title: Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial.
abstract: OBJECTIVE
  The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.
  
  
  BACKGROUND
  Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.
  
  
  METHODS
  Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.
  
  
  RESULTS
  At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.
  
  
  CONCLUSIONS
  The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.
authors.affiliation: Sanatorio Otamendi, Cardiac Unit, Capital federal, Buenos Aires, Argentina. rodriguezalfredo.e@gmail.com
authors.forename: Alfredo E
authors.initials: AE
authors.lastname: Rodriguez
authors.forename: Cesar F
authors.initials: CF
authors.lastname: Vigo
authors.forename: Alejandro
authors.initials: A
authors.lastname: Delacasa
authors.forename: Juan
authors.initials: J
authors.lastname: Mieres
authors.forename: Carlos
authors.initials: C
authors.lastname: Fernandez-Pereira
authors.forename: Victor
authors.initials: V
authors.lastname: Bernardi
authors.forename: Marcelo
authors.initials: M
authors.lastname: Bettinoti
authors.forename: Alfredo M
authors.initials: AM
authors.lastname: Rodriguez-Granillo
authors.forename: Gaston
authors.initials: G
authors.lastname: Rodriguez-Granillo
authors.forename: Omar
authors.initials: O
authors.lastname: Santaera
authors.forename: Valeria
authors.initials: V
authors.lastname: Curotto
authors.forename: Bibiana
authors.initials: B
authors.lastname: Rubilar
authors.forename: Jorge
authors.initials: J
authors.lastname: Tronge
authors.forename: Igor F
authors.initials: IF
authors.lastname: Palacios
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001118:Argentina; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D019276:Glycocalyx; D006801:Humans; D053208:Kaplan-Meier Estimate; D019344:Lactic Acid; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D017239:Paclitaxel