ABSTRACT NUMBER: ESOC2026LB157 LB157 - INCIDENT ISCHAEMIC STROKE IN THE RANDOMISED, PLACEBO-CONTROLLED, EVENT-DRIVEN OCEANIC-STROKE TRIAL OF ASUNDEXIAN FOR SECONDARY STROKE PREVENTION: SEVERITY, TREATMENT AND OUTCOMES

Abstract Background and aims Asundexian 50 mg once daily added to antiplatelet therapy reduced the occurrence of ischemic stroke (IS) compared with placebo (cause-specific hazard ratio [csHR], 0.74; 95% CI: 0.65–0.84). We describe the severity, acute treatment and outcomes of incident IS. Methods We randomised 12,327 participants ≤72 h of non-cardioembolic IS or high-risk TIA to asundexian or placebo. Incident IS after randomisation were characterised by occurrence of haemorrhagic transformation (HT), maximum NIHSS during hospitalisation and 90-day modified Rankin Scale (mRS). Incident disabling stroke was defined as mRS ≥3 or increase by 1 point in mRS (if baseline mRS ≥3). Results Fewer IS occurred with asundexian (384 [6.2%]) vs placebo (518 [8.4%]). Of these, an NIHSS ≥8 was less likely with asundexian (22.9%) vs placebo (30.3%; P=0.045). Asundexian reduced the occurrence of disabling stroke (csHR, 0.69; 95% CI: 0.55–0.87). Of the incident IS, 122 (13.5%) were treated with IVT and/or EVT (asundexian, 40 [10.4%]; placebo, 82 [15.8%]). In the overall population, EVT was less likely with asundexian (csHR, 0.61; 95% CI: 0.38–0.99). Outcomes after acute treatment of incident IS assessed by mRS at 90 days post stroke, were similar. HT occurred in 20 (0.3%) asundexian and 21 (0.3%) placebo (csHR, 0.96; 95% CI: 0.52–1.76). Conclusions In patients with non-cardioembolic IS or high-risk TIA, asundexian reduced the occurrence and severity of incident IS, and the occurrence of disabling stroke. HT occurrence was similar between treatment groups. EVT was less likely with asundexian, consistent with a lower incidence of large artery occlusion. Conflict of interest Table 1 - belongs to Results