Document Detail


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.
MedLine Citation:
PMID:  19720939     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. METHODS AND 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:
Emilio Di Lorenzo; Rosario Sauro; Attilio Varricchio; Giannignazio Carbone; Giuliana Cortese; Michele Capasso; Tonino Lanzillo; Fiore Manganelli; Ciro Mariello; Francesco Siano; Maria Rosaria Pagliuca; Giovanni Stanco; Giuseppe Rosato; Giuseppe De Luca
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Retracted Publication     Date:  2009-08-31
Journal Detail:
Title:  Circulation     Volume:  120     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-09-15     Completed Date:  2009-10-08     Revised Date:  2010-03-31    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  964-72     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiology, Laboratory of Cardiac Catheterization and Interventional Cardiology, S.G. Moscati Hospital, Via Otranto, Avellino 83100, Italy. emidilorenzo@tin.it
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary*
Coronary Angiography
Disease-Free Survival
Drug-Eluting Stents* / statistics & numerical data
Electrocardiography
Female
Follow-Up Studies
Humans
Immunosuppressive Agents / administration & dosage
Incidence
Kaplan-Meiers Estimate
Male
Metals
Middle Aged
Myocardial Infarction / mortality,  radiography,  therapy*
Paclitaxel / administration & dosage*
Sirolimus / administration & dosage*
Treatment Outcome
Tubulin Modulators / administration & dosage
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Metals; 0/Tubulin Modulators; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Comments/Corrections
Retraction In:
Circulation. 2010 Mar 2;121(8):e228   [PMID:  20194873 ]

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


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