| Enoxaparin in primary and facilitated percutaneous coronary intervention A formal prospective nonrandomized substudy of the FINESSE trial (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events). | |
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MedLine Citation:
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PMID: 20170878 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: The aim of this study was to assess the risk-benefit of enoxaparin (Sanofi-Aventis, Paris, France) in primary percutaneous coronary intervention (PCI). BACKGROUND: Randomized studies have demonstrated the superiority of enoxaparin over unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytics. METHODS: In the FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) trial--a double-blind, placebo-controlled study-2,452 patients with STEMI were randomized to primary PCI or facilitated PCI with abciximab alone or with half-dose reteplase. In this prospective FINESSE substudy, centers pre-specified use of either enoxaparin (0.5 mg/kg intravenous [IV], 0.3 mg/kg subcutaneous [SC]) or UFH (40 U/kg IV, 3,000 U maximum) with PCI. A logistic-regression model and a propensity multivariate model, both adjusted for baseline variables, were used to evaluate primary safety and secondary efficacy end points for enoxaparin versus UFH. RESULTS: Enoxaparin was administered to 759 patients and UFH to 1,693 patients. Nonintracranial Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding was not significantly different, but lower nonintracranial TIMI major bleeding was found with enoxaparin (2.6% vs. UFH 4.4%, logistic-regression adjusted odds ratio [OR]: 0.55; 95% confidence interval [CI]: 0.31 to 0.99, p = 0.045), whereas intracranial hemorrhage was similar (0.27% vs. 0.24%, adjusted OR: 1.03; 95% CI: 0.11 to 9.68, p = 0.980). Lower death, myocardial infarction, urgent revascularization, or refractory ischemia through 30 days was also associated with enoxaparin (5.3%) versus UFH (8.0%, adjusted OR: 0.47, 95% CI: 0.31 to 0.72, p = 0.0005) as was all-cause mortality through 90 days (3.8% vs. 5.6%, respectively, adjusted OR: 0.59, 95% CI: 0.35 to 0.99, p = 0.046). End points evaluating the net clinical benefit also significantly favored enoxaparin over UFH. CONCLUSIONS: Enoxaparin seems to be associated with a lower risk of cardiovascular outcomes compared with UFH in patients with STEMI undergoing primary PCI. Confirmation of these findings in a randomized study is warranted. (A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction [Finesse]; NCT00046228). |
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Authors:
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Gilles Montalescot; Stephen G Ellis; Mark A de Belder; Luc Janssens; Olivier Katz; Wladyslaw Pluta; Patrick Ecollan; Michal Tendera; Ad J van Boven; Petr Widimsky; Henning R Andersen; Amadeo Betriu; Paul Armstrong; Bruce R Brodie; Howard C Herrmann; Franz-Josef Neumann; Mark B Effron; Jiandong Lu; Elliot S Barnathan; Eric J Topol; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: JACC. Cardiovascular interventions Volume: 3 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-02-22 Completed Date: 2011-06-02 Revised Date: 2012-08-29 |
Medline Journal Info:
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Nlm Unique ID: 101467004 Medline TA: JACC Cardiovasc Interv Country: United States |
Other Details:
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Languages: eng Pagination: 203-12 Citation Subset: IM |
Copyright Information:
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Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Pitiè-Salpêtrière University Hospital, Paris, France. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00046228 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angioplasty, Balloon, Coronary* Anticoagulants / therapeutic use* Confidence Intervals Coronary Artery Disease / drug therapy*, therapy Enoxaparin / therapeutic use* Female Fibrinolytic Agents / therapeutic use Heparin / therapeutic use* Humans Logistic Models Male Middle Aged Odds Ratio Prospective Studies Risk Factors |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants; 0/Enoxaparin; 0/Fibrinolytic Agents; 9005-49-6/Heparin |
| Comments/Corrections | |
Comment In:
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JACC Cardiovasc Interv. 2010 Feb;3(2):213-4
[PMID:
20170879
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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