Document Detail

Incidence and predictors of bleeding events after fibrinolytic therapy with fibrin-specific agents: a comparison of TNK-tPA and rt-PA.
MedLine Citation:
PMID:  11728145     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European heart journal     Volume:  22     ISSN:  0195-668X     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2001 Dec 
Date Detail:
Created Date:  2001-11-30     Completed Date:  2002-02-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  2253-61     Citation Subset:  IM    
Copyright Information:
Copyright 2001 The European Society of Cardiology.
Department of Cardiology, University of Leuven, Leuven, Belgium.
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MeSH Terms
Age Factors
Alberta / epidemiology
Body Weight
California / epidemiology
Cerebral Hemorrhage / chemically induced,  epidemiology
Double-Blind Method
Drug Administration Schedule
Europe / epidemiology
Fibrinolytic Agents / administration & dosage,  adverse effects*
Hemorrhage / chemically induced*,  epidemiology*
Infusions, Intravenous
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*
Reg. No./Substance:
0/Fibrinolytic Agents; EC 3.4.21.-/TNK-tissue plasminogen activator; EC Plasminogen Activator
Comment In:
Eur Heart J. 2001 Dec;22(24):2221-3   [PMID:  11728139 ]

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

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