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Tirofiban-Enoxaparin Combination Fails to Show Benefit Compared to Heparin in Heart Attack Patients: Presented at AHA

By Ed Susman

CHICAGO, IL -- November 20, 2002 -- Use of a combination of the low molecular weight heparin enoxaparin and the glycoprotein IIb/IIIa inhibitor tirofiban in patients who suffered a heart attack failed to show benefit greater than unfractionated heparin and/or tirofiban.

"The primary objective of demonstrating a 30 percent relative risk reduction was not realized in this challenging high-risk patient population," said Marc Cohen, MD, chief of the division of cardiology at Newark Beth Israel Hospital, in Newark, New Jersey, United States.

The 30-day end point of death, recurrent heart attack or recurrent angina was experienced by 15.4 percent of patients receiving enoxaparin alone, 16.1 percent of patients on enoxaparin and tirofiban, 17.3 percent of patients on unfractionated heparin alone, and 17.2 percent of patients on unfractionated heparin and tirofiban.

The comparison of all patients taking enoxaparin versus all patients on unfractionated heparin showed that 15.7 percent of patients on the low molecular weight heparin experienced an event compared with 17.3 percent of patients on unfractionated heparin. The result was not statistically significant (p=0.471), Dr. Cohen said, but showed a trend that favoured enoxaparin.

"The study showed that tirofiban did not benefit the patients nor did it harm patients," Dr. Cohen said.

In the Treatment with Enoxaparin and Tirofiban in Acute Myocardial Infarction (TETAMI) study presented here November 19 at the 2002 Scientific Sessions of the American Heart Association (AHA), researchers sought to determine if there was a benefit in treating heart attack patients who had slipped passed the early symptom window for therapy with thrombolytic drugs such as tissue plasminogen activator (t-PA).

Researchers enrolled 1,224 patients who had a myocardial infarction with ST-segment elevation and who were no longer eligible for reperfusion therapies because they presented more than 24 hours after onset of symptoms. They were treated with one of the four antithrombotic strategies for two to eight days.

Dr. Cohen said post hoc analyses of the data suggest there could be a role for enoxaparin as an alternative for heparin in non-perfused patients with ST-segment elevation myocardial infarction.

Augustus Grant, MD, professor of medicine at Duke University, in Durham, North Caroline, United States, said the TETAMI trial again showed "that for heart attack patients, the sooner you get to the hospital the greater the benefits you can get from the tools that we have available." He suggested, however, that use of tirofiban -- in the patient population of TETAMI -- did not seem warranted.

The trial was sponsored by Aventis Pharmaceuticals.

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