title: TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation.
abstract: BACKGROUND
  The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR).
  
  
  RESULTS
  The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length < or =30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization [TLR]). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent).
  
  
  CONCLUSIONS
  Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.
authors.affiliation: Division of Cardiology, 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: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Guido
authors.initials: G
authors.lastname: Selbach
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Manfred
authors.initials: M
authors.lastname: Staberock
authors.forename: Pim
authors.initials: P
authors.lastname: de Feyter
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Muzaffer
authors.initials: M
authors.lastname: Degertekin
authors.forename: Jurgen M R
authors.initials: JM
authors.lastname: Ligthart
authors.forename: Clemens
authors.initials: C
authors.lastname: Disco
authors.forename: Bianca
authors.initials: B
authors.lastname: Backx
authors.forename: Mary E
authors.initials: ME
authors.lastname: Russell
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000517:prevention & control / Q000628:therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D004343:Drug Implants / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D003692:Delayed-Action Preparations; D004343:Drug Implants; D011108:Polymers; D017239:Paclitaxel