Same Drug, Different Results – ESC Working Group on Cardiovascular Pharmacotherapy
ESC Working Group on Cardiovascular Pharmacotherapy shared a post on LinkedIn about a recent article by Valeria Caso et al., published in European Heart Journal – Cardiovascular Pharmacotherapy, adding:
“New in EHJ-CVP – Current Opinion
The OCEANIC trial journey: from failure to breakthrough? Why did the same dose of the same FXIa inhibitor produce opposite results in two Phase 3 trials?
Valeria Caso, Hugo Ten cate and Isabelle van Gelder examine why the same dose of the same factor XIa inhibitor gave opposite results in two Phase 3 trials.
OCEANIC-AF: asundexian 50 mg once daily was inferior to apixaban for stroke or systemic embolism in AF (1.3% vs 0.4%, HR 3.79), and the trial stopped early.
OCEANIC-STROKE: in 12,327 patients with recent non-cardioembolic ischaemic stroke or high-risk TIA, asundexian added to standard antiplatelet therapy reduced recurrent ischaemic stroke (6.2% vs 8.4%, HR 0.74, 95% CI 0.65 to 0.84) with no significant increase in ISTH major bleeding (1.9% vs 1.7%).
The authors argue the difference may also reflect specific thrombotic mechanisms: FXIa inhibition targets thrombus amplification in platelet-driven atherothrombosis, but appears insufficient as sole anticoagulation in coagulation-dominant cardioembolism.
They also discuss possible underdosing, differences in thrombin generation between asundexian and apixaban, and the open question of optimal treatment duration.
Ongoing LIBREXIA-STROKE and LIBREXIA-AF will provide further mechanistic and pharmacological information.”
Rachelle MA, Sr. Manager Patient Engagement at Bayer, shared this post on LinkedIn, adding:
“For stroke survivors living with daily uncertainty, this isn’t just a p-value.
It’s evidence that we can do better than accepting residual risk as inevitable.”
Title: The OCEANIC trial journey: from failure to breakthrough?
Authors: Valeria Caso, Hugo ten Cate, Isabelle C van Gelder
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