In a trial comparing dexamethasone with surgery in patients with chronic subdural hematoma, “dexamethasone treatment was not found to be noninferior to burr-hole drainage with respect to functional outcomes and was associated with more complications and a greater likelihood of later surgery,” Dexamethasone Therapy versus Surgery for Chronic Subdural Hematoma (DECSA) collaborators concluded.
At 12 hospitals in the Netherlands, symptomatic patients with chronic subdural hematoma were randomized to a 19-day tapering course of dexamethasone or to burr-hole drainage. In this multicenter, open-label, controlled, noninferiority trial, the primary endpoint was the functional outcome at 3 months based on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]).
The results showed: “From September 2016 through February 2021, we enrolled 252 patients of a planned sample size of 420; 127 were assigned to the dexamethasone group and 125 to the surgery group. The mean age of the patients was 74 years, and 77% were men. The trial was terminated early by the data and safety monitoring board owing to safety and outcome concerns in the dexamethasone group. The adjusted common odds ratio for a lower (better) score on the modified Rankin scale at 3 months with dexamethasone than with surgery was 0.55 (95% confidence interval, 0.34 to 0.90), which failed to show noninferiority of dexamethasone. The scores on the Markwalder Grading Scale and Extended Glasgow Outcome Scale were generally supportive of the results of the primary analysis. Complications occurred in 59% of the patients in the dexamethasone group and 32% of those in the surgery group, and additional surgery was performed in 55% and 6%, respectively.”
Editorial: “[This] matter is not likely to be cleanly settled by clinical trials, regardless of the level of evidence,” an editorialist writes. “The term ‘subdural hematoma’ is a misnomer. The fluid collection is believed to be intradural — born of the disruption of the dural border layer, the cause of which varies among cases. Thus, what we uncritically call chronic subdural hematoma arises from several entities. For example, chronic subdural hematomas that are associated with cerebral hypotension due to occult leaks of the cerebrospinal fluid (CSF) will not respond to either surgical drainage or medications such as dexamethasone; they instead require repair of the leakage site. With respect to another situation of subdural hematoma, acute drainage in an older person with severe brain atrophy would promote acute rebleeding, and the hematoma would probably best be treated with gradual drainage and minimal disruptions of CSF dynamics. In cases in which fragile capillary formation has occurred in an encapsulated hematoma, middle meningeal artery embolization has shown promising results in reducing recurrences. In yet another circumstance, cessation of anticoagulation medications and observation of a mildly symptomatic or asymptomatic chronic hematoma might be adequate in cases induced by anticoagulant agents. Simply stated, the treatment of chronic subdural hematomas needs to be individualized according to the patient’s condition and the cause of the hematoma, and this type of care beats algorithms.”