Asundexian added to antiplatelet therapy reduced recurrent ischaemic stroke compared with placebo (HR 0.74; 95% CI 0.65-0.84), with consistent effects across high-risk patient subgroups.
RCT (n=12,327)
Does asundexian added to antiplatelet therapy reduce recurrent ischaemic stroke in patients with acute non-cardioembolic ischaemic stroke or high-risk TIA?
Asundexian added to antiplatelet therapy consistently reduces the risk of recurrent ischaemic stroke in patients with acute non-cardioembolic stroke, regardless of baseline risk factors.
Effect estimate: HR 0.74 (95% CI 0.65-0.84)
Abstract Background and aims In OCEANIC-STROKE, asundexian 50 mg once daily added to antiplatelet therapy reduced ischaemic stroke (IS) compared with placebo (cause-specific hazard ratio HR, 0.74; 95% confidence interval CI: 0.65–0.84). We examined predictors of recurrent IS and whether these modified the treatment effect of asundexian. Methods We randomized 12,327 participants within 72 h of acute non-cardioembolic IS or high-risk TIA to asundexian or placebo. The primary efficacy endpoint was time to first IS. Multivariable regression identified baseline predictors of recurrent IS in patients with qualifying IS (n=11,677) at study entry. Potential interactions between these variables and the treatment effect of asundexian for the primary efficacy endpoint were explored using the intention-to-treat principle. Results Over a median follow-up of 1.6 years, 843 IS occurred; the annualised rate of IS was 5.1%. Assignment to asundexian was independently associated with lower risk of recurrent IS (HR, 0.73; 95% CI: 0.64–0.84). Older age (HR per year; 1.01; 1.00–1.02), Black (1.67; 1.14–2.45) and Other race (1.68; 1.22–2.32) versus White race, history of diabetes (1.39; 1.21–1.60), previous stroke or TIA (2.05; 1.77–2.36), index IS attributed to large-artery atherosclerosis (1.41; 1.23–1.62) and medical history of atherosclerosis (1.26; 1.09–1.46) were associated with higher risk of recurrent IS. No heterogeneity in the treatment effect of asundexian was observed across these variables (Figure). Conclusions Baseline characteristics identify patients with acute non-cardioembolic IS at increased risk of IS recurrence. Asundexian consistently reduced recurrent IS without evidence of treatment-effect heterogeneity across these higher-risk subgroups of patients. Conflict of interest Figure 1 - belongs to Results
Shoamanesh et al. (Fri,) conducted a rct in Acute non-cardioembolic ischaemic stroke or high-risk TIA (n=12,327). Asundexian vs. Placebo was evaluated on Time to first ischaemic stroke (HR 0.74, 95% CI 0.65-0.84). Asundexian added to antiplatelet therapy reduced recurrent ischaemic stroke compared with placebo (HR 0.74; 95% CI 0.65-0.84), with consistent effects across high-risk patient subgroups.