Abstract
(1) Background: The approach of bleeding complications in patients treated with non-vitamin K oral anticoagulants (NOACs) represents an important issue in clinical practice. Both dabigatran and apixaban are substrates for P-glycoprotein and, therefore, ABCB1 gene variations may be useful in individualizing NOACs treatment, especially in high-risk patients. (2) Methods: ABCB1 rs1045642 and rs4148738 were determined in 218 atrial fibrillation patients treated with dabigatran or apixaban (70.94 ± 9.04 years; 51.83% men). (3) Results: Non-major bleeding appeared in 7.34% NOACs–treated patients. The logistic tested models based on the four genetic models revealed no significant association between the variant genotype of two ABCB1 SNPs and the risk of bleeding (p > 0.05). Among the four two-locus haplotypes, TA and CA haplotypes had the highest frequency in NOACs-treated patients with bleeding, involving a possible positive association with the susceptibility of bleeding complications (OR = 1.04 and OR = 1.91, respectively). The logistic model found no significant association of estimated haplotypes with bleeding (p > 0.05) except for the TG haplotype which had a trend toward statistical significance (p = 0.092). Among the risk factors for bleeding, only age > 70 years and stroke/TIA showed a tendency toward statistical significance. (4) Conclusions: We found no significant associations between the studied ABCB1 variant genotypes with non-major bleeding risk in NOACs-treated patients. A trend of association between TG haplotype with bleeding risk was observed, implying a protective role of this haplotype against bleeding in patients treated with dabigatran or apixaban.
Highlights
Assuming that the presence of genetic polymorphisms may influence the effects of non-vitamin K oral anticoagulants (NOACs) treatment on the clinical outcome of non-valvular atrial fibrillation (NVAF) patients, this study aimed to evaluate the association of the ABCB1 gene SNPs with bleeding in patients from the real-world clinical practice treated with dabigatran and apixaban
We did not find statistically significant differences in the distribution of demographic characteristics in patients treated with dabigatran and those treated with apixaban (p > 0.05)
We did not find a statistically significant difference in CHA2DS2-VASc (p = 0.975) and HAS-BLED scores (p = 0.206), as well as in echocardiographic parameters values in patients treated with dabigatran vs. those receiving apixaban
Summary
Current guidelines recommend NOACs as first-line treatment in NVAF patients due to the certain clinical benefits they have shown for vitamin-K antagonists (VKA) in the prophylaxis of thromboembolic events, especially strokes [4,5]. NOACs have a wide therapeutic window and predictable pharmacokinetics [6], they present several disadvantages that make the clinical decision difficult: inability of routine coagulation monitoring, and compliance monitoring, marked inter-individual variability in plasma levels, and interactions with certain drugs, some frequently used in the treatment of AF that may increase the risk of bleeding complications, especially in vulnerable patients [7]. Dabigatran etexilate, a direct selective thrombin inhibitor, has a reversible linear anticoagulant effect. It is administered at a dose of 150 mg b.i.d or 110 mg b.i.d in patients at a high risk of bleeding [10]
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