This Article Full Text Full Text (PDF) CME: Take the course for this article: Circulation: September 15, 2009, Volume 120, Number 11 All Versions of this Article: 120/11/964    most recent CIRCULATIONAHA.108.830372v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Google Scholar Articles by Di Lorenzo, E. Articles by De Luca, G. PubMed PubMed Citation Articles by Di Lorenzo, E. Articles by De Luca, G. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Medline Plus Health Information Angioplasty Heart Attack Hazardous Substances DB TAXOL Related Collections Catheter-based coronary interventions: stents Acute myocardial infarction Related Article

(Circulation. 2009;120:964-972.)
© 2009 American Heart Association, Inc.

Interventional Cardiology

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

Emilio Di Lorenzo, MD, PhD; Rosario Sauro, MD; Attilio Varricchio, MD, PhD; Giannignazio Carbone, MD; Giuliana Cortese, PhD; Michele Capasso, MD; Tonino Lanzillo, MD; Fiore Manganelli, MD; Ciro Mariello, MD; Francesco Siano, MD; Maria Rosaria Pagliuca, MD; Giovanni Stanco, MD; Giuseppe Rosato, MD; Giuseppe De Luca, MD, PhD

From the Division of Cardiology, S.G. Moscati, Avellino (E.D.L., R.S., A.V., G. Carbone, M.C., T.L., F.M., C.M., F.S., M.R.P., G.S., G.R.); Department of Statistical Sciences, University of Padova, Padova (G. Cortese); and Division of Cardiology, Ospedale "Maggiore della Carità," and Centro di Biotecnologie per la Ricerca Medica Applicata, Eastern Piedmont University, Novara (G.D.L.), Italy.

Correspondence to Emilio Di Lorenzo, MD, Division of Cardiology, Laboratory of Cardiac Catheterization and Interventional Cardiology, S.G. Moscati Hospital, Via Otranto, 83100 Avellino, Italy. E-mail emidilorenzo{at}tin.it

Received January 24, 2009; accepted July 6, 2009.

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.

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Clinical Summaries
Circulation 2009 120: 919-920. [Extract] [Full Text]