• Am J Ther · Nov 2019

    Comparative Study

    Comparative Effectiveness and Safety of Rivaroxaban in Adults With Nonvalvular Atrial Fibrillation.

    • Wilbert S Aronow and Tatyana A Shamliyan.
    • Department of Medicine and Cardiology Research, Westchester Medical Center, New York Medical College, Valhalla, NY.
    • Am J Ther. 2019 Nov 1; 26 (6): e679-e703.

    BackgroundAll evidence regarding benefits and harms of rivaroxaban for stroke prevention has not been appraised yet.Study QuestionWhat are the comparative effectiveness and safety of rivaroxaban in adults with nonvalvular atrial fibrillation?Data SourcesRandomized controlled trials (RCTs), meta-analyses, and observational studies were identified in several databases in October 2018.Study DesignRapid review with evidence appraisal using the Grading of Recommendations Assessment, Development and Evaluation working group approach.ResultsTwo direct RCTs (23,021 patients) suggest that rivaroxaban is noninferior to warfarin in the prevention of stroke and systemic embolism (pooled relative risk [RR] 0.73, 95% confidence interval [CI], 0.43-1.24), reduces risk of hemorrhagic stroke (RR 0.59, 95% CI, 0.38-0.92), fatal bleeding (RR 0.49, 95% CI, 0.31-0.76), and cardiac arrest (RR 0.45, 95% CI, 0.25-0.82, 2 RCTs), but increases risk of major gastrointestinal bleeding (RR 1.46, 95% CI, 1.19-1.78). In observational studies, rivaroxaban is associated with lower risk of ischemic stroke (RR 0.87, 95% CI, 0.77-0.99, 222,750 patients), acute myocardial infarction (RR 0.61, 95% CI, 0.48-0.78, 73,739 patients), and intracranial hemorrhage (RR 0.64, 95% CI, 0.45-0.92, 197,506 patients) but higher risk of gastrointestinal bleeding (RR 1.30, 95% CI, 1.19-1.42, 188,968 patients) and higher risk of mortality when compared with warfarin in European studies (RR 1.19, 103,270 patients in the UK; RR 2.02, 22,358 patients in Denmark) but lower risk of mortality in Taiwan (RR 0.58, 40,000 patients). Network meta-analyses and observational studies suggest that rivaroxaban is associated with higher risk of bleeding when compared with apixaban (RR 2.14, 72,586 patients), dabigatran (RR 1.24, 67,102 patients), and edoxaban (RR 1.32, 71,683 patients).ConclusionsResearch on the long-term comparative effectiveness, safety, and effects on quality of life between rivaroxaban and other novel oral anticoagulants is urgently needed.

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