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Atrial fibrillation (AF) is the most common sustained arrhythmia reported in adult patients [1] and is associated with an at least a five-fold increase in the risk of stroke [2]. Vitamin K antagonists (VKAs) formed the cornerstone of thromboembolic prophylaxis in patients with AF for many years. The introduction of non-vitamin K anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban and edoxaban, provided physicians with agents with comparative efficacy and reduced potential for bleeding compared with vitamin K antagonists, while removing the need for dose titration, periodic laboratory testing and dietary restrictions that are necessary with VKAs [3,4,5]. Evidence from phase III studies showed that rivaroxaban, one of several oral direct Factor Xa inhibitors, is noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF [6] and significantly reduces rates of intracranial and fatal haemorrhages, but not rates of bleeding overall. Based on these results, rivaroxaban is now licensed in more than 130 countries worldwide for stroke prevention in patients with AF.

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At 4-monthly intervals, all routinely performed tests (including INR, haemoglobin, platelet count and creatinine), vital signs as well as all major events (stroke/transient ischaemic attack [TIA], bleeding / site of bleeding, death, myocardial infarction [MI], acute coronary syndrome [ACS], peripheral embolism) and hospitalizations/medical consultations are documented. For patients who switch to VKAs, data are also collected on INR, INR frequency and outcome related to INR fluctuation.

Data are captured using an electronic case report form (eCRF) designed by eClinicalHealth Services, Stirling, UK and submitted electronically via a secure website to the registry-coordinating centre at the Thrombosis Research Institute who were responsible for checking the completeness and accuracy of data collected from medical records. All patients are assigned a unique identifier and personal identifiable data will be removed at the hospital source, ensuring anonymity and protecting confidentiality.

Other ongoing non-interventional registries also provide real-world data on the effectiveness and safety of rivaroxaban, including the Global Anticoagulant Registry in the FIELD (GARFIELD)-AF [17], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT)-AF I and ORBIT-AF II [18,19,20,21], the Global Registry on Long-Term Oral Anthithrombotic Treatment in pateints with Atrial Fribrillation (GLORIA-AF) [22,23,24,25,26] and the Dresden NOAC Registry [4, 5, 27] (Additional file 1: Table S2).

Table S1. Evaluations performed at Baseline and at Follow-Up Visits. Table S2. Study design of ongoing real-world studies of rivaroxaban. Table S3. Comparison of distribution of baseline CHADS2, CHA2DS2-VASc or HAS-BLED scores of patients from observational RIVER, XANTUS, EXPAND and XAPASS studies. (DOC 155 kb)

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