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COMPARATIVE STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
Thrombolysis in myocardial infarction (TIMI): comparative studies of coronary reperfusion and systemic fibrinogenolysis with two forms of recombinant tissue-type plasminogen activator.
Journal of the American College of Cardiology 1987 September
Coronary recanalization rates and changes in plasma proteins of the fibrinolytic system were evaluated with two preparations of recombinant tissue-type plasminogen activator (rt-PA): the early formulation in liquid excipient ("old" rt-PA) and the later lyophilized form ("new" rt-PA). The dose dependency of coronary recanalization and of effects on plasma proteins was evaluated for the new rt-PA. Four groups of patients were studied: Study 1, 80 mg old rt-PA infused intravenously over 3 hours (n = 113); Study A, 80 mg new rt-PA over 3 hours (n = 47); Study B, 100 mg new rt-PA over 3 hours (n = 83); and Study C, 150 mg new rt-PA over 6 hours (n = 62). With equal doses of 80 mg, coronary recanalization rates at 90 minutes of infusion, determined angiographically, averaged 62% (Study 1) and 45% (Study A) with no overlap of 95% confidence limits. Increasing the dose of the new rt-PA to 100 mg, recanalization rates at 90 minutes averaged 71% (Study B), similar to those observed in Study 1. An increase to 150 mg resulted in higher recanalization rates at 30 minutes of infusion, 42% compared with 24% in Study 1 with no overlap of 95% confidence limits, and comparable rates at 90 minutes, 76 versus 62%. A linear trend test indicated a significant relation (p less than 0.01) between the dose of the new rt-PA and the rate of coronary recanalization at 30, 60 and 90 minutes of infusion. The new rt-PA affected plasma proteins of the fibrinolytic system less than the old form. There was a dose-dependent relation (p less than 0.001) in the effect of the new rt-PA on the plasma proteins. The frequency of bleeding complications was similar in the four study groups. These results indicate that the new rt-PA is less potent than the old rt-PA, in relation to both coronary reperfusion and systemic fibrinogenolysis. A higher and longer dosage regimen caused more rapid recanalization with similar effects on fibrinogenolysis.
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