Bivalirudin Beats Heparin for PCI Patients in BRIGHT Study
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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