Mechanical Thrombectomy Versus Best Medical Treatment in the Late Time Window in Non-DEFUSE-Non-DAWN Patients: A Multicenter Cohort Study

Abstract

Background: We assessed the efficacy and safety of mechanical thrombectomy (MT) in adult stroke patients with anterior circulation large vessel occlusion presenting in the late time window not fulfilling the DEFUSE-3 (Thrombectomy for Stroke at 6 to 16 Hours With Selection by Perfusion Imaging trial) and DAWN (Thrombectomy 6 to 24 Hours After Stroke With a Mismatch Between Deficit and Infarct trial) inclusion criteria. Methods: Cohort study of adults with anterior circulation large vessel occlusion admitted between 6 and 24 hours after last-seen-well at 5 participating Swiss stroke centers between 2014 and 2021. Mismatch was assessed by computer tomography or magnetic resonance imaging perfusion with automated software (RAPID or OLEA). We excluded patients meeting DEFUSE-3 and DAWN inclusion criteria and compared those who underwent MT with those receiving best medical treatment alone by inverse probability of treatment weighting using the propensity score. The primary efficacy end point was a favorable functional outcome at 90 days, defined as a modified Rankin Scale score shift toward lower categories. The primary safety end point was symptomatic intracranial hemorrhage within 7 days of stroke onset; the secondary was all-cause mortality within 90 days. Results: Among 278 patients with anterior circulation large vessel occlusion presenting in the late time window, 190 (68%) did not meet the DEFUSE-3 and DAWN inclusion criteria and thus were included in the analyses. Of those, 102 (54%) received MT. In the inverse probability of treatment weighting analysis, patients in the MT group had higher odds of favorable outcomes compared with the best medical treatment alone group (modified Rankin Scale shift: acOR, 1.46 [1.02–2.10]; P =0.04) and lower odds of all-cause mortality within 90 days (aOR, 0.59 [0.37–0.93]; P =0.02). There were no significant differences in symptomatic intracranial hemorrhage (MT versus best medical treatment alone: 5% versus 2%, P =0.63). Conclusions: Two out of 3 patients with anterior circulation large vessel occlusion presenting in the late time window did not meet the DEFUSE-3 and DAWN inclusion criteria. In these patients, MT was associated with higher odds of favorable functional outcomes without increased rates of symptomatic intracranial hemorrhage. These findings support the enrollment of patients into ongoing randomized trials on MT in the late window with more permissive inclusion criteria.

Automated advanced imaging in acute ischemic stroke. Certainties and uncertainties

“…Furthermore, another important shortcoming affecting patient selection is the potential exclusion of some patients who could benefit from treatment due to the current restricted criteria [72] . This overselection was well described in two recent studies suggesting that the use of more permissive inclusion criteria could increase the number of patients treated with EVT in the late time window [73] , [74] . Lopez-Rivera and coworkers reported that the number of treatments with EVT in AIS patients with large vessel occlusion (LVO) admitted in both early and late time window was higher in centers with low advanced imaging utilization compared to those in which CTP was routinely used, without a significant increase in the incidence of poor outcome and hemorrhagic transformation [73] .…”

“…Lopez-Rivera and coworkers reported that the number of treatments with EVT in AIS patients with large vessel occlusion (LVO) admitted in both early and late time window was higher in centers with low advanced imaging utilization compared to those in which CTP was routinely used, without a significant increase in the incidence of poor outcome and hemorrhagic transformation [73] . More recently, Dittrich and colleagues showed that patients undergoing EVT at 6–24 h from onset and not satisfying DEFUSE 3 and DAWN inclusion criteria had an elevated probability to achieve a favorable outcome, without a higher frequency of symptomatic hemorrhagic transformation, compared to controls treated with best medical therapy [74] . In the attempt to further extend the patient population receiving EVT in the late time window, the opportunity of treating patients with large core were extensively explored [75] .…”

Mechanical thrombectomy for large vessel occlusion between 6 and 24 h: outcome comparison of DEFUSE-3/DAWN eligible versus non-eligible patients

“…The study period spans from January 2014 to May 2021. RESCUE EVT aims at assessing the role of endovascular stroke treatment beyond 6 h. 12 The study was approved in advance by the responsible cantonal ethics committee (ID 2020-00552).…”

Advanced Imaging in the Current Era of Acute Reperfusion Therapies

“…3). 102 Interpretation should always start by assessing image quality metrics before evaluating the color maps. 72 Some important and frequent technical errors are due to patient motion, poor cardiac output, loss of intravenous access, truncation artifact/incomplete wash out, incorrect selection of Regions of Interest (ROIs).…”