title: One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.
abstract: OBJECTIVE
  We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES.
  
  
  BACKGROUND
  Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR.
  
  
  METHODS
  Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months.
  
  
  RESULTS
  281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES.
  
  
  CONCLUSIONS
  In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES.
authors.affiliation: Institut Cardiovasculaire Paris-Sud, Massy, France. b.chevalier@icps.com.fr
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Robert
authors.initials: R
authors.lastname: Moulichon
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.forename: Philippe
authors.initials: P
authors.lastname: Brunel
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Metzger
authors.forename: Michel
authors.initials: M
authors.lastname: Pansieri
authors.forename: Didier
authors.initials: D
authors.lastname: Carrie
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
authors.forename: Kristel
authors.initials: K
authors.lastname: Wittebols
authors.forename: Christian
authors.initials: C
authors.lastname: Spaulding
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage; D020123:Sirolimus / Q000008:administration & dosage*
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus