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European Heart Journal 1996 17(10):1522-1531;
Copyright © 1996 by the European Society of Cardiology.
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© 1996 The European Society of Cardiology

ESPRIT: a European study of the prevention of reocclusion after initial thrombolysis with duteplase in acute myocardial infarction

A. D. Malcolm, M. Keltai* and M. J. Walsh{dagger}

Glaxo Wellcome Research and Development Beckenham, Kent, UK
*The Hungarian Institute of Cardiology Budapest, Hungary
{dagger}St James's Hospital Dublin, Republic of Ireland

revised 15 January 1996; accepted 15 February 1996.

Dr Alasdair D. Malcolm, Lake House, Copthorne Road, Felbridge, West Sussex RHI9 2QQ, U.K.

Abstract

BACKGROUND: The goal of thrombolytic treatment in acute myocardial infarction is reperfusion of the infarct-related coronary artery. Duteplase is a double-chain recombinant tissue-type plasminogen activator. Its efficacy and safety were evaluated in patients with acute myocardial infarction treated within 4 h of onset of chest pain in this multicentre, open, non-controlled trial.

METHODS AND RESULTS: A total of 273 patients were enrolled and treated with duteplase 0·6 . MU. kg–1 over 4 h, with concomitant oral aspirin and intravenous heparin. Coronary arteriography was performed at 60 min, 90 min and approximately 24 h after the start of duteplase infusion to assess the perfusion grade (TIMI scoring) of the infarct-related coronary artery. Safety was assessed by monitoring patients closely for bleeding and for all other adverse experiences during the 72-h study period. Reinfarction during the study period was also recorded, and deaths at any time during the period in hospital were documented.

TIMI: grade 2 or 3 patency of the infarct-related coronary artery at 90 min was achieved in 70% of the patients and 7% of these ‘patent’ infarct-related coronary arteries had reoccluded by 20 to 36 h. Clinical reinfarction during the 72-h study period was observed in 7%. Total in-hospital mortality was 8%. Serious or life-threatening bleeding occurred in 4% of the patients. There was one haemorrhagic stroke, and this was fatal.

CONCLUSIONS: Weight-adjusted duteplase infusion, together with oral aspirin and intravenous heparin, in acute myocardial infarction resulted in patency of the infarct-related coronary artery and a safety profile comparable to those reported for the other form of tissue-type plasminogen activator, alteplase, However, there remains a problem with reocclusion and reinfarction after initially successful thrombolysis.

(Eur Heart J 1996; 17: 1522–1531)

Key Words: Thrombolysis • acute myocardial infarction • t-PA • duteplase • ateriographic patency • safety


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