Until recently, most randomized clinical trials of EVT excluded patients with LCIS. Results from these six new trials are the first dedicated to addressing EVT in LCIS.
LCIS is defined as Alberta Stroke Program Early CT Score (ASPECTS) ≤ 5 on imaging within 6 hours of stroke onset. For patients at 6-24 hours of stroke onset, the definition also includes the CT perfusion scan definition of an area with hypoperfusion volume (cerebral blood flow < 30%) of > 70 cc.
LCIS represents about 25% of ischemic strokes attributable to large vessel occlusion (LVO) among those presenting to referral centers within 8 hours. This, said the advisory authors note, highlights the “substantial clinical relevance” of interventions that could improve outcomes for these patients.
The AHA advisory group searched medical databases for randomized controlled clinical trials (RCTs) published within the past 3 years that compared EVT with MM in patients with an acute ischemic stroke presenting with a large core infarct. The final analysis was based on six RCTs. These included:
The trials included a total of 1887 patients, all of whom had major arterial occlusions at the anterior circulation — either the internal carotid artery or middle cerebral artery.
The mean age of participants was mid- to late 60s in trials with upper age limits and mid-70s in the two trials without upper age limits. The median National Institutes of Health Stroke Scale (NIHSS) score of participants ranged from 16 to 22.
Most patients had good pre-stroke functional status with an average modified Rankin Score [mRS] of 0-1.
A total of 78.2% of patients had baseline ASPECTS 3-5, and 16.9% had ASPECTS 0-2. The LASTE trial included a large proportion of patients with very large cores — 56.6% of participants had ASPECTS 0-2.
The minimum NIHSS score for eligibility was 6 in all studies except TENSION, which had no lower limit.
The MRI-based stroke studies consisted of participants primarily in earlier time windows. They were randomized within 6 hours of last known well in RESCUE-Japan LIMIT and 6.5 hours in LASTE.
Among the CT-based studies, TENSION had an intermediate window, randomizing within 11 hours and completing thrombectomy by 12 hours. ANGEL-ASPECT, SELECT2, and TESLA enrolled patients up to 24 hours from the last known well.
The choice of EVT technique, such as stent retriever, aspiration, or both, with or without balloon protection, was at the discretion of the treating physician in all trials. Acute angioplasty, stenting, and intra-arterial thrombolysis were variably permitted.
The primary outcome in all studies was an mRS score at 90 days, which was assessed by blinded assessors. Intravenous thrombolysis candidates received alteplase in all studies.
The authors incorporated adjusted odds ratios (ORs) and their CIs from each study into a unified analysis. The primary analysis produced a combined OR of 1.57 (95% CI, 1.40-1.76).
Higher rates of functional independence were observed after EVT compared with MM in all trials. The difference was most apparent in ANGEL-ASPECT, where 30% of EVT-treated patients achieved functional independence compared with 11.6% of those receiving MM. Other trials showed more modest, but still favorable, results for EVT.
Independent ambulation, which was assessed as part of the Rankin score assessment, was achieved more frequently among those treated with EVT. This was most notable in ANGEL-ASPECT, with 47.0% of patients who received EVT regaining the ability to walk independently vs 33.3% for MM.
An update to the AHA 2019 acute ischemic stroke guideline is in process, and publication is expected in early 2026.
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