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Abstract
Background Direct oral anticoagulant (DOAC) users are at risk of upper gastrointestinal bleeding (UGIB). There is limited evidence on test-and-treat strategy for Helicobacter pylori (HP) in high-risk subjects. We aimed to investigate whether HP eradication can reduce the subsequent risk of UGIB among new DOAC users in an Asian population.
Methods A population-based, territory-wide registry retrospective study was performed in Hong Kong. Subjects with new exposure to apixaban, dabigatran, edoxaban or rivaroxaban between 2011 and 2020 were included. HP test and treatment records were extracted based on rapid urease test, histology, diagnosis code and drug prescription (standard triple/quadruple therapies).
Subjects were classified into two groups, ‘HP tested-and-treated’ (as HP infection diagnosed and treated on or before DOAC exposure) and ‘Unknown HP status’. Inverse probability of treatment weighting (IPTW) was applied to balance the baseline demographics, comorbidities, laboratory results, concurrent drugs, and the type and dosage of DOACs between the two groups.
The primary outcome was severe UGIB, defined as UGIB-related deaths or endoscopically confirmed bleeders with one of the following criteria: hemoglobin drop >2g/dL, blood transfusion, rebleeding requiring endoscopic, radiological or surgical reinterventions within 30 days. Subjects were followed for 2 years from the DOAC exposure, and censored at DOAC discontinuation if any. Non-UGIB-related death was considered a competing risk.
Results 57,976 subjects were included in the study, where 3,348 (5.8%) of them were tested-and-treated for HP (IDDF2024-ABS-0395 Table 1). All baseline characteristics were balanced. The 2-year cumulative incidences of severe UGIB in ‘HP tested-and-treated’ and ‘unknown HP status’ groups were 0.94% (95% confidence interval (C.I.) = [0.53%,1.36%] and 1.00% (95% C.I. = [0.91%, 1.09%]) respectively. The ‘HP tested-and-treated’ group was not associated with a lower risk of severe UGIB during the first 2 years after new DOAC exposure (Sub-distribution hazard ratio by Fine-Gray model = 0.97, 95% C.I. = [0.62, 1.54]). (IDDF2024-ABS-0395 Figure 1. Cumulative incidence of severe upper gastrointestinal bleeding)
Baseline characteristics
Conclusions A test-and-treat strategy for HP was not associated with a reduced risk of UGIB among DOAC users in the first 2 years after drug initiation.
Cumulative incidence of severe upper gastrointestinal bleeding