Does asundexian added to antiplatelet therapy reduce recurrent ischaemic stroke in patients with acute non-cardioembolic ischaemic stroke or high-risk TIA?
12,327 participants within 72 hours of acute non-cardioembolic ischaemic stroke or high-risk TIA (n=11,677 with qualifying ischaemic stroke at study entry)
Asundexian 50 mg once daily added to antiplatelet therapy
Placebo added to antiplatelet therapy
Time to first ischaemic strokehard clinical
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.
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
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Ashkan Shoamanesh
Jose Férro
Hanne Christensen
European Stroke Journal
Hadassah Medical Center
Bayer (Germany)
Population Health Research Institute
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Shoamanesh et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7e5cbfa21ec5bbf068cb — DOI: https://doi.org/10.1093/esj/aakag023.1896