ACUITY: The Acute Catheterization and Urgent Intervention Triage StrategY Trial:
The PCI Subanalysis

• Summary
• Trial Design
• Clinical Outcomes

Summary

• Angiomax® (bivalirudin) results in ACUITY patients undergoing percutaneous coronary intervention (PCI) were consistent with REPLACE-2 findings¹
• Demonstrated in ACUITY, the largest clinical trial to evaluate ANGIOMAX in patients with moderate- and high-risk acute coronary syndromes (ACS) undergoing an early invasive strategy (N = 13,800)¹
• 56% of patients underwent PCI¹
  • 76% of the PCI population had elevated cardiac biomarkers or ST-segment deviation²
  • 27% of the PCI population had diabetes²
• Proven efficacy with ANGIOMAX alone versus heparin(s) + glycoprotein (GP) IIb/IIIa in preventing ischemic events at 30 days (8.8% vs 8.2%; P = .45)^2,3
• Significant 49% reduction in non-coronary artery bypass graft (CABG) major bleeding in the ANGIOMAX alone group vs the heparin(s) + GP IIb/IIIa group (3.5% vs 6.8%; P <.001)^2,3

Trial Design

Study Design — First Randomization⁴

• Moderate- and high-risk unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI) patients undergoing an invasive strategy
• Prospective, randomized, active-controlled trial

^*Stratified by preangiography thienopyridine use or administration
^†Heparin(s) = unfractionated heparin (UFH) or enoxaparin
 NSTEMI = non-ST-segment elevation myocardial infarction; R = randomized
^‡ANGIOMAX monotherapy = ANGIOMAX monotherapy with GP IIb/IIIa reserved for severe breakthrough ischemia and procedural complications during PCI

CKMB = creatine kinase-MB; CrCl = creatinine clearance; INR = international normalized ratio; LMWH = low-molecular-weight heparin; STEMI = ST-segment elevation myocardial infarction; UFH = unfractionated heparin.

• The safety and effectiveness of ANGIOMAX have not been established in patients with ACS who are not undergoing PCI.

Clinical End Points

• Net clinical outcome
  • Death, myocardial infarction (MI), unplanned revascularization for ischemia or non-CABG major bleeding
• Composite ischemia
  • Death, MI, or unplanned revascularization for ischemia
• Non-CABG major bleeding
  • Intracranial, intraocular, or retroperitoneal bleeding
  • Access site bleed requiring intervention/surgery
  • Hematoma >5 cm
  • Hemoglobin (Hgb) >4 g/dL without an overt source
  • Hgb >3 g/dL with an overt source
  • Reoperation for bleeding
  • Any blood transfusions

Baseline Characteristics in PCI Subpopulation²

P = Not significant for all values.

Baseline High-Risk Features²

																																																																Heparin(s) + GP IIb/IIIa (n = 2,561)																														ANGIOMAX alone (n = 2,619)
Cardiac biomarker (MB or troponin)																																																																65.1%																														66.4%
- Troponin																																																																64.8%																														66.2%
ST-segment ∆ >1 mm																																																																35.4%																														35.3%
Cardiac biomarker or ST-segment ∆																																																																76.8%																														77.0%

Clinical Outcomes

ACUITY 30-day outcomes for PCI subset^1,2,3

Heparin(s) = UFH or enoxaparin
^†Important Bleeding Definitions

^* IN THE ACUITY ANGIOMAX-ALONE GROUP: 91% of PCI patients

received ANGIOMAX monotherapy.¹

• Results in the ANGIOMAX + GP llb/llla arm (n = 2,609) vs heparin(s) + GP IIb/IIIa²
  
  —Net clinical outcome, 14.9% (P = .10)
  —Composite ischemia, 9.3% (P = .16)
  —Major bleed, 7.5% (P = .32)

Safety

ANGIOMAX Reduces Bleeding Regardless of Scale

• On both the ACUITY and TIMI scales, ANGIOMAX resulted in significantly less bleeding than heparin(s) + GP IIb/IIIa
• Significant 49% reduction in non-CABG major bleeding in the ANGIOMAX alone group vs the heparin(s) + GP IIb/IIIa group(3.5% vs 6.8%; P <.001)^2,3

ACUITY 30-Day Bleeding Outcomes in PCI Subset^2,3

Safety Considerations

ANGIOMAX with provisional use of glycoprotein IIb/IIIa inhibitor is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. The most common (10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration. Please see complete prescribing information.