Document Detail

Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease.
MedLine Citation:
PMID:  19422982     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The aim of this trial was to compare the safety and efficacy of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for treatment of unprotected left main coronary artery (uLMCA) disease. BACKGROUND: Both PES and SES have reduced the risk of restenosis, particularly in high-risk patient and lesion subsets. However, their comparative performance in uLMCA lesions is not known. METHODS: In this randomized study, 607 patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA were enrolled: 302 were assigned to receive a PES (Taxus, Boston Scientific, Natick, Massachusetts) and 305 assigned to receive a SES (Cypher, Cordis, Johnson & Johnson, New Brunswick, New Jersey). The primary end point was the combined incidence of death, myocardial infarction, and target lesion revascularization (TLR) at 1 year. The secondary end point was angiographic restenosis on the basis of the LMCA area analysis at follow-up angiography. RESULTS: At 1 year the cumulative incidence of death, myocardial infarction, or TLR was 13.6% in the PES and 15.8% in the SES group (relative risk [RR]: 0.85, 95% confidence interval [CI]: 0.56 to 1.29, p = 0.44). One patient in the PES group (0.3%) and 2 patients in the SES group (0.7%) experienced definite stent thrombosis (p = 0.57). Mortality at 2 years was 10.7% in the PES and 8.7% in the SES group (RR: 1.14, 95% CI: 0.66 to 1.95, p = 0.64). Angiographic restenosis was 16.0% with PES and 19.4% with SES (RR: 0.82, 95% CI: 0.57 to 1.19, p = 0.30). CONCLUSIONS: Implantation of either PES or SES in uLMCA lesions is safe and effective; both of these drug-eluting stents provide comparable clinical and angiographic outcomes. (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).
Julinda Mehilli; Adnan Kastrati; Robert A Byrne; Olga Bruskina; Raisuke Iijima; Stefanie Schulz; Jürgen Pache; Melchior Seyfarth; Steffen Massberg; Karl-Ludwig Laugwitz; Josef Dirschinger; Albert Schömig;
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  53     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-05-08     Completed Date:  2009-06-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1760-8     Citation Subset:  AIM; IM    
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary
Confidence Intervals
Coronary Angiography
Coronary Artery Disease / drug therapy*,  therapy
Coronary Restenosis / drug therapy*,  therapy
Drug-Eluting Stents*
Immunosuppressive Agents / therapeutic use*
Myocardial Infarction / drug therapy,  therapy
Paclitaxel / therapeutic use*
Platelet Aggregation Inhibitors / therapeutic use
Sirolimus / therapeutic use*
Ticlopidine / analogs & derivatives,  therapeutic use
Tubulin Modulators / therapeutic use*
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Platelet Aggregation Inhibitors; 0/Tubulin Modulators; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel
Comment In:
J Am Coll Cardiol. 2009 May 12;53(19):1769-72   [PMID:  19422983 ]

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