title: A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis.
abstract: OBJECTIVE
  This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).
  
  
  BACKGROUND
  Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.
  
  
  METHODS
  We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.
  
  
  RESULTS
  Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.
  
  
  CONCLUSIONS
  In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.
authors.affiliation: Unidad de Hemodinámica, Servicio de Cardiología Intervencionista, Instituto Cardiovascular, University Hospital San Carlos, Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain. falf@hotmail.com
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: Javier
authors.initials: J
authors.lastname: Zueco
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.forename: Ramón
authors.initials: R
authors.lastname: Mantilla
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.forename: José R
authors.initials: JR
authors.lastname: López-Minguez
authors.forename: Juan
authors.initials: J
authors.lastname: Angel
authors.forename: José M
authors.initials: JM
authors.lastname: Augé
authors.forename: Manuel
authors.initials: M
authors.lastname: Gómez-Recio
authors.forename: César
authors.initials: C
authors.lastname: Morís
authors.forename: Ricardo
authors.initials: R
authors.lastname: Seabra-Gomes
authors.forename: María J
authors.initials: MJ
authors.lastname: Perez-Vizcayno
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011174:Portugal / Q000453:epidemiology; D016016:Proportional Hazards Models; D012008:Recurrence; D012086:Reoperation; D012307:Risk Factors; D016037:Single-Blind Method; D013030:Spain / Q000453:epidemiology; D015607:Stents / Q000009:adverse effects* / Q000592:standards; D016019:Survival Analysis; D016896:Treatment Outcome