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European Heart Journal 1995 16(Supplement D):22-27; doi:10.1093/eurheartj/16.suppl_D.22
Copyright © 1995 by the European Society of Cardiology.
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© 1995 The European Society of Cardiology

Recombinant hirudin and front-loaded alteplase in acute myocardial infarction: Final results of a pilot study HIT-I (hirudin for the improvement of thrombolysis)

U. Zeymer, R. Von Essen, U. Tebbe, H.-R. Michels, A. Jessel, A. Vogt, M. Roth, K.-F. Appel and K.-L. Neuhaus

Medizinische Klinik II, Städtische Kliniken Kassel, Germany

Correspondence: Dr Uwe Zrymer, Städtische Kliniken Kassel, Medizinische Klinik II. Mönchebergstrasse 41–43. D-34125 Kassel, Germany.

Recombinant hirudin, a specific thrombin inhibitor, has been shown to accelerate thrombolysis and reduce reocclusions in experimental models. In a pilot trial recombinant hirudin (HBW 023) was used as an adjunctive therapy to thrombolysis with front-loaded tissue plasminogen activator (t-PA) (100 mg .90 min –1) in 40 patients with acute myocardial infarction whose duration of symptoms was less than 6 h. Patients received a bolus of r-hirudin of 0·07 mg. kg–1 b.w. followed by an infusion of 0·05 mg. kg –1. h–1 over 48 h. Complete patency (TIMI grade 3) of the infarct-related artery at 30, 60 and 90 min after the start of thrombolytic therapy was seen in 38·5% 64·1% and 71·0% of patients, respectively. After 24–48 h, 80% of patients had a complete patent infarct vessel. A very early, complete and sustained patency (TIMI grade 3 at 60 and 90 min and at 24–48 h) was observed in 55% of patients. Reocclusions during the hirudin therapy appeared in six (16·1%) patients, two of whom had a PTCA at 90 min. The only reinfarction tvas seen after 6 h; this was successfully treated with additional thrombolysis. Major bleedings, mostly related to the invusive procedure, were observed in three patients. Spontaneous organ bleedings and intracerebral haemorrhages did not occur. There was one in-hospital death due to a late retroperitoneul bleeding.

In was concluded that, with regard to safety and eficacy, the general feasibility of r-hirudin as adjunctive therapy to thrombolysis with front-loaded t-PA, hus been demonstrated. Subsequently, a dose escalation study (HIT-II) with a sequential design has been started; three doses of r-hirudin, increasing in strength, are being investigated with regard to eficacy and safety.

Key Words: Thrombolysis • acute myocardial infarction • adjunctive therapy • hirudin


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