Table 3.
Distribution of New MRI Lesions After Randomization in the Favorable and Unfavorable Subgroups of the Treatment Arm, as Well as the Sham Arm.
| 0–12 Months |
0–6 Months |
6–12 Months |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Sham (n=42) |
Unfavorable (n=30) |
Favorable (n=38) |
Sham (n=42) |
Unfavorable (n=30) |
Favorable (n=38) |
Sham (n=42) |
Unfavorable (n=30) |
Favorable (n=38) |
|
| Freedom from new or enlarged T2 lesionsa | 23 (54.8); RR 1.49 (1.09 to 2.04), p=0.016 |
16 (53.3); RR 1.53 (1.06 to 2.21), p=0.018 |
31 (81.6) | 31 (73.8); RR 1.14 (0.91 to 1.43), p=0.287 |
19 (63.3); RR 1.33 (0.98 to 1.80), p=0.089 |
32 (84.2) | 28 (66.7); RR 1.46 (1.17 to 1.82), p<0.001 |
20 (66.7); RR 1.46 (1.13 to 1.89), p<0.001 |
37 (97.4) |
| Freedom from new Gd-enhancing T1 lesionsa | 25 (59.5); RR 1.55 (1.19 to 2.02), p<0.001 |
18 (60.0); RR 1.54 (1.13 to 2.09), p=0.003 |
35 (92.1) | 33 (78.6); RR 1.24 (1.05 to 1.46), p=0.016 |
22 (73.3); RR 1.33 (1.06 to 1.66), p=0.008 |
37 (97.4) | 30 (71.4); RR 1.29 (1.04 to 1.60), p=0.023 |
23 (76.7); RR 1.20 (0.97 to 1.49), p=0.094 |
35 (92.1) |
| Freedom from new combined lesionsa | 20 (47.6); RR 1.66 (1.16 to 2.37), p=0.005 |
13 (43.3); RR 1.82 (1.17 to 2.83), p=0.005 |
30 (79.0) | 29 (69.1); RR 1.22 (0.95 to 1.56), p=0.125 |
17 (56.7); RR 1.49 (1.06 to 2.09), p=0.016 |
32 (84.2) | 25 (59.5); RR 1.55 (1.19 to 2.02), p<0.001 |
19 (63.3); RR 1.45 (1.09 to 1.94), p=0.006 |
35 (92.1) |
Abbreviations: Gd, gadolinium; MRI, magnetic resonance imaging; PTA, percutaneous transluminal angioplasty.
a
Data are presented as the number (percentage); relative risk (RR) with the 95% confidence interval in parentheses, and the p value comparing the sham and the unfavorable groups to the favorable group.