Table 3. Clinical Outcomes at 3 Months for Tier 1, Tier 2, and the Overall Trial of Combination Treatment Versus rt-PA–Only Groups.
Tier 1 | Tier 2 | Overall | |||||||
---|---|---|---|---|---|---|---|---|---|
Combined | Control | P Value | Combined | Control | P Value | Combined | Control | P Value | |
n | 29 | 11 | 40 | 14 | 69 | 25 | |||
mRS score 0–1 or return to baseline* | 9 (31%) | 5 (45%) | 0.47 | 12 (30%) | 7 (50%) | 0.21 | 21 (30%) | 12 (48%) | 0.14 |
Barthel index ≤95* | 12 (41%) | 8 (73%) | 0.16 | 20 (50%) | 10 (71%) | 0.22 | 32 (46%) | 18 (72%) | 0.04 |
Glasgow outcome score 0* | 13 (45%) | 5 (45%) | 1.0 | 15 (38%) | 8 (57%) | 0.23 | 28 (41%) | 13 (52%) | 0.35 |
Symptomatic ICH | 1 (3%) | 1 (9%) | 0.48 | 0 (0%) | 1 (7%) | 0.26 | 1 (1%) | 2 (8%) | 0.17 |
Any ICH | 5 (17%) | 3 (27%) | 0.66 | 3 (8%) | 2 (14%) | 0.60 | 8 (12%) | 5 (20%) | 0.32 |
Death at 90 days | 8 (28%) | 1 (9%) | 0.40 | 7 (18%) | 2 (14%) | 1.0 | 15 (22%) | 3 (12%) | 0.38 |
Death at 7 days | 4 (14%) | 1 (9%) | 1.0 | 5 (12%) | 0 (0%) | 0.31 | 9 (13%) | 1 (4%) | 0.28 |
NIHSS score decrease ≥4 in 24 hours | 14 (48%) | 6 (54%) | 1.0 | 15 (38%) | 5 (36%) | 1.0 | 29 (42%) | 11 (44%) | 1.0 |
NIHSS score ≤2 at 24 hours | 2 (7%) | 1 (9%) | 1.0 | 7 (18%) | 4 (29%) | 0.45 | 9 (13%) | 5 (20%) | 0.51 |
Data are expressed as n (%); comparisons were made with Fisher's exact test owing to small numbers.
Deaths (n=18) and missing (n=4) patients were coded as “bad” outcome.