Table 2.
Primary and secondary efficacy outcomes in the intention-to-treat population after removing centers with perceived endovascular equipoise shift.
| Variables | Intervention (n = 310) |
Control (n = 314) |
Unadjusted OR (95% CI) |
p | Adjusteda
OR (95% CI) |
p |
|---|---|---|---|---|---|---|
| Primary outcome: ordinal analysis of mRS score at 90 days (median, IQR) | ||||||
| USb | 2.0 (1.0–4.0) | 3.0 (1.0–4.0) | 1.22 (0.88–1.68) | 0.22 | 1.20 (0.87–1.68) | 0.27 |
| Globalc | 2.0 (1.0–4.0) | 3.0 (1.0–4.0) | 1.16 (0.86–1.54) | 0.33 | 1.20 (0.89–1.62) | 0.24 |
| Secondary outcomes | ||||||
| mRS score at 7 days or discharged US | 3.0 (1.0–4.0) | 4.0 (1.0–5.0) | 1.18 (0.86–1.63) | 0.30 | 1.20 (0.86–1.67) | 0.27 |
| mRS score at 7 days or discharged Global | 3.0 (1.0–4.0) | 4.0 (1.0–5.0) | 1.12 (0.84–1.50) | 0.43 | 1.22 (0.90–1.64) | 0.20 |
| mRS score at 90 days 0–1; USb, n (%) | 80 (34.5%) | 69 (29.6%) | 1.25 (0.85–1.85) | 0.27 | 1.30 (0.85–2.00) | 0.22 |
| mRS score at 90 days 0–1; Globalc, n (%) | 94 (33.2%) | 88 (31.2%) | 1.10 (0.77–1.56) | 0.65 | 1.17 (0.80–1.72) | 0.41 |
| mRS score at 90 days 0–2; USb, n (%) | 122 (52.6%) | 103 (44.2%) | 1.40 (0.97–2.02) | 0.08 | 1.53 (1.01–2.31) | 0.04 |
| mRS score at 90 days 0–2; Globalc, n (%) | 144 (50.9%) | 125 (44.3%) | 1.30 (0.93–1.81) | 0.13 | 1.47 (1.02–2.13) | 0.04 |
| Independent functional outcome at 90 dayse; USb, n (%) | 92 (39.7%) | 82 (35.2%) | 1.21 (0.83–1.76) | 0.34 | 1.25 (0.84–1.86) | 0.27 |
| Independent functional outcome at 90 dayse; Globalc, n (%) | 109 (38.5%) | 102 (36.2%) | 1.10 (0.79–1.55) | 0.60 | 1.18 (0.83–1.69) | 0.36 |
| Dramatic clinical recovery at 2 hf; US, n (%) | 54 (22.0%) | 52 (20.5%) | 1.10 (0.71–1.69) | 0.74 | 1.12 (0.72–1.74) | 0.63 |
| Dramatic clinical recovery at 2 hf; Global, n (%) | 56 (18.8%) | 57 (18.7%) | 1.00 (0.67–1.51) | 1.00 | 1.05 (0.68–1.61) | 0.84 |
| Clinical recovery at 24 hg; US, n (%) | 78 (32.6%) | 90 (36.1%) | 0.86 (0.59–1.24) | 0.45 | 0.85 (0.58–1.25) | 0.42 |
| Clinical recovery at 24 hg; Global, n (%) | 95 (32.8%) | 102 (34.3%) | 0.93 (0.66–1.31) | 0.73 | 0.96 (0.68–1.37) | 0.84 |
| Neurological improvement at 24 hh; US, n (%) | 141 (59.0%) | 139 (55.8%) | 1.14 (0.79–1.63) | 0.52 | 1.16 (0.80–1.69) | 0.43 |
| Neurological improvement at 24 hh; Global, n (%) | 169 (58.3%) | 163 (54.9%) | 1.15 (0.83–1.59) | 0.45 | 1.20 (0.86–1.69) | 0.29 |
| Neurological deterioration at 24 hi; US, n (%) | 20 (8.4%) | 17 (6.8%) | 1.25 (0.63–2.44) | 0.61 | 1.17 (0.58–2.37) | 0.66 |
| Neurological deterioration at 24 hi; Global, n (%) | 26 (9.0%) | 19 (6.4%) | 1.44 (0.78–2.67) | 0.28 | 1.29 (0.69–2.44) | 0.43 |
| NIHSSj at day 7 US, median (IQR) | 5 (1–10.25) | 6 (1–13) | 0.25 | |||
| NIHSSj at day 7 Global, median (IQR) | 5 (1–11) | 6 (1–12.75) | 0.24 | |||
| NIHSSk at day 90 US, median (IQR) | 2 (0–5) | 2 (0–5) | 0.37 | |||
| NIHSSk at day 90 Global, median (IQR) | 2 (0–6) | 2 (0–6) | 0.26 | |||
| Duration of hospital stay until discharge; US, days, median (IQR)l | 7 (5–10.25) | 7 (5.0–11.00) | 0.77 | |||
| Duration of hospital stay until discharge; Global, days, median (IQR)m | 7 (5–12) | 7 (4.75–11.00) | 0.92 | |||
Intervention: sonothrombolysis.
Control: intravenous thrombolysis.
ORs were adjusted for age, NIHSS score at baseline; time from stroke onset to tPA bolus, and baseline serum glucose.
Patients treated with intravenous thrombolysis within 3 h from symptom onset; there were 23 and 28 patients with missing data in the intervention and control arms, respectively.
Patients treated with intravenous thrombolysis within 4.5 h from symptom onset; there were 27 and 32 patients with missing data in the intervention and control arms, respectively.
There were 26 subjects in the intervention arm 20 subjects in the control arm missing day 7 or discharge mRS in the US cohort. There were 31 subjects in the intervention arm and 25 in the control arm missing day 7 or discharge mRS for the Global cohort.
Independent functional outcome adjusting for pretreatment NIHSS assessed at 90 ± 10 days post-treatment includes a mRS score of 0–1 for subjects with pretreatment NIHSS 10–14, or a mRS score of 0–2 for subjects with pretreatment NIHSS > 14.
Dramatic clinical recovery assessed at 120 ± 15 mins after headframe activation includes a reduction of 10 or more points on NIHSS compared with pretreatment, or a total NIHSS score of 3 or less. There were 31 and 33 patients with missing data in the intervention and control arms, respectively, for the US outcome of dramatic clinical recovery. There were 36 and 39 patients with missing data in the intervention and control arms, respectively, for the Global outcome of dramatic clinical recovery.
Clinical recovery assessed at 24 ± 2 h after headframe activation includes a reduction of 10 or more points on NIHSS compared with pretreatment, or a total NIHSS score of 3 or less. There were 37 and 37 patients with missing data in the intervention and control arms, respectively, for the US outcome of clinical recovery. There were 44 and 45 patients with missing data in the intervention and control arms, respectively, for the Global outcome of dramatic clinical recovery.
Neurological improvement assessed at 24 ± 2 h after headframe activation requires a reduction of 5 or more points on NIHSS compared with the pretreatment score. There were 37 and 37 patients with missing data in the intervention and control arms, respectively, for the US outcome of neurological improvement at 24 h. There were 44 and 45 patients with missing data in the intervention and control arms, respectively, for the Global outcome of neurological improvement at 24 h.
Neurological worsening assessed at 24 ± 2 h after headframe activation requires an increase of 4 or more points on NIHSS compared with the pretreatment score. There were 37 and 37 patients with missing data in the intervention and control arms, respectively, for the US outcome of neurological worsening at 24 h. There were 44 and 45 patients with missing data in the intervention and control arms, respectively, for the Global outcome of neurological worsening at 24 h.
There were 31 subjects in the intervention arm 24 subjects in the control arm missing day 7 NIHSS in the US cohort. There were 39 subjects in the intervention arm and 32 in the control arm missing day 7 NIHSS for the Global cohort.
There were 92 subjects in the intervention arm 102 subjects in the control arm missing day 90 NIHSS in the US cohort. There were 111 subjects in the intervention arm and 118 in the control arm missing day 90 NIHSS for the Global cohort.
There were 39 and 29 patients with missing data in the intervention and control arms respectively.
There were 47 and 38 patients with missing data in the intervention and control arms, respectively.
Common ORs were computed using ordinal logistic regression analyses after collapsing mRS scores 5 and 6.
CI, confidence interval; IQR, interquartile range; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale; OR, odds ratio; SD, standard deviation; tPA, tissue plasminogen activator.