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 language | English |
|---|---|
| Article number | e5467 |
| Journal | Medicine (United States) |
| Volume | 95 |
| Issue number | 47 |
| DOIs | |
| Publication status | Published - 2016 Jan 1 |
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All Science Journal Classification (ASJC) codes
- Medicine(all)
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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 journal › Article
TY - JOUR
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
PY - 2016/1/1
Y1 - 2016/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85006004191&partnerID=8YFLogxK
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U2 - 10.1097/MD.0000000000005467
DO - 10.1097/MD.0000000000005467
M3 - Article
C2 - 27893694
AN - SCOPUS:85006004191
VL - 95
JO - Medicine (United States)
JF - Medicine (United States)
SN - 0025-7974
IS - 47
M1 - e5467
ER -