title: A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions.
abstract: OBJECTIVE
  This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention.
  
  
  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.
  
  
  METHODS
  Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté 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.
  
  
  RESULTS
  Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberté stents. In-stent LLL was significantly lower in Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority <0.0001, p superiority <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.
  
  
  CONCLUSIONS
  The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus Carbostent and Taxus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions [NEXT]; NCT01373502).
authors.affiliation: Service de Cardiologie, Centre Hospitalier Universitaire Rangueil, Toulouse, France. carrie.didier@chu-toulouse.fr
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.forename: Jacques
authors.initials: J
authors.lastname: Berland
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Karl Eugen
authors.initials: KE
authors.lastname: Hauptmann
authors.forename: Mathias
authors.initials: M
authors.lastname: Vrolix
authors.forename: Roberto
authors.initials: R
authors.lastname: Violini
authors.forename: Alain
authors.initials: A
authors.lastname: Dibie
authors.forename: Sergio
authors.initials: S
authors.lastname: Berti
authors.forename: Eric
authors.initials: E
authors.lastname: Maupas
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel