LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.
After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.
"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.
Evidence supporting decompressive surgery
Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.
A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.
The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.
Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).
DESTINY II results
Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.
The number needed to treat was just 4, Dr. Hacke reported.
At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).
An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.
Retrospective consent to surgery
When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.
This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.
Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.
"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.