Baseline Clinical Characteristics of Patients from the Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Türkiye (ETAF-TR) Study

OBJECTIVE
Post-authorization safety study focusing on the safety of edoxaban treatment in Türkiye with a prospective design has not been performed yet. The Evaluation of Treatment safety in patients with Atrial Fibrillation on edoxaban therapy in real-life in TüRkiye (ETAF-TR) study is designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation (AF). The baseline results of the ETAF-TR study describe the demographic, clinical, and laboratory characteristics of the study population.

METHOD
The ETAF-TR study (NCT04594915) is a prospective, national, multicentre, observational, post-authorization safety study conducted in 50 outpatient cardiology clinics.

RESULTS
Overall, 1,053 patients with AF treated with edoxaban for stroke prevention were enrolled in the study between August 2020 and May 2022. The mean age of the study population was 70.1±11.3 years, and 59.0% of the patients were female. Mean CHA2DS2-VASc and HAS-BLED scores were 3.5 and 1.6, respectively. Of the 1053 patients, 843 (80.1%) received standard dose edoxaban and 210 (19.9%) received reduced dose edoxaban. Of the 1053 patients, 38 patients (3.6%) had off-label usage of edoxaban therapy. Among the remaining 1015 patients, 834 (82.2%) received the appropriate dose of edoxaban, and 181 (17.8%) received an inappropriate dose of edoxaban according to the summary of product characteristics (SmPC) criteria.

CONCLUSION
Edoxaban has been used wide spectrum of patients with AF in daily routine practice with a good overall adherence to the SmPC. As the biggest national pharmacovigilance study to date, the ETAF-TR Study will provide detailed insight into the safety of edoxaban treatment.

*ETAF-TR Investigators
Eyüp Avcı, Çağatay Önal, Ferit Böyük, Salih Kılıç, Serhat Çalışkan, Özkan Vural, Nurullah Çetin, Eren Ozan Bakır, Turgay Işık, Özcan Başaran, Oğuzhan Çelik, Nijad Bakhshaliyev, Ufuk Eryılmaz, Mustafa Çalışkan, Ömer Faruk Baycan, Adem Atıcı, Aysu Oktay, Sinan İnci, Mehmet Erdoğan, Ender Özgün Çakmak, Özge Turgay Yıldırım, Mehmet Ballı, Fazilet Ertürk Sağ, Nihat Söylemez, Fatma Köksal, Mahmut Yılmaz, Veysel Özgür Barış, Şahin Dost, Serhat Sığırcı, Şahin Topuz, Ataç Çelik, Erkan Borazan, Ömer Taşbulak, Gökhan Demirci, Mustafa Ali Yavaş, Demet Menekşe Gerede Uludağ, İrem Müge Akbulut Koyuncu, Mehmet Emre Özerdem, Mustafa Yenerçağ, Deniz Elçik, Bahadır Kırılmaz, Uğur Küçük, Ebru Özpelit, Zeynep Kumral, Turhan Turan, Selim Kul, Veysel Yavuz, Kamil Tülüce, Selcen Yakar Tülüce, Burcu Yağmur, Anar Mammadli, Ersin Sarıçam, Ramazan Düz, Müjgan Tek, Mustafa Kurşun.