title: One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry.
abstract: BACKGROUND
  Even in the drug-eluting stent (DES) era treatment of in-stent restenosis (ISR) is still a relatively common problem for which a satisfactory solution is yet to be found. We wished to assess the efficacy of a new paclitaxel-coated drug-eluting balloon (DEB) in the treatment of these lesions.
  
  
  METHODS
  In this prospective multicenter registry 126 patients with ISR, treated with a new paclitaxel-eluting balloon (3.0 μg/m(2) balloon surface area), were included. All lesions were predilated using conventional balloon angioplasty. The DEB was inflated for a minimum of 60 seconds. Dual antiplatelet therapy was recommended for at least 1 month. The only exclusion criteria were acute STEMI and cardiogenic shock.
  
  
  RESULTS
  Thirty-three percent of patients were diabetic and 51% presented acutely. Interestingly, 48% had ISR of DES, 54% had ISR in a small vessel, and 29% involved bifurcation lesions. The pattern of ISR was focal in 59% and the most treated artery was the left anterior descending artery (LAD). Angiographic success was 96%. In 2 centers, repeat angiography was performed in 79% and restenosis observed in 6 patients (17.6%). MACE rate at a median of 12 (6-13) months was 16.7% (4.0% cardiac death, 4.0% MI, and 12.0% TLR). There was only 1 probable thombotic event (ARC). As compared with BMS-ISR, patients with DES-ISR were more often diabetic (40 vs. 28%) and had more re-restenosis (TLR 14.8 vs. 9.2%).
  
  
  CONCLUSIONS
  In a real-world population, treatment of ISR (including 48% DES-ISR) with this DEB provides good mid-term results with 12% TLR at 1 year, especially in ISR pattern IC (9% MACE).
authors.affiliation: Interventional Cardiology Unit, Hospital del Mar, Barcelone, Spain. beavaquerizo@yahoo.es
authors.forename: Beatriz
authors.initials: B
authors.lastname: Vaquerizo
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
authors.forename: Faustino
authors.initials: F
authors.lastname: Miranda-Guardiola
authors.forename: Vanesa
authors.initials: V
authors.lastname: Martínez
authors.forename: Joan
authors.initials: J
authors.lastname: Antoni Gómez-Hospital
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.forename: Eduardo
authors.initials: E
authors.lastname: Fernández
authors.forename: José
authors.initials: J
authors.lastname: Ramón Rumoroso
authors.forename: Francisco
authors.initials: F
authors.lastname: Bosa
authors.forename: Imanol
authors.initials: I
authors.lastname: Otaegui
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation* / Q000379:methods; D000925:Anticoagulants / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D016001:Confidence Intervals; D017023:Coronary Angiography / Q000295:instrumentation*; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D013030:Spain; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000972:Antineoplastic Agents, Phytogenic; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin