scholarly journals MO123USE OF RIVAROXABAN VERSUS WARFARIN IN PATIENTS WITH ATRIAL FIBRILLATION AND ADVANCED CHRONIC KIDNEY DISEASE*

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Sherzod Abdullaev ◽  
Rano Igamberdieva ◽  
Olimkhon Sharapov

Abstract Background and Aims Patients with chronic kidney disease (CKD) develop bleeding and thromboembolic tendencies, so the indication for the use of anticoagulants for atrial fibrillation (AF) is difficult. AF is the most common chronic cardiac arrhythmia, and thromboembolism and ischemic stroke in particular are the main complications. In recent years, new oral anticoagulants (rivaroxaban) have been developed and have shown superiority over classic anti-vitamin K anticoagulants in preventing the risk of stroke, systemic embolism and bleeding. Aim is to evaluate the safety parameters of rivaroxaban in patients with stage 4 chronic kidney disease (CKD) or a transient sustained decrease in glomerular filtration rate (GFR) to 15–29 ml/min/1,73 m2 in the presence of atrial fibrillation (AF). Method Multicenter prospective randomized study that included patients from cardiology departments in 2019. Of 5448 hospitalized patients, 109 (2%) patients with AF and CKD stage 4 or a sustained decrease in GFR to 15-29 ml/min/1.73 m2 were randomized in a 2:1 ratio to rivaroxaban 15 mg/day (n=73) or warfarin (n=36). Primary endpoint: development of large, small and small clinically significant bleeding according to the BARC (Bleeding Academic Research Consortium) and ISTH (International Society on Thrombosis and Hemostasis) scales. The average follow-up period is 12 months. Results Patients taking warfarin were significantly more likely to develop minor bleeding according to BARC scales (n=26 (72.2%) versus n=31 (42.4%), p<0.01) and ISTH (n=22 (61.1%) versus n=27 (36.9%), p<0.01) and all clinically significant (minor clinically significant and major) bleeding according to the ISTH scale [n=10 (27.7%) versus n=8 (10.9%), p=0.03]. The number of readmissions was 32 (43.8% of patients) in the rivaroxaban group, 17 (47.2% of patients) in the warfarin group (p=0.57), of which 12 (37.5%) and 7 (41.1%) (in the rivaroxaban and warfarin groups, respectively) - for urgent reasons (p=0.96). A significant improvement in the dynamics of creatinine levels, GFR (according to CKD-EPI) in the rivaroxaban group was revealed. Conclusion The study provides evidence of a favorable safety profile for rivaroxaban compared with warfarin in patients with AF and advanced CKD.

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Tapio Hellman ◽  
Markus Hakamäki ◽  
Roosa Lankinen ◽  
Niina Koivuviita ◽  
Jussi Pärkkä ◽  
...  

Abstract Background The prevalence of left atrial enlargement (LAE) and fragmented QRS (fQRS) diagnosed using ECG criteria in patients with severe chronic kidney disease (CKD) is unknown. Furthermore, there is limited data on predicting new-onset atrial fibrillation (AF) with LAE or fQRS in this patient group. Methods We enrolled 165 consecutive non-dialysis patients with CKD stage 4–5 without prior AF diagnosis between 2013 and 2017 in a prospective follow-up cohort study. LAE was defined as total P-wave duration ≥120 ms in lead II ± > 1 biphasic P-waves in leads II, III or aVF; or duration of terminal negative portion of P-wave > 40 ms or depth of terminal negative portion of P-wave > 1 mm in lead V1 from a baseline ECG, respectively. fQRS was defined as the presence of a notched R or S wave or the presence of ≥1 additional R waves (R’) or; in the presence of a wide QRS complex (> 120 ms), > 2 notches in R or S waves in two contiguous leads corresponding to a myocardial region, respectively. Results Mean age of the patients was 59 (SD 14) years, 56/165 (33.9%) were female and the mean estimated glomerular filtration rate was 12.8 ml/min/1.73m2. Altogether 29/165 (17.6%) patients were observed with new-onset AF within median follow-up of 3 [IQR 3, range 2–6] years. At baseline, 137/165 (83.0%) and 144/165 (87.3%) patients were observed with LAE and fQRS, respectively. Furthermore, LAE and fQRS co-existed in 121/165 (73.3%) patients. Neither findings were associated with the risk of new-onset AF within follow-up. Conclusion The prevalence of LAE and fQRS at baseline in this study on CKD stage 4–5 patients not on dialysis was very high. However, LAE or fQRS failed to predict occurrence of new-onset AF in these patients.


Kardiologiia ◽  
2020 ◽  
Vol 60 (11) ◽  
pp. 94-100
Author(s):  
M. I. Chashkina ◽  
D. A. Andreev ◽  
N. L. Kozlovskaya ◽  
Z. K. Salpagarova ◽  
A. Yu. Suvorov ◽  
...  

Aim To evaluate safety of using rivaroxaban in patients with stage 4 chronic kidney disease (CKD) or transient, stable decline of glomerular filtration rate (GFR) to 15–29 ml /min / 1.73 m2 in the presence of atrial fibrillation (AF).Material and methods This multicenter prospective, randomized study included patients admitted to cardiology departments from 2017 through 2019. Of 10 224 admitted patients 109 (3 %) patients with AF and stage 4 CKD or a stable decline of GFR to 15–29 ml /min / 1.73 m2 were randomized at 2:1 ratio to the rivaroxaban 15 mg /day (n=73) treatment group or to the warfarin treatment group (n=36). The primary endpoint was development of BARC and ISTH major, minor, and clinically relevant minor bleeding. Mean follow-up duration was 18 months.Results Patients receiving warfarin had a significantly higher incidence of BARC (n=26 (72.2 %) vs. n=31 (42.4 %), р<0.01) and ISTH (n=22 (61.1 %) vs. n=27 (36.9 %), p<0.01) minor bleeding and all ISTH clinically relevant (minor clinically relevant and major bleedings) n=10 (27.7 %) vs. n=8 (10.9 %), р=0.03]. The number of repeated hospitalizations was 65 (43% of patients) in the rivaroxaban treatment group and 27 (48% of patients) in the warfarin treatment group (р=0.57), including 24 (36.9 %) and 11 (40.7 %) emergency admissions in the rivaroxaban and warfarin treatment groups, respectively (р=0.96). Significant improvement of changes in creatinine clearance and GFR (by CKD-EPI and Cockroft-Gault) was observed in the rivaroxaban treatment group.Conclusion The study provided evidence for a more beneficial safety profile of rivaroxaban compared to warfarin in patients with AF and advanced CKD.


Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 422
Author(s):  
Mihai Ciprian Stoica ◽  
Zsolt Gáll ◽  
Mirela Liana Gliga ◽  
Carmen Denise Căldăraru ◽  
Orsolya Székely

Over the past few decades, a series of innovative medicines have been developed in order to optimize anticoagulation therapy for atrial fibrillation (AF). As a result, a number of nonvitamin K antagonist oral anticoagulants (NOAC) that directly target the enzymatic activity of factor II and factor Xa have been successfully licensed providing a more predictable effect and better safety profile compared to conventional anticoagulants (heparins and vitamin K antagonists (VKAs)). However, comparative efficacy and safety data is limited in patients with advanced chronic kidney disease (i.e., CKD stage 4/5 and end stage renal disease) because patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 were actively excluded from landmark trials, thus representing a major clinical limitation for the currently available agents. However, the renal function of AF patients can be altered over time. On the other hand, patients with CKD have an increased risk of developing AF. This review article will provide an overview of current concepts and recent evidence guiding the clinical use of NOACs in patients with CKD requiring chronic anticoagulation, and the associated risks and benefits of treatment in this specific patient population.


2019 ◽  
Vol 54 (6) ◽  
pp. 554-560 ◽  
Author(s):  
Kyle Herndon ◽  
Tommie Jo Guidry ◽  
Katelyn Wassell ◽  
Whitney Elliott

Background: Warfarin has been the cornerstone of therapy for patients with stage 4 and 5 chronic kidney disease (CKD) requiring anticoagulation. These patients were omitted from landmark clinical trials involving apixaban. Apixaban’s safety profile is still largely unclear in this population. Objectives: To compare major bleeding, secondary bleeding outcomes, stroke, and thromboembolism in veterans with CKD stage 4, with CKD stage 5, and on dialysis on apixaban or warfarin. Methods: A retrospective chart review identified veterans with CKD stage 4 and stage 5, and on dialysis who received either apixaban or warfarin from 2013 to 2019 at the Memphis Veterans Affairs Medical Center. The primary outcome was incidence of major bleeding. Secondary outcomes were clinically relevant nonmajor and minor bleeding, composite bleeding, venous thromboembolism (VTE), and stroke. Results: A total of 111 patients were included in this study (warfarin group, n = 57; apixaban group, n = 54). Primary and secondary outcomes were analyzed using the χ2 or Fisher exact tests as appropriate. There was no difference in major bleeding between groups (14% vs 7%, P = 0.362). There were increased rates of minor bleeding (26% vs 6%, P = 0.004) and composite bleeding (46% vs 20%, P = 0.004) in patients receiving warfarin. There were no differences in rates of stroke or VTE between the 2 groups. Conclusion and Relevance: There was no difference in major bleeding in patients who received apixaban compared with warfarin. Apixaban may be a reasonable alternative to warfarin in veterans with CKD stage 4 and 5, including those on dialysis.


2020 ◽  
Author(s):  
Markus Hakamäki ◽  
Tapio Hellman ◽  
Roosa Lankinen ◽  
Niina Koivuviita ◽  
Jussi Pärkkä ◽  
...  

Abstract Background Atrial fibrillation (AF) and chronic kidney disease (CKD) are commonly co-existing conditions. However, data on epidemiology of AF in patients with CKD stage 4–5 is scarce. Methods We prospectively enrolled 210 consecutive non-dialysis patients with CKD stage 4–5 between 2013 and 2017. Follow-up data on AF incidence along with medical history, laboratory tests and echocardiography at baseline were gathered. Results At baseline, mean age was 62 years, estimated glomerular filtration rate 12.8 ml/min and 73/210 (34.8%) of the participants were female. Altogether 41/210 (19.5%) patients had a previous diagnosis of AF. After median follow-up of 46 [IQR 27] months, new-onset AF occurred in 33/169 (19.5%) patients (69.9 events/1000 person-years). Overall, 22/33 (66.7%) of patients with new-onset AF were identified with a triggering condition and 21/33 (63.6%) were receiving renal replacement therapy (dialysis or acquired kidney transplant) at the time of AF detection, respectively. In Cox proportional hazard model age > 60 years (HR 4.27, CI95% 1.57–11.64, p < 0.01), elevated troponin T (TnT) > 50 ng/l (HR 3.61, CI95% 1.55–8.37, p < 0.01) and left atrial volume index (LAVI) > 30 ml/m2 (HR 4.82, CI95% 1.11-21.00, p = 0.04) independently predicted the incidence of new-onset AF. Conclusions The prevalence and incidence of AF was markedly high in this prospective study on patients with CKD stage 4–5. Elevated TnT and increased LAVI were identified as independent predictors for new-onset AF in patients with severe CKD.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Basma Sultan ◽  
Hamdy Omar ◽  
Housseini Ahmed ◽  
Mahmoud Elprince ◽  
Osama Anter adly ◽  
...  

Abstract Background and Aims Vascular calcification (VC) plays a major role in cardiovascular disease (CVD), which is one of the main causes of mortality in patients with chronic kidney disease (CKD). The study aims at early detection of breast arterial calcification (BAC) in different stages of CKD (stage 2, 3& 4) patients as an indicator of systemic VC. Method A case control study was conducted targeting CKD women, aged 18- 60 years old. The sample was divided into 3 groups; A,B,C (representing stage 2, 3 & 4 of CKD) from women who attended nephrology and Internal medicine clinics and admitted in inpatient ward in Suez Canal University Hospital. A 4th group (D) was formed as a control group and included women with normal kidney functions (each group (A, B, C, D) include 22 women). The selected participants were subjected to history taking, mammogram to detect BAC and biochemical assessment of lipid profile, Serum creatinine (Cr), Mg, P, Ca, PTH and FGF23. Results Our study detected presence of BAC in about 81.8% of hypertensive stage 4 CKD patients compared with 50% in stage 3 CKD, also in the majority of stage 4 CKD patients who had abnormal lipid profile parameters and electrolyte disturbance. Most of the variables had statistical significance regarding the presence of BAC. Conclusion Although it is difficult to determine the definite stage at which the risk of VC begins but in our study, it began late in stage 2 CKD, gradually increased prevalence through stage 3 and became significantly higher in stage 4. These results suggest that preventive strategies may need to begin as early as stage 2 CKD.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None


2020 ◽  
pp. BJGP.2020.0871
Author(s):  
Clare Elizabeth MacRae ◽  
Stewart Mercer ◽  
Bruce Guthrie

Background: Many drugs should be avoided or require dose-adjustment in chronic kidney disease (CKD). Previous estimates of potentially inappropriate prescribing rates have been based on data on a limited number of drugs and mainly in secondary care settings. Aim: To determine the prevalence of contraindicated and potentially inappropriate primary care prescribing in a complete population of people with CKD. Method: Cross-sectional study of prescribing patterns in a complete geographical population of people with CKD defined using laboratory data. Drugs were organised by British National Formulary advice. Contraindicated (CI) drugs: “avoid”. Potentially high risk (PHR) drugs: “avoid if possible”. Dose inappropriate (DI) drugs: dose exceeded recommended maximums. Results: 28,489 people with CKD were included in analysis, of whom 70.0% had CKD 3a, 22.4% CKD 3b, 5.9% CKD 4, and 1.5% CKD 5. 3.9% (95%CI 3.7-4.1) of people with CKD stages 3a-5 were prescribed one or more CI drug, 24.3% (95%CI 23.8-24.8) PHR drug, and 15.2% (95% CI 14.8-15.62) DI drug. CI drugs differed in prevalence by CKD stage, and were most commonly prescribed in CKD stage 4 with a prevalence of 36.0% (95%CI 33.7–38.2). PHR drugs were commonly prescribed in all CKD stages ranging from 19.4% (95%CI 17.6-21.3) in stage 4 to 25.1% (95%CI 24.5–25.7) in stage 3b. DI drugs were most commonly prescribed in stage 4, 26.4% (95%CI 24.3-28.6). Conclusion: Potentially inappropriate prescribing is common at all stages of CKD. Development and evaluation of interventions to improve prescribing safety in this high-risk populations are needed.


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