LONDON, United Kingdom — Whether the benefits of early decompressive surgery in older stroke patients with malignant infarction of the middle cerebral artery (MCA) were worth the costs was one of the subjects up for discussion at the recent XXII European Stroke Conference (ESC).
This followed presentation of the Decompressive Surgery for the Treatment of malignant INfarction of the middle cerebral artery (DESTINY II) trial, which showed lower mortality and generally reduced scores on the modified Rankin scale (mRS) in patients receiving early surgery compared with those treated conservatively.
The results of the trial, which were first presented at the 8th World Stroke Congress last fall, showed that the primary endpoint — mRS score of 0 to 4 (signifying a good outcome) at 6 months — occurred in 39% of the surgery group compared with 17% of the conservatively treated group, a 22–percentage point absolute difference, with a number needed to treat of just 5. Mortality at 6 months was almost halved.
Presenting the results here, Werner Hacke, MD, PhD, University of Heidelberg, Germany, concluded, "We have achieved a positive result in the primary endpoint and have shown that decompressive surgery is associated with a significant increase in patients surviving with a modified Rankin score better than 5."
Is mRS Score of 5 Better Than Death?
But several members of the audience questioned whether the results were as positive as they first appeared. Discussion centered on the observation that although mortality was greatly reduced, the number of patients left alive but in a severely disabled state (mRS score of 5) was greater in the surgical group.
Myron Ginsberg, MD, University of Miami Miller School of Medicine, Florida, took issue with the combining of mRS scores of 5 and 6 (6 being death). "Many would say that death is actually preferable to being left at a score of 5, and this surgery increases the probability of being left at 5," he stated.
Dr. Hacke argued that "there were not proportionally more patients left at 5 in the surgical group," but Philip Bath, MD, University of Nottingham, United Kingdom (UK), pointed out that there were numerically more patients left at a score of 5, and he raised the issue of the financial cost of caring for these patients. "This has huge economic implications," he said.
Dr. Hacke retorted, "If we just looked at economics, we would say the best outcome for stroke is death."
Commenting on the trial for Medscape Medical News, neurosurgeon David Mendelow, University of Newcastle, UK, said, "This trial showed the benefits of a significant reduction in mortality and a few extra patients in mRS score 3 with surgery. But this is offset somewhat by the large number of very disabled patients left at a score 5. These patients cost up to £200,000 per QALY [quality-adjusted life-year]. We have to ask ourselves if we can afford that."
Professor Mendelow noted that the trial showed a reduced death rate by about a half and a slight increase in each of the other mRS score bands. "Yes, there was a small increase in those with a score of 3, signifying a worthwhile recovery, but this comes at an enormous cost of more people surviving in an extremely disabled state. I look after these patients, and they have terrible complications. We can't even resource our A&E [accident and emergency] departments properly in the UK, so we have to consider the health economic arguments here."
He added that he had to make tough choices of how neurosurgical time was used, saying he would prioritize having the staff to operate on young people with head injuries at the weekend rather than spending hours saving elderly patients with stroke who are then left in a severely disabled state.
MCA Strokes Have 70% to 80% Early Mortality
In his presentation, Dr. Hacke explained that malignant MCA infarcts are the deadliest subtype of ischemic brain infarction, and patients have a poor prognosis even with maximum intensive care treatment, with a 70% to 80% early in-hospital mortality. A surgical approach with early hemicraniectomy has been shown to reduce mortality without increasing the risk for very severe disability in patients younger than age 60 years, but there is a lack of firm data in patients older than age 60.
They therefore conducted DESTINY II, a randomized trial testing the efficacy of early hemicraniectomy in patients with malignant MCA infarction who were older than 60 years.
The trial, conducted at 30 German hospitals, included 112 patients (mean age, 70 years) who were within 48 hours of onset of MCA infarction. They were randomly assigned to early surgery (n = 49) or conservative treatment (n = 63).
The data safety monitoring board stopped the trial after 82 patients had reached the 6-month endpoint because of a significant benefit in the surgical group.
Table 1. Six-Month Outcomes at the Time the Trial Was Stopped
| mRS Score | Surgery Group (%) | Conservative Group (%) |
| 0-4 | 40 | 19 |
| 5-6 | 60 | 81 |
An additional 30 patients had already been randomly assigned when the trial was stopped, and including these patients in the intention-to-treat analysis, which is the primary outcome, changed the results very little.
Table 2. Six-Month Outcomes: Intention-to-Treat Analysis
| mRS Score | Surgery Group (%) | Conservative Group (%) |
| 0-4 | 39 | 17 |
| 5-6 | 61 | 83 |
The shift analysis also showed that outcome was also improved with surgery (P < .001). These results were presented as a bar chart, and the numbers have been approximated in the table below:
Table 3. Approximate Results of Shift Analysis at 6 Months
| mRS Score | Surgery Group (%) | Conservative Group (%) |
| 3 | 6 | 4 |
| 4 | 33 | 14 |
| 5 | 26 | 12 |
| 6 | 35 | 70 |
Dr. Hacke noted that the shift analysis changed slightly by 1 year because several patients died between 6 and 12 months.
Patients and carers were asked retrospectively if they would again consent to the treatment received now that they knew the outcomes, and 77% of the surgical group vs 73% of the conservative group said they would. Dr. Hacke said this showed acceptance of being alive with disability rather than being dead.
The study received no commercial funding. Dr. Hacke has disclosed no relevant financial relationships.
XXII European Stroke Conference (ESC). Large Clinical Trials C: 4. Presented May 31, 2013.
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Cite this: Is Surgery for MCA Stroke in Over 60s Worth the Cost? - Medscape - Jun 11, 2013.
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