PARIS, September 2 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today 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(R) 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 favor 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(R) indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutan
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