title: Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis.
abstract: BACKGROUND
  Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.
  
  
  RESULTS
  One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38+/-0.61 mm in the drug-eluting stent group versus 0.17+/-0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15).
  
  
  CONCLUSIONS
  Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.
authors.affiliation: Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Unverdorben
authors.forename: Christian
authors.initials: C
authors.lastname: Vallbracht
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Hubertus
authors.initials: H
authors.lastname: Heuer
authors.forename: Christian
authors.initials: C
authors.lastname: Hengstenberg
authors.forename: Christian
authors.initials: C
authors.lastname: Maikowski
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Werner
authors.forename: Diethmar
authors.initials: D
authors.lastname: Antoni
authors.forename: Franz X
authors.initials: FX
authors.lastname: Kleber
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Bocksch
authors.forename: Matthias
authors.initials: M
authors.lastname: Leschke
authors.forename: Hanns
authors.initials: H
authors.lastname: Ackermann
authors.forename: Michael
authors.initials: M
authors.lastname: Boxberger
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
authors.forename: Ralf
authors.initials: R
authors.lastname: Degenhardt
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control / Q000628:therapy*; 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*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D050257:Tubulin Modulators / Q000008:administration & dosage*
chemical_list: D010975:Platelet Aggregation Inhibitors; D050257:Tubulin Modulators; D017239:Paclitaxel