Table 1. Baseline characteristics of included trials.
Variable | NINDS A | NINDS B | ECASS I | ECASS II | ATLANTIS A | ATLANTIS B | ECASS III | EPITHET | IST-3 | TOTAL |
---|---|---|---|---|---|---|---|---|---|---|
Number randomized | 291 | 333 | 620 | 800 | 142 | 613 | 821 | 101 | 3035 | 6756 |
Alteplase | 144 (49%) | 168 (50%) | 313 (50%) | 409 (51%) | 71 (50%) | 301 (49%) | 418 (51%) | 52 (51%) | 1515 (50%) | 3391 (50%) |
Control | 147 (51%) | 165 (50%) | 307 (50%) | 391 (49%) | 71 (50%) | 312 (51%) | 403 (49%) | 49 (49%) | 1520 (50%) | 3365 (50%) |
Treatment delay (hours) | 2.0 (0.6) | 2.0 (0.6) | 4.4 (1.1) | 4.3 (1.1) | 4.3 (1.1) | 4.4 (0.8) | 4.0 (0.4) | 4.9 (0.8) | 4.2 (1.2) | 4.0 (1.2) |
>0, ≤3 | 290 (>99%) | 333 (100%) | 87 (14%) | 158 (20%) | 22 (15%) | 39 (6%) | - | - | 620 (20%) | 1549 (23%) |
>3, ≤4.5 | 1 (<1%) | - | 233 (38%) | 265 (33%) | 53 (37%) | 249 (41%) | 788 (96%) | 31 (31%) | 1148 (38%) | 2768 (41%) |
>4.5 | - | - | 295 (48%) | 370 (46%) | 67 (47%) | 321 (52%) | 6 (1%) | 69 (68%) | 1266 (42%) | 2394 (35%) |
Missing | - | - | 5 (1%) | 7 (1%) | - | 4 (1%) | 27 (3%) | 1 (1%) | 1 (<1%) | 45 (1%) |
Age (years) | 66 (11) | 68 (12) | 65 (12) | 66 (11) | 66 (13) | 66 (11) | 65 (12) | 72 (13) | 77 (12) | 71 (13) |
≤80 | 279 (96%) | 289 (87%) | 615 (>99%) | 792 (99%) | 142 (100%) | 608 (>99%) | 805 (98%) | 76 (75%) | 1418 (47%) | 5024 (74%) |
>80 | 12 (4%) | 44 (13%) | 5 (1%) | 8 (1%) | - | 3 (<1%) | 15 (2%) | 25 (25%) | 1617 (53%) | 1729 (26%) |
Missing | - | - | - | - | - | 2 (<1%) | 1 (<1%) | - | - | 3 (<1%) |
Stroke severity (NIHSS) | 14 (7) | 15 (7) | 12 (6) | 12 (6) | 13 (7) | 11 (6) | 10 (5) | 13 (6) | 12 (7) | 12 (7) |
>0, ≤4 | 16 (5%) | 13 (4%) | 34 (5%) | 47 (6%) | 10 (7%) | 47 (8%) | 98 (12%) | 1 (1%) | 400 (13%) | 666 (10%) |
>4, ≤10 | 78 (27%) | 98 (29%) | 189 (30%) | 339 (42%) | 57 (40%) | 279 (46%) | 389 (47%) | 40 (40%) | 1064 (35%) | 2533 (37%) |
>10, ≤15 | 68 (23%) | 63 (19%) | 183 (30%) | 232 (29%) | 28 (20%) | 128 (21%) | 163 (20%) | 22 (22%) | 601 (20%) | 1488 (22%) |
>15, ≤21 | 76 (26%) | 78 (23%) | 146 (24%) | 113 (14%) | 25 (18%) | 106 (17%) | 142 (17%) | 29 (29%) | 618 (20%) | 1333 (20%) |
>21 | 45 (15%) | 74 (22%) | 28 (5%) | 43 (5%) | 20 (14%) | 33 (5%) | 18 (2%) | 9 (9%) | 352 (12%) | 622 (9%) |
Missing | 8 (3%) | 7 (2%) | 40 (6%) | 26 (3%) | 2 (1%) | 20 (3%) | 11 (1%) | - | * | 114 (2%) |
Female | 120 (41%) | 142 (43%) | 231 (37%) | 331 (41%) | 45 (32%) | 250 (41%) | 325 (40%) | 43 (43%) | 1570 (52%) | 3057 (45%) |
History of hypertension | 188 (65%) | 220 (66%) | 258 (42%) | 412 (52%) | 87 (61%) | 364 (59%) | 514 (63%) | 71 (70%) | 1954 (64%) | 4068 (60%) |
History of stroke | 49 (17%) | 34 (10%) | 83 (13%) | 158 (20%) | 31 (22%) | 89 (15%) | 89 (11%) | 11 (11%) | 699 (23%) | 1243 (18%) |
History of diabetes mellitus | 64 (22%) | 67 (20%) | 81 (13%) | 169 (21%) | 27 (19%) | 130 (21%) | 129 (16%) | 23 (23%) | 388 (13%) | 1078 (16%) |
History of atrial fibrillation | 55 (19%) | 60 (18%) | 113 (18%) | 188 (24%) | 37 (26%) | 97 (16%) | 108 (13%) | 42 (42%) | 914 (30%) | 1614 (24%) |
Antiplatelet use | 78 (27%) | 93 (28%) | 87 (14%) | 196 (25%) | 59 (42%) | 211 (34%) | 201 (24%) | 30 (30%) | 1306 (43%) | 2261 (33%) |
Weight (kg) | 78 (17) | 78 (19) | 74 (12) | 75 (14) | 80 (20) | 79 (18) | 78 (15) | 75 (19) | 72 (15) | 75 (16) |
Systolic blood pressure (mmHg) | 154 (21) | 152 (21) | 154 (23) | 152 (21) | 152 (24) | 152 (21) | 153 (21) | 148 (19) | 155 (24) | 154 (22) |
Diastolic blood pressure (mmHg) | 85 (13) | 85 (14) | 87 (13) | 84 (13) | 81 (14) | 82 (14) | 84 (14) | 78 (13) | 82 (15) | 83 (14) |
Categorical data presented as n (%), continuous data presented as mean (SD). NINDS=National Institute of Neurological Disorders and Stroke; ECASS=European Cooperative Acute Stroke Study; ATLANTIS=Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke; EPITHET=Echoplanar Imaging Thrombolytic Evaluation Trial; IST=International Stroke Trial.
In IST-3, 244 patients had their baseline NIHSS score predicted from other measurements recorded at their baseline assessment. Ignoring these patients, the numbers of IST-3 patients in each category of baseline NIHSS score above would be 385, 972, 531, 559 and 344 respectively.