Table 5.
Desmoteplase 90 µg/kg | Desmoteplase 125 µg/kg | Placebo | DIAS/DEDAS vs DIAS-2 | ||||
---|---|---|---|---|---|---|---|
DIAS/DEDAS (n=29) | DIAS-2 (n=57) | DIAS/DEDAS (n=30) | DIAS-2 (n=66) | DIAS/DEDAS (n=35) | DIAS-2 (n=63) | p value | |
NIHSS | 11.6 (4.4); | 10.7 (5.6); | 11.1 (4.9); | 10.4 (4.6); | 11.8 (4.5); | 10.3 (5.0); | 0.053 |
11 (8 to 15) | 9 (7 to 14) | 11 (7 to 16) | 9 (7 to 15) | 12 (8 to 16) | 9 (6 to 14) | ||
Men | 15 (52%) | 27 (47%) | 16 (53%) | 29 (44%) | 19 (54%) | 37 (59%) | 0.70 |
Core lesion volume (cm3) | 35.8 (26.0); | 21.3 (32.0); | 40.1 (36.6); | 17.6 (17.7); | 30.1 (25.4); | 16.2 (17.1); | <0.0001 |
27.6 (14 to 53) | 7.9 (3 to 25) | 22.1 (13 to 68) | 11.3 (3 to 31) | 23.5 (10 to 47) | 12.3 (4 to 20) | ||
Mismatch volume (cm3) | 117.4 (117.4); | 83.3 (80.2); | 133.6 (90.9); | 87.0 (70.4); | 115.1 (101.7); | 75.8 (72.6); | 0.008 |
113.9 (13 to 195) | 51.9 (25 to 127) | 129.9 (44 to 219) | 66.2 (32 to 138) | 99.2 (23 to 205) | 48.8 (26 to 106) | ||
Mismatch volume (%) | 550 (650); | 3400 (14 000); | 950 (1400); | 4200 (12 000); | 540 (670); | 1400 (2900); | 0.002 |
310 (50 to 870) | 510 (120 to 1700) | 240 (160 to 1400) | 530 (210 to 2400) | 270 (75 to 730) | 480 (220 to 1500) | ||
Vessel occlusion* | |||||||
TIMI 0–1 | 15 (54%) | 14 (26%) | 16 (59%) | 22 (36%) | 20 (59%) | 17 (27%) | 0.0001 |
Time since stroke onset | |||||||
3–6 h | 6 (21%) | 19 (33%) | 19 (63%) | 24 (36%) | 23 (66%) | 26 (41%) | 0.03 |
Data are mean (SD), median (IQR), or number (%). DIAS/DEDAS=Desmoteplase In Acute ischemic Stroke/Dose Escalation study of Desmoteplase in Acute ischemic Stroke phase II studies.
Patients with available TIMI assessment (DIAS/DEDAS vs DIAS-2): 90 µg/kg (n=28 vs 54); 125 µg/kg (n=27 vs 62); and placebo (n=34 vs 63).