title: Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.
abstract: OBJECTIVE
  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.
authors: University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.
authors: Eric
authors: E
authors: Jüttler
authors: Stefan
authors: S
authors: Schwab
authors: Peter
authors: P
authors: Schmiedek
authors: Andreas
authors: A
authors: Unterberg
authors: Michael
authors: M
authors: Hennerici
authors: Johannes
authors: J
authors: Woitzik
authors: Steffen
authors: S
authors: Witte
authors: Ekkehart
authors: E
authors: Jenetzky
authors: Werner
authors: W
authors: Hacke
mesh_terms: D000328:Adult; D003399:Craniotomy; D019299:Decompression, Surgical / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function; D020521:Stroke / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome