1. Angiographic Findings in Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) Trial
Alexandra J. Lansky1, Ken Mori1, Ricardo A. Costa1, Michel Bertrand2, Frederick Feit3, Cordy Pietras1, Ecatarina Cristea1, Stuart Pocock4, Magnus Ohman5, Gregg W. Stone1
1. Cardiovascular Research Foundation, New York, NY;
2. Hospital Cardiologique, Lambersart, France
3. New York University Medical Center, NY
4. London School of Hygiene and Tropical Medicine, London, United Kingdom
5. University of North Carolina, Chapel Hill, NC

2. Background
A number of angiographic morphologic parameters of prognostic importance have been identified in ACS pts undergoing PCI including the extent of disease, the presence of thrombus and coronary flow characteristics.
ACUITY Angiographic substudy was designed to investigate the angiographic findings in a cohort of patients enrolled in US.

3. ACUITY Trial Design
Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,800)
UFH or
Enoxaparin
+ GP IIb/IIIa
Bivalirudin
Alone R*
Angiography within 72h
Medical
management
PCI
CABG
Moderate-
high risk
ACS
Aspirin in all
Clopidogrel
dosing and timing
per local practice
*Stratified by pre-angiography thienopyridine use or administration
ACUITY Design. Stone GW et al. AHJ 2004;148:764–75

4. Major entry criteria Inclusion Criteria Exclusion Criteria
Moderate-high risk unstable angina or NSTEMI
Inclusion Criteria
Age ≥18 years
Chest pain ≥10’ within 24h
At least one of:
New ST depression or transient ST elevation ≥1 mm
Troponin I, T, or CKMB
Documented CAD
All other 4 TIMI risk criteria
Age ≥65 years
Aspirin within 7 days
≥2 angina episodes w/i 24h
≥3 cardiac risk factors
Written informed consent
Exclusion Criteria
No angiography within 72h
Acute STEMI or shock
Bleeding diathesis or major bleed within 2 weeks
Platelet count ≤100,000/mm3
INR >1.5 control
CrCl ≤30 ml/min
Abcx or ≥2 prior LMWH doses
Prior UFH, LMWH (1 dose), eptifibatide and tirofiban were allowed
Allergy to drugs, contrast

5. ACUITY Primary Results (ITT)
Heparin* + IIb/IIIa vs. Bivalirudin + IIb/IIIa vs. Bivalirudin Alone
PNI <0.001
PSup = 0.015
PNI = 0.011
PSup = 0.32
PSup <0.001
*Heparin=unfractionated or enoxaparin

6. ACUITY: Angiographic Substudy
Objectives:
Investigate the angiographic basis of observed differences in efficacy of angiographic parameters in acute coronary syndrome patients.
Methods:
Angiographic films were analyzed in a blinded manner by the independent Core Laboratory:
Baseline Angiography on all patients to assess the extent of disease
Serial analysis of diseased vessels for patients undergoing PCI to determine procedural complications and final QCA results.

7. Consort Diagram

8. Baseline clinical characteristics
UFH/Enoxaparin + GP IIb/IIIa
(N=4,603)
Bivalirudin GP IIb/IIIa
(N=4,604)
Bivalirudin alone
(N=4,612)
Age (median [range], yrs)
63 [23-91]
63 [21-95]
63 [20-92]
Male
70.6%
69.9%
69.3%
Diabetes
28.4%
27.7%
28.1%
- Insulin requiring
8.5%
8.7%
8.9%
Hypertension
66.8%
67.2%
67.1%
Hyperlipidemia
57.2%
57.4%
57.0%
Current smoker
29.0%
29.3%
Prior MI
31.6%
30.5%
31.8%
Prior PCI
39.0%
37.8%
39.9%
Prior CABG
18.2%
17.4%
18.1%
Renal insufficiency*
19.2%
19.1%
18.9%
*CrCL < 60ml/min as determined by the Cockcroft-Gault equation

9. Baseline angiographic characteristics
UFH+GPI
N=2314
Biv+GPI
N=2301
Bivalirudin
N=2306
P value
Lesions / pts
4.1 ± 2.9
4.1 ± 3.0
0.56
# of diseased vessel, %
- 0VD
9.0
9.9
0.43
- 1VD
18.5
18.6
18.3
0.94
- 2VD
27.1
28.0
29.2
0.27
- 3VD
45.5
44.4
42.6
0.15
Extent of disease, mm
40.7 ± 30.8
39.8 ± 29.3
39.3 ± 30.2
Lesion Location, %
- LAD
74.5
75.6
73.8
0.36
- RCA
69.5
69.0
66.6
0.08
- LCX
65.0
63.3
64.1
0.49
Diseased vessel is defied as %DS>30%

10. Baseline angiographic characteristics
UFH+GPI
N=2314
Biv+GPI
N=2301
Bivalirudin
N=2306
P value
Jeopardy Score
2.4 ± 2.8
2.4 ± 2.7
2.3 ± 2.8
0.19
Ejection Fraction, %
63.7 ± 11.9
64.3 ± 12.7
64.6 ± 12.0
0.05
TIMI flow glade
- 0/1
9.0
8.6
8.2
0.22
- 2
4.9
4.7
5.1
0.59
- 3
86.0
86.7
0.43
Myocardial Blush grade
8.8
8.4
0.67
12.3
12.7
12.9
0.63
79.1
78.4
78.7
0.69

11. LAD angiographic characteristics
UFH+GPI
N=2275
Biv+GPI
N=2272
Bivalirudin
N=2267
P value
# of lesions
1.5 ± 1.3
0.99
Extent of diseases, mm
22.1 ± 16.6
20.9 ± 14.9
21.3 ± 15.7
0.57
Lesion Morphology, %
Thrombus
5.8
4.7
5.7
0.17
Eccentric
8.4
8.2
0.97
Ulcerated
2.0
1.8
1.4
0.34
Aneurysm
1.7
1.1
0.06
Ectasia
3.3
3.2
0.96
Calcium
- Moderate
18.5
19.9
20.0
0.36
- Severe
5.3
5.5
5.2
0.93
Diseased vessel is defied as %DS>30%

12. LAD angiographic characteristics
UFH+GPI
N=2275
Biv+GPI
N=2272
Bivalirudin
N=2267
P value
TIMI flow glade, %
- 0/1
5.3
4.4
5.5
0.20
- 2
6.5
6.7
6.2
0.78
- 3
88.2
88.9
88.3
0.72
Myocardial Blush Score, %
5.7
5.8
6.1
0.83
13.0
13.1
14.1
0.55
81.3
81.1
79.8
0.42
Collaterals, %
7.5
7.0
7.7
0.66
Rentrop classification
n=179
n=165
n=180
- 0
2.8
3.6
1.1
0.30
- 1
20.1
19.4
26.1
0.25
53.1
52.1
55.6
0.80
24.0
24.8
17.2
0.16

13. RCA angiographic characteristics
UFH+GPI
N=2231
Biv+GPI
N=2227
Bivalirudin
N=2221
P value
# of lesions
1.5 ± 1.4
0.10
Extent of diseases, mm
23.1 ± 15.8
22.6 ± 16.7
22.8 ± 17.9
0.17
Lesion Morphology, %
Thrombus
7.3
7.9
0.68
Eccentric
9.0
9.9
8.4
0.22
Ulcerated
2.9
3.2
2.6
0.42
Aneurysm
2.0
1.6
2.2
Ectasia
6.8
6.7
5.3
0.06
Calcium
- Moderate
16.7
17.6
16.5
0.58
- Severe
3.9
4.5
4.4
Diseased vessel is defied as %DS>30%

14. RCA angiographic characteristics
UFH+GPI
N=2231
Biv+GPI
N=2227
Bivalirudin
N=2221
P value
TIMI flow glade, %
- 0/1
14.4
14.0
12.5
0.14
- 2
5.7
5.2
6.1
0.41
- 3
79.9
80.8
81.4
0.45
Myocardial Blush Score, %
11.6
13.1
11.5
0.23
12.4
14.1
13.4
0.27
76.0
72.8
75.0
0.06
Collaterals
17.7
16.8
15.8
Rentrop classification
n=405
n=382
n=356
- 0
0.5
1.6
1.7
0.25
- 1
9.9
10.7
9.0
0.73
54.8
49.2
47.8
0.12
34.8
38.5
41.6
0.16

15. LCX angiographic characteristics
UFH+GPI
N=2268
Biv+GPI
N=2261
Bivalirudin
N=2264
P value
# of lesions
1.2 ± 1.2
1.1 ± 1.2
0.58
Extent of diseases, mm
19.3 ± 14.5
18.9 ± 13.6
19.0 ± 13.7
0.95
Lesion Morphology, %
Thrombus
4.6
5.2
5.6
0.33
Eccentric
5.4
6.1
5.8
0.61
Ulcerated
1.2
1.6
1.0
0.17
Aneurysm
1.1
0.32
Ectasia
3.3
2.9
3.4
Calcium
- Moderate
13.2
13.5
12.8
0.76
- Severe
2.0
2.3
0.72
Diseased vessel is defied as %DS>30%

16. LCX angiographic characteristics
UFH+GPI
N=2268
Biv+GPI
N=2261
Bivalirudin
N=2264
P value
TIMI flow glade, %
- 0/1
7.5
7.3
6.6
0.50
- 2
2.6
2.3
3.0
0.28
- 3
90.0
90.4
90.3
0.88
Myocardial Blush Score, %
8.4
7.6
7.4
0.47
11.6
11.0
11.2
0.81
80.0
81.4
81.3
0.42
Collaterals
9.5
10.1
0.13
Rentrop classification
n=225
n=227
n=200
- 0
2.2
4.5
- 1
18.2
20.7
18.0
0.72
54.7
56.8
49.5
0.30
24.9
20.3
28.0
0.17

17. PCI patients characteristics

18. Angiographic Characteristics
UFH+GPI
N=1616
Biv+GPI
N=1680
Bivalirudin
N=1617
P value
Lesions / pts
4.3 ± 2.6
4.4 ± 2.7
0.86
# of diseased vessel, %
0.3
1.0
0.04
- 1VD
19.3
19.1
18.5
0.88
- 2VD
33.3
34.8
0.64
- 3VD
47.1
47.4
45.7
0.66
Extent of disease, mm
39.7 ± 27.1
39.2 ± 26.1
39.0 ± 26.6
0.90
Lesion Location, %
- LAD
79.7
81.9
79.9
0.31
- RCA
77.2
76.1
73.7
0.12
- LCX
70.2
69.7
71.6
0.58
Jeopardy Score
2.6 ± 2.3
2.7 ± 2.3
0.29
Ejection fraction, %
63.4 ± 11.8
64.1 ± 12.5
64.1 ± 12.3
0.26
Women were older, more frequent DM, HT , current HL renal insufficiency.

19. PCI patients lesion characteristics
UFH+GPI
N=1616
Biv+GPI
N=1680
Bivalirudin
N=1617
P value
Target Vessel, %
- LAD
32.9
35.2
35.9
0.16
- RCA
36.4
34.6
31.5
0.01
- LCX
30.8
30.2
32.5
0.32
- SVG
7.0
8.0
8.6
0.23
- IMA
0.4
0.2
0.57
Lesion Length, mm
15.8 ± 10.2
15.6 ± 10.4
15.7 ± 10.2
0.60

20. PCI patients lesion characteristics
UFH+GPI
N=1616
Biv+GPI
N=1680
Bivalirudin
N=1617
P value
Lesion Morphology, %
Thrombus
14.2
14.6
15.9
0.32
Eccentric
20.2
21.7
20.9
0.61
Ulcerated
4.5
5.4
4.0
0.16
Aneurysm
1.2
1.3
1.5
0.78
Ectasia
5.9
6.0
5.5
0.77
Calcium
- Moderate
21.9
21.5
20.4
0.58
- Severe
3.2
3.6
0.83
ACC/AHA B2/C
67.5
65.1
67.3
0.24

21. PCI patients lesion characteristics
UFH+GPI
N=1616
Biv+GPI
N=1680
Bivalirudin
N=1617
P value
TIMI flow glade, %
- 0/1
12.5
11.6
13.2
0.39
- 2
9.2
9.3
10.1
0.67
- 3
78.3
79.1
76.8
0.27
Myocardial Blush Score, %
16.1
14.2
16.3
0.23
14.7
15.1
17.1
0.18
69.2
70.7
66.6
0.06
Myocardial Blush Score (TIMI3 patients), %
1.6
2.5
2.1
0.30
14.9
14.3
16.8
83.5
83.2
81.1
0.28

22. Side branch UFH+GPI N=1616 Biv+GPI N=1680 Bivalirudin N=1617 P value
Bifurcation lesion, %
18.9
18.8
0.99
Pre Procedure
%DS
35.9 ± 30.9
35.0 ± 29.8
32.9 ± 28.7
0.63
50-75%
17.5
16.0
14.4
0.57
>75%
14.3
12.7
11.4
Worst SB %DS
59.9 ± 32.6
56.6 ± 32.0
60.5 ± 30.4
0.35
Post Procedure
41.0 ± 35.3
40.2 ± 34.5
43.7 ± 34.5
0.36
SB treated, %
26.0
22.2
21.9

23. QCA results UFH+GPI N=1616 Biv+GPI N=1680 Bivalirudin N=1617 P value
Pre procedure
RVD, mm
2.8 ± 0.6
0.85
MLD, mm
0.7 ± 0.5
0.91
%DS
73.5 ± 16.0
73.7 ± 15.5
72.5 ± 16.0
0.94
Lesion length, mm
15.8 ± 10.2
15.6 ± 10.4
15.7 ± 10.2
0.60
Post procedure
In-segment
2.3 ± 0.6
0.88
17.7 ± 12.4
17.0 ± 11.4
16.8 ± 10.9
0.25
Acute gain
1.6 ± 0.6
0.82
In-stent
2.7 ± 0.5
8.2 ± 6.2
8.1 ± 5.1
8.3 ± 6.0
0.70

24. Conclusions
The ACUITY trial demonstrated that a bivalirudin alone strategy results in a significantly improved net clinical outcome at 30 days when compared with heparin (unfractionated or enoxaparin) plus a GP IIb/IIIa inhibitor
A further analysis of the baseline angiographic characteristics demonstrated that angiographic parameters were well-balanced between the treatment groups
There were no clinically significant differences in the angiographic outcome of patients who underwent further PCI
Despite being older and with more co-morbidities, women with AMI treated with primary stenting had similar early and late outcome compared to men.
These favorable results may be related to the fact that women had similar time to reperfusion and smaller infract size compared to men.
Discrepancy for the other previous reports might be due to no significant differences in diabetes rate and symptom onset to balloon time.
In the EMERALD trial, despite women was older, had smaller BSA and comorbidites, women with AMI treated with primary PCI showed a similar early and late outcomes compared to men. This might be related that women had good ST-resolution and smaller infarct size compared to men. Prior CABG, infarct size and renal insufficiency were independence predictors of 6-month MACE after primary PCI.
Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.