title: Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.
abstract: OBJECTIVE
  Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.
  
  
  RESULTS
  One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period.
  
  
  CONCLUSIONS
  The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).
authors.affiliation: Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, 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 / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011474:Prosthesis Design; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel