The incidence of stent thrombosis (ARC definite/probable) at 2 years was also similar between the 2 treatment groups (4.6% in the Angiomax group vs. 4.3% in the UFH plus GP IIb/IIIa inhibitor group).ACUITYACUITY was a large multicenter, prospective, open-label, 3-arm trial designed to establish the optimal antithrombotic treatment regimens in patients with UA/NSTEMI undergoing early invasive management. 30-Day Results

Bivalirudin monotherapy provided superior net clinical outcomes compared to any heparin regimen with GP IIb/IIIa inhibitor (10.1% vs 11.7%) at 30 days. The incidence of ACUITY scale major bleeding (non-CABG) was decreased significantly by 47% in the bivalirudin monotherapy group vs the heparin with GP IIb/IIIa inhibitor group (3.0% vs 5.7%) at 30 days.1-Year Results

Bivalirudin alone demonstrated no difference in the rates of composite ischemic complications (death, MI, unplanned revascularization for ischemia) versus heparin with GP IIb/IIIa inhibition (16.4% vs 16.3%) at 12 months.REPLACE-2REPLACE-2 was a multicenter, double-blind, triple-dummy randomized clinical trial in patients with low to moderate risk for ischemic complications undergoing PCI.
The most common (≥10%) adverse events of bivalirudin are back pain, pain, nausea, headache, and hypotension.Bivalirudin is classified as Pregnancy Category B.

Pediatric experience
The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity for bivalirudin, based on studies submitted in response to a written request by the FDA to investigate the use of bivalirudin in pediatric patients aged birth to 16-years old. The submission was based on a prospective, open-label, multi-center, single arm study evaluating bivalirudin as a procedural anticoagulant in the pediatric population undergoing intravascular procedures for congenital heart disease. Study outcomes suggest that the pharmacokinetic (PK) and pharmacodynamic (PD) response of bivalirudin in the pediatric population is predictable and behaves in a manner similar to that in adults. Comparative results
Bivalirudin is supported by 7 major randomized trials. These trials include REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2), BAT (Bivalirudin Angioplasty Trial), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy Trial), and HORIZONS AMI (Harmonizing Outcomes With Revascularization and Stents in AMI). A total of 25,000 patients with a low to high risk for ischemic complications undergoing PCI were evaluated. Bivalirudin with or without provisional GPIIb/IIIa demonstrated similar angiographic and procedural outcomes and improved clinical outcomes when compared with heparin plus GPIIb/IIIa.HORIZONS-AMIHORIZONS AMI was a prospective, randomized, open-label, double-arm multicenter trial in STEMI patients undergoing primary PCI.