medwireNews: Two studies published in The New England Journal of Medicine suggest that endovascular treatment (EVT) may be no more beneficial than medical therapy alone for strokes with occlusion of medium or distal vessels.
Neither of the studies found that EVT reduced disability or the incidence of death at 90 days to a significantly greater extent than medical therapy alone, while one found an increased risk for death with EVT.
“These findings are fundamental to any future consideration of thrombectomy for stroke unrelated to large-vessel occlusion,” says J Mocco (Icahn School of Medicine, New York, USA) in a related editorial.
He adds: “Further effort, grounded in high-quality data science, is needed to evaluate alternative approaches for medium- or distal-vessel occlusion, be they medical or procedural.”
The first of the two studies – DISTAL – involved 534 participants (56% men, median age 77 years) with an isolated occlusion of medium or distal vessels, predominantly of the M2 segment (44.0%) or M3 segment (26.9%) of the middle cerebral artery.
The patients had a median baseline National Institutes of Health Stroke Scale (NIHSS) score of 6 points out of a possible 42 points, where a higher score indicates more severe symptoms, and the majority (80.3%) had a prestroke modified Rankin Scale (mRS) score of 0 or 1 points, indicating no symptoms or significant disability. Only 8.3% had a score of 3 or 4 points, reflecting moderate-to-severe disability.
Among the 271 patients who were randomly assigned to receive EVT (primarily a combination of stent retrievers and aspiration) within 24 hours of symptom onset in addition to best medical treatment, 84.5% underwent the procedure and 71.7% had successful reperfusion.
Their median mRS score at 90 days was 2 points, which was the same for the 272 patients assigned to receive best medical treatment alone, and a comparable 34.7% and 37.5% had mRS scores of 0 or 1 point, respectively.
Urs Fischer (University Hospital Bern, Switzerland) and colleagues comment that “subgroup analyses suggest that the lack of superiority of EVT did not depend on baseline severity of neurologic deficit, time to treatment, occlusion location, or administration of intravenous thrombolysis.”
They also note that there was no “substantial difference” in the rates of all-cause death, at 15.5% in those receiving additional EVT and 14.0% in patients receiving best medical therapy alone, nor the number of serious adverse events (AEs), at 114 versus 88.
Corroborative findings were reported in the second study – ESCAPE-MeVO – for 255 patients randomly assigned to receive EVT within 12 hours of symptom onset plus usual care and 274 assigned to receive usual care alone.
The median age of the participants was 75 years and there were nearly equal numbers of men and women. Most (84.7%) of the patients had primary occlusions in a branch of the middle cerebral artery, and they had a median NIHSS score at baseline of 8 points.
EVT involved combinations of stent retrievers and aspiration and there was a 75.1% rate of successful reperfusion.
At 90 days, the median mRS score was 2 points in both groups, and a similar 41.6% of patients in the EVT plus usual care and 43.1% in the usual care alone group had mRS scores of 0 or 1 point.
Unlike the DISTAL study, the incidence of serious AEs was higher in the EVT group than the usual care only group, at 33.9% versus 25.7%. These included symptomatic intracranial hemorrhage (5.4 vs 2.2%) and stroke progression (5.4 vs 1.8%), which the study authors suggest “may be attributable to the EVT procedure itself,” and could partly explain why EVT did not result in better outcomes than usual care alone.
There was also a significantly higher rate of all-cause death with EVT at 90 days, at 13.3% versus 8.4% in controls, giving a significant adjusted hazard ratio of 1.82.
Michael Hill (University of Calgary, Alberta, Canada) and co-workers suggest other potential reasons for the lack of benefit with EVT include the absence of technical EVT success in some patients and the longer time from symptom onset to recanalization (median 359 minutes) compared with previous trials (eg, 241 minutes in the ESCAPE trial).
They conclude: “The results of our trial do not support routine endovascular treatment of acute ischemic stroke due to medium-vessel occlusion. Further work is needed to improve the safety profile of the EVT procedure and to identify a population of patients who may benefit from this treatment approach.”
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