title: Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials.
abstract: BACKGROUND
  Malignant infarction of the middle cerebral artery (MCA) is associated with an 80% mortality rate. Non-randomised studies have suggested that decompressive surgery reduces this mortality without increasing the number of severely disabled survivors. To obtain sufficient data as soon as possible to reliably estimate the effects of decompressive surgery, results from three European randomised controlled trials (DECIMAL, DESTINY, HAMLET) were pooled. The trials were ongoing when the pooled analysis was planned.
  
  
  METHODS
  Individual data for patients aged between 18 years and 60 years, with space-occupying MCA infarction, included in one of the three trials, and treated within 48 h after stroke onset were pooled for analysis. The protocol was designed prospectively when the trials were still recruiting patients and outcomes were defined without knowledge of the results of the individual trials. The primary outcome measure was the score on the modified Rankin scale (mRS) at 1 year dichotomised between favourable (0-4) and unfavourable (5 and death) outcome. Secondary outcome measures included case fatality rate at 1 year and a dichotomisation of the mRS between 0-3 and 4 to death. Data analysis was done by an independent data monitoring committee.
  
  
  RESULTS
  93 patients were included in the pooled analysis. More patients in the decompressive-surgery group than in the control group had an mRS<or=4 (75%vs 24%; pooled absolute risk reduction 51% [95% CI 34-69]), an mRS<or=3 (43%vs 21%; 23% [5-41]), and survived (78%vs 29%; 50% [33-67]), indicating numbers needed to treat of two for survival with mRS<or=4, four for survival with mRS<or=3, and two for survival irrespective of functional outcome. The effect of surgery was highly consistent across the three trials.
  
  
  CONCLUSIONS
  In patients with malignant MCA infarction, decompressive surgery undertaken within 48 h of stroke onset reduces mortality and increases the number of patients with a favourable functional outcome. The decision to perform decompressive surgery should, however, be made on an individual basis in every patient.
authors.affiliation: Department of Neurology, Assistance Publique, Hôpitaux de Paris, Lariboisière Hospital, Paris, France.
authors.forename: Katayoun
authors.initials: K
authors.lastname: Vahedi
authors.forename: Jeannette
authors.initials: J
authors.lastname: Hofmeijer
authors.forename: Eric
authors.initials: E
authors.lastname: Juettler
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.forename: Bernard
authors.initials: B
authors.lastname: George
authors.forename: Ale
authors.initials: A
authors.lastname: Algra
authors.forename: G Johan
authors.initials: GJ
authors.lastname: Amelink
authors.forename: Peter
authors.initials: P
authors.lastname: Schmiedeck
authors.forename: Stefan
authors.initials: S
authors.lastname: Schwab
authors.forename: Peter M
authors.initials: PM
authors.lastname: Rothwell
authors.forename: Marie-Germaine
authors.initials: MG
authors.lastname: Bousser
authors.forename: H Bart
authors.initials: HB
authors.lastname: van der Worp
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
mesh_terms: D000293:Adolescent; D000328:Adult; D001037:Aphasia / Q000209:etiology; D019299:Decompression, Surgical; D005260:Female; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000401:mortality / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000401:mortality / Q000601:surgery; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome