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

Objectives: We compared the efficacy of the Cypher Select (TM) (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus (TM) or Taxus Liberte (TM) 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. (J Interven Cardiol 2012;25:586595)