6%: death 0.5%, myocardial infarction 2.7%, and target lesion revascularization (TLR) 5.3%. Sub-acute thrombosis was 0.5%. The TLR rates in the two 30-day release groups were 0% and 3.4%.
  
  
  CONCLUSIONS
  This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.
authors: Erasmus Medical Center, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors: Patrick W
authors: PW
authors: Serruys
authors: Georgios
authors: G
authors: Sianos
authors: Alexandre
authors: A
authors: Abizaid
authors: Jiro
authors: J
authors: Aoki
authors: Peter
authors: P
authors: den Heijer
authors: Hans
authors: H
authors: Bonnier
authors: Pieter
authors: P
authors: Smits
authors: Dougal
authors: D
authors: McClean
authors: Stefan
authors: S
authors: Verheye
authors: Jorge
authors: J
authors: Belardi
authors: Jose
authors: J
authors: Condado
authors: Michel
authors: M
authors: Pieper
authors: Louise
authors: L
authors: Gambone
authors: Marco
authors: M
authors: Bressers
authors: Janette
authors: J
authors: Symons
authors: Eduardo
authors: E
authors: Sousa
authors: Frank
authors: F
authors: Litvack
mesh_terms: D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology; D016503:Drug Delivery Systems; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D011446:Prospective Studies; D015607:Stents; D013997:Time Factors; D017539:Tunica Intima / Q000187:drug effects* / Q000473:pathology; D018084:Ultrasonography, Interventional
chemical_list: D011108:Polymers; D017239:Paclitaxel