But the therapy also carries a greater risk of intracranial hemorrhage, according to the non-blinded randomized test in 203 patients.
Current guidelines recommend endovascular therapy for patients with an ASPECTS score of at least 6. The higher the number on the 10-point scale, the lower the infarct burden.
The new open-label study, known as RESCUE-Japan LIMIT, involved patients with scores of 3 to 5.
The results were reported at the International Stroke Conference and online in the New England Journal of Medicine.
Treatment was successful, as gauged by a modified Rankin scale score of 0 to 3 at the 90-day mark, in 31.0% of the patients who received endovascular therapy and 12.7% of those who received medical care alone (P=0.002).
On that scale, a 0 signifies no disability and a 3 means the person is moderately disabled but can walk unassisted.
A benefit for endovascular therapy was also seen when the researchers used the 42-point National Institutes of Health Stroke Scale (NIHSS). An improvement of at least 8 points was seen in 31.0% of endovascular therapy recipients versus 8.8% of those in the control group.
Endovascular therapy options included using a stent retriever, aspiration catheter, carotid-artery stent, intracranial stent, and balloon angioplasty.
All the patients were eligible for alteplase therapy and about 27% in each group received that treatment.
But the benefits came at a risk. While 31.4% in the control group experienced any intracranial hemorrhage within 48 hours, the rate was 58.0%, or 85% higher, with endovascular treatment (P<0.001).
"Overall, there were significantly more intracranial hemorrhages in the endovascular-therapy group than in the medical-care group, but the difference in the percentage of patients with symptomatic intracranial hemorrhage was not significant," the research team, led by Dr. Takeshi Morimoto of Hyogo College of Medicine in Nishinomiya, Japan, writes in their report.
Those odds were 9.0% with endovascular therapy and 4.9% without (P=0.25).
The test was done at 45 hospitals. Forty seven percent of the patients ultimately enrolled had an occlusion of the internal carotid artery and 71% had an occlusion of the M1 segment of the middle cerebral artery. Mean age was 76 years. The median ASPECTS score was 3. The median NIHSS score was 22. People who had an acute intracranial hemorrhage or were judged to have a high risk of developing a hemorrhage were excluded from the study.
While 6.9% of patients in the medical-care only group saw their modified Rankin score improve to the 0 to 2 range, 14.0% in the endovascular therapy group saw a comparable improvement. The odds of improving into the 0 to 1 range were 2.9% and 5.0% respectively. But those results were not statistically significant.
The odds of death within 90 days were 18.0% with endovascular therapy and 23.5% without it, but that 23% reduction in deaths was also not statistically significant.
"Our expectations for patients with large infarctions to meet these secondary outcome criteria were limited," the researchers said.
The team noted that the patient population was Japanese and the dose of alteplase, 0.6 milligram per kilogram of body weight, was low compared to the standard in many other countries.
If the drug "had been used more often or at higher doses in our trial, the outcomes might have been improved in both groups," they write. "But there might have been an increased percentage of patients with intracranial hemorrhage in both groups."
SOURCE: https://bit.ly/3stcaEP The New England Journal of Medicine, online February 9, 2022.
By Gene Emery
(Editing by Christine Soares)
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