User Manual Part 4

B-22
CLINICAL STUDY - COMPANION
depicted in Figure B-5 on page B-22. These numbers correspond to an annual
mortality rate of 19% in the OPT arm and 12% in the CRT-D arm, with a hazard
ratio of 0.64, 95% CI (0.48, 0.86). These results demonstrated that CRT-D
was associated with a 36% reduction in the risk of all-cause mortality when
compared to OPT alone.
1080 720 630 540 450 360 270 180 90 0
100
90
80
70
60
50
% of Patients Event-Free
Days from Randomization
All-cause Mortality
CRT-D vs. OPT: p = 0.003
Number of Events
OPT: 77
CRT-D: 105
OPT
CRT-D
308
595
Number of
Patients at Risk
OPT
CRT-D
284
555
255
517
217
470
186
420
141
331
94
219
57
148
45
95
HR = 0.64. 95% CI (0.48, 0.86)
25
47
4
21
2
1
810 900 990
Figure B-5. Secondary Endpoint: Al l-cause m orta lity
In addition to the hazard ratio, point estimates o f risk reduction were also
calculated (Table B-8 on page B-22). These estimates will vary with time from
the true treatment effect, and thus should be interpreted with caution.
Table B-8. Mortality en dpoint risk reduction point estimates
% Failure
Absolute Risk
Reduction
Relative Risk
Reduction
OPT CRT-D
6months
9.0%
(5.7%, 12. 2%)
7.3%
(5.1%, 9.3%)
1.7% 18.9%
- DRAFT -