ARISTOTLE: Combining NSAIDs With Oral Anticoagulants Increases Bleeding Risk in AF

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While the use of NSAIDs was low in the ARISTOTLE trial, NSAID users had a higher risk for bleeding than non-users.

The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.

CHICAGO — Taking nonsteroidal anti-inflammatory drugs (NSAIDs) during anticoagulant therapies may cause an increased risk for bleeding, according to research presented at the Scientific Sessions of the American Heart Association, held November 10-12, 2018.

Study investigators analyzed data from the ARISTOTLE trial of 17,430 individuals with atrial fibrillation, who did not have severe renal or liver disease. The goal was to determine the effect of NSAIDs at onset, to compare the uniqueness of NSAID users with nonusers, and to study NSAID interactions with apixaban and warfarin.

Results showed that patients taking NSAIDs at onset (n=715) were older, heavier, and more likely to be from North America than non-NSAID users. Compared with non-NSAID users, NSAID users were more likely to have a history of bleeding (25.6% vs 16.3%) and less likely to have a history of heart failure (22% vs 35.2%). Additionally, participants who used NSAIDs had a higher HAS-BLED score: 2.4 vs 1.7.

In NSAID users, the rate of major bleed was 3.1 in apixaban users compared with 4.1 in warfarin users. The rates of gastrointestinal (GI) bleeds were 0.9 with apixaban and 1.3 with warfarin. The rates of major or clinically relevant non-major (CRNM) bleeds were 5.6 with apixaban and 8.3 with warfarin. The rate of (heart failure) HF hospitalization was 1.8 for users of both apixaban and warfarin. The rate of all-cause morbidity was also similar for apixaban and warfarin: 2.4 vs 2.5. Stroke or embolism rates for apixaban and warfarin were 0.6 and 1.3, respectively. Intracranial bleed rates were 0.2 with apixaban and 0.8 with warfarin.

For non-NSAID users, the major bleed rate was 2.1 with apixaban use and 3.0 with warfarin. The results were similar for the GI bleed rate, at 0.7 with both drugs. The rate of major or CRNM bleed was 4.0 with apixaban and 5.8 with warfarin, and HF hospitalization rates were similar, at 2.3 for both drugs. The rates of all-cause death were 3.4 for apixaban and 3.9 for warfarin. Stroke and embolism rates were 1.3 for apixaban and 1.6 for warfarin. For intracranial bleed, the rates were 0.4 for apixaban and 0.8 for warfarin.  

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Researchers concluded “NSAID users were significantly different and had a higher risk of bleeding than nonusers.”

Disclosures: Please refer to abstract link for full list of author disclosures.

For more coverage of AHA 2018, click here.


Al-Khatib SM, Mulder H, Wojdyla DM, et al. NSAID use is associated with worse outcomes but similar benefits of apixaban over warfarin in patients with atrial fibrillation: results from the ARISTOTLE trial. Presented at: AHA 2018; November 10-12, 2018; Chicago, Illinois. Abstract Su3024/3024.