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Credit: Bill Branson

WASHINGTON, DC—The latest results from the BRIGHT trial suggest bivalirudin confers benefits over heparin monotherapy and heparin plus tirofiban for patients with acute myocardial infarction undergoing percutaneous coronary intervention.

Patients who received bivalirudin had a significantly lower incidence of net adverse clinical events (NACE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, stroke, or any bleeding, both at 30 days and at 1 year.

Bivalirudin conferred a lower risk of bleeding at both time points as well.

However, there were no significant differences between the treatment arms with regard to stent thrombosis or major adverse cardiac and cerebral events (MACCE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, or stroke.

Yaling Han, MD, of the General Hospital of Shenyang Military Region in China, presented these data at TCT 2014.

The BRIGHT trial included 2194 patients who had acute myocardial infarction and were eligible for emergency percutaneous coronary intervention. They were randomized to receive bivalirudin alone (n=735), heparin alone (n=729), or heparin plus tirofiban (n=730).

The primary endpoint was NACE at 30 days. Secondary endpoints were NACE at 1 year, any bleeding at 30 days and 1 year, and MACCE at 30 days and 1 year. Safety endpoints were thrombocytopenia at 30 days and stent thrombosis at 30 days and 1 year.

Bivalirudin was superior to both heparin monotherapy and heparin plus tirofiban in reducing the primary composite endpoint. At 30 days, NACE had occurred in 8.8%, 13.2%, and 17.0% of patients, respectively (P<0.001).

Bivalirudin was also superior with regard to bleeding at 30 days. Bleeding occurred in 4.1% of patients in the bivalirudin arm, 7.5% in the heparin arm, and 12.3% in the heparin-tirofiban arm (P<0.001).

However, there was no significant difference between the arms for the incidence of MACCE at 30 days—5.0%, 5.8%, and 4.9%, respectively (P=0.74). Likewise, there was no significant difference in the rate of stent thrombosis at 30 days—0.6%, 0.9%, and 0.7%, respectively (P=0.77).

There were differences between the arms in the 30-day thrombocytopenia rate, which was 0.1% in the bivalirudin arm, 0.7% in the heparin arm, and 1.1% in the heparin-tirofiban arm (P=0.04 for bivalirudin vs pooled heparin, P=0.12 for bivalirudin vs heparin, P=0.02 for bivalirudin vs heparin-tirofiban).

The differences between the treatment arms at 1 year were similar to those observed at the 30-day mark. Bivalirudin remained significantly superior when it came to NACE and bleeding, but there were no significant differences with regard to MACCE and stent thrombosis.

At 1-year, NACE had occurred in 12.8% of patients in the bivalirudin arm, 16.5% in the heparin arm, and 20.5% in the heparin-tirofiban arm (P<0.001). Bleeding had occurred in 6.3%, 9.9%, and 14.2% of patients, respectively (P<0.001).

The incidence of MACCE was 6.7% in the bivalirudin arm, 7.3% in the heparin arm, and 6.8%, in the heparin-tirofiban arm. And stent thrombosis had occurred in 1.2%, 1.9%, and 1.2% of patients, respectively.

This research was funded by Salubris Pharmaceutical Co. Ltd, makers of bivalirudin, and the National Key Science and Technology R&D project of the 12th Five-Year Plan. ht-logo-end


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