International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER)

Jan Beyer-Westendorf,Jean-Yves Le Heuzey,Sylvia Haas,Ajay K Kakkar,Alexander G G Turpie,Saverio Virdone,A John Camm,Keith A A Fox

doi:10.1186/s12959-019-0195-7

Abstract

BackgroundReal-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment.Methods and resultsBetween January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines).ConclusionsThe RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.Trial registrationUnique identifier: NCT02444221. Registerd 14 May 2015; Retrospectively Registered.

Highlights

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]
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 Vitamin K antagonist (VKA) [3,4,5]
This paper describes the design of the RIVaroxaban Evaluation in Real life setting (RIVER) registry and baseline characteristics of patients who received rivaroxaban as part of routine care

Summary

Introduction

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]. Real-world studies (such as Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF] [7], ORBIT-AF I & II) [8] and GLORIA-AF [9, 10] have demonstrated that NOAC use is increasing while post-marketing surveillance (such as Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation [XANTUS]) [11] and national studies (such as the EXPAND) [12, 13] have provided data on the safety and efficacy of rivaroxaban Most of these registries are disease-specific and evaluate treatment patterns and outcomes across different treatments. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment

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