This is the first clinical study evaluating the use of DOAC in patients with cirrhosis. DOAC display similar safety characteristics when compared to traditional anticoagulation in patients with cirrhosis and are potentially attractive agents for anticoagulation therapy. Larger studies are now needed to better understand the safety and efficacy of these agents in cirrhosis.
Essentials
The safety of apixaban in patients on dialysis is currently debated.Bleeding events were retrospectively compared for dialysis patients on warfarin vs apixaban.Overall bleeding events were significantly less frequent in apixaban group compared to warfarin group.Apixaban appears to be a safe and effective choice for anticoagulation in patients on dialysis.
BackgroundThe use of apixaban for stroke prophylaxis or for the treatment of venous thromboembolism in end stage renal disease (ESRD) patients maintained on dialysis is based on one single‐dose pharmacokinetic study. There is a deficiency of clinical evidence supporting safety in this population.ObjectiveThe purpose of this study was to determine the safety and efficacy of apixaban compared with warfarin in dialysis patients.Patients/methodsThis is a retrospective cohort study conducted at the University of Virginia Medical Center. A total of 124 ESRD patients maintained on dialysis who either received apixaban (n = 74) or warfarin (n = 50) between January 1, 2014 and October 31, 2016 were included in the study. We used multivariable logistic regression to compare the likelihood of patients experiencing a bleeding event based on anticoagulant therapy.ResultsThe apixaban group experienced fewer overall bleeding events than the warfarin group (18.9% vs 42.0%; P = .01); this significant difference persisted in adjusted analysis (OR = 0.15; 95% CI = 0.05‐0.46; P = .001). Major bleeding events were less frequent in the apixaban group compared with patients on warfarin (5.4% vs 22.0%; P = .01). There were no recurrent ischemic strokes in either groups. A lower, non‐significant, incidence of recurrent VTE was found in patients on apixaban compared with warfarin (4.4% vs 28.6%; P = .99).ConclusionCompared to warfarin, our findings suggest that apixaban is a safe and effective alternative in patients with ESRD maintained on dialysis, with apixaban patients experiencing fewer bleeding events than warfarin patients.
The risk of thrombosis in patients with chronic liver disease is increasingly recognized. As patients with cirrhosis develop indications for anticoagulation therapy (e.g., venous thromboembolism, portal vein thrombosis, or atrial fibrillation), providers are left to make difficult decisions when selecting therapeutics with little evidence to rely on. Current practice supports the use of low molecular weight heparin or vitamin K antagonists in select patients with cirrhosis requiring anticoagulation. While traditional anticoagulants may be safe and effective in select patients with compensated cirrhosis, the use of direct oral anticoagulants (DOAC) is more controversial. DOAC are desirable as they do not require routine monitoring and can be taken orally. Unfortunately, patients with chronic liver disease were excluded from clinical trials that demonstrated efficacy and safety when compared to traditional anticoagulation. Data are now emerging that support the use of DOAC in well-compensated cirrhosis patients. However, further study is needed with all (traditional and DOAC) anticoagulation medications in patients with cirrhosis to better ensure safety and further understand pharmacologic properties in this challenging population.
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