A recent study presented at the European Society of Cardiology Congress 2024 revealed that asundexian, a new oral anticoagulant, is less effective than apixaban in preventing strokes and systemic embolism in high-risk patients with atrial fibrillation (AF).
The research, part of the phase III OCEANIC-AF trial, was led by Professor Manesh Patel from Duke University Medical Center and involved over 14,000 patients.
Atrial fibrillation is a common heart condition that can lead to serious complications like stroke, which carries a high risk of permanent disability or death.
While current direct-acting oral anticoagulants (DOACs) like apixaban have improved stroke prevention compared to older treatments, they still carry a risk of bleeding, leading some patients to avoid them.
Asundexian, which works by inhibiting activated factor XI (XIa), had shown promise in earlier trials, reducing the risk of bleeding compared to apixaban.
The OCEANIC-AF trial aimed to see if asundexian could match apixaban in preventing strokes while offering the added benefit of lower bleeding risks.
In the double-blind, randomized trial, 14,830 patients with high stroke risk due to AF were assigned either asundexian 50 mg daily or apixaban at standard doses.
After a median follow-up of 160 days, the study found that the rate of stroke or systemic embolism was higher in the asundexian group (1.3%) compared to the apixaban group (0.4%).
This led researchers to conclude that asundexian was inferior to apixaban for stroke prevention, with a hazard ratio (HR) of 3.79.
However, the study also found that asundexian had a lower rate of major bleeding compared to apixaban (0.2% vs. 0.7%), and lower rates of the composite measure of major or clinically relevant non-major bleeding (1.1% vs. 2.6%).
These results highlight asundexian’s potential for reducing bleeding risks, although this benefit was not enough to offset its reduced effectiveness in preventing strokes.
Professor Patel noted that the lower-than-expected stroke rate in the apixaban group might be due to prior use of oral anticoagulants and improved medical therapy. He suggested that a stronger dose of asundexian might be needed to effectively prevent thrombus formation.
Despite the study’s findings, the need for better antithrombotic therapies in AF patients remains, especially those that offer lower bleeding risks than current options like DOACs. The results of this trial provide valuable insights but also indicate that further research is needed to find an optimal balance between stroke prevention and bleeding risk.
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Source: KSR.
