Effectiveness and Safety of Rivaroxaban Versus Warfarin in Nonvalvular Atrial Fibrillation Patients with Severe Kidney Disease or Undergoing Hemodialysis.
Am J Med. 2019 May 02;:
Authors: Coleman CI, Kreutz R, Sood N, Bunz TJ, Eriksson D, Meinecke AK, Baker WL
BACKGROUND: Nonvalvular atrial fibrillation patients with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban versus warfarin in nonvalvular atrial fibrillation patients with stage 4 or 5 chronic kidney disease or undergoing hemodialysis in routine practice.
METHODS: Using MarketScan data from 1/2012-12/2017, we identified oral anticoagulant (OAC)-naïve nonvalvular atrial fibrillation patients with stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12-months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a stroke/systemic embolism or major bleeding event, OAC discontinuation/switch, insurance disenrollment or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the OAC cohorts were calculated using Cox regression.
RESULTS: We identified 1896 rivaroxaban (38.7% received a dose <20mg/day) and 4848 warfarin users. Eighty-eight percent of included patients had stage 5 chronic kidney disease or were undergoing hemodialysis. Rivaroxaban did not significantly reduce stroke/systemic embolism (HR=0.55, 95%CI=0.27-1.10) or ischemic stroke (HR=0.67, 95%CI=0.30-1.50) alone, but was associated with a significant 32% (95%CI=1-53%) reduction in major bleeding risk versus warfarin.
CONCLUSION: Among nonvalvular atrial fibrillation patients with stage 4 or 5 chronic kidney disease or undergoing hemodialysis, rivaroxaban appears associated with significantly less major bleeding compared to warfarin.
PMID: 31054829 [PubMed - as supplied by publisher]