Abstract Number: Esoc2026a890 Use of the Win Ratio to Estimate Treatment Effects in Patients With Acute Ischemic Stroke and Large Infarct: A Secondary Analysis of the Tension Trial

Abstract Background and aims Traditional endpoints in acute ischemic stroke trials, most commonly the modified Rankin Scale (mRS), are limited in capturing the full spectrum of functional outcomes. The Win Ratio (WR) is a hierarchical method for analyzing composite outcomes by prioritizing endpoints according to clinical importance. In this study, we applied the WR method to the TENSION trial to assess the treatment benefit of endovascular thrombectomy (EVT) plus best medical treatment (BMT) versus BMT alone. Methods Of 253 randomized patients, 128 received EVT+BMT and 125 BMT alone. Endpoints were ranked hierarchically: (1) time to death, (2) median mRS at 12 months, (3) occurrence of any serious adverse event, and (4) EuroQOL 5-dimension scores at 12 months. Outcomes were analyzed using the WR method. Results The overall WR was 1.61 (95% CI, 1.19–2.18; p=0.002), indicating treatment benefit of EVT+BMT in approximately 60% of patient pairs. The win difference was 22.8% (95% CI, 8.3%–36.3%; p=0.002), of which 15.7% were attributable to survival. Treatment benefit was significant across subgroups, including both sexes, age ≤80 years, baseline mRS 0–1, conscious state, ASPECTS 5, and M1 occlusions. Conclusions This study illustrates the value of the WR as a clinically useful method to evaluate outcomes in acute ischemic stroke. Using a hierarchical composite outcome, our results demonstrated consistent treatment benefits of EVT+BMT and revealed that treatment effect in the TENSION trial was mainly derived from survival. Our findings support the complementary use of hierarchical composite outcomes in future neurointerventional trials. 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.