User Manual Part 4

B-24
CLINICAL STUDY - COMPANION
55%
1.08
7.6
60
50
40
20
10
30
0
1.2
1.0
0.8
0.4
0.2
0.6
0.0
8
6
4
2
0
35%
Proportion of Patients with ≥ 1 Event (%)
0.52
Event Rate (Events/Patient-Year)
4.5
Duration (Days/Patient-Year)
Frequency (per Patient)
36% reduction
p < 0.0001
Duration
41% reduction
p < 0.0001
Frequency (per Patient Year)
52% reduction
p < 0.0001
OPT (n = 308) CRT-D (n = 595)
Figure B-6. Secondary En dp oin t: cardiac morbidity
Caution must be used in interpreting p-values; analysis does not account for
compe ting risk of death.
0.68
0.8
0.6
0.4
0.2
0.0
0.42
Events per Patient Year
0.57
0.31
0.38
0.06 0.06
0.08
0.04
0.05
0.02 0.02
OPT
CRT-D
Hospitalization
for acute
decompensation
of HF
Worsening HF
resulting in IV
inotrope or
vasoactive > 4
hours
Cardiac surgery,
including
percutaneous
intervention
Hospitalization
resulting in
death from
cardiac causes
Mechanical
respiratory or
cardiac support
Resuscitated
cardiac arrest or
sustained VT
requiring
external
intervention
38% reduction
p < 0.0001
46% reduction
p < 0.0001
84% reduction
p < 0.0001
50% reduction
p = 0.016
17% reduction
p = 0.54
No change
p = 0.55
Figure B-7. Cardiac morbidity by major component
- DRAFT -