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Effects of Blood Pressure Lowering Across Hematoma Volume in Acute Intracerebral Hemorrhage: Pooled Analysis of the Four
<scp>INTERACT</scp>
and
<scp>ATACH</scp>
‐2 Trials
(Wiley, 2026-04-01)
Xinwen Ren
;
Qiang Li
;
Menglu Ouyang
;
Xiaoying Chen
;
Chen Chen
<jats:sec> <jats:title>Objective</jats:title> <jats:p>The objective of this study was to assess the heterogeneity in treatment effect of intensive blood pressure (BP)‐lowering across hematoma volume after acute intracerebral hemorrhage (ICH).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>We undertook a pooled analysis of individual patient data from the pivotal trials of early intensive BP‐lowering in ICH (the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 4 [INTERACT4] and Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 [ATACH‐2] studies). The primary outcome was functional recovery, defined by the distribution of scores on modified Rankin scale (mRS). Secondary outcomes were hematoma expansion (HE) over 24 hours, defined by absolute (<0, 0–6, 6–12.5, and >12.5 ml) and relative HE (<0, 0–33, 33–66, and >66%). Generalized linear mixed models with trial as a random effect were conducted. We further assessed effect modification by hematoma volume and plotted the treatment effect curve.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p> Among 6,125 individuals with available hematoma volume, intensive BP‐lowering improved functional recovery (odds ratio [OR] for unfavorable shift in mRS score = 0.90, 95% confidence interval [CI] = 0.82 to 0.99, <jats:italic>p</jats:italic> = 0.027). In 3,897 participants with available HE, intensive BP‐lowering reduced the risk of absolute (OR = 0.88, 95% CI = 0.78 to 0.99, <jats:italic>p</jats:italic> = 0.043) and relative (OR = 0.88, 95% CI = 0.78 to 0.99, <jats:italic>p</jats:italic> = 0.034) HE. We found effect modification of treatment on functional outcome and absolute HE by hematoma volume (p for interaction = 0.043 and 0.025, respectively). U‐shaped curves were observed, with benefits seen in cases with hematoma volume of 7.5 to 27.5 and 7.0 to 32.5 ml, respectively, both peaking at 20 ml. </jats:p> </jats:sec> <jats:sec> <jats:title>Interpretation</jats:title> <jats:p>Early intensive BP‐lowering improves functional outcome and reduces HE in ICH. Heterogeneity by hematoma volume indicates the importance of patient selection in future trials and clinical practice. ANN NEUROL 2026</jats:p> </jats:sec>
1
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Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage
(Ovid Technologies (Wolters Kluwer Health), 2026-04-14)
Xia Wang
;
Thanh G. Phan
;
Xinwen Ren
;
Henry H. Ma
;
Qiang Li
1
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Low-Intensity Monitoring for Mild-to-Moderate Acute Ischemic Stroke Is Cost Saving: Economic Evaluation for OPTIMISTmain
(Ovid Technologies (Wolters Kluwer Health), 2026-03)
Lizheng Xu
;
Menglu Ouyang
;
Emily R. Atkins
;
Debbie Summers
;
Yi Sui
<jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>OPTIMISTmain (Main Optimal Post rtPA-IV Monitoring in Ischemic Stroke Trial) has shown that low-intensity monitoring is feasible and safe compared with standard monitoring in stable patients who receive thrombolysis treatment for acute ischemic stroke of mild-to-moderate neurological impairment. We aimed to estimate the economic benefits of low-intensity care compared with standard care.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>A cost-minimization analysis based on OPTIMISTmain was conducted for Australia, China, Malaysia, the United Kingdom, the United States, and Vietnam. A decision tree model comprising 2 arms was developed from the trial design. State transition probabilities for each country were extracted from the trial, and cost data were sourced from the existing literature. Mean costs over the 90-day duration of follow-up were compared, and univariate and probabilistic sensitivity and scenario analyses were performed.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p>Low-intensity monitoring had the highest probability of cost saving in China (100.00%) and the United Kingdom (100.00%), followed by Australia (99.94%), the United States (95.91%), and Vietnam (86.66%), as patients in this group incurred US dollars savings of 239, 133, 647, 943, and 3 in direct costs compared with patients in the standard group, respectively. In Malaysia, however, the intervention costs slightly exceeded those for standard care (US dollars 5643 versus 5378). Countries with higher proportions of patients having intensive care unit monitoring had greater cost savings. Cost-saving thresholds of monitoring costs were 1.24, 1.30, 1.26, 1.24, 1.01, and 0.91 times the base case value in Australia, China, the United Kingdom, the United States, Vietnam, and Malaysia, respectively.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>The low-intensity monitoring protocol was cost saving in countries with high proportions of intensive care resources for postthrombolysis treatment monitoring, such as in the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>REGISTRATION:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT03734640. URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/">https://www.anzctr.org.au/</jats:ext-link> ; Unique identifier: ACTRN 12619001556134p. </jats:p> </jats:sec>
2
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Mediation Analysis to Identify Individual Component Effects of the Care Bundle to Improve Functional Outcome After ICH in the INTERACT3 Study
(Ovid Technologies (Wolters Kluwer Health), 2025-10)
Xinwen Ren
;
Qiang Li
;
Menglu Ouyang
;
Laurent Billot
;
Xiaoying Chen
1Scopus© Citations 6
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Influence of Multiple Long-Term Conditions on Outcome after Thrombolysis for Acute Ischaemic Stroke: Secondary Analysis of the ENCHANTED Trial
(S. Karger AG, 2025-08-06)
Xinwen Ren
;
Yang Zhao
;
Menglu Ouyang
;
Qiang Li
;
Chen Chen
Introduction: The influence of multiple long-term conditions on the outcomes from acute ischaemic stroke (AIS) is not well defined. This study aimed to determine the association of multiple long-term conditions in participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Methods: ENCHANTED was an international, multicentre, 2 × 2 quasi-factorial, open, randomized controlled, blinded endpoint assessed trial that assessed the effectiveness and safety of intensive blood pressure lowering and low-dose thrombolysis against standard of care in adults with AIS. Multiple long-term condition was defined as two or more coexisting chronic conditions according to medical history. The primary outcome was function recovery (distribution of scores on the modified Rankin scale) and mortality at 90 days post-randomization. Associations were estimated in multivariate logistic regression models, and an assessment of heterogeneity was undertaken in subgroups including age, sex, baseline systolic blood pressure, and clinical features. Results: In 4,566 AIS participants (mean age 66.7 years, 37.8% female), those with multiple long-term conditions were older, more often female, and had more severe neurological impairment. Multiple long-term conditions increased the odds of poor functional outcome (adjusted odds ratio [aOR] 1.16, 95% confidence interval [CI]: 1.03–1.30; p = 0.020) and mortality (aOR 1.35, 95% CI: 1.04–1.76; p = 0.024). The association between multiple long-term conditions and mortality/functional outcome was consistent across all subgroups. Conclusion: Individuals with multiple long-term conditions have higher odds of poor functional outcome and death after thrombolytic treatment for AIS.
9
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STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection
(BMJ, 2025-04)
Carlos Delfino
;
Cheryl Carcel
;
Xiaolei Lin
;
MUÑOZ VENTURELLI, PAULA ANDREA
;
Sharon L Naismith
<jats:sec> <jats:title>Introduction</jats:title> <jats:p>Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p>The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.</jats:p> </jats:sec> <jats:sec> <jats:title>Ethics and dissemination</jats:title> <jats:p>This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>The study protocol is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04904536">NCT04904536</jats:ext-link>).</jats:p> </jats:sec>
3
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Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials
(Elsevier BV, 2025-07)
Xia Wang
;
Xinwen Ren
;
Qiang Li
;
Menglu Ouyang
;
Chen Chen
Scopus© Citations 1 2
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Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial
(Elsevier BV, 2025-05)
Craig S Anderson
;
Debbie Summers
;
Menglu Ouyang
;
Yi Sui
;
Brenda Johnson
2Scopus© Citations 15
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Effects of Intensive Blood Pressure Lowering on Brain Swelling in Thrombolyzed Acute Ischemic Stroke: The ENCHANTED Results
(Ovid Technologies (Wolters Kluwer Health), 2025-06)
Guobin Zhang
;
Chen Chen
;
Xinwen Ren
;
Yang Zhao
;
Menglu Ouyang
2
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Influence of renal function on blood pressure control and outcome in thrombolyzed patients after acute ischemic stroke: post-hoc analysis of the ENCHANTED trial
(Frontiers Media SA, 2024-12-09)
Xinwen Ren
;
Chen Chen
;
Xia Wang
;
Qiang Li
;
Yang Zhao
<jats:sec><jats:title>Background</jats:title><jats:p>The effect of renal impairment in patients who receive intravenous thrombolysis for acute ischemic stroke (AIS) is unclear. We aimed to determine the associations of renal impairment and clinical outcomes and any modification of the effect of intensive versus guideline-recommended blood pressure (BP) control in the BP arm of the International Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a <jats:italic>post-hoc</jats:italic> analysis of the ENCHANTED BP arm, which involved 2,196 thrombolyzed AIS patients. Logistic regression models were used to define the association between eGFR and clinical outcomes of death, death or major disability [modified Rankin scale (mRS) scores 3–6], and major disability (mRS 3–5) at 90 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 2,151 patients with available baseline renal function data (mean age 66.9 years; 38% women), 993 (46.2%), 822 (38.2%), and 336 (15.6%) had normal (eGFR ≥ 90 mL/min/1.73 m<jats:sup>2</jats:sup>), mildly (60–89), and moderate-to-severely impaired (&lt;60) renal function, respectively. Compared with patients with normal eGFR, mortality was higher in those with moderate-to-severe renal impairment (adjusted odds ratio 1.77, 95% confidence interval 1.05–2.99; <jats:italic>p</jats:italic> = 0.031 for trend). However, the difference in death or major disability (mRS 3–6) was not significant between groups. There was no heterogeneity in the effect of intensive versus guideline-recommended BP-lowering treatment on death by grades of renal function (<jats:italic>p</jats:italic> for interaction = 0.545).</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>The presence of moderate-to-severe renal impairment is associated with increased mortality in thrombolyzed patients with AIS. Renal function does not modify the effect of early intensive BP-lowering treatment on death in this patient group.</jats:p></jats:sec>
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