ENTRUST-AF PCI study of Lixiana shows non-inferiority in atrial fibrillation, and is published in The Lancet

Daiichi Sankyo announced results from ENTRUST-AF PCI, the first large randomised study to evaluate the efficacy and safety of once-daily Lixiana (edoxaban) plus a P2Y12 inhibitor against a regimen of vitamin K antagonist (VKA) plus P2Y12 inhibitor and acetyl salicylic acid (ASA) in atrial fibrillation (AF) patients following successful percutaneous coronary intervention (PCI). The study showed the edoxaban-based regimen is non-inferior compared with the VKA-based triple therapy regimen on the composite endpoint of major or clinically-relevant non-major bleeding over 12 months. Major or clinically relevant non-major bleeding, the study's primary endpoint, occurred in 128 (17.0%; annualised: 20.7%) patients in the edoxaban group and 152 (20.1%; annualised: 25.6%) patients in the VKA group, demonstrating non-inferiority of the edoxaban-based dual therapy for the 12 months post PCI.

There was a trend toward less bleeding with edoxaban, though, results did not show statistical superiority (p=0.115). Similar rates of the main efficacy composite outcome of cardiovascular death, stroke, systemic embolic events, spontaneous myocardial infarction, and definite stent thrombosis were observed for the edoxaban-based dual therapy regimen and the VKA-based triple therapy regimen. In the ENTRUST-AF PCI study, bleeding events were consistent across all commonly applied bleeding definitions (ISTH, TIMI, BARC). Intracranial hemorrhage occurred in four (0.58% per year) of edoxaban-treated patients and nine (1.32% per year) VKA-treated patients. Fatal bleeding occurred in one patient receiving edoxaban and seven patients receiving VKA treatment. The results were presented at ESC Congress 2019 and published in The Lancet.

See: "Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial" Pascal Vranckx et al. The Lancet Online first, September 03, 2019 DOI:https://doi.org/10.1016/S0140-6736(19)31872-0