title: Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.
abstract: OBJECTIVE
  This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.
  
  
  BACKGROUND
  The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.
  
  
  METHODS
  This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm(2) balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥ 70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.
  
  
  RESULTS
  During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).
  
  
  CONCLUSIONS
  Treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981).
authors.affiliation: Klinik für Innere Medizin, III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany. bruno.scheller@uks.eu
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
authors.forename: Bettina
authors.initials: B
authors.lastname: Kelsch
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: Ulrich
authors.initials: U
authors.lastname: Speck
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality; D057785:Catheters; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel