Table 3.
Associations between change in systolic BP from baseline to day 2 and clinical outcomes
| Overall | >15% decrease | 5%–15% decrease | 5% decrease to 5% increase | >5% increase | |||
| cOR/OR/HR/MD (95% CI) | P value | cOR/OR/HR/MD (95% CI) | P value | (Reference) | cOR/OR/HR/MD (95% CI) | P value | |
| N (%) | 994 | 601 | 401 | 230 | |||
| Baseline systolic BP, mm Hg, mean (SD) | 188.1 (24.6) | 167.8 (20.5) | 157.8 (20.2) | 143.5 (19.9) | |||
| Haematoma | |||||||
| Change in volume from baseline to 24 hours*, mL | −0.58 (-3.07, 1.92) | 1.00 | −0.27 (-2.73, 2.19) | 1.00 | 0 | −0.73 (-2.46, 3.92) | 1.00 |
| Haematoma expansion (%) | 0.95 (0.69, 1.29) | 0.72 | 0.83 (0.61, 1.13) | 0.23 | 1 | 1.04 (0.71, 1.54) | 0.83 |
| Day 2 | |||||||
| Death (%) | 0.58 (0.24, 1.42) | 0.24 | 0.48 (0.18, 1.25) | 0.13 | 1 | 1.54 (0.60, 3.94) | 0.37 |
| SAEs (%) | 1.22 (0.91, 1.64) | 0.18 | 0.97 (0.72, 1.30) | 0.83 | 1 | 1.34 (0.93, 1.93) | 0.12 |
| Day 7 | |||||||
| Death (%) | 0.71 (0.42, 1.19) | 0.19 | 0.43 (0.24, 0.76) | 0.003 | 1 | 1.78 (1.02, 3.12) | 0.044 |
| SAEs (%) | 1.26 (0.95, 1.68) | 0.11 | 1.05 (0.79, 1.40) | 0.72 | 1 | 1.55 (1.08, 2.22) | 0.018 |
| Day 90 | |||||||
| Primary outcome | |||||||
| mRS [/6] | 1.07 (0.84, 1.35) | 0.59 | 1.00 (0.79, 1.27) | 0.97 | 1 | 1.34 (0.99, 1.81) | 0.063 |
| Death (%) | 0.79 (0.59, 1.06) | 0.11 | 0.83 (0.62, 1.11) | 0.21 | 1 | 1.08 (0.77, 1.53) | 0.66 |
| SAEs (%) | 1.21 (0.91, 1.62) | 0.19 | 1.03 (0.78, 1.37) | 0.82 | 1 | 1.35 (0.94, 1.95) | 0.11 |
| Tranexamic acid, N (%) |
491 | 293 | 210 | 122 | |||
| Baseline systolic BP, mm Hg, mean (SD) | 187.6 (24.8) | 166.6 (20.5) | 158 (21.7) | 142.2 (19.2) | |||
| Haematoma | |||||||
| Change in volume from baseline to 24 hours*, mL | −1.81 (-5.21, 1.58) | 0.95 | −2.15 (-5.51, 1.21) | 0.55 | 0 | −0.22 (-4.48, 4.03) | 1.00 |
| Haematoma expansion (%) | 0.99 (0.63, 1.55) | 0.95 | 0.91 (0.58, 1.43) | 0.68 | 1 | 1.01 (0.58, 1.77) | 0.97 |
| Day 2 | |||||||
| Death (%) | 0.32 (0.09, 1.08) | 0.07 | 0.35 (0.09, 1.46) | 0.15 | 1 | 2.13 (0.62, 7.31) | 0.23 |
| SAEs (%) | 1.24 (0.82, 1.87) | 0.32 | 0.97 (0.64, 1.47) | 0.88 | 1 | 1.13 (0.67, 1.89) | 0.65 |
| Day 7 | |||||||
| Death (%) | 0.41 (0.20, 0.85) | 0.017 | 0.37 (0.16, 0.82) | 0.015 | 1 | 1.87 (0.85, 4.12) | 0.12 |
| SAEs (%) | 1.19 (0.80, 1.77) | 0.40 | 0.83 (0.56, 1.24) | 0.37 | 1 | 1.18 (0.72, 1.94) | 0.52 |
| Day 90 | |||||||
| Primary outcome | |||||||
| mRS [/6] | 0.95 (0.68, 1.32) | 0.76 | 1.08 (0.78, 1.50) | 0.64 | 1 | 1.35 (0.89, 2.06) | 0.16 |
| Death (%) | 0.62 (0.42, 0.93) | 0.022 | 0.75 (0.49, 1.13) | 0.17 | 1 | 0.99 (0.61, 1.60) | 0.97 |
| SAEs (%) | 1.09 (0.73, 1.63) | 0.67 | 0.84 (0.56, 1.24) | 0.37 | 1 | 0.89 (0.54, 1.46) | 0.64 |
| Placebo, N (%) | 503 | 308 | 191 | 108 | |||
| Baseline systolic BP, mm Hg, mean (SD) | 188.6 (24.3) | 168.9 (20.5) | 157.7 (18.4) | 144.9 (20.7) | |||
| Haematoma | |||||||
| Change in volume from baseline to 24 hours*, mL | 0.60 (-3.07, 4.28) | 1.00 | 1.42 (-2.19, 5.03) | 1.00 | 0 | 1.49 (-3.33, 6.32) | 1.00 |
| Haematoma expansion (%) | 0.92 (0.59, 1.42) | 0.69 | 0.76 (0.49, 1.16) | 0.20 | 1 | 1.05 (0.60, 1.83) | 0.87 |
| Day 2 | |||||||
| Death (%) | 1.35 (0.34, 5.30) | 0.67 | 0.66 (0.16, 2.77) | 0.57 | 1 | 1.04 (0.21, 5.22) | 0.96 |
| SAEs (%) | 1.21 (0.79, 1.84) | 0.38 | 0.97 (0.64, 1.46) | 0.87 | 1 | 1.54 (0.91, 2.61) | 0.11 |
| Day 7 | |||||||
| Death (%) | 1.21 (0.57, 2.58) | 0.62 | 0.52 (0.23, 1.18) | 0.12 | 1 | 1.78 (0.78, 4.06) | 0.17 |
| SAEs (%) | 1.36 (0.90, 2.06) | 0.15 | 1.33 (0.88, 2.00) | 0.17 | 1 | 1.99 (1.17, 3.39) | 0.011 |
| Day 90 | |||||||
| Primary outcome | |||||||
| mRS [/6] | 1.18 (0.84, 1.65) | 0.35 | 0.91 (0.65, 1.27) | 0.56 | 1 | 1.32 (0.85, 2.07) | 0.22 |
| Death (%) | 0.98 (0.64, 1.52) | 0.94 | 0.81 (0.52, 1.26) | 0.34 | 1 | 0.98 (0.58, 1.64) | 0.93 |
| SAEs (%) | 1.37 (0.90, 2.08) | 0.14 | 1.28 (0.85, 1.93) | 0.24 | 1 | 2.14 (1.24, 3.70) | 0.007 |
Ordinal, binary, multiple linear or Cox regression with adjustment for baseline prognostic factors. The 5% decrease to 5% increase group is the reference group for comparisons.
Bold p-values indicate <0.05
*Adjusted for baseline haematoma volume.
BP, blood pressure; cOR, common OR; MD, mean difference; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SAEs, serious adverse events.