Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial

2012 ◽  
Vol 33 (22) ◽  
pp. 2821-2830 ◽  
Author(s):  
Stefan H Hohnloser ◽  
Ziad Hijazi ◽  
Laine Thomas ◽  
John H Alexander ◽  
John Amerena ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Impaired Renal Function ◽  
Bleeding Events ◽  
Disease Epidemiology ◽  
Increased Risk ◽  
Novel Oral Anticoagulant ◽  
Stroke Death

AbstractAimsAtrial fibrillation (AF) is common among patients with impaired renal function. Apixaban, a novel oral anticoagulant with partial renal excretion, was compared with warfarin and reduced the rate stroke, death and bleeding in the ARISTOTLE trial. We evaluated these outcomes in relation to renal function.Methods and resultsBaseline glomerular filtration rate (GFR) was estimated using the Cockcroft–Gault and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations as well as cystatin C measurements. According to baseline Cockcroft–Gault, there were 7518 patients (42%) with an estimated GFR (eGFR) of >80 mL/min, 7587 (42%) between >50 and 80 mL/min, and 3017 (15%) with an eGFR of ≤50 mL/min. The rate of cardiovascular events and bleeding was higher at impaired renal function (≤80 mL/min). Apixaban was more effective than warfarin in preventing stroke or systemic embolism and reducing mortality irrespective of renal function. These results were consistent, regardless of methods for GFR estimation. Apixaban was associated with less major bleeding events across all ranges of eGFRs. The relative risk reduction in major bleeding was greater in patients with an eGFR of ≤50 mL/min using Cockcroft–Gault {hazard ratio (HR) 0.50 [95% confidence interval (CI) 0.38–0.66], interaction P = 0.005} or CKD-EPI equations [HR 0.48 (95% CI 0.37–0.64), interaction P = 0.003].ConclusionIn patients with AF, renal impairment was associated with increased risk of cardiovascular events and bleeding. When compared with warfarin, apixaban treatment reduced the rate of stroke, death, and major bleeding, regardless of renal function. Patients with impaired renal function seemed to have the greatest reduction in major bleeding with apixaban.

Risk of Stroke, Bleeding, and Death in Patients with Nonvalvular Atrial Fibrillation and Chronic Kidney Disease

Cardiology ◽  
2020 ◽  
Vol 145 (3) ◽  
pp. 178-186
Author(s):  
Yoav Arnson ◽  
Moshe Hoshen ◽  
Adi Berliner-Sendrey ◽  
Orna Reges ◽  
Ran Balicer ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Renal Function ◽  
Kidney Disease ◽  
Impaired Renal Function ◽  
Bleeding Risk ◽  
Intracranial Bleeding ◽  
Increased Risk ◽  
Ckd Stage ◽  
Stroke Death

Introduction: Atrial fibrillation (AF) and chronic kidney disease (CKD) are both associated with increased risk of stroke, and CKD carries a higher bleeding risk. Oral anticoagulation (OAC) treatment is used to reduce the risk of stroke in patients with nonvalvular AF (NVAF); however, the risk versus benefit of OAC for advanced CKD is continuously debated. We aim to assess the management and outcomes of NVAF patients with impaired renal function within a population-based cohort. Methods: We conducted a retrospective observational cohort study using ICD-9 healthcare coding. Patients with incident NVAF between 2004 and 2015 were identified stratified by CKD stage. We compared treatment strategies and estimated risks of stroke, death, or any major bleeding based on CKD stages and OAC treatment. Results: We identified 85,116 patients with incident NVAF. Patients with impaired renal function were older and had more comorbidities. OAC was most common among stage 2 CKD patients (49%) and least in stages 4–5 CKD patients (27.6%). Higher CKD stages were associated with worse outcomes. Stroke rates increased from 1.04 events per 100 person-years (PY) in stage 1 CKD to 3.72 in stages 4–5 CKD. Mortality increased from 3.42 to 32.95 events/100 PY, and bleeding rates increased from 0.89 to 4.91 events/100 PY. OAC was associated with reduced stroke and intracranial bleeding risk regardless of CKD stage, and with a reduced mortality risk in stages 1–3 CKD. Conclusion: Among NVAF patients, advanced renal failure is associated with higher risk of stroke, death, and bleeding. OAC was associated with reduced stroke and intracranial bleeding risk, and with improved survival in stages 1–3 CKD.

Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Matthew R Weir ◽  
Lloyd Haskell ◽  
Jeffrey S Berger ◽  
Veronica Ashton ◽  
François Laliberté ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Data Availability ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Claims Database ◽  
Increased Risk

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

scholarly journals Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial

2020 ◽  
Vol 41 (30) ◽  
pp. 2848-2859 ◽  
Author(s):  
Michael Böhm ◽  
Martina Brueckmann ◽  
John W Eikelboom ◽  
Michael Ezekowitz ◽  
Mandy Fräßdorf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
High Risk ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Bleeding Events ◽  
High Risk Patients ◽  
Increased Risk ◽  
Risk Patients

Abstract Aims A J-shaped association of cardiovascular events to achieved systolic (SBP) and diastolic (DBP) blood pressure was shown in high-risk patients. This association on oral anticoagulation is unknown. This analysis from RELY assessed the risks of death, stroke or systemic emboli, and bleeding according to mean achieved SBP and DBP in atrial fibrillation on oral anticoagulation. Methods and results RE-LY patients were followed for 2 years and recruited between 22 December 2005 until 15 December 2007. 18.113 patients were randomized in 951 centres in 54 countries and 18,107 patients with complete blood pressure (BP) data were analysed with a median follow-up of 2.0 years and a complete follow-up in 99.9%. The association between achieved mean SBP and DBP on all-cause death, stroke and systemic embolic events (SSE), major, and any bleeding were explored. On treatment, SBP >140 mmHg and <120 mmHg was associated with all-cause death compared with SBP 120–130 mmHg (reference). For SSE, risk was unchanged at SBP <110 mmHg but increased at 140–160 mmHg (adjusted hazard ratio (HR) 1.81; 1.40–2.33) and SBP ≥160 mmHg (HR 3.35; 2.09–5.36). Major bleeding events were also increased at <110 mmHg and at 110 to <120 mmHg. Interestingly, there was no increased risk of major bleeding at SBP >130 mmHg. Similar patterns were observed for DBP with an increased risk at <70 mmHg (HR 1.55; 1.35–1.78) and >90 mmHg (HR 1.88; 1.43–2.46) for all-cause death compared to 70 to <80 mmHg (reference). Risk for any bleeding was increased at low DBP <70 mmHg (HR 1.46; 1.37–1.56) at DBP 80 to <90 mmHg (HR 1.13; 1.06–1.31) without increased risk at higher achieved DBP. Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved. Similar results were obtained for baseline BP, time-updated BP, and BP as time-varying covariate. Conclusion Low achieved SBP associates with increased risk of death, SSE, and bleeding in patients with atrial fibrillation on oral anticoagulation. Major bleeding events did not occur at higher BP. Low BP might identify high-risk patients not only for death but also for high bleeding risks. Clinical trial registration  ClinicalTrials.gov—Identifier: NCT00262600.

scholarly journals Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Renal Dysfunction

2021 ◽  
Vol 17 (1) ◽  
pp. 62-72
Author(s):  
Z. D. Kobalava ◽  
A. A. Shavarov ◽  
M. V. Vatsik-Gorodetskaya
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Renal Function ◽  
Kidney Disease ◽  
Renal Dysfunction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Disease Epidemiology ◽  
Increased Risk ◽  
Estimate Glomerular Filtration Rate

Atrial fibrillation and renal dysfunction often coexist, each disorder may predispose to the other and contribute to worsening prognosis. Both atrial fibrillation and chronic kidney disease are associated with increased risk of stroke and thromboembolic complications. Oral anticoagulation for stroke prevention is therefore recommended in patients with atrial fibrillation and decreased renal function. Each direct oral anticoagulant has unique pharmacologic properties of which clinician should be aware to optimally manage patients. The doses of direct oral anticoagulants require adjustment for renal function. There is debate regarding which equation, the Chronic Kidney Disease Epidemiology (CKD-EPI) equation vs. the Cockcroft-Gault equation, should be used to estimate glomerular filtration rate in patients with atrial fibrillation treated with direct oral anticoagulants. Our review tries to find arguments for benefit of direct oral anticoagulants in patients with renal dysfunction.

P4769Optimal rivaroxaban dose in Asian patients with atrial fibrillation and normal or mildly impaired renal function

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E.-K Choi ◽  
S R Lee ◽  
K D Han ◽  
J H Jung ◽  
S Oh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Major Bleeding ◽  
Impaired Renal Function ◽  
Gi Bleeding ◽  
Nonsignificant Trend ◽  
Off Label ◽  
Asian Patients

Abstract Background Although rivaroxaban 15 mg was only given to patients with creatinine clearance (CrCl) <50mL/min in the pivotal clinical trial, this dose has been commonly prescribed in Asian patients with non-valvular atrial fibrillation (AF) regardless of renal function. There is a paucity of information regarding the clinical outcomes of rivaroxaban 15 mg compared to rivaroxaban 20 mg in patients with CrCl ≥50mL/min. This study aimed to examine the effectiveness and safety of two doses of rivaroxaban in Asian patients with AF and CrCl ≥50mL/min. Methods Using the Korean National Health Insurance Service database, patients with AF and normal or mildly impaired renal function (CrCl ≥50mL/min) and naïve to rivaroxaban or warfarin were included from January 2014 to December 2016. Three separate 1:1 propensity score-matched cohorts were conducted: rivaroxaban 20 mg (R20) vs. warfarin (n=15,584), rivaroxaban 15 mg (R15) vs. warfarin (n=11,554), and R20 vs. R15 (n=10,392). Hazard ratios (HRs) for ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding, major bleeding, all-cause death, and composite clinical outcome were analyzed. Results Among the pooled total study population, mean age was 66.9±10.9 years, 62.2% were male, mean CHA2DS2-VASc score was 3.16±1.79, and mean CrCl was 83.6±42.0 mL/min (median 78.4 mL/min, IQR 67.7–91.0 mL/min). A substantial proportion (42.6%) of patients with CrCl ≥50 mL/min were prescribed off-label R15 for stroke prevention in the Korean AF population. Compared to warfarin, both R20 and R15 showed significantly lower risk for ischemic stroke, major bleeding (mainly through reduction of ICH), and all-cause death (Figure). Overall, both R20 and R15 had better results for the composite clinical outcome compared to warfarin (HR: 0.617, 95% CI: 0.550–0.691 for R20, and HR: 0.759, 95% CI: 0.675–0.853 for R15). Compared to off-label R15, on-label R20 showed a nonsignificant trend toward lower risks of ischemic stroke, hospitalization for GI bleeding, hospitalization for major bleeding, and all-cause death. Overall, on-label R20 had better results for the composite clinical outcome compared to off-label R15 in patients with CrCl ≥50 mL/min (HR: 0.852, 95% CI: 0.735–0.988). This benefit was consistently observed in patients aged ≥80 years and those <50 kg. In patients with CrCl 50–60 mL/min, R20 showed a nonsignificant trend toward a higher risk of hospitalization for major bleeding compared to R15 (HR: 1.828, 95% CI 0.994–3.452). Conclusions Among Asians with AF and CrCl ≥50mL/min, both R20 and R15 were associated with reduced risk of ischemic stroke, ICH, major bleeding, and all-cause death without significantly increased risk of GI bleeding compared with warfarin. In patients with CrCl ≥50mL/min, on-label R20 showed better results for the composite clinical outcome compared to off-label R15.

P391Estimated glomerular filtration rate levels and risk of stroke in individuals with diabetes mellitus and atrial fibrillation

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
R Westreich ◽  
O Barrett ◽  
L Kezerle ◽  
M Leventer Roberts ◽  
M Avgil Tsadok ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Renal Function ◽  
Glomerular Filtration Rate ◽  
Glomerular Filtration ◽  
Mortality Risk ◽  
Impaired Renal Function ◽  
Filtration Rate ◽  
Historical Cohort ◽  
Increased Risk

Abstract Funding Acknowledgements pfizer Background Diabetes mellitus (DM) is associated with increased risk of embolic complications in non-valvular atrial fibrillation (NVAF). Chronic kidney disease (CKD) has been shown in some studies to increase the risk of stroke. This finding is not consistent among all studies. Therefore the relationship between kidney function, diabetes and stroke risk is complex and warrants further investigation. Purpose To assess the incidence rates and risk of ischemic stroke and mortality by baseline Estimated Glomerular Filtration Rate (eGFR) levels among individuals with AF and DM. Methods A prospective, historical cohort study using our electronic medical records database. The study population included all members 21 years old, with a first diagnosis of NVAF between January 1, 2010 to December 31, 2016 and a minimal follow-up period of 1 year. Among those patients identified as diabetics, we compared three groups of patients according to eGFR levels at the time of AF diagnosis: eGFR ≥ 60, between 30-60 and ≤ 30 or chronic dialysis or kidney transplant. Results A total of  17,567 cases were included in the final analysis, of them, 11013 (62.7%) had eGFR ≥ 60, 4930 (28%) with eGFR between 30-60 and 1624 (9.24%) with eGFR ≤30 . The median age was 75 years (IQR 65-83) with a majority of females in all groups, 52.5%, 51.2% and 55.5% respectively. The incidence of stroke per 100 person-years in the three study groups was: 1.88 in patients with eGFR ≥ 60, 2.69 in patients with eGFR between 30-60 and 3.34 in those with eGFR ≤ 30 . Impaired renal function was associated with increased risk of stroke in univariate analysis, but not found in the adjusted model  (Adjusted Hazard Ratio (AHR) = 1.04 {95% 0.89-1.23} for eGFR 30-60  and 1.16 {95% CI 0.88-1.51} for eGFR ≤ 30 compared to GFR ≥ 60). incidence of mortality per 100 person-years was 10.78 in patients with  eGFR ≥ 60, 21.49 in patients with eGFR 30-60 and 41.55 in those with eGFR ≤ 30. In both univariate and multivariate analyses, decreased levels of eGFR were associated with increased mortality risk compared to subjects with normal renal function (AHR 1.22 {95%CI 1.14-1.27} and AHR 2.09 {95%CI 1.95-2.24} for eGFR between 30-60 and for eGFR ≤ 30, respectively). Conclusion In this observational prospective cohort of patients with newly diagnosed NVAF, impaired renal function was not found to be associated with increased risk of stroke. Lower eGFR levels were associated with an increased mortality risk.

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.

Prognostic impact of renal function trajectories and temporal variability amongst anticoagulated atrial fibrillation patients: a subgroup analysis of the SPORTIF III and V trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
J Gumprecht ◽  
G.F Romiti ◽  
G.Y.H Lip
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Creatinine Clearance ◽  
Major Bleeding ◽  
Temporal Variability ◽  
Adverse Outcomes ◽  
Prognostic Impact ◽  
Increased Risk ◽  
The Impact

Abstract Background Renal function is a major determinant of major adverse outcomes in patients with atrial fibrillation (AF). Scarce data are available about the impact of renal function trajectories and creatinine clearance (CrCl) temporal variability, on prognosis. Aim To evaluate the progression and impact of renal function impairment and variability on outcomes over a long-term follow-up observation in a cohort of anticoagulated AF patients. Methods We included warfarin-treated AF patients in SPORTIF trials with available creatinine clearance (according to Cockroft-Gault) at baseline and at least 4 evaluations throughout their follow-up. Patients with a BMI ≥45 kg/m2 were excluded from the analysis. Average successive variability (ASV) was used as measure of variability. Results Among 3665 original patients, 3366 (91.8%) were included in this analysis. Median [IQR] CHA2DS2-VASc score was 3 [2–4] and HAS-BLED was 3 [2–4]. At baseline, 876 (26.0%) patients had CKD (CrCl &lt;60 mL/min), with 14 (0.4%) patients having severe CKD (&lt;30 mL/min), with a mean (SD) CrCl of 86.7 (47.4) mL/min. Over a mean (SD) 577.1 (122.1) days of follow-up, a total of 521 new CKD cases were found with an overall incidence of 13.1 per 100 patient-years, with 91 new severe CKD cases (1.71 per 100 patient-years). Across follow-up, prevalence of CKD and severe CKD increased progressively (both p&lt;0.001) [Figure]. Mean (SD) AVS was −0.567 (±2.803) mL/min. According to AVS, patients were divided into quartiles: i) Q1: +34.012/+0.450; ii) Q2: +0.449/−0.443; iii) Q3: −0.443/−1.503; Q4: −1.505/−19.750. While no difference was found in stroke/systemic embolism, rate of major bleeding was higher in Q4 (4.5%) and Q1 (4.0%) than in other quartiles (Q2 2.5%, Q3 2.0%; p=0.009) as well as all-cause death (Q4: 6.7%; p=0.003 compared to other quartiles). A Cox multivariate adjusted model documented that AVS Q1 and Q4 were independently associated with a higher risk of major bleeding, while Q4 was associated with a higher risk of all-cause death (Table). Conclusion In a cohort of AF patients treated with warfarin, characterized by a progressive increase in the proportion with CKD and severe CKD, the largest reduction in CrCl throughout follow-up was associated to an increased risk of major bleeding and all-cause death. Renal Function Trajectories Funding Acknowledgement Type of funding source: None

Relationship of particular matter and temperature on the risk of adverse events in atrial fibrillation patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.M Rivera-Caravaca ◽  
V Roldan ◽  
V Vicente ◽  
G.Y.H Lip ◽  
F Marin
Keyword(s):  
Atrial Fibrillation ◽  
Air Pollution ◽  
Ischemic Stroke ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Air Pollutant ◽  
Aerodynamic Diameter ◽  
Increased Risk ◽  
The Impact

Abstract Background Ambient particulate matter (PM), is a principal component of air pollutant and the main culprit of the adverse effects of air pollution on humans' health. In particular, PM with aerodynamic diameter &lt;10 μm (PM10) has been shown to be associated with worse clinical outcomes. Similarly, cardiovascular risk increases during colder temperatures/seasons. Thus, both, air pollution and temperature fluctuations are examples confirming how the climate change is affecting our health. However, our knowledge about the impact of air pollution and temperature in anticoagulated atrial fibrillation (AF) patients is scarce. Purpose Herein, we investigated if PM10 and temperature are associated with an increased risk of adverse clinical outcomes in patients with AF taking vitamin K antagonists (VKAs). Methods We included AF patients who were stable on VKAs (INR 2.0–3.0) for 6 months in a tertiary hospital (Murcia, South-east Spain). During a median follow-up of 6.5 (IQR 4.3–7.9) years, ischemic strokes, major bleeds, adverse cardiovascular events, and mortality were recorded. From 2007–2016, data on average temperature and PM10 (PM with aerodynamic diameter &lt;10 μm) were obtained and related to clinical outcomes. Results 1361 patients (48.7% male; median age 76, IQR 71–81 years) were included. High PM10 and low temperatures were associated with higher risk of major bleeding (adjusted Hazard Ratio, aHR 1.44, 95% CI 1.22–1.70 and aHR 1.03, 95% CI 1.01–1.05) and mortality (aHR 1.50, 95% CI 1.34–1.69 and aHR 1.04, 95% CI 1.02–1.06) (Table 1). PM10 was also significantly associated with ischemic stroke and temperature with cardiovascular events. The relative risk for cardiovascular events and mortality increased in months in the lower quartile (Q1) of temperature (&lt;12.74°C) (RR 1.12, 95% CI 1.04–1.21 and RR 1.41, 95% CI 1.15–1.74; respectively). Comparing seasons, there were higher risks of cardiovascular events in spring, autumn, and winter than in summer, whereas the risk of mortality increased only in winter. Conclusions In AF patients taking VKAs highPM10 and low temperature were associated with an increased the risk of ischemic stroke and cardiovascular events, respectively. Both factors increased major bleeding and mortality risks, which were higher during colder months and seasons. Table 1. Univariate and Multivariate Cox Funding Acknowledgement Type of funding source: None

The Impact of Body Weight and Renal Function on the Risk of Bleeding With Direct Oral Anticoagulants in Atrial Fibrillation

2021 ◽  
pp. 106002802199520
Author(s):  
Hannah Whittemore ◽  
Andrew K. Posen ◽  
Erika L. Hellenbart ◽  
Vicki Groo ◽  
Eric Wenzler ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Body Weight ◽  
Renal Dysfunction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
The Impact

Background: Atrial fibrillation (AF) increases the risk of stroke and direct oral anticoagulants (DOACs) are first-line agents for prevention. Gaps in the literature cause reluctance in prescribing DOACs for patients with renal dysfunction and/or extremes in body weight. Objective: To evaluate the impact body weight and renal function have on major and clinically relevant nonmajor (CRNM) bleeding events and ischemic strokes in AF patients receiving a DOAC. Methods: This retrospective cohort study included adults with nonvalvular atrial fibrillation (NVAF) or atrial flutter (AFL) receiving a DOAC ≥12 months. The primary outcome was a composite of major and CRNM bleeding events. Secondary outcomes included ischemic stroke and risk factors for bleeding events. Results: Of the 233 patients analyzed, 25 patients experienced a bleeding event. Patients who bled weighed 10 kg less ( P = 0.043) than those who did not and had a higher HASBLED score ( P = 0.003). Multivariate logistic regression identified weight ( P = 0.048), serum creatinine (SCr; P = 0.027), and HASBLED score ( P = 0.024) as the significant predictors for experiencing a bleed. Three patients experienced a stroke. Conclusion and Relevance: This study demonstrates an association between higher baseline SCr, elevated HASBLED score, and lower weight, with an increased risk of bleeding in patients with NVAF or AFL receiving a DOAC. These findings add to prescribing considerations when initiating DOACs. Closer monitoring is advised for patients with significant renal dysfunction and/or low body weight, even with renal dose adjustments.

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