BACKGROUND: Whether the large effect size of endovascular thrombectomy (EVT) for stroke due to large-vessel occlusion applies to stroke due to medium-vessel occlusion is unclear.
METHODS: In a multicenter, prospective, randomized, open-label trial with blinded outcome evaluation, we assigned patients with acute ischemic stroke due to medium-vessel occlusion who presented within 12 hours from the time that they were last known to be well and who had favorable baseline noninvasive brain imaging to receive EVT plus usual care or usual care alone. The primary outcome was the modified Rankin scale score (range, 0 [no symptoms] to 6 [death]) at 90 days, reported as the percentage of patients with a score of 0 or 1.
RESULTS: A total of 530 patients from five countries were enrolled between April 2022 and June 2024, with 255 patients assigned to the EVT group and 275 to the usual-care group. Most patients (84.7%) had primary occlusions in a middle-cerebral-artery branch. A modified Rankin scale score of 0 or 1 at 90 days occurred in 106 of 255 patients (41.6%) in the EVT group and in 118 of 274 (43.1%) in the usual-care group (adjusted rate ratio, 0.95; 95% confidence interval [CI], 0.79 to 1.15; P = 0.61). Mortality at 90 days was 13.3% in the EVT group and 8.4% in the usual-care group (adjusted hazard ratio, 1.82; 95% CI, 1.06 to 3.12). Symptomatic intracranial hemorrhage occurred in 14 of 257 patients (5.4%) in the EVT group and in 6 of 272 (2.2%) in the usual-care group.
CONCLUSIONS: Endovascular treatment for acute ischemic stroke due to medium-vessel occlusion within 12 hours did not lead to better outcomes at 90 days than usual care. (Funded by the Canadian Institutes for Health Research and Medtronic; ESCAPE-MeVO ClinicalTrials.gov number, NCT05151172.).
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Hospital Doctor/Hospitalists | |
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Neurology | |
Emergency Medicine |
The study did not demonstrate the efficacy of EVT in medium vessels occlusion, which unfortunately often causes serious disabling symptoms. Many of the probable reasons for the trial's negative outcome could have been overcome, so further trials are needed.
The variability in medium vessel occlusion and the complexity of different intervention options make it difficult to generalize findings beyond the specific conditions of the trial. In patients with medium vessel occlusion treated within 12 hours, endovascular therapy using the Solitaire X device did not result in better 90-day outcomes compared with standard care.
Well performed RCT indicating that "usual care" is equal to or better than endovascular thrombectomy for stroke patients with medium-size vessel occlusion. An important finding!
The inconsistency of the results in this study, which do not show the efficacy of endovascular treatment for mid-vessel occlusion stroke, with the results of previous clinical trials suggests that the latter may have been affected by selection biases and confounding factors. This highlights the importance of conducting well-conducted RCTs.