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4
Celsius Control™ System
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Study Design
Acute STEMI
Anterior or Large Inferior
(< 6 hrs of Sx onset)
1 : 1
Standard Care (PCI)
Standard Care (PCI) +
Hypothermia
• Secondary Endpoints:
CK-MB, NYHA Functional Class at Day 30, MACE
6
Acute MI Location
By Baseline ECG
Hypothermia Control
P
N = 114 N = 114
7
Demographics
Hypothermia Control
P
N = 114 N = 114
Age
Mean ± SD (years) 57 ± 13 57 ± 12 0.99
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Baseline Clinical Characteristics
Hypothermia Control
P
N = 114 N = 114
Stroke 2% 1% 1.00
TIA 1% 1% 1.00
Arrhythmia 4% 1% 0.37
CHF 3% 0% 0.25
Prior MI 0% 2% 0.50
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Angiographic Parameters
Hypothermia Control P
No. CAD Vessels N = 114 N = 114
1-vessel 45% 40% 0.88
2-vessel 28% 34%
3-vessel 20% 20%
4-vessel 4% 4%
Other 3% 2%
Collateral Flow N = 106 N = 108
Grade 0 74% 69% 0.91
Grade 1 20% 23%
Grade 2 5% 5%
Grade 3 2% 3%
Mean ± SD 0.35 ± 0.66 0.41 ± 0.71 0.51
LV-gram Done N = 79 N = 83 0.56
LVEF (Mean ± SD) 47 ± 11 49 ± 12 0.15
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PCI Results: TIMI Flow
Hypothermia Control
P
N = 104 N = 105
Initial TIMI Flow
0 64% 68% 0.91
1 13% 11%
2 11% 10%
3 12% 11%
Mean ± SD 0.69 ± 1.1 0.64 ± 1.1 0.63
Final TIMI Flow
0 0% 0% 0.80
1 0% 0%
2 11% 10%
3 89% 90%
Mean ± SD 2.9 ± 0.3 2.9 ± 0.3 0.80
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PCI Results (Cont.)
Hypothermia Control
P
N = 104 N = 105
PCI Successful* 104 (100%) 104 (99%) 1.00
Sx-to-Door (min) 137 ± 98 132 ± 90 0.84
Door-to-Balloon (min) 103 ± 66 93 ± 42 0.27
Ancillary Device
98 / 104 (94%) 101 / 105 (96%) 0.54
Used
Stent 100% 99% 1.00
Thrombectomy 13% 14% 0.90
Embolic Protection 2% 1% 0.62
Control Hypothermia
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Mean Manual Temp. (C)
* * *
* * * * *
36 * *
*
35
*P < 0.0001
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33
-2 0 2 4 6 8 10 12 14 16 18
Time (hours)
13
Age-Stratified Mortality Rates
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Major Adverse Cardiac Events
All Patients
Hypothermia Control P
MACE thru Day 30 N = 114 N = 114
any MACE 10 6 0.29
death (any) 9 4 0.15
re-infarction 2 0 0.25
stroke 0 0 ***
severe CHF 0 3 0.25
MACE (any) @ 3 mo. 10 8 0.62
MACE (any) @ 6 mo. 11 9 0.59
MACE (any) @ 12 mo. 12 11 0.58
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Major Adverse Cardiac Events
Patients < 75 years-old
Hypothermia Control P
MACE thru Day 30 N = 100 N = 108
any MACE 5 4 0.74
death (any) 4 2 0.43
re-infarction 1 0 0.48
stroke 0 0 ***
severe CHF 0 3 0.25
MACE (any) @ 3 mo. 5 5 1.00
MACE (any) @ 6 mo. 6 6 0.82
MACE (any) @ 12 mo. 7 8 0.77
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Other Adverse Events
No Significant Differences
Hypothermia Control
P
N = 114 N = 114
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Primary Efficacy Endpoint
Day 30 SPECT Infarct Size
20 P = 0.77
23% Relative Reduction
P = 0.14
14.2
15 13.5 13.2
10.2
Hypothermia
% 10 Control
25
20.9
20
15.3
15
Hypothermia
%
10 Control
7.4
6.5
0 N = 41 N = 45 N = 58 N = 60
Anterior Inferior
27% Relative Reduction 12% Relative Reduction
P = 0.15 P = 0.60
N Relative
Protocol Compliance P
(Hyp / Ctl) Reduction*
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Temp at PCI – All Sites
Anterior MIs – Mean SPECT Infarct Size^ (% of LV)
P = 0.13 (28% reduction)
20
17.6
16.3
0
Hypothermia Control
^No imputed values 22
Temp at PCI – All Sites
Inferior MIs – Mean SPECT Infarct Size^ (% of LV)
P = 0.60 (12% reduction)
7.7
8 7.4
6.5
6 Control (N = 59)
% 4.5
All Hypo (N = 50)
4 Tpci <35 (N = 19)
Tpci >35 (N = 31)
2
0
Hypothermia Control
^No imputed values 23
Secondary Endpoint
Normalized Peak CK-MB (Value / ULN)
11% Relative Reduction
P = 0.096
60
54
50 48
40
CK-MB
Hypothermia
30
Control
20
P = 0.079
10 5.9 4.8
0 N = 70 N = 68 N = 88 N = 87
Admission Peak
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Conclusions
• ICE-IT-1
¾ Baseline population imbalance
• Hypothermia arm had more elderly patients ≥ 75yrs.
• Age-adjusted mortality and MACE rates virtually identical
• ICE-IT-2
¾ Initial planning underway
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