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Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle
Katayoun Vahedi1, Eric Vicaut, Joaquim Mateo
1Service de Neurologie, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Paris, France. katayoun.vahedi@lrb.aphp.fr
Insights
Early decompressive craniectomy significantly improves outcomes for malignant middle cerebral artery infarction. This surgical intervention reduces mortality by over half and increases moderate disability rates in patients.
Area of Science:
- Neurosurgery
- Neurology
- Critical Care Medicine
Background:
- Malignant middle cerebral artery (MCA) infarction lacks effective medical treatments.
- Decompressive craniectomy is a potential intervention for severe stroke cases.
Purpose of the Study:
- To evaluate the efficacy of early decompressive craniectomy in patients with malignant MCA infarction.
- To compare functional outcomes between surgical and non-surgical treatment groups.
Main Methods:
- A multicenter, randomized, single-blind trial was conducted in France.
- Patients aged 18-55 with malignant MCA infarction were included.
- The primary outcome was a modified Rankin scale score of ≤3 at 6 months.
Main Results:
- The trial was stopped early due to slow recruitment, with 38 patients randomized.
- Decompressive craniectomy showed a trend towards improved functional outcomes (25% vs 5.6% at 6 months).
- A significant 52.8% absolute reduction in mortality was observed in the surgery group (P<0.0001).
Conclusions:
- Early decompressive craniectomy significantly reduces mortality in malignant MCA infarction.
- The procedure also increases the likelihood of moderate disability, indicating improved survival.
Background And Purpose:
There is no effective medical treatment of malignant middle cerebral artery (MCA) infarction. The purpose of this clinical trial was to assess the efficacy of early decompressive craniectomy in patients with malignant MCA infarction.
Methods:
We conducted in France a multicenter, randomized trial involving patients between 18 and 55 years of age with malignant MCA infarction to compare functional outcomes with or without decompressive craniectomy. A sequential, single-blind, triangular design was used to compare the rate of development of moderate disability (modified Rankin scale score < or =3) at 6 months' follow-up (primary outcome) between the 2 treatment groups.
Results:
After randomization of 38 patients, the data safety monitoring committee recommended stopping the trial because of slow recruitment and organizing a pooled analysis of individual data from this trial and the 2 other ongoing European trials of decompressive craniectomy in malignant MCA infarction. Among the 38 patients randomized, the proportion of patients with a modified Rankin scale score < or =3 at the 6-month and 1-year follow-up was 25% and 50%, respectively, in the surgery group compared with 5.6% and 22.2%, respectively, in the no-surgery group (P=0.18 and P=0.10, respectively). There was a 52.8% absolute reduction of death after craniectomy compared with medical therapy only (P<0.0001).
Conclusions:
In this trial, early decompressive craniectomy increased by more than half the number of patients with moderate disability and very significantly reduced (by more than half) the mortality rate compared with that after medical therapy.