scholarly journals Direct-Acting Oral Anticoagulants Versus Warfarin in Medicare Patients With Chronic Kidney Disease and Atrial Fibrillation

Stroke ◽  
2020 ◽  
Vol 51 (8) ◽  
pp. 2364-2373 ◽  
Author(s):  
James B. Wetmore ◽  
Nicholas S. Roetker ◽  
Heng Yan ◽  
Jorge L. Reyes ◽  
Charles A. Herzog
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
Intention To Treat ◽  
Hazard Ratios ◽  
Direct Acting ◽  
Direct Acting Oral Anticoagulants

Background and Purpose: The comparative effectiveness of direct-acting oral anticoagulants, compared with warfarin, for risks of stroke/systemic embolism, major bleeding, or death have not been studied in Medicare beneficiaries with atrial fibrillation and nondialysis-dependent chronic kidney disease. Methods: Medicare data from 2011 to 2017 were used to identify patients with stages 3, 4, or 5 chronic kidney disease and new atrial fibrillation who received a new prescription for warfarin, apixaban, rivaroxaban, or dabigatran. We estimated marginal hazard ratios with 95% CIs for the association of each direct-acting oral anticoagulant, compared with warfarin, for the outcomes of interest using inverse-probability-of-treatment weighted Cox proportional hazards models in as-treated and intention-to-treat analyses. Results: A total of 22 739 individuals met criteria (46.3% warfarin, 29.6% apixaban, 17.2% rivaroxaban, 6.9% dabigatran). Across the groups of anticoagulant users, mean age was 78.4 to 79.0 years; 50.3% to 51.4% were women, and 80.3% to 82.8% had stage 3 chronic kidney disease. In the as-treated analysis, for stroke/systemic embolism, hazard ratios, all compared with warfarin, were 0.70 (0.51–0.96) for apixaban, 0.80 (0.54–1.17) for rivaroxaban, and 1.15 (0.69–1.94) for dabigatran. For major bleeding, analogous hazard ratios were 0.47 (0.37–0.59) for apixaban, 1.05 (0.85–1.30) for rivaroxaban, and 0.95 (0.70–1.31) for dabigatran. There was no difference in the risk of all-cause mortality between the direct-acting oral anticoagulants and warfarin. Results of the intention-to-treat analysis were similar. Conclusions: Apixaban, compared with warfarin, was associated with decreased risk of stroke/systemic embolism and major bleeding; risks for both outcomes with rivaroxaban and dabigatran did not differ from risks with warfarin.

scholarly journals Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Prognostic Marker ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
The Mean

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 <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<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

Impact of weight on the efficacy and safety of direct-acting oral anticoagulants in patients with non-valvular atrial fibrillation: a meta-analysis

EP Europace ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. 361-367 ◽  
Author(s):  
Aaqib H Malik ◽  
Srikanth Yandrapalli ◽  
Suchith Shetty ◽  
Wilbert S Aronow ◽  
Diwakar Jain ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Outcome Data ◽  
Phase Iii ◽  
Safety And Efficacy ◽  
Low Bmi ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Oral Anticoagulants

Abstract Aims This study sought to determine the impact of weight and body mass index (BMI) on the safety and efficacy of direct-acting oral anticoagulants (DOACs) compared with warfarin in patients with non-valvular atrial fibrillation. Methods and results A systematic literature search was employed in PubMed, Embase, and Cochrane clinical trials with no language or date restrictions. Randomized trials or their substudies were assessed for relevant outcome data for efficacy that included stroke or systemic embolization (SSE), and safety including major bleeding and all-cause mortality. Binary outcome data and odds ratios from the relevant articles were used to calculate the pooled relative risk. For SSE, the data from the four Phase III trials showed that DOACs are better or similarly effective with low BMI 0.73 (0.56–0.97), normal BMI 0.72 (0.58–0.91), overweight 0.87 (0.76–0.99), and obese 0.87 (0.76–1.00). The risk of major bleeding was also better or similar with DOACs in all BMI subgroups with low BMI 0.62 (0.37–1.05), normal BMI 0.72 (0.58–0.90), overweight 0.83 (0.71–0.96), and obese 0.91 (0.81–1.03). There was no impact on mortality in all the subgroups. In a meta-regression analysis, the effect size advantage of DOACs compared with warfarin in terms of safety and efficacy gradually attenuated with increasing weight. Conclusion Our findings suggest that a weight-based dosage adjustment may be necessary to achieve optimal benefits of DOACs for thromboembolic prevention in these patients with non-valvular atrial fibrillation. Further dedicated trials are needed to confirm these findings. PROSPERO 2019 CRD42019140693. Available from: https://www.crd.york.ac.uk/prospero/display_record.php? ID=CRD42019140693.

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 Comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in atrial fibrillation: a nationwide cohort study

2020 ◽  
Vol 6 (2) ◽  
pp. 75-85 ◽  
Author(s):  
Ole-Christian W Rutherford ◽  
Christian Jonasson ◽  
Waleed Ghanima ◽  
Fabian Söderdahl ◽  
Sigrun Halvorsen
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Routine Clinical Practice ◽  
Systemic Embolism ◽  
Nationwide Study ◽  
Hazard Ratios

Abstract Aims The aim of this study was to compare the risk of stroke or systemic embolism (SE) and major bleeding in patients with atrial fibrillation (AF) using dabigatran, rivaroxaban, and apixaban in routine clinical practice. Methods and results Using nationwide registries in Norway from January 2013 to December 2017, we established a cohort of 52 476 new users of non-vitamin K antagonist oral anticoagulants (NOACs) with AF. Users of individual NOACs were matched 1:1 on the propensity score to create three pairwise-matched cohorts: dabigatran vs. rivaroxaban (20 504 patients), dabigatran vs. apixaban (20 826 patients), and rivaroxaban vs. apixaban (27 398 patients). Hazard ratios (HRs) for the risk of stroke or SE and major bleeding were estimated. In the propensity-matched comparisons of the risk of stroke or SE, the HRs were 0.88 [95% confidence interval (CI) 0.76–1.02] for dabigatran vs. rivaroxaban, 0.88 (95% CI 0.75–1.02) for dabigatran vs. apixaban, and 1.00 (95% CI 0.89–1.14) for apixaban vs. rivaroxaban. For the risk of major bleeding, the HRs were 0.75 (95% CI 0.64–0.88) for dabigatran vs. rivaroxaban, 1.03 (95% CI 0.85–1.24) for dabigatran vs. apixaban, and 0.79 (95% CI 0.68–0.91) for apixaban vs. rivaroxaban. Conclusion In this nationwide study of patients with AF in Norway, we found no statistically significant differences in risk of stroke or SE in propensity-matched comparisons between dabigatran, rivaroxaban, and apixaban. However, dabigatran and apixaban were both associated with significantly lower risk of major bleeding compared with rivaroxaban.

scholarly journals Meta-analysis comparing the efficacy and safety of direct acting oral anticoagulants to warfarin in patients with atrial fibrillation with and without diabetes

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Shetty ◽  
H Malik
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
P Value ◽  
Efficacy And Safety ◽  
Systemic Embolization ◽  
Direct Acting ◽  
Direct Acting Oral Anticoagulants

Abstract Background Direct-acting oral anticoagulants (DOACs) are now the preferred choice over warfarin in patients with atrial fibrillation (AF). The comparative efficacy and safety of DOACs over warfarin in patients with and without diabetes mellitus (DM) has not been fully evaluated. Purpose To evaluate the efficacy and safety of DOACs compared to warfarin in patients with non-valvular atrial fibrillation with and without DM. Methods A comprehensive review of the literature was performed to identify RCTs with data on DOACs compared to warfarin in the subgroups of DM and nonN-DM. Our outcome of interest were stroke/systemic embolization (SSE) and major bleeding. A random-effects meta-analysis was performed. We further performed a network meta-analysis to assess the most effective of all the therapies for the above mentioned subgroups. Results Our search identified 4 RCTs with 71,683 randomized patients, of which 22,087 were DM and 49,596 were non-DM. The mean duration of follow up was 2.3 years. Our results showed that the DOACS were associated with lower odds for SSE in diabetics (OR 0.80; 95% CI 0.67–0.95; p-value=0.01) and non-diabetics (OR 0.81; 95% CI 0.71–0.92; p-value&lt;0.01). For major bleeding, DOACs were non-inferior to warfarin in DM (OR 0.94; 95% CI 0.80–1.09; p-value=0.42) and non-DM (OR 0.82; 95% CI 0.62–1.07; p-value=0.15). (Fig 1) Network meta-analysis showed that dabigatran was the most effective for the outcome of SSE irrespective of DM status. However, edoxaban and apixaban were the safest of the DOACs for the outcome of major bleeding (Table 1) Conclusion In this meta-analysis of RCT, we found that DOACs are more effective and similarly safe compared to warfarin irrespective of the diabetic status of the patient. Funding Acknowledgement Type of funding source: None

scholarly journals Effectiveness and Safety of NOAC Versus Warfarin in Patients With Atrial Fibrillation and Aortic Stenosis

2021 ◽  
Author(s):  
Line Melgaard ◽  
Thure Filskov Overvad ◽  
Martin Jensen ◽  
Thomas Decker Christensen ◽  
Gregory Y. H. Lip ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Aortic Stenosis ◽  
Major Bleeding ◽  
Randomized Trials ◽  
Oral Anticoagulants ◽  
Eligibility Criteria ◽  
Intention To Treat ◽  
Hazard Ratios ◽  
Number Of Patients

Background Guideline recommendations on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with aortic stenosis are based on studies including a low number of patients with aortic stenosis. The aim of this study was to estimate the effects of NOAC versus warfarin on thromboembolism and major bleeding among AF patients with aortic stenosis. Methods and Results We emulated a target trial using observational data from Danish nationwide registries between 2013 and 2018. Thromboembolism was defined as a hospital diagnosis of ischemic stroke and/or systemic embolism, and major bleeding was defined as a hospital diagnosis of intracranial bleeding, gastrointestinal bleeding, or major or clinically relevant bleeding in other anatomic sites. Treatment effect estimates were based on an intention‐to‐treat and per‐protocol approach. A total of 3726 patients with AF and aortic stenosis claimed a prescription for either a NOAC (2357 patients) or warfarin (1369 patients) and met the eligibility criteria for the trial. During 3 years of follow‐up, the adjusted hazard ratios for thromboembolism and major bleeding were 1.62 (95% CI, 1.08–2.45) and 0.73 (0.59–0.91) for NOAC compared with warfarin in the intention‐to‐treat analyses. Similar results were observed in the per‐protocol analyses. Conclusions In this observational study, we observed a higher risk of thromboembolism but a lower risk of major bleeding for treatment with NOACs compared with warfarin in patients with AF and aortic stenosis. This observation needs confirmation in large randomized trials in these commonly encountered patients.

Risk for stroke and systemic embolism in patients with atrial fibrillation and heart failure according to heart failure type

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.S Uhm ◽  
H.T Yu ◽  
T.H Kim ◽  
H.N Pak ◽  
M.H Lee ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Oral Anticoagulants ◽  
Funding Source ◽  
Systemic Embolism ◽  
National Budget ◽  
Hazard Ratios ◽  
Public Grant

Abstract Introduction Risk for stroke and systemic embolism (SE) in patients with atrial fibrillation (AF) and heart failure (HF) with mid-range (mr) ejection fraction (EF) is not well known. Methods Total 10,780 patients (age, 66.8±11.1 years; men, 64.7%) with AF were included in a prospective, multicenter AF registry. The patients were grouped into four according to HF type: no-HF, HF with preserved EF (HFpEF), HFmrEF, and HF with reduced EF (HFrEF). Baseline characteristics, cumulative incidence and hazard ratios for stroke/SE, major bleeding, and mortality were compared among the four groups. Results Proportion of patients with HF was 10.3%: HFpEF, 43.7%; HFmrEF, 23.6%; HFrEF, 32.7%. CHA2DS2-VASc score was significantly higher in the HFpEF, HFmrEF, and HFrEF groups than the no-HF group (4.0±1.7, 3.8±1.8, 3.5±1.8, and 2.5±1.6, respectively). Oral anticoagulants were administered in 83.6% of patients with CHA2DS2-VASc score ≥1. Annual incidence of stroke/SE was 2.0% in HFpEF group, 0.6% in HFmrEF group, 1.1% in HFrEF group, and 0.7% in no-HF group for 23.0±9.5 months of follow-up period. Cumulative incidence of stroke/SE was significantly higher in the HFpEF group than the no-HF and HFmrEF groups (p&lt;0.001 and p=0.042, respectively; Figure). Risk for stroke/SE was significantly higher in the HFpEF group than the no-HF group [hazard ratio, 1.929; 95% confidence interval, 1.171–3.179, p=0.010]. There were no significant differences in risk for stroke/SE in the HFmrEF and HFrEF groups, compared with the no-HF group. There were no significant differences in major bleeding and mortality among the groups. Conclusions Risk for stroke/SE is highest in HFpEF and lowest in HFmrEF in patients with AF and HF. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Research Foundation of Korea

Abstract P682: Risk of All Cause Stroke and Major Bleeding Events When Switching From Warfarin to Apixaban in Patients With Advanced Chronic Kidney Disease and Prevalent Atrial Fibrillation

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Katherine Garlo ◽  
Thomas Mavrakanas ◽  
Elisabeth Burdick ◽  
Wei Wang ◽  
David Charytan
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Major Bleeding ◽  
The United States ◽  
Bleeding Events ◽  
Part D ◽  
Major Bleeding Events ◽  
Ischemic Attack ◽  
Direct Acting

Introduction: Apixaban is the preferred direct acting oral anticoagulant in patients with chronic kidney disease (CKD). Reporting on the incidence of all cause stroke and major bleeding after switching from warfarin to apixaban in patients with prevalent atrial fibrillation (AF) and CKD are limited. Methods: Individuals with stage 4-5 CKD not on dialysis and prevalent non valvular AF on warfarin who switched to apixaban were identified from the United States Data Renal System from Jan 1,2012-Dec 31, 2015. The incidences of combined all cause stroke, transient ischemic attack, or systemic thromboembolism and major bleeding events were estimated. Outcomes were compared between individuals switching to apixaban and continuing on warfarin using logistic regression and survival analyses adjusted with inverse probability treatment weighting. Individuals were censored at anticoagulation discontinuation, discontinuous Medicare part D, dialysis, kidney transplant, a 2 nd switch in anticoagulant, or death. Results: 1762 individuals with advanced CKD with AF were on warfarin; 71 (4.0%) switched to apixaban (57.8% male, mean age 78.2 years (SD ±6.6), 78.9% white, mean CHA 2 DS 2 -VASc 5.0 (SD ±1.5), mean HAS-BLED 2.2 (SD ±0.5) and 1691 (41.3%) continued warfarin (47.6% male, mean age 80.1 years (SD ±8.7), 87.9% white, mean CHA 2 DS 2 -VASc 5.5 (SD ±1.6), mean HAS-BLED 2.5 (SD ±0.8). Incidence of all cause stroke in the apixaban switch and warfarin continuation groups were 0.020/patient year (95%CI 0.002- 0.123) and 0.061/patient year (95%CI 0.054-0.068) (p=0.211). Incidence of major bleeding in the two groups were 0.018/patient year (95% CI 0.002 - 0.125) and 0.045 (95% CI 0.033 - 0.044) (p =0.438). The risk of all cause stroke (OR 0.06; 95% CI 0.01-0.45; HR 0.18 (95%CI 0.03-1.35)) and major bleeding (OR 0.09; 95%CI 0.01-0.68; HR is 0.31 95%CI (0.04-2.27)) were lower in the apixaban switch compared to the warfarin continuation group. Conclusions: The incidence and risk of all cause stroke and major bleeding are lower in individuals with stage4-5 CKD and prevalent AF who switch from warfarin to apixaban versus continuing on warfarin. Data are limited by few events and short duration on apixaban.

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