International journal of stroke : official journal of the International Stroke Society · 2025
Early neurological improvement with deferoxamine after intracerebral hemorrhage: A post hoc analysis of the i-DEF trial.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Polymeris Alexandros A, Lioutas Vasileios-Arsenios, Foster Lydia D, Incontri Diego, Heistand Elizabeth C, Marchal Juliette, Lazar Alexa, Fischer Urs, Engelter Stefan T, Seiffge David J, Yeatts Sharon D, Selim Magdy H
Аннотация
BACKGROUND: Little is known about early major neurological improvement (EMNI) after intracerebral hemorrhage (ICH).
AIMS: We performed a post hoc analysis of the Intracerebral Hemorrhage-Deferoxamine trial (i-DEF; NCT02175225) to comprehensively evaluate EMNI and assess whether deferoxamine treatment affects it.
METHODS: Comparing repeated assessments of National Institutes of Health Stroke Scale (NIHSS) on days 2, 3, 4, and 7 (or discharge, if it was earlier) versus NIHSS score at presentation, and defining EMNI as an NIHSS score decrement of an absolute ⩾4 points from presentation, we determined its presence or absence on day 2, day 3, day 4, and day 7(/discharge). Using adjusted generalized linear mixed-effects or logistic models as appropriate, we examined the association of deferoxamine with EMNI as repeated measure, as well as EMNI's overall frequency, time course, determinants, and association with favorable long-term outcome (modified Rankin Scale 0-2).
RESULTS: Among 291 i-DEF participants in the modified intention-to-treat population (median age 61 years, 38.5% female, median NIHSS score 13, 144 randomized to deferoxamine and 147 to placebo), the proportion of participants with EMNI continuously increased from 20% on day 2 to 36% on day 7(/discharge). Deferoxamine was associated with an average twofold higher odds of EMNI (odds ratio (OR): 2.30, 95% confidence interval (CI): 1.07 to 4.95, p = 0.033 after adjustment for the prespecified trial covariates onset-to-treatment time, baseline ICH volume, and presenting NIHSS score), without clear evidence for treatment-by-time interaction (pinteraction = 0.092). Secondary and sensitivity analyses using alternative EMNI definitions (as relative ⩾20% or ⩾30% NIHSS score decrement) and additional covariate adjustment yielded consistent findings. Race, ICH volume and location were also associated with EMNI. EMNI was independently associated with twofold to sixfold higher odds of favorable 90-day and 180-day outcome, regardless of assessment timepoint.
CONCLUSION: In a post hoc analysis of the i-DEF trial, the likelihood of EMNI over the first week following ICH was higher with deferoxamine. EMNI showed a continuous upward trajectory and strong association with favorable long-term functional outcome.
AIMS: We performed a post hoc analysis of the Intracerebral Hemorrhage-Deferoxamine trial (i-DEF; NCT02175225) to comprehensively evaluate EMNI and assess whether deferoxamine treatment affects it.
METHODS: Comparing repeated assessments of National Institutes of Health Stroke Scale (NIHSS) on days 2, 3, 4, and 7 (or discharge, if it was earlier) versus NIHSS score at presentation, and defining EMNI as an NIHSS score decrement of an absolute ⩾4 points from presentation, we determined its presence or absence on day 2, day 3, day 4, and day 7(/discharge). Using adjusted generalized linear mixed-effects or logistic models as appropriate, we examined the association of deferoxamine with EMNI as repeated measure, as well as EMNI's overall frequency, time course, determinants, and association with favorable long-term outcome (modified Rankin Scale 0-2).
RESULTS: Among 291 i-DEF participants in the modified intention-to-treat population (median age 61 years, 38.5% female, median NIHSS score 13, 144 randomized to deferoxamine and 147 to placebo), the proportion of participants with EMNI continuously increased from 20% on day 2 to 36% on day 7(/discharge). Deferoxamine was associated with an average twofold higher odds of EMNI (odds ratio (OR): 2.30, 95% confidence interval (CI): 1.07 to 4.95, p = 0.033 after adjustment for the prespecified trial covariates onset-to-treatment time, baseline ICH volume, and presenting NIHSS score), without clear evidence for treatment-by-time interaction (pinteraction = 0.092). Secondary and sensitivity analyses using alternative EMNI definitions (as relative ⩾20% or ⩾30% NIHSS score decrement) and additional covariate adjustment yielded consistent findings. Race, ICH volume and location were also associated with EMNI. EMNI was independently associated with twofold to sixfold higher odds of favorable 90-day and 180-day outcome, regardless of assessment timepoint.
CONCLUSION: In a post hoc analysis of the i-DEF trial, the likelihood of EMNI over the first week following ICH was higher with deferoxamine. EMNI showed a continuous upward trajectory and strong association with favorable long-term functional outcome.