Abstract Body: Abstract
Importance: Acute ischemic stroke patients due to intracranial internal carotid artery (ICA) occlusion often have poor functional outcomes despite endovascular treatment (EVT).
Objective: To investigate the efficacy and safety of intravenous methylprednisolone as adjunct treatment to EVT for patients with intracranial ICA occlusion.
Design, Setting, and Participants: This was a post-hoc analysis of the MARVEL randomized, double blind, placebo-controlled clinical trial conducted from February 2022 to June 2023 at 82 stroke centers across China. The primary trial enrolled 1680 patients with large vessel occlusion within 24 hours from last known well time in the intracranial ICA, M1 or M2 middle cerebral artery segments, of whom 579 patients had intracranial ICA occlusion. Data were analyzed in April 2024.
Intervention: Patients were randomly assigned to intravenous methylprednisolone at 2 mg/kg/d (maximum dose of 160 mg) for 3 days plus EVT versus placebo plus EVT.
Main outcomes and measures: The primary outcome was independent ambulation at 90 days defined as a score of 0-3 on the modified Rankin Scale (range from 0 [no symptoms] to 6 [death]). Safety outcomes included death within 90 days, symptomatic intracranial hemorrhage (sICH) within 48 hours and decompressive hemicraniectomy to relieve midline-shift and intracranial pressure after EVT.
Results: Among 579 patients (median age 69 years; 41.6% female), there were 286 and 293 patients in the methylprednisolone and placebo group, respectively. The proportion of patients who achieved 90-day independent ambulation was significantly higher in the methylprednisolone group than in the placebo group (53.2% vs 42.7%; adjusted OR, 1.46, 95% CI 1.16 to 1.84, P=0.001). The incidence of sICH was lower in the methylprednisolone than the placebo group (9.4% vs. 15.5%, adjusted RR, 0.6, 95% CI 0.38 to 0.94，P=0.026). The rate of decompressive hemicraniectomy was lower in the methylprednisolone compared to the placebo group (5.6% vs 9.9%; adjusted RR, 0.54 [95% CI, 0.30-0.98]; P =0.044). No significant difference was observed in mortality between groups.
Conclusion and relevance: Intravenous methylprednisolone was associated with improved ambulation, reduced symptomatic intracranial hemorrhage and decompressive hemicraniectomy in patients with acute ischemic stroke secondary to intracranial ICA occlusion undergoing EVT within 24 hours of last known well.