title: Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.
abstract: BACKGROUND
  Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial.
  
  
  RESULTS
  TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA.
  
  
  CONCLUSIONS
  Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Muzaffer
authors.initials: M
authors.lastname: Degertekin
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Charles
authors.initials: C
authors.lastname: Chan
authors.forename: Thomas
authors.initials: T
authors.lastname: Munzel
authors.forename: Jorge
authors.initials: J
authors.lastname: Belardi
authors.forename: Witold
authors.initials: W
authors.lastname: Ruzyllo
authors.forename: Luc
authors.initials: L
authors.lastname: Bilodeau
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Keith
authors.initials: K
authors.lastname: Dawkins
authors.forename: Louis
authors.initials: L
authors.lastname: Roy
authors.forename: Bradley H
authors.initials: BH
authors.lastname: Strauss
authors.forename: Clemens
authors.initials: C
authors.lastname: Disco
authors.forename: Jörg
authors.initials: J
authors.lastname: Koglin
authors.forename: Mary E
authors.initials: ME
authors.lastname: Russell
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control*; D001158:Arteries / Q000000981:diagnostic imaging*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D011108:Polymers / Q000627:therapeutic use; D015607:Stents; D017539:Tunica Intima / Q000473:pathology; D014463:Ultrasonography
chemical_list: D008670:Metals; D011108:Polymers; D017239:Paclitaxel