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

<h4>Background</h4>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.<...

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Main Authors: 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
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0268113
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author 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
author_facet 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
author_sort Inki Moon
collection DOAJ
description <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.
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spelling doaj.art-3f237c54bf1449cc817a362c87fe8a312022-12-22T00:44:08ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01176e026811310.1371/journal.pone.0268113Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.Inki MoonTae-Hwa GoJang Young KimDae Ryong KangSuk Ho SohnHyun-Jung LeeJae-Woong ChoiJun-Bean ParkHo-Young HwangHyung-Kwan KimYong-Jin KimKyung-Hwan KimSeung-Pyo Lee<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0268113
spellingShingle 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
Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
PLoS ONE
title Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
title_full Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
title_fullStr Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
title_full_unstemmed Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
title_short Effectiveness and safety of non-vitamin K direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve.
title_sort effectiveness and safety of non vitamin k direct oral anticoagulants in atrial fibrillation patients with bioprosthetic valve
url https://doi.org/10.1371/journal.pone.0268113
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