Abstract 2649: Bivalirudin Monotherapy Improves 30 Day Clinical Outcomes In Diabetics With Acute Coronary Syndrome (ACS). Report From The ACUITY Trial
Objective: The ACUITY trial, in which 13,819 patients with moderate or high risk acute coronary syndrome (ACS) were prospectively randomized to heparin (unfractionated or enoxaparin) plus IIb/IIIa inhibition (Hep + GPI), Bivalirudin (Bival) + GPI or Bival monotherapy, demonstrated that Bival monotherapy results in superior net clinical outcomes. Whether these results apply to high risk patients with diabetes is unknown.
Methods: We evaluated the impact of diabetes on 30-day net clinical outcomes (composite ischemia: death, MI and unplanned ischemic revascularization, and bleeding), overall and by antithrombotic strategy.
Results: The ACUITY trial enrolled 3852 diabetic patients (27.9%) and 9857 non-diabetic patients (71.3%). Compared with non-diabetics, diabetics had significantly higher rates of net clinical adverse outcomes (12.8% vs. 10.5%, p<0.001), composite ischemia (8.6% vs. 7.2%, p=0.004) and major bleeding (5.7% vs. 4.2%, p<0.001) at 30 days. Diabetics treated with bivalirudin monotherapy had statistically significant improvements in net clinical outcomes, with less major bleeding and similar rates of ischemia (Table⇓).
Conclusion: Diabetes is associated with higher event rates including net clinical outcome, composite ischemia and bleeding in ACS. Compared with Hep + GPI, the use of bivalirudin monotherapy in diabetic patients results in statistically superior net clinical outcomes and less major bleeding with similar protection from ischemic events.