Document Detail


Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial.
MedLine Citation:
PMID:  11145489     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention, are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. METHODS: We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 microg/kg boluses 10 min apart and a continuous infusion of 2.0 microg/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. FINDINGS: The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). INTERPRETATION: Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment to the bailout situation.
Authors:
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  356     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  2000 Dec 
Date Detail:
Created Date:  2000-12-28     Completed Date:  2001-01-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  2037-44     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Disease / drug therapy*,  therapy
Cross-Over Studies
Double-Blind Method
Female
Humans
Male
Middle Aged
Peptides*
Platelet Aggregation Inhibitors / therapeutic use*
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
Stents*
Chemical
Reg. No./Substance:
0/Peptides; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/eptifibatide
Comments/Corrections
Comment In:
Lancet. 2001 Dec 8;358(9297):1997   [PMID:  11747953 ]
Erratum In:
Lancet 2001 Apr 28;357(9265):1370

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


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