What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation and prior gastrointestinal bleeding (n=42048). Intervention: NOACs vs. Warfarin. Primary outcome: Composite outcome (combined ischemic stroke and major bleeding) (HR 0.661, 95% CI 0.606-0.721).

January 8, 2021

Non–Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation and Prior Gastrointestinal Bleeding

Key Result

NOAC use was associated with lower risks of ischemic stroke (HR 0.608; 95% CI 0.543-0.680) and major bleeding (HR 0.731; 95% CI 0.642-0.832) compared with warfarin in AF patients with prior GIB.

Study Design

Type

Cohort (n=42,048)

Structured PICO

Do NOACs reduce ischemic stroke and major bleeding compared to warfarin in oral anticoagulant-naive patients with atrial fibrillation and prior gastrointestinal bleeding?

Population

42,048 oral anticoagulant-naive patients with atrial fibrillation and prior gastrointestinal bleeding.

Exposure

Non-vitamin K oral anticoagulants (NOACs)

Comparator

Warfarin

Outcome

Ischemic stroke, major bleeding, and the composite outcome (combined ischemic stroke and major bleeding)composite

NOACs are associated with lower risks of ischemic stroke and major bleeding compared to warfarin in patients with atrial fibrillation and a history of gastrointestinal bleeding.

Main Result

Hazard Ratio: 0.661 (95% CI 0.606–0.721)

Abstract

Background and Purpose: Limited data support the benefits of non–vitamin K oral anticoagulants (NOACs) among atrial fibrillation patients with prior gastrointestinal bleeding (GIB). We aimed to evaluate the effectiveness and safety of NOACs compared with those of warfarin among atrial fibrillation patients with prior GIB. Methods: Oral anticoagulant–naive individuals with atrial fibrillation and prior GIB between January 2010 and April 2018 were identified from the Korean claims database. NOAC users were compared with warfarin users by balancing covariates using the inverse probability of treatment weighting method. The primary outcomes were ischemic stroke, major bleeding, and the composite outcome (combined ischemic stroke and major bleeding). Fatal events from each outcome were evaluated as secondary outcomes. Results: A total of 42 048 patients were included (24 781 in the NOAC group and 17 267 in the warfarin group). The mean time from prior GIB to the initiation of oral anticoagulant was 3.1±2.6 years. After inverse probability of treatment weighting, baseline characteristics were balanced between the two groups (mean age, 72 years; men, 56.8%; and mean CHA 2 DS 2 -VASc score, 3.7). Lower risks of ischemic stroke, major bleeding, and the composite outcome were associated with NOAC use than with warfarin use (weighted hazard ratio, 0.608 95% CI, 0.543–0.680; hazard ratio, 0.731 95% CI, 0.642–0.832; and hazard ratio, 0.661 95% CI, 0.606–0.721, respectively). For all secondary outcomes, NOACs showed greater risk reductions compared with warfarin. Conclusions: NOACs were associated with lower risks of ischemic stroke and major bleeding than warfarin among atrial fibrillation patients with prior GIB.