New, Improved Combination Treatment Option Proves Safe for Acute Coronary Syndrome Patients

A recent study presented at the European Society of Cardiology Meetings indicates that two new forms of blood-thinning medication, low-molecular-weight heparin and powerful new antiplatelet drugs, can be safely combined in patients with heart disease.

Dr. James J. Ferguson, associate director of clinical cardiology research at the Texas Heart Institute at St. Luke's Episcopal Hospital and principal investigator of the study, announced the results of the National Investigators Collaborating on Enoxaparin (NICE 3) clinical trials at the European Society of Cardiology's 22nd Annual Congress, this year held in Amsterdam, the Netherlands.

Patients with blood clots in the vessels that supply blood to the heart - a condition known as acute coronary syndrome, frequently suffer from recurring chest pain (unstable angina) and are susceptible to certain forms of heart attack. The condition is commonly treated with a combination of anticoagulant medications including standard heparin and new antiplatelet drugs called GP IIb/IIIa antagonists. Very often, an invasive procedure in the cardiac catheterization laboratory, such as angioplasty, or even surgery, may be necessary in these patients. While standard heparin has traditionally been used to reduce the risk of blood clots, newer forms of low molecular weight heparin--such as enoxaparin, commercially known as Lovenox--appear to be a significant improvement over the older form of therapy. They are easier to administer, do not require laboratory monitoring or frequent dose adjustments; and are often more effective than standard heparin.

"A number of studies suggest that the low molecular weight heparins are a better therapy for patients with acute coronary syndromes," says Dr. Ferguson, "but physicians must become comfortable with their safety in the context of other new therapies such as coronary intervention and new antiplatelet drugs. Our findings should allay physician concerns and support entirely new management strategies for physicians to improve patient care."

The NICE 3 study was a non-randomized, observational safety evaluation of 661 patients at 46 investigative sites in North America. Patients enrolled in the study received aspirin, enoxaparin, and a GP IIb/IIIa antagonist. If patients required angiography, enoxaparin and the Ilb/IlIa antagonist were continued, whereas in the past, these patients might have had to be switched to standard heparin. The evaluation focused on the incidence of major bleeding for patients who did not undergo coronary artery bypass grafting (CABG) surgery, and also looked at the incidence of heart attack, also known as myocardial infarction, and the need for urgent revascularization. The results of NICE 3 compared very favorably to previous studies involving Ilb/Illa antagonists. The incidence of non-CABG major bleeding was 1.9 percent. At 30 days, the incidence of death was 1.3 percent, heart attack 4.4 percent and urgent revascularization, 5.3 percent.

"The promising results of this study establish an important foundation for future advances in the 'standard of care, and set the stage for more comprehensive studies that will evaluate these sort of combination therapies," says Dr. Ferguson.

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©2006 Texas Medical Center

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