A Multicenter Analysis of Factors Associated With Apixaban-Related Bleeding in Hospitalized Patients With End-Stage Renal Disease on Hemodialysis

Steuber, Taylor D.; Shiltz, Dane L.; Cairns, Alex C.; Ding, Qian; Binger, Katie J.; Courtney, Julia

doi:10.1177/1060028017717282

Cited by 23 publications

(22 citation statements)

References 17 publications

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“…In contrast to the above, a recent retrospective analysis of factors associated with apixaban related bleeding events in ESRD patients on hemodialysis, describe increased risk of bleeding with increased exposure to apixaban . This retrospective analysis did not include a warfarin comparator group.…”

Section: Discussionmentioning

confidence: 99%

“…found no statistically significant difference in the major or overall bleeding event rate of patients taking apixaban vs warfarin, including the subgroup of patients on dialysis . In addition, continuation of apixaban after inpatient admission, the daily dose of apixaban, and the number of hemodialysis sessions have been associated with an increased risk of bleeding …”

Section: Introductionmentioning

confidence: 99%

“…29 In addition, continuation of apixaban after inpatient admission, the daily dose of apixaban, and the number of hemodialysis sessions have been associated with an increased risk of bleeding. 30 The University of Virginia Medical Center's Hematology Consult service has recommended apixaban use in some of its dialysis patients. The purpose of this study was to compare bleeding events between maintenance dialysis patients at our institution on apixaban vs warfarin.…”

Section: Introductionmentioning

confidence: 99%

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Safety and effectiveness of apixaban compared to warfarin in dialysis patients

Reed

Palkimas

Hockman

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and effectiveness of apixaban compared to warfarin in dialysis patients

Reed

Palkimas

Hockman

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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“…Because of its high degree of protein binding, dialysis clearance is low (18 ml/min), resulting in a 14% decrease in drug exposure (49). In a recent retrospective analysis of patients on hemodialysis, cumulative days of apixaban use in an outpatient setting, higher total daily apixaban doses, and total hemodialysis sessions were independent risk factors for bleeding events (adjusted odds ratio, 13.07; 95% CI, 1.54 to 110.54; adjusted odds ratio, 1.72; 95% CI, 1.20 to 2.48; and adjusted odds ratio, 2.04; 95% CI, 1.06 to 3.92, respectively) (50). Another PK/PD study prescribed a single 10-mg dose to 24 patients with CKD and various categories of creatinine clearance and eight healthy controls (51).…”

Section: Pharmacology In Kidney Diseasementioning

confidence: 99%

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Jain¹,

Reilly²

2018

CJASN

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Oral anticoagulants are commonly used drugs in patients with CKD and patients with ESKD to treat atrial fibrillation to reduce stroke and systemic embolism. Some of these drugs are used to treat or prevent deep venous thrombosis and pulmonary embolism in patients with CKD who undergo knee and hip replacement surgeries. Warfarin is the only anticoagulant that is approved for use by the Food and Drug Administration in individuals with mechanical heart valves. Each oral anticoagulant affects the coagulation profile in the laboratory uniquely. Warfarin and apixaban are the only anticoagulants that are Food and Drug Administration approved for use in patients with CKD and patients with ESKD. However, other oral anticoagulants are commonly used off label in this patient population. Given the acquired risk of bleeding from uremia, these drugs are known to cause increased bleeding events, hospitalization, and overall morbidity. Each anticoagulant has unique pharmacologic properties of which nephrologists need to be aware to optimally manage patients. In addition, nephrologists are increasingly asked to aid in the management of adverse bleeding events related to oral anticoagulant use in patients with CKD and patients with ESKD. This article summarizes the clinical pharmacology of these drugs and identifies knowledge gaps in the literature related to their use.

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“…58 Other retrospective studies confirmed these findings. Two subsequent meta-analyses, 59,60 which included smaller observational studies, [61][62][63][64] found that apixaban was associated with less major bleeding in HD patients with NVAF than warfarin with similar efficacy in prevention of stroke and systemic embolism. A recent systematic review concluded that in HD patients, compared to warfarin there was an increased risk of major bleeding with rivaroxaban (RR, 1.45; 95% CI, 1.09-1.93) and dabigatran (RR, 1.76; 95% CI, 1.44-2.15), while there was no difference between apixaban and warfarin.…”

Section: Safe T Y Con Cern S With Warfarin V Er Sus N Oac Smentioning

confidence: 99%

Warfarin in nonvalvular atrial fibrillation—Time for a change?

Reilly

Jain

2019

Seminars in Dialysis

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Warfarin is the most commonly prescribed anticoagulant in hemodialysis (HD) patients with nonvalvular atrial fibrillation (NVAF). Recent trends show that Nephrologists are increasingly prescribing novel oral anticoagulants, despite the fact that no randomized clinical trials have been conducted in dialysis patients. Difficulties maintaining international normalized ratio in the therapeutic range, increased risk of intracranial hemorrhage and concerns regarding warfarin‐induced vascular calcification and calciphylaxis may be responsible. Anticoagulation quality is poor in HD patients. A variety of factors contribute to this: increased antibiotic exposure; comorbid illness; decreased adherence and vitamin K deficiency. Attempts to address this with standardized protocols have been uniformly unsuccessful. In nonadherent patients, thrice weekly observed therapy improved quality. Low‐dose vitamin K supplementation improves time in the therapeutic range (TTR) in those with normal kidney function and should be studied in HD patients given their high frequency of vitamin K deficiency. Vascular and valvular calcification associated with warfarin could result from reduced carboxylation of matrix Gla protein (MGP), a well‐known inhibitor of vascular calcification. Multiple observational studies also link calciphylaxis to warfarin; warfarin‐induced hypercoagulability and decreased carboxylation of MGP could explain this. A large observational study, two meta‐analyses, and a systematic review in HD patients with NVAF showed reduced bleeding with apixaban compared to warfarin with similar efficacy in reducing stroke and systemic embolism. Given these results, apixaban is a reasonable alternative to warfarin for anticoagulation of HD patients with NVAF, especially in those with low TTR, until data from randomized clinical trials become available.

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A Multicenter Analysis of Factors Associated With Apixaban-Related Bleeding in Hospitalized Patients With End-Stage Renal Disease on Hemodialysis

Abstract: The association between these factors and increased bleeding should prompt concern for long-term anticoagulation with apixaban in patients with ESRD receiving chronic HD.

Cited by 23 publications

References 17 publications

Safety and effectiveness of apixaban compared to warfarin in dialysis patients

Safety and effectiveness of apixaban compared to warfarin in dialysis patients

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Warfarin in nonvalvular atrial fibrillation—Time for a change?

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