Concomitant NSAIDs and Anticoagulants in Atrial Fibrillation

Study Questions:

What is the impact of nonsteroidal anti-inflammatory drug (NSAID) use on clinical outcomes in patients taking dabigatran for atrial fibrillation?


This was a post hoc analysis of NSAIDs in the RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) study, which compared dabigatran etexilate 150 and 110 mg twice daily with warfarin in patients with atrial fibrillation. Adjusted Cox regression analysis was used.


Among 18,113 patients in the RE-LY study, 2,279 patients used NSAIDs at least once during the trial. Major bleeding was significantly elevated with NSAID use (hazard ratio [HR], 1.68; p < 0.0001). Gastrointestinal major bleeding was significantly elevated with NSAID use (HR, 1.81; p < 0.0001). The rate of stroke or systemic embolism (stroke/SE) with NSAID use was significantly elevated (HR, 1.50; p = 0.007). The use of NSAIDs did not significantly alter the relative efficacy on stroke/SE for dabigatran 150 or 110 mg BID relative to warfarin. Myocardial infarction rates were similar with NSAID use compared with no NSAID use. Patients were more frequently hospitalized if they used an NSAID (HR, 1.64; p < 0.0001).


The use of NSAIDs was associated with increased risk of major bleeding, stroke/SE, and hospitalization. The safety and efficacy of dabigatran etexilate 150 and 110 mg twice daily relative to warfarin were not altered.


The rates of major bleeding, gastrointestinal major bleeding, stroke/SE, ischemic stroke, and hospitalization when NSAID was used in combination with oral anticoagulation therapy were significantly elevated compared with patients who did not use NSAIDs. This finding is consistent with prior literature, which demonstrated a higher thrombotic risk in patients who are taking NSAIDs. The bleeding profile of NSAIDs was not affected differentially by dabigatran vwesus warfarin. Given the high prevalence of atrial fibrillation, the requirement for anticoagulation, and widespread use of NSAIDs, a large number of patients are harmed each year. Physicians should routinely advise these patients on how to limit NSAID use.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Anti-Inflammatory Agents, Non-Steroidal, Arrhythmias, Cardiac, Atrial Fibrillation, Brain Ischemia, Embolism, Gastrointestinal Hemorrhage, Geriatrics, Hemorrhage, Myocardial Infarction, Secondary Prevention, Stroke, Warfarin

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