Incidence and predictors of bleeding events after fibrinolytic therapy with fibrin-specific agents. A comparison of TNK-tPA and rt-PA

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-t...

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Bibliographic Details
Published in:European heart journal 2001-12, Vol.22 (24), p.2253-2261
Main Authors: Van de Werf, F., Barron, H.V., Armstrong, P.W., Granger, C.B., Berioli, S., Barbash, G., Pehrsson, K., Verheugt, F.W.A., Meyer, J., Betriu, A., Califf, R.M., Li, X., Fox, N.L.
Format: Article
Language:English
Subjects:
Adult
Age Factors
Aged
Alberta - epidemiology
Body Weight
California - epidemiology
Cerebral Hemorrhage - chemically induced
Cerebral Hemorrhage - epidemiology
Double-Blind Method
Drug Administration Schedule
Europe - epidemiology
Female
Fibrinolysis
Fibrinolytic Agents - administration & dosage
Fibrinolytic Agents - adverse effects
haemorrhage
Hemorrhage - chemically induced
Hemorrhage - epidemiology
Humans
Incidence
Infusions, Intravenous
Male
Medicin och hälsovetenskap
Middle Aged
Multivariate Analysis
myocardial infarction
Myocardial Infarction - prevention & control
North Carolina - epidemiology
Partial Thromboplastin Time
Risk Factors
Sex Factors
thrombolysis
Tissue Plasminogen Activator - administration & dosage
Tissue Plasminogen Activator - adverse effects
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Summary: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, 16949 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 75 years and body weight 75 years of age who weighed
ISSN:0195-668X
1522-9645
DOI:10.1053/euhj.2001.2686