title: Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.
abstract: BACKGROUND
  Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty.
  
  
  RESULTS
  Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization.
  
  
  CONCLUSIONS
  This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.
authors.affiliation: Division of Cardiology, Laboratory of Cardiac Catheterization and Interventional Cardiology, S.G. Moscati Hospital, Via Otranto, Avellino 83100, Italy. emidilorenzo@tin.it
authors.forename: Emilio
authors.initials: E
authors.lastname: Di Lorenzo
authors.forename: Rosario
authors.initials: R
authors.lastname: Sauro
authors.forename: Attilio
authors.initials: A
authors.lastname: Varricchio
authors.forename: Giannignazio
authors.initials: G
authors.lastname: Carbone
authors.forename: Giuliana
authors.initials: G
authors.lastname: Cortese
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
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Luca
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015994:Incidence; 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*; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
chemical_list: D007166:Immunosuppressive Agents; D008670:Metals; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus