User Manual Part 4

D-18
CLINICAL STU DY - CONTAK CD
Table D-10. Ch ange in Quality of Life (continued)
All Patients
NYHA Class III/IV
QOL (points)
CRT
(N = 234)
No CRT
(N = 225)
P-value
a
CRT
(N = 107)
No C RT
(N = 96)
P-value
a
3 Months 36.6 ± 1.5 37.3 ± 1.6 0.711 41.9 ± 2.4 47.5 ± 2.6 0.078
6 Months 34.8 ± 1.8 36.9 ± 1.8 0.395 37.2 ±- 3.1 47.3 ± 3.2 0.017
a. P-values reflect the between-group differences with respect to baseline.
NYHA Class––the determination of New York Heart Association (NYHA) Class
is based on mutual assessment by the patient and the patient’s physician of
the patient’s heart failure symptoms both at rest and while performing ordinary
physical activity. NYHA Class was determined at each follow-up visit by a
physician who was blinded to the patient’s randomized therapy. Figure D-6 on
pageD-18andTableD-11onpageD-18providethechangeinNYHAClass
results.
60
40
20
0
Change in NYHA Class (%)
CRT
(n = 109)
No CRT
(n = 116)
CRT
(n = 45)
No CRT
(n = 48)
Improve ≥ 2 Classes
Worsen ≥ 1 Class
Improve = 1 Class
No change
All Patients
(NYHA Class II / III / IV)
p = 0.10
NYHA Class III / IV
p = 0.006
Figure D-6. Change in NYHA Class
Table D-11. Change in N YHA Class
All Patients
NYHA Class III/IV
CRT
(N = 109)
No CRT
(N = 116)
CRT
(N = 45)
No CRT
(N = 48)
Change in NYHA Class
N
%
N
%
P-value
a
N
%
N
%
P-value
a
Improve 2 or More Classes
12 11.0 2 1.7 0.10 12 26.7 2 4.2 0.006
Improve1Class
27 24.8 35 30.2 21 46.7 24 50.0
No Change
56 51.4 59 50.9 10 22.2 18 37.5
- DRAFT -