Abstract

Background: The optimal BP-lowering target in the acute phase of severe stroke is uncertain. We aimed to compare the efficacy and safety of individualised BP lowering with standard BP lowering in severe stroke. Methods: We conducted a randomised, multicentre study in 26 hospitals in China. Eligible patients were randomised into an individualised BP-lowering group (with 10-15% reduction in systolic BP [SBP] from admission level) or standard BP-lowering group (with a target SBP of <200 mm Hg in acute ischaemic stroke and <180 mm Hg in intracerebral haemorrhage). The primary outcome was the proportion of patients with a poor outcome at 90 days. Findings: Between January 1, 2017, and August 31, 2018, 500 patients with acute severe stroke were enrolled, and 483 eligible participants were included in the analysis: 242 received individualised BP-lowering treatment and 241 received standard treatment. The primary outcome event was observed in 71.1% of the participants in the individualised treatment group and in 73.4% of the standard treatment group (odds ratio with individualised treatment, 0.75; 95% confidence interval [CI], 0.47 to 1.19; P = 0.222). The generalised linear analysis showed that the as compared with standard treatment, individualised treatment had a significant effect on reducing the neurological deficits at hospital discharge, as evaluated by the National Institutes of Health Stroke Scale (beta estimate, -0.13; 95% CI, -0.2 to -0.03; P = 0.009). The rates of serious adverse events within 90 days in the two groups were similar (27.7% vs. 28.2%, P = 0.897). Interpretation: In patients with acute severe stoke, individualised BP-lowering treatment did not significantly reduce the rate of 3-month death or dependence. Acute lowering of SBP to 10% to 15% reduction from baseline is safe and may be effective for reducing neurological deficits at hospital discharge. Trial Registration: This trial is registered at ClinicalTrials.gov, number NCT02982655. Funding: The CHASE trial is funded by the Shaanxi Province Key Research and Development Projects (2013KTZB03-02-02 and 2017ZDCXL-SF-02-02). Declaration of Interests: The authors declare no financial or other conflict of interests. Ethical Approval: The ethics committee of Xijing Hospital, which is the leading research site in this trial, approved the scientificity and ethical rationality of this study.

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