What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation and liver disease (n=1238). Intervention: Oral anticoagulation vs. No oral anticoagulation. Primary outcome: 5-year composite thromboembolism (ischaemic stroke, TIA, or venous thromboembolism) in patients with CHA2DS2-VASc score >2 (men) or >3 (women) (average risk ratio 0.66, 95% CI 0.45-0.87, p=0.001).

May 21, 2022Open Access

Thromboembolism and bleeding in patients with atrial fibrillation and liver disease – A nationwide register-based cohort study

Key Result

Oral anticoagulation in patients with liver disease, incident atrial fibrillation, and a high CHA2DS2-VASc score reduced thromboembolism risk (RR 0.66) without increasing bleeding risk.

Study Design

Type

Cohort (n=1,238)

Multicenter

Yes

Structured PICO

Does oral anticoagulation reduce thromboembolism and affect bleeding risk in patients with liver disease and atrial fibrillation?

Population

1,238 anticoagulant-naive patients with liver disease and incident atrial fibrillation/flutter, with a CHA2DS2-VASc score ≥1 (men) or ≥2 (women), followed for up to 5 years.

Exposure

Oral anticoagulation (including vitamin K-antagonists and direct oral anticoagulants)

Comparator

No oral anticoagulation

Outcome

Thromboembolism (composite of ischaemic stroke, transient ischaemic attack, or venous thromboembolism) and Bleeding (composite of gastrointestinal, intracerebral, or urogenital bleeding requiring hospitalisation, or epistaxis requiring emergency department visit or hospital admission)composite

Oral anticoagulation in patients with liver disease and incident atrial fibrillation with high CHA2DS2-VASc scores is associated with reduced thromboembolism risk without significantly increasing bleeding risk.

Main Result

Relative Risk: 0.66 (95% CI 0.45–0.87)

Absolute Event Rate: 15.6% vs 23.6%

p-value: p=0.001

Limitations

Observational nature prevents finite inferences about causality
Potential confounding by indication
Unable to explore specific reasons for not prescribing OAC
Patient characteristics and risk scores were only assessed at baseline and may have changed over time
Modified version of the HAS-BLED score used due to lack of information on uncontrolled hypertension
Unable to incorporate data on labile INR
Not possible to differentiate between mild and end-stage liver disease
Absence of information hindered calculation of the Child-Pugh score

Abstract

BACKGROUND: Balancing the risk of thromboembolism and bleeding in patients with liver disease and atrial fibrillation/flutter is particularly challenging. PURPOSE: To examine the risks of thromboembolism and bleeding with use/non-use of oral anticoagulation (including vitamin K-antagonists and direct oral anticoagulants) in patients with liver disease and AF. METHODS: -VASc-score≥1 (men) or ≥2 (women), alive 30 days after atrial fibrillation/flutter diagnosis. Thromboembolism was a composite of ischaemic stroke, transient ischaemic attack, or venous thromboembolism. Bleeding was a composite of gastrointestinal, intracerebral, or urogenital bleeding requiring hospitalisation, or epistaxis requiring emergency department visit or hospital admission. Cause-specific Cox-regression was used to estimate absolute risks and average risk ratios standardised to covariate distributions. Because of significant interactions with anticoagulants, results for thromboembolism were stratified for CHA2DS2-VASc-score, and results for bleeding were stratified for cirrhotic/non-cirrhotic liver disease. RESULTS: Four hundred and nine of 1,238 patients with liver disease and new atrial fibrillation/flutter initiated anticoagulants. Amongst patients with a CHA2DS2-VASc-score of 1-2 (2-3 for women), five-year thromboembolism incidence rates were low and similar in the anticoagulant (6.5%) versus no anticoagulant (5.5%) groups (average risk ratio 1.19 95%CI, 0.22-2.16). In patients with a CHA2DS2-VASc-score>2 (>3 for women), incidence rates were 16% versus 24% (average risk ratio 0.66 95%CI, 0.45-0.87). Bleeding risks appeared higher amongst patients with cirrhotic versus non-cirrhotic disease but were not significantly affected by anticoagulant status. CONCLUSION: Oral anticoagulant initiation in patients with liver disease, incident new atrial fibrillation/flutter, and a high CHA2DS2-VASc-score was associated with a reduced thromboembolism risk. Bleeding risk was not increased with anticoagulation, irrespective of the type of liver disease.

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