Key result
OAC plus antiplatelets linked to ~42% higher major bleeding risk vs OAC alone in AF.
Why the study?
The combination of oral anticoagulant and antiplatelet drug increases bleeding risk in atrial fibrillation, and the current status, time trends, and outcomes of combination therapy with NOAC use were unclear.
Does combination therapy with an oral anticoagulant and antiplatelet drug increase the risk of major bleeding and stroke/systemic embolism compared to oral anticoagulant alone in patients with atrial fibrillation?
Observational (n=2,378)
Yes
Does combination therapy with an oral anticoagulant and antiplatelet drug increase the risk of major bleeding and stroke/systemic embolism compared to oral anticoagulant alone in patients with atrial fibrillation?
Hazard Ratio: 1.42 (95% CI 1.03–1.95)
In Japanese patients with atrial fibrillation, combination therapy with an oral anticoagulant and antiplatelet drug is associated with higher risks of both major bleeding and stroke/systemic embolism compared to oral anticoagulation alone.
Combination OAC+APD was associated with higher bleeding and stroke risk in AF; leaves open whether APD deprescribing improves net outcomes.
BACKGROUND: The combination of oral anticoagulant (OAC) and antiplatelet drug (APD) increases the bleeding risk in atrial fibrillation (AF). Non-vitamin K antagonist OAC (NOAC) have been increasingly used since 2011. We investigated current status, time trends and outcomes of AF patients using combination therapy in 2011-2017. METHODS AND RESULTS: The Fushimi AF Registry is a community-based prospective survey of AF patients in Fushimi-ku, Kyoto, Japan. Of 2,378 patients with OAC at enrollment, 521 (22%) received combination therapy, while 1,857 (78%) received OAC alone. When compared with OAC alone, combination therapy patients had more comorbidities, but approximately 30% had no atherosclerotic disease. From 2011 to 2017, the prevalence of combination therapy decreased from 26% to 14%. The prevalence of NOAC increased in those on combination therapy. Off-label under-dosing of NOAC increased year by year, especially in combination therapy. During follow-up, the incidence of major bleeding (hazard ratio [HR], 1.42; 95% CI: 1.03-1.95) and stroke/systemic embolism (HR, 1.48; 95% CI: 1.09-2.00) was higher in the combination therapy than in the OAC alone group. CONCLUSIONS: In Japanese AF patients receiving OAC, the prevalence of combination therapy decreased, with the proportion of NOAC use increasing in 2011-2017. Many patients, however, received off-label NOAC under-dosing, especially in the combination therapy group. Patients with combination therapy had higher incidences of major bleeding as well as stroke/systemic embolism, compared with OAC monotherapy.
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Masunaga et al. (2018) conducted an observational in Atrial Fibrillation (n=2,378). Combination therapy (oral anticoagulant plus antiplatelet drug) vs. Oral anticoagulant alone was evaluated on Incidence of major bleeding during the follow-up period (HR 1.42, 95% CI 1.03-1.95). Combination therapy with oral anticoagulants and antiplatelet drugs was associated with a higher incidence of major bleeding (HR 1.42) compared to oral anticoagulants alone in Japanese patients with atrial fibrillation.
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