BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 43 / 176

Lumax Technical Manual 35
Table 7: Composite of Six Minute Walk Test and QOL
(Effectiveness)
Category
Study
Group
(N = 74)
Mean
±
SE
Control
Group
(N = 38)
Mean
±
SE
P-value*
Distance Walked at
Baseline
310.51 ±
10.89
288.76 ±
15.37
0.249
Distance Walked at
Six-Months
340.77 ±
12.32
301.84 ±
17.02
0.067
∆ Distance Walked
30.26 ±
10.40
17.27% ±
5.59%
13.08 ±
13.05
8.71% ±
5.26%
0.322
0.326
QOL Score at
Baseline
44.39 ± 2.78 45.53 ± 4.13 0.817
QOL Score at Six-
Months
28.68 ± 2.66 33.95 ± 4.35 0.279
∆ in QOL Score**
15.72± 2.83
19.08% ±
12.21%
11.58 ± 3.45
-13.42% ±
34.54%
0.376
0.281
Composite Rate***
18.18% ±
7.07%
-2.36% ±
17.73%
0.030
*The calculated p-values are associated with a Student's t-test (2-sided)
of the equality of means in the two groups, except for the p-value of the
composite rate, which is associated with a test of equivalence (non-
inferiority).
**
∆ in QOL Score is calculated as the average of the individual
differences between Baseline and Six-Months for each patient. Negative
values for mean
∆ QOL in percent are possible when positive mean
values for absolute changes in QOL are recorded. In some cases, small,
negative changes in absolute QOL scores resulted in relatively large
percentage changes.
***The Composite Rate (=(
∆ Distance Walked (%) + ∆ QOL Score (%)) /
2) is calculated for each patient and then averaged to obtain the
Composite Rates. For all calculations, a positive number represents
improvement from Baseline to Six-Months.