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European Heart Journal 1990 11(8):730-739;
Copyright © 1990 by the European Society of Cardiology.
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© 1990 The European Society of Cardiology

A randomized dose-ranging study of rt-PA in acute myocardial infarction. Effects on coronary patency and fibrinolytic parameters

R. W. KOSTER*,, R. VAN STRALEN*, A. J. MCNEILL{dagger}, A. A. J. ADGEY{dagger}, K. A. A. FOX{ddagger}, D. DYMOND||, C. SPONZILLI||, D. JEWITT§, C. BUCKNALL§, C. KLUFT and A. F. COHEN**

*Academic Medical Centre, Amsterdam the Netherlands
{dagger}Royal Victoria Hospital Belfast
{ddagger}University Hospital Cardiff
||St Bartholomew's Hospital London
§King's College Hospital London
Gaubius Institute TNO Leiden, the Netherlands
**The Wellcome Research Laboratories Beckenham, Kent, U.K.

Received 31 August 1989; revised 5 February 1989; .

Address for correspondence: Rudolph W. Koster, M.D., Academic Medical Centre, Department of Cardiology, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

Abstract

This study was designed to examine the relationships between dose of Wellcome two-chain recombinant tissue type-plasminogen activator (BWrt-PA) and coronary patency and fibrinolytic parameters in acute myocardial infarction (AMI). In an open randomized study, patients with AMI (determined by ECG) and symptoms of less than 4 h duration without contraindications for fibrinoly tic therapy were treated with rt-PA in nominal doses of 20 (7.7 MU), 50 (14.8–29.6 MU) or 1OOmg (29.6–48.2 MU) administered over 90 min followed by intravenous heparin. Coronary patency was determined by coronary arteriography of the infarct-related artery and haematological parameters (fibrinogen, plasminogen, a2-antiplasmin and fibrin (ogen) degradation products) measured at 90 min.

Coronary patency increased in a dose-related manner to 53% (95% C.I. 37–69%) in the 100 mg/90 min group. Logistic regression demonstrated a relationship between dose (in MU kg–1) and coronary patency. Fibrinogen at 90 m was reduced to 74 (61.5–86.4%) of the pooled plasma standard in the nominal 100 mg group. Patients with a higher predosefibrinogen had higher reductions of fibrinogen. Serious bleeding occurred in three (3%) patients, and no intracranial bleeds were reported.

B W rt-PA produces dose-related patency of the coronary arteries with moderate, dose-related reduction in fibrinogen.

Key Words: Thrombolysis • acute myocardial infarction • recombinant tissue-type plasminogen activator • coronary patency • fibrinogen • plasminogen • fibrinogen degradation products


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