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| |  ACC: Enoxaparin/rt-PA Combo Equivalent To Unfractionated Heparin/rt-PA For Heart Attack Patients ANAHEIM, CA -- March 14, 2000 -- Results of the HART II (Heparins and Aspirin Reperfusion Therapy) study were presented at the American College of Cardiology 49th Annual Scientific Session by researchers at George Washington University Medical Center. The study compared heart attack patients who received a newer anticoagulant ("blood thinner"), Lovenox(R) (enoxaparin sodium), to patients who received standard unfractionated heparin. Enoxaparin is a low-molecular-weight heparin that is easier to administer, requires less laboratory monitoring and is potentially more cost-effective than the conventional anticoagulant (unfractionated heparin) that has been used in hospitals for decades. The study demonstrated that patients who received enoxaparin in conjunction with an agent that dissolves blood clots (rt-PA, "Activase(R)") achieved equivalent artery patency at 90 minutes as compared with those patients who received rt-PA and standard unfractionated heparin (UFH). In the trial, there was a strong trend toward higher rates of restored artery patency with enoxaparin. Patency at 90 minutes was 80.1 percent for the enoxaparin group versus 75.1 percent for the UFH group. Reocclusion rates within one week also trended strongly in favor of the enoxaparin group (3.1 percent for enoxaparin versus 9.1 percent for UFH). Adverse events such as bleeding, stroke or death were similar for both groups. "The results of HART II demonstrate that enoxaparin can be effectively substituted for standard unfractionated heparin as an adjunct to thrombolytic therapy for the treatment of a heart attack," said Allan M. Ross, MD, Director of the Cardiovascular Research Institute at George Washington University Medical Center and HART II study chairman. "The low-molecular-weight heparin enoxaparin would be a more convenient, and potentially a more cost-effective option than standard heparin, without compromising safety." HART II is an open-label, multicenter, international trial of 400 heart attack patients. At randomization, patients received a dose of weight-adjusted rt-PA (front-loaded method) and aspirin. Patients then were given intravenous unfractionated heparin or the low-molecular-weight heparin enoxaparin. Enoxaparin was administered as an initial IV bolus, followed by subsequent subcutaneous injections at 15 minutes and every 12 hours thereafter for a minimum of 72 hours. One-third of the 1.5 million Americans who suffer a heart attack die each year. According to the World Health Organization in 1996, ischemic heart disease was responsible for the deaths of 7.2 million people worldwide.
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