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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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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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Patterns and Clinical Implications of Hemorrhagic Transformation After Thrombolysis in Acute Ischemic Stroke
(Ovid Technologies (Wolters Kluwer Health), 2024-12-10)
Yanan Wang
;
Toshiki Maeda
;
Shoujiang You
;
Chen Chen
;
Leibo Liu
2
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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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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>
2
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Intensive Blood Pressure Lowering and Renal Function in Ischemic Stroke Patients: Secondary Analysis of the ENCHANTED Trial
(2024)
Chen Chen
;
Xinwen Ren
;
Yang Zhao
;
Menglu Ouyang
;
Qiang Li Mbiostat
<jats:p>Introduction: Renal failure is a major safety concern of intensive systolic blood pressure (SBP) lowering. We aimed to determine the effect of this treatment on early change in renal function in participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Methods: Post hoc analysis of the ENCHANTED BP-arm in which thrombolyzed patients with acute ischemic stroke (AIS) were randomized to intensive (target 130–140 mm Hg within 1 h) or guideline-recommended (target &lt;180 mm Hg) management within 6 h of symptom onset. Primary outcome is the early change in renal function, defined by a difference in estimated glomerular filtration rate (∆eGFR = 24 h – baseline eGFR), analyzed using linear regression with adjustment for clinical variables. Key SBP parameters were attained (mean), variability (standard deviation), and magnitude of reduction within 24 h. Results: Of 2,151 participants (mean age 66.9 years; 38% female) included with the available baseline eGFR, there were significant differences in attained 144.3 ± 10.2 versus 149.8 ± 12.0 [Δ5.5 mm Hg]; p &lt; 0.0001), variation (15.1 ± 5.4 vs. 14.0 ± 5.6 mm Hg; p &lt; 0.0001), and magnitude of reduction (44.6 ± 16.2 vs. 38.7 ± 17.6 mm Hg; p &lt; 0.0001) in SBP within 24 h. 1,718 (79.9%) participants with complete follow-up eGFR were included in the primary analysis, and there was no significant difference in ∆eGFR (adjusted mean difference −1.10, 95% confidence interval [CI] −3.14 to −0.94; p = 0.29) between the intensive and guideline groups, respectively. The neutral effect on ∆eGFR was consistent in patients with different baseline eGFR stages and in sensitivity analysis after multiple imputations for missing follow-up eGFR. SBP variability was significantly associated with decreasing ∆eGFR (per 5 mm Hg increase by category: adjusted mean difference −1.35, 95% CI: −2.43 to −0.28; p for trend = 0.01). Conclusion: Intensive SBP lowering with a target of 130–140 mm Hg had no impact on early renal function in thrombolyzed AIS patients. Wide SBP variability was associated with a larger decline in eGFR. </jats:p>
1
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Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke
(2017)
Craig S. Anderson
;
Hisatomi Arima
;
LAVADOS GERMAIN, PABLO MANUEL
;
Laurent Billot
;
Maree L. Hackett
7Scopus© Citations 166
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Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage
(2013)
Craig S. Anderson
;
Emma Heeley
;
Yining Huang
;
Jiguang Wang
;
Christian Stapf
Scopus© Citations 1333 1
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Statistical analysis plan for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): a large-scale investigation to solve longstanding controversy over the most appropriate management of elevated blood pressure in the hyperacute phase of intracerebral hemorrhage
(2013)
Craig Anderson
;
Emma Heeley
;
Stephane Heritier
;
Hisatomi Arima
;
Mark Woodward
The Statistical analysis plan (SAP) for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2).
2Scopus© Citations 10

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