Table 3.
Primary and secondary outcomes
| TLT (n=410) |
Sham (n=368) |
Difference* | P | ||
|---|---|---|---|---|---|
|
mRS ≤ 2, N = 878 (Dichotomized analysis) |
167 (40.73%) |
119 (32.34%) |
8.39% | 0.003† | |
| Stratified mRS, n (%) | 0.005‡ | ||||
| 0 | 28 (6.83%) |
19 (5.16%) |
1.67% | ||
| 1 | 73 (17.8%) |
46 (12.5%) |
5.3 | ||
| 2 | 66 (16.1%) |
54 (14.67%) |
1.43% | ||
| 3 | 76 (18.54%) |
74 (20.11%) |
−1.57% | ||
| 4 | 75 (18.29%) |
82 (22.28%) |
−3.99% | ||
| 5 and death | 92 (22.44%) |
93 (25.27%) |
−2.83% | ||
| SAE | 35.4% | 41.3% | 0.09 | ||
The results are shown according tomodified Rankin scale (mRS)at day 90 or the last rating. ThemRS, in six categories, range from 0, indicating no residual symptoms, to 5, indicating bedbound, requiring constant nursing care.
*
The value is the percentage in the TLT group minus the percentage in the sham group for each category.
†
Adjusted for baseline NIHSS, TFSO, previous stroke, previous diabetes and hypertension Scores
‡
Cochran-Mantel-Haenszel (CMH) test
SAE= Serious Adverse Events, included symptomatic intracranial hemorrhages