Table 2.
GAMES-Pilot patients versus historical controls (subset of EPITHET and MMI-MRI subjects with baseline DWI lesion volume >82 cm3)
| Patient characteristic | GAMES-Pilot (n = 10)
|
Subset of EPITHET with DWI > 82 cm3 (n = 15)
|
Subset of MMI-MRI with DWI > 82 cm3 (n = 16)
|
|||
|---|---|---|---|---|---|---|
| Mean or % | 95 % CIa | Mean or % | 95 % CIa | Mean or % | 95 % CIa | |
| Age, mean (SD) | 50.5 (15.3) | (39.6, 61.4) | 70 (13) | (62.8, 77.6) | 59.6 (14.5) | (51.8, 67.3) |
| Onset to MRI (h), mean (SD) | 5.3 (1.9) | (3.9, 6.7) | 4.1 (0.9) | (3.6, 4.6) | 3.0 (1.1) | (2.4, 3.6) |
| Baseline NIHSS, median (IQR) | 18 (8) | (13.6, 22.0) | 19 (5.5) | (16.7, 21.6) | 20 (4.5) | (18.5, 22.8) |
| Baseline glucose, mean (SD) | 7.0 (1.7) | (5.7, 8.2) | 8 (3.4) | (6.6, 10.3) | 8.3 (4.9) | (5.3, 11.2) |
| Initial DWI lesion volume, mean (SD) | 102 (22.6) | (84.4, 119.2) | 141.9 (34.1) | (123.0, 160.8) | 125.3 (43.8) | (102.0, 148.7) |
| Initial hemisphere volume, mean (SD) | 468.2 (73.7) | (420.1, 516.3) | 460.3 (62.7) | |||
| Final visit hemisphere volume, mean (SD) | 507.9 (59.2) | (469.2, 546.6) | 531.8 (59.6) | |||
| IV rt-PA, % (n) | 90 % (9) | (55.5 %, 99.8 %) | 53.3 % (8) | (26.6 %, 78.7 %) | 37.5 % (6) | (15.2 %, 64.6 %) |
| Vessel occlusion | 0 % | (0 %, 30.1 %) | N/A | 0 % | (0 %, 20.6 %) | |
| ICA alone, % (n) | 30 % (3) | (0.3 %, 44.5 %) | N/A | 62.5 % | (35.4 %, | |
| Tandem ICA and MCA, % (n) | 100 % (10) | (69.2 %, 100 %) | N/A | (10) | 84.8 %) | |
| MCA, % (n) | 37.5 % (6) | (15.2 %, 64.6 %) | ||||
| Clinical outcomes | ||||||
| Post-baselineb NIHSS improvement of 4 or more points, % (n) | 40 % (4) | (12.2 %, 73.8 %) | 16.7 % (2/12) | (2.1 %, 48.4 %) | 33.3 % (3/9) | (7.5 %, 70.1 %) |
| 90 day mRSc, median (IQR) | 4 (1) | (2.9, 4.5) | 5 (2) | (4.0, 5.6) | 5 (2) | (4.2, 5.7) |
| 90 day mRSc (0–3), % (n) | 40 % (4) | (12.2 %, 73.8 %) | 13.3 % (2) | (1.7 %, 40.5 %) | 16.7 % (2/12) | (2.1 %, 48.4 %) |
| 90 day mRSc (0–4), % (n) | 90 % (9) | (55.5 %, 99.8 %) | 33.3 % (5) | (11.8 %, 61.6 %) | 33.3 % (4/12) | (9.9 %, 65.1 %) |
| 90 day mRSc (0–4 without DC), % (n) | 80 % (8) | (44.4 %, 97.5 %) | 26.7 % (4) | (7.8 %, 55.1 %) | 26.7 % (4/15) | (7.8 %, 55.1 %) |
| DC, % (n) | 20 % (2) | (2.5 %, 55.6 %) | 6.7 % (1) | (0.2 %, 32.0 %) | 57.1% (8/14) | (28.9 %, 82.3 %) |
| Mortality, % (n) | 10 % (1) | (0.3 %, 44.5 %) | 40 % (6) | (16.3 %, 67.7 %) | 41.7 % (5/12) | (15.2 %, 72.3 %) |
| PH1/PH2, % (n) | 0 % | (0 %, 30.1 %) | 26.7 % (4) | (7.8 %, 55.1 %) | 8.3 %d (1/12) | (0.2 %, 38.5 %) |
a
Results shown for proportions are based on Clopper–Pearson (exact) methods
b
Post-baseline NIHSS was at day 7 for GAMES-Pilot and MMI-MRI and at day 3 for EPITHET
c
Summary includes the 90 day mRS score for one subject who was deemed lost to follow up but was later determined (external to the study) to have an mRS of 3
d
Based on symptomatic hemorrhage