Early versus delayed antihypertensive treatment in patients with acute ischaemic stroke: multicentre, open label, randomised, controlled trial
Document Type
Article
Abstract
OBJECTIVES: To compared the effect of early antihypertensive treatment started within 24-48 h of stroke onset versus delaying treatment until day eight on reducing dependency or death. DESIGN: Multicentre, randomised, open label trial. SETTING: 106 hospitals in China between 13 June 2018 and 10 July 2022. PARTICIPANTS: 4810 patients (≥40 years) were enrolled with acute ischaemic stroke within 24-48 h of symptom onset and elevated systolic blood pressure between 140 mm Hg and <220 mm Hg. INTERVENTIONS: Patients were randomly assigned to receive antihypertensive treatment immediately after randomisation (aimed at reducing systolic blood pressure by 10%-20% within the first 24 h and a mean blood pressure <140/90 mm Hg within seven days) or to discontinue antihypertensive medications for seven days if they were taking them, and then receive treatment on day 8 (aimed at achieving mean blood pressure <140/90 mm Hg). MAIN OUTCOME MEASURES: The primary outcome was the combination of functional dependency or death (modified Rankin scale score ≥3) at 90 days. Intention to treat analyses were conducted. RESULTS: 2413 patients were assigned to the early treatment group and 2397 were assigned to the delayed treatment group. Mean systolic blood pressure was reduced by 9.7% (from 162.9 mm Hg to 146.4 mm Hg) in the early treatment group and by 4.9% (from 162.8 mm Hg to 154.3 mm Hg) in the delayed treatment group within 24 h after randomisation (P for group difference <0.001). Mean systolic blood pressure was 139.1 mm Hg in the early treatment group and 150.9 mm Hg in the delayed treatment group on day seven (P for group difference <0.001). Additionally, 54.6% of patients in the early treatment group and 22.4% in the delayed treatment group had blood pressure of less than 140/90 mm Hg (P<0.001 for group difference) on day seven. At day 90, 289 trial participants (12.0%) in the early treatment group, compared with 250 (10.5%) in the delayed treatment group, had died or experienced a dependency (odds ratio 1.18 (95% confidence interval 0.98 to 1.41), P=0.08). No significant differences in recurrent stroke or adverse events were reported between the two groups. CONCLUSIONS: Among patients with mild-to-moderate acute ischaemic stroke and systolic blood pressure between 140 mm Hg and <220 mm Hg who did not receive intravenous thrombolytic treatment, early antihypertensive treatment did not reduce the odds of dependency or death at 90 days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03479554.
Medical Subject Headings
Humans; Antihypertensive Agents; Stroke (complications, drug therapy); Hypertension (complications, drug therapy); Brain Ischemia (complications, drug therapy); Treatment Outcome; Blood Pressure; Ischemic Stroke; Hypotension
Publication Date
10-9-2023
Publication Title
BMJ (Clinical research ed.)
E-ISSN
1756-1833
Volume
383
First Page
e076448
PubMed ID
37813418
Digital Object Identifier (DOI)
10.1136/bmj-2023-076448
Recommended Citation
Liu, Liping; Xie, Xuewei; Pan, Yuesong; Wang, Aili; Wei, Yufei; Liu, Jingyi; Nie, Ximing; Liu, Dacheng; Zhao, Zilin; Wang, Penglian; Shen, Suwen; Zhong, Chongke; Xu, Tan; Wang, Dali; Wang, Gui-Chun; Song, Denghua; Ma, Yunsheng; Zhao, Jinguo; Jiang, Yong; Jing, Jing; Meng, Xia; Obst, Katherine; Chen, Chung-Shiuan; Wang, David; Wang, Yilong; Zhang, Yonghong; Wang, Yongjun; and He, Jiang, "Early versus delayed antihypertensive treatment in patients with acute ischaemic stroke: multicentre, open label, randomised, controlled trial" (2023). Neurology. 1780.
https://scholar.barrowneuro.org/neurology/1780