Ömer Gedikli1, Servet Altay2, Serkan Ünlü3, Hüseyin Altuğ Çakmak4, Lütfü Aşkın5, Ahmet Yanık6, Feyzullah Beşli7, Ümit Yaşar Sinan8, Uğur Canpolat9, Mahmut Şahin1, Seçkin Pehlivanoğlu10. 1. Department of Cardiology, Faculty of Medicine, Ondokuz Mayıs University; Samsun-Turkey. 2. Department of Cardiology, Faculty of Medicine, Trakya University; Edirne-Turkey. 3. Department of Cardiology, Faculty of Medicine, Gazi University, Ankara-Turkey. 4. Department of Cardiology, Mustafa Kemal Paşa State Hospital, Bursa-Turkey. 5. Department of Cardiology, Faculty of Medicine, Adıyaman University; Adıyaman-Turkey. 6. Department of Cardiology, Samsun Education and Research Hospital; Samsun-Turkey. 7. Department of Cardiology, Faculty of Medicine, Harran University; Şanlıurfa-Turkey. 8. Institute of Cardiology, Faculty of Medicine, İstanbul University; İstanbul-Turkey. 9. Department of Cardiology, Faculty of Medicine, Hacettepe University, Ankara-Turkey. 10. Department of Cardiology, Faculty of Medicine, Başkent University, İstanbul-Turkey.
Abstract
OBJECTIVE: This study aimed to evaluate the safety of direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (NVAF) during daily clinical practice. METHODS: This was a prospective study conducted between January 01, 2016, and April 01, 2017, in patients aged ≥18 years with a diagnosis of NVAF. We performed the study in 9 clinical centers from different regions of Turkey, and the mean follow-up period was 12+2 months. We investigated major and minor bleeding events of DOAC. RESULTS: A total of 1807 patients with NVAF were enrolled. The mean age of the patients was 73.6±10.2 years, CHA2DS2-VASc score was 3.6±1.4, and HAS-BLED score was 2±1.2. The most frequently prescribed DOAC was dabigatran 110 mg bid in 409 (22.6%) patients. The patients on apixaban 2.5 mg bid were older (p<0.001). Patients on rivaroxaban 15 mg od also had a higher prevalence of chronic renal failure, 46 (16.7%) patients. A total of 205 (11.4%) bleeding events were observed; among these, 34 (1.9%) patients had major bleeding and 171 (9.4%) patients had minor bleeding. The major and minor bleeding events were 2/273 (0.7%) and 30/273 (10.9%) in patients receiving dabigatran 150 mg bid, 13/409 (3%) and 44/409 (10.7%) in patients receiving dabigatran 110 mg bid, 4/385 (1%) and 42/385 (10.9%) in patients receiving rivaroxaban 20 mg od, 8/276 (2.9%) and 27/276 (9.7%) in patients receiving rivaroxaban 15 mg od, 3/308 (0.9%) and 14/308 (4.5%) in patients receiving apixaban 5 mg bid, 4/156 (2.5%) and 14/156 (9%) in patients receiving apixaban 2.5 mg bid, respectively. The total bleeding events were 17 (5.6%) in patients receiving apixaban 5 mg, less than those receiving other DOACs. On multivariate analyses, rivaroxaban 20 mg od (p=0.002), ATRIA and HAS-BLED scores, and peripheral artery disease were independent indicators of bleeding. The most frequent location of major bleeding was the gastrointestinal system (GIS) [17 (0.9%) patients], and the most frequent location of minor bleeding was the gingiva [45 (2.5%) patients]. CONCLUSION: This study showed that similar results as the previous real-life study; however, we had some different results, such as the GIS tract bleeding was more frequent in patients receiving dabigatran 110 mg bid. The major and intracranial bleeding events were similar for different DOACs; and among DOACs, only rivaroxaban 20 mg od was associated with a high risk of bleeding.
OBJECTIVE: This study aimed to evaluate the safety of direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (NVAF) during daily clinical practice. METHODS: This was a prospective study conducted between January 01, 2016, and April 01, 2017, in patients aged ≥18 years with a diagnosis of NVAF. We performed the study in 9 clinical centers from different regions of Turkey, and the mean follow-up period was 12+2 months. We investigated major and minor bleeding events of DOAC. RESULTS: A total of 1807 patients with NVAF were enrolled. The mean age of the patients was 73.6±10.2 years, CHA2DS2-VASc score was 3.6±1.4, and HAS-BLED score was 2±1.2. The most frequently prescribed DOAC was dabigatran 110 mg bid in 409 (22.6%) patients. The patients on apixaban 2.5 mg bid were older (p<0.001). Patients on rivaroxaban 15 mg od also had a higher prevalence of chronic renal failure, 46 (16.7%) patients. A total of 205 (11.4%) bleeding events were observed; among these, 34 (1.9%) patients had major bleeding and 171 (9.4%) patients had minor bleeding. The major and minor bleeding events were 2/273 (0.7%) and 30/273 (10.9%) in patients receiving dabigatran 150 mg bid, 13/409 (3%) and 44/409 (10.7%) in patients receiving dabigatran 110 mg bid, 4/385 (1%) and 42/385 (10.9%) in patients receiving rivaroxaban 20 mg od, 8/276 (2.9%) and 27/276 (9.7%) in patients receiving rivaroxaban 15 mg od, 3/308 (0.9%) and 14/308 (4.5%) in patients receiving apixaban 5 mg bid, 4/156 (2.5%) and 14/156 (9%) in patients receiving apixaban 2.5 mg bid, respectively. The total bleeding events were 17 (5.6%) in patients receiving apixaban 5 mg, less than those receiving other DOACs. On multivariate analyses, rivaroxaban 20 mg od (p=0.002), ATRIA and HAS-BLED scores, and peripheral artery disease were independent indicators of bleeding. The most frequent location of major bleeding was the gastrointestinal system (GIS) [17 (0.9%) patients], and the most frequent location of minor bleeding was the gingiva [45 (2.5%) patients]. CONCLUSION: This study showed that similar results as the previous real-life study; however, we had some different results, such as the GIS tract bleeding was more frequent in patients receiving dabigatran 110 mg bid. The major and intracranial bleeding events were similar for different DOACs; and among DOACs, only rivaroxaban 20 mg od was associated with a high risk of bleeding.
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