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In patients with acute stroke and a large infarct of unrestricted size, thrombectomy and medical care led to better functional outcomes and lower mortality compared with medical care alone, the prospective randomized LASTE trial showed.
At 90 days, the median modified Rankin scale score was 4, indicating moderately severe disability, in the thrombectomy group versus 6 in the control group, indicating death (generalized OR 1.63, 95% CI 1.29-2.06, P<0.001), reported Caroline Arquizan, MD, of the Hôpital Gui de Chauliac in Montpellier, France, and co-authors. Scores of 5 and 6 were combined into one score in the analysis.
Death from any cause at 90 days occurred in 36.1% of patients in the thrombectomy group compared with 55.5% of those in the control group (adjusted relative risk [aRR] 0.65, 95% CI 0.50-0.84), they wrote in the . Benefits of thrombectomy were sustained at 180 days.
In previous trials of endovascular thrombectomy in acute stroke, patients with the largest infarcts, or cores, were excluded because of concerns about potential injury from reperfusion. These trials showed benefits with thrombectomy, but few had unrestricted infarct size, the authors pointed out.
Notably, patients with (ASPECTS) values of 0 or 1, the largest infarcts, were included in the current study.
"The effect favoring thrombectomy was similar in magnitude to that seen in other thrombectomy trials, including those that only enrolled patients with a small or moderately sized baseline infarct; however, no direct comparisons with other trials can be made because of differences in trial designs and patient populations," Arquizan and team wrote.
Pierre Fayad, MD, of the University of Nebraska Medical Center in Omaha, who was not involved in the study, told app that this patient population has "the most severe strokes and they have very high mortality, very high morbidity, and very high risk of disability. So we're looking at the very, very, very, very difficult patients here."
This study "provides new information that even in the lower ASPECTS score as defined by MRI, there is hope," he added.
Still, he cautioned that "some people will look at the glass half full, and others will see it half empty. So there are concerns in such a population that ... they're not dying, but you're improving them to become disabled."
Amrou Sarraj, MD, of the Case Western Reserve University School of Medicine in Cleveland, called the study a "welcome addition to evidence from previous trials" in an email to app.
"Now that we have clear and irrefutable benefit of thrombectomy in large core," clinical guidelines should incorporate its use in the large core patient population, he said. Both Sarraj and Fayad both stressed the importance of pooling all data from large core trials to inform future treatment.
The open-label was stopped early because results from similar trials supported thrombectomy. From April 2019 through March 2022, a total of 333 patients from 30 hospitals in France and Spain were randomized 1:1 to thrombectomy plus medical care (median age 73, 82% men) or medical care alone (median age 74, 88% men).
Median baseline infarct volume was 135 mL, larger than in other trials, which the authors said could have contributed to higher rates of death and severe disability in this trial. MRI was the predominant imaging method used in the study.
Patients were eligible for study inclusion if they had an ASPECTS value of 5 or less on CT or MRI (except for patients older than 80, who were eligible if they had a baseline ASPECTS value of 4 or 5); occlusion of the proximal segment of the internal carotid artery or the proximal segment of the middle cerebral artery; a pre-stroke score of 0 or 1 on the modified Rankin scale; and an score of at least 6 (scores range from 0 to 42, with higher scores indicating more severe stroke).
Patients had to be able to undergo randomization within 6.5 hours of symptom onset, and were excluded if they showed evidence of intracerebral hemorrhage.
Procedure-related complications, including arterial dissection, perforation, and embolization in a previously uninvolved territory, and complications at the vascular access site, occurred in 11 patients in the thrombectomy group.
The percentage of patients with symptomatic intracerebral hemorrhage -- an ancillary safety outcome -- was 9.6% in the thrombectomy group and 5.7% in the control group (aRR 1.73, 95% CI 0.78-4.68), a non-significant difference.
The authors were limited by the early termination of the trial and the use of MRI as the main imaging method, since CT is the predominant method to assess acute stroke. Benefits for patients older than 80 with ASPECTS scores of 0-3 could not be determined, because these patients were excluded.
Disclosures
The study was funded by Montpellier University Hospital.
Arquizan reported relationships with Amgen and Medtronic Vascular.
Co-authors reported numerous financial relationships, including with industry.
Fayad reported no financial conflicts of interest.
Sarraj reported being the principal investigator of the SELECT and SELECT2 trials, funded by Stryker Neurovascular.
Primary Source
New England Journal of Medicine
Costalat V, et al "Trial of thrombectomy for stroke with a large infarct of unrestricted size" N Engl J Med 2024; DOI: 10.1056/NEJMoa2314063.