| Incidence and predictors of bleeding events after fibrinolytic therapy with fibrin-specific agents: a comparison of TNK-tPA and rt-PA. | |
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MedLine Citation:
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PMID: 11728145 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Fibrinolytic therapy increases the risk of bleeding events. TNK-tPA (tenecteplase) is a variant of rt-PA with greater fibrin specificity and reduced plasma clearance that can be given as a single bolus. We compared the incidence and predictors of bleeding events after treatment with TNK-tPA and rt-PA. METHODS AND RESULTS: In the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT)-2 trial, 16 949 patients with acute myocardial infarction were randomly assigned a single weight-adjusted bolus of TNK-tPA or a 90-min infusion of rt-PA. A total of 4.66% of patients in the TNK-tPA group experienced major non-cerebral bleeding, in comparison with 5.94% in the rt-PA group (P=0.0002). This lower rate was associated with a significant reduction in the need for blood transfusion (4.25% vs 5.49%, P=0.0003) and was consistent across subgroups. Independent risk factors for major bleeding were older age, female gender, lower body weight, enrolment in the U.S.A. and a diastolic blood pressure <70 mmHg. Females at high risk (age >75 years and body weight <67 kg) were less likely to have major bleeding when treated with TNK-tPA even after other risk factors were taken into account. A total of 0.93% of patients in the TNK-tPA and 0.94% of patients in the rt-PA group experienced an intracranial haemorrhage. Female patients >75 years of age who weighed <67 kg tended to have lower rates of intracranial haemorrhage when treated with TNK-tPA (3/264, 1.14% vs 8/265, 3.02%). CONCLUSIONS: The increased fibrin specificity and single bolus administration of TNK-tPA do not increase the risk of intracranial haemorrhage but are associated with less non-cerebral bleeding, especially amongst high-risk patients. |
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Authors:
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F Van de Werf; H V Barron; P W Armstrong; C B Granger; S Berioli; G Barbash; K Pehrsson; F W Verheugt; J Meyer; A Betriu; R M Califf; X Li; N L Fox; |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: European heart journal Volume: 22 ISSN: 0195-668X ISO Abbreviation: Eur. Heart J. Publication Date: 2001 Dec |
Date Detail:
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Created Date: 2001-11-30 Completed Date: 2002-02-14 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8006263 Medline TA: Eur Heart J Country: England |
Other Details:
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Languages: eng Pagination: 2253-61 Citation Subset: IM |
Copyright Information:
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Copyright 2001 The European Society of Cardiology. |
Affiliation:
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Department of Cardiology, University of Leuven, Leuven, Belgium. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Age Factors Aged Alberta / epidemiology Body Weight California / epidemiology Cerebral Hemorrhage / chemically induced, epidemiology Double-Blind Method Drug Administration Schedule Europe / epidemiology Female Fibrinolytic Agents / administration & dosage, adverse effects* Hemorrhage / chemically induced*, epidemiology* Humans Incidence Infusions, Intravenous Male Middle Aged Multivariate Analysis Myocardial Infarction / prevention & control* North Carolina / epidemiology Partial Thromboplastin Time Risk Factors Sex Factors Tissue Plasminogen Activator / administration & dosage, adverse effects* |
| Chemical | |
Reg. No./Substance:
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0/Fibrinolytic Agents; EC 3.4.21.-/TNK-tissue plasminogen activator; EC 3.4.21.68/Tissue Plasminogen Activator |
| Comments/Corrections | |
Comment In:
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Eur Heart J. 2001 Dec;22(24):2221-3
[PMID:
11728139
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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