scholarly journals Safety and efficacy of low-dose rivaroxaban in Asian patients with atrial fibrillation and chronic kidney disease

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Liu ◽  
Y.J Tseng ◽  
P.L Lin ◽  
W.R Chiou ◽  
Y.H Lee
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Low Dose ◽  
Standard Dose ◽  
Major Adverse Cardiovascular Events ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Asian Patients ◽  
Event Rates

Abstract Background Low-dose rivaroxaban (10mg/day) has been commonly used in Asia for patients with atrial fibrillation (AF). However, its effectiveness and safety, particularly in patients with chronic kidney disease (CKD), is limited. Moreover, inappropriate low-dose rivaroxaban is frequently prescribed. We aimed to evaluate the effectiveness and safety of low-dose rivaroxaban in patients with or without CKD, compared to that of the standard dose in real-world practice. Methods 3122 patients with AF treated with rivaroxaban between October 2012 and December 2016 were included in this retrospective multicenter study. We compared the different doses of rivaroxaban stratified according to renal function in this cohort. Bleeding events and major adverse cardiovascular events (MACE) including CV death, MI, stroke, and thromboembolism were recorded. Results 1218 (39%) patients received standard-dose rivaroxaban (20mg/day). 1147 (36.7%) patients with eGFR>50 mL/min/1.73m2 and 757 (24.3%) patients with eGFR<50 mL/min/1.73m2 received low-dose rivaroxaban (10mg/day). The patients who received low-dose rivaroxaban were older, more likely to be female, and with more comorbidities. After adjustment, the use of low-dose rivaroxaban was significantly associated with increased risks of MACE in the patients without CKD compared to the patients with CKD (HR: 1.75; 95% CI: 1.07 to 2.89). Also, the risk of bleeding was highest in CKD patients despite low-dose rivaroxaban treatment. There was no difference in bleeding between the standard-dose and low-dose of rivaroxaban in patients without CKD (HR: 1.29; 95% CI: 0.8 to 2.08). Conclusions The use of inappropriate low-dose rivaroxaban in patients without CKD increased MACE significantly, compared to low-dose rivaroxaban in CKD patients. In addition, the risk of bleeding was strongly associated with CKD, not with the dose of rivaroxaban. Cumulative Event Rates Funding Acknowledgement Type of funding source: None

scholarly journals Impact of antithrombotic therapy in the prognosis of atrial fibrillation patients with advanced chronic kidney disease

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.M Andreu Cayuelas ◽  
S Raposeiras-Roubin ◽  
E Fortuny Frau ◽  
A Garcia Del Egido ◽  
J Seller-Moya ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Antithrombotic Therapy ◽  
Anticoagulation Therapy ◽  
Bleeding Event ◽  
Funding Source ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Cox Regression Analysis

Abstract Introduction Chronic kidney disease (CKD) is associated with an elevated thromboembolic and bleeding risk in atrial fibrillation (AF) patients, so the decision of antithrombotic therapy is a challenge. Purpose To analyze mortality, embolic and bleeding events in patients with advanced CKD and AF. Methods Multicentric retrospective registry on patients with AF and advanced CKD (CKD-EPI <30 mL/min/1.73 m2). For death, multivariable Cox regression analysis was developed. For embolic and bleeding events, competing-risks regression based on Fine and Gray's proportional subhazards model was performed, being death the competing event Results We analysed 405 patients with advanced CKD and newly diagnosed AF. 57 patients were not treated with antithrombotic therapy (14.1%), 80 only with antiplatelet/s (19.8%), 211 only with anticoagulation (52.1%), and 57 with anticoagulant plus antiplatelet/s (14.1%). During a follow-up of 4.6±2.5 years, 205 died (50.6%), 34 had embolic events (8.4%) and 85 had bleeding outcomes (21.0%). Bleeding event rate was significantly lower in patients without antithrombotic therapy (Figure). After multivariate analysis, anticoagulant treatment was associated with higher bleeding rates, without differences in mortality or embolic events (Table). Conclusion Anticoagulation therapy was associated with a significant increase in bleeding events in patients with advanced CKD and newly diagnosed AF. None of the antithrombotic therapy regimens resulted in lower embolic events rate neither benefit in mortality. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): This study was supported by an unconditional grant from BMS-Pfizer

scholarly journals Amiodarone Toxicity Screening: What are the Clinicians Supposed to Tell Patients

2020 ◽  
pp. 1-5
Author(s):  
John D Rozich ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Clinical Practice ◽  
Kidney Disease ◽  
Low Dose ◽  
The Elderly ◽  
Toxicity Screening ◽  
Nonvalvular Atrial Fibrillation ◽  
Routine Testing ◽  
Continued Use

The use of amiodarone in clinical practice continues to be widespread in the setting of nonvalvular atrial fibrillation (NVAF). Use of amiodarone continues especially in the elderly where the drug’s favorable characteristics and outcomes in the setting of chronic kidney disease coupled to its low inherent proarrhythmic profile has ensured its continued use. The present work focuses on the information that clinicians should tell their patients regarding requisite toxicity screening during daily treatment with amiodarone when it is maintained at a low dose of 200 mgs per day or less. Several questions need be answered in pursuit of the fundamental query as to whether routine testing for toxicity should still be advised. Most importantly, has ongoing screening shown to be of any proven value?

scholarly journals Safety of dabigatran in patients with atrial fibrillation and chronic kidney disease: pharmacokinetic and pharmacogenetic aspects

2020 ◽  
pp. 65-73
Author(s):  
A. I. Skripka ◽  
P. O. Bochkov ◽  
K. A. Akmalova ◽  
R. V. Shevchenko ◽  
P. M. Krupenin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Nucleotide Polymorphisms ◽  
Bleeding Events ◽  
Day Range ◽  
High Interindividual Variability ◽  
Trough Concentrations ◽  
Moderate Chronic Kidney Disease ◽  
D Values

Background: despite well-studied safety profile of dabigatran its interactions with genetic polymorphism parameters are poorly understood, especially in patients with moderate chronic kidney disease (CKD). This study was aimed to evaluate relationships between CES1 and ABCB1 polymorphism, dabigatran trough plasma concentration (DTPC) and bleeding events in patients with AF and CKD.Methods: patients with atrial fibrillation (AF) and stage 3 CKD treated with dabigatran 110mg or 150 mg have been included in the study. Real-time PCR was used to evaluate single nucleotide polymorphisms (SNPs) of the ABCB1 gene (rs1045642, rs4148738) and CES1 gene (rs2244613). A plasma trough concentration/dose (C/D) ratio was used as a pharmacokinetic index.Results: a total of 60 patients, aged 51–89 years (median age 76 years) were evaluated. Compared with patients given 150 mg twice a day, those given 110 mg twice a day were older (79 vs 67.5, p < 0.0001) and had lower creatinine clearance (CrCl) (50.5 vs 60.5 mL/min/1.73 m2, p = 0.015). We found C/D values to have high interindividual variability (mean 365.9 ± 290.4 μg/ml: mg/day, range 23.64-1452.73). Individuals with CKD 3B had higher concentration of dabigatran compared with those with 3A stage (488.7 ± 232.3 vs 332 ± 297.8 μg/ml : mg/day, p = 0.02). Consequently, there also was negative correlation of C/D with CrCl (r = -0.4, p = 0.0015). Evaluated SNPs (rs1045642, rs4148738, and rs2244613) did not affect C/D values (H test p > 0.05).Conclusions: C/D values were significantly higher in patients with CKD 3B stage and those treated with dabigatran 110 mg. There was no influence of aforementioned SNPs on dabigatran trough concentrations and clinical outcomes.

scholarly journals Apixaban vs. Warfarin in Atrial Fibrillation Patients With Chronic Kidney Disease

2021 ◽  
Vol 8 ◽  
Author(s):  
Chung-Ming Fu ◽  
Lung-Chih Li ◽  
Yueh-Ting Lee ◽  
Shih-Wei Wang ◽  
Chien-Ning Hsu
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Kidney Function ◽  
Major Bleeding ◽  
Lower Risk ◽  
Standard Dose ◽  
Healthcare Delivery ◽  
Real World Evidence ◽  
Record Data

Background and Objectives: Real-world evidence of apixaban treatment in patients with chronic kidney disease remains scarce. This study aimed to compare the relative risk of stroke or systemic embolism (SE) and major bleeding between apixaban and warfarin in atrial fibrillation (AF) patients with different degrees of kidney function.Design, Setting, Participants, and Measurements: We evaluated newly diagnosed AF patients between 2004 and 2018, who were receiving apixaban or warfarin. Electronic medical record data were collected from a large healthcare delivery network in Taiwan. The outcomes of hospitalization for stroke/SE and major bleeding were compared with propensity-score matched apixaban and warfarin cohorts. Stratified analyses according to initial apixaban dose (standard dose of 10 mg/day vs. lower dose of 2.5–5.0 mg/day) and baseline estimated glomerular filtration rate were performed.Results: Each cohort involved 1,625 matched patients. Apixaban was significantly associated with a lower risk of stroke/SE (adjusted hazard ratio [aHR]: 0.74; 95% confidence interval [CI]:0.57–0.97; p = 0.03). The risk of major bleeding was not increased whether in standard doses (aHR: 0.66; 95% CI: 0.45–0.96; p = 0.03) or reduced doses (aHR, 0.84; 95% CI, 0.63–1.12; p = 0.23) of apixaban. Regarding kidney function, apixaban reduced the risk of stroke/SE by 37% in those with an eGFR of &lt;30 ml/min/1.73 m2 (aHR: 0.63; 95% CI: 0.40–0.98; p = 0.04).Conclusions: Compared to warfarin, apixaban is associated with a reduced risk of stroke/SE and is consistent with a subset of AF patients with eGFR &lt;30 ml/min/1.73 m2. Both standard and reduced doses of apixaban showed lower risk of major bleeding than those of warfarin.

scholarly journals An Elderly Comorbid Patient with Atrial Fibrillation: What is Important to Know and What Should be Considered When Prescribing Anticoagulants?

2020 ◽  
Vol 16 (6) ◽  
pp. 1031-1038
Author(s):  
T. V. Pavlova
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Randomized Clinical Trials ◽  
Simple Algorithm ◽  
Cardiovascular Complications ◽  
Efficacy And Safety ◽  
Risk Of Bleeding ◽  
Number Of Patients

Anticoagulant therapy in elderly patients with atrial fibrillation and concomitant diseases is often the challenge for clinicians. The high risk of stroke is inherent in atrial fibrillation, and it increases when combined with coronary heart disease and chronic kidney disease. On the other hand, the comorbidity increases the risk of bleeding. Older age is also the risk factor of thrombotic and hemorrhagic complications. As a consequence, the choice of specific anticoagulant should be based on a solid evidences, obtained both from randomized clinical trials and from daily clinical practice. In the ROCKET AF trail the direct oral anticoagulant rivaroxaban showed a tendency to reduce the risk of thromboembolism by 20% compared with warfarin in the patients aged 75 years and older. The safety of rivaroxaban has been evaluated in the XANTUS POOLED program. According to the follow-up results for 12 months, more than 96% of patients didn't have any adverse event, and the number of patients with major bleeding was 1.5%. Several meta-analyzes reported a reduction of cardiovascular complications in patients treated by rivaroxaban. In the ROCKET AF trail, a “renal” dose of rivaroxaban (15 mg OD) was studied in patients with chronic kidney disease. The efficacy and safety of rivaroxaban were validated in this patients, and a simple algorithm for selecting the dose of this drug in patients with chronic kidney disease was provided. 

scholarly journals The association between atrial fibrillation and in-hospital outcomes in chronic kidney disease patients with acute coronary syndrome: findings from the improving care for cardiovascular disease in China-acute coronary syndrome (CCC-ACS) project

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lijiao Yang ◽  
Nan Ye ◽  
Guoqin Wang ◽  
Weijing Bian ◽  
Fengbo Xu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiovascular Disease ◽  
Chronic Kidney Disease ◽  
Acute Coronary Syndrome ◽  
Kidney Disease ◽  
Hospital Mortality ◽  
Major Adverse Cardiovascular Events ◽  
Coronary Syndrome ◽  
Risk Of Mortality ◽  
Increased Risk

Abstract Background Atrial fibrillation (AF) is the most common cardiac arrhythmia in patients with chronic kidney disease (CKD) and acute coronary syndrome (ACS). This study aimed to explore the frequency and impact of AF on clinical outcomes in CKD patients with ACS. Methods CKD inpatients with ACS between November 2014 and December 2018 were included based on the improving care for cardiovascular disease in China-ACS (CCC-ACS) project. Included patients were divided into an AF group and a non-AF group according to the discharge diagnosis. Multivariable logistic regression was used to adjust for potential confounders. Results A total of 16,533 CKD patients with ACS were included. A total of 1418 (8.6%) patients had clinically recognized AF during hospitalization, 654 of whom had an eGFR of 45 to < 60 ml/min/1.73 m2, and 764 had an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m2. Compared with the non-AF group, the AF group had a higher risk of in-hospital mortality [OR 1.250; 95% CI (1.001–1.560), P = 0.049] and major adverse cardiovascular events (MACEs) [OR 1.361; 95% CI (1.197–1.547), P < 0.001]. We also found that compared with patients with eGFR 45 to < 60 ml/min/1.73 m2, patients with eGFR < 45 ml/min/1.73 m2 had a 1.512-fold increased risk of mortality and a 1.435-fold increased risk of MACEs. Conclusions AF was a risk factor affecting the short-term prognosis of ACS patients in the CKD population. Furthermore, the lower the eGFR, the higher the risk of in-hospital mortality and MACEs in CKD patients with ACS. Trial registry: Clinicaltrial.gov, NCT02306616. Registered 29 November 2014, https://clinicaltrials.gov/ct2/show/NCT02306616?term=NCT02306616&draw=2&rank=1

scholarly journals Stroke and Major Bleeding when Switching from Warfarin to Apixaban in Patients with Advanced Chronic Kidney Disease and Prevalent Atrial Fibrillation

2021 ◽  
Author(s):  
Katherine Garlo ◽  
Thomas Mavrakanas ◽  
Wei Wang ◽  
Elisabeth Burdick ◽  
David Charytan
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Major Bleeding ◽  
The United States ◽  
Bleeding Events ◽  
Part D ◽  
Stage 4 ◽  
Ischemic Attack

Abstract Background Apixaban is the most widely used direct oral anticoagulant in patients with chronic kidney disease (CKD). Data on the incidence of stroke and major bleeding after switching from warfarin to apixaban in patients with prevalent atrial fibrillation (AF) and CKD are limited.Methods Warfarin users with stage 4-5 CKD not on dialysis and non-valvular AF prior to Jan 1,2012 were identified from the United States Data Renal System CKD dataset and individuals switching to apixaban from Jan 1,2012 -Dec 31, 2015 were identified. The incidence of stroke (ischemic or hemorrhagic), transient ischemic attack, or systemic thromboembolism and major bleeding events were estimated. Outcomes were compared between individuals switching to apixaban and those continuing warfarin using survival analyses with inverse probability treatment weighting. Individuals were censored at the time of anticoagulation discontinuation, loss of Medicare part D coverage, dialysis, kidney transplant, a 2nd switch in anticoagulant class, or death. Results 1762 individuals with advanced CKD and AF were initially on warfarin; 71 (4.0%) switched to apixaban (57.8% male, mean age 78.2 years (SD ±6.6), 78.9% white, mean CHA2DS2-VASc 5.0 (SD ±1.5), mean HAS-BLED 2.2 (SD ±0.5) and 1691 (96.0%) continued warfarin (47.6% male, mean age 80.1 years (SD ±8.7), 87.9% white, mean CHA2DS2-VASc 5.5 (SD ±1.6), mean HAS-BLED 2.5 (SD ±0.8). The incidence of stroke in the apixaban switch and warfarin continuation groups were 0.02/patient-year (95%CI 0.002-0.12) and 0.06/patient-year (95%CI 0.05-0.07) (p=0.21). Incidence of major bleeding were 0.02/patient-year (95% CI 0.002-0.13) and 0.06 (95% CI 0.03-0.04) (p =0.44) in the switch and warfarin groups, respectively. In adjusted models, the risk of stroke (HR 0.27 (95% CI 0.04-1.99)) and major bleeding (HR 0.41 (95% CI 0.06-3.02)) trended lower in the apixaban switch compared to the warfarin continuation group.Conclusions The incidence and risk of stroke and major bleeding trended lower in individuals with stage 4-5 CKD and prevalent AF who switched from warfarin to apixaban than individuals continuing warfarin. Our findings support a strategy of switching prevalent AF patients with late stage CKD from warfarin to apixaban. Additional studies including a larger number of events with a longer-duration of follow-up are needed to refine effect estimates.

scholarly journals Reclassification, Thromboembolic, and Major Bleeding Outcomes Using Different mates of Renal Function in Anticoagulated Patients With Atrial Fibrillation: Insights From the PREFER-in-AF and PREFER-in-AF Prolongation Registries

2021 ◽  
Author(s):  
Miklos Rohla ◽  
Ladislav Pecen ◽  
Roberto Cemin ◽  
Giuseppe Patti ◽  
Jolanta M. Siller-Matula ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Dose Reduction ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Disease Epidemiology ◽  
Anticoagulated Patients

Background: The Cockcroft-Gault formula is recommended to determine a renal indication for dose reduction of dabigatran, edoxaban, and rivaroxaban. Nephrology guidelines now recommend the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulae as more accurate estimates of glomerular filtration rate. Methods: We analyzed anticoagulated patients with atrial fibrillation who were enrolled in the Prevention of Thromboembolic Events – European Registry in Atrial Fibrillation (PREFER in AF). The proportion of patients with dissimilar renal dosing indications was assessed when applying Cockcroft-Gault, MDRD, or CKD-EPI. Thromboembolic and major bleeding events at 1 year were compared in patients in whom Cockcroft-Gault and CKD-EPI provided concordant or discordant results around a threshold of 50 mL/minute. Results: Out of 1288 patients with atrial fibrillation with chronic kidney disease in whom Cockcroft-Gault suggested a dose reduction of dabigatran, edoxaban, or rivaroxaban (creatinine clearance ≤50 mL/minutes), 19% and 16% were reclassified to the respective higher doses, and 24% and 23% to the respective lower doses by applying the MDRD and CKD-EPI formulae, respectively. In patients potentially receiving a different dose of dabigatran, edoxaban, or rivaroxaban when using CKD-EPI, we observed an excess of thromboembolic events (4.1% versus 0.8%; odds ratio, 5.5 [95% CI, 1.5–20.8]; P =0.01). Major bleeding rates were nonsignificantly different in the discordance versus concordance group (5.7% versus 2.7%; odds ratio, 2.2 [95% CI, 0.9–5.6]; P =0.09). Conclusions: The MDRD and CKD-EPI formulae suggest a different dosing in up to a quarter of anticoagulated patients with atrial fibrillation. This seems to impact hard outcomes.

Sign in / Sign up

Export Citation Format

Share Document