sanofi-aventis announced that one year findings from the landmark ExTRACT-TIMI 25 and Steeple studies confirm clear net clinical benefit for patients with acute ST-segment elevation myocardial infarction (STEMI) for Lovenox vs Unfractionnated Heparin (UFH).
The ExTRACT-TIMI 25 and Steeple one year results were presented during hotline sessions at the European Society of Cardiology (ESC) Congress in Vienna, Austria.
ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction -- Study 25) trial showed that in patients with STEMI treated with fibrinolysis, at one year, the primary endpoint of death or nonfatal myocardial infarction remained significantly in favour or enoxaparin vs UFH (15.8% vs 17.0% p-0.01). Net clinical benefit (all cause of death / nonfatal MI / nonfatal disabling stroke) was also significantly in favour of enoxaparin vs UFH through one year of follow up (16.0% vs 17.3% p=0.007).
"This was a very large trial with conclusive results at 30 days. The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin as adjunctive anticoagulant therapy to fibrinolysis in the STEMI patient population," noted ExTRACT TIMI 25 principal investigator Dr. Elliott Antman, M.D., senior Investigator TIMI Study Group, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study.
ExTRACT TIMI 25 was a major randomized clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the new Lovenox indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
Steeple (SafeTy and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients) trial one year follow up shows that the composite of all cause death at 1 year and major bleeding was 3.1% for Lovenox 0.5 mg/kg (p=0.06 vs. UFH), 3.4% for Lovenox 0.75 mg/kg (p=0.07 vs. UFH), 3.3% for the two Lovenox arms combined (p=0.03 vs. UFH) and 4.7% for UFH. There were low and statistically similar 1-year death rates in the enoxaparin groups (0.5mg/kg or 0.75 mg/kg) and UFH during and after elective percutaneous intervention (PCI). In addition to patient risk factors, ischemic events and major bleeding were found to be independent predictors of death at 1 year.
Commenting on the results, Dr. Gilles Montalescot who is Professor of Cardiology at the Institute of Cardiology, Hôpital de la Pitié Salpétrière, Institut du Coeur, Paris, France and a member of the Steeple steering committee noted, "The significant reduction in major bleeding and similar efficacy compared with UFH confirms Lovenox is an appropriate anticoagulant for elective PCI."
Lovenox is a unique chemical entity in a class of antithrombotic agents known as lowmolecular weight heparin (LMWH). The no. 1 selling low-molecular weight heparin in the world, Lovenox is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of unfractionated heparin.
Lovenox is the most widely studied LMWH, with 20 years of use in the treatment of 185 million patients in 96 countries. Its clinical applications are linked to its antithrombotic properties. It is used to inhibit clot formation in venous and arterial vessels to prevent potential acute or chronic complications of venous or arterial thrombosis. As with all anticoagulants, the most frequently reported side effect with Lovenox is bleeding. Clinical indications for Lovenox may vary from one country to another.