Endovascular thrombectomy shows better functional outcomes than medical care in ischemic stroke

recently published New England Journal of MedicineNew findings from the SELECT2 trial (NCT03876457), an international, randomized, open-label phase 3 clinical trial, suggest that endovascular thrombectomy (EVT) is more effective than medical care in patients with major ischemic stroke 24 hours after onset. shown to provide superior functional outcomes.1 These results provide evidence for the efficacy and safety of endovascular thrombectomy in patients with massive ischemic stroke. This has so far been done in limited populations.

The generalized odds ratio for a shift in the distribution of modified Rankin scale (mRS) scores to better outcomes in favor of EVT was 1.51 (95% CI, 1.20–1.89; P. <.001). Notably, a total of 20% of patients in the EVT group and his 7% in the medical group had functional independence (RR, 2.97; 95% CI, 1.60–5.51).

These findings will be presented at the Clinical Trials Plenary Session at the 2023 American Academy of Neurology (AAN) Annual Meeting in Boston, Massachusetts, April 22-27, 2023, by lead author Amrou Sarraj, M.D. It was also presented as an oral presentation by the department director). Center and Comprehensive Stroke Center at University Hospital Cleveland Medical Center. This session featured the latest clinical trial results impacting the landscape of patient care in all subspecialties of neurology.2

Between September 2019 and September 2022, when the study was stopped, 958 patients had been screened, of whom 352 were eligible and enrolled. This trial included a stroke patient due to occlusion of the first segment of the internal carotid artery or middle cerebral artery and evaluated his EVT during the 24-hour period after onset. Patients enrolled had either large ischemic core volume as defined by an Alberta Stroke Program Early Computed Tomography score of 3–5 (range 0–10, with lower scores indicating larger infarcts), or I had at least 50 mL. Tomographic perfusion or diffusion-weighted MRI.

Patients were assigned in a 1:1 ratio to the combined EVT and medical care group (n = 178) or medical care only group (n = 174). Her mRS score after 90 days (ranging from 0 to 6, with higher scores indicating greater disability) was the primary outcome, and functional independence was a secondary outcome.

Mortality was similar in both groups. Arterial access site complications occurred in five of his patients, including dissection in 10 patients, cerebrovascular perforation in 7 patients, and transient vasospasm in 11 patients, all of which belonged to his EVT group. One of her patients in the EVT group and two of her patients in the medical group experienced symptomatic intracranial hemorrhage.

Trial limitations include early termination and a smaller than expected sample size. Treatment was unblinded, but outcome assessment was performed by raters blinded to study group assignment. Additionally, some patients enrolled had lower ischemic core volumes than intended for enrollment, and only about 20% of patients received intravenous thrombolytics prior to randomization.

Previous coverage of SELECT2 identified no safety concerns during a 90-day outcome review of the first 200 included participants.3 The results of that analysis will be presented by Sarraj at the 2022 International Stroke Congress (ISC), February 9-11, 2022, in New Orleans, Louisiana. In the analysis, 200 patients were enrolled in the phase 3 trial, 100 patients randomized to receive his EVT, and 100 patients randomized to medical management (MM). was given.

Data presented at ISC 2023 showed that the median age of participants in the EVT group was 66.5 years (IQR, 58.5-75) and that in the MM group was 67.5 years (IQR, 59-76). ) was. National Institutes of Health Stroke Scale (NIHSS) scores were similar, with a mean of 19 (IQR, 15-23) in the EVT group and a mean of 19 (IQR, 15-23) in the MM group, with randomization from stroke onset. The time was the same. Mean 9.3 hours in the EVT group (IQR, 5.0-15.25) and 9.9 hours in the MM group (IQR, 5.95-15.9); , 4 (IQR, 4-5) for the MM group. Overall, his NCCT ASPECTS in 176 patients was 3–5 with a median ischemic core of 72 mL (IQR, 38.5–108.5). A total of 145 patients had an ischemic core of 50 mL and a median ischemic core of 94 (IQR, 72-138).

Click here for more information on AAN 2023.

1. Trials of endovascular thrombectomy for large ischemic stroke, including Saraj A, Hassan AE, Abraham MG. N Engl J Med2023;388(14):1259-1271. doi:10.1056/NEJMoa2214403
2. Sarraj, A. A randomized trial of endovascular thrombectomy and medical management for ischemic stroke with large core infarction by non-contrast CT or perfusion imaging. Announcement Location: 2023 AAN Annual Meeting. April 22-27, Boston, MA. Clinical trial plenary session.
3. Sarraj A. An alternative weight loss regimen of ticagrelor for neuroendovascular patients. Presented at ISC 2022. February 9-11. New Orleans, Louisiana and Virtual. Presentation LB13.

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