Article Figures & Data
- Figure 1
Forest plot for symptomaticintracerebral haemorrhage (ICH) variables at 90 days. ECASS2/3, second and third European Cooperative AcuteStroke Studies; IST3, third International Stroke Trial; NINDS, National Institute of Neurological Disorders andStroke; SITS-MOST, Safe Implementation of Thrombolysis inStroke-Monitoring Study.
- Table 1
Baseline patient characteristics and management by smoking status
Variables Non-smoking
(N=3532)Smoking
(N=1008)P value Time from symptom onset to randomisation, min 2.9 (2.2–3.7) 2.9 (2.2–3.8) 0.680 Time from symptom onset to intravenous alteplase, min 170 (129–217) 175 (131–224) 0.068 Age, years 68.2 (12.7) 61.5 (11.2) <0.001 Female 1583 (44.8) 132 (13.1) <0.001 Asian 2245 (63.6) 282 (28.0) <0.001 Systolic blood pressure 154 (19) 152 (19) <0.001 Diastolic blood pressure 86 (13) 88 (13) <0.001 Heart rate 79 (16) 79 (14) 0.549 NIHSS score 8 (5–13) 7 (4–12) <0.001 GCS 15 (13–15) 15 (14–15) <0.001 Medical history Hypertension 2360/3532 (66.8) 573/1008 (56.8) <0.001 Stroke 653/3532 (18.5) 168/1008 (16.7) 0.185 Coronary artery disease 534/3532 (15.1) 109/1008 (10.8) 0.001 Other heart diseases 232/3532 (6.6) 49/1008 (4.9) 0.047 Atrial fibrillation 698/3528 (19.8) 107/1008 (10.6) <0.001 Diabetes mellitus 755/3532 (21.4) 170/1008 (16.9) 0.002 Hypercholesterolaemia 572/3532 (16.2) 132/1008 (13.1) 0.017 Premorbid symptom-free (mRS 0) 2905/3530 (82.3) 869/1007 (86.3) 0.003 Antihypertensive agent(s) 1698/3532 (48.1) 373/1008 (37.0) <0.001 Statin/other lipid-lowering 708/3529 (20.1) 135/1007 (13.4) <0.001 Aspirin/other antiplatelet agent(s) 831/3530 (23.5) 153/1007 (15.2) <0.001 Warfarin anticoagulation 90/3530 (2.5) 10/1007 (1.0) 0.003 Glucose lowering agent(s) 484/3530 (13.7) 98/1007 (9.7) 0.001 Pathological subtype Large-artery occlusion 1377/3394 (40.6) 427/963 (44.3) <0.001 Cardioembolism 781/3394 (23.0) 276/963 (28.7) Small-vessel or perforator disease 684/3394 (20.2) 112/963 (11.6) Other/uncertain aetiology 552/3394 (16.3) 148/963 (15.4) Management Intubation and ventilation 181/3480 (5.2) 46/988 (4.7) 0.491 Nasogastric feeding 636/3479 (18.3) 153/988 (15.5) 0.042 Physiotherapy mobilisation 1579/3479 (45.4) 391/988 (39.6) 0.001 Compression stockings 320/3478 (9.2) 62/988 (6.3) 0.004 Subcutaneous heparin 710/3532 (20.1) 151/1008 (15.0) <0.001 Antithrombotic agent in first 24 hours 593/3522 (16.8) 152/1007 (15.1) 0.188 Haemicraniectomy 34/3480 (1.0) 13/988 (1.3) 0.357 Intensive care unit admission 785/3479 (22.6) 216/988 (21.9) 0.641 Rehabilitation 1725/3480 (49.6) 495/988 (50.1) 0.768 Decision to withdrawal active care 97/3481 (2.8) 14/988 (1.4) 0.015 Data are n/N (%), mean (SD) or median (IQR).
GCS, Glasgow Coma Scale; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
- Table 2
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.
- Table 3
Logistic regression models for primary outcome, with variable exclusions
Outcome Models OR (95% CI) P value Ordinal mRS Model 1 1.23 (1.07 to 1.40) 0.003 Model 2 1.26 (1.10 to 1.43) 0.001 Model 3 1.12 (0.98 to 1.27) 0.088 Model 4 0.96 (0.85 to 1.09) 0.557 Model 1: fully adjusted for sex, age, ethnic group, baseline National Institutes of Health Stroke Scale (NIHSS), baseline systolic blood pressure, history of hypertension, acute coronary syndrome, other heart disease, diabetes mellitus, hypercholesterolaemia, prior use of antiplatelet use, anticoagulant use, glucose lowering agent, lipid lowering agent, modified Rankin Scale (mRS) before stroke.
Model 2: variables in model 1 with exclusion of sex.
Model 3: variables in model 1 with exclusion of age and sex.
Model 4: variables in model 1 with exclusion of age, sex and baseline NIHSS score.
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