Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial).
OBJECTIVE
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.
Vahedi
Katayoun
K
Service de Neurologie, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Paris, France. katayoun.vahedi@lrb.aphp.fr
Vicaut
Eric
E
Mateo
Joaquim
J
Kurtz
Annie
A
Orabi
Mikael
M
Guichard
Jean-Pierre
JP
Boutron
Carole
C
Couvreur
Gregory
G
Rouanet
François
F
Touzé
Emmanuel
E
Guillon
Benoît
B
Carpentier
Alexandre
A
Yelnik
Alain
A
George
Bernard
B
Payen
Didier
D
Bousser
Marie-Germaine
MG
D000293:Adolescent; D000328:Adult; D003399:Craniotomy; D019299:Decompression, Surgical / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013223:Statistics as Topic; D015996:Survival Rate; D016896:Treatment Outcome