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The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment : Results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial

Identifieur interne : 008019 ( Main/Exploration ); précédent : 008018; suivant : 008020

The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment : Results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial

Auteurs : Harvey D. White [Nouvelle-Zélande] ; Richard Gallo [Canada] ; Marc Cohen [États-Unis] ; Ph. Gabriel Steg [France] ; Philip E. Aylward [Australie] ; Christoph Bode [Allemagne] ; Steve Steinhubl [États-Unis] ; Gilles Montalescot [France]

Source :

RBID : Pascal:09-0049445

Descripteurs français

English descriptors

Abstract

Background The STEEPLE trial assessed outcomes of patients undergoing elective percutaneous coronary intervention randomized to receive a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg, n = 2,298) or activated clotting time-adjusted unfractionated heparin (UFH, n = 1,230), stratified according to planned glycoprotein IIb/IIIa inhibitor use. Methods In this subanalysis, we assessed outcomes in patients with renal impairment (creatinine clearance <60 mL/min, n = 659). Results Major bleeding occurred more often in patients with renal impairment compared with those without (2.7% vs 1.5%, P=.04). Enoxaparin was associated with less major bleeding than UFH with normal renal function (0.9% for enoxaparin 0.5 mg/kg or 1.0% for enoxaparin 0.75 mg/kg vs 2.6%, respectively; both P=.01 vs UFH), with a trend toward less major bleeding with impaired renal function (2.6% or 1.8% vs 3.8%, P =.18 for enoxaparin 0.5 mg/kg and P =.47 for 0.75 mg/kg vs UFH). Minor bleeding rates were similar irrespective of renal function or anticoagulation regimen. The incidence of death, nonfatal myocardial infarction, or urgent target-vessel revascularization was similar between patients with and without renal impairment (5.7% vs 6.5%, P =.45). In patients with renal impairment, event rates were 6.2% or 5.3% with enoxaparin vs 5.6% with UFH (P = nonsignificant). Target anticoagulation levels were achieved 4 to 5 times more often with enoxaparin compared with UFH in patients with normal and impaired renal function (both P<.0001). Conclusions A single bolus of enoxaparin was associated with similar ischemic events and a trend for less major bleeding compared with UFH in patients with renal impairment undergoing percutaneous coronary intervention. Enoxaparin can be administered safely without dose adjustment in these patients.


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<title xml:lang="en" level="a">The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment : Results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial</title>
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<region type="region">Île-de-France</region>
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<sZ>8 aut.</sZ>
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<term>Angioplasty</term>
<term>Cardiology</term>
<term>Cardiovascular disease</term>
<term>Circulatory system</term>
<term>Complication</term>
<term>Coronary artery</term>
<term>Efficiency</term>
<term>Elective</term>
<term>Enoxaparin sodium</term>
<term>Evaluation</term>
<term>Human</term>
<term>Instrumentation therapy</term>
<term>International</term>
<term>Intravenous administration</term>
<term>Randomization</term>
<term>Renal failure</term>
<term>Result</term>
<term>Safety</term>
<term>Toxicity</term>
<term>Use</term>
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<term>Insuffisance rénale</term>
<term>Pathologie de l'appareil circulatoire</term>
<term>Utilisation</term>
<term>Voie intraveineuse</term>
<term>Enoxaparine sodique</term>
<term>Electif</term>
<term>Angioplastie</term>
<term>Artère coronaire</term>
<term>Homme</term>
<term>Résultat</term>
<term>Sécurité</term>
<term>Complication</term>
<term>Toxicité</term>
<term>Efficacité</term>
<term>International</term>
<term>Randomisation</term>
<term>Evaluation</term>
<term>Appareil circulatoire</term>
<term>Cardiologie</term>
<term>Traitement instrumental</term>
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<div type="abstract" xml:lang="en">Background The STEEPLE trial assessed outcomes of patients undergoing elective percutaneous coronary intervention randomized to receive a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg, n = 2,298) or activated clotting time-adjusted unfractionated heparin (UFH, n = 1,230), stratified according to planned glycoprotein IIb/IIIa inhibitor use. Methods In this subanalysis, we assessed outcomes in patients with renal impairment (creatinine clearance <60 mL/min, n = 659). Results Major bleeding occurred more often in patients with renal impairment compared with those without (2.7% vs 1.5%, P=.04). Enoxaparin was associated with less major bleeding than UFH with normal renal function (0.9% for enoxaparin 0.5 mg/kg or 1.0% for enoxaparin 0.75 mg/kg vs 2.6%, respectively; both P=.01 vs UFH), with a trend toward less major bleeding with impaired renal function (2.6% or 1.8% vs 3.8%, P =.18 for enoxaparin 0.5 mg/kg and P =.47 for 0.75 mg/kg vs UFH). Minor bleeding rates were similar irrespective of renal function or anticoagulation regimen. The incidence of death, nonfatal myocardial infarction, or urgent target-vessel revascularization was similar between patients with and without renal impairment (5.7% vs 6.5%, P =.45). In patients with renal impairment, event rates were 6.2% or 5.3% with enoxaparin vs 5.6% with UFH (P = nonsignificant). Target anticoagulation levels were achieved 4 to 5 times more often with enoxaparin compared with UFH in patients with normal and impaired renal function (both P<.0001). Conclusions A single bolus of enoxaparin was associated with similar ischemic events and a trend for less major bleeding compared with UFH in patients with renal impairment undergoing percutaneous coronary intervention. Enoxaparin can be administered safely without dose adjustment in these patients.</div>
</front>
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