title: A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis.
abstract: BACKGROUND
  The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR).
  
  
  METHODS
  This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up.
  
  
  RESULTS
  Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03).
  
  
  CONCLUSIONS
  This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB.
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. Electronic address: sh10461@kchnet.or.jp.
authors.forename: Seiji
authors.initials: S
authors.lastname: Habara
authors.forename: Masashi
authors.initials: M
authors.lastname: Iwabuchi
authors.forename: Naoto
authors.initials: N
authors.lastname: Inoue
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nakamura
authors.forename: Ryuta
authors.initials: R
authors.lastname: Asano
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shiode
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Yuji
authors.initials: Y
authors.lastname: Ikari
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Joji
authors.initials: J
authors.lastname: Hosokawa
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.forename: Jun-ichi
authors.initials: J
authors.lastname: Kotani
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000628:therapy*; D006801:Humans; D007564:Japan; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D008670:Metals; D017239:Paclitaxel