Document Detail

Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials.
MedLine Citation:
PMID:  17303527     Owner:  NLM     Status:  MEDLINE    
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.
FINDINGS: 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.
INTERPRETATION: 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.
Katayoun Vahedi; Jeannette Hofmeijer; Eric Juettler; Eric Vicaut; Bernard George; Ale Algra; G Johan Amelink; Peter Schmiedeck; Stefan Schwab; Peter M Rothwell; Marie-Germaine Bousser; H Bart van der Worp; Werner Hacke;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Lancet. Neurology     Volume:  6     ISSN:  1474-4422     ISO Abbreviation:  Lancet Neurol     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-02-16     Completed Date:  2007-03-14     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101139309     Medline TA:  Lancet Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  215-22     Citation Subset:  IM    
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MeSH Terms
Aphasia / etiology
Decompression, Surgical*
Infarction, Middle Cerebral Artery / mortality,  surgery*
Magnetic Resonance Imaging
Middle Aged
Neurosurgical Procedures*
Patient Selection
Prospective Studies
Randomized Controlled Trials as Topic
Stroke / mortality,  surgery
Tomography, X-Ray Computed
Treatment Outcome
Comment In:
Lancet Neurol. 2007 Mar;6(3):200-1   [PMID:  17303520 ]
Curr Neurol Neurosci Rep. 2007 Nov;7(6):511-2   [PMID:  17999897 ]
Lancet Neurol. 2007 Jul;6(7):580; author reply 580-1   [PMID:  17582356 ]

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