Daiichi Sankyo Company, Limited announces results from ELIMINATE-AF, a prospective, randomised, open label, blinded endpoint evaluation (PROBE) design study assessing the safety and efficacy of uninterrupted oral, once-daily edoxaban (known by the brand name LIXIANA®▼) 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 data were presented today during a late-breaker session at EHRA 2019, the annual congress of the European Heart Rhythm Association, in Lisbon, Portugal.
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 (>97%) and VKA treatment was well managed.
The primary safety objective was to compare descriptively the incidence of ISTH-defined major bleeding in the edoxaban group against the VKA group in the period from date of first intake of study medication to end of treatment/Day 90. 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).
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.
ELIMINATE-AF is one of more than 10 randomised, controlled trials (RCTs), registries and non-interventional studies that comprise the Edoxaban Clinical Research Programme. More than 100,000 patients worldwide are expected to participate in the Edoxaban Clinical Research Programme studies, the goal of which is to generate new clinical and real-world data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment confidence.
Daiichi Sanko have also announced the results from a research study, EMIT-AF/VTE, part of the Edoxaban Clinical Research Programme.
Daiichi Sankyo Europe GmbH announced the results from EMIT-AF/VTE, a prospective, non-interventional study of oral, once-daily edoxaban (known by the brand name LIXIANA®▼) in the peri-procedural management of AF, and VTE patients undergoing diagnostic and therapeutic procedures.
The data from 1,155 patients across seven European countries showed that peri-procedural edoxaban management in routine clinical practice was associated with low bleeding incidence, even in procedures at high bleeding-risk as classified by EHRA, and with low rates of thromboembolic/ischemic complications. The data were presented today during a late-breaker session at EHRA 2019, the annual congress of the European Heart Rhythm Association, in Lisbon, Portugal.
EMIT-AF/VTE is the first large observational, multicentre, multinational study on peri-procedural management and outcomes of edoxaban. It is the first large, single NOAC-prospective, non-interventional study to apply the EHRA peri-procedural bleeding risk classification, which was introduced in April 2018,1 in a routine clinical practice setting.
Patients enrolled onto EMIT-AF/VTE were 62% male, elderly (mean age = 71.9 ± 10.4 years, 45% ≥ 75 years of age) and had multiple co-morbidities. Of the participants, 294 (26%) had minor EHRA bleeding risk, 581 (50%) had low-risk, and 280 (24%) had high-risk. Additionally, 30% (345/1,155) of patients continued edoxaban treatment without any interruption during the peri-procedural period, whereas 73% (847/1,155) of patients were on edoxaban on the day after procedure with no post-procedural interruption.
The primary safety outcome of major bleeding (MB), as defined by the International Society of Thrombosis and Haemostasis (ISTH), from five days before to 30 days after a procedure, occurred in 0.4% (5 of 1,155) of patients. Bleeding incidence was low, even in the 280 EHRA-classified high-risk procedures: with 0.7% (2 of 280) major bleedings and 1.4% (4 of 280) clinically relevant non-major bleedings (CRNMB).