title: Impact of drug-eluting stents on distal vessels.
abstract: BACKGROUND
  Previous studies have not addressed vessel response >5 mm distal to the stent edge. Therefore, we investigated the impact of paclitaxel-eluting stents (PES) versus bare metal stents (BMS) on distal vessels in the serial intravascular ultrasound substudies of TAXUS IV, V, and VI.
  
  
  RESULTS
  TAXUS IV, V, and VI were double-blind, randomized, multicenter, controlled trials comparing PES with BMS. In their intravascular ultrasound substudies, 103 patients (54 BMS, 49 PES) had intravascular ultrasound data ≥10 mm distal to the stent both postprocedure and at 9 months follow-up. Baseline characteristics were similar between the 2 groups. Multilevel modeling was used to account for the variation between patients and within patients among distal segments. Effect of stent type, time, and their interaction was tested using a mixed effect model controlling for distal segments. Postprocedure lumen and vessel were not significantly different between PES versus BMS; however, lumen (P=0.006) and vessel (P=0.0001) were significantly reduced for BMS at 9-month follow-up but not for PES. Conversely, there was a significant plaque increase from postprocedure to 9-month follow-up for PES (P=0.0008) but not for BMS. These vessel responses were statistically consistent among 0- to 5-mm versus 5- to 10-mm versus 10- to 15-mm segments distal to the stent in both groups.
  
  
  CONCLUSIONS
  PES use was associated with plaque increase from baseline to 9-month follow-up >5 mm distal to the stent along with positive remodeling, whereas BMS use was associated with negative remodeling and no plaque increase. These vessel responses were consistent in 5-mm long subsegments: 0 to 5 mm versus 5 to 10 mm versus 10 to 15 mm distal to the stent.
  
  
  BACKGROUND
  URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.
authors.affiliation: Washington Hospital Center, Washington, DC 20010, USA.
authors.forename: Kohei
authors.initials: K
authors.lastname: Wakabayashi
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turco
authors.forename: Rajbabu
authors.initials: R
authors.lastname: Pakala
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: Sameer
authors.initials: S
authors.lastname: Desale
authors.forename: Ana
authors.initials: A
authors.lastname: Laynez-Carnicero
authors.forename: Rafael
authors.initials: R
authors.lastname: Romaguera
authors.forename: Gabriel
authors.initials: G
authors.lastname: Sardi
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D054059:Coronary Occlusion / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018084:Ultrasonography, Interventional; D014945:Wound Healing
chemical_list: D017239:Paclitaxel