title: Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.
abstract: BACKGROUND
  Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting.
  
  
  METHODS
  We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events.
  
  
  RESULTS
  Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02).
  
  
  CONCLUSIONS
  Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).
authors.affiliation: Universitätsklinikum des Saarlandes, Homburg/Saar, Germany. bruno.scheller@uniklinikum-saarland.de
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.forename: Christoph
authors.initials: C
authors.lastname: Hehrlein
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Bocksch
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rutsch
authors.forename: Dariush
authors.initials: D
authors.lastname: Haghi
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dietz
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D015607:Stents
chemical_list: D017239:Paclitaxel