New combination therapy could reduce Ischaemia after heart attack

August 23, 2001

N.B. Please note that if you are outside North America the embargo for Lancet press material is 0001hours UK time Friday 24th August 2001.

The treatment of acute heart attack requires combination of several therapies. Fibrinolytic agents given together with aspirin and unfractionated heparin often fail to restore coronary artery bloodflow. Frans Van de Werf and colleagues from Gasthuisberg University, Leuven, Belgium, did an exploratory trial to identify whether specific combinations with newer antithrombotic agents might provide clinical benefit. The aim of the study was to compare the efficacy and safety of three antithrombotic therapies with the fibrinolytic agent tenecteplase.

6095 patients (from 575 hospitals in 26 countries) with acute heart attack of less than six hours were randomly assigned one of three combinations: full-dose tenecteplase and enoxaparin (a low-molecular-weight heparin) for a maximum of 7 days (enoxaparin group); half-dose tenecteplase with weight-adjusted low-dose unfractionated heparin and a 12-hour infusion of abciximab ,a glycoprotein IIb/IIIa inhibitor of platelet aggregation,(abciximab group); or full-dose tenecteplase with weight-adjusted unfractionated heparin for 48 hours(unfractionated heparin reference group.) The primary endpoints were the composites of death within 30 days, recurrence of heart attack in hospital, or ischaemia in hospital. A further endpoint of intracranial bleeding or other bleeding complications was added to assess therapeutic safety.

There were significantly fewer endpoints in the enoxaparin and abciximab groups than in the unfractionated heparin group (11.4% and 11.1% compared with 15.4%); Similar differences between groups were found when the combined efficacy plus safety outcome was assessed (13.7% and 14.2% compared with 17%)

Frans Van de Werf comments: "The tenecteplase plus enoxaparin or abciximab regimens studied here reduce the frequency of ischaemic complications of an acute heart attack. Taking into account efficacy and safety, the combination of full-dose tenecteplase and prolonged subcutaneous administration of enoxaparin emerged as the best treatment in this trial. Because of additional advantages such as the ease of administration and the lack of need for monitoring of anticoagulation, this combination should be regarded as an attractive alternative pharmacological reperfusion strategy deserving further study."
Contact: Professor Frans Van de Werf,Department of Cardiology, Gasthuisberg University Hospital, Herestraat 49, Leuven, B-3000, Belgium; T) 32-16-34-34-72; F) 32-16-34-34-67, E)


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