Bivalirudin was superior to both heparin plus tirofiban and heparin alone in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI), a multi-center trial has found. Findings from the study are published in the Journal of the American Medical Association.
Earlier multi-center trials have shown that bivalirudin is superior to heparin plus glycoprotein IIb/IIIA inhibitors (GPI), but data from the recent HEAT-PPCI trial showed the priority of heparin monotherapy vs. bivalirudin monotherapy; the study also showed an increased rate of stent thrombosis in patients treated with bivalirudin.
Researchers conducted a multi-center, open-label trial, BRIGHT, that compared bivalirudin alone (n=735) to heparin alone (n=729) and heparin plus tirofiban (n=730) in patients with AMI undergoing PCI. The primary endpoint was 30-day net adverse clinical events (NACE) , a composite of major adverse cardiac and cerebral events (MAACE: all-cause death, reinfarction, ischemia-driven target vessel revascularization, stroke) or any bleeding as defined by the Bleeding Academic Research Consortium (BARC) definition.
NACE occurred in 8.8% of bivalirudin-treated patients vs. 13.2% of heparin-treated patients and 17% of heparin plus tirofiban-treated patients after 30 days. Also, bleeding at 30 days was lower with bivalirudin (4.1%) vs. heparin alone (7.5%) and heparin plus tirofiban (12.3%). There were no statistically significant differences among treatments in the 30-day rates of MACCE, stent thrombosis, nor in acute stent thrombosis.
Bivalirudin significantly improved overall 30-day and one year outcomes compared to both heparin and heparin plus tirofiban in patients with AMI undergoing primary PCI.
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