Real life efficacy and safety of edoxaban for stroke prevention in atrial fibrillation – Results of the prospective NOAC registry (NCT01588119)

L. Tittl, J. Hecker, L. Wunder, T. Schreier, A. Reitter, J. Beyer-Westendorf (Dresden, Germany)

Antithrombotic treatment
Date: 17.02.2017,
Time: 17:15 - 18:15

Objective: The effectiveness and safety of long-term anticoagulation with direct oral anticoagulants (DOACs) such as edoxaban needs to be evaluated in daily care patients.

Methods: In the prospective, non-interventional Dresden NOAC registry a network of more than 230 physicians enroll eligible patients. More than 3200 DOAC patients receive prospective follow up by phone visits by the registry office. All events are centrally adjudicated using standard scientific definitions.

Results: Between 1 January 2016 and 31 July 2016, 217 patients receiving edoxaban for atrial fibrillation were enrolled (54% male, mean age 73.2 years, mean CHA2DS2-VASc-Score 3.5). 20 patients (9.2%) were switched from VKA to edoxaban, mainly due to patient’s inconvenience (40.0%) or instable INR (30.0%). 15 patients (6.9%) had a history of stroke or TIA. 11 patients (5.1%) had a history of malignant disease. 177 (81.6%) of all patients received edoxaban 60 mg OD, remaining 40 (18.4%) received 30 mg OD. Reason for does recommendation was renal impairment (CrCL 15 – 50 mL/min) in 10 cases (25%), low body weight (≤ 60 kg) in 8 cases (20%) and both in 1 case (2.5%). Reasons for dose reduction were unknown for the remaining 21 cases (52.5%). During follow-up, mean duration of edoxaban exposure was 130.5±75.3 days (median 98 days; 25th/75th percentile 85/182 days). So far no major cardiovascular events (such as stroke, TIA or systemic embolism) have occurred. One patient suffered a fatal intracranial bleeding on treatment. There were no further major bleeding events. Up to this point, edoxaban treatment discontinuation occurred in a total of 14 patients. Most common reasons for discontinuation were non-bleeding side effects (7/217, 3.2%), patient’s inconvenience (5/217, 2.3%) and others (2/217, 0.9%).

Conclusion: In comparison to our other DOAC-cohorts, patients receiving edoxaban are younger and healthier than previously enrolled patients receiving dabigatran or rivaroxaban, possibly because older and higher-risk patients were already treated with a NOAC before edoxaban approval.