Abstract
Introduction
Non-vitamin K antagonist oral anticoagulants (NOACs) such as rivaroxaban offer potential advantages over warfarin in patients with non-valvular atrial fibrillation (NVAF). However, long-term real-world data evaluating their efficacy and safety, particularly in high-risk subgroups, remain limited.
Materials and Methods
This prospective observational cohort study enrolled 140 patients with newly diagnosed NVAF receiving rivaroxaban (20 mg daily or 15 mg daily in cases of renal impairment) for stroke prevention. Clinical, biochemical, and echocardiographic parameters were collected at baseline and monitored over 12 months. Primary efficacy and safety endpoints included stroke/systemic embolism and major bleeding (ISTH criteria), respectively. Secondary endpoints included TIA, cardiovascular hospitalization/mortality, non-major bleeding, renal/hepatic dysfunction, and treatment discontinuation. Kaplan-Meier survival analysis and multivariate logistic regression were used to evaluate outcomes and predictors.
Results
Stroke and systemic embolism occurred in 3.57% and 0.71% of patients, respectively. Major bleeding occurred in 5.71%, including gastrointestinal (2.86%) and intracranial (1.43%) events. Clinically relevant non-major bleeding and minor bleeding were reported in 8.57% and 12.86% of patients, respectively. Treatment was discontinued in 10% due to adverse events, primarily bleeding and renal function deterioration. Regression analysis identified age, CHA2DS2-VASc, HAS-BLED score, renal impairment, low hemoglobin, and prior stroke/TIA as independent predictors of adverse outcomes.
Conclusions
Rivaroxaban demonstrated favorable efficacy and acceptable safety in NVAF patients, including elderly and comorbid populations. Bleeding and renal dysfunction were notable risks. Close monitoring and individualized risk stratification remain essential for optimizing anticoagulation outcomes in real-world clinical practice.