title: Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries: a serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT).
abstract: BACKGROUND
  The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH).
  
  
  RESULTS
  Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 microg/mm2; high dose: 3.10 microg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31+/-22 mm3 in control, 18+/-15 mm3 in low dose, and 13+/-14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments.
  
  
  CONCLUSIONS
  Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.
authors.affiliation: Department of Medicine, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea.
authors.forename: Myeong-Ki
authors.initials: MK
authors.lastname: Hong
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.forename: Jong-Min
authors.initials: JM
authors.lastname: Song
authors.forename: Ki-Hoon
authors.initials: KH
authors.lastname: Han
authors.forename: Duk-Hyun
authors.initials: DH
authors.lastname: Kang
authors.forename: Jae-Kwan
authors.initials: JK
authors.lastname: Song
authors.forename: Jae-Joong
authors.initials: JJ
authors.lastname: Kim
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Neal E
authors.initials: NE
authors.lastname: Fearnot
authors.forename: Seong-Wook
authors.initials: SW
authors.lastname: Park
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
mesh_terms: D002455:Cell Division / Q000187:drug effects; D020099:Coated Materials, Biocompatible / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004343:Drug Implants / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000000981:diagnostic imaging / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects; D018084:Ultrasonography, Interventional
chemical_list: D020099:Coated Materials, Biocompatible; D004343:Drug Implants; D017239:Paclitaxel