Individualized tool in ENCHANTED

An individualized decision making tool for use of low versus standard dose alteplase in acute ischemic stroke

Population of interest:  thrombolysis eligible patients with acute ischemic stroke

Outcome:

      Benefit: scores 0-1 on the modified Rankin Scale at 90-days;

      Risk: symptomatic intracerebral hemorrhage defined by SITS-MOST or NINDS

Predictors:

  • Age
  • Ethnicity
  • Baseline NIHSS score
  • SBP
  • Pre-stroke mRS
  • Atrial Fibrillation
  • Diabetes mellitus
  • Time from onset to alteplase initiation

Risk Score Calculators

Interactive
Excel spreadsheets

Table 1 Final predictive model for benefit* at 90 days

Estimate SE P value
AF denotes atrial fibrillation, DM diabetes mellitus, mRS modified Rankin scale, NIHSS National Institutes of Health Stroke Scale, SBP systolic blood pressure, SE standard error
*according to scores 0-1 on the mRS at 90-days
†per 10 units increase
‡per hour increase
Age, years† -0.1242 0.052 0.016
Ethnicity Non-Asian
Asian
-0.1203 0.15 0.421
Baseline NIHSS score -0.0794 0.032 0.013
SBP, mmHg† -0.0166 0.029 0.567
Pre-stroke mRS 0
1
-1.1929 0.221 <0.0001
AF No
Yes
0.212 0.945 0.823
DM No
Yes
-0.7413 0.252 0.003
Time from onset to treatment‡ 0.1134 0.121 0.348
Randomized treatment Standard dose
Low dose
0.9903 0.918 0.281
Age × AF -0.0811 0.131 0.537
Ethnicity × pre-stroke mRS 0.7106 0.311 0.022
Ethnicity × DM 0.4534 0.304 0.136
Baseline NIHSS score × time from onset to treatment -0.0195 0.011 0.076
Age × randomized treatment 0.0222 0.073 0.762
Ethnicity× randomized treatment -0.0195 0.212 0.927
Baseline NIHSS score × randomized treatment -0.0169 0.047 0.722
SBP × randomized treatment -0.0844 0.042 0.043
Pre-stroke mRS × randomized treatment 0.4818 0.308 0.118
AF × randomized treatment 2.3149 1.33 0.082
DM × randomized treatment 0.0262 0.347 0.94
Time from onset to treatment × randomized treatment 0.0593 0.174 0.733
Age × AF × randomized treatment -0.3065 0.186 0.098
Ethnicity × pre-stroke mRS × randomized treatment -0.5287 0.445 0.234
Ethnicity × DM × randomized treatment 0.4223 0.428 0.324
Baseline NIHSS score × time from onset to treatment × randomized treatment -0.00502 0.016 0.758

 

Table 2 Final predictive model forthe risk of symptomatic intracranial hemorrhage*

Estimate SE P value
AF denotes atrial fibrillation, DM diabetes mellitus, mRS modified Rankin scale, NIHSS National Institutes of Health Stroke Scale, SBP systolic blood pressure, SE standard error
*defined according to the National Institute of Neurological Disorders and Stroke (NINDS) or the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST)
†per 10 units increase
‡per hour increase
Age, years† 0.0797 0.0985 0.4184
Ethnicity Non-Asian
Asian
0.1018 0.2679 0.7041
Baseline NIHSS score 0.0227 0.0429 0.5962
SBP, mmHg† 0.1135 0.0507 0.0251
Pre-stroke mRS 0
1
-0.1552 0.3606 0.6668
AF No
Yes
1.3155 1.2962 0.3102
DM No
Yes
0.0423 0.4233 0.9204
Time from onset to treatment‡ -0.2861 0.2121 0.1774
Randomized treatment Standard dose
Low dose
0.0648 1.7599 0.9706
Age × AF -0.1055 0.1792 0.556
Ethnicity × pre-stroke mRS 0.4049 0.4703 0.3893
Ethnicity × DM 0.3606 0.5 0.4707
Baseline NIHSS score × time from onset to treatment 0.0176 0.0146 0.2269
Age × randomized treatment -0.1301 0.1457 0.3719
Ethnicity× randomized treatment -0.013 0.4032 0.9744
Baseline NIHSS score × randomized treatment -0.0173 0.0698 0.8039
SBP × randomized treatment 0.0181 0.078 0.8166
Pre-stroke mRS × randomized treatment -0.6081 0.5743 0.2897
AF × randomized treatment -3.9182 2.2326 0.0793
DM × randomized treatment 0.9612 0.5673 0.0902
Time from onset to treatment × randomized treatment 0.1776 0.3205 0.5795
Age × AF × randomized treatment 0.5161 0.303 0.0885
Ethnicity × pre-stroke mRS × randomized treatment -0.0343 0.8097 0.9662
Ethnicity × DM × randomized treatment -1.6965 0.7337 0.0208
Baseline NIHSS score × time from onset to treatment × randomized treatment 0.00184 0.0228 0.9357