OC 71.4 - Effectiveness and safety of edoxaban therapy in daily-care patients with atrial fibrillation. Results from the DRESDEN NOAC REGISTRY

Wednesday, July 13, 2022

11:00 AM – 11:15 AM

Location: S11B

Presentation Format: Virtual

Presenting Author(s)

Jan Beyer-Westendorf, MD,PhD

Head of thrombosis research unit
University Hospital “Carl Gustav Carus”, Technische Universität Dresden, Division of Hematology and Hemostasis, Department of Medicine I Thrombosis Research, Dresden, Saxony, Germany
Dresden, Sachsen, Germany

Co-Author(s)

LT

Luise Tittl

Study Coordinator
Thrombosis Research Unit, University Hospital Carl Gustav Carus
Dresden, Sachsen, Germany
CK

Christina Köhler

MD
University Hospital Carl Gustav Carus - Thrombosis Research Unit
Dresden, Sachsen, Germany

Background: Edoxaban is a non-vitamin K dependent oral anticoagulant (NOAC) licensed for stroke prevention in atrial fibrillation (SPAF).

Aims: Confirmation of effectiveness and safety of edoxaban for SPAF in unselected patients in routine clinical care.

Methods: In the prospective, non-interventional DRESDEN NOAC REGISTRY a network of more than 230 physicians enrolled > 5000 NOAC patients who received prospective central follow up by the registry office. All reported outcome events (stroke/transient ischemic attack/systemic embolism; ISTH bleeding; death) are centrally adjudicated using standard scientific definitions.

Results: During 1st January 2016 and 31st August 2021, 1258 patients receiving edoxaban for SPAF were enrolled (Table 1). The mean duration of follow-up was 927.1±562.2 days with a mean duration under edoxaban exposure of 790.3±577.2 days. Edoxaban was discontinued by 274 patients (10.1/100 patient-years; 95% CI 8.9-11.3).
The combined endpoint of stroke/TIA/systemic embolism occurred at a rate of 1.7/100 patients-years (95% CI 1.3-2.3) in the intention-to-treat analysis and at 1.3/100 patient-years (95% CI 0.9-1.9) in the on-treatment analysis (censored 3 days after last edoxaban intake). There were no significant differences between the rates of ISTH major bleeding in patients receiving edoxaban 30 mg (3.6/100 patient-years; 95% CI 2.2-5.5) compared with the 60 mg dose (2.5/100 patient-years; 95% CI 1.8-3.2) in the on-treatment analysis (Table 2).
During follow-up 151 patients (12.0%) died. Causes of death were non-stroke cardiovascular events (n=50), followed by infection/sepsis (n=40) and terminal malignant disease (n=31), age related deaths (n=11), fatal bleedings (n=8), stroke (n=5) and other reasons (n=6).

Conclusion(s): Our rates of effectiveness and safety outcomes bleedings are in line with latest real-world data (such as ETNA-AF registry) and the ENGAGE-AF trial that led to approval of edoxaban. Non-thrombotic cardiovascular and infectious diseases were the leading causes of death in our cohort, whereas fatal stroke and fatal bleeding were rare.