title: SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study.
abstract: OBJECTIVE
  This study sought to assess the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an international, multicenter, prospective, large-scale registry study.
  
  
  BACKGROUND
  In small randomized trials, PCB angioplasty was superior to uncoated balloon angioplasty for treatment of bare-metal stent (BMS) and drug-eluting stent (DES) restenosis.
  
  
  METHODS
  Patients treated with SeQuent Please PCBs were included. The primary outcome measure was the clinically driven target lesion revascularization (TLR) rate at 9 months.
  
  
  RESULTS
  At 75 centers, 2,095 patients with 2,234 lesions were included. The TLR rate was 5.2% after 9.4 months. Definite vessel thrombosis occurred in 0.1%. PCB angioplasty was performed in 1,523 patients (72.7%) with DES or BMS restenosis and 572 patients (27.3%) with de novo lesions. The TLR rate was significantly lower in patients with PCB angioplasty for BMS restenosis compared with DES restenosis (3.8% vs. 9.6%, p < 0.001). The TLR rate did not differ for PCB angioplasty of paclitaxel-eluting stent and non-paclitaxel-eluting sten restenosis (8.3% vs. 10.8%, p = 0.46). In de novo lesions (small vessels), the TLR rate was low and did not differ between PCB angioplasty with and without additional BMS implantation (p = 0.31).
  
  
  CONCLUSIONS
  PCB angioplasty in an all-comers, prospective, multicenter registry was safe and confirmed in a large population the low TLR rates seen in randomized clinical trials. PCB angioplasty was more effective in BMS restenosis compared with DES restenosis, with no difference regarding the type of DES.
authors.affiliation: Department of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany. jochen.woehrle@uniklinik-ulm.de
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Mariusz
authors.initials: M
authors.lastname: Zadura
authors.forename: Sven
authors.initials: S
authors.lastname: Möbius-Winkler
authors.forename: Matthias
authors.initials: M
authors.lastname: Leschke
authors.forename: Christian
authors.initials: C
authors.lastname: Opitz
authors.forename: Waqas
authors.initials: W
authors.lastname: Ahmed
authors.forename: Paul
authors.initials: P
authors.lastname: Barragan
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Simon
authors.forename: Graham
authors.initials: G
authors.lastname: Cassel
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D002309:Cardiology / Q000379:methods; D057785:Catheters; D023903:Coronary Restenosis / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel