Document Detail


The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial.
MedLine Citation:
PMID:  19539255     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: 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:
Emilio Di Lorenzo; Giuseppe De Luca; Rosario Sauro; Attilio Varricchio; Michele Capasso; Tonino Lanzillo; Fiore Manganelli; Ciro Mariello; Francesco Siano; Maria Rosaria Pagliuca; Giovanni Stanco; Giuseppe Rosato
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-22     Completed Date:  2009-08-27     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  515-23     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00759850
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*,  mortality
Cardiovascular Agents / administration & dosage*
Coronary Angiography
Drug-Eluting Stents*
Female
Humans
Kaplan-Meier Estimate
Male
Metals*
Middle Aged
Myocardial Infarction / mortality,  radiography,  therapy*
Paclitaxel / administration & dosage*
Patient Selection
Platelet Aggregation Inhibitors / therapeutic use
Prospective Studies
Prosthesis Design
Recurrence
Risk Assessment
Sirolimus / administration & dosage*
Stents*
Thrombosis / etiology,  prevention & control
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 0/Metals; 0/Platelet Aggregation Inhibitors; 33069-62-4/Paclitaxel; W36ZG6FT64/Sirolimus

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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