title: The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty.
  
  
  BACKGROUND
  Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients.
  
  
  METHODS
  We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months.
  
  
  RESULTS
  From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively).
  
  
  CONCLUSIONS
  This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850).
authors.affiliation: Division of Cardiology, Ospedale SG Moscati, Avellino, Italy. emidilorenzo@tin.it
authors.forename: Emilio
authors.initials: E
authors.lastname: Di Lorenzo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Luca
authors.forename: Rosario
authors.initials: R
authors.lastname: Sauro
authors.forename: Attilio
authors.initials: A
authors.lastname: Varricchio
authors.forename: Michele
authors.initials: M
authors.lastname: Capasso
authors.forename: Tonino
authors.initials: T
authors.lastname: Lanzillo
authors.forename: Fiore
authors.initials: F
authors.lastname: Manganelli
authors.forename: Ciro
authors.initials: C
authors.lastname: Mariello
authors.forename: Francesco
authors.initials: F
authors.lastname: Siano
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Pagliuca
authors.forename: Giovanni
authors.initials: G
authors.lastname: Stanco
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosato
mesh_terms: D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel; D020123:Sirolimus