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Decompressive Hemicraniectomy in Malignant Middle Cerebral Artery Infarct: A Randomized Controlled Trial Enrolling Patients up to 80 Years Old
Neurocritical Care , 04/24/2012
Zhao J et al. – For patients up to 80years who suffered malignant middle cerebral artery infarction (mMCAI), decompressive hemicraniectomy (DHC) within 48h of stroke onset not only is a life–saving treatment, but also increases the possibility of surviving without severe disability.
Methods- This is a prospective, randomized, controlled trail comparing the outcomes with or without DHC in patients aged 18-80 with mMCAI.
- The primary outcome measure was the modified Rankin Scale (mRS) scores at 6months.
- The secondary outcome measures included the 6- and 12-month mortality and the mRS scores after 1year.
- The prognosis of patients was evaluated independently by two blinded investigators.
- In addition, subgroup analyses were done for those above 60years of age.
- All analyses were by intention-to-treat.
- A significant reduction in the poor outcome (mRS>4) following DHC was reached after 36 patients had completed the follow-up period of 6months.
- The trial was then terminated when 47 participants (24 in the surgical group vs. 23 in the medical group) had been recruited.
- The final analysis, based on the outcome data of the 47 patients, showed that DHC significantly reduced mortality at 6 and 12months (12.5 vs. 60.9 %, P=0.001 and 16.7 vs. 69.6 %, P<0.001, respectively), and significantly fewer patients had a mRS score >4 after surgery (33.3 vs. 82.6 %, P=0.001 and 25.0 vs. 87.0 %, P<0.001, respectively).
- Similar results were present in the subgroup analyses of elderly participants.