Abstract Number: Esoc2026a1647 Minimal Clinically Important Difference of Follow-Up Infarct Volume in Patients With Acute Ischemic Stroke and Large Infarct: A Secondary Analysis of the Tension Trial

Abstract Background and aims Follow-up infarct volume (FIV) on early follow-up imaging has been shown to predict functional outcomes after acute ischemic stroke. However, the minimal clinically important difference in FIV for patients with large infarcts remains unclear. We aimed to quantify FIV differences corresponding to 1%, 5%, and 10% increases in the probability of a favorable outcome. Methods This secondary analysis included patients from the TENSION randomized controlled trial. Infarct volumes were measured on 24-hour follow-up imaging. Favorable outcome was defined as modified Rankin Scale (mRS) 0–2 at 90 days. Adjusted logistic regression assessed associations between FIV and outcome. Results A total of 253 patients were included: 125 received endovascular thrombectomy (EVT) and 128 received best medical treatment (BMT) alone. Median FIV was 199.4 mL (IQR 128.8–292.9), and 24 patients (10.7%) achieved favorable outcomes. In the EVT group, FIV was significantly associated with favorable outcome (OR 0.98 per 1 mL increase; 95% CI 0.97–0.99; p0.001). No significant association between FIV and outcome was observed in the BMT group. FIV reductions of approximately 18 mL, 93 mL, and 185 mL corresponded to 1%, 5%, and 10% increases in the probability of favorable outcomes, respectively. Conclusions In patients with acute ischemic stroke and large infarcts, FIV differences of approximately 18 mL, 90 mL, and 185 mL translated into 1%, 5%, and 10% higher probabilities of achieving a favorable outcome. Conflict of interest MDH reports funding from Nil; grants to the University of Calgary for the TEMPO-2 trial from Boehringer Ingelheim, Biogen, NoNO (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Canadian Institute for Health Research (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Medtronic (HERMES collaboration), Alberta Innovates (QuICR Alberta Stroke Program); that some of the funds were used for the ESCAPE-NA1 trial from Alberta Innovates; consulting fees from Sun Pharma Brainsgate (paid work for adjudication of clinical trial outcomes); US patents 62/086,077 (licensed to Circle NVI) and 10,916,346 (licensed to Circle NVI); private stock ownership from Circle and PUreWeb; participation as data and safety monitoring committee chair of the RACECAT trial (end 2020), the Oncovir Hiltonel trial (ongoing), and the DUMAS trial (ongoing); participation as a data and safety monitoring committee member of the ARTESIA trial (ongoing), and the BRAIN-AF trial (ongoing); and is president of the Canadian Neurological Sciences Federation (not for profit) and a Board member of the Canadian Stroke Consortium (not for profit). JF reports funding from the European Commission; personal consulting fees from Acandis, Cerenovus, Medtronic, Microvention, Phenox, Stryker, and Roche; consulting at Philips (no payments); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Penumbra and Tonbridge; support for attending meetings or travel from Medtronic and Penumbra; stock or stock options from Tegus Medical, Eppdata, and Vastrax; and participation in a Data Safety Monitoring Board or Advisory Board at Phenox (personal fees) and Stryker (personal fees) and is a past president of ESMINT. GT reports funding from the European Commission (EUHorizon 2020 research and innovation programme, 754640; payments to the institution); personal consulting fees from Acandis, AstraZeneca, Bayer, Boehringer Ingelheim, and Stryker; personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Acandis, Alexion, Marin, Bayer, Boehringer Ingelheim, BristolMyersSquibb/Pfizer, Daiichi Sankyo, and Stryker; participation as DSMB member for the TEA Stroke Trial (no payments) and ReSCInD trial (no payments); work as a speaker of the Commission for Cerebrovascular Diseases of the German Society of Neurology (DGN; no payments); and membership of the Board of Directors of the European Stroke Organisation (ESO; no payments). DFV reports research grants from MicroVention; consulting fees from Medtronic; and paid lectures from Cerenovus and Johnson consulting fees from Siemens; and support for attending meetings or travel from Europa Group. MB reports funding from EU Horizon 2020 and Deutsche Forschungsgemeinschaft (payments to the institution); honoraria for lectures from Novartis, Boehringer Ingelheim, and Seagen; and consulting fees from NeuroScios and Boehringer Ingelheim and is an editor in chief of Clinical Neuroradiology (Springer). OC and PH: Nothing to disclose.