A Multicenter Randomized Trial Comparing Amphilimus-With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions

作者：Carrie Didier^*; Berland Jacques; Verheye Stefan; Hauptmann Karl Eugen; Vrolix Mathias; Violini Roberto; Dibie Alain; Berti Sergio; Maupas Eric; Antoniucci David; Schofer Joachim

来源：Journal of the American College of Cardiology, 2012, 59(15): 1371-1376.

DOI：10.1016/j.jacc.2011.12.009

• coronary artery disease
• drug-eluting stent(s)
• percutaneous coronary intervention
• randomized controlled trial

Objectives This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberte, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention. %26lt;br%26gt;Background Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain. %26lt;br%26gt;Methods Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberte stents. Primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound was performed in 20% of the patients. All patients will be clinically followed up to 5 years. %26lt;br%26gt;Results Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberte stents. In-stent LLL was significantly lower in Cre8 group (0.14 +/- 0.36 mm vs. 0.34 +/- 0.40 mm, p noninferiority %26lt;0.0001, p superiority %26lt;0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups. %26lt;br%26gt;Conclusions The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberte stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus