title: Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis.
abstract: OBJECTIVE
  The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.
  
  
  BACKGROUND
  Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown.
  
  
  METHODS
  This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up.
  
  
  RESULTS
  At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%; p = 0.0001) and target lesion revascularization (4.3% vs. 41.7%; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96% vs. 60%; p = 0.005).
  
  
  CONCLUSIONS
  In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA.
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. sh10461@kchnet.or.jp
authors.forename: Seiji
authors.initials: S
authors.lastname: Habara
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kadota
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Goto
authors.forename: Satoki
authors.initials: S
authors.lastname: Fujii
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Harumi
authors.initials: H
authors.lastname: Katoh
authors.forename: Naoki
authors.initials: N
authors.lastname: Oka
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Fuku
authors.forename: Shingo
authors.initials: S
authors.lastname: Hosogi
authors.forename: Akitoshi
authors.initials: A
authors.lastname: Hirono
authors.forename: Takeshi
authors.initials: T
authors.lastname: Maruo
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tanaka
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Shigemoto
authors.forename: Daiji
authors.initials: D
authors.lastname: Hasegawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tasaka
authors.forename: Mana
authors.initials: M
authors.lastname: Kusunose
authors.forename: Suguru
authors.initials: S
authors.lastname: Otsuru
authors.forename: Yoji
authors.initials: Y
authors.lastname: Okamoto
authors.forename: Naoki
authors.initials: N
authors.lastname: Saito
authors.forename: Yuki
authors.initials: Y
authors.lastname: Tsujimoto
authors.forename: Haruki
authors.initials: H
authors.lastname: Eguchi
authors.forename: Koshi
authors.initials: K
authors.lastname: Miyake
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Yoshino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus