Journal Club: Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomized controlled trials

Title and Citation

Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomized controlled trials

Lancet Neurology 2007

Background and importance

Malignant MCA infarct associated with 80% mortality.

Trial design

Pooled analysis of 18-60 year old patients with space occupying MCA infarction included in DECIMAL, DESTINY, or HAMLET treated within 48h after stroke onset.

All trials randomized patients to either decompressive surgery or conservative treatment

Inclusion Criteria

18-60 years old

NIHSS>15

CT demonstrating at least 50% infarction in MCA territory

Or infarct volume >145 cubic cm on diffusion weighted imaging

Inclusions within 45h after onset of symptoms

Exclusion Criteria

Prestrike mRS greater than or equal to 2

Two fixed dilated pupils

Contralateral ischemia

Space occupying hemorrhagic transformation of infarct

Life expectancy ❤ years

Coagulopathy or systemic bleeding disorder

Contraindication for anesthesia

Pregnancy

Serious illness that could affect outcome

Primary endpoint

Modified Rankin scale (mRS) at 1 year dichotomized favourable (0-4) and unfavourable (5 and death)

Fatality rate at 1 year dichotomized between mRS 0-3 and mRS 4-death

Statistical Analysis

Mann-Whitney U test

Based on intention to treat

Results

93 patients were included in pooled analysis (DECIMAL:38, DESTINY:32, HAMLET:23)

51 randomized to surgery and 42 to conservative treatment

Significantly fewer patients had an unfavourable outcome (mRS 5 or more) at 12 months following surgery compared to conservative treatment.

Limitations

Unable to fully blind due to nature of intervention

Subgroup analyses for age and interval between onset of symptoms and treatment not powered to show effect

Author’s Conclusion

Decompressive surgery within 48 hours of stroke onset reduces mortality and increases number of favourable functional outcome in patients with malignant MCA infarction

Applicability

Numbers to guide decisions or possibly discussion with families: probability of survival increases from 28% to ~80%, probability of survival with mRS of less than or equal to 3 doubles, but probability of surviving needing assistance mRS=4, increases more than ten times

Study excluded patients greater than 60 which is difficult since many stroke patients are >60 years old