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