Asundexian Effect Consistent Across Vascular Risk Levels in OCEANIC-STROKE

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

1. 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.

2. 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

3. 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.

4. HCPLive. Asundexian reduces ischemic stroke without increasing bleeding regardless of infarct pattern. https://www.hcplive.com/view/asundexian-reduces-ischemic-stroke-without-increasing-bleeding-regardless-of-infarct-pattern. Published November 3, 2026. Accessed November 7, 2026.