Warfarin faced further competition, from a new oral direct factor Xa inhibitor, at the European Society of Cardiology Congress on Sunday.
The groundbreaking findings, which were concurrently published on the website of the New England Journal of Medicine, showed that apixaban cut the risk of stroke, systemic embolism and death in patients with atrial fibrillation (AF).
These are seen as the strongest results yet for one of the new oral anticoagulants for AF – putting apixaban ahead of dabigatran and rivaroxaban in the race to replace warfarin.
Apibixaban, which is marketed by Pfizer/B-MS as Eliquis, was shown to cause less bleeding and significantly lower the primary outcome, ischaemic or haemorrhagic stroke or systemic embolism, in comparison with warfarin, in the study AF patients.
The trial results are based on the randomised, double-blind ARISTOTLE trial involving 18,201 patients with AF plus one other risk factor for stroke that was published in the New England Journal of Medicine.
Patients were followed up for a median of 1.8 years. The primary outcome occurred in 1.27% per year among patients taking apixaban, compared with 1.60% of those taking warfarin (hazard ratio = 0.79; p<0.001).
Major bleeding was seen in 2.13% of patients in the apixaban group per year, compared with 3.09% of those using warfarin.
Lead author Christopher Granger (Duke University, Durham, US) and co-workers said: “In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.”