Published Online
on August 9, 2007

A more recent version of this article appeared on September 1, 2007

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Submitted on February 22, 2007
Revised on April 24, 2007
Accepted on April 26, 2007

Sequential-Design, Multicenter, Randomized, Controlled Trial of Early Decompressive Craniectomy in Malignant Middle Cerebral Artery Infarction (DECIMAL Trial)

Katayoun Vahedi MD^*; Eric Vicaut MD, PhD; Joaquim Mateo MD; Annie Kurtz MS; Mikael Orabi MD; Jean-Pierre Guichard MD; Carole Boutron BS; Gregory Couvreur MD; François Rouanet MD; Emmanuel Touzé MD; Benoît Guillon MD; Alexandre Carpentier MD; Alain Yelnik MD; Bernard George MD; Didier Payen MD, PhD; Marie-Germaine Bousser MD; on behalf of the DECIMAL Investigators

From Service de Neurologie (K.V., A.K., M.-G.B.), Unité de Recherche Clinique (E.V., C.B.), Département d’Anesthésie Réanimation et Réanimation Chirurgicale (J.M., D.P.), Service de Neurochirurgie (M.O., A.C., B.G.), and Service de Neuroradiologie (J.-P.G.), Assistance Publique–Hôpitaux de Paris, Hôpital Lariboisière, Paris; Service de Neurologie (G.C.), Centre Hospitalier Universitaire de Dijon, Dijon; Service de Neurologie (F.R.), Centre Hospitalier Universitaire de Bordeaux, Bordeaux; Service de Neurologie (E.T.), Centre Hospitalier Sainte-Anne, Paris; Service de Neurologie (B.G.), Centre Hospitalier Universitaire de Nantes, Nantes; and Service de Rééducation et de Réadaptation Fonctionnelles (A.Y.), Assistance Publique–Hôpitaux de Paris, Hôpital Fernand–Widal, Paris, France.

^* To whom correspondence should be addressed. E-mail: katayoun.vahedi{at}lrb.aphp.fr.

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 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 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.

Key words: clinical trials • craniectomy • middle cerebral artery

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