Document Detail


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).
MedLine Citation:
PMID:  20170878     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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).
Authors:
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:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  3     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-22     Completed Date:  2011-06-02     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  203-12     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00046228
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MeSH Terms
Descriptor/Qualifier:
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:
0/Anticoagulants; 0/Enoxaparin; 0/Fibrinolytic Agents; 9005-49-6/Heparin
Comments/Corrections
Comment In:
JACC Cardiovasc Interv. 2010 Feb;3(2):213-4   [PMID:  20170879 ]

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