Abstract
IMPORTANCE: Patients with acute ischemic stroke (AIS) due to intracranial internal carotid artery (ICA) occlusion often have poor functional outcomes despite undergoing endovascular thrombectomy (EVT). OBJECTIVE: To investigate the effectiveness and safety associated with intravenous methylprednisolone as adjunctive treatment to EVT for patients with AIS due to 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 9, 2022, to June 30, 2023, at 82 stroke centers across China with a 3-month follow-up. The primary trial enrolled 1680 patients with large vessel occlusion within 24 hours from last known well time in the intracranial ICA, the first segment of the middle cerebral artery (M1), or the second segment of the middle cerebral artery (M2), of whom 579 patients had intracranial ICA occlusion. INTERVENTION: Intravenous methylprednisolone, 2 mg/kg/d (maximum dose, 160 mg) for 3 days plus EVT vs placebo plus EVT. MAIN OUTCOMES AND MEASURES: The primary outcome was independent ambulation at 90 days, defined as a score of 0 to 3 on the modified Rankin Scale (range, 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, 69.0 years [IQR, 59.0-76.0 years]; 338 men [58.4%]), there were 286 patients in the methylprednisolone group and 293 patients in the placebo group. The proportion of patients who achieved 90-day independent ambulation was significantly higher in the methylprednisolone group than in the placebo group (151 of 284 [53.2%] vs 125 of 293 [42.7%]; adjusted risk ratio [RR], 1.27 [95% CI, 1.07-1.52]; P = .007). The incidence of sICH was lower in the methylprednisolone group than in the placebo group (26 of 277 [9.4%] vs 45 of 290 [15.5%]; adjusted RR, 0.55 [95% CI, 0.35-0.87]; P = .01). The rate of decompressive hemicraniectomy was lower in the methylprednisolone group compared with the placebo group (16 of 286 [5.6%] vs 29 of 293 [9.9%]; adjusted RR, 0.54 [95% CI, 0.30-0.98]; P = .04). No significant difference was observed in mortality between groups (methylprednisolone, 92 of 284 [32.4%] vs placebo, 111 of 239 [37.9%]; adjusted RR, 0.84 [95% CI, 0.67-1.05]; P = .13). CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial of intravenous methylprednisolone vs placebo for patients with intracranial ICA occlusion undergoing EVT, intravenous methylprednisolone was associated with improved ambulation. These findings suggest that the use of intravenous methylprednisolone as an adjunct to EVT may hold promise as a treatment option for patients with AIS due to intracranial ICA occlusion. TRIAL REGISTRATION: ChiCTR.org.cn Identifier: ChiCTR2100051729.