on August 9, 2007
Published online before print August 9, 2007, doi: 10.1161/STROKEAHA.107.485649
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Submitted on February 22, 2007
From the Department of Neurology (E.J., S.S., W.H.), University Hospital Heidelberg, University of Heidelberg, Heidelberg; the Department of Neurology (S.S.), University Hospital Erlangen, University of Erlangen, Erlangen; the Department of Neurosurgery (P.S., J.W.), University Hospital Mannheim, University of Heidelberg, Heidelberg; the Department of Neurosurgery (A.U.), University Hospital Heidelberg, University of Heidelberg, Heidelberg; the Department of Neurology (M.H.), University Hospital Mannheim, University of Heidelberg, Heidelberg; and the Institute of Medical Biometry and Informatics (S.W., E.J.), University of Heidelberg, Heidelberg, Germany. * To whom correspondence should be addressed. E-mail: werner.hacke{at}med.uni-heidelberg.de.
Background and Purpose—Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. Methods—DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. Results—A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). Conclusions—DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.
Revised on April 27, 2007
Accepted on May 3, 2007
Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY). A Randomized, Controlled Trial
Eric Jüttler MD;
Key words: decompressive surgery • malignant middle cerebral artery infarction • randomized trials
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