Direct Oral Anticoagulants in Cirrhosis Patients Pose Similar Risks of Bleeding When Compared to Traditional Anticoagulation

Abstract

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.

Efficacy and Safety of Non–Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients With Impaired Liver Function: A Retrospective Cohort Study

“…No significant difference in all‐cause bleeding was observed between traditional anticoagulants and NOACs during 3‐year follow‐up 16, 17, 18. Decreased risk of major bleeding was found in the NOAC group in one of the studies 16. The reason for the discrepancy between this study and ours may be that the enrollment of our study consisted of much older patients (mean age of 77 years versus 57–60 years in the previous study).…”

“…ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep‐Vein Thrombosis as First‐Line Therapy), ENGAGE AF (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation), and Hokusai‐VTE (Comparative Investigation of Low Molecular Weight Heparin/Edoxaban Tosylate Versus Low Molecular Weight Heparin/Warfarin in the Treatment of Symptomatic Deep‐Vein Blood Clots and/or Lung Blood Clots) trials excluded patients with AST or ALT levels greater than twice the upper limit of normal or total bilirubin levels >1.5‐fold the upper limit of normal,10, 11, 24, 26 which was used as the criteria for ILF in the present study. Because major trials of NOAC excluded patients with ILF, data comparing NOAC and warfarin therapies in patients with ILF are restricted to small cohort studies 16, 17, 18. Three retrospective cohort studies compared the bleeding risk between NOAC and traditional anticoagulant therapies for thrombosis and stroke prevention in AF patients with cirrhosis or chronic liver disease 16, 17, 18.…”

“…Because major trials of NOAC excluded patients with ILF, data comparing NOAC and warfarin therapies in patients with ILF are restricted to small cohort studies 16, 17, 18. Three retrospective cohort studies compared the bleeding risk between NOAC and traditional anticoagulant therapies for thrombosis and stroke prevention in AF patients with cirrhosis or chronic liver disease 16, 17, 18. No significant difference in all‐cause bleeding was observed between traditional anticoagulants and NOACs during 3‐year follow‐up 16, 17, 18.…”

“…Three retrospective cohort studies compared the bleeding risk between NOAC and traditional anticoagulant therapies for thrombosis and stroke prevention in AF patients with cirrhosis or chronic liver disease 16, 17, 18. No significant difference in all‐cause bleeding was observed between traditional anticoagulants and NOACs during 3‐year follow‐up 16, 17, 18. Decreased risk of major bleeding was found in the NOAC group in one of the studies 16.…”

“…In particular, these patients are also affected by coagulopathy, with which high bleeding and thrombotic risks are anticipated 3. A few recent studies reported comparable bleeding rates between NOAC and conventional anticoagulant therapies in patients with chronic liver disease or cirrhosis 15, 16, 17, 18. However, given the small sample sizes of these studies and the few studies evaluating efficacy and safety concurrently, more data are needed to establish the efficacy and safety of NOAC therapy in patients with ILF.…”