Phase IIIb ELIMINATE-AF study of Lixiana shows safety and efficacy in bleeding events

Daiichi Sankyo announced results from phase IIIb ELIMINATE-AF, a prospective, randomised, open label, blinded endpoint evaluation (PROBE) design study assessing the safety and efficacy of uninterrupted oral, once-daily Lixiana (edoxaban) 60 mg versus uninterrupted vitamin K antagonists (VKA) in atrial fibrillation (AF) patients undergoing catheter ablation. The study showed the uninterrupted anticoagulation regimen with edoxaban in patients undergoing catheter ablation resulted in low event rates for both thromboembolic and bleeding events. The primary efficacy objective of ELIMINATE-AF was to compare descriptively the time to first all-cause death, stroke, or International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding, assessed in the per-protocol population from the end of ablation procedure to the end of treatment. The incidence of the primary endpoint was 0.3% (1/316) in the edoxaban group and 2.0% (2/101) in the VKA group (HR 0.16; 95% CI 0.02, 1.73).

The event rate was low and similar in both treatment arms; most events were procedure -related. All three events were major bleedings, and there were no deaths in the study. Edoxaban adherence was excellent (above 97%) and VKA treatment was well managed. The primary safety endpoint in the mITT (modified Intent to Treat) population occurred in 2.5% (10/405) in the edoxaban group and 1.5% (3/197) in the VKA group (HR 1.68; 95 CI 0.46, 6.07). The data were presented during a late-breaker session at EHRA 2019.

Comment: Until recently, there has been a lack of data to support the uninterrupted peri-procedural use of non-VKA, oral anticoagulants (NOACs) during AF ablation. ELIMINATE-AF was the first randomised controlled trial on the use of edoxaban for catheter ablation of AF.