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Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States.

ABSTRACT: BACKGROUND:Patients with end-stage kidney disease (ESKD) on dialysis were excluded from clinical trials of direct oral anticoagulants for atrial fibrillation (AF). Recent data have raised concerns regarding the safety of dabigatran and rivaroxaban, but apixaban has not been evaluated despite current labeling supporting its use in this population. The goal of this study was to determine patterns of apixaban use and its associated outcomes in dialysis-dependent patients with ESKD and AF. METHODS:We performed a retrospective cohort study of Medicare beneficiaries included in the United States Renal Data System (October 2010 to December 2015). Eligible patients were those with ESKD and AF undergoing dialysis who initiated treatment with an oral anticoagulant. Because of the small number of dabigatran and rivaroxaban users, outcomes were only assessed in patients treated with apixaban or warfarin. Apixaban and warfarin patients were matched (1:3) based on prognostic score. Differences between groups in survival free of stroke or systemic embolism, major bleeding, gastrointestinal bleeding, intracranial bleeding, and death were assessed using Kaplan-Meier analyses. Hazard ratios (HRs) and 95% CIs were derived from Cox regression analyses. RESULTS:The study population consisted of 25?523 patients (45.7% women; 68.2±11.9 years of age), including 2351 patients on apixaban and 23?172 patients on warfarin. An annual increase in apixaban prescriptions was observed after its marketing approval at the end of 2012, such that 26.6% of new anticoagulant prescriptions in 2015 were for apixaban. In matched cohorts, there was no difference in the risks of stroke/systemic embolism between apixaban and warfarin (HR, 0.88; 95% CI, 0.69-1.12; P=0.29), but apixaban was associated with a significantly lower risk of major bleeding (HR, 0.72; 95% CI, 0.59-0.87; P<0.001). In sensitivity analyses, standard-dose apixaban (5 mg twice a day; n=1034) was associated with significantly lower risks of stroke/systemic embolism and death as compared with either reduced-dose apixaban (2.5 mg twice a day; n=1317; HR, 0.61; 95% CI, 0.37-0.98; P=0.04 for stroke/systemic embolism; HR, 0.64; 95% CI, 0.45-0.92; P=0.01 for death) or warfarin (HR, 0.64; 95% CI, 0.42-0.97; P=0.04 for stroke/systemic embolism; HR, 0.63; 95% CI, 0.46-0.85; P=0.003 for death). CONCLUSIONS:Among patients with ESKD and AF on dialysis, apixaban use may be associated with a lower risk of major bleeding compared with warfarin, with a standard 5 mg twice a day dose also associated with reductions in thromboembolic and mortality risk.

SUBMITTER: Siontis KC

PROVIDER: S-EPMC6202193 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States.

Siontis Konstantinos C KC Zhang Xiaosong X Eckard Ashley A Bhave Nicole N Schaubel Douglas E DE He Kevin K Tilea Anca A Stack Austin G AG Balkrishnan Rajesh R Yao Xiaoxi X Noseworthy Peter A PA Shah Nilay D ND Saran Rajiv R Nallamothu Brahmajee K BK

Circulation 20181001 15

<h4>Background</h4>Patients with end-stage kidney disease (ESKD) on dialysis were excluded from clinical trials of direct oral anticoagulants for atrial fibrillation (AF). Recent data have raised concerns regarding the safety of dabigatran and rivaroxaban, but apixaban has not been evaluated despite current labeling supporting its use in this population. The goal of this study was to determine patterns of apixaban use and its associated outcomes in dialysis-dependent patients with ESKD and AF.<h ...[more]

PMID: 29954737

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Project description:Rationale & objectiveAlthough end-stage kidney disease (ESKD) adversely affects fertility, pregnancies can occur among women receiving dialysis. ESKD increases the risk for adverse pregnancy outcomes and little is known about contraceptive use in women undergoing dialysis.Study designRetrospective cohort study.Setting & participantsUsing the US Renal Data System covering January 1, 2005, through December 31, 2014, we evaluated for each calendar year women who for the entire year were aged 15 to 44 years, receiving dialysis, and with Medicare as the primary payer.PredictorsAge, race/ethnicity, and calendar year of prevalent ESKD.OutcomeContraceptive use.Analytic approachWe determined rates of contraceptive use and used multivariable logistic regression to identify factors associated with contraceptive use.ResultsThe study cohort included 35,732 women and represented 115,713 person-years. The rate of contraceptive use was 5.30% of person-years (95% CI, 5.17%-5.42%). Overall, contraceptive use increased from 2005 to 2014 (4.21%; 95% CI, 3.84%-4.59% vs 6.54%, 95% CI, 6.10%-6.99%). Compared with women aged 25 to 29 years, contraceptive use was higher in women aged 15 to 24 years (OR, 1.30; 95% CI, 1.18-1.43) and lower in women aged 30 to 34 years (OR, 0.74; 95% CI, 0.68-0.81), 35 to 39 years (OR, 0.46; 95% CI, 0.42-0.50), and 40 to 44 years (OR, 0.30; 95% CI, 0.27-0.34). Compared with White women, contraceptive use was higher in Black (OR, 1.12; 95% CI, 1.02-1.24) and Native American women (OR, 1.60; 95% CI, 1.25-2.05). Women with ESKD due to glomerulonephritis had a higher likelihood of contraceptive use than women with ESKD due to diabetes (OR, 1.22; 95% CI, 1.06-1.42). Women receiving peritoneal dialysis had a lower likelihood of contraceptive use than women receiving hemodialysis (OR, 0.85; 95% CI, 0.78-0.93). Compared with women without predialysis nephrology care, contraceptive use was higher in women who received predialysis nephrology care for 12 or fewer months (OR, 1.22; 95% CI, 1.09-1.37) and more than 12 months (OR, 1.33; 95% CI, 1.20-1.47).LimitationsRetrospective design and use of administrative data.ConclusionsAmong women with ESKD undergoing dialysis, contraceptive use remains low at 5.30%. Younger age, Native American and Black race/ethnicity, ESKD due to glomerulonephritis, hemodialysis, and predialysis nephrology care are associated with a higher likelihood of contraceptive use. The study highlights the importance of prepregnancy counseling for contraceptive use in women receiving dialysis.

Project description:BACKGROUND: Despite warfarin's marked efficacy, not all eligible patients receive it for stroke prevention in AF. The aim of this meta-analysis was to evaluate the association between prescriber and/or patient characteristics and subsequent prescription of warfarin for stroke prevention in patients with atrial fibrillation (AF). METHODS: Observational studies conducted in the US using multivariate analysis to determine the relationship between characteristics and the odds of receiving warfarin for stroke prevention were identified in MEDLINE, EMBASE and a manual review of references. Effect estimates of prescriber and/or patient characteristics from individual studies were pooled to calculate odds ratios (ORs) with 95% confidence intervals. RESULTS: Twenty-eight studies reporting results of 33 unique multivariate analyses were identified. Warfarin use across studies ranged from 9.1%-79.8% (median=49.1%). There was a moderately-strong correlation between warfarin use and year of study (r=0.60, p=0.002). Upon meta-analysis, characteristics associated with a statistically significant increase in the odds of warfarin use included history of cerebrovascular accident (OR=1.59), heart failure (OR=1.36), and male gender (OR=1.12). Those associated with a significant reduction in the odds of warfarin use included alcohol/drug abuse (OR=0.62), perceived barriers to compliance (OR=0.87), contraindication(s) to warfarin (OR=0.81), dementia (OR=0.32), falls (OR=0.60), gastrointestinal hemorrhage (OR=0.47), intracranial hemorrhage (OR=0.39), hepatic (OR=0.59), and renal impairment (OR=0.69). While age per 10-year increase (OR=0.78) and advancing age as a dichotomized variable (cut-off varied by study) (OR=0.57) were associated with significant reductions in warfarin use; qualitative review of results of studies evaluating age as a categorical variable did not confirm this relationship. CONCLUSIONS: Warfarin use has increased somewhat over time. The decision to prescribe warfarin for stroke prevention in atrial fibrillation is based upon multiple prescriber and patient characteristics. These findings can be used by family practice prescribers and other healthcare decision-makers to target interventions or methods to improve utilization of warfarin when it is indicated for stroke prevention.

Project description:BackgroundIt is well-known that patients with chronic kidney disease and end-stage renal disease are at increased risk of pulmonary embolism than patients with normal kidney function. However, the data on trends, outcomes, and predictors of mortality in pulmonary embolism patients with chronic kidney disease and end-stage renal disease in the United States are limited.MethodsWe queried the National Inpatient Sample database from 2010 to 2014. International Classification of Diseases-Ninth Revision-Clinical Modification codes were used to identify patients with normal kidney function, chronic kidney disease, and end-stage renal disease. The frequency of pulmonary embolism, complications, in-hospital mortality, and length of stay were calculated for each cohort. Multivariable logistic regression models were constructed to determine the predictors of mortality.ResultsIn the study population (2010-2014), there were 766,176 pulmonary embolism hospitalizations with normal kidney function, 79,824 with chronic kidney disease, and 9147 with end-stage renal disease. Among the study cohorts, the mortality rate was 2.7% in normal kidney function, 4.5% in chronic kidney disease, and 6.8% in end-stage renal disease hospitalizations. Median length of stay was highest in the end-stage renal disease cohort and lowest in the normal kidney function cohort. After adjusting for confounders, pulmonary embolism patients with chronic kidney disease died 1.15 times more often than those with normal kidney function and pulmonary embolism patients with end-stage renal disease died 4.2 times more often than those with normal kidney function.ConclusionThe mortality rate and length of stay in pulmonary embolism patients with chronic kidney disease and end-stage renal disease were significantly higher than those in pulmonary embolism patients with normal kidney function. Also, pulmonary embolism patients with chronic kidney disease and end-stage renal disease were at higher risk of in-hospital mortality than those with normal kidney function. There was statistically significant higher risk of mortality in elderly and Black patients with pulmonary embolism and concurrent chronic kidney disease or end-stage renal disease.

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Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States.

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Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States.

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