Abstract | BACKGROUND: METHODS: In a randomised open-label trial, patients presenting with ST-elevation myocardial infarction were randomly assigned (1:1) to receive an intravenous bolus of 0·5 mg/kg of enoxaparin or unfractionated heparin before primary PCI. Wherever possible, medical teams travelling in mobile intensive care units (ambulances) selected, randomly assigned (using an interactive voice response system at the central randomisation centre), and treated patients. Patients who had received any anticoagulant before randomisation were excluded. Patients and caregivers were not masked to treatment allocation. The primary endpoint was 30-day incidence of death, complication of myocardial infarction, procedure failure, or major bleeding. The main secondary endpoint was the composite of death, recurrent acute coronary syndrome, or urgent revascularisation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00718471. FINDINGS: 910 patients were assigned to treatment with enoxaparin (n=450) or unfractionated heparin (n=460). The primary endpoint occurred in 126 (28%) patients after anticoagulation with enoxaparin versus 155 (34%) patients on unfractionated heparin (relative risk [RR] 0·83, 95% CI 0·68-1·01, p=0·06). The incidence of death ( enoxaparin, 17 [4%] vs heparin, 29 [6%] patients; p=0·08), complication of myocardial infarction (20 [4%] vs 29 [6%]; p=0·21), procedure failure (100 [26%] vs 109 [28%]; p=0·61), and major bleeding (20 [5%] vs 22 [5%]; p=0·79) did not differ between groups. Enoxaparin resulted in a significantly reduced rate of the main secondary endpoint (30 [7%] vs 52 [11%] patients; RR 0·59, 95% CI 0·38-0·91, p=0·015). Death, complication of myocardial infarction, or major bleeding (46 [10%] vs 69 [15%] patients; p=0·03), death or complication of myocardial infarction (35 [8%] vs 57 [12%]; p=0·02), and death, recurrent myocardial infarction, or urgent revascularisation (23 [5%] vs 39 [8%]; p=0·04) were all reduced with enoxaparin. INTERPRETATION: Intravenous enoxaparin compared with unfractionated heparin significantly reduced clinical ischaemic outcomes without differences in bleeding and procedural success. Therefore, enoxaparin provided an improvement in net clinical benefit in patients undergoing primary PCI. FUNDING: Direction de la Recherche Clinique, Assistance Publique-Hôpitaux de Paris; Sanofi-Aventis.
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Authors | Gilles Montalescot, Uwe Zeymer, Johanne Silvain, Bertrand Boulanger, Marc Cohen, Patrick Goldstein, Patrick Ecollan, Xavier Combes, Kurt Huber, Charles Pollack Jr, Jean-François Bénezet, Olivier Stibbe, Emmanuelle Filippi, Emmanuel Teiger, Guillaume Cayla, Simon Elhadad, Frédéric Adnet, Tahar Chouihed, Sébastien Gallula, Agnès Greffet, Mounir Aout, Jean-Philippe Collet, Eric Vicaut, ATOLL Investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 378
Issue 9792
Pg. 693-703
(Aug 20 2011)
ISSN: 1474-547X [Electronic] England |
PMID | 21856483
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Elsevier Ltd. All rights reserved. |
Chemical References |
- Anticoagulants
- Enoxaparin
- Fibrinolytic Agents
- Platelet Aggregation Inhibitors
- Heparin
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Topics |
- Aged
- Angioplasty, Balloon, Coronary
- Anticoagulants
(administration & dosage)
- Electrocardiography
- Enoxaparin
(administration & dosage)
- Female
- Fibrinolytic Agents
(administration & dosage)
- Heparin
(administration & dosage)
- Humans
- Injections, Intravenous
- Male
- Middle Aged
- Myocardial Infarction
(mortality, physiopathology, therapy)
- Platelet Aggregation Inhibitors
(therapeutic use)
- Recurrence
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