1. In this randomized controlled trial, endovascular thrombectomy resulted in better functional outcomes than medical care in patients with large ischemic strokes.
2. For patients with large ischemic strokes, endovascular thrombectomy was associated with more vascular complications than medical care.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Endovascular thrombectomy has been shown to be more effective than medical therapy alone in reducing disability in patients with ischemic stroke. However, there is a gap in knowledge as to understanding the safety and efficacy of thrombectomy in patients with a significant ischemic stroke burden and whether endovascular thrombectomy within 24 hours after stroke onset (defined as the time the patient was last known to be well) leads to better functional outcomes than standard medical care alone. Overall, this study found that endovascular thrombectomy, in addition to standard medical care, resulted in better functional outcomes than medical care alone in patients with large ischemic infarcts. Although, thrombectomy was associated with procedural vascular complications. This study was limited by its early termination and smaller sample size than expected. Nevertheless, these study’s findings are still significant, as they demonstrate that endovascular thrombectomy may improve functional outcomes for patients with large ischemic strokes.
Click to read the study in NEJM
Relevant Reading: Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct
In-Depth [randomized controlled trial]: This phase three, randomized, open-label clinical trial was conducted at 31 sites across the United States, Canada, Europe, Australia, and New Zealand. Patients who were 18 to 85 years of age and had an acute ischemic stroke due to occlusion of the internal carotid artery (either cervical or intracranial) or the M1 segment (main trunk) of the middle cerebral artery or both were eligible for the study. Patients who did not have a large ischemic stroke as estimated on computed tomography perfusion imaging were excluded from the study. The primary outcome was the ordinal score on the modified Rankin scale at 90 days, with higher scores indicating more significant disability. Outcomes in the primary analysis were assessed via the intention-to-treat principle. Based on the primary analysis, the trial was ended early due to efficacy, as thrombectomy had an odds ratio for better outcomes was 1.51 (95% Confidence Interval [CI], 1.2 to 1.89). In total, 20% of the patients in the thrombectomy group had functional independence, compared to 7% of the medical care group (Relative Risk, 2.97; 95% CI, 1.6 to 5.51). Mortality was similar in the two groups, though in the thrombectomy group, vascular complications occurred. Arterial access-site complications occurred in five patients, dissection in 10 patients, cerebral-vessel perforation in seven patients, and transient vasospasm in 11 patients. In summary, this study demonstrates that endovascular thrombectomy results in better functional outcomes than medical care alone in patients with large ischemic strokes.
Image: PD
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