The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS.
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Transcript of The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS.
Transfusion is Associated With Increased One-Year
Mortality and Ischemic Events in Patients With ACS: Results
from the ACUITY TrialSteven V. Manoukian, Michele D. Voeltz, Frederick Feit, Sunil V. Rao, Steven
R. Steinhubl, George D. Dangas, Roxana Mehran, and Gregg W. Stone
Emory University School of Medicine, Atlanta, GA; New York University School of Medicine, New York, NY; Duke Clinical Research Institute, Durham, NC;
University of Kentucky, Lexington, KY; Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY
● The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS.
Moderate-high risk
ACS
An
gio
gra
ph
y w
ith
in 7
2h
Aspirin in allClopidogrel
dosing and timingper local practice
UFH orUFH orEnoxaparinEnoxaparin+ GP IIb/IIIa+ GP IIb/IIIa
BivalirudinBivalirudin+ GP IIb/IIIa+ GP IIb/IIIa
BivalirudinBivalirudinAlone Alone
R*
Medicalmanagement
PCI
CABG
STUDY DESIGN
ACUITY Primary Results – 30 Days
7.3%
5.7%
11.7%
7.7%
11.8%
5.3%
3.0%
10.1%
7.8%
Net clinicaloutcome
Compositeischemia
Major bleeding(non-CABG)
30
da
y e
ve
nts
(%
)
UFH/Enox+ GP IIb/IIIa (N=4603)
Bivalirudin+GP IIb/IIIa (N=4604)Bivalirudin alone (N=4612)
PNI = 0.011 PSup = 0.32
PNI <0.001PSup <0.001
PNI <0.001PSup = 0.015
ACUITY Primary Results – 1 Year
0 1 2
0.96 (0.77-1.18)
HR (95% CI)Hazard ratio
±95% CIHazard ratio
±95% CI
Bivalirudin alone betterBivalirudin alone better Heparin + GPI betterHeparin + GPI better
CompositeIschemia
Mortality
1.06 (0.95-1.17)
P-value
0.67
0.29
● Blood product transfusion is an important
complication in ACS patients treated with potent
antithrombotic and antiplatelet agents.● Transfusion is associated with an increase in
adverse outcomes in ACS, including mortality.● In ACUITY, transfusion was defined as the
administration of any non-CABG related blood
product, including whole blood, packed red blood
cells, platelets, or fresh frozen plasma within 30
days. ● We assessed the relationship between transfusion
and rates of 30-day and 1-year ischemic events
and mortality in patients with ACS in the ACUITY
trial.
BACKGROUND & OBJECTIVES
Baseline Characteristics
Transfusion(N=319)
No Transfusion(N=13,500)
P-value
Age (median [range], yrs) 72 (38, 95) 63 (20, 93) <0.0001
Female 56.1 29.5 <0.0001
Weight (median [IQR], kg) 76 (66, 90) 84 (73, 95) <0.0001
Diabetes 43.8 27.7 <0.0001
Hypertension 80.9 66.7 <0.0001
Hyperlipidemia 61.0 57.1 0.18
Current smoker 21.5 29.3 0.003
Prior MI 33.1 31.3 0.49
Prior PCI 35.6 39.0 0.23
Prior CABG 22.0 17.8 0.05
Baseline CrCl <60 mL/min 49.0 18.4 <0.0001
CKMB/Troponin 65.2 59.3 0.04
Transfusion and 30-Day Event Rates
9.4%
2.3%
18.8%
11.3%
29.5%
4.8%7.1%
1.3%
CompositeIschemia
Death MI (all) UnplannedRevasc
30-d
ay e
ven
t ra
tes
Transfusion (N=319) No Transfusion (N=13,500)
P<0.0001 all
Transfusion and 1-Year Event Rates
21.9%
40.1%
15.1%
3.4%
Composite Ischemia Death
1-ye
ar e
ven
t ra
tes
Transfusion (N=319) No Transfusion (N=13,500)
P<0.0001 both
30-Day Transfusion Rates by Treatment
2.7% 2.6%
1.6%
Transfusion
30-D
ay e
ven
t ra
tes
UFH/Enox+GPI (N=4603) Bivalirudin+GPI (N=4604) Bivalirudin alone (N=4612)
P=0.0003
P=0.70
P=0.0003
P=0.70
Baseline Independent Predictors of 30-Day Transfusion
0 1 2 3 4 5
P -valueRR (95% CI)
Heparin(s) + GPI (vs. Bivalirudin)
Hypertension
High -risk (ST / biomarkers)
Female gender
Diabetes
CrCl <60mL/min
Anemia
Age >75 (vs. 55 -75)
Heparin(s) + GPI (vs. Bivalirudin)
Hypertension
High -risk (ST / biomarkers)
Female gender
Diabetes
CrCl <60mL/min
Anemia
Age >75 (vs. 55 -75)
0.0007
0.0241
0.0003
<0.0001
0.0060
<0.0001
<0.0001
0.0006
1.73 (1.26 -2.38)
1.46 (1.05 -2.02)
1.75 (1.30 -2.37)
2.23 (1.74 -2.87)
1.56 (1.21 -2.01)
2.10 (1.57 -2.80)
3.76 (2.92 -4.86)
1.42 (1.06 -1.91)
0.0007
0.0241
0.0003
<0.0001
0.0060
<0.0001
<0.0001
0.0006
1.73 (1.26 -2.38)
1.46 (1.05 -2.02)
1.75 (1.30 -2.37)
2.23 (1.74 -2.87)
1.56 (1.21 -2.01)
2.10 (1.57 -2.80)
3.76 (2.92 -4.86)
1.42 (1.06 -1.91)
Risk ratio ± 95% CIRisk ratio ± 95% CI
Independent Predictors of 1-Year Mortality
Pre-randomization UFH 1.23 (1.00-1.50)
Diabetes 1.60 (1.34-1.91)
30-day major bleed w/out transfusion 1.80 (1.16-2.80)
30-day transfusion 3.95 (2.92-5.33)
30-day MI 2.55 (1.96-3.32)
ECG changes at baseline 1.68 (1.39-2.02)
CKMB/Troponin+ at baseline 1.56 (1.27-1.92)
History of CAD 1.31 (1.07-1.60)
Male 1.62 (1.31-2.00)
Current Smoker 1.33 (1.11-1.59)
Prior CVA 1.35 (1.10-1.65)
Anemia 1.31 (1.06-1.62)
Age (each 10 years) 1.82 (1.63-2.03)
Pre-randomization UFH 1.23 (1.00-1.50)
Diabetes 1.60 (1.34-1.91)
30-day major bleed w/out transfusion 1.80 (1.16-2.80)
30-day transfusion 3.95 (2.92-5.33)
30-day MI 2.55 (1.96-3.32)
ECG changes at baseline 1.68 (1.39-2.02)
CKMB/Troponin+ at baseline 1.56 (1.27-1.92)
History of CAD 1.31 (1.07-1.60)
Male 1.62 (1.31-2.00)
Current Smoker 1.33 (1.11-1.59)
Prior CVA 1.35 (1.10-1.65)
Anemia 1.31 (1.06-1.62)
Age (each 10 years) 1.82 (1.63-2.03)
0.1 1 10
HR ±95% CI HR (95% CI)
CONCLUSIONS
● Blood product transfusion is
associated with increased rates of
30-day and 1-year composite
ischemic events and mortality in
patients with ACS.
● Transfusion rates are significantly
lower in patients treated with
bivalirudin alone compared to those
treated with heparin plus a GPI.
● Transfusion is a significant
independent predictor of 1-year
mortality in patients with ACS.