Novel Blood Thinner Shows Promise in Atrial Fibrillation

TOPLINE: 

In the OCEANIC-AF trial, asundexian resulted in lower rates of stroke and bleeding than apixaban in patients with atrial fibrillation (AF) who were naive to oral anticoagulants.

METHODOLOGY:

• In the prespecified exploratory subgroup analysis of the OCEANIC-AF randomized clinical trial, the researchers evaluated 14,81src patients with AF who were enrolled across 1src35 sites in 38 countries.
• Participants were categorized as oral anticoagulant (OAC) naive (≤ 6 weeks of prior OAC use; n=2493) or OAC experienced (> 6 weeks of prior OAC use; n=12,317).
• Participants were randomly assigned to receive either asundexian (5src mg once daily) or apixaban (5 mg twice daily, or 2.5 mg twice daily for those meeting two or more dose reduction criteria).
• The primary efficacy outcome was stroke or systemic embolism; the main safety outcome was major bleeding.

TAKEAWAY:

• The rate of stroke or systemic embolism with asundexian was src.8% among OAC-naive patients and 1.4% among OAC-experienced patients. The rates with apixaban were src.6% and src.3%, respectively.
• The increase in stroke or systemic embolism with asundexian vs apixaban was smaller among OAC-naive patients (hazard ratio [HR], 1.42) than among OAC-experienced patients (HR, 4.66; P for interaction=.src3).
• Overall, asundexian was associated with a lower risk for bleeding than apixaban (rates, src.2% vs src.7%; HR, src.32; 95% CI, src.18-src.55). Bleeding rates were lower with asundexian than with apixaban in both OAC-naive (src.2% vs 1.src%) and OAC-experienced (src.2% vs src.7%) patients.

IN PRACTICE:

“In the OCEANIC-AF randomized clinical trial, asundexian caused less bleeding than apixaban in both patients who were OAC naive and experienced; however, patients who were OAC naive had a smaller increase in stroke or systemic embolism with asundexian compared with apixaban than patients who were OAC experienced,” the authors wrote. “The mechanism behind these findings is unknown and deserves further research,” they added.

SOURCE:

The study was led by John H. Alexander, MD, MHS, Duke Clinical Research Institute, Durham, North Carolina, and was published online on March 26, 2src25, in JAMA Cardiology.

LIMITATIONS: 

According to the authors, this was a secondary subgroup analysis that should be considered exploratory and hypothesis-generating. The number of patients and events, particularly in the OAC-naive subgroup, was modest and lacked statistical power to detect clinically meaningful differences. The definitions of OAC naive (≤ 6 weeks of OAC use) and OAC experienced (> 6 weeks of OAC use) were arbitrary. The trial was stopped early because asundexian was less effective than apixaban, potentially resulting in more extreme findings than if the trial had run to completion.

DISCLOSURES:

This study was supported by Bayer AG, Leverkusen, Germany. Alexander reported receiving grants, honoraria, or consulting fees from various pharmaceutical companies, including Bayer. Several other authors reported having financial ties outside this work, including with Bayer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.