What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation and liver disease (n=393507). Intervention: Oral anticoagulant (OAC) vs. No OAC. Primary outcome: Stroke (HR 0.80, 95% CI 0.70-0.92).

February 28, 2020Open Access

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study

Key Result

In patients with atrial fibrillation and liver disease, oral anticoagulant use was associated with a reduced risk of stroke (HR 0.80; 95% CI 0.70-0.92), major bleeding, and all-cause death.

Study Design

Type

Cohort (n=393,507)

Multicenter

Yes

Structured PICO

Does oral anticoagulant therapy reduce stroke, major bleeding, and all-cause death in patients with atrial fibrillation and concomitant liver disease?

Population

393,507 patients aged ≥40 years with atrial fibrillation admitted to hospital from 2000 to 2018, of whom 16,168 had concomitant liver disease.

Exposure

Oral anticoagulant (OAC) therapy

Comparator

No oral anticoagulant therapy

Outcome

Stroke, major bleeding, and all-cause deathhard clinical

In patients with atrial fibrillation and concomitant liver disease, oral anticoagulant use is associated with a net clinical benefit, reducing the risks of stroke, major bleeding, and all-cause death.

Main Result

Hazard Ratio: 0.8 (95% CI 0.7–0.92)

Abstract

AIMS: Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention are limited. METHODS AND RESULTS: A retrospective observational population-based cohort study on the administrative health databases of Lombardy region Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. Atrial fibrillation and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical codes. Primary study outcomes were stroke, major bleeding, and all-cause death. Among 393 507 AF patients, 16 168 (4.1%) had concomitant LD. Liver disease AF patients were significantly less treated with OAC. Concomitant LD was associated with an increased risk in all the study outcomes hazard ratio (HR): 1.18, 95% confidence interval (CI): 1.11-1.25 for stroke; HR: 1.57, 95% CI: 1.47-1.66 for major bleeding; HR: 1.41, 95% CI: 1.39-1.44 for all-cause death. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70-0.92), major bleeding (HR: 0.86, 95% CI: 0.74-0.99), and all-cause death (HR: 0.77, 95% CI: 0.73-0.80), with similar results according to subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375-0.472). CONCLUSION: In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant favourable benefit/risk ratio, even in high-risk patient subgroups.