Primary and secondary outcomes at 3 months
| Outcome | Non-smoking | Smoking | Univariate | Multivariable | ||
| N=3532 | N=1008 | OR (95% CI) | P value | OR (95% CI) | P value | |
| Primary outcome—ordinal mRS | 0.88 (0.77 to 0.99) | 0.038 | 1.15 (1.04 to 1.28) | 0.009* | ||
| Secondary outcome—dichotomised mRS | ||||||
| 1–6 versus 0 | 2571/3467 (74.2) | 728/981 (74.2) | 1.00 (0.85 to 1.18) | 0.973 | 1.24 (1.09 to 1.43) | 0.002 |
| 2–6 versus 0–1 | 1756/3467 (50.7) | 469/981 (47.8) | 0.89 (0.78 to 1.03) | 0.117 | 1.18 (1.05 to 1.33) | 0.007 |
| 3–6 versus 0–2 | 1265/3467 (36.5) | 319/981 (32.5) | 0.84 (0.72 to 0.98) | 0.022 | 1.18 (1.04 to 1.33) | 0.009 |
| 4–6 versus 0–3 | 875/3467 (25.2) | 187/981 (19.1) | 0.70 (0.59 to 0.83) | <0.001 | 0.98 (0.85 to 1.12) | 0.741 |
| 5–6 versus 0–4 | 532/3467 (15.3) | 111/981 (11.3) | 0.70 (0.57 to 0.88) | 0.002 | 1.01 (0.86 to 1.20) | 0.889 |
| Death | 338/3532 (9.6) | 71/1008 (7.0) | 0.72 (0.55 to 0.94) | 0.015 | 0.94 (0.77 to 1.16) | 0.586 |
| Death or neurological deterioration in 24 hours† | 305/3532 (8.6) | 87/1008 (8.6) | 1.00 (0.78 to 1.28) | 0.997 | 1.26 (1.03 to 1.54) | 0.023 |
| Death or neurological deterioration in 7 days† | 444/3532 (12.6) | 123/1008 (12.2) | 0.97 (0.78 to 1.20) | 0.757 | 1.18 (0.99 to 1.40) | 0.059 |
| Symptomatic ICH‡ | ||||||
| SITS-MOST criteria | 56/3532 (1.6) | 15/1008 (1.5) | 0.94 (0.53 to 1.67) | 0.826 | 1.17 (0.74 to 1.84) | 0.509 |
| NINDS criteria | 246/3532 (7.0) | 67/1008 (6.6) | 0.95 (0.72 to 1.26) | 0.725 | 1.29 (1.03 to 1.60) | 0.026 |
| ECASS2 criteria | 160/3532 (4.5) | 39/1008 (3.9) | 0.85 (0.59 to 1.21) | 0.367 | 1.17 (0.89 to 1.53) | 0.268 |
| ECASS3 criteria | 73/3532 (2.1) | 19/1008 (1.9) | 0.91 (0.55 to 1.52) | 0.718 | 1.01 (0.66 to 1.53) | 0.981 |
| IST3 criteria | 96/3532 (2.7) | 26/1008 (2.6) | 0.95 (0.61 to 1.47) | 0.810 | 1.06 (0.74 to 1.53) | 0.747 |
| Any ICH | 670/3532 (19.0) | 173/1008 (17.2) | 0.89 (0.74 to 1.06) | 0.193 | 1.09 (0.94 to 1.27) | 0.248 |
| Any clinical-reported ICH | 298/3532 (8.4) | 77/1008 (7.6) | 0.90 (0.69 to 1.17) | 0.417 | 1.12 (0.91 to 1.38) | 0.298 |
| Any adjudicated ICH | 593/3532 (16.8) | 155/1008 (15.4) | 0.90 (0.74 to 1.09) | 0.287 | 1.11 (0.95 to 1.30) | 0.174 |
| Fatal ICH | 36/3532 (1.0) | 8/1008 (0.8) | 0.78 (0.36 to 1.68) | 0.520 | 0.95 (0.52 to 1.73) | 0.857 |
*The common OR was estimated from an ordinal logistic-regression model and indicates the odds of a decrease of 1 in the modified Rankin Scale (mRS) score.
†Neurological deterioration (≥4 points increase in National Institutes of Health Stroke Scale (NIHSS) score) or death within 24–36 hours.
‡The main definition of symptomatic intracerebral haemorrhage (ICH) used was from Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST), as a large local or remote parenchymal intracerebral haemorrhage (>30% of the infarcted area affected by haemorrhage with mass effect or extension outside the infarct) in combination with neurological deterioration from baseline (increase of ≥4 in in the NIHSS score) or death within 36 hours. Symptomatic ICH was also assessed according to other trial criteria (see appendix).
CI, confidence interval; ECASS2 and ECASS 3, second and third European Cooperative Acute Stroke Studies; IST3, third International Stroke Study; NINDS, National Institute of Neurological Disorders and Stroke; OR, odds ratio.