TABLE 2.
Outcomes
| BEST: TI n = 46 | BEST: TE n = 52 | P value (BEST-TE vs BEST-TI) | DAWN (untreated) n = 99 | DEFUSE-3 (untreated) n = 90 | P value (BEST-TI vs DAWN) | P value (BEST-TI vs DEFUSE-3) | |
|---|---|---|---|---|---|---|---|
| Primary efficacy outcome | |||||||
| Good functional outcome* at 90 d | 16/45 (36%) | 14/47 (30%) | .56 | 13 (13%) | 15 (17%) | <.01 | .01 |
| Secondary efficacy outcomes | |||||||
| Successful recanalization (TICI 2b/3) | 40 (87%) | 44 (85%) | .74 | NR | NR | n/a | n/a |
| NIHSS at 24 h, median (IQR) | 11 (5-15) | 12 (5-18) | .66 | NR | NR | n/a | n/a |
| Change in NIHSS from 0 h to 24 h, median (IQR) | −1 (−4 to 3) | −5 (−11 to 0) | <.01 | NR | NR | n/a | n/a |
| Favorable discharge disposition‡ | 36 (78%) | 44 (85%) | .42 | NR | NR | n/a | n/a |
| mRS at 90 d, median (IQR) | 3 (2-5) | 3 (2-5) | .74 | NR | 4 (3-6) | n/a | – |
| Safety outcomes | |||||||
| Symptomatic ICH§ within 72 h | 6 (13%) | 2 (4%) | .14 | 3 (3%) | 4 (4%) | .02 | .05 |
| Any ICH|| | 15 (33%) | 17 (33%) | .99 | 33 (33%) | NR | 1.00 | n/a |
| Death by 90 d | 8/45 (18%) | 6/47 (13%) | .50 | 18 (18%) | 23 (26%) | 1.00 | .30 |
IQR, interquartile range; ICH, intracerebral hemorrhage; mRS, modified Rankin Scale score; NIHSS, National Institutes of Health Stroke Scale; NR, not reported; TI, trial-ineligible
*Good functional outcome indicates a mRS score of 0 to 2.
‡Favorable discharge disposition indicates discharge to home or an acute inpatient rehabilitation facility.
§In BEST, “symptomatic ICH” indicated any ICH within 72 h with a worsening in NIHSS of ≥4 points from 0 to 24 h. For DAWN, symptomatic ICH meant any extravascular blood in the cranium with a worsening in NIHSS of ≥4 points within 24 h. For DEFUSE-3, symptomatic ICH meant any ICH within 36 h with a worsening in NIHSS of ≥4 points by 36 h.
||In BEST, “any ICH” indicated any ICH within 72 h. For DAWN, this window was limited to 24 h. Because of these differences in definitions, statistical comparisons were not made.