title: A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial.
abstract: OBJECTIVE
  We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).
  
  
  BACKGROUND
  Treatment of patients with ISR remains a challenge.
  
  
  METHODS
  The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year.
  
  
  RESULTS
  Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p < 0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p < 0.003).
  
  
  CONCLUSIONS
  In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.
authors.affiliation: Clinico San Carlos University Hospital, Madrid, Spain. falf@hotmail.com
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: Maria-José
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernandez
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.forename: Vicens
authors.initials: V
authors.lastname: Martí
authors.forename: Jose R
authors.initials: JR
authors.lastname: López-Mínguez
authors.forename: Juan
authors.initials: J
authors.lastname: Angel
authors.forename: Ramón
authors.initials: R
authors.lastname: Mantilla
authors.forename: Cesar
authors.initials: C
authors.lastname: Morís
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Raúl
authors.initials: R
authors.lastname: Moreno
authors.forename: Camino
authors.initials: C
authors.lastname: Bañuelos
authors.forename: Alfonso
authors.initials: A
authors.lastname: Suárez
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D020123:Sirolimus