Effect of Direct Oral Anticoagulants Versus Traditional Anticoagulation in Budd-Chiari Syndrome

Abstract

Background

This systematic review aimed to evaluate the comparative effectiveness and safety of direct oral anticoagulants (DOACs) versus traditional anticoagulants, including vitamin K antagonists (VKAs) and low-molecular-weight heparins (LMWHs), in the treatment of Budd-Chiari Syndrome (BCS).

Methods

A comprehensive literature search was conducted in the PubMed and Embase databases up to July 2025. Studies were selected based on predefined inclusion criteria, focusing on patients with BCS who received DOACs (specifically dabigatran, rivaroxaban, apixaban, or edoxaban) compared to those treated with VKAs or LMWHs.

Results

Of 68 identified records, two retrospective studies met the inclusion criteria. Sharma et al (India, n = 98) compared dabigatran with VKAs after percutaneous endovascular intervention. Stent patency and major bleeding rates were similar between groups, with no difference in mortality, suggesting that dabigatran was noninferior to VKAs. Semmler et al (Austria, n = 43) compared DOACs with VKAs/LMWH in primary BCS patients, many with underlying myeloproliferative neoplasms. Over a median follow-up of 82.5 months, DOACs demonstrated comparable complete response rates and major bleeding risks. Both studies emphasized the convenience of DOACs due to oral administration and lack of INR monitoring.

Conclusion

Current evidence, though limited to small retrospective cohorts, suggests that DOACs may be as effective and safe as traditional anticoagulants in BCS management. DOACs offer practical advantages, particularly in patients with difficulties maintaining therapeutic INR or requiring long-term anticoagulation. Larger prospective studies and randomized controlled trials are warranted to validate these findings.

Keywords

Budd-Chiari syndrome direct oral anticoagulants vitamin K antagonists anticoagulation liver disease

Introduction

Budd-Chiari syndrome (BCS)¹ is a rare but severe vascular liver disorder characterized by the obstruction of hepatic venous outflow, leading to portal hypertension and potential liver failure. The syndrome is classified as primary when the obstruction results from thrombosis, and secondary when it is caused by external compression or invasion of the hepatic veins (HV) or inferior vena cava (IVC). The management of BCS typically involves a stepwise approach,^2,3 starting with anticoagulation to prevent further thrombotic events, followed by more invasive interventions such as angioplasty, stenting, transjugular intrahepatic portosystemic shunt (TIPS), or orthotopic liver transplantation (OLT) in cases of treatment failure or progressive disease.

Traditionally, anticoagulation in BCS has been managed using vitamin K antagonists (VKAs) such as warfarin or low-molecular-weight heparin (LMWH).³ However, the use of VKAs is often complicated by the need for frequent monitoring of the international normalized ratio (INR), dose adjustments, and the risk of bleeding complications. Moreover, patients with liver disease, particularly those with cirrhosis, may have altered coagulation profiles, complicating the achievement and maintenance of therapeutic INR levels. These limitations have led to the exploration of alternative anticoagulation strategies, including direct oral anticoagulants (DOACs). DOACs have emerged as promising alternatives to traditional anticoagulants due to their predictable pharmacokinetics, fixed dosing regimens, and lack of need for routine monitoring.

DOACs have been extensively studied and are widely used in the management of venous thromboembolism⁴ and non-valvular atrial fibrillation.^5,6 However, their use in BCS remains off-label, and data on their effectiveness and safety in this specific population are limited. Nevertheless, an expanding body of observational evidence—including systematic reviews and cohort studies—suggests that DOACs may achieve recanalization rates and bleeding outcomes comparable to, or in some reports better than, VKAs or LMWH in portal and mesenteric vein thrombosis, albeit with important limitations related to study design, selection, and heterogeneous liver disease.^7,8 In parallel, there are valid reasons for clinical caution in BCS: factor Xa inhibitors undergo substantial hepatic metabolism and all DOACs have variable renal contributions to clearance, raising concerns in the setting of hepatic dysfunction; product labeling and expert reviews recommend avoidance or caution in moderate-to-severe hepatic impairment; and although on-label reversal agents exist, considerations of availability, cost, and post-reversal thrombotic risk may influence anticoagulant selection.

Recent studies have begun to shed light on the potential role of DOACs in the management of BCS.^9‐13 Therefore, this systematic review aims to synthesize the available evidence on the effectiveness, safety, and clinical outcomes associated with DOACs and traditional anticoagulants in patients with BCS.

Methods

Ethical approval was not required for this systematic review, as it exclusively involved the analysis of previously published, anonymized, and aggregated data. No individual patient data were disclosed, ensuring the privacy and confidentiality of all subjects.

Eligibility Criteria

The inclusion criteria for this review were defined to ensure the relevance and quality of the selected studies. The criteria were as follows: (1) Population: The study population comprised patients with a confirmed diagnosis of BCS, irrespective of the underlying etiology or the severity of liver disease. (2) Intervention: The intervention of interest was treatment with DOACs, specifically dabigatran, rivaroxaban, apixaban, or edoxaban. (3) Comparison: The comparison group included patients treated with traditional anticoagulation therapies, such as VKAs or LMWH. (4) Outcomes: The outcomes assessed were consistent with those reported in the original studies, focusing on both effectiveness and safety measures. (5) Study Design: Both randomized controlled trials (RCTs) and observational studies were considered for inclusion.

Studies were excluded if they involved patients with portal vein thrombosis treated with DOACs. Additionally, single-arm studies that focused solely on DOACs without providing a comparative analysis against VKAs or LMWH were excluded. Irrelevant studies, such as animal experiments, case reports, reviews, meta-analyses, editorials, and meeting abstracts, were excluded. In cases of duplicate publications, preference was given to studies with longer follow-up or larger sample sizes to enhance data reliability.

Literature Search

A comprehensive literature search was conducted in the PubMed and Embase databases, covering studies published up to July 2025. The search strategy employed a combination of keywords, including: (1)“non-vitamin K antagonist oral anticoagulants” OR “direct oral anticoagulants” OR “dabigatran” OR “rivaroxaban” OR “apixaban” OR “edoxaban”; (2) “vitamin K antagonists” OR “warfarin” OR “low-molecular-weight heparins”; and (3) “Budd-Chiari Syndrome”. To ensure no relevant studies were overlooked, a manual review of references from prior reviews and meta-analyses^14‐18 was also conducted.

Study Selection and Data Collection

Following the literature search, two independent reviewers screened the titles and abstracts of the identified studies. The full-text screening phase was then conducted to determine which studies met the inclusion criteria. Any disagreements between the reviewers were resolved through discussion, with a third reviewer consulted if necessary.

For each included study, the following data were extracted: authors’ names, publication year, study design, sample size, demographic details (age and sex), liver disease severity, common symptoms, site of venous blockage, interventions, underlying conditions, types of DOACs and traditional anticoagulants used, outcomes assessed, and follow-up duration.

Quality Assessment

The quality of the observational studies was evaluated using the Newcastle-Ottawa Scale (NOS),¹⁹ which assesses three key domains: the selection of study groups, the comparability of groups, and the ascertainment of exposure or outcomes. Studies achieving an NOS score of 6 or higher were deemed to be of moderate to high quality.^20‐22

Data Synthesis

Given the heterogeneity of the study populations and endpoints, coupled with the limited number of included studies, a meta-analysis was not performed to avoid potentially misleading conclusions. Instead, a narrative synthesis was employed to provide a more contextual and nuanced interpretation of the potential clinical benefits of DOACs in the treatment of BCS. The results of the included studies were synthesized narratively, with a focus on the comparative effectiveness and safety of DOACs versus traditional anticoagulation therapies in patients with BCS. Key effectiveness and safety outcomes were summarized to provide a comprehensive overview of the findings.

Results

Literature Search

As shown in Figure 1, the search was performed in two major databases, PubMed and Embase, yielding a total of 68 studies. After removing 18 duplicate publications, 50 studies remained for title and abstract screening. During this screening phase, 44 studies were excluded based on irrelevance to the research question. Subsequently, 6 studies were selected for full-text review. Of these, 4 studies^23‐26 were excluded because they focused on cirrhotic patients with portal vein thrombosis treated with DOACs rather than BCS. Ultimately, 2 studies^9,11 met the inclusion criteria and were included in the systematic review. Baseline characteristics of these two included studies are presented in Table 1.

Figure 1.

Flowchart of Study Selection Process for the Systematic Review.

Table 1.

Baseline Characteristics of Included Studies.

Study	Sharma et al, 2019	Semmler et al,2023
Study Design	Retrospective analysis, single-center in India	Retrospective multicenter study
Number of Patients	98 (36 on dabigatran, 62 on VKAs)	43 (22 on DOACs, 21 on LMWH/VKAs)
Mean Age (Years)	29.5 (dabigatran), 28 (VKAs)	37.9
Sex (Male:Female)	Dabigatran: 47.2% female; VKAs: 38.7% female	59.6% females
Liver Disease Severity	Comparable Child-Pugh and MELD scores	Median Child-Pugh score: 7; 63.8% decompensated liver disease
Common Symptoms	Ascites, hepatomegaly, splenomegaly	Ascites, portal hypertension, splenomegaly
Site of Venous Blockage	HV and IVC	Not explicitly stated
Interventions	Angioplasty, stenting, TIPS	TIPS, angioplasty, OLT
Underlying Conditions	Protein C deficiency, APS, JAK2, PNH, FVL, Behçet's	Myeloproliferative neoplasms, PNH
Types of DOACs Used	Dabigatran	Edoxaban, apixaban, rivaroxaban, dabigatran
Follow-Up Duration	Mean follow-up: 10.5 months (dabigatran), 14.1 months (VKAs)	Median follow-up: 82.5 months
NOS score	6 points	7 points

Abbreviations: DOACs, Direct Oral Anticoagulants; HV, Hepatic Veins; IVC, Inferior Vena Cava; LMWH, Low-Molecular-Weight Heparin; MELD, Model for End-Stage Liver Disease; NOS, Newcastle-Ottawa Scale; OLT, Orthotopic Liver Transplantation; TIPS, Transjugular Intrahepatic Portosystemic Shunt; VKAs, Vitamin K Antagonists; APS, antiphospholipid antibody syndrome; PNH, paroxysmal nocturnal hemoglobinuria; FVL, factor V Leiden.

Baseline Characteristics and Key Findings

Study by Sharma et al

Sharma et al¹¹ conducted a retrospective study (single-center investigation conducted in India) involving 98 patients with BCS who underwent percutaneous endovascular intervention. Patients were stratified into two groups: 36 treated with dabigatran and 62 treated with VKAs. Baseline characteristics were comparable between groups. The mean age was approximately 30 years, with a slight male predominance. Common presenting symptoms included ascites, hepatomegaly, and splenomegaly. Liver disease severity, assessed by Child-Pugh and Model for End-Stage Liver Disease (MELD) scores, was similar in both groups. The HV and IVC were the most frequent sites of venous obstruction. Interventions such as angioplasty, stenting, and TIPS were equally distributed between groups.

Stent patency rates at 6, 12, and 18 months were comparable between the dabigatran and VKA groups (91% vs 96.5%, 91% vs 93%, and 91% vs 93%, respectively). The rates of freedom from major bleeding at 6, 12, and 18 months were 97%, 97%, and 97% in the dabigatran group, and 98%, 94%, and 94% in the VKA group, respectively (log-rank test, P = .895). The composite endpoint of mortality and major bleeding also showed no significant differences between groups. The authors concluded that dabigatran was at least noninferior to VKAs in maintaining stent patency and demonstrated a comparable safety profile regarding bleeding complications and mortality in BCS patients post-endovascular intervention.

Study by Semmler et al

Semmler et al⁹ conducted a retrospective multicenter study involving 43 patients with primary BCS from six Austrian hospitals. The mean age was 37.9 years, with a slight female predominance (59.6%). Most patients (63.8%) had decompensated liver disease at enrollment, and 87.2% exhibited clinical signs of portal hypertension. The median Child-Pugh score was 7, indicating moderate liver dysfunction, and the mean MELD score was 13.1. Underlying etiologies included myeloproliferative neoplasms (MPN) in 42.6% of patients, with the JAK2-V617F mutation being the most common. Other comorbidities included paroxysmal nocturnal hemoglobinuria (8.5%) and antiphospholipid syndrome (4.3%). Splenomegaly was present in 61.7% of patients, and 74.1% had portosystemic collaterals or varices. The study compared outcomes between patients treated with DOACs and those on traditional anticoagulation (LMWH or VKAs).

Over a median follow-up of 82.5 months, the complete response rate was 63.6% in the DOAC group. Treatment failure occurred in 27.3% of DOAC patients and 30.7% of LMWH/VKA patients. Major spontaneous bleeding occurred in 18.2% of DOAC patients and 14.3% of LMWH/VKA patients. The authors concluded that DOACs might be effective and safe for long-term anticoagulation in BCS patients, with clinical outcomes comparable to those treated with LMWH or VKAs.

Discussion

The findings from this systematic review suggest that DOACs may represent potential alternatives to traditional anticoagulation therapies in the management of BCS. However, given that the available evidence is limited to two retrospective studies with relatively small patient populations, the strength of inference is inherently constrained. While the reviewed studies indicate that DOACs, including dabigatran, rivaroxaban, apixaban, and edoxaban, appear to demonstrate comparable effectiveness in maintaining stent patency and preventing thrombotic events in BCS patients, these observations should be regarded as hypothesis-generating rather than definitive. Importantly, the safety profile of DOACs appears broadly similar to that of traditional anticoagulants, but the evidence remains insufficient to draw firm conclusions.

Importantly, the issue of bleeding warrants further emphasis. The retrospective studies included in this review reported broadly comparable risks of major bleeding between DOACs and traditional anticoagulants, with Sharma et al observing no significant difference in bleeding-free survival between dabigatran and VKAs following endovascular intervention, and Semmler et al reporting similar rates of major spontaneous bleeding between DOACs and LMWH/VKA users . Nonetheless, the absolute incidence of bleeding remains clinically relevant, particularly in patients with advanced liver disease and portal hypertension, where variceal hemorrhage and mucosal bleeding are common complications. Moreover, isolated case reports have described severe bleeding events with DOACs in BCS, including gingival hemorrhage under rivaroxaban therapy,²⁷ highlighting that individual susceptibility may vary. The availability of specific reversal agents, such as idarucizumab for dabigatran and andexanet alfa for factor Xa inhibitors, offers additional safety measures; however, their role in the BCS population remains unstudied. In summary, while current evidence indicates that DOACs have a generally comparable bleeding profile to traditional anticoagulants, clinicians should exercise caution, especially in patients with high-risk features such as large varices, advanced cirrhosis, or concomitant myeloproliferative neoplasms. Larger prospective studies are needed to clarify the true bleeding risk associated with long-term DOAC use in BCS.

One of the key advantages of DOACs over traditional anticoagulants is their ease of administration. Unlike VKAs, which require regular monitoring of the INR and frequent dose adjustments, DOACs offer a fixed-dose regimen without the need for routine laboratory monitoring. This can significantly improve patient compliance and reduce the burden of treatment, especially in resource-limited settings. Additionally, the rapid onset of action and shorter half-life of DOACs may provide a more predictable anticoagulant effect, which is crucial in the acute management of BCS.

The reviewed studies also highlight the potential role of DOACs in specific subgroups of BCS patients, such as those with MPNs or other hypercoagulable states. While the data are limited, DOACs appear to be effective in maintaining stent patency and preventing thrombotic complications in these high-risk populations. However, further research is needed to confirm these findings and to explore the long-term outcomes of DOAC therapy in BCS patients with MPNs or other prothrombotic conditions.

Notably, the use of DOACs in BCS remains off-label, and current guidelines do not specifically recommend their use in this patient population. The decision to use DOACs should be made on a case-by-case basis, taking into account the patient's liver function, risk of bleeding, and ability to adhere to the treatment regimen. Moreover, the availability of reversal agents for DOACs, such as idarucizumab for dabigatran, may provide an additional safety net in the event of major bleeding, although this remains an area for further investigation.

Recent systematic and narrative syntheses of the literature on DOACs in splanchnic vein thrombosis (SVT), encompassing portal, mesenteric, and splenic vein thromboses, provide a broader context for our BCS-specific findings. Several comprehensive systematic reviews and pooled analyses report that DOACs achieve rates of recanalization and major bleeding that are broadly comparable to those observed with VKAs or LMWH, with some meta-analyses suggesting favorable bleeding profiles for DOACs in selected SVT cohorts.^7,14‐18,28 These reviews consistently emphasize, however, that the evidence is largely derived from retrospective and heterogeneous observational cohorts and that randomized data are sparse, limiting causal inference.^7,17 Importantly, extrapolating pooled SVT data to BCS requires caution: BCS frequently involves hepatic vein and/or IVC obstruction often managed with endovascular procedures, stenting, or TIPS, and the haemodynamic and anatomic milieu differs from that of isolated portal or mesenteric vein thrombosis.⁸ Thus, although the available SVT literature supports the biologic plausibility and preliminary safety signal for DOAC use, the marked heterogeneity of patient populations, variable degrees of hepatic dysfunction, and predominance of observational study designs mean that BCS-specific evidence, such as the two retrospective series synthesized here, remains essential and nonredundant. We therefore reiterate that while DOACs appear promising and may offer practical advantages (fixed dosing and avoidance of routine INR monitoring), definitive practice recommendations for BCS must await larger prospective studies and randomized trials specifically performed in BCS populations.^7,17

Limitations

This systematic review has several limitations that should be acknowledged. First, the included studies were retrospective in nature, which introduces the potential for selection bias and confounding factors. Retrospective studies rely on existing medical records, which may not capture all relevant clinical data, particularly in the case of minor bleeding events or treatment adherence. Additionally, the small sample sizes in the included studies limit the generalizability of the findings and may not adequately capture rare adverse events. Second, the heterogeneity in study designs, patient populations, and treatment protocols across the reviewed studies makes it difficult to draw definitive conclusions. Third, the follow-up durations in the reviewed studies were relatively short, ranging from a few months to a few years. Given that BCS is a chronic condition requiring lifelong anticoagulation, longer-term data are needed to fully assess the safety and effectiveness of DOACs in this patient population. Specifically, the risk of late-onset complications, such as hepatocellular carcinoma or recurrent thrombosis, remains poorly understood in the context of DOAC therapy.

Conclusion

Supplemental Material

sj-docx-1-cat-10.1177_10760296251384904 - Supplemental material for Effect of Direct Oral Anticoagulants Versus Traditional Anticoagulation in Budd-Chiari Syndrome

Supplemental material, sj-docx-1-cat-10.1177_10760296251384904 for Effect of Direct Oral Anticoagulants Versus Traditional Anticoagulation in Budd-Chiari Syndrome by Xiaojuan Wu, Lijuan Liang and Jinghong Liu in Clinical and Applied Thrombosis/Hemostasis

Footnotes

ORCID iD

Jinghong Liu

Author Contributions

Dr Wu conceptualized and designed the study, Dr Liang and Dr Liu performed the literature search, screening, and data extraction, all authors contributed to data analysis and interpretation, Dr Wu drafted the initial manuscript, and all authors critically revised the manuscript for important intellectual content and approved the final version.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Availability of Data and Materials

All relevant data and materials are presented in the paper.

Supplemental Material

Supplemental material for this article is available online.

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