TROMBIX-DZ: A real-world, prospective, observational study of Algerian patients with atrial fibrillation treated with rivaroxaban

Background: Atrial Fibrillation (AF) is the most prevalent cardiac arrhythmia worldwide, representing the primary cardiac etiology of stroke. In recent years, direct oral anticoagulants (DOACs) have shown favorable results in terms of efficacy and safety in the prevention of thromboembolism in patients with AF. TROMBIX-DZ study investigated the safety and efficacy of rivaroxaban in routine clinical settings in response to the need for real-world evidence on the use of DOACs. Methods: We carried a national, multicenter, prospective, observational cohort study to evaluate the safety and efficacy of rivaroxaban in Algerian patients with atrial fibrillation. Patients were followed-up at 3 months intervals for 1 year. The primary outcome of this study was to evaluate the safety of rivaroxaban, reported as the frequency of treatment-emergent serious adverse events (SAEs); Secondary outcomes assessed the frequency of thromboembolic events, adverse events (AEs), and treatment persistence. Results: TROMBIX-DZ enrolled 398 eligible patients with AF from 19 specialized public and private cardiology centers across different regions in Algeria. The mean age was 70.5 {+/-} 11.94. 71.9% of patients received once daily rivaroxaban 20mg, and 28.1% received the 15mg dose. The most common comorbidities included, hypertension (77.1%), diabetes (28.6%) and heart failure (25.4%), prior strokes and TIA (8.8%), and prior major bleeding (3.1%). The mean CHA2DS2-VASc score was 3.147 {+/-} 1.3, and the mean HAS-BLED score was 1.682 {+/-} 1.198; 14.06% of patients had Creatinine clearance < 50 ml/min. A total of 5.77% had treatment-emergent AE, and 1.76% had treatment-emergent SAE. The incidence rate (events per 100 patient-years) of treatment-emergent major bleeding events, treatment-emergent thromboembolic events and all-cause death during the study period were 2.1, 0.9, and 4.18, respectively. Treatment persistence was 75.88% at the end of the study. Conclusion: TROMBIX-DZ study, the first cohort in the Maghreb region, provides important insights into the safety and efficacy of rivaroxaban in Algerian population with atrial fibrillation receiving standard medical care. Rates of major bleeding and stroke were low and broadly consistent with previous international real-world registries. Trial registration number: Clinicaltrial.gov: (NCT06184204). Keywords: Direct oral anticoagulants, Rivaroxaban, Atrial fibrillation, Major bleeding, Stroke, Thromboembolism, The Maghreb region, Real-world.