Daiichi Sankyo has reported positive data from the ENTRUST-AF PCI study of Lixiana (edoxaban) and a P2Y12 inhibitor combination as an anti-thrombotic in patients with atrial fibrillation (AF) following percutaneous coronary intervention (PCI).
Edoxaban is an oral, direct inhibitor of factor Xa, which is involved in blood clotting. The inhibition is expected to make the blood thin and reduce clotting.
The Phase IIIb ENTRUST-AF PCI study compared a 60mg once-daily edoxaban plus a P2Y12 inhibitor with a regimen of vitamin K antagonist (VKA) plus P2Y12 inhibitor and 100mg acetyl salicylic acid (ASA) over 12 months.
Conducted in 1,506 subjects, the trial monitored the composite of major or clinically relevant non-major bleeding as the primary safety outcome.
The trial results demonstrated non-inferiority of the edoxaban combination on the primary outcome when compared to the VKA-based regimen.
Major or clinically relevant non-major bleeding was observed in 128 participants treated with the investigational regimen versus 152 in the VKA arm.
Data also showed a trend toward less bleeding with Daiichi Sankyo’s drug but statistical superiority was not achieved.
Both treatment groups had similar rates of stroke, cardiovascular death, definite stent thrombosis, systemic embolic events and spontaneous myocardial infarction, the main efficacy composite outcome.
The bleeding events in the trial were consistent for all common definitions. Four patients and nine subjects on edoxaban and VKA regimens, respectively, had intracranial haemorrhage.
One patient treated with the investigational combination and seven patients who had VKA treatment experienced fatal bleeding.
Daiichi Sankyo global medical affairs specialty & value products vice-president Hans Lanz said: “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 without significant differences in ischemic events.”
The ENTRUST-AF PCI trial is part of the company’s EDOSURE clinical research programme, which comprises a total of ten studies of edoxaban.