Background
Multiple randomized trials have demonstrated the efficacy and safety of endovascular thrombectomy in patients with large ischemic stroke. The objective of this study was to evaluate the long-term (i.e., one year) evidence of the benefit of thrombectomy for these patients.
Methods
SELECT2 was a phase 3, international, open-label, randomized controlled trial with blinded endpoint evaluation, conducted at 31 hospitals in the US, Canada, Spain, Switzerland, Australia, and New Zealand.
Patients aged 18 to 85 years with ischemic stroke due to proximal occlusion of the internal carotid artery or the first segment of the middle cerebral artery, showing a large ischemic core on non-contrast CT (Stroke Program early computed tomographic score of Alberta 3 to 5) [range 0-10, with lower values indicating larger infarcts]) or who measured 50 ml or more in perfusion by CT and MRI, were randomly assigned, within 24 h after onset of ischemic stroke, to thrombectomy plus medical care or to medical care alone .
The primary outcome of this analysis was the modified ordinal Rankin Scale (range 0 to 6, with higher scores indicating greater disability) at 1-year follow-up in an intention-to-treat population.
The trial is registered at ClinicalTrials.gov (NCT03876457).
Results
The trial was terminated early for efficacy at 90-day follow-up after 352 patients were randomized (178 to thrombectomy and 174 to medical care only) between October 11, 2019 and September 9, 2022.
Thrombectomy significantly improved the modified Rankin Scale score distribution in years versus medical care alone (Wilcoxon-Mann-Whitney probability of superiority 0.59 [95% CI 0.53–0.64]; p = 0 . 0019; generalized odds ratio 1.43 [95% CI 1.14–1.78]).
At 1-year follow-up, 77 (45%) of 170 patients who received thrombectomy had died, compared with 83 (52%) of 159 patients who received medical care alone (relative risk of 1-year mortality 0.89 [95% CI]. %). 0·71–1·11]).
Interpretation
In patients with ischemic stroke due to proximal occlusion and a large ischemic core on non-contrast CT, thrombectomy plus medical care provided a significant functional benefit compared with medical care alone at 1-year follow-up.
Funds : Stryker Neurovascular.
