Asundexian reduced ischemic stroke without increasing major bleeding compared with placebo across baseline vascular risk categories in patients with non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), according to an exploratory post hoc analysis of the phase 3 OCEANIC-STROKE trial presented at the American Heart Association (AHA) Scientific Sessions 2026.1
Ischemic stroke hazard ratios (HRs) were 0.62 (95% CI, 0.28–1.36) in the low-risk, 0.89 (95% CI, 0.60–1.31) in the intermediate-risk, and 0.73 (95% CI, 0.63–0.84) in the high-risk non-laboratory Framingham Risk Score (FRS) categories, with no significant interaction (P for interaction = .58).1
For the composite of cardiovascular death, myocardial infarction (MI), or stroke, HRs were 0.83, 0.84, and 0.83, respectively (P for interaction = .99). No significant interaction was observed for major bleeding (P for interaction = .60).1
“The AHA Scientific Sessions are an opportunity to share research and perspectives with the broader cardiovascular community,” said Robert Perkins, MD, vice president, CVR, US Medical Affairs, Bayer, in a release ahead of the meeting. “We look forward to engaging in scientific dialogue that may help shape future approaches to cardiovascular and cerebrovascular care.”3
OCEANIC-STROKE design and asundexian efficacy by Framingham risk
OCEANIC-STROKE randomized 12,327 patients within 72 hours of a non-cardioembolic ischemic stroke or high-risk TIA to asundexian 50 mg once daily or placebo, added to planned single or dual antiplatelet therapy.2 In the primary analysis, ischemic stroke occurred in 6.2% vs 8.4% of patients (HR, 0.74; 95% CI, 0.65–0.84; P < .001), and major bleeding occurred in 1.9% vs 1.7% (HR, 1.10; 95% CI, 0.85–1.44).2
For the post hoc analysis, investigators classified patients by non-laboratory FRS, incorporating age, sex, body mass index, systolic blood pressure, antihypertensive use, current smoking, and diabetes, into low (5% to <10%), intermediate (10% to 19%), and high (≥20%) 10-year cardiovascular risk.1 Of the analyzed patients, 570 were low risk, 1871 were intermediate risk, and 9823 were high risk, with 63 excluded for incomplete scores.1 High-risk patients had a mean age of 69.6 years and a diabetes prevalence of 40.8%, compared with 50.9 years and 4.0% in the low-risk group.1
Ischemic stroke occurred in 6.6% of high-risk patients receiving asundexian and 9.1% receiving placebo, compared with 3.5% and 5.6% in the low-risk group.1 For the cardiovascular composite, the high-risk HR was 0.83 (95% CI, 0.73–0.93).1
Bleeding and net clinical benefit with asundexian by baseline vascular risk
Major bleeding occurred in 1.1% vs 1.8% of low-risk patients (HR, 0.55; 95% CI, 0.13–2.33), 0.9% vs 0.6% of intermediate-risk patients (HR, 1.42; 95% CI, 0.49–4.08), and 2.1% vs 2.0% of high-risk patients (HR, 1.09; 95% CI, 0.83–1.44).1 Results for major or clinically relevant nonmajor bleeding were also consistent across categories (P for interaction = .47).1
For the net clinical benefit outcome of ischemic stroke or major bleeding, the overall HR was 0.82 (95% CI, 0.72–0.93), with no interaction by FRS category (P for interaction = .92).1 For the composite of all-cause mortality, disabling stroke, fatal bleeding, or symptomatic intracranial bleeding, the overall HR was 0.81 (95% CI, 0.67–0.99; P for interaction = .28).1 The investigators noted most participants were in the high-risk category, and estimates in the small low-risk group should be interpreted with caution.1
Bayer presented the analysis as a late-breaking oral presentation alongside new finerenone data across its cardiovascular and kidney portfolio.3 Separate OCEANIC-STROKE analyses have shown consistent asundexian benefit regardless of infarct pattern on imaging.4
References
Sharma M, Joundi R, Schulze K, et al. Outcomes in the OCEANIC-STROKE randomized, placebo-controlled trial of FXIa inhibition with asundexian in participants with non-cardioembolic stroke or transient ischemic attack by non-laboratory Framingham Risk Score category. Presented at: American Heart Association Scientific Sessions 2026; November 7, 2026; Chicago, IL.
Sharma M, Dong Q, Hirano T, et al. Asundexian for secondary stroke prevention. N Engl J Med. 2026;394(15):1467-1479. doi:10.1056/NEJMoa2513880
Bayer. Bayer to present new cardiovascular, kidney and stroke data at the 2026 American Heart Association (AHA) Scientific Sessions. Published November 3, 2026. Accessed November 7, 2026.
