Table 2.
Estimated group difference for primary and secondary outcomes at 3 months, 8 months, and 12 months, based on intention-to-treat analysis
| rt-PA (n=1515) | Control (n=1520) |
Adjusted analysis* |
Unadjusted analysis† |
|||||
|---|---|---|---|---|---|---|---|---|
| Odds ratio (95% CI) | p value | Odds ratio (95% CI) | p value | Absolute difference per 1000 (95% CI)‡ | ||||
| Died within 7 days | 163 (11%) | 107 (7%) | 1·60 (1·22 to 2·08) | 0·001 | 1·59 (1·23 to 2·07) | 0·0004 | 37 (17 to 57) | |
| Died between 7 days and 6 months | 245 (16%) | 300 (20%) | 0·73 (0·59 to 0·89) | 0·002 | 0·78 (0·65 to 0·95) | 0·011 | −36 (−63 to −8) | |
| Status at 6 months | ||||||||
| Vital status unknown, disability imputed | 11 | 13 | ‥ | ‥ | ‥ | ‥ | ‥ | |
| Alive at 6 months, disability imputed | 31 | 41 | ‥ | ‥ | ‥ | ‥ | ‥ | |
| Known 6 month vital and disability status | 1473 | 1466 | ‥ | ‥ | ‥ | ‥ | ‥ | |
| Number included in analysis (status known or imputed) | 1515 | 1520 | ‥ | ‥ | ‥ | ‥ | ‥ | |
| OHS at 6 months§ | ||||||||
| 0 | 138 (9%) | 116 (8%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| 1 | 225 (15%) | 204 (13%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| 2 | 191 (13%) | 214 (14%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| 3 | 235 (16%) | 193 (13%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| 4 | 115 (8%) | 140 (9%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| 5 | 203 (13%) | 246 (16%) | ‥ | ‥ | ‥ | ‥ | ‥ | |
| Died before 6 months | 408 (27%) | 407 (27%) | 0·96 (0·80 to 1·15) | 0·672 | 1·01 (0·86 to1·19) | 0·924 | 2 (−30 to 33) | |
| Alive and favourable outcome (0+1) | 363 (24%) | 320 (21%) | 1·26 (1·04 to 1·53) | 0·018 | 1·18 (0·99 to 1·41) | 0·055 | 29 (−1 to 59) | |
| Alive and independent (0+1+2)¶ | 554 (37%) | 534 (35%) | 1·13 (0·95 to 1·35) | 0·181 | 1·06 (0·92 to1·24) | 0·409 | 14 (−20 to 48) | |
Data are number (%) unless otherwise stated. rt-PA=recombinant tissue plasminogen activator. OHS=Oxford Handicap Scale.
Odds ratios and p values were calculated by logistic regression after adjusting for age (linear), National Institutes of Health Stroke Scale (linear), time (linear), and presence or absence of visible acute ischaemic change on baseline scan as judged by the expert reader.
p value calculated from test of difference between percentages for rt-PA and control, using normal approximation.
Absolute difference calculated as rt-PA–control, so a positive number indicates this outcome was more frequent in the treatment group.
OHS: 0, no symptoms at all; 1, symptoms, but these do not interfere with everyday life; 2, symptoms that have caused some changes in lifestyle but patients are still able to look after themselves; 3, symptoms that have significantly changed lifestyle and patients need some help looking after themselves; 4, severe symptoms requiring help from other people but not so bad as to need attention day and night; 5, severe handicap needing constant attention day and night.
Primary outcomes.