Enoxaparin and Streptokinase combination is effective for patients with acute myocardial infarction

14-Nov-2000

Rotterdam, The Netherlands, November 13, 2000 -Results from a Phase II trial demonstrate for the first time that combining enoxaparin sodium (Clexane®/Lovenox®) and streptokinase, significantly improves restoration of normal coronary blood flow and improves outcome in patients with acute myocardial infarction. These findings are based on results from the AMI-SK (Acute myocardial infarction - StreptoKinase) study presented today at a Symposium preceding the American Heart Association meeting in New Orleans, Louisiana.

The study of 496 acute myocardial infarction patients showed that the combination of enoxaparin and streptokinase restored normal coronary blood flow in the blocked artery by a relative increase of 22% vs. streptokinase with placebo. In addition, researchers found a better early reperfusion as measured by electrocardiogram (ECG) ST-segment resolution and a relative risk reduction of 36% in the triple endpoint (death, reinfarction and recurrent angina). Overall, these results showed that the enoxaparin/streptokinase combination improves early reperfusion and late patency at day 5-10 over streptokinase with placebo. In addition, the combination group had fewer clinical events suggesting less reocclusion.

"The AMI-SK results are encouraging news for physicians and acute myocardial infarction (AMI) patients because we now have a combination treatment that appears to be more effective and as safe as streptokinase alone," said Professor Maarten L. Simoons, MD, chairman, Steering Committee, from the Thoraxcenter, Erasmus University and University Hospital Rotterdam, The Netherlands. "This is an important therapeutic advance because streptokinase is the most widely used thrombolytic agent worldwide. The efficacy of streptokinase has been well documented in earlier studies (GISSI, ISIS-II). This efficacy is significantly improved by adding enoxaparin. As the standard of care advances, physicians need to be able to safely combine treatments like fibrinolytics (streptokinase) and anticoagulants (enoxaparin). All patients also received aspirin. Such combination therapy is especially important in the field of cardiology where new combinations like this one have the potential to save more lives," said Dr. Simoons.

Study Background

The overall purpose of AMI-SK was to assess the efficacy of subcutaneous enoxaparin as adjunctive therapy to streptokinase. An important new aspect of AMI-SK is the use of enoxaparin instead of unfractionated heparin (the conventional anticoagulant), which has not shown any beneficial effects on mortality when combined with streptokinase, and is not recommended in clinical guidelines. 1,2 An alternative might be combination with more powerful antiplatelet therapy. However, streptokinase in combination with GPIIb/IIIa antagonists has not been shown to be a v

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