title: Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: insights from serial intravascular ultrasound analysis in the TAXUS II study.
abstract: BACKGROUND
  The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents.
  
  
  RESULTS
  TAXUS II is a randomized, double-blind trial comparing slow-release (SR) and moderate-release (MR) TAXUS stents with bare-metal control stents (BMSs). One hundred sixty-one event-free patients (SR, 43; MR, 41; and BMS, 77) underwent serial intravascular ultrasound (IVUS) analysis after the procedure and at 6 months and 2 years. At 2 years, neointimal responses continued to be significantly suppressed in the SR and MR groups when compared with the BMS group (BMS, 1.49+/-1.12 mm2; SR, 0.94+/-0.76 mm2 [P=0.004]; and MR, 1.06+/-0.90 mm2 [P=0.02]). Between 6 months and 2 years, the BMS group showed compaction of the neointima (Delta, -0.22+/-1.05 mm2 [P=0.08]). In contrast, both the SR and MR groups exhibited an increase (Delta SR, 0.30+/-0.76 mm2 (P=0.01); MR, 0.41+/-0.94 mm2 [P=0.009]). Between 6 months and 2 years, the initial increase in plaque outside the stent regressed in the BMS and SR groups to levels comparable to those after the procedure, whereas expansive remodeling partially regressed in the MR group (Delta between after the procedure and 2 years BMS, -0.34+/-1.28 mm2 [P=0.05]; SR, -0.02+/-1.40 mm2 [P=0.93]; MR, 0.32+/-1.56 mm2 [P=0.27]).
  
  
  CONCLUSIONS
  The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Jiro
authors.initials: J
authors.lastname: Aoki
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Banning
authors.forename: Janusz
authors.initials: J
authors.lastname: Drzewiecki
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Zmudka
authors.forename: Francois
authors.initials: F
authors.lastname: Schiele
authors.forename: Mary E
authors.initials: ME
authors.lastname: Russell
authors.forename: Joerg
authors.initials: J
authors.lastname: Koglin
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D049109:Cell Proliferation / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D015607:Stents / Q000009:adverse effects*; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology*; D018084:Ultrasonography, Interventional
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011108:Polymers; D017239:Paclitaxel