Abstract
Abstract BACKGROUND AND AIMS We aimed to estimate the clinical characteristics and outcomes of rivaroxaban and warfarin in patients with nonvalvular atrial fibrillation (NVAF) and concurrent obesity, type two diabetes (T2D) and chronic kidney disease (CKD). METHOD A multicenter prospective cohort study, where consecutive eligible rivaroxaban or warfarin treated patients with NVAF concurrent obesity, T2D and CKD, were registered. Patients were also required to be ≥18 years of age, and have obesity, which was defined as BMI ≥30 kg/m2 diabetes and CKD. Patients were followed-up for clinical events over a mean period of 1 year. Primary outcome was a composite of 1-year mortality, stroke or systemic embolism, major bleeding and myocardial infarction, end-stage kidney disease, while secondary outcomes included those components separated. Treatment cohorts were matched using propensity scores and were compared for stroke/systemic embolism (SE) and major bleeding using Cox proportional hazards models. RESULTS A total of 194 (n = 103, rivaroxaban; n = 91, warfarin) matched pairs of NVAF patients with obesity, T2D and CKD who initiated treatment with rivaroxaban or warfarin were included. Prior to matching, rivaroxaban patients were younger than warfarin patients (mean age, 67.9 versus 69.2 years) and had lower mean scores for the QCI, CHA2DS2-VASc and HAS-BLED. In the intent-to-treat analysis, patients receiving rivaroxaban had a significant 19% reduction in the composite risk of stroke or SE compared with those receiving warfarin [HR 0.85 (95% CI 0.77–0.90)]. The risk of each component of the composite outcome was lower in the rivaroxaban cohort versus the warfarin cohort with significant differences for ischemic stroke and hemorrhagic stroke. The difference in SE was not statistically significant. Outcome rates were lower in the as-treated sensitivity analysis, with significant reductions in the composite outcome of stroke/SE risk observed for rivaroxaban versus warfarin [HR 0.70 (95% CI 0.61–0.80)]. Ischemic stroke and hemorrhagic stroke risks were also significantly lower with rivaroxaban versus warfarin in the as-treated sensitivity analysis. The risk of major bleeding was similar between the rivaroxaban cohort and the warfarin cohort [HR 0.91 (95% CI 0.79–1.06)]. CONCLUSION In NVAF patients with comorbidities of obesity, T2D and CKD, who initiated rivaroxaban had a significantly lower risk of stroke/SE compared with patients initiating warfarin. The risk of major bleeding was not significantly different between treatment groups. Patients receiving rivaroxaban had a significantly higher rate of adherence to treatment, supporting the use of rivaroxaban as an alternative to warfarin in NVAF patients with comorbidities of obesity, T2D and CKD.
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