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In ASSENT-2, treatment with TNKase resulted in a 30-day mortality rate of 6.2%-comparable to Activase® (Alteplase)1
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Mortality in ASSENT-2 was the lowest observed in a major, double-blind, randomized thrombolytic trial for AMI
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At 1 year, mortality rates remained similar between both lytics (9.2% TNKase, 9.1% Activase)2 |
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Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.
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Sinnaeve P, Alexander J, Belmans A, et al. One-year follow-up of the ASSENT-2 trial: a double-blind, randomized comparison of single bolus tenecteplase and front-loaded alteplase in 16,949 patients with ST-elevation acute myocardial infarction. Am Heart J. 2003;146(1);27-32. |
Indication: For use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
Safety Information: TNKase therapy is contraindicated in the following conditions due to an increased risk of bleeding: active internal bleeding, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and severe uncontrolled hypertension.
All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, particularly in elderly patients. In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or percutaneous coronary intervention (PCI) as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate.
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