Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Liver Disease

Lee, So‐Ryoung; Lee, Hyun Jung; Han, Kyung Do; Jung, Jae-Hun; Jin, Myung; Oh, Seil; Lip, Gregory Y.H.

doi:10.1016/j.jacc.2019.04.052

Cited by 99 publications

(104 citation statements)

References 37 publications

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“…Based on the results of our review, DOAC use appears relatively safe in select liver transplant recipients and is potentially associated with a lower incidence of clinically significant bleeding relative to warfarin. Similar results were reported in non‐transplant patients with clinically significant liver disease by Lee et al in a review of the Korean National Health Insurance Service database, which found a reduction in hospitalization for major bleeding among patients prescribed DOACs relative to warfarin for PAF (HR = 0.62; 95% CI, 0.42‐0.93) . A subgroup analysis of the ENGAGE‐AF TIMI‐48 trial found similar reductions in bleeding using edoxaban relative to warfarin in patients with PAF and clinically relevant liver disease .…”

Section: Discussionsupporting

confidence: 79%

Safety of direct‐acting oral anticoagulants relative to warfarin in a matched cohort of liver transplant recipients

Santeusanio

Weinberg

Florman

et al. 2019

Clinical Transplantation

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Despite increasingly widespread utilization of direct-acting oral anticoagulants (DOACs), there remains limited experience with the use of these agents following liver transplantation. We performed a single-center, retrospective review of liver transplant recipients prescribed DOACs or warfarin between January 2014 and January 2018. Patients receiving DOACs were matched with warfarin-treated controls based on discrete clinical parameters and followed from the time of anticoagulant prescription, until treatment discontinuation or study conclusion. The primary endpoint for this review was the incidence of clinically relevant major or non-major bleeding among the treatment groups. Twenty-seven patients prescribed DOACs were identified for inclusion in the review, of which 20 could be matched with suitable warfarin controls. At the conclusion of the study, warfarin-treated patients had a significantly higher incidence of clinically relevant bleeding (45% vs 15%; P = .01). No statistically significant differences were found in the rate of new or recurrent thrombotic events.Multivariable logistic regression demonstrated that warfarin treatment was associated with a significantly higher odds of a bleeding event compared to treatment with a DOAC (OR = 6.9; 95% CI, 1.1-44.6). DOAC use appears relatively safe compared with warfarin in select liver transplant recipients. Patient-specific factors still bear consideration when selecting between the various anticoagulant options. K E Y W O R D Salgorithm, anticoagulants, clotting, hemorrhage, liver transplantation

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Section: Discussionsupporting

confidence: 79%

Safety of direct‐acting oral anticoagulants relative to warfarin in a matched cohort of liver transplant recipients

Santeusanio

Weinberg

Florman

et al. 2019

Clinical Transplantation

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“…Several new studies have been published since the release of the latest guidelines [67] and previous reviews on the use of DOACs in patients with cirrhosis [5,[74][75][76]. Original studies evaluating the use of DOACs vs traditional anticoagulants in patients with CLD are reported in Table 1 [77][78][79][80][81][82][83][84][85][86][87][88][89].…”

Section: Evidence From Real-world Studiesmentioning

confidence: 99%

“…However, these results should be interpreted with caution [90,91]. The strengths of these studies are the large population-based sample and that propensity score weighting methods were used to balance covariates between the two anticoagulation treatment groups in the two largest studies [88,89]. Nevertheless, they have several weaknesses.…”

Section: Evidence From Real-world Studiesmentioning

confidence: 99%

See 1 more Smart Citation

Direct Oral Anticoagulants in Patients with Liver Disease in the Era of Non-Alcoholic Fatty Liver Disease Global Epidemic: A Narrative Review

Ballestri¹,

Capitelli²,

Fontana³

et al. 2020

Adv Ther

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Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent and relevant healthcare issues. Direct oral anticoagulants (DOACs) are now the first-choice for anticoagulant treatment of these conditions displaying a better efficacy/safety profile than vitamin-K antagonists, mainly due to significantly reduced risk of major bleeding, especially of intracranial haemorrhage. Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in developed countries showing a continuously growing prevalence. Nonalcoholic steatohepatitis (NASH), its evolutive form, will be the leading cause for liver transplantation by 2020. NAFLD is independently associated with an increased risk of abnormalities of cardiac structure and function, including cardiac rhythm disorders (mainly AF). Moreover, data suggest an increased risk of unprovoked VTE associated with NAFLD/NASH. Therefore, a growing number of patients with chronic liver disease (CLD) will be candidate for anticoagulant therapy in the near future. Cirrhosis of any etiology is characterized by an unstable thrombosis/bleeding haemostatic balance, making anticoagulant therapy particularly challenging in this condition. Given that patients with significant active liver disease and cirrhosis were excluded from all pivotal randomized controlled trials on DOACs, this comprehensive review aims at critically discussing real-world evidence, including the latest population studies, regarding the use of DOACs in patients with CLD/cirrhosis.

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“…The Korea National Health Insurance Service (NHIS) is an obligatory single‐payer health insurance system in Korea covering 97.2% of the Korean population . Given this unique strength in capturing all disease cases of interest, many studies using the NHIS database have been conducted and published, and additional studies are being added to the available literature . Several studies involving the Korean population with IBD have also been published in recent years; however, there is a growing concern over the study methodology being applied, particularly the use of heterogeneous across‐study case definitions.…”

Section: Introductionmentioning

confidence: 99%

Nationwide validation study of diagnostic algorithms for inflammatory bowel disease in Korean National Health Insurance Service database

Lee

et al. 2019

J of Gastro and Hepatol

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Background and Aim:We conducted a nationwide validation study of diagnostic algorithms to identify cases of inflammatory bowel disease (IBD) within the Korea National Health Insurance System (NHIS) database. Method: Using the NHIS dataset, we developed 44 algorithms combining the International Classification of Diseases (ICD)-10 codes, codes for Rare and Intractable Diseases (RID) registration and claims data for health care encounters, and pharmaceutical prescriptions for IBD-specific drugs. For each algorithm, we compared the case identification results from electronic medical records data with the gold standard (chart-based diagnosis). A multiple sampling test verified the validation results from the entire study population. Results: A random nationwide sample of 1697 patients (848 potential cases and 849 negative control cases) from 17 hospitals were included for validation. A combination of the ICD-10 code, ≥ 1 claims for health care encounters, and ≥ 1 prescription claims (reference algorithm) achieved excellent performance (sensitivity, 93.1% [95% confidence interval 91-94.7]; specificity, 98.1% [96.9-98.8]; positive predictive value, 97.5% [96.1-98.5]; negative predictive value, 94.5% [92.8-95.8]) with the lowest error rate (4.2% [3.3-5.3]).The multiple sampling test confirmed that the reference algorithm achieves the best performance regarding IBD diagnosis. Algorithms including the RID registration codes exhibited poorer performance compared with that of the reference algorithm, particularly for the diagnosis of patients affiliated with secondary hospitals. The performance of the reference algorithm showed no statistical difference depending on the hospital volume or IBD type, with P-value < 0.05. Conclusions:We strongly recommend the reference algorithm as a uniform standard operational definition for future studies using the NHIS database.bs_bs_banner Including (i) 5-aminosalicylate (oral agents for Crohn's disease, oral and/or suppository agents for ulcerative colitis) for 1 month; (ii) immunomodulators (azathioprine or 6-mercaptopurine) at least once; and (iii) biologics (infliximab or adalimumab) at least once. ¶ Including (i) oral or topical 5-aminosalicylic acids for at least 1 month; (ii) at least one prescription of topical steroid; and (iii) thiopurines (azathioprine or 6mercaptopurine) and antitumor necrosis factor-α agents (infliximab or adalimumab). IBD, inflammatory bowel disease, ICD, International Classification of Diseases; RID, rare and intractable diseases registration.

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Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Liver Disease

Cited by 99 publications

References 37 publications

Safety of direct‐acting oral anticoagulants relative to warfarin in a matched cohort of liver transplant recipients

Safety of direct‐acting oral anticoagulants relative to warfarin in a matched cohort of liver transplant recipients

Direct Oral Anticoagulants in Patients with Liver Disease in the Era of Non-Alcoholic Fatty Liver Disease Global Epidemic: A Narrative Review

Nationwide validation study of diagnostic algorithms for inflammatory bowel disease in Korean National Health Insurance Service database

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