Abstract 2648: Comparison of Heparin Plus IIb/IIIa Inhibition Versus Bivalirudin With or Without IIb/IIIa Inhibition in Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The ACUITY Trial
Background. Heparin (Hep) and glycoprotein IIb/IIIa inhibitors (GPI) are standard of care for pts with acute coronary syndromes (ACS; unstable angina or NSTEMI) undergoing percutaneous coronary intervention (PCI). Whether bivalirudin (Biv) alone or in combination with GPI offers superior outcomes is unknown.
Methods. In ACUITY, 13,819 pts with moderate and high risk ACS were randomized to Hep (unfractionated or enoxaparin) + GPI, Biv + GPI or Biv monotherapy (mono) with provisional GPI allowed for ischemic complications. Following angiography, pts were treated with PCI (56%), CABG (11%) or medical therapy (33%). Primary 30d endpoints included composite ischemia (death, MI, unplanned revasc), non-CABG major bleeding and net clinical outcomes (ischemia + bleeding).
Results. PCI was performed in 7,789 pts; median age was 63 years, 73% were male, 27% had diabetes and 18% renal insufficiency. Troponins or CKMB were elevated in 65%, and 36% had ST-segment changes. Multivessel PCI was performed in 17%. DES were implanted in 60% and BMS in 37%. In the Biv alone group, GPI was used in 9.1% of pts. Results appear in the Table⇓.
Conclusions. Among moderate and high risk pts with ACS undergoing PCI, compared to either Hep or Biv with GP IIb/IIIa inhibition, a Biv mono strategy (with provisional GPI in <10% of pts) results in similar protection from adverse ischemic events with a marked reduction in major bleeding, minor bleeding and need for blood transfusions.