Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

Abstract:

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.

journal_name

Stroke

journal_title

Stroke

authors

Jüttler E,Schwab S,Schmiedek P,Unterberg A,Hennerici M,Woitzik J,Witte S,Jenetzky E,Hacke W,DESTINY Study Group.

doi

10.1161/STROKEAHA.107.485649

subject

Has Abstract

pub_date

2007-09-01 00:00:00

pages

2518-25

issue

9

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.107.485649

journal_volume

38

pub_type

杂志文章,多中心研究,随机对照试验

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