1. ACUITY: Death, MI, revascularization for ischemia, or major bleeding by 30 days
11.7
10.1
11.8 5 10 15 %
Heparin +
GPI IIb/IIIa
Bivalirudin +
GPI IIb/IIIa
Bivalirudin
alone
p = for superiority of bivalrudin alone vs. hep+GPI
p < for non-inferiority of hep+GPI vs. bival+GPI
Stone GW, et al. N Engl J Med 2006;355:

2. Primary Endpoint Measures (ITT) — 30 Days UFH/Enoxaparin + GPI vs
Primary Endpoint Measures (ITT) — 30 Days UFH/Enoxaparin + GPI vs. Bivalirudin Alone
Primary Endpoint
Bivalirudin Alone
UFH/Enoxaparin + GPI
p Value
Noninferior
Superior
Net clinical outcome
10.1%
11.7%
< 0.001
0.015
Ischemic composite
7.8%
7.3%
0.01
0.32
Major bleeding
3.0%
5.7%
GPI = glycoprotein IIb/IIIa inhibitor; ITT = intention to treat; UFH = unfractionated heparin.
Presented at ACC.07 and Stone GW et al. N Engl J Med 2006;355:

3. Kaplan-Meier Curves for Mortality in Patients With or Without Major Bleeding
Manoukian S et al. J Am Coll Cardiol 2007;49:

4. ACUITY Trial Treatment Strategy
UFH or Enoxaparin + GPI
Bivalirudin + GPI
Bivalirudin Alone
PCI (%)
2,561
(55.6)
2,609
(56.7)
2,619
(56.8%)
CABG Surgery (%)
549
(11.9)
499
(10.8)
491
(10.6)
Medical Management (%)
1,493
(32.4)
1,496
(32.5)
1,502
(32.6)
UFH = unfractionated heparin; GPI = glycoprotein IIb/IIIa inhibitor; PCI = percutaneous coronary intervention;
CABG = coronary artery bypass graft. Stone GW et al. N Engl J Med 2006;355:

5. 1-Year ACUITY Trial Results PCI Cohort
In moderate- to high-risk ACS patients undergoing PCI,
bivalirudin alone vs. heparin + GP IIb/IIIa inhibitor led to:
Significant ↓bleeding at 30 days with bivalirudin alone
Comparable composite endpoint of ischemia/mortality at 1 year
Mortality at 1 year not dependent on timing of clopidogrel
In patients already on heparin, switching to bivalirudin is safe and effective, leading to similar reductions in major bleeding (~50% ) and 1-year outcomes as bivalirudin alone
PCI patients with major bleed experience significantly longer LOS (5 vs. 3 days; p <0.0001) than patients without major bleeds
A strong association between early bleeding and late mortality
ESC ‘07
ACS = acute coronary syndrome; GP = glycoprotein; LOS = length of stay; PCI = percutaneous coronary intervention.

6. 1-Year ACUITY Trial Conclusion
These results suggest bivalirudin monotherapy should be the preferred adjunctive antithrombotic strategy in moderate- and high-risk acute coronary syndrome patients undergoing percutaneous coronary intervention and add to the evidence on the relationship between early bleeding and long-term outcome.