BACKGROUND: Endovascular thrombectomy is an established treatment for acute ischemic stroke. Whether the benefit extends to patients with salvageable brain tissue in the infarct who present more than 24 hours after symptom onset or the time when they were last known to be well is uncertain.
METHODS: We conducted an open-label, randomized trial with blinded outcome assessment at comprehensive stroke centers in China. Patients with acute ischemic stroke from large-vessel occlusion of the anterior circulation and imaging-identified salvageable brain tissue at 24 to 72 hours were assigned to receive endovascular therapy plus standard medical care (intervention group) or standard medical care alone (control group). The primary outcome was functional status, defined by the score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death) at 90 days, with results assessed as the distribution of scores in each group. Secondary outcomes included disability, neurologic impairment, and safety.
RESULTS: A total of 336 patients were included in the intention-to-treat population, with 168 assigned to each group. The median time from symptom onset or from the point when the patient was last known to be well to randomization was 38.5 hours. Endovascular therapy resulted in a more favorable distribution of modified Rankin scale scores at 90 days than standard medical care alone (common odds ratio for a better functional outcome, 1.74; 95% confidence interval, 1.19 to 2.55). Symptomatic intracranial hemorrhage occurred in 4.8% of the patients in the intervention group and in no patients in the control group, and the 90-day case fatality rate was 6.0% and 1.8%, respectively.
CONCLUSIONS: Among patients who presented 24 to 72 hours after an acute ischemic stroke from large-vessel occlusion of the anterior circulation and had imaging-identified salvageable tissue, endovascular therapy resulted in better functional outcomes than standard care but led to a higher risk of intracranial hemorrhage and death. (Funded by the National Health Commission Capacity Building and Continuing Education Center and others; LATE-MT ClinicalTrials.gov number, NCT05326932.).
| Discipline Area | Score |
|---|---|
| Neurology |  |
| Emergency Medicine |  |
| Intensivist/Critical Care | |
| Surgery - Neurosurgery | Coming Soon... |
Acceptance of mechanical thrombectomy for acute ischemic stroke with salvageable brain has increased over the past decade as the number of supporting trials has grown (https://emergencymedicine.wustl.edu/items/endovascular-stroke-treatment/ and current ACEP Clinical Policy http://pmid.us/37479410). The problem is that too many ischemic stroke patients present beyond 24 hours and have historically been excluded from mechanical thrombectomy. This trial explores the 24-to-72-hour window beyond symptom onset with demonstration of both patient-centered benefits and real harms. So, at best, this work should encourage shared decision-making between the patient and acute stroke team.
In this RCT from China, patients were more likely to have a better outcome as per mRS with thrombectomy than with standard medical care with the presence of a penumbra. This seems to make sense when there's salvageable brain tissue. However safety signals were concerning: 6.8x more ICH, almost 5% more sICH, and Death was 3.5x higher with thrombectomy (although did not make statistical significance). More studies will need to be performed to evaluate which patients could benefit from this extended time window of >24 hours as the risk/benefit ratio has not clearly been answered.
Expanding stroke treatment yet again, now up to several days. Of course, this needs confirmation and studies in other populations, but is potentially a significant increase in eligibility if confirmed.
Definitive evidence of benefit of EVT in a subgroup of patients defined by perfusion status. There is an increase in mortality and symptomatic ICH with treatment and translation to practice will require attention to patient values and preferences.
These results will likely not affect current practice, but they will open the door to new trials and innovations because we now have evidence that tissue is salvageable 24 to 72 hours after the early signs of stroke.