Use Instructions

34
Table 11: Change in Log10 NT-proBNP at 6 Months – Intended Use
Second, Initial and Combined Cohorts
BAT + Medical
Management
Medical
Management
Difference*
Cohort
N
Mean±SD
(95% CI)**
N
Mean±SD
(95% CI)**
Δ Means
(95% CI)**
p-
value
Initial
67
-16.7% ± 0.3
(-30.2%, -0.5%)
82
1.9% ± 0.3
(-12.4%,
18.5%)
-17.9%
(-34.3%, 2.7%)
0.08
Second
53
-26.4% ± 0.4
(-43.7%, -3.9%)
41
6.4% ± 0.3
(-15.9%,
34.5%)
-36.5%
(-55.2%, -10.1%)
0.01
Combined
120
-21.1% ± 0.4
(-32.3%, -8.2%)
123
3.3% ± 0.3
(-8.9%, 17.2%)
-24.6%
(-37.6%, -8.7%)
0.004
*The difference is evaluated based on an ANCOVA model adjusting for the baseline value.
**Results modeled parametrically on the log10 scale. Results are converted to percent change from baseline usi
ng [10**(log10(a) - log10(b)) - 1 = (a-b)/b]. Standard deviation is on log10 scale.
Table 11 below shows the New York Heart Association (NYHA) Class functional status
differences between the arms in the Combined (Initial and Second Cohorts) of the
Intended Use Population.
Table 12: Change in NYHA Class at 6 Months– Intended Use, Combined Cohort
BAT + Medical
Management
Medical
Management
Change in
NYHA
N
N (%)
N
N (%)
P-value
Improved 2 Classes
120
16 (13.3%)
125
3 (2.4%)
<.001
Improved 1 Class
62 (51.7%)
36 (28.8%)
No Change
42 (35.0%)
84 (67.2%)
Deteriorated
0 (0.0%)
2 (1.6%)