title: Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry.
abstract: BACKGROUND
  Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice.
  
  
  METHODS
  Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization.
  
  
  RESULTS
  A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR.
  
  
  CONCLUSIONS
  This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.
authors.affiliation: CHU Rennes, Service de Cardiologie et Maladies Vasculaires, Rennes, F-35000, France; INSERM, U1099, Rennes, F-35000, France; Université de Rennes 1, LTSI, Rennes, F-35000, France.
authors.forename: V
authors.initials: V
authors.lastname: Auffret
authors.affiliation: Clinique Saint Hilaire Rouen, Service de Cardiologie, F-76000, France.
authors.forename: J
authors.initials: J
authors.lastname: Berland
authors.affiliation: Polyclinique Les Fleurs Ollioules, Service de Cardiologie, F-83190, France.
authors.forename: P
authors.initials: P
authors.lastname: Barragan
authors.affiliation: Medical Scientific Affairs, B. Braun Melsungen AG, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Waliszewski
authors.affiliation: Département de Cardiologie Centre Hospitalo, Universitaire Nord, Marseille, F-13915, France.
authors.forename: L
authors.initials: L
authors.lastname: Bonello
authors.affiliation: Centre Hospitalier de Pau, Service de Cardiologie, F-64000, France.
authors.forename: N
authors.initials: N
authors.lastname: Delarche
authors.affiliation: Centre Hospitalier Universitaire Angers, Service de Cardiologie, F-49100, France.
authors.forename: A
authors.initials: A
authors.lastname: Furber
authors.affiliation: Centre Hospitalier de Chartres, Service de Cardiologie, F-28018, France.
authors.forename: F
authors.initials: F
authors.lastname: Albert
authors.affiliation: CHU de Toulouse, Service de Cardiologie, F-31059, France.
authors.forename: D
authors.initials: D
authors.lastname: Carrié
authors.affiliation: CHU de Rouen, Service de Cardiologie, F-76000, France.
authors.forename: H
authors.initials: H
authors.lastname: Eltchaninoff
authors.affiliation: Centre Hospitalier Avignon, Service de Cardiologie, F-84000, France.
authors.forename: M
authors.initials: M
authors.lastname: Pansieri
authors.affiliation: Hôpital Albert Schweitzer, Colmar, Service de Cardiologie, F-68024, France.
authors.forename: M
authors.initials: M
authors.lastname: Schneeberger
authors.affiliation: CHU de Montpellier, Service de Cardiologie, F-34090, France.
authors.forename: C
authors.initials: C
authors.lastname: Piot
authors.affiliation: Centre Hospitalier de Bourges, Service de Cardiologie, F-18000, France.
authors.forename: P
authors.initials: P
authors.lastname: Marcollet
authors.affiliation: CHU Rennes, Service de Cardiologie et Maladies Vasculaires, Rennes, F-35000, France; INSERM, U1099, Rennes, F-35000, France; Université de Rennes 1, LTSI, Rennes, F-35000, France. Electronic address: marc.bedossa@chu-rennes.fr.
authors.forename: M
authors.initials: M
authors.lastname: Bedossa
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000601:surgery*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D005602:France; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D012042:Registries; D012086:Reoperation; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: Drug-eluting stent in-stent restenosis; Paclitaxel-coated balloon; Target lesion revascularization