Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials - 16/08/11

Doi : 10.1016/S1474-4422(07)70036-4

Katayoun Vahedi, MD ^a, Jeannette Hofmeijer, MD ^d, Eric Juettler, MD ^g, Eric Vicaut, PhD ^b, Bernard George, MD ^c, Ale Algra, MD ^d,^e, G Johan Amelink, MD ^f, Peter Schmiedeck, MD ^h, Stefan Schwab, MD ^g,ⁱ, Peter M Rothwell, MD ^j, Marie-Germaine Bousser, MD ^a, H Bart van der Worp, MD ^d, Werner Hacke, ProfMD ^g,^⁎

for the DECIMAL, DESTINY, and HAMLET investigators

^a Department of Neurology, Assistance Publique, Hôpitaux de Paris, Lariboisière Hospital, Paris, France

^b Unité de Recherche Clinique, Assistance Publique, Hôpitaux de Paris, Lariboisière Hospital, Paris, France

^c Department of Neurosurgery, Assistance Publique, Hôpitaux de Paris, Lariboisière Hospital, Paris, France

^d Department of Neurology, Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Utrecht, Netherlands

^e Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, Netherlands

^f Department of Neurosurgery, Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Utrecht, Netherlands

^g Department of Neurology, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany

^h Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany

ⁱ Department of Neurology, University of Erlangen, Erlangen, Germany

^j Stroke Prevention Research Unit, Department of Clinical Neurology, University of Oxford, Oxford, UK

^* Correspondence to: Prof Werner Hacke, Department of Neurology, Ruprecht-Karls-University Heidelberg, Im Neuenheimer Feld 400, D 69120 Heidelberg, Germany

Summary

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.

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Vol 6 - N° 3

P. 215-222 - mars 2007 Retour au numéro

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Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials - 16/08/11

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