MARVEL
Trial question
What is the role of adjunctive methylprednisolone added to endovascular thrombectomy in patients with AIS due to large vessel occlusion?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 1680
1680 patients (727 female, 953 male).
Inclusion criteria: adult patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known to be well.
Key exclusion criteria: ICH; mRS score ≥ 2 before onset; pregnancy; allergy to contrast agents or corticosteroids; uncontrolled SBP > 185 mmHg or DBP > 110 mmHg.
Interventions
N=839 methylprednisolone (an IV dose of 2 mg/kg/day for 3 days).
N=841 placebo (matching IV placebo for 3 days).
Primary outcome
Median 90-day modified Rankin Scale score
3 points
3 points
3.0 points
2.3 points
1.5 points
0.8 points
0.0 points
Methylprednisolone
Placebo
No significant
difference ↔
No significant difference in median 90-day mRS score (3 points vs. 3 points; GenOR 1.1, 95% CI 0.96 to 1.25).
Secondary outcomes
Significant increase in mRS score of 0-4 at day 90 (71.5% vs. 66.2%; RR 1.07, 95% CI 1 to 1.14).
No significant difference in mRS score of 0-2 at day 90 (44.1% vs. 40.9%; RR 1.07, 95% CI 0.95 to 1.19).
No significant difference in mRS score of 0-1 or return to premorbid score at day 90 (26.7% vs. 26.5%; RR 0.99, 99% CI 0.84 to 1.16).
Safety outcomes
No significant differences in radiologic ICH, gastrointestinal bleeding within 7 days after endovascular thrombectomy.
Significant differences in death (23.2% vs. 28.5%), symptomatic ICH (8.6% vs. 11.7%), pneumonia (46.5% vs. 55.4%).
Conclusion
In adult patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known to be well, methylprednisolone was not superior to placebo with respect to median 90-day mRS score.
Reference
MARVEL Trial Authors for the MARVEL Investigators, Qingwu Yang, Changwei Guo et al. Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke: The MARVEL Randomized Clinical Trial. JAMA. 2024 Mar 12;331(10):840-849.
Open reference URL