Effectiveness and Safety of Rivaroxaban versus Warfarin Among Nonvalvular Atrial Fibrillation Patients with Obesity and Polypharmacy

Am J Cardiovasc Drugs. 2022 Jul;22(4):425-436. doi: 10.1007/s40256-021-00520-7. Epub 2022 Jan 29.

Abstract

Background: Current evidence suggests that rivaroxaban may be well tolerated and effective in patients with nonvalvular atrial fibrillation (NVAF) and obesity; however, there is limited evidence on the impact of polypharmacy in this population. This study evaluated real-world clinical outcomes with rivaroxaban versus warfarin in patients with NVAF and obesity according to the number of concurrent medications.

Methods: This retrospective cohort study identified patients with one or more pharmacy claim for rivaroxaban or warfarin from two large claims databases. Patients were required to have an atrial fibrillation diagnosis, body mass index ≥ 30 kg/m2 and the presence of polypharmacy (1-4, 5-9, or ≥ 10 concurrent medications). Outcomes of stroke, systemic embolism, and major bleeding were compared between the rivaroxaban and warfarin cohorts after propensity score matching (PSM).

Results: A total of 95,875 patients were identified with one or more claim for either rivaroxaban or warfarin. After PSM, patient characteristics were balanced between cohorts (n = 21,547 in each cohort). The overall composite risk of stroke and systemic embolism was significantly lower in the rivaroxaban cohort compared with the warfarin cohort (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.70-0.84; p < 0.001). The risks of ischemic stroke, hemorrhagic stroke, and systemic embolism separately were also significantly reduced with rivaroxaban. Major bleeding risk was similar between cohorts (HR 0.93, 95% CI 0.81-1.06; p = 0.2842), and results were consistent across the three polypharmacy groups.

Conclusions: In this real-world study of NVAF patients with obesity, rivaroxaban was associated with lower risks of stroke and systemic embolism and similar risk of major bleeding versus warfarin across polypharmacy categories.

MeSH terms

  • Anticoagulants / adverse effects
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / drug therapy
  • Embolism* / drug therapy
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Hemorrhage / epidemiology
  • Humans
  • Obesity / complications
  • Obesity / drug therapy
  • Obesity / epidemiology
  • Polypharmacy
  • Retrospective Studies
  • Rivaroxaban / adverse effects
  • Stroke* / epidemiology
  • Stroke* / etiology
  • Stroke* / prevention & control
  • Treatment Outcome
  • Warfarin / adverse effects

Substances

  • Anticoagulants
  • Warfarin
  • Rivaroxaban