scholarly journals Safety performance of rivaroxaban versus warfarin in patients with atrial fibrillation and advanced chro­nic kidney disease

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.

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&lt;0.01) and ISTH (n=22 (61.1%) versus n=27 (36.9%), p&lt;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.


2021 ◽  
Author(s):  
Katherine Garlo ◽  
Thomas Mavrakanas ◽  
Wei Wang ◽  
Elisabeth Burdick ◽  
David Charytan

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.


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.


2019 ◽  
Vol 8 (6) ◽  
pp. 823
Author(s):  
Hsiao-Fen Hsu ◽  
Chia-Chan Kao ◽  
Ti Lu ◽  
Jeremy C. Ying ◽  
Sheng-Yu Lee

The current study explored the differences in the effectiveness of first and second generation long-acting injections and orally administered antipsychotics in reducing the rehospitalization rate among patients with schizophrenia receiving home care services in a medical center in Southern Taiwan. Longitudinal data between 1 January 2006, and 31 December 2015, were collected retrospectively. Patients were classified into three treatment groups: First generation antipsychotic (FGA) long-acting injection (LAI), second generation antipsychotic long-acting injection (SGA) (LAI), and oral antipsychotics. The primary outcomes were the rehospitalization rate and the follow-up time (duration of receiving home care services) until psychiatric rehospitalization. A total of 78 patients with schizophrenia were recruited. The average observation time was about 40 months. The oral treatment group tended to be older with a higher number of female patients and a lower level of education. The FGA treatment group tended to have a higher frequency and duration of hospitalization before receiving home care services. We found no significant differences in the follow-up time or psychiatric rehospitalization rate after receiving home care services among the three treatment groups. We propose that oral and LAI antipsychotics were equally effective when patients received home care services. Our results can serve as a reference for the choice of treatment for patients with schizophrenia in a home care program.


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


2021 ◽  
pp. 1-8
Author(s):  
Roosa Lankinen ◽  
Markus Hakamäki ◽  
Tapio Hellman ◽  
Niina S. Koivuviita ◽  
Kaj Metsärinne ◽  
...  

<b><i>Background and Aims:</i></b> Abdominal aortic calcification (AAC) is common in chronic kidney disease (CKD) patients and associated with increased mortality. Comparative data on the AAC score progression in CKD patients transitioning from conservative treatment to different modalities of renal replacement therapy (RRT) are lacking and were examined. <b><i>Methods:</i></b> 150 study patients underwent lateral lumbar radiograph to study AAC in the beginning of the study before commencing RRT (AAC1) and at 3 years of follow-up (AAC2). We examined the associations between repeated laboratory tests taken every 3 months, echocardiographic and clinical variables and AAC increment per year (ΔAAC), and the association between ΔAAC and outcomes during follow-up. <b><i>Results:</i></b> At the time of AAC2 measurement, 39 patients were on hemodialysis, 39 on peritoneal dialysis, 39 had a transplant, and 33 were on conservative treatment. Median AAC1 was 4.8 (0.5–9.0) and median AAC2 8.0 (1.5–12.0) (<i>p</i> &#x3c; 0.0001). ΔAAC was similar across the treatment groups (<i>p</i> = 0.19). ΔAAC was independently associated with mean left ventricular mass index (LVMI) (log LVMI: β = 0.97, <i>p</i> = 0.02) and mean phosphorus through follow-up (log phosphorus: β = 1.19, <i>p</i> = 0.02) in the multivariable model. Time to transplantation was associated with ΔAAC in transplant recipients (per month on the waiting list: β = 0.04, <i>p</i> = 0.001). ΔAAC was associated with mortality (HR 1.427, 95% confidence interval 1.044–1.950, <i>p</i> = 0.03). <b><i>Conclusion:</i></b> AAC progresses rapidly in patients with CKD, and ΔAAC is similar across the CKD treatment groups including transplant recipients. The increment rate is associated with mortality and in transplant recipients with the time on the transplant waiting list.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Simon Kircher ◽  
Arash Arya ◽  
David Altmann ◽  
Sascha Rolf ◽  
Andreas Bollmann ◽  
...  

Introduction: Pulmonary vein (PV) isolation forms the cornerstone of any ablation procedure for atrial fibrillation (AF). There is, however, no uniform strategy how to detect and target left atrial (LA) arrhythmogenic substrate outside the PV antra. Fibrosis that corresponds well to LA low-voltage areas (LVAs) seems to play a key role in AF arrhythmogenesis and might therefore be a suitable target for additional substrate modification (SM). Objective: The purpose of this prospective randomized study was to compare a novel technique for SM based on ablation of potentially arrhythmogenic LA LVAs with a standard approach consisting of empiric LA linear ablation. Methods: Patients (pts) with symptomatic paroxysmal or persistent AF were randomized to standard (group 1) or personalized (group 2) SM. Circumferential PV isolation was the primary step in both groups. In group 1, pre-defined linear lesions were applied at the LA roof and bottom, respectively, and at the mitral isthmus only in pts with persistent AF. In group 2, targets for SM (i.e. LVAs) were identified by detailed bipolar voltage mapping (BVM) during sinus rhythm irrespective of AF type. Peak-to-peak electrogram amplitudes were defined as “normal” (> 0.5 mV), as “low voltages” (0.2 to 0.5 mV), or as “scar” (< 0.2 mV). LVAs were targeted by tissue homogenization and / or strategic linear lesions. The primary endpoint was freedom from any atrial arrhythmia (i.e. AF, atrial flutter, or atrial tachycardia) > 30 seconds off antiarrhythmic drugs on serial 7-d-Holter ECG recordings after a follow-up period of 12 months. Results: In total, 124 ablation-naïve pts (mean age 63 ± 9 years, 62 % male, 49 % with persistent AF) were enrolled in this study. LVAs were present in 18 % of pts with paroxysmal and in 41 % of pts with persistent AF (p<0.05). At the end of the follow-up period, 25 out of 59 pts (42 %) in the conventional group were free from arrhythmia recurrence as compared to 40 out of 59 pts (68 %) in the BVM-guided group (unadjusted log rank p = 0.003). Conclusion: Personalized SM guided by endocardial BVM is associated with a higher success rate compared to a conventional approach applying empirical SM based on AF phenotype.


Author(s):  
Steven B Deitelzweig ◽  
Erin Buysman ◽  
Brett Pinsky ◽  
Michael Lacey ◽  
Yonghua Jing ◽  
...  

Introduction Warfarin discontinuation among real world nonvalvular atrial fibrillation (NVAF) patients is common. Hypothesis We hypothesized that in a managed care population, warfarin discontinuation is associated with increased stroke risk. Methods Patients who initiated warfarin therapy between Jan 2005 and Jun 2009 and had a healthcare claim related to AF within 30 days prior to the first warfarin claim, but no evidence of valvular disease, were included. Warfarin discontinuation was defined as a supply gap of >60 days without evidence of International Normalized Ratio (INR) measurements. Follow-up was divided into periods of warfarin treatment and discontinuation. Stroke events were identified based on claims for inpatient stays with a primary diagnosis for stroke or transient ischemic attack (TIA). Cox proportional hazards models were constructed to assess the relationship between warfarin discontinuation and incident stroke while adjusting for baseline demographics, stroke and bleeding risk, and comorbidities, as well as time-dependent antiplatelet use, stroke, and bleeding events in the prior warfarin treatment period. Results The mean (SD) age of the study sample (N=16,253) was 67±12 years; 64.8% was male. Mean CHADS2 score was 1.84±1.30; mean HAS-BLED score was 2.00±1.18. Half (51.4%) of patients discontinued warfarin therapy at least once and the overall sample had a mean of 1.87 warfarin treatment periods during a mean of 668 days follow-up. Approximately 1186 patients (7%) had a stroke or TIA at any site of service during follow-up. Risk of stroke significantly increased during warfarin discontinuation periods compared with therapy periods (HR 1.60; 95%CI 1.35-1.90; P<.0001). Stroke risk was significantly increased for patients with baseline CHADS2 score ≥2 (HR 2.69; 95%CI 1.44-5.03; P=.002), HAS-BLED score ≥3 (HR 1.46; 95%CI 1.05-2.05; P=.027), or who had a bleeding (HR 1.29; 95%CI 1.06-1.57; P=.013) or stroke event (HR 3.04; 95%CI 2.47-3.75; P<.0001) in the prior treatment period. Conclusions In the real world, over half of patients on anticoagulation therapy had treatment gaps or permanently discontinued therapy. These usage patterns, as well as prior bleeding, were associated with increased stroke risk.


2017 ◽  
Vol 26 (1) ◽  
pp. 12-24
Author(s):  
ASM Tanim Anwar ◽  
Md Nizamuddin Chowdhury ◽  
Md Nazrul Islam ◽  
Parvez Iftekher Ahmed ◽  
Sohely Ahmed Sweety ◽  
...  

This was a hospital based prospective, interventional study which included CKD stage 3- 5 patients with higher level of uric acid (male>7mg/dl, female>6mg/dl). The objective of the study was to evaluate the effect of allopurinol on inflammatory markers in patients with chronic kidney disease (stage 3-5) with asymptomatic hyperuricaemia. One hundred and twenty patients were distributed in two groups. Sixty patients were placed in treatment group and sixty in control group. Purposive sampling technique was followed. In the study mean age was 49 (±9) years in treatment group and 45 (±11) years in control groups. Male were predominant in both groups. There were no significant difference in baseline characteristics between treatment group and control group (p>0.05). Sixty patients of treatment group were administered a dose of 100 mg/d of allopurinol. Follow up assessment was done at basally, at 4 months and at 8 month after starting treatment. No significant differences were seen between baseline SBP, DBP, Hb and HbA1c with 4th month and 8th month follow up in both treatment group and control group, but mean Hb was significantly decreased in control group from the baseline after 8 month. No significant change was found in case of mean ESR at 4th and 8th month in any group. But base line mean CRP was significantly reduced in treatment group and increased in control group at 4th and 8th month of follow up. Serum uric acid was decreased in treatment group while it was significantly raised from the base line at 4th month and 8th month in control group. While comparing between two groups results showed means of serum uric acid and CRP were significantly decreased in treatment group compared to control group after 8th month. There was a positive correlation between Uric Acid with CRP level after 8 month of allopurinol treatment although this finding was not statistically significant. So, allopurinol may have a protective role in CKD by decreasing serum uric acid level and reduction of inflammatory response in patients with chronic kidney disease stage 3 - 5 with asymptomatic hyperuricaemia.J Dhaka Medical College, Vol. 26, No.1, April, 2017, Page 12-24


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