Uninterrupted anticoagulation with edoxaban (Lixiana, Daiichi Sankyo) resulted in low rates of thromboembolic and bleeding events in patients with atrial fibrillation undergoing catheter ablation, according to data from ELIMINATE AF, presented at a late breaking session at the European Heart Rhythm Association (EHRA 2019, 17–19 March) congress in Lisbon, Portugal, and published online in the European Heart Journal. Researchers say the trial demonstrates a role for edoxaban, a non-vitamin K antagonist oral anticoagulant (NOAC), to be used instead of continuous anticoagulation with a vitamin K antagonist in this patient cohort.
Principal study investigator Stefan Hohnloser (Johann Wolfgang Goethe University, Frankfurt, Germany) told the conference: “ELIMINATE AF shows that an uninterrupted anticoagulation regimen with edoxaban 60mg QD in patients undergoing AF catheter ablation results in low rates for both thromboembolic and bleeding events. It demonstrates therefore that uninterrupted edoxban treatment represents an alternative to continuous anticoagulation with VKA in these patients.”
Catheter ablation for atrial fibrillation is the most commonly performed ablation procedure worldwide. But complications such as stroke/transient ischaemic attack or bleeding events can occur during the procedure. Uninterrupted edoxaban therapy has been shown to reduce stroke risk, but there are no data assessing its efficacy in ablation procedures.
ELIMINATE-AF is a prospective, randomised, open label, blinded endpoint evaluation (PROBE) to assess the safety and efficacy of uninterrupted oral, once-daily edoxaban 60mg versus uninterrupted vitamin K antagonists (VKA) in patients receiving atrial fibrillation catheter ablation. Its aim was to compare descriptively the incidence of a composite efficacy endpoint of all-cause death, stroke, and major bleeding (as defined by the International Society on Thrombosis and Haemostasis [ISTH]), and to compare descriptively the incidence of the primary safety endpoint of major bleeding in patients undergoing catheter ablation of atrial fibrillation.
ELIMINATE-AF was an all-comers trial, accepting all patients with atrial fibrillation, including those for re-ablation. They were randomised 2:1 to receive either edoxaban or vitamin K antagonists for at least 21 days before undergoing transoesophageal echocardiography (TEE) or intraprocedural intracardiac echocardiography (ICE), followed by ablation. Follow-up was for 90 days.
The per-protocol population of 417 patients was assessed from the end of the ablation procedure to the end of treatment. Average age was 60 years, with about 70% of each group being male, and almost half of subjects had a CHA2DS2VASC score ≥2. Hohnloser described subjects as having “significant comorbidity”.
From the per-protocol analysis, the incidence of the primary endpoint was 0.3% (1/316) in the edoxaban group, and 2.0% (2/101) in the group receiving vitamin K antagonists (hazard ratio [HR] 0.16, 95% confidence interval [CI] 0.02–1.73, p=0.1315). The event rate was low and similar in both treatment arms; most events were procedure-related. All of the three events that occurred were major bleedings (one in the edoxaban arm and two in the VKA arm), and there were no deaths in the study. Edoxaban adherence was high (>97%), and vitamin K antagonist treatment was well managed. Investigators used unfractionated heparin to maintain anticoagulation, but the amount used in the edoxaban arm was significantly higher (14IU vs. 11IU, p<0.0001) than that required in the VKA arm.