What is a “good outcome” for stroke patients? Is it “alive”? Or is it “alive & independent”, as in most of the tPA trials? Through what lens ought we interpret the findings of some of these highly intensive interventions for stroke?
This is DESTINY-II, which enrolled elderly patients with malignant intracranial swelling following significant MCA territory infarction. In this study, patients were randomized either to usual care or hemicraniectomy, a potential life-saving intervention that relieves intracranial pressure and reduces cerebral herniation. The untreated cohort had awful outcomes – at 12 months, zero patients were free from disability, zero had mild disability, and 5% had moderate disability. The remainder were severely disabled in dead. The hemicraniectomy cohort also had awful outcomes – at 12 months, zero patients were free from disability, zero had mild disability, and 6% had moderate disability.
So, of course, this study was stopped early because of overwhelming benefit to the hemicraniectomy cohort.
The key difference – hemicraniectomy patients survived to be severely disabled, while control patients died. 76% of patients in the control group died vs. 43% of the hemicraniectomy group. Most of the difference was made up by patients with mRS 4: “Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.“
Determining the value of survival with complete dependence vs. death is clearly a challenging ethical decision. Should this therapy be more widespread, given the resource intensive care and the ultimately dismal disability outcomes? Those questions remain to be answered – but at least this study helps us better share the prognosis of either option with patients and families.
“Hemicraniectomy in Older Patients with Extensive Middle-Cerebral-Artery Stroke”
http://www.nejm.org/doi/full/10.1056/NEJMoa1311367