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Treatment With Bivalirudin Alone Gets Equivalent Results as Heparins or GP IIb/IIIa Inhibitors: Presented at ACC

By Ed Susman

NEW ORLEANS, LA -- March 28, 2007 -- Monotherapy with the thrombin inhibitor bivalirudin (Angiomax) has similar results as other strategies in patients undergoing percutaneous coronary interventions, researchers said here at the 56^th annual meeting of the American College of Cardiology (ACC).

"In patients with and high-risk acute coronary syndromes undergoing an early invasive strategy with the use of GPIIb/IIIa inhibitors, bivalirudin is an acceptable substitute for either unfractionated heparin or enoxaparin," said Gregg Stone, MD, professor of medicine at Columbia University, New York, New York, United States.

Dr. Stone presented the 1-year results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial in an oral presentation on March 26^th.

The ACUITY trial randomised 13,819 patients with moderate-risk and high-risk acute coronary syndrome into 3 research arms. After 1-year of follow-up, the 3 study arms were as follows: 4,516 patients received heparin or enoxaparin and GP IIb/IIIa inhibitors; 4,502 patients received bivalirudin and GP IIb/IIIa inhibitors; and 4,521 patients received bivalirudin alone.

The average age of the patients was 63 years; about 70% of the patients were men.

In the ischaemic composite endpoint, no significant differences were seen between the groups in rates of mortality, myocardial infarction or unplanned revascularisation (16.4% with heparins; 16.5% with bivalirudin and GP IIb/IIIa inhibitors; 16.4% with bivalirudin alone).

Myocardial infarction rates were not significantly different among the 3 groups at 1 year (6.2% of patients on heparins; 6.4% on bivalirudin plus GP IIb/IIIa inhibitors; 7.1% on bivalirudin alone). None of the differences reached statistical significance.

Neither was there any statistical significance among the groups in patients who required unplanned revascularisation (8.6% vs 9.5% vs 8.9%, respectively).

There were 524 deaths in the cohort after 1 year, Dr. Stone reported, but the differences between the arms were again not significant (4.4% vs 4.2% vs 3.8%, respectively).


[Presentation title: A Prospective, Randomized Trial of Bivalirudin in Acute Coronary Syndromes: One Year Results From the ACUITY Trial. Abstract 2414-5]

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