• Curr Med Res Opin · Aug 2019

    Effectiveness and safety of rivaroxaban in nonvalvular atrial fibrillation: data from a contemporary Spanish registry.

    • Cesar Caro Martinez, Juan José Cerezo Manchado, Pedro José Flores Blanco, Ginés Elvira Ruíz, Helena Albendín Iglesias, Alejandro Lova Navarro, Francisco Arregui Montoya, Arcadio García Alberola, Domingo Andrés Pascual Figal, Jose Luis Bailén Lorenzo, Begoña Navarro-Almenzar, Faustino García-Candel, and Sergio Manzano Fernández.
    • a Servicio de Cardiología , Hospital Vega Baja , Alicante , Spain.
    • Curr Med Res Opin. 2019 Aug 1; 35 (8): 1463-1471.

    AbstractObjective: To ascertain the clinical profile, management and rates of thromboembolic and bleeding complications in a contemporary cohort of patients with nonvalvular atrial fibrillation (NVAF) on rivaroxaban treatment, with a particular focus on some subgroups of patients. Methods: Retrospective study that included all NVAF patients who started treatment with rivaroxaban for the prevention of stroke or systemic embolism between December 2012 and December 2015. Rates of outcomes (stroke, nonfatal myocardial infarction, major bleeding, intracranial bleeding and death) during follow-up were calculated. Results: A total of 732 patients (mean age 76.4 ± 9.2 years; 54.5% women) were included. Comorbidities were common (hypertension 87.5%; diabetes 26.5%; renal insufficiency 24.6%; prior stroke/transient ischemic attack 16.8%). Mean CHA2DS2-VASc was 3.9 ± 1.5 and HAS-BLED 2.3 ± 0.9; 61.9% of patients were rivaroxaban naïve users. After a mean treatment period of 22.7 ± 7.4 months, rates of stroke, nonfatal myocardial infarction, major bleeding, intracranial bleeding and death were 1.8, 1.0, 3.2, 0.4 and 5.5 events per 100 patient-years, respectively. Rates of stroke and death were higher in patients >75 years (vs. ≤75 years) and in patients with prior stroke/transient ischemic attack or renal insufficiency. Rates of major bleeding were higher among patients >75 years and in patients with prior stroke/transient ischemic attack. Conclusions: In this contemporary Spanish cohort of NVAF patients on rivaroxaban, patients had many comorbidities, a high thromboembolic risk and a moderate bleeding risk. Overall, rates of stroke and bleeding complications were low and similar to other previous studies. These data suggest that rivaroxaban is effective and safe in routine practice.

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