Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve

Inki Moon, Tae Hwa Go, Jang Young Kim, Dae Ryong Kang, Suk Ho Sohn, Hyun Jung Lee, Jae Woong Choi, Jun Bean Park, Ho Young Hwang, Hyung Kwan Kim, Yong Jin Kim, Kyung Hwan Kim, Seung Pyo Lee

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Background Non-vitamin K direct oral anticoagulant (DOAC) is effective for prevention of embolic events in nonvalvular atrial fibrillation (AF) patients. However, the effectiveness and safety of DOAC in AF patients who have bioprosthetic heart valve (BPHV) is largely unknown. Methods We retrospectively identified patients with AF and BPHV, using the diagnostic code and medical device and surgery information from the Korean National Health Insurance Service database, between 2013 and 2018. A 1:2 propensity score-matched cohort (n = 724 taking warfarin; n = 362 taking DOAC) was constructed and analyzed for the primary clinical outcome, a composite of ischemic stroke and systemic embolism. Important secondary outcomes included major bleeding, all-cause death, and the net clinical outcome, defined as a composite of all embolic events, major bleeding, and death. Results The mean age was 78.9±6.8 years old, and 45% (n = 489) were male. The mean CHA2DS2-VASc score was 4.7±1.4. DOAC was non-inferior to warfarin for preventing ischemic stroke and systemic embolism (hazard ratio [HR] 1.14, 95% confidence interval [CI] 0.56–2.34), major bleeding (HR 0.80, 95% CI 0.32–2.03) and all-cause death (HR 1.09, 95% CI 0.73–1.63). As for the net clinical outcome, DOAC was also similar to warfarin (HR 1.06, 95% CI 0.76–1.47). These outcomes were not different in various subgroups analyzed. Conclusion In this nationwide Korean AF population with a BPHV, DOAC was at least as effective and safe as warfarin for the prevention of systemic embolic events. These results suggest that DOAC may be an excellent alternative to warfarin in AF patients with BPHV.

Original languageEnglish
Article numbere0268113
JournalPLoS ONE
Issue number6 June
StatePublished - Jun 2022
Externally publishedYes


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