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May 14, 2026Journal of the American College of Cardiology

NSAID use in AF is linked to ~68% higher risk of major bleeding and stroke.

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Why the study?

NSAIDs are commonly used medications that can potentially increase the risk of bleeding and thrombosis in anticoagulated patients.

Does NSAID use increase the risk of adverse clinical outcomes in patients with atrial fibrillation receiving oral anticoagulants?

Population

18,113 patients with AF in the RE-LY study

Comparison

NSAID use vs no NSAID use

Design

Post hoc analysis of a randomized controlled trial

Key result

Concomitant NSAID use in patients with atrial fibrillation was associated with an increased risk of major bleeding (HR 1.68; 95% CI 1.40-2.02; p<0.0001) and stroke or systemic embolism.

Authors

AKAnthony P. KentMBMartina BrueckmannMFMandy Fraessdorf

Discussion

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Member takes

Overview

May warrant caution with NSAID use in anticoagulated AF patients; leaves open whether avoidance improves outcomes.

Key Points

  • This study aimed to quantify the effects of NSAIDs on bleeding and thromboembolism outcomes in patients with atrial fibrillation within the RE-LY trial.
  • Post hoc analysis of NSAID use in the RE-LY study
  • Compared dabigatran etexilate with warfarin
  • Cox regression models assessed clinical outcomes based on NSAID use.
  • NSAID use significantly elevated major bleeding risk (HR: 1.68; 95% CI: 1.40 to 2.02; p < 0.0001).
  • Gastrointestinal major bleeding also increased with NSAID use (HR: 1.81; 95% CI: 1.35 to 2.43; p < 0.0001).
  • Stroke or systemic embolism risk was elevated with NSAID use (HR: 1.50; 95% CI: 1.12 to 2.01; p = 0.007).

Study Design

Type

RCT (n=18,113)

Structured PICO

Does NSAID use increase the risk of adverse clinical outcomes in patients with atrial fibrillation receiving oral anticoagulants?

P
Population
18,113 patients with atrial fibrillation from the RE-LY trial
I
Intervention
NSAID use (concomitant with oral anticoagulants: dabigatran etexilate 150 mg or 110 mg twice daily, or warfarin)
C
Comparator
No NSAID use
O
Outcome
Major bleedingsafety

Main Result

Effect estimate: HR 1.68 (95% CI 1.40 to 2.02)

p-value: p=< 0.0001

In patients with atrial fibrillation on oral anticoagulants, concomitant NSAID use is associated with significantly increased risks of major bleeding, stroke/systemic embolism, and hospitalization.

Limitations

  • Post hoc analysis

Cite This Study

Kent et al. (2018) conducted an RCT in Atrial fibrillation (n=18,113). NSAIDs vs. No NSAID use was evaluated on Major bleeding (HR 1.68, 95% CI 1.40 to 2.02, p=< 0.0001). Concomitant NSAID use in patients with atrial fibrillation was associated with an increased risk of major bleeding (HR 1.68; 95% CI 1.40-2.02; p<0.0001) and stroke or systemic embolism.

synapsesocial.com/papers/6a053f25874cea25422d70b2https://doi.org/10.1016/j.jacc.2018.04.063
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