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.

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Direct oral anticoagulants have been shown safe and effective in the treatment of pulmonary emboli and deep vein thrombi. Their role in the treatment of patients with hypercoagulability is uncertain. We designed a retrospective exploratory analysis of all patients with definite heparin induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS) that were treated with either apixaban or rivaroxaban from September 2011 through November 2015. Patients were reviewed for several clinico-pathologic features, including efficacy and safety. 23 patients were identified (12 patients with HIT and 11 patients with APS). Sixteen patients (70 %) were treated with apixaban and seven patients (30 %) were treated with rivaroxaban over a median follow up of 7 months (range 2-39). Zero patients developed recurrent thrombi. Two patients being treated for HIT developed major bleeding leading to discontinuation of all anticoagulation. Therefore, apixaban and rivaroxaban appear safe and effective for treatment of patients with HIT and APS in this small retrospective cohort and should be considered on an individual basis for patients who refuse, fail or are intolerant of warfarin. There were no sources of funding.

Introduction: Patients with cirrhosis have historically been excluded from clinical trials of anticoagulant therapies due to concerns about safety. While erroneously thought to be "auto-anticoagulated," patients with cirrhosis may actually be at increased risk for venous thromboemboli (VTE) due to an imbalance in pro coagulant and anticoagulant factors and do require therapeutic anticoagulation when thrombotic events occur. Traditionally low molecular weight heparins, and less commonly warfarin, have been the anticoagulants of choice in cirrhotic patients, though there are challenges with their use due to difficulty with access, administration and blood monitoring. Direct Oral Anticoagulants (DOACs) are increasingly replacing warfarin for the treatment of VTE and for stroke prevention in non-valvar atrial fibrillation. The administration and standardized dosing make DOACs an attractive alternative for safe and effective therapeutic anticoagulation but very little evidence exists for their use in patients with cirrhosis. Methods: We designed a retrospective analysis of all patients with cirrhosis at the University of Virginia who were treated with a DOAC between January 2012 and May 2016 for all indications. All patients were required to be treated with a DOAC with documented follow up for assessment of adverse events. Medical charts were reviewed for age, gender, weight, cirrhosis etiology, DOAC, dose, indication and length of treatment, Model for End-Stage Liver Disease (MELD) and Child-Turcotte-Pugh (CTP) scores, bleeding events and appearance of thrombus on repeat imaging. All bleeding events were recorded and graded according the Common Toxicity Criteria for Adverse Events, v4.0. Major bleeding events were reviewed by all investigators. Results: Eighty patients were identified, with 11 patients excluded after not starting a DOAC or being mislabeled as cirrhosis, leaving 69 patients for analysis. Median age was 73 years old (range 44-92) with 77% male. The most common etiologies of cirrhosis were NASH (66%) and HCV (22%). Thirty seven patients (54%) were treated with apixaban, 25 (36%) were treated with rivaroxaban and 7 (10%) were treated with dabigatran. Median length of time on anticoagulation was 6 months. Sixty-eight percent were treated for non-tumoral PVT or DVT while 32% were treated for stroke prevention in atrial fibrillation. Most patients had well compensated cirrhosis, but several had advanced cirrhosis (CTP class A/B/C: 33/26/10). Fourteen percent had an underlying malignancy, most commonly hepatocellular carcinoma, and 52% had esophageal varices. Of those treated for atrial fibrillation, none developed a clot while on a DOAC. Of those treated for VTE, 81% had resolution, 13% unchanged and 6% progression of their clot on repeat imaging. No patient developed drug induced liver injury or discontinued anticoagulation due to liver injury. Sixteen patients (23%) suffered a bleeding event, mostly epistaxis and easy bruising. Major bleeding, defined as grade 3 or higher, occurred in 12% of patients. Most major bleeding was gastrointestinal bleeding; with most but not all requiring endoscopy and transfusions. One subdural hematoma occurred. No variceal bleeding occurred, despite that majority of patients having esophageal varices identified on endoscopy. Of those with major bleeding, all were CTP class B or C with an average MELD of 22, compared to an average MELD of 14 in patients without major bleeding. All patients with major bleeding were treated with either apixaban or rivaroxaban. Conclusion: Similar to other anticoagulants, DOACs should be used with caution in patients with cirrhosis, particularly CTP class B or C. In this case series, the largest to our knowledge, direct oral anticoagulants in patients with cirrhosis compare favorably to historical controls (Delgado, Clin Gastroenterol Hepatol. 2012 Jul;10(7):776-83) with lower incidence of major bleeding and increased clot resolution. Further prospective studies are needed in this at risk and under studied patient population. Table Table. Disclosures No relevant conflicts of interest to declare.

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Background: Direct oral anticoagulants (DOACs) remain mostly investigational in patients with moderate to severe hepatic cirrhosis, yet are often selected over traditional anticoagulants including warfarin and enoxaparin in this setting. Objective: To determine the safety and efficacy of DOACs in patients with moderate to severe hepatic cirrhosis as compared with traditional anticoagulation. Methods: This was a retrospective, single-center cohort study evaluating inpatients and outpatients who were prescribed a DOAC, warfarin, or enoxaparin for therapeutic anticoagulation with Child-Turcotte-Pugh (CTP) B or C status at the time that the prescription was written. Included patients were followed until first bleeding or thromboembolic event, or until discontinuation of anticoagulation therapy. Data were collected by manual chart review. The primary outcomes included both bleeding events and thromboembolic events in the DOAC population as compared with traditional anticoagulation. Results: A total of 101 patients were included in the study, 69 treated with DOAC therapy and 32 with traditional anticoagulation. Bleeding events occurred in 36% of patients in the DOAC group and 22% of patients in the traditional group ( P = 0.149). In both groups, bleeds were most commonly gastrointestinal. Thromboembolic events occurred in 4% of the DOAC population and no patients in the traditional population ( P = 0.55). No fatal bleeding or thromboembolic events occurred. Conclusion and Relevance: DOACs do not appear to be more harmful than traditional anticoagulation in patients with CTP B or C status. These results support the use of DOACs in patients with CTP B or C hepatic cirrhosis when considering safety, efficacy, and convenience.