title: Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study.
abstract: OBJECTIVE
  We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).
  
  
  BACKGROUND
  Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown.
  
  
  METHODS
  The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points.
  
  
  RESULTS
  At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure.
  
  
  CONCLUSIONS
  In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.
authors.affiliation: University Hospital, Clinico San Carlos, Madrid, Spain. falf@hotmail.com
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: María-José
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernández
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.forename: Vicens
authors.initials: V
authors.lastname: Martí
authors.forename: José R
authors.initials: JR
authors.lastname: López-Mínguez
authors.forename: Juan
authors.initials: J
authors.lastname: Angel
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.forename: César
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: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
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; D015906:Angioplasty, Balloon, Coronary; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000903:Antibiotics, Antineoplastic; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D020123:Sirolimus