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The safety and efficacy of vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding

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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.

No MeSH data available.


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Annual incidence of major bleeding events between patients with and without VKA treatment stratified by a HAS-BLED score of 3.
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Figure 4: Annual incidence of major bleeding events between patients with and without VKA treatment stratified by a HAS-BLED score of 3.

Mentions: We calculated the bleeding risk of AF patients with previous ulcer bleeding on VKA treatment. Compared to the no-VKA group, VKA treatment significantly increased the risk of major bleeding by 2.7%/year (95% CI, 0.20–5.16, P = 0.04, Fig. 4) in patients with a HAS-BLED score of <3, and by 4.4%/year (95% CI, 1.87–6.89, P = 0.002) in those with a HAS-BLED score ≥3. Bleeding risk was not significantly increased by coprescription of antiplatelet agent with VKA (Supplementary Fig. 1a log rank P = 0.27). Increased bleeding risk by VKA treatment was also noted in patients with PPI prescription (Supplementary Fig. 1b, log rank P = 0.004). The overall bleeding risk of the HAS-BLED <3 group (mean HAS-BLED score 1.37 ± 0.65) was 3.5%/year (95% CI, 2.34–5.01), which was significantly higher than the risk in those with a HAS-BLED score of 2 included in the Euro Heart Survey[6] (1.9%/year, RR 1.85, 95% CI 0.98–3.51, P = 0.05) and Japanese AF patients with HAS-BLED score of 2[19] (1.0%/year, RR 2.46, 95% CI, 1.15–3.77, P < 0.001).


The safety and efficacy of vitamin K antagonist in atrial fibrillation patients with previous ulcer bleeding
Annual incidence of major bleeding events between patients with and without VKA treatment stratified by a HAS-BLED score of 3.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5134887&req=5

Figure 4: Annual incidence of major bleeding events between patients with and without VKA treatment stratified by a HAS-BLED score of 3.
Mentions: We calculated the bleeding risk of AF patients with previous ulcer bleeding on VKA treatment. Compared to the no-VKA group, VKA treatment significantly increased the risk of major bleeding by 2.7%/year (95% CI, 0.20–5.16, P = 0.04, Fig. 4) in patients with a HAS-BLED score of <3, and by 4.4%/year (95% CI, 1.87–6.89, P = 0.002) in those with a HAS-BLED score ≥3. Bleeding risk was not significantly increased by coprescription of antiplatelet agent with VKA (Supplementary Fig. 1a log rank P = 0.27). Increased bleeding risk by VKA treatment was also noted in patients with PPI prescription (Supplementary Fig. 1b, log rank P = 0.004). The overall bleeding risk of the HAS-BLED <3 group (mean HAS-BLED score 1.37 ± 0.65) was 3.5%/year (95% CI, 2.34–5.01), which was significantly higher than the risk in those with a HAS-BLED score of 2 included in the Euro Heart Survey[6] (1.9%/year, RR 1.85, 95% CI 0.98–3.51, P = 0.05) and Japanese AF patients with HAS-BLED score of 2[19] (1.0%/year, RR 2.46, 95% CI, 1.15–3.77, P < 0.001).

View Article: PubMed Central - PubMed

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&#8202;&lt;&#8202;0.001), and reduced major adverse cardiac events (MACE) (5.4%/year vs 10.0%/year, P&#8202;&lt;&#8202;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&#8202;&lt;&#8202;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) &ge;65%, VKA significantly decreased MACE (2.8%/year vs 10.0%/year, P&#8202;&lt;&#8202;0.001) without increasing major bleeding. Net clinical benefit model showed beneficial effects of VKA in patients with TTR &ge;65%, and harmful effects in those with TTR&#8202;&lt;&#8202;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 &ge;65%), as the gastrointestinal bleeding (GIB) risk significantly increased.

No MeSH data available.


Related in: MedlinePlus