TY - JOUR
T1 - Early decompressive surgery in malignant infarction of the middle cerebral artery
T2 - a pooled analysis of three randomised controlled trials
AU - Vahedi, Katayoun
AU - Hofmeijer, Jeannette
AU - Juettler, Eric
AU - Vicaut, Eric
AU - George, Bernard
AU - Algra, Ale
AU - Amelink, G. Johan
AU - Schmiedeck, Peter
AU - Schwab, Stefan
AU - Rothwell, Peter M.
AU - Bousser, Marie Germaine
AU - van der Worp, H. Bart
AU - Hacke, Werner
N1 - Funding Information:
DECIMAL was supported by grants from the Programme Hospitalier de Recherche Clinique of the French Ministry of Health and sponsored by Département de la Recherche Clinique et du Développement of Assitance Publique-Hôpitaux de Paris (AOM 00148, P001004). HAMLET was supported by a grant from the Netherlands Heart Foundation (grant number 2002B138). DESTINY was funded by the Department of Neurology, University of Heidelberg, and by the Kompetenznetzwerk Schlaganfall, established by the German ministery of Science (BMBF) and the German research coucil (DFG). Funding sources played no role in the writing of the manuscript nor in the decision to submit the manuscript for publication.
PY - 2007/3
Y1 - 2007/3
N2 - 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≤4 (75% vs 24%; pooled absolute risk reduction 51% [95% CI 34-69]), an mRS≤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≤4, four for survival with mRS≤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.
AB - 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≤4 (75% vs 24%; pooled absolute risk reduction 51% [95% CI 34-69]), an mRS≤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≤4, four for survival with mRS≤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.
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=33846892907&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(07)70036-4
DO - 10.1016/S1474-4422(07)70036-4
M3 - Article
C2 - 17303527
AN - SCOPUS:33846892907
SN - 1474-4422
VL - 6
SP - 215
EP - 222
JO - Lancet neurology
JF - Lancet neurology
IS - 3
ER -
