Real-life data of major and minor bleeding events with direct oral anticoagulants in the one-year follow-up period: The NOAC-TURK study.

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.