SAN FRANCISCO, CA—Non-steroidal anti-inflammatory drug (NSAID) use “is associated with a substantial independent risk of serious bleeding” in patients with atrial fibrillation (AFib), “especially in combination with antithrombotic therapy,” a study reported at ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session.
Noting bleeding risk is assumed to be increased with NSAID use, “the actual impact on serious bleeding complications in patients with AFib is undefined,” Gunnar H. Gislason, MD, PhD, of the Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark, and colleagues noted. They investigated the risk of serious bleeding and thromboembolism with ongoing NSAID and antithrombotic therapy in “real-life” patients with Afib.
In Denmark, over-the-counter availability of NSAIDs is limited to 200mg, Dr. Gislason told eMPR.com.
Using nationwide registries, the study authors identified 131,106 Danish patients hospitalized with non-valvular AFib between 1997–2009. Risk of bleeding and thromboembolism was assessed in adjusted Cox regression models.
Dr. Gislason and colleagues found that of the patients included in the study, 17,476 (13.3%) used an NSAID during a mean follow-up of 3.9 years; 14,193 (10.8%) serious bleeding events and 18,274 (13.9%) thromboembolic events occurred.
The treatment regimens were divided into no antithrombotic therapy; no antithrombotic therapy + NSAID (aspirin); single antiplatelet (clopidogrel); single antiplatelet + NSAID; oral anticoagulant (OAC) as reference; OAC + NSAID; OAC + single antiplatelet; and OAC + single antiplatelet + NSAID. These applied to the analyses in measuring risk of thromboembolism.
Further analyses showed that risk of serious bleeding with NSAIDs was doubled (HR 2.11, 95% CI 2.00–2.23), compared with no NSAID treatment, and also with concomitant antithrombotic therapy.
Risk of thromboembolism was increased with NSAID use (HR 1.33, 95% CI 1.25–1.41). Also, a poorer prognosis with NSAID exposure at a time of nonfatal bleeding (HR 1.09, 95% CI 1.04–1.16) or thromboembolic episode (HR 1.09, 95% CI 1.00–1.18) was observed.
“Caution in any use of NSAIDs in AFib patients is warranted and NSAIDs should only be considered after careful assessment of the balance between risk and benefit,” the investigators concluded.