User Manual Part 4

CLINICAL STUDY - COMPANION
B-23
Table B-8. Mortality endpoint risk reduction point estimates (con tinued)
% Failure
Absolute Risk
Reduction
Relative Risk
Reduction
OPT CRT-D
12 months
18.9%
(14.1%, 23.5%)
12.1%
(9.3%, 14.8% )
6.8% 36.0%
18 months
28.4%
(22.3%, 34.1%)
18.0%
(14.4%, 21.5%)
10.4% 36.6%
Results for Secondary Cardiac Morbidity Endpoint
During a h ospitalization more than one of the p re-specified cardiac morbid
events could occur. The Anderson-Gill extension to the Cox proportional
hazard model was used to analyze time to multiple cardiac morbid events.
Caution must be used in interpreting p-values in this analysis because this
analysis does not account for the competing risk of death.
In Figure B-6 on page B-24, the frequency and duration of cardiac morbid
events are illustrated. CRT-D was a ssociated with a 36% re duction (p <
0.0001) in the proportion of patients with at least one event, a 52% reduction
(p < 0.0001) in events on an annual basis, and a 41% reduction (p < 0.0001)
in the hospital duration on an annual basis. These reductions are primarily
due to the reduction of hospitalizations for acute decompensation of heart
failure, worsening heart failure resulting in IV inotrope or vasoactive therapy
> 4 hours (during an inpatient hospitalization) and cardiac surgery (including
percutaneous intervention) (Figure B-7 on page B-24).
- DRAFT -