Direct Oral Anticoagulants Versus Warfarin for Treatment of Thrombosis or Atrial Fibrillation in Patients With Cirrhosis: A Retrospective Cohort Study

2021 ◽  
pp. 106002802110250
Author(s):  
Eric M. Coons ◽  
Britta A. Staubes ◽  
Ashley L. Casey ◽  
Stephanie A. Elagizi-Youssef ◽  
Alaa E. Mohammed ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Major Bleeding ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Small Sample ◽  
Class B ◽  
Class C

Background Evidence for direct oral anticoagulants (DOACs) in patients with cirrhosis is limited. Few patients with Child-Turcotte-Pugh (CTP) class B and C cirrhosis have been studied. Objective To compare major bleeding rates in patients with cirrhosis receiving a DOAC versus warfarin. Methods A retrospective cohort study was conducted in adults with cirrhosis receiving a DOAC versus warfarin for venous thromboembolism, portal-vein thrombosis, or atrial fibrillation. The primary outcome was the rate of major bleeding. Secondary outcomes included time to major bleeding, clinically relevant nonmajor bleeding, all bleeding, gastrointestinal bleeding, intracranial bleeding, and new thromboembolic events. The study was approved by the Ochsner Health System Institutional Review Board. Results A total of 44 patients receiving a DOAC and 41 patients receiving warfarin were included. Major bleeding occurred in 4 patients receiving a DOAC and 6 patients receiving warfarin (9.1% vs 14.6%; P = 0.881). Rates of major bleeding were similar in 24 DOAC and 17 warfarin patients with CTP Class B (4.2% vs 17.6%; P = 0.37) and 8 DOAC and 9 warfarin patients with CTP Class C (37.5% vs 11.1%; P = 0.41) cirrhosis. Secondary bleeding and efficacy outcomes were similar between cohorts. The study was limited by a small sample size. Conclusion and Relevance Treatment with DOACs in patients with cirrhosis was associated with a similar rate of major bleeding compared with warfarin. Inclusion of CTP class C patients in future studies remains valuable to evaluate safety and efficacy of DOACs in this population.

scholarly journals A Real-world Experience of the Safety and Efficacy of Non-vitamin K Oral Anticoagulants Versus Warfarin in Patients with Non-valvular Atrial Fibrillation— A Single-centre Retrospective Cohort Study in Singapore

2020 ◽  
Vol 49 (11) ◽  
pp. 838-847
Author(s):  
Wen Jun Tiew ◽  
Vivien LX Wong ◽  
Vern Hsen Tan ◽  
Yong Chuan Tan ◽  
Elena MS Lee
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Vitamin K ◽  
Major Bleeding ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Oral Anticoagulants ◽  
Single Centre ◽  
Safety And Efficacy

Introduction: Non-vitamin K oral anticoagulants (NOACs) were shown to have better outcomes than warfarin for non-valvular atrial fibrillation (NVAF). Given limited local real-world data, this study aims to evaluate the safety and efficacy of NOACs versus warfarin for NVAF in Singapore. Methods: This single-centre retrospective cohort study included 439 patients ≥ 21 years old that were newly prescribed with oral anticoagulants (OACs) for NVAF in 2015. Follow-ups for patients upon OAC initiation lasted either for 2 years or until the occurrence of bleeding or thromboembolism event or death (whichever was earlier). Primary endpoints included major bleeding and stroke, while secondary endpoints included overall bleeding and thromboembolic events. Time-to-events was evaluated via Kaplan-Meier survival analysis. Data on time in therapeutic range (TTR) and compliance were analysed. Results: Patients were assigned to 4 groups: warfarin (157, 35.8%), rivaroxaban (154, 35.1%), apixaban (98, 22.3%) and dabigatran (30, 6.8%). With a mean age of 70.8 (±10.8) years old, the population were predominantly males (56.5%) and comprised Chinese (73.8%), Malays (18.7%) and others (7.5%). The rates of stroke per year were 0.7%, 1.7%, 2.2% and 0% for warfarin, rivaroxaban, apixaban and dabigatran, respectively (P=0.411), whereas those of major bleeding were 2.7%, 1.4%, 2.2% and 0% (P=0.560). As compared to warfarin, no significant differences were observed for risks of stroke and of major bleeding for rivaroxaban (adjusted hazard ratio (HR) 4.19, 95% confidence interval (CI) 0.68–26.05, P=0.124 and adjusted HR 0.43, 95% CI 0.12–1.59, P=0.207) and apixaban (adjusted HR 5.33, 95% CI 0.85–33.34, P=0.074 and adjusted HR 1.54, 95% CI 0.39–6.15, P=0.538). Mean TTR was 68.8% (±24.3%) for warfarin. Compliance rates for rivaroxaban, apixaban, and dabigatran were 56.6%, 59.2%, and 44.8% respectively (P=0.177). Conclusion: NOACs were associated with similar stroke and major bleeding rates as warfarin for NVAF. Keywords: Anticoagulant, Asian, atrial fibrillation, compliance, haemorrhage, thrombosis

Direct Oral Anticoagulants in Patients with Cirrhosis Appear Safe and Effective

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3827-3827 ◽  
Author(s):  
Paul R Kunk ◽  
Hampton Collins ◽  
Surabhi Palkimas ◽  
Nicolas M Intagliata ◽  
Hillary S. Maitland
Keyword(s):  
Atrial Fibrillation ◽  
Liver Injury ◽  
Adverse Events ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Therapeutic Anticoagulation ◽  
Class B ◽  
Repeat Imaging

Abstract 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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