Document Detail


Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study).
MedLine Citation:
PMID:  18754967     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES. BACKGROUND: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient. METHODS: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively. RESULTS: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26-0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42-0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes. CONCLUSIONS: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.
Authors:
Kishore J Harjai; Pamela Orshaw; Chetan Shenoy; Subasit Acharji; Daniel Sporn; Ali Aboufares; Dwight Stapleton
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  21     ISSN:  1540-8183     ISO Abbreviation:  J Interv Cardiol     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-29     Completed Date:  2009-01-02     Revised Date:  2009-03-04    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  315-24     Citation Subset:  IM    
Affiliation:
Guthrie Clinic, One Guthrie Square, Sayre, Pennsylvania 18840, USA. harjai_kishore@guthrie.org
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials, Phase III as Topic
Coronary Artery Disease / surgery,  therapy*
Coronary Restenosis / prevention & control*
Drug-Eluting Stents*
Female
Humans
Male
Middle Aged
Prospective Studies
Registries
Stents*
Treatment Outcome
Comments/Corrections
Erratum In:
J Interv Cardiol. 2008 Oct;21(5):441

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


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