Safety of New Oral Anticoagulants for Patients with Chronic Kidney Disease

2019 ◽  
Vol 24 (38) ◽  
pp. 4505-4510 ◽  
Author(s):  
Krasiński Zbigniew ◽  
Stępak Hubert ◽  
Jawień Andrzej ◽  
Stanisic Michal
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Daily Practice ◽  
Rapid Onset ◽  
Onset Of Action ◽  
Reasonable Choice ◽  
Moderate Chronic Kidney Disease

In daily practice, chemical substances called “direct oral anticoagulants” or DOACs are more convenient to administer when set beside vitamin K antagonists (VKA) due to improved pharmacologic properties, fewer drug interactions and rapid onset of action. The objective of this review was to assess whether DOACs are the alternative for VKA in subjects with mild-to-moderate chronic kidney disease (CKD). An analysis of current DOAC trials and studies was performed focusing on subjects with CKD. This review concludes that although DOACS are not recommended in the course of advanced chronic kidney disease (CrCl<30mL/min) or during dialysis, DOACS are a reasonable choice for individuals with mild to moderate CKD.

DOAC use in patients with chronic kidney disease

Phlebologie ◽  
2018 ◽  
Vol 47 (03) ◽  
pp. 146-154 ◽  
Author(s):  
S. Kücükköylü ◽  
L. C. Rump
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Renal Disease ◽  
Severe Renal Impairment ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Calcineurin Inhibitors ◽  
Patients At Risk

SummaryDirect oral anticoagulants (DOACs) are increasingly prescribed substances in patients with indication for effective anticoagulation. Patients with chronic kidney disease (CKD) have a high burden of cardiovascular risk and are more likely to develop atrial fibrillation (AF) than patients without CKD. Patients with mild to moderate CKD benefit from DOACs, especially when having intolerance to vitamin K-antagonists (VKA). DOACs may in some cases be considered in patients with rare renal disease and hypercoagulabilic state. DOACs are to a large extent eliminated by renal excretion. Since prospective randomised data in CKD patients are sparse, the decision for anticoagulative therapy is challenging especially in patients with severe renal impairment. The direct factor Xa-inhibitors are approved for use even in patients with an estimated glomerular filtration rate (eGFR) between 15 and 30 ml/min. Careful monitoring of renal function on a regular basis is essential before initiation and after start of DOAC, especially for patients at risk for acute renal failure (elderly, diabetics, patients with preexisting kidney disease). None of the DOACs is approved in CKD patients with end-stage-renal-disease (ESRD) with or without dialysis. DOACs are not recommended for kidney transplant patients under immunosuppression with calcineurin inhibitors. In these patients conventional therapy with VKA is the only option, which has to be monitored closely since it has potential adverse effects.Nachdruck aus und zu zitieren als: Hämostaseologie 2017; 37: 286–294 https://doi.org/10.5482/HAMO-17-01-1657857

DOAC use in patients with chronic kidney disease

2017 ◽  
Vol 37 (04) ◽  
pp. 286-294
Author(s):  
Seher Kcükköylü ◽  
Lars Rump
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Renal Disease ◽  
Severe Renal Impairment ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Calcineurin Inhibitors ◽  
Patients At Risk

SummaryDirect oral anticoagulants (DOACs) are increasingly prescribed substances in patients with indication for effective anticoagulation. Patients with chronic kidney disease (CKD) have a high burden of cardiovascular risk and are more likely to develop atrial fibrillation (AF) than patients without CKD. Patients with mild to moderate CKD benefit from DOACs, especially when having intolerance to vitamin K-antagonists (VKA). DOACs may in some cases be considered in patients with rare renal disease and hypercoagulabilic state. DOACs are to a large extent eliminated by renal excretion. Since prospective randomised data in CKD patients are sparse, the decision for anticoagulative therapy is challenging especially in patients with severe renal impairment. The direct factor Xa-inhibitors are approved for use even in patients with an estimated glomerular filtration rate (eGFR) between 15 and 30 ml/min. Careful monitoring of renal function on a regular basis is essential before initiation and after start of DOAC, especially for patients at risk for acute renal failure (elderly, diabetics, patients with preexisting kidney disease). None of the DOACs is approved in CKD patients with end-stage-renal-disease (ESRD) with or without dialysis. DOACs are not recommended for kidney transplant patients under immunosuppression with calcineurin inhibitors. In these patients conventional therapy with VKA is the only option, which has to be monitored closely since it has potential adverse effects.

scholarly journals Direct oral anticoagulants and digestive bleeding: therapeutic management and preventive measures

2017 ◽  
Vol 10 (6) ◽  
pp. 495-505 ◽  
Author(s):  
David Deutsch ◽  
Christian Boustière ◽  
Emile Ferrari ◽  
Pierre Albaladejo ◽  
Pierre-Emmanuel Morange ◽  
...  
Keyword(s):  
Renal Function ◽  
Gastrointestinal Bleeding ◽  
Preventive Measures ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Rapid Onset ◽  
Treatment Monitoring ◽  
Onset Of Action

The use of direct oral anticoagulants (DOACs) was an important step forward in the management of atrial fibrillation and venous thromboembolism (VTE). The DOACs, anti-IIa for dabigatran and anti-Xa for rivaroxaban, apixaban and edoxaban, all have a rapid onset of action and a short half life. There is no need for routine hemostasis testing for treatment monitoring of a DOAC. Compared with vitamin K antagonists (VKAs), DOACs may increase the risk of gastrointestinal bleeding (relative risk 1.25). Withholding the DOAC treatment, evaluating the time of the last intake and estimating the patient’s renal function are the first steps in the management of gastrointestinal bleeding. For patients without impaired renal function, achieving low coagulation takes around 24 h after the last intake of a DOAC. The use of DOAC antagonists will be helpful in controlling bleeding in the most severe and urgent situations. Idarucizumab is available for clinical use for dabigatran and andexanet is currently being reviewed by drug agencies for rivaroxaban, apixaban and edoxaban. It is important to assess the bleeding risk associated with the planned procedure, and the patient’s renal function before withholding DOAC therapy for a scheduled intervention. It is mandatory to strengthen the local hemostasis strategies in DOAC-treated patients undergoing a therapeutic endoscopic procedure. Resuming or not resuming anticoagulation with a DOAC after bleeding or a risky procedure depends on the thrombotic and bleeding risk as well as the procedure involved. This discussion should always involve the cardiologist and decisions should be taken by a pluridisciplinary team.

scholarly journals Anticoagulant therapy in patients with atrial fibrillation and concomitant chronic kidney disease: the results of a prospective study

2019 ◽  
pp. 14-19
Author(s):  
I. S. Daabul ◽  
A. A. Sokolova ◽  
I. L. Tsarev ◽  
D. A. Napalkov ◽  
V. V. Fomin
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Kidney Function ◽  
Anticoagulant Therapy ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Thromboembolic Complications ◽  
Hemorrhagic Events

In recent years, both Russian and foreign authors have published many papers on anticoagulant therapy for atrial fibrillation (AF). The largest are devoted to the study of direct oral anticoagulants (DOACs), which have appeared in this field since 2009, and their comparison with vitamin K antagonists (VKAs) in terms of efficacy, safety and other important characteristics. There are far fewer studies on DOACs and their comparison with VKAs and with each other in patients with AF and reduced kidney function. Most of them are retrospective. Meanwhile, the prevalence of chronic kidney disease (CKD) in the population is very high, and doctors are faced with a problem of selecting anticoagulant therapy for these patients.Purpose. To assess the effect of VKAs and DOACs on renal function in real clinical practice in patients with AF depending on the stage of CKD.Materials and methods. A prospective single-centre non-randomized non-interventional observational study in parallel groups was conducted. The study included 92 patients with AF and CKD of 1-4 stages (S1-S4). The comparison group consisted of 35 patients with AF without concomitant CKD. The patients’ age ranged from 44 to 94 years (mean age was 72.2 ± 8.5 years). Patients of both groups received anticoagulant therapy with VKA (warfarin) or one of the registered in the Russian Federation DOACs (dabigatran, rivaroxaban, apixaban). During the observation (median was 10 months), follow-up visits were every 3 months. On visits we conducted the evaluation of effectiveness (strokes / TIA and thromboembolic complications) and safety (major and minor hemorrhagic events) of anticoagulant therapy, as well as the dynamics of kidney function (CC by Cockroft-Gault, GFR by CKD-EPI).Results. The main results are devoted to patients with AF and concomitant CKD. Significant dynamics of the kidney function depending on the anticoagulant taken (VKA or representatives of the DOACs class) were not identified. There were not any thromboembolic complications and major bleedings during the observation period. Statistically significant more minor bleedings on any dose of rivaroxaban in comparison with other anticoagulants were identified.Conclusions. In patients with AF and CKD, there was no significant effect of one or another anticoagulant on the kidney function, which is probably related to the concomitant nephroprotective therapy obtained in a large percentage of cases (ACE inhibitors / ARA, calcium antagonists, statins). Therapy with DOACs and warfarin in patients with AF and CKD for an average of 10 months of followup was effective and safe. In case of AF and CKD combination, the use of dabigatran or apixaban seems to be more preferable in relation to minor bleedings, the use of which less often leads to the development of hemorrhagic events. 

scholarly journals Thromboembolic and Bleeding Risk in Atrial Fibrillation Patients with Chronic Kidney Disease: Role of Anticoagulation Therapy

2020 ◽  
Vol 10 (1) ◽  
pp. 83
Author(s):  
Michele Magnocavallo ◽  
Antonio Bellasi ◽  
Marco Valerio Mariani ◽  
Maria Fusaro ◽  
Maura Ravera ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Therapeutic Window ◽  
Hemorrhagic Risk

Atrial fibrillation (AF) and chronic kidney disease (CKD) are strictly related; several independent risk factors of AF are often frequent in CKD patients. AF prevalence is very common among these patients, ranging between 15% and 20% in advanced stages of CKD. Moreover, the results of several studies showed that AF patients with end stage renal disease (ESRD) have a higher mortality rate than patients with preserved renal function due to an increased incidence of stroke and an unpredicted elevated hemorrhagic risk. Direct oral anticoagulants (DOACs) are currently contraindicated in patients with ESRD and vitamin K antagonists (VKAs), remaining the only drugs allowed, although they show numerous critical issues such as a narrow therapeutic window, increased tissue calcification and an unfavorable risk/benefit ratio with low stroke prevention effect and augmented risk of major bleeding. The purpose of this review is to shed light on the applications of DOAC therapy in CKD patients, especially in ESRD patients.

scholarly journals Non-vitamin K antagonist oral anticoagulants vs. vitamin-K antagonists in patients with atrial fibrillation and chronic kidney disease: a nationwide cohort study

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Emma Kirstine Laugesen ◽  
Laila Staerk ◽  
Nicholas Carlson ◽  
Anne-Lise Kamper ◽  
Jonas Bjerring Olesen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
All Cause Mortality ◽  
Comparable Population

Abstract Background We aimed to compare effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin-K antagonists (VKA) in atrial fibrillation (AF) patients with chronic kidney disease (CKD) not receiving dialysis. Methods By using personal identification numbers, we cross-linked individual-level data from Danish administrative registries. We identified every citizen with a prior diagnosis of AF and CKD who initiated NOAC or VKA (2011–2017). An external analysis of 727 AF patients with CKD (no dialysis) was performed to demonstrate level of kidney function in a comparable population. Study outcomes included incidents of stroke/thromboembolisms (TEs), major bleedings, myocardial infarctions (MIs), and all-cause mortality. We used Cox proportional hazards models to determine associations between oral anticoagulant treatment and outcomes. Results Of 1560 patients included, 1008 (64.6%) initiated VKA and 552 (35.4%) initiated NOAC. In a comparable population we found that 95.3% of the patients had an estimated glomerular filtration rate (eGFR) < 59 mL/min. Patients treated with NOAC had a significantly decreased risk of major bleeding (hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.26–0.84) compared to VKA. There was not found a significant association between type of anticoagulant and risk of stroke/TE (HR: 0.83, 95% CI: 0.39–1.78), MI (HR: 0.45, 95% CI: 0.18–1.11), or all-cause mortality (HR: 0.99, 95% CI: 0.77–1.26). Conclusion NOAC was associated with a lower risk of major bleeding in patients with AF and CKD compared to VKA. No difference was found in risk of stroke/TE, MI, and all-cause mortality.

scholarly journals Complex clinical scenarios with the use of direct oral anticoagulants in patients with atrial fibrillation: a multidisciplinary expert advisory board

2020 ◽  
Vol 28 (10) ◽  
pp. 504-513 ◽  
Author(s):  
B. A. Mulder ◽  
J. ten Berg ◽  
H. ten Cate ◽  
N. van Es ◽  
M. E. W. Hemels ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Treatment Guidelines ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Daily Practice ◽  
Advisory Board ◽  
Vascular Surgeon ◽  
Clinical Scenarios

Abstract The risk of developing atrial fibrillation (AF) and the risk of stroke both increase with advancing age. As such, many individuals have, or will develop, an indication for oral anticoagulation to reduce the risk of stroke. Currently, a large number of anticoagulants are available, including vitamin K antagonists, direct thrombin or factor Xa inhibitors (the last two also referred to as direct oral anticoagulants or DOACs), and different dosages are available. Of the DOACs, rivaroxaban can be obtained in the most different doses: 2.5 mg, 5 mg, 15 mg and 20 mg. Many patients develop co-morbidities and/or undergo procedures that may require the temporary combination of anticoagulation with antiplatelet therapy. In daily practice, clinicians encounter complex scenarios that are not always described in the treatment guidelines, and clear recommendations are lacking. Here, we report the outcomes of a multidisciplinary advisory board meeting, held in Utrecht (The Netherlands) on 3 June 2019, on decision making in complex clinical situations regarding the use of DOACs. The advisory board consisted of Dutch cardiovascular specialists: (interventional) cardiologist, internist, neurologist, vascular surgeon and general practitioners invited according to personal title and specific field of expertise.

scholarly journals Direct oral anticoagulants in chronic kidney disease

2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Thomas A. Mavrakanas ◽  
David M. Charytan ◽  
Wolfgang C. Winkelmayer
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants
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