Clinical Event Rates and Patient Satisfaction with Generic Rivaroxaban in Atrial Fibrillation: The Prospective Guardian Study

Abstract Background The use of oral anticoagulants (OACs), especially direct oral anticoagulants (DOACs), for thromboprophylaxis in atrial fibrillation (AF) has increased over the last decade, and an increasing number of generic DOAC medications (particularly regarding rivaroxaban and apixaban) have been marketed recently. The aim of the present study was to prospectively observe clinical event rates and patient satisfaction with a generic rivaroxaban for thromboprophylaxis in patients with AF. Methods Adult patients with AF in whom long-term OAC was indicated for thromboprophylaxis were included in this international, prospective, non-interventional, observational study with 1-year follow-up, conducted in the Republic of Serbia and Bosnia and Herzegovina. Data were collected at baseline and 3-, 6-, and 12-month follow-up visits. The primary endpoints were stroke/systemic embolism (SE), major bleeding, and all-cause mortality. Secondary endpoints included adverse events and patient satisfaction with generic rivaroxaban therapy. Results Of 1092 patients (mean age 67.9 ± 9.8, 42.9% female), 72 (6.6%) discontinued the treatment due to different reasons. The mean value of the CHA 2 DS 2 –VASc score (Congestive heart failure, Hypertension, Age > 75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65–74 years, Sex category) and HAS–BLED (Hypertension [uncontrolled], Abnormal renal and/or liver function, Stroke history, Bleeding history, Labile International Normalised Ratio, Elderly [>65 years], Drugs [non-steroidal anti-inflammatory drugs, aspirin]/Alcohol use [>8 drinks per week]) score was 3.15 ± 1.55 and 1.18 ± 0.92, respectively. Overall, seven patients (0.64%) experienced a symptomatic thromboembolic event (two strokes, three transient ischaemic attack, and two SE), and major bleeding occurred in two patients (0.18%). At the 3-, 6- and 12-month follow-up visits, 1068 (97.8%), 1031 (94.4%) and 1014 participants (92.9%), respectively, were still taking generic rivaroxaban. At 3 and 12 months, 1024/1071 patients (95.6%) and 1005/1020 (98.5%), respectively, were very satisfied or satisfied with generic rivaroxaban. Conclusions The observed clinical event rates during the use of generic rivaroxaban in AF patients were low, with very good 1-year persistence to treatment and persistently high level of patient satisfaction with generic rivaroxaban, including those previously taking another OAC. More studies with larger sample size are needed to allow additional analyses of factors associated with specific outcomes, including non-persistence to treatment with generic rivaroxaban.