Abstract 2651: Major Bleeding is Associated with Increased Short-Term Mortality and Ischemic Complications in Non-ST Elevation Acute Coronary Syndromes: The ACUITY Trial
Background: Major bleeding remains a frequent complication of non-ST elevation acute coronary syndromes (NSTE-ACS). We evaluated the impact of major bleeding on short-term mortality and ischemic events in patients with moderate and high-risk NSTE-ACS undergoing an invasive strategy.
Methods: The ACUITY Trial was a prospective, randomized comparison of:
bivalirudin alone (BIV),
heparin or enoxaparin + glycoprotein inhibition (H+GPI), and
BIV + glycoprotein inhibition (BIV+GPI) in moderate and high-risk NSTE-ACS.
We evaluated patients with major bleeding (non-CABG-related), defined as: intracranial, intraocular, or retroperitoneal bleed; access site bleed with intervention; hematoma ≥5 cm; hemoglobin drop ≥3g/dL with source or ≥4g/dL without source; or transfusion.
Results: Of 13819 patients, 644 (4.7%) had major bleeding. Patients with major bleeding were older, more likely to be female, of lower body weight, and have diabetes, hypertension, and impaired creatinine clearance. They were more likely to present with elevated cardiac biomarkers or as high-risk (ST-changes or elevated cardiac biomarkers). In contrast, they were less likely to use tobacco and have prior PCI (p<0.05 for all). Major bleeding was less frequent in patients treated with BIV vs. H+GPI (3.0% vs. 5.7%, p<0.0001) and BIV vs. BIV+GPI (3.0% vs. 5.3%, p<0.0001). Patients with major bleeding had higher 30-day mortality and ischemic event rates (Table⇓).
Conclusions: Major bleeding is associated with a dramatic increase in short-term mortality and ischemic event rates in patients with NSTE-ACS undergoing an invasive strategy. The use of bivalirudin alone results in lower rates of major bleeding compared to glycoprotein inhibitor-based strategies. Prevention of major bleeding is essential in order to minimize short-term mortality and ischemic outcomes in patients with NSTE-ACS.