User Manual Part 4

B-32
CLINICAL STUDY - COMPANION
Tab le B-10. Patient population characteristics (continued)
Characteristic CRT
(N = 318)
OPT
(N = 87)
P-value
a
Ischemic Etiology Ischemic
141 (44.3) 42 (48.3)
0.51
Non-ischemic
177 (55.7) 45 (51.7)
LVEF (%) Mean ± SD
22.5 ± 6.9 22.2 ± 8.0 0.79
Range 5.0–35.0 5.0–35.0
Resting Heart Rate (bpm) Mean ± SD
73.1 ± 12.8 73.5 ± 11.5 0.78
Range 46.0–122.0 54.0–103.0
QRS W idth (ms) Mean ± SD
159.2 ± 25.0 155.7 ± 25.8 0.26
Range 1 20.0–276.0 120.0–224.0
LBBB/NSIVCD (%)
LBBB
230 (72.3) 62 (71.3)
0.60
Nonspecific 54 (17.0) 18 (20.7)
RBBB
34 (10 .7) 7 (8.0)
Peak VO
2
(ml/kg/min) Mean ± SD
12.7 ± 3.3 12.4 ± 3.3 0.42
Range 3.0–21.2 4.8–21.5
Six-MInute Walk D istance (m) Mean ± SD
292.4 ± 65.5 291.6 ± 70.5 0.92
Range 152.0–411.5 162.4–414.0
Quality of Life Score (points) Mean ± SD
59.8 ± 23.1 55.4 ± 23.3 0.12
Range 0.0–105.0 0.0–97.0
Heart Failure Medications [N (%)]
Diuretic
300 (94.3) 82 (94.3)
0.98
ACE Inhibitor or ARB 286 (89.9) 82 (94.3)
0.22
Beta Blockers
240 (75.5) 60 (69.0)
0.22
Aldosterone Antagonist
178 (56.0) 51 (58.6)
0.66
Digoxin
239 (75.2) 65 (74.7)
0.93
a. Continuous data were analyzed using a two-tailed t-test procedure, and categorical data were analyzed using a two-tailed
chi-square procedure. A p-value < 0.05 is considered significant.
CRT Effectiveness
Peak VO
2
— Peak VO
2
was determined from a standardized protocol for
exercise testing as a means of measuring a patient’s capacity for performing
physical activity (Figure B-13 on page B-33, Table B-11 on page B-33).
- DRAFT -