Dataset Information

Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study.

ABSTRACT:

Background

The association between peripheral leukocyte count and bleeding events in nonvalvular atrial fibrillation (NVAF) patients treated with dabigatran remains unclear. This study aimed to explore the association between leukocyte count and bleeding events after excluding other confounders in NVAF patients taking dabigatran.

Methods

A total of 851 NVAF patients treated with dabigatran (110 mg bid) were recruited from 12 centers in China from February 2015 to December 2017. Follow-up was completed by May 2018. The exposure and outcome variables were leukocyte count measured at baseline and the number of bleeding events within the subsequent 6 months. Multivariate Cox proportional hazards models were constructed to analyze independent associations, and a Cox proportional hazards regression with cubic spline functions and smooth curve fitting (penalized spline method) was used to address nonlinearity between leukocyte count and bleeding. The inflection point was calculated using a recursive algorithm, and then a two-piecewise Cox proportional hazards model for both sides of the inflection point was constructed.

Results

During 6-month follow-up, 87 participants occurred bleeding events. For every 1 × 10/L increase in leukocyte count, the risk of bleeding increased by 11% (hazard ratio [HR]: 1.11, 95% confidence interval [CI]: 0.99-1.25). The smooth curve showed nonlinear relationship between leukocyte count and bleeding events. The inflection point of the leukocyte count was 6.75 × 10/L. For leukocyte counts < 6.75 × 10/L, the HR (95% CI) was 0.88 (0.69-1.13), and for leukocyte counts ≥ 6.75 × 10/L, the HR (95% CI) was 1.28 (1.09-1.51).

Conclusion

This study found a J-shaped association between baseline leukocyte count and risk of bleeding in NVAF patients treated with dabigatran.

Clinical trial registration

NCT02414035, https://clinicaltrials.gov.

SUBMITTER: Zhou W

PROVIDER: S-EPMC6797159 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study.

Zhou Wei W Wang Tao T Zhu Ling-Juan LJ Wen Ming-Hua MH Hu Li-Hua LH Huang Xiao X You Chun-Jiao CJ Li Ju-Xiang JX Wu Yan-Qing YQ Wu Qing-Hua QH Bao Hui-Hui HH Cheng Xiao-Shu XS

Chinese medical journal 20190901 18

<h4>Background</h4>The association between peripheral leukocyte count and bleeding events in nonvalvular atrial fibrillation (NVAF) patients treated with dabigatran remains unclear. This study aimed to explore the association between leukocyte count and bleeding events after excluding other confounders in NVAF patients taking dabigatran.<h4>Methods</h4>A total of 851 NVAF patients treated with dabigatran (110 mg bid) were recruited from 12 centers in China from February 2015 to December 2017. Fo ...[more]

PMID: 31490268

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Project description:BackgroundLimited data are available about the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs).ObjectivesTo compare the major bleeding risk among newly anticoagulated non-valvular atrial fibrillation (NVAF) patients initiating apixaban, warfarin, dabigatran or rivaroxaban in the United States.Methods and resultsA retrospective cohort study was conducted to compare the major bleeding risk among newly anticoagulated NVAF patients initiating warfarin, apixaban, dabigatran or rivaroxaban. The study used the Truven MarketScan(®) Commercial & Medicare supplemental US database from 1 January 2013 through 31 December 2013. Major bleeding was defined as bleeding requiring hospitalisation. Cox model estimated hazard ratios (HRs) of major bleeding were adjusted for age, gender, baseline comorbidities and co-medications. Among 29 338 newly anticoagulated NVAF patients, 2402 (8.19%) were on apixaban; 4173 (14.22%) on dabigatran; 10 050 (34.26%) on rivaroxaban; and 12 713 (43.33%) on warfarin. After adjusting for baseline characteristics, initiation on warfarin [adjusted HR (aHR): 1.93, 95% confidence interval (CI): 1.12-3.33, P=.018] or rivaroxaban (aHR: 2.19, 95% CI: 1.26-3.79, P=.005) had significantly greater risk of major bleeding vs apixaban. Dabigatran initiation (aHR: 1.71, 95% CI: 0.94-3.10, P=.079) had a non-significant major bleeding risk vs apixaban. When compared with warfarin, apixaban (aHR: 0.52, 95% CI: 0.30-0.89, P=.018) had significantly lower major bleeding risk. Patients initiating rivaroxaban (aHR: 1.13, 95% CI: 0.91-1.41, P=.262) or dabigatran (aHR: 0.88, 95% CI: 0.64-1.21, P=.446) had a non-significant major bleeding risk vs warfarin.ConclusionAmong newly anticoagulated NVAF patients in the real-world setting, initiation with rivaroxaban or warfarin was associated with a significantly greater risk of major bleeding compared with initiation on apixaban. When compared with warfarin, initiation with apixaban was associated with significantly lower risk of major bleeding. Additional observational studies are required to confirm these findings.

Project description:BackgroundThe correlation between the gamma-glutamyl transferase-to-albumin ratio (GAR) and the risk of bleeding in patients with non-valvular atrial fibrillation (NVAF) undergoing treatment with the dabigatran anticoagulant is poorly understood. This study aims to explore whether GAR is associated with bleeding events among patients with NVAF receiving dabigatran anticoagulant therapy.MethodsWe conducted a multicenter, observational cohort study in 12 Chinese hospitals from six provinces, including Beijing, Shanghai and Guangzhou, to evaluate the effectiveness and safety of dabigatran (110 mg) treatment in NVAF patients who were consecutively enrolled during February 2015 and December 2017. All patients had completed a 3-month follow-up period. The baseline variable of interest was the GAR, and the outcome variable was the occurrence of bleeding events. Both univariate and multivariate Cox proportional hazard models were used to evaluate the relationship between GAR and bleeding outcome.ResultsThis prospective cohort study included a total of 834 patients (mean age 65.6±11.1 years; 56.8% male). Overall, 82 subjects experienced bleeding. The patients were categorized based on the tertiles of the GAR. Participants in tertile 2 (0.59-1.03) [hazard ratio (HR): 0.28; 95% confidence interval (CI): 0.14-0.55; P<0.001] and tertile 3 (≥1.04) (HR: 0.47; 95% CI: 0.25-0.89; P=0.02) exhibited a lower rate of bleeding compared to the reference group (T1: ≤0.58). Multivariable models with restricted cubic splines demonstrated a nonlinear relationship between GAR and bleeding outcome, with a GAR inflection point of 0.68. The HR (95% CI) was 0.05 (0.01-0.31) (P=0.002) for GAR values <0.68 and 0.96 (0.70-1.31) (P=0.78) for GAR values ≥0.68. Moreover, the correlation between decreased GAR and an increase in bleeding events remained consistent across various subgroups.ConclusionsGAR is a prevalent, independent predictor of dabigatran-related bleeding in NVAF patients. Moreover, a significant L-shaped association between GAR and bleeding events has been observed.

Dataset Information

Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study.

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