title: Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.
abstract: BACKGROUND
  The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES.
  
  
  METHODS
  A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization.
  
  
  RESULTS
  Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773).
  
  
  CONCLUSIONS
  In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.
authors: Instituto de Clinicas Urologia Tamanaco, Caracas, Venezuela.
authors: Carlos
authors: C
authors: Calderas
authors: Hospital Centro Medico de Caracas y Hospital Miguel Perez Carreno, Caracas, Venezuela.
authors: Jose Francisco
authors: JF
authors: Condado
authors: Hospital Centro Medico de Caracas y Hospital Miguel Perez Carreno, Caracas, Venezuela.
authors: Jose Antonio
authors: JA
authors: Condado
authors: Instituto de Clinicas Urologia Tamanaco, Caracas, Venezuela.
authors: Alejandra
authors: A
authors: Flores
authors: Medlogics Device Corporation, Santa Rosa, CA, USA.
authors: Amy
authors: A
authors: Mueller
authors: Medlogics Device Corporation, Santa Rosa, CA, USA.
authors: Jack
authors: J
authors: Thomas
authors: Stanford University, Stanford, CA, USA.
authors: Daisaku
authors: D
authors: Nakatani
authors: Stanford University, Stanford, CA, USA.
authors: Yasuhiro
authors: Y
authors: Honda
authors: Stanford University, Stanford, CA, USA.
authors: Katsuhisa
authors: K
authors: Waseda
authors: Stanford University, Stanford, CA, USA. Electronic address: crci-cvmed@stanford.edu.
authors: Peter
authors: P
authors: Fitzgerald
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D049109:Cell Proliferation; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: Coronary artery disease; Drug eluting stent; Paclitaxel eluting stent