Patients with large ischemic strokes are often excluded from clinical trials on endovascular thrombectomy. To address this knowledge gap, the SELECT02 trial evaluated the efficacy and safety of thrombectomy, compared to standard medical care in this patient population. The results of this trial, recently published in the New England Journal of Medicine, show that endovascular thrombectomy improves functional outcomes but comes at the cost of procedural complications in these patients.
Patients with ischemic stroke due to large-vessel occlusion have been shown to have better functional outcomes with endovascular thrombectomy than with standard of care (SOC). However, previous large trials have generally excluded patients with large strokes due to concerns about haemorrhagic transformations of the infarct and the generally poor prognosis of these patients. To address this knowledge gap, a new trial assessed the safety and efficacy of endovascular thrombectomy in patients with acute ischemic stroke and a large ischemic core volume.
The international phase III SELECT02 trial included 352 adults with acute ischemic stroke due to an occlusion of the internal carotid artery or the first segment of the middle cerebral artery and a large ischemic-core volume. Patients were randomly assigned in a 1:1 ratio to endovascular thrombectomy within 24 hours plus SOC (n=178) or to SOC alone (n=174). The primary outcome was the modified Rankin scale score at 90 days. Scores range from 0 to 6, with higher scores indicating greater disability. Functional independence was a secondary outcome.
The median score on modified Rankin scale at 90 days was 4 vs. 5 in the thrombectomy and SOC groups, respectively, with generalised odds ratio demonstrating superiority of thrombectomy over SOC (95%CI: 1.51[1.21-1.89]; p< 0.001). Functional independence at 90 days was also improved in the thrombectomy group (20.3% vs. 7.0%; relative risk: 2.97[95%CI: 1.60-5.51]). The incidence of intracranial haemorrhage within 24 hours was similar between the two groups (0.6% vs. 1.1% in the thrombectomy and SOC groups, respectively; relative risk: 0.49[95%CI: 0.04-5.36]), as was the mortality rate within 90 days (38.4% vs. 41.5%, relative risk 0.91[95%CI: 0.71-1.18]). However, 18.5% of the patients in the thrombectomy group had procedural complications, including dissection (5.6%), vessel perforation (3.9%) and vasospasm (6.2%).
The authors conclude that in patients with acute ischemic stroke due to a proximal large-vessel occlusion and with a large ischemic-core volume, endovascular thrombectomy plus SOC resulted in better functional outcomes at 90 days than SOC alone, but it was associated with procedural complications.