Association of categorical baseline systolic blood pressure with outcomes
Subgroup | Clopidogrel plus aspirin (N=1502) | Aspirin alone (N=1413) | Treatment effect metric | Unadjusted | Adjusted | Pint value | |||
Treatment difference (95% CI) | P value | Treatment difference (95% CI) | P value | ||||||
Primary outcome | |||||||||
END at 7 days* | SBP<140 mm Hg | 17/496 (3.4) | 19/454 (4.2) | RD† | −0.8 (−3.2 to 1.7) | 0.54 | −0.8 (−3.2 to 1.7) | 0.54 | 0.50 |
SBP≥140 mm Hg | 55/1006 (5.5) | 76/959 (7.9) | −2.5 (−4.7 to −0.2) | 0.03 | −2.5 (−4.1 to −1.0) | <0.01 | |||
Secondary outcomes | |||||||||
mRS 0–1 at 90 days‡ | SBP<140 mm Hg | 395/489 (80.8) | 346/441 (78.5) | RD† | 2.3 (−2.9 to 7.5) | 0.38 | 2.3 (−2.9 to 7.5) | 0.38 | 0.90 |
SBP≥140 mm Hg | 735/981 (74.9) | 669/920 (72.7) | 2.2 (−1.7 to 6.2) | 0.27 | 2.2 (−0.6 to 5.0) | 0.12 | |||
mRS at 90 days‡ | SBP<140 mm Hg | NA | NA | OR§ | 1.07 (0.84 to 1.36) | 0.59 | 1.07 (0.84 to 1.36) | 0.59 | 0.96 |
SBP≥140 mm Hg | NA | NA | 1.10 (0.93 to 1.29) | 0.28 | 1.09 (0.97 to 1.23) | 0.14 | |||
Change in NIHSS at 14 day¶ | SBP<140 mm Hg | −0.69 (−1.25 to −0.34) | −0.65 (−1.61 to −0.34) | GMR† | 0.02 (−0.57 to 0.59) | 0.96 | −0.15 (−0.72 to 0.42) | 0.60 | 0.98 |
SBP≥140 mm Hg | −0.51 (−0.92 to −0.22) | −0.51 (-0.92 to −0.22) | 0.32 (−0.28 to 0.91) | 0.29 | 0.32 (−0.09 to 0.73) | 0.13 | |||
New stroke within 90 days** | SBP<140 mmHg | 3/489 (0.6) | 3/441 (0.7) | HR†† | 0.90 (0.18 to 4.47) | 0.90 | 0.90 (0.18 to 4.47) | 0.90 | 0.74 |
SBP≥140 mm Hg | 9/981 (0.9) | 10/920 (1.1) | 0.85 (0.34 to 2.08) | 0.71 | 0.82 (0.33 to 2.04) | 0.65 | |||
Other vascular events or death within 90 days | SBP<140 mm Hg | 6/489 (1.2) | 2/441 (0.5) | HR†† | 2.72 (0.55 to 13.47) | 0.22 | 2.72 (0.55 to 13.47) | 0.22 | 0.39 |
SBP≥140 mm Hg | 10/981 (1.0) | 10/920 (1.1) | 0.94 (0.39 to 2.25) | 0.89 | 0.93 (0.39 to 2.24) | 0.87 | |||
Safety outcomes | |||||||||
Any bleeding events | SBP<140 mm Hg | 6/496 (1.2) | 5/454 (1.1) | RD† | 0.1 (−1.3 to 1.5) | 0.88 | 0.1 (−1.3 to 1.5) | 0.88 | 0.65 |
SBP≥140 mm Hg | 4/1006 (0.4) | 9/959 (0.9) | −0.5 (−1.3 to 0.2) | 0.14 | −0.5 (−1.1 to 0.0) | 0.05 | |||
Intracranial haemorrhage | SBP<140 mm Hg | 1/496 (0.2) | 1/454 (0.2) | RD† | 0.0 (−0.6 to 0.6) | 0.95 | 0.0 (−0.6 to 0.6) | 0.95 | 0.99 |
SBP≥140 mm Hg | 0/1006 (0.0) | 1/959 (0.1) | −0.1 (−0.3 to 0.1) | 0.31 | −0.1 | 0.14 |
The data were shown with median (IQR) for continuous characteristic or frequency (percentages) for categorical characteristic.
*END was defined as an increase between baseline and 7 days of ≥2 on the NIHSS score, but not as result of cerebral haemorrhage.18
†Calculated using the generalised liner model.
‡Scores on the mRS of functional disability range from 0 (no symptoms) to 6 (death).
§A shift measures of function according to the full range of scores on the mRS at 90 days was analysed by ordinal logistic regression.
¶Patients with NIHSS scores of 4–10 were eligible for this study; NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit. The log (NIHSS+1) was analysed using generalised linear model.
**New stroke included ischaemic stroke and haemorrhagic stroke.
††Calculated using the Cox regression model.
END, early neurological deterioration; GMR, geometric mean ratio; mRS, modified Rankin Scale; NA, not applicable; NIHSS, National Institute of Health Stroke Scale; RD, risk difference; SBP, systolic blood pressure.