Document Detail

Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data.
MedLine Citation:
PMID:  11830196     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: To obtain more reliable and precise estimates of the effect of direct thrombin inhibitors in the management of acute coronary syndromes, including patients undergoing percutaneous coronary intervention, we undertook a meta-analysis based on individual patients' data from randomised trials comparing a direct thrombin inhibitor (hirudin, bivalirudin, argatroban, efegatran, or inogatran) with heparin. METHODS: We included trials that involved at least 200 patients. The primary efficacy outcome was death or myocardial infarction, and the primary safety outcome was major bleeding. Data from individual trials were combined by use of a modified Mantel-Haenszel method. FINDINGS: In 11 randomised trials, 35,970 patients were assigned up to 7 days' treatment with a direct thrombin inhibitor or heparin and followed up for at least 30 days. Compared with heparin, direct thrombin inhibitors were associated with a lower risk of death or myocardial infarction at the end of treatment (4.3% vs 5.1%; odds ratio 0.85 [95% CI 0.77-0.94]; p=0.001) and at 30 days (7.4% vs 8.2%; 0.91 [0.84-0.99]; p=0.02). This was due primarily to a reduction in myocardial infarctions (2.8% vs 3.5%; 0.80 [0.71-0.90]; p<0.001) with no apparent effect on deaths (1.9% vs 2.0%; 0.97 [0.83-1.13]; p=0.69). Subgroup analyses suggested a benefit of direct thrombin inhibitors on death or myocardial infarction in trials of both acute coronary syndromes and percutaneous coronary interventions. A reduction in death or myocardial infarction was seen with hirudin and bivalirudin but not with univalent agents. Compared with heparin, there was an increased risk of major bleeding with hirudin, but a reduction with bivalirudin. There was no excess in intracranial haemorrhage with direct thrombin inhibitors. INTERPRETATION: Direct thrombin inhibitors are superior to heparin for the prevention of death or myocardial infarction in patients with acute coronary syndromes. This information should prompt further clinical development of direct thrombin inhibitors for the management of arterial thrombosis.
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Publication Detail:
Type:  Comparative Study; Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  359     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  2002 Jan 
Date Detail:
Created Date:  2002-02-06     Completed Date:  2002-02-27     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  294-302     Citation Subset:  AIM; IM    
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MeSH Terms
Angina, Unstable / drug therapy*,  mortality
Antithrombins / therapeutic use*
Glycine / analogs & derivatives*,  therapeutic use
Heparin / therapeutic use
Hirudin Therapy
Hirudins / analogs & derivatives*
Myocardial Infarction / drug therapy*,  mortality
Oligopeptides / therapeutic use
Peptide Fragments / therapeutic use
Pipecolic Acids / therapeutic use
Piperidines / therapeutic use
Randomized Controlled Trials as Topic
Recombinant Proteins / therapeutic use
Survival Rate
Thrombin / antagonists & inhibitors*
Reg. No./Substance:
0/Antithrombins; 0/Hirudins; 0/Oligopeptides; 0/Peptide Fragments; 0/Pipecolic Acids; 0/Piperidines; 0/Recombinant Proteins; 0/inogatran; 105806-65-3/efegatran; 128270-60-0/bivalirudin; 56-40-6/Glycine; 74863-84-6/argatroban; 9005-49-6/Heparin; EC
Comment In:
Lancet. 2002 Aug 10;360(9331):491-2; author reply 492   [PMID:  12241752 ]

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

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