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J Am Coll Cardiol, 1988; 11:1-11
© 1988 by the American College of Cardiology Foundation
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Thrombolysis in Myocardial Infarction (TIMI) Trial--phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase

AK Rao, C Pratt, A Berke, A Jaffe, I Ockene, TL Schreiber, WR Bell, G Knatterud, TL Robertson, and ML Terrin

Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, Bethesda, Maryland.

Two hundred ninety patients with acute myocardial infarction were treated according to random assignment with an intravenous infusion of either 80 mg of recombinant tissue plasminogen activator (rt-PA) over 3 h or 1.5 million units of streptokinase over 1 h. Patients received an intravenous bolus of heparin (5,000 U [USP]) before pretreatment coronary angiography and a continuous infusion (1,000 U/h) starting 3 h later. The frequency of major and minor hemorrhagic events (33% rt-PA, 31% streptokinase) and associated transfusions (22% rt-PA, 20% streptokinase) were comparable in both groups. More than 70% of bleeding episodes in each group occurred at catheterization or vascular puncture sites. Precipitable fibrinogen levels, measured in plasma samples collected in the presence of a protease inhibitor (aprotinin), declined in rt-PA and streptokinase groups by averages of 26 and 57% at 3 h and by 33 and 58% at 5 h, respectively (rt-PA versus streptokinase, p less than 0.001). At 5 h the plasma plasminogen declined by 57% (rt-PA) and 82% (streptokinase) (p less than 0.001); plasma fibrin(ogen) degradation products were higher in streptokinase-treated patients (244 +/- 12 micrograms/ml, mean +/- SE) than in rt-PA-treated patients (97 +/- 9 micrograms/ml, p less than 0.001). At 27 h, plasma fibrinogen and plasminogen levels were lower and fibrin(ogen) degradation products higher than pretreatment levels in both groups. The frequency of hemorrhagic events was higher in patients with greater changes in plasma factors at 5 h; within treatment groups the levels of fibrin(ogen) degradation products correlated with bleeding complications (p less than 0.005). Thus, in the doses administered, rt-PA induces systemic fibrinogenolysis that is substantially less intense than that induced by streptokinase. The high frequency of bleeding encountered is related to the protocol used, including vigorous anticoagulation, arterial punctures and thrombolytic therapy. These findings emphasize the need for avoidance of invasive procedures and for meticulous care in the selection and management of patients subjected to thrombolytic therapy.


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CirculationHome page
S. R. Steinhubl, S. G. Ellis, K. Wolski, A. M. Lincoff, and E. J. Topol
Ticlopidine Pretreatment Before Coronary Stenting Is Associated With Sustained Decrease in Adverse Cardiac Events : Data From the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) Trial
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The EPILOG Investigators
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Med Decis MakingHome page
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NEJMHome page
The EPIC Investigators
Use of a Monoclonal Antibody Directed against the Platelet Glycoprotein IIb/IIIa Receptor in High-Risk Coronary Angioplasty
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The Search for the Ideal Thrombolytic Agent: Maximize the Benefit and Minimize the Risk
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Hemorrhagic Events during Therapy with Recombinant Tissue-Type Plasminogen Activator, Heparin, and Aspirin for Acute Myocardial Infarction: Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial
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JAMAHome page
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Coronary Thrombolysis for the Elderly?
JAMA, April 3, 1991; 265(13): 1720 - 1723.
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Streptokinase and Recombinant Tissue Plasminogen Activator (rt-PA) Are Equally Effective in Treating Acute Myocardial Infarction
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