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Association between body mass index and the risk of bleeding in elderly patients with non-valvular atrial fibrillation taking dabigatran: a cohort study.

ABSTRACT: Background:Uncertainty remains regarding the association between body mass index (BMI) and the risk of bleeding in patients with non-valvular atrial fibrillation (NVAF). We aimed to investigate the association between BMI and the risk of bleeding in elderly NVAF patients taking dabigatran. Methods:A total of 509 elderly NVAF patients, who were being treated at twelve centers in China from February 2015 to December 2017 and taking dabigatran, were analyzed. The exposure and outcome variables were BMI at baseline and bleeding events within the subsequent six months, respectively. Cox proportional hazards regression analysis was used to evaluate the association between BMI and the risk of bleeding. Moreover, the Cox proportional hazards regression with cubic spline functions and smooth curve fitting was conducted. Results:During the six-month follow-up, 50 participants experienced bleeding. Every 1 kg/m2 increase in BMI was associated with a 12% increased risk of bleeding (P = 0.021). Compared to those with BMI values in Tertile 1 (< 22.5 kg/m2), the adjusted hazard ratio (HR) of bleeding for participants in Tertile 2 (22.5-25.3 kg/m2) and Tertile 3 (> 25.3 kg/m2) were 2.71 (95% CI: 1.02-7.17) and 3.5 (95% CI: 1.21-8.70), respectively. The P trend-value was significant in all models. The adjusted smooth curve showed a linear association between BMI and bleeding. None of the stratified variables showed significant effect modification on the association between BMI and bleeding (P interaction > 0.05). Conclusions:BMI was significantly and positively associated with the risk of bleeding in elderly NVAF patients treated with dabigatran.

SUBMITTER: Li MH

PROVIDER: S-EPMC7189264 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Association between body mass index and the risk of bleeding in elderly patients with non-valvular atrial fibrillation taking dabigatran: a cohort study.

Li Ming-Hui MH Hu Li-Hua LH Xiong Yu-Rong YR Yu Yu Y Zhou Wei W Wang Tao T Zhu Ling-Juan LJ Liu Xi X Bao Hui-Hui HH Cheng Xiao-Shu XS

Journal of geriatric cardiology : JGC 20200401 4

<h4>Background</h4>Uncertainty remains regarding the association between body mass index (BMI) and the risk of bleeding in patients with non-valvular atrial fibrillation (NVAF). We aimed to investigate the association between BMI and the risk of bleeding in elderly NVAF patients taking dabigatran.<h4>Methods</h4>A total of 509 elderly NVAF patients, who were being treated at twelve centers in China from February 2015 to December 2017 and taking dabigatran, were analyzed. The exposure and outcome ...[more]

PMID: 32362917

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Project description:ImportanceIt remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice.ObjectiveTo compare the risk of bleeding associated with dabigatran and warfarin using Medicare data.Design, setting, and participantsIn this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011.ExposuresDabigatran users (n = 1302) and warfarin users (n = 8102).Main outcomes and measuresWe identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities.ResultsDabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease.Conclusions and relevanceDabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.

Dataset Information

Association between body mass index and the risk of bleeding in elderly patients with non-valvular atrial fibrillation taking dabigatran: a cohort study.

Publications

Association between body mass index and the risk of bleeding in elderly patients with non-valvular atrial fibrillation taking dabigatran: a cohort study.

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