Interim Analysis Finds No Safety Concerns for SELECT2 Trial in Acute Ischemic Stroke

The data safety monitoring board reviewed 90-day outcomes for the first 200 patients, recommending that investigators continue the study as it currently stands.

The first interim analysis of the phase 3 SELECT2 trial (NCT03876457) was completed by a data safety monitoring board on February 2, 2022, identifying no safety concerns during a review of 90-day outcomes for the first 200 included participants.1

To be included, patients must have acute ischemic stroke due to large vessel occlusion in the distal internal carotid artery, the M1 segment of the middle cerebral artery, or tandem occlusions, as well as large core on either noncontrastCT or advanced perfusion imaging. A second interim analysis is anticipated to be conducted in the third quarter of 2022, including 380 patients.

Findings from the analysis were presented at the 2022 International Stroke Conference (ISC) February 9-11, in New Orleans, Louisiana, by AmrouSarraj, MD, George M Humphrey II Endowed Professor of Neurology, Case Western Reserve University; and director, Comprehensive Stroke Center and Stroke System, University Hospitals Cleveland Medical Center. The SELECT2 trial aims to evaluate safety and efficacy of endovascular thrombectomy (EVT) compared to medical management (MM) alone for up to 24 hours of stroke onset, as well as to evaluate the heterogeneity of thrombectomy treatment effect on CT compared with perfusion imaging. Modified Rankin Scale (mRS) score shift at 90 days is the primary end point, with secondary end points identified as mRS score of 0-2 at day 90 and mRS shift and 0-2 at the 1-year follow-up mark.

A total of 200 patients were enrolled in the phase 3 study as of Oct 19, 2021, with 100 patients randomized to receive EVT and 100 randomized to MM. Participants in the EVT group had a median age of 66.5 years (IQR, 58.5-75) and those in the MM group had a median age of 67.5 (IQR, 59-76). Presentation National Institutes of Health Stroke Scale (NIHSS) scores were similar, averaging 19 (IQR, 15-23) for the EVT group and 19 (IQR, 15-23) in the MM group, as was time from stroke onset to randomization, averaging 9.3 hours (IQR, 5.0-15.25) for the EVT group and 9.9 hours (IQR, 5.95-15.9) for the MM group, and physician read CV Alberta Stroke Program Early CT Scores (ASPECTS), at 4 (IQR, 4-5) for the EVT group and 4 (IQR, 4-5) for the MM group.

Overall, 176 patients had NCCT ASPECTS between 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, with a median ischemic core of 94 (IQR, 72-138).

Patients were enrolled at 30 sites across the US, Spain, Australia, New Zealand, and Canada, and were required to be between the age 0f 18-85 years, with an NIHSS score of 6 or greater and a baseline mRS score between 0-1. To be included, patients also present with NCCT ASPECTS between 3-5 and/or with a CT perfusion or MR imaging ischemic school of 50 mL or greater. Maximum enrollment is set at 560 patients across the study sites.

For more coverage of ISC 2022, click here.

REFERENCE
1. Sarraj A. An alternative reduced dose regimen of ticagrelor for neuroendovascular patients. Presented at ISC 2022; February 9-11; New Orleans, LA and Virtual. Presentation LB13.