Study results have shown that a regimen of once-daily edoxaban (brand name Lixiana) combined with a P2Y12 inhibitor is noninferior to the current recommended treatment for patients with atrial fibrillation following successful percutaneous coronary intervention.

The study, ENTRUST-AF PCI, is 1 of more than 10 randomized, controlled trials, registries, and nonrandomized clinical studies in the Edoxaban Clinical Research Programme. The program is expected to involve over 100,000 patients in order to generate clinical and real-world data regarding edoxaban use in populations with atrial fibrillation and venous thromboembolism.

The edoxaban-based regimen studied was compared with a regimen of vitamin K antagonist (VKA), a P2Y12 inhibitor, and acetyl salicylic acid.

The VKA-based triple therapy is the current recommendation for patients with atrial fibrillation that also present with coronary artery disease (CAD). An estimated 20-40% of atrial fibrillation patients also have CAD, but the triple therapy has been associated with significantly increased risk of bleeding. 

The researchers studied 1506 patients with atrial fibrillation following successful stent placement for acute coronary syndromes or stable CAD. Major or clinically relevant nonmajor bleeding occurred in 128 patients in the edoxaban group, and 152 patients in the VKA group. Although the results did not show statistical superiority of edoxaban, there was a trend toward less bleeding in those patients.

Intracranial hemorrhage occurred in 4 of the edoxaban-treated patients and 9 VKA-treated patients, while fatal bleeding occurred in 1 patient receiving edoxaban and 7 patients receiving the VKA-based regimen.

"These results reinforce the value of the approved regimen of edoxaban for AF treatment in post-PCI patients, providing the potential for less bleeding compared to current standard-of-care VKA-based triple therapies with significant differences in ischemic events," said Hans Lanz, MD, Vice President of Global Medical Affairs Specialty and Value Products, Daiichi Sankyo, in a prepared statement.


Daiichi Sankyo Presents Positive Results of the ENTRUST-AF PCI Study of LIXIANA® (edoxaban) in Patients with Atrial Fibrillation [news release]. Tokyo, Japan and Munich, Germany; September 4, 2019: Daiichi Sankyo website. Published September 4, 2019. Accessed September 6, 2019.