Table 1.
Patient and biopsy characteristics according to Ishak fibrosis stage; and laboratory information at enrollment and presence of esophageal varices according to Ishak fibrosis stage and fragmentation.*
| Ishak Stage | |||||||
|---|---|---|---|---|---|---|---|
| All | 2 | 3 | 4 | 5 | 6 | ||
| Number of randomized patients |
1,050 | 79 | 355 | 188 | 231 | 197 | p-value for trend |
| Mean days from baseline biopsy to randomization |
269 (177) |
277 (192) |
273 (187) |
303 (175) |
245 (161) |
253 (166) |
0.05 |
| Randomized to treatment |
49.2% | 51.9% | 48.7% | 50.5% | 51.1% | 45.7% | 0.55 |
| Biopsy characteristics | |||||||
| Length ≥1.5 cm | 62.9% | 60.8% | 67.6% | 59.6% | 62.8% | 58.4% | 0.11 |
| Area ≥10 (n=1004) | 69.0% | 70.5% | 70.5% | 66.1% | 74.8% | 61.5% | 0.23 |
| Portal triads ≥10 (n=1,002) |
74.7% | 65.3% | 71.5% | 84.2% | 76.8% | 72.6% | 0.21 |
| Fragmented (%) | 23.5% | 8.9% | 22.5% | 17.6% | 29.9% | 29.4% | 0.0002 |
| Laboratory Information |
|||||||
| Days from biopsy to laboratory testing |
94 (137) |
108 (131) |
90 (126) |
113 (153) |
78 (139) |
95 (140) |
0.47 |
| All biopsies | |||||||
| Platelet count (103/mm3) |
165 (66) |
221 (59) |
187 (62) |
169 (59) |
143 (60) |
125 (51) |
<0.0001 |
| AST/ALT ratio | 0.88 (0.29) |
0.78 (0.26) |
0.84 (0.28) |
0.87 (0.28) |
0.90 (0.29) |
0.98 (0.32) |
<0.0001 |
| Total Bilirubin (mg/dl) |
0.79 (0.40) |
0.68 (0.29) |
0.71 (0.35) |
0.78 (0.37) |
0.85 (0.41) |
0.92 (0.49) |
<0.0001 |
| Albumin (g/dl) | 3.87 (0.39) |
4.02 (0.31) |
3.94 (0.35) |
3.93 (0.35) |
3.81 (0.40) |
3.69 (0.46) |
<0.0001 |
| INR | 1.04 (0.11) |
0.99 (0.08) |
1.02 (0.12) |
1.02 (0.10) |
1.07 (0.10) |
1.08 (0.11) |
<0.0001 |
| Esophageal varices (%) (n=1016) |
25.7 | 10.5 | 13.5 | 23.1 | 34.5 | 45.3 | <0.0001 |
| Non-fragmented Biopsies | |||||||
| Platelet count** (103/mm3) |
171 (67) |
225 (59) |
196 (60) |
172 (59) |
148 (64) |
121 (49) |
<0.0001 |
| AST/ALT ratio** | 0.87 (0.30) |
0.78 (0.26) |
0.82 (0.27) |
0.86 (0.29) |
0.88 (0.29) |
1.02 (0.34) |
<0.0001 |
| Total Bilirubin (mg/dl)** |
0.77 (0.38) |
0.67 (0.29) |
0.68 (0.34) |
0.77 (0.36) |
0.82 (0.36) |
0.94 (0.46) |
<0.0001 |
| Albumin (g/dl) | 3.89 (0.38) |
4.03 (0.31) |
3.96 (0.32) |
3.94 (0.33) |
3.84 (0.38) |
3.68 (0.47) |
<0.0001 |
| INR | 1.03 (0.11) |
0.99 (0.08) |
1.01 (0.11) |
1.02 (0.10) |
1.07 (0.10) |
1.09 (0.11) |
<0.0001 |
| Esophageal varices (%) |
24.0 | 11.4 | 10.3 | 22.5 | 34.2 | 47.1 | <0.0001 |
| Fragmented Biopsies | |||||||
| Platelet count (103/mm3) |
144 (57) |
176 (47) |
157 (61) |
155 (61) |
131 (50) |
133 (54) |
0.0006 |
| AST/ALT ratio | 0.90 (0.28) |
0.72 (0.27) |
0.88 (0.30) |
0.88 (0.25) |
0.95 (0.29) |
0.91 (0.24) |
0.10 |
| Total Bilirubin (mg/dl) |
0.85 (0.46) |
0.72 (0.27) |
0.80 (0.38) |
0.81 (0.41) |
0.93 (0.50) |
0.85 (0.56) |
0.21 |
| Albumin (g/dl) | 3.82 (0.43) |
4.01 (0.35) |
3.89 (0.42) |
3.87 (0.40) |
3.76 (0.45) |
3.74 (0.44) |
0.007 |
| INR | 1.06 (0.12) |
1.00 (0.08) |
1.05 (0.15) |
1.05 (0.10) |
1.08 (0.10) |
1.07 (0.11) |
0.08 |
| Esophageal varices (%) |
31.1 | 0.0 | 24.4 | 27.3 | 35.3 | 41.1 | 0.009 |
*
Mean (SD) or %