Abstract 3220: Bivalirudin Monotherapy Provides Similar One-Year Survival Compared to Heparin plus GP IIb/IIIa Inhibitors in Diabetic Patients with Acute Coronary Syndromes: Results from the Randomized ACUITY Trial
Background: Among diabetic patients with acute coronary syndromes (ACS) in the ACUITY trial, bivalirudin (Biv) monotherapy (Mono) provided similar survival and protection from ischemic events with significantly less major bleeding compared to heparin (unfractionated or enoxaparin) plus GP IIb/IIIa inhibitors (Hep+GPI) at 30 days. Whether this protection from ischemic events persists to one year is unknown.
Methods: In the ACUITY trial, patients with moderate and high risk (ACS) were randomized to Hep+GPI, Biv+gPI, or Biv Mono. We evaluated the impact of treatment group on composite ischemia (death, MI, or unplanned revascularization) and mortality at one year in diabetic patients using Kaplan Meier survival analysis and log rank tests.
Results: Of patients enrolled in the ACUITY trial, 3852 were diabetic (28.1%) and 9857 (71.9%) were non-diabetic. Compared with non-diabetics, diabetics had higher rates of mortality at one year (6.1% vs 3.4%, p<0.001). There was no significant difference in the rate of composite ischemia at one year for diabetic patients who received Biv Mono vs Hep+GPI (19.7% vs 18.9%, p=0.39) or Biv+GPI vs Hep+GPI (20.9% vs 18.9%, p=0.16). Mortality rates for diabetic patients by treatment group are shown below.
Conclusions: In the ACUITY Trial, diabetic patients had lower survival rates at one year than non-diabetics. Among diabetic patients, treatment with Biv Mono resulted in similar rates of composite ischemia and survival at one year compared to those treated with Hep+GPI. Combined with the early reduction in major bleeding, these findings indicate that Biv Mono is a suitable alternative to Hep + GPI for diabetic patients with moderate and high risk ACS.