Comparison of dual drug-eluting Cilotax stent and paclitaxel-eluting Taxus Liberte stent in native coronary artery lesions

Abstract

Cilotax stent is a new type of drug-eluting stent (DES) designed to increase the antirestenotic performance of the paclitaxel-eluting stent and decrease the risk of stent thrombosis by the incorporation of cilostazol. Therefore, we investigated the safety and efficacy of Cilotax dual DESs and compared their performance to that of paclitaxel-eluting Taxus Liberte. Patients undergoing percutaneous coronary intervention for de novo coronary artery lesions at 2 centers in Korea were randomized to receive Cilotax (n = 55) or Taxus Liberte (n = 56) stents. The primary end point was in-segment late loss at 8 months. The 2 groups had similar baseline characteristics. Cilotax stent was not inferior to Taxus Liberte stent as determined by in-segment late loss (0.28 ± 0.30 vs 0.42 ± 0.45 mm, difference -0.14, 95% confidence interval -0.27 to -0.01, 1-sided p = 0.028 for noninferiority). In-stent late loss was significantly lower in the Cilotax than in the Taxus Liberte group (0.22 ± 0.31 vs 0.50 ± 0.55 mm, p = 0.002). Although in-segment restenosis rate did not differ significantly between the 2 groups (3.8% vs 10.9%, respectively, p = 0.271), in-stent restenosis rate was significantly lower in the Cilotax stent group (0% vs 10.9%, p = 0.027). There was no stent thrombosis at 8 months in either group. Rates of death, myocardial infarction, and any target lesion revascularization at 8 months were 0%, 0%, and 1.9%, respectively, in the Cilotax group and 1.8%, 0% and 3.6%, respectively, in the Taxus Liberte group. In conclusion, the Cilotax stent was safe and effective in decreasing late loss, indicating that this stent represents a promising new type of DES system.