The safety and efficacy of Vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding Long-term results from a multicenter study

Seung Jun Lee, Jung Hoon Sung, Jin Bae Kim, Min Soo Ahn, Hye Young Lee, Jae Sun Uhm, Hui Nam Pak, Moon Hyoung Lee, Jong Yun Kim, Boyoung Joung

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Abstract

This study aimed to evaluate the safety and efficacy of Vitamin K antagonist (VKA) in atrial fibrillation (AF) patients with previous ulcer bleeding. In this multicenter, retrospective analysis, clinical outcomes of 754 AF patients with a history of ulcer bleeding were evaluated. After ulcer treatment, 458 patients (61%) were treated with VKA, and the outcomes were compared to 296 patients (39%) without VKA. VKA treatment significantly increased major bleeding (7.3%/year vs 3.2%/year, P<0.001), and reduced major adverse cardiac events (MACE) (5.4%/year vs 10.0%/year, P<0.001). Specifically, risk of gastrointestinal bleeding was significantly higher in the VKA group than no-VKA group (5.7%/year vs 2.6%/year, P<0.001). Consequently, there was no difference in the incidence of composite of a MACE and major bleeding, between the 2 groups. In patients with time in the therapeutic range (TTR) ?65%, VKA significantly decreased MACE (2.8%/year vs 10.0%/year, P<0.001) without increasing major bleeding. Net clinical benefit model showed beneficial effects of VKA in patients with TTR ?65%, and harmful effects in those with TTR<55%. In AF patients with previous ulcer bleeding, VKA treatment did not improve clinical outcomes unless the international normalized ratio level was constantly maintained (TTR ?65%), as the gastrointestinal bleeding (GIB) risk significantly increased.

Original languageEnglish
Article numbere5467
JournalMedicine (United States)
Volume95
Issue number47
DOIs
Publication statusPublished - 2016 Jan 1

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Vitamin K
Atrial Fibrillation
Multicenter Studies
Ulcer
Hemorrhage
Safety
Therapeutics
International Normalized Ratio
Incidence

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Lee, Seung Jun ; Sung, Jung Hoon ; Kim, Jin Bae ; Ahn, Min Soo ; Lee, Hye Young ; Uhm, Jae Sun ; Pak, Hui Nam ; Lee, Moon Hyoung ; Kim, Jong Yun ; Joung, Boyoung. / The safety and efficacy of Vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding Long-term results from a multicenter study. In: Medicine (United States). 2016 ; Vol. 95, No. 47.
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title = "The safety and efficacy of Vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding Long-term results from a multicenter study",
abstract = "This study aimed to evaluate the safety and efficacy of Vitamin K antagonist (VKA) in atrial fibrillation (AF) patients with previous ulcer bleeding. In this multicenter, retrospective analysis, clinical outcomes of 754 AF patients with a history of ulcer bleeding were evaluated. After ulcer treatment, 458 patients (61{\%}) were treated with VKA, and the outcomes were compared to 296 patients (39{\%}) without VKA. VKA treatment significantly increased major bleeding (7.3{\%}/year vs 3.2{\%}/year, P<0.001), and reduced major adverse cardiac events (MACE) (5.4{\%}/year vs 10.0{\%}/year, P<0.001). Specifically, risk of gastrointestinal bleeding was significantly higher in the VKA group than no-VKA group (5.7{\%}/year vs 2.6{\%}/year, P<0.001). Consequently, there was no difference in the incidence of composite of a MACE and major bleeding, between the 2 groups. In patients with time in the therapeutic range (TTR) ?65{\%}, VKA significantly decreased MACE (2.8{\%}/year vs 10.0{\%}/year, P<0.001) without increasing major bleeding. Net clinical benefit model showed beneficial effects of VKA in patients with TTR ?65{\%}, and harmful effects in those with TTR<55{\%}. In AF patients with previous ulcer bleeding, VKA treatment did not improve clinical outcomes unless the international normalized ratio level was constantly maintained (TTR ?65{\%}), as the gastrointestinal bleeding (GIB) risk significantly increased.",
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The safety and efficacy of Vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding Long-term results from a multicenter study. / Lee, Seung Jun; Sung, Jung Hoon; Kim, Jin Bae; Ahn, Min Soo; Lee, Hye Young; Uhm, Jae Sun; Pak, Hui Nam; Lee, Moon Hyoung; Kim, Jong Yun; Joung, Boyoung.

In: Medicine (United States), Vol. 95, No. 47, e5467, 01.01.2016.

Research output: Contribution to journalArticle

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T1 - The safety and efficacy of Vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding Long-term results from a multicenter study

AU - Lee, Seung Jun

AU - Sung, Jung Hoon

AU - Kim, Jin Bae

AU - Ahn, Min Soo

AU - Lee, Hye Young

AU - Uhm, Jae Sun

AU - Pak, Hui Nam

AU - Lee, Moon Hyoung

AU - Kim, Jong Yun

AU - Joung, Boyoung

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N2 - This study aimed to evaluate the safety and efficacy of Vitamin K antagonist (VKA) in atrial fibrillation (AF) patients with previous ulcer bleeding. In this multicenter, retrospective analysis, clinical outcomes of 754 AF patients with a history of ulcer bleeding were evaluated. After ulcer treatment, 458 patients (61%) were treated with VKA, and the outcomes were compared to 296 patients (39%) without VKA. VKA treatment significantly increased major bleeding (7.3%/year vs 3.2%/year, P<0.001), and reduced major adverse cardiac events (MACE) (5.4%/year vs 10.0%/year, P<0.001). Specifically, risk of gastrointestinal bleeding was significantly higher in the VKA group than no-VKA group (5.7%/year vs 2.6%/year, P<0.001). Consequently, there was no difference in the incidence of composite of a MACE and major bleeding, between the 2 groups. In patients with time in the therapeutic range (TTR) ?65%, VKA significantly decreased MACE (2.8%/year vs 10.0%/year, P<0.001) without increasing major bleeding. Net clinical benefit model showed beneficial effects of VKA in patients with TTR ?65%, and harmful effects in those with TTR<55%. In AF patients with previous ulcer bleeding, VKA treatment did not improve clinical outcomes unless the international normalized ratio level was constantly maintained (TTR ?65%), as the gastrointestinal bleeding (GIB) risk significantly increased.

AB - This study aimed to evaluate the safety and efficacy of Vitamin K antagonist (VKA) in atrial fibrillation (AF) patients with previous ulcer bleeding. In this multicenter, retrospective analysis, clinical outcomes of 754 AF patients with a history of ulcer bleeding were evaluated. After ulcer treatment, 458 patients (61%) were treated with VKA, and the outcomes were compared to 296 patients (39%) without VKA. VKA treatment significantly increased major bleeding (7.3%/year vs 3.2%/year, P<0.001), and reduced major adverse cardiac events (MACE) (5.4%/year vs 10.0%/year, P<0.001). Specifically, risk of gastrointestinal bleeding was significantly higher in the VKA group than no-VKA group (5.7%/year vs 2.6%/year, P<0.001). Consequently, there was no difference in the incidence of composite of a MACE and major bleeding, between the 2 groups. In patients with time in the therapeutic range (TTR) ?65%, VKA significantly decreased MACE (2.8%/year vs 10.0%/year, P<0.001) without increasing major bleeding. Net clinical benefit model showed beneficial effects of VKA in patients with TTR ?65%, and harmful effects in those with TTR<55%. In AF patients with previous ulcer bleeding, VKA treatment did not improve clinical outcomes unless the international normalized ratio level was constantly maintained (TTR ?65%), as the gastrointestinal bleeding (GIB) risk significantly increased.

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