Clinical event rates and patient satisfaction with generic rivaroxaban in atrial fibrillation: The prospective Guardian study

Vollständiger Abstract

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Background and aim: The use of oral anticoagulants (OAC), especially direct OACs (DOACs) for thromboprophylaxis in atrial fibrillation (AF) has increased over the last decade, and increasing number of generic DOAC medications (particularly regarding rivaroxaban and apixaban) has 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 Republic of Serbia and Bosnia and Herzegovina. Data were collected at baseline and 3-, 6- and 12-month follow-up visit. 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 CHA2DS2-VASc and HAS-BLED score was 3.15+1.55 and 1.18+0.92, respectively. Overall, 7 patients (0.64%) experienced a symptomatic thromboembolic event (2 strokes, 3 transient ischemic attack and 2 patients SE), and major bleeding occurred in 2 patients (0.18%). At the 3-, 6- and 12-month follow-up visits, 1068 participants (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%) 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.