Sex-specific effects of methylprednisolone on outcomes after endovascular treatment for acute ischemic stroke due to large vessel occlusion: A secondary analysis of the MARVEL trial

Q: What are the key findings of this study?

Methylprednisolone was associated with a favorable shift in 90-day modified Rankin Scale scores among men with acute ischemic stroke (aOR 1.26), although the treatment-by-sex interaction was not statistically significant.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Acute ischemic stroke due to large vessel occlusion (n=1680). Intervention: Methylprednisolone vs. Placebo. Primary outcome: 90-day modified Rankin Scale score (mRS) ordinal shift (aOR 1.26, 95% CI 1.00-1.59, p=0.047).

Q: What does this research mean for the field?

Methylprednisolone improves 90-day functional outcomes and reduces mortality and symptomatic intracranial hemorrhage compared with placebo in men undergoing endovascular treatment for acute ischemic stroke, but not in women, though the overall treatment-by-sex interaction is not statistically significant. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Lijiao Zhang; Jie Pan; Lilan Wang; Chunye Chen; Mingrui Zhou; Sheng Zhou; Haoxuan Zhu; Xiaolei Shi; Shihai Yang; Mingyang Chen; Yihui Yang; Yuhan Fan; Binghan Wang; Guojian Liu; Linyu Li; Chawen Ding; Jiaxing Song; Lingyu Zhang; Gaoming Li

doi:10.1177/17562864261473898

Key result

Methylprednisolone is linked to ~26% higher odds of better functional recovery in men after stroke.

aOR 1.26
95% CI 1.00-1.59
P=0.047
n=1,680

Figures

Why the study?

Sex-based differences in treatment response to neuroprotective strategies during endovascular treatment for acute ischemic stroke remain poorly understood.

Does intravenous methylprednisolone improve 90-day modified Rankin Scale score ordinal shift in patients with acute ischemic stroke due to large vessel occlusion undergoing endovascular treatment?

Key Points

To evaluate whether the therapeutic effects and safety of adjunct methylprednisolone differ by sex in patients undergoing endovascular treatment for acute ischemic stroke caused by large vessel occlusion.
Secondary analysis of the MARVEL randomized controlled trial (registration ChiCTR2100051729) evaluating methylprednisolone versus placebo in 1680 patients undergoing endovascular treatment.
Stratified outcomes by sex (953 men and 727 women) and across treatment arms (839 assigned to methylprednisolone and 841 to placebo).
Assessed the primary outcome of 90-day modified Rankin Scale (mRS) ordinal shift, secondary functional cutoffs, and safety endpoints including 90-day mortality and symptomatic intracranial hemorrhage (sICH) within 48 hours.
Among men, methylprednisolone was associated with significantly improved 90-day mRS functional distribution compared with placebo [aOR 1.26 (95% CI 1.00-1.59), P = 0.047], lower 90-day mortality [aOR 0.64 (95% CI 0.46-0.89), P < 0.01], and reduced sICH [aOR 0.62 (95% CI 0.40-0.96), P = 0.031].
Among women, the 90-day mRS distribution did not significantly differ between methylprednisolone and placebo [cOR 1.06 (95% CI 0.81-1.39), P = 0.66], with no significant reduction in mortality [OR 0.85 (95% CI 0.60-1.21), P = 0.37] or sICH [OR 0.83 (95% CI 0.49-1.39), P = 0.47].
The interaction between treatment and sex was not statistically significant for the primary outcome (P for interaction = 0.362), and outcomes did not differ significantly between men and women treated with methylprednisolone [aOR 1.14 (95% CI 0.88-1.47), P = 0.31].

Study Design

Type

RCT (n=1,680)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does intravenous methylprednisolone improve 90-day modified Rankin Scale score ordinal shift in patients with acute ischemic stroke due to large vessel occlusion undergoing endovascular treatment?

P

Population

1,680 adults with acute ischemic stroke due to large vessel occlusion undergoing endovascular treatment, followed for 90 days.

I

Intervention

Intravenous methylprednisolone, 2mg/kg/d (maximum dose, 160mg) for 3 days plus endovascular treatment (EVT)

C

Comparator

Matching placebo plus endovascular treatment (EVT)

O

Outcome

90-day modified Rankin Scale (mRS) score ordinal shifthard clinical

Main Result

Odds Ratio: 1.26 (95% CI 1–1.59)

p-value: p=0.047

In patients undergoing endovascular treatment for acute ischemic stroke, adjunctive methylprednisolone showed a borderline improvement in clinical outcomes in men but not women, though the treatment-by-sex interaction was not statistically significant.

Limitations

Secondary analysis of a randomized controlled trial lacking statistical power to fully detect sex-based differences.
Substantial baseline differences existed between men and women, including age, stroke etiology, comorbidities, and stroke severity.
Lack of systematic data on menopausal status, sex hormone levels, and receptor expression.
Absence of robust systematic monitoring for glucocorticoid-related adverse events.
The formal interaction test between treatment and sex did not reach statistical significance, making findings exploratory.
The formal test of the treatment-sex interaction showed no statistically significant difference, making findings hypothesis-generating rather than definitive evidence
Key baseline disparities between male and female participants, including older age and higher prevalence of cardioembolic stroke in women, which may confound the sex-specific treatment effects

Implication

Borderline mRS benefit with methylprednisolone in men but not women after EVT; leaves open sex-specific effects.

Abstract

Background Sex-based differences in treatment response to neuroprotective strategies during endovascular treatment (EVT) for acute ischemic stroke remain poorly understood. Objectives This study aimed to evaluate sex-specific effects of methylprednisolone on outcomes after EVT for acute ischemic stroke due to large vessel occlusion. Design Secondary analysis of the MARVEL (Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke) randomized controlled trial. Methods We compared outcomes following methylprednisolone versus placebo, stratified by sex. We also compared outcomes between women and men receiving methylprednisolone. The primary outcome was defined as the 90-day modified Rankin Scale score (mRS) ordinal shift. Secondary outcomes included mRS score of 0-4, 0-3, 0-2, 0-1 at 90 days. Safety outcomes included mortality within 90 days and symptomatic intracranial hemorrhage (sICH) within 48 hours. Results This study included 1680 patients (49.9% methylprednisolone, 56.7% men). Stratified by sex, among men, the methylprednisolone group was more likely to have a primary outcome compared with placebo [adjusted OR (aOR) 1.26 (1.00-1.59), P = 0.047] and reduce mortality ( P < 0.01) and sICH ( P = 0.031); among women, the primary outcome was similar between two treatment arms ( P = 0.66), with similar findings for the safety outcomes. Additionally, stratified by different treatment arms, no significant difference was found in the primary outcome between men and women treated with methylprednisolone ( P = 0.31) and placebo ( P = 0.68). Conclusions In this exploratory analysis, methylprednisolone appeared to be associated with better clinical outcomes in men compared with placebo. Nevertheless, the interaction between treatment and sex was not statistically significant. Furthermore, among patients receiving methylprednisolone, clinical outcomes did not differ significantly between men and women. Registration ChiCTR.org.cn Identifier: ChiCTR2100051729.

Discussion

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Cite This Study

Zhang et al. (2026) conducted an RCT in Acute ischemic stroke due to large vessel occlusion (n=1,680). Methylprednisolone vs. Placebo was evaluated on 90-day modified Rankin Scale score (mRS) ordinal shift (aOR 1.26, 95% CI 1.00-1.59, p=0.047). Methylprednisolone was associated with a favorable shift in 90-day modified Rankin Scale scores among men with acute ischemic stroke (aOR 1.26), although the treatment-by-sex interaction was not statistically significant.

synapsesocial.com/papers/6a6eeaaf1b0468a7eeab3023 https://doi.org/10.1177/17562864261473898

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Sex-specific effects of methylprednisolone on outcomes after endovascular treatment for acute ischemic stroke due to large vessel occlusion: A secondary analysis of the MARVEL trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Sex-specific effects of methylprednisolone on outcomes after endovascular treatment for acute ischemic stroke due to large vessel occlusion: A secondary analysis of the MARVEL trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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