Abstract 3303: Safety and Efficacy of Bivalirudin in Patients with non-ST Elevation Acute Coronary Syndromes Undergoing Medical Management: Results from the Randomized ACUITY Trial
Background: Depending on coronary anatomy, patients presenting with non ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing an invasive strategy are treated either by revascularization or pharmacologic medical management. We sought to compare the safety and efficacy of three different pharmacologic strategies in patients who underwent medical management in the ACUITY trial.
Methods: In ACUITY, 13,819 patients with moderate and high risk NSTE-ACS were randomly assigned to one of three pharmacologic strategies: unfractionated heparin or enoxaparin + a glycoprotein IIb/IIIa inhibitor (Hep+GPI), bivalirudin (BIV) + GPI or bivalirudin monotherapy (BIV), followed by angiography within 72 hours and subsequent treatment. Three 30 day primary endpoints were followed: composite ischemia (death, MI or urgent revascularization), non-CABG major bleeding and net clinical outcomes (composite ischemia + bleeding).
Results: Following angiography, 4,491 patients (32.5%) were triaged to medical management. Compared to patients managed with percutaneous or surgical revascularization, those managed medically were younger, more likely to be female, less likely to have elevated cardiac biomarkers and had more hypertension, prior MI, CABG and PCI. Medically managed patients had lower rates of composite ischemia (3.1% vs. 9.8%, p<0.001) and major bleeding (2.9% vs. 5.5%, p<0.001) than those requiring PCI or CABG. Primary endpoints at 30 days by randomized therapy appear in the table⇓. 30 Day Results for Medically Managed Patients
Conclusion: Medically managed patients with moderate and high risk NSTE-ACS comprise a unique patient cohort, with significantly less major bleeding and ischemic event rates than patients requiring revascularization. By reducing major bleeding, bivalirudin (with or without GPI) improves clinical outcomes in medically managed NSTE-ACS patients compared to Hep+GPI.