Major Bleeding is Associated with Increased 30-Day Mortality and Ischemic Complications in Patients with Non-ST Elevation Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The ACUITY Trial Steven V. Manoukian 1 , Michele D. Voeltz 1 , Frederick Feit 2 , Roxana Mehran 3 , Eugenia Nikolsky 3 , George D. Dangas 3 , Ramin Ebrahimi 4 , A. Michael Lincoff 5 , Spencer B. King, III 6 , Gregg W. Stone 3 1 Emory University School of Medicine, Atlanta, GA 2 New York University School of Medicine, New York, NY 3 Columbia University Medical Center, New York, NY 4 University of California Los Angeles, Los Angeles, CA 5 The Cleveland Clinic, Cleveland, OH
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Major Bleeding is Associated with Increased 30-Day Mortality and Ischemic Complications in Patients with Non-ST Elevation Acute Coronary Syndromes Undergoing.
Background: Major Bleeding in ACS and PCI Major bleeding is a significant complication of acute coronary syndromes (ACS) and percutaneous coronary intervention (PCI). Recent data suggest that major bleeding is associated with an increase in adverse outcomes in ACS and PCI, including mortality. We evaluated the impact of major bleeding on mortality and ischemic events in patients with ACS undergoing PCI from the ACUITY Trial. Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.
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Major Bleeding is Associated with Increased 30-Day Mortality and
Ischemic Complications in Patients with Non-ST Elevation Acute Coronary
Major Bleeding is Associated with Increased Mortality in ACS
Background: OASIS Registry, OASIS-2, and CURE
Major Bleeding is Associated with Increased Mortality in ACS
Eikelboom JW et al. Circulation 2006;114:774-782.Eikelboom JW et al. Circulation 2006;114:774-782.
Methods: The ACUITY Trial
Study Design and Definitions• The ACUITY Trial compared: heparin or
enoxaparin + glycoprotein inhibition (H+GPI), bivalirudin + glycoprotein inhibition (BIV+GPI), and bivalirudin monotherapy (BIV) in 13819 patients with moderate and high-risk NSTE-ACS.
• Major bleeding (non-CABG-related) was defined as: intracranial, intraocular, or retroperitoneal, access site with intervention, hematoma >5cm, Hgb drop >3g/dL with source or >4g/dL without source, transfusion.
Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.
Moderate-high risk
ACS
Methods: The ACUITY Trial (N=13819)
First Randomization
Ang
iogr
aphy
with
in 7
2h
Aspirin in allClopidogrel
dosing and timingper local practice
UFH orEnoxaparin+ GP IIb/IIIa
Bivalirudin+ GP IIb/IIIa
BivalirudinAlone
R*
*Stratified by pre-angiography thienopyridine use or administration
Stone GW et al. AHJ 2004;148:764–75.
Medicalmanagement
PCI
CABG
Moderate and high-risk unstable angina or NSTEMI undergoing an Moderate and high-risk unstable angina or NSTEMI undergoing an invasive strategyinvasive strategy
Moderate and high-risk unstable angina or NSTEMI undergoing an Moderate and high-risk unstable angina or NSTEMI undergoing an invasive strategyinvasive strategy
Methods: The ACUITY Trial (N=13819)
Overall Primary Endpoint Measures for Upstream vs. Deferred IIb/IIIa
Major Bleeding (Non-CABG Related) in ACS Patients Undergoing PCI
• 462 (5.9%) of 7789 patients had major bleeding by 30 days.• Patients with major bleeding were (p<0.05):
– older, female, and had lower body weight, diabetes, hypertension, impaired creatinine clearance, high-risk (ST-changes or elevated biomarkers), and elevated biomarkers.
– less likely to have prior PCI.– more likely to receive a glycoprotein inhibitor, have PCI duration >1h,
sheath dwell time >6h.• Major bleeding was less frequent for:
– Bivalirudin vs. Heparin(s) + GPI (3.5% vs. 6.8%, p<0.0001),– Bivalirudin vs. Bivalirudin + GPI (3.5% vs. 7.5%, p<0.0001).
• Major bleeding was associated with higher 30-day mortality and ischemic event rates.
Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.
Results: The ACUITY Trial PCI Population (N=7789)
Major Bleeding and Baseline CharacteristicsMajor Bleeding(N=462, 5.9%)