Abstract 12404: Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Normal Renal Function over Time: Insights From the ARISTOTLE Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Ziad Hijazi ◽  
Stefan H. H Hohnloser ◽  
Ulrika Andersson ◽  
John H Alexander ◽  
Christopher B Granger ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Major Bleeding ◽  
Normal Renal Function ◽  
Cox Regression ◽  
Factor Xa ◽  
Efficacy And Safety ◽  
Major Bleed ◽  
Over Time

Introduction: It has been recently observed that one oral factor-Xa inhibitor (at the dose studied) might be associated with decreased efficacy in patients with atrial fibrillation (AF) and normal renal function. In the ARISTOTLE trial, apixaban compared to warfarin reduced stroke, mortality, and major bleeding irrespective of renal function at baseline. Our aim was to evaluate the efficacy and safety of apixaban vs. warfarin in patients with normal renal function over time. Methods: In ARISTOTLE, 16,971 patients had serial creatinine measurements available after randomization. There were a total of 397 stroke or systemic embolic events, 286 ischemic or unspecified strokes, and 712 major bleed events during median follow-up of 1.8 years. Normal renal function was predefined as an estimated glomerular filtration rate (eGFR) >80 mL/min. The relations between renal function, treatment, and outcomes were investigated by using Cox regression with renal function as a continuous time dependent covariate, fitted using restricted splines. Hazard ratios with 95% confidence intervals (CI) were analyzed based on continuous eGFR level during follow-up using both the Cockcroft-Gault and CKD-EPI equations. Results: The relative risk of stroke or systemic embolism was consistently lower in participants randomized to apixaban compared with warfarin. The patterns were similar for the ischemic or unspecified stroke outcome as well as for major bleeding (Table). Conclusions: Apixaban, relative to warfarin, demonstrated preserved efficacy and safety in AF patients with normal renal function over time.

Abstract 17126: Efficacy and Safety of Dabigatran Compared With Warfarin in Patients With Atrial Fibrillation and Normal Renal Function Over Time: Insights From the RE-LY Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Ziad Hijazi ◽  
Stefan H Hohnloser ◽  
Jonas Oldgren ◽  
Ulrika Andersson ◽  
Stuart J Connolly ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Relative Risk ◽  
Major Bleeding ◽  
Normal Renal Function ◽  
Cox Regression ◽  
Factor Xa ◽  
Renal Elimination ◽  
Efficacy And Safety

Background: In patients with atrial fibrillation (AF) and normal renal function it has been reported that one oral factor-Xa inhibitor is associated with decreased efficacy compared to warfarin. In the RE-LY trial of patients with AF dabigatran, with approximately 80% renal elimination, was superior to warfarin for prevention of stroke and systemic embolism (SEE) with the 150 mg dose and non-inferior with the 110 mg dose and associated with significantly less major bleeding with the 110 mg dose. This is a post hoc analysis of the efficacy and safety of dabigatran vs. warfarin treatment in patients with normal renal function during the study. Methods: In the RE-LY trial among patients who received at least one dose of study medication, 17882 had creatinine measurements available at baseline, out of which 91% also had measurements after randomization. There were a total of 382 stroke/SEE, 280 ischemic strokes, and 1018 major bleed events during median follow-up of 1.8 years. The relations between outcomes, treatment, and renal function (Cockcroft-Gault estimated glomerular filtration rate (eGFR)) during follow-up were evaluated using Cox regression including treatment, eGFR as a continuous time dependent covariate, fitted using restricted cubic splines, and interaction. Hazard ratios (95% CI) comparing treatment effects were analyzed according to eGFR level. Results: In patients with normal renal function the relative risk of stroke/SEE was consistently lower in those treated with dabigatran as compared with warfarin. The patterns were similar for major bleeding with a trend of greater relative risk reduction with dabigatran as compared to warfarin at normal renal function. Conclusions: In patients with AF and normal renal function during treatment the efficacy of dabigatran compared to warfarin was consistent with the overall result of the RELY study. Both dabigatran doses were associated with lower risk of major bleeding in patients with normal renal function.

scholarly journals Efficacy and Safety of Non-Vitamin K Anticoagulants for Atrial Fibrillation in Relation to Different Renal Function Levels: A Network Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-26
Author(s):  
Hao Jin ◽  
Kongbo Zhu ◽  
Lina Wang ◽  
Yifan Li ◽  
Jingjun Meng ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Renal Impairment ◽  
Major Bleeding ◽  
Normal Renal Function ◽  
Meta Analysis ◽  
Effective Drug ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Mild Renal Impairment

Background. We performed a network meta-analysis (NMA) comparing the efficacy (stroke or systemic embolism) and safety (major bleeding) among different non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) and renal impairment, with the aim of recommending the proper drug and the dose based on renal function. Methods. We searched PubMed, EMBASE, Web of Science, and Cochrane Library with the items “dabigatran, edoxaban, apixaban, rivaroxaban, warfarin, and atrial fibrillation” through August 2019. NMA was analyzed with R (version 3.5.1, R Foundation for Statistical Computing) with the packages gemtc recalling JAGS (version 4.3.0) for the efficacy and safety of each drug with regard to different levels of renal function. NetMetaXL (version 1.6.1) and winBUGS (version 1.4.3) were used to obtain the cumulative ranking curve (SUCRA) of each drug. Result. In patients with normal renal function, dabigatran150 was ranked as the most effective drug (SUCRA 0.90), followed by dabigatran110 (SUCRA 0.68), apixaban (SUCRA 0.66), and rivaroxaban (SUCRA 0.59). With regard to the safety for preventing major bleeding, there was high probability that edoxaban30 (SUCRA 0.99) ranked first, compared to dabigatran110 (SUCRA 0.78) and edoxaban60 (SUCRA 0.66). For patients with mild renal impairment, with respect to the most effective drug for preventing stroke or systemic embolism, edoxaban60 ranked first (SUCRA 0.98), in comparison with dabigatran150 (SUCRA 0.74) and apixaban (SUCRA 0.64). Possibility of ranking first for the safest drug was edoxaban30 (SUCRA 0.99), followed by dabigatran110 (SUCRA 0.70) and apixaban (SUCRA 0.69). In patients with moderate renal function, dabigatran150 (SUCRA 0.95) ranked as the most effective drug in comparison with apixaban (SUCRA 0.66). Dabigatran110 (SUCRA 0.53), rivaroxaban (SUCRA 0.51), and edoxaban60 (SUCRA 0.50) had the similar probability of ranking third. When referred to the safest drug, probability of ranking first for preventing major bleeding was edoxaban30 (SUCRA 0.98), followed by apixaban (SUCRA 0.85) and edoxaban60 (SUCRA 0.64). Conclusion. In patients with AF and renal impairment and for patients with normal renal function, dabigatran 110 mg (bid) might have a better effect on the clinical results. And it does not coincide with patients taking dabigatran 110 mg with dose reduction for other factors including aged ≥75 years, renal impairment (CrCL 30–50 mL/min), gastritis, esophagitis, or gastroesophageal reflux, receiving concomitant verapamil, and so on. For patients with mild renal impairment, apixaban 5 mg (bid) would be a better choice for preventing stroke or systemic embolism and major bleeding, while apixaban 5 mg (bid) and edoxaban 60 mg (qd) were recommended for patients with moderate renal impairment. However, considering the fact of no RCTs for the head-to-head comparison, caution should be exercised over selecting each of NOACs for patients.

scholarly journals Relationship between the Renal Function and Adverse Clinical Events in Patients with Atrial Fibrillation: A Japanese Multicenter Registry Substudy

2020 ◽  
Vol 9 (1) ◽  
pp. 167
Author(s):  
Yasuhumi Yuzawa ◽  
Keiichiro Kuronuma ◽  
Yasuo Okumura ◽  
Katsuaki Yokoyama ◽  
Naoya Matsumoto ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Major Bleeding ◽  
Normal Renal Function ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real World Data ◽  
Clinical Events ◽  
Gault Formula

Background: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist, but the real-world data after approval of direct oral anticoagulants (DOACs) are still lacking in Japan. We investigated the association of the baseline renal function and adverse clinical events and risk of adverse clinical events with DOACs compared to warfarin for each renal functional level in Japanese AF patients. Methods: The present substudy was based on the SAKURA AF Registry, a Japanese multicenter observational registry (median follow-up period: 39 months). The creatinine clearance (CrCl) values were estimated by the Cockcroft–Gault formula, and divided into normal renal function, and mild and moderate-severe CKD (CrCl ≥ 80, 50–79, <50 mL/min). Results: In the SAKURA AF Registry, the baseline CrCl data were available for 3242 patients (52% for DOAC and 48% for warfarin user). The relative risk of adverse clinical events was significantly higher in the patients with a CrCl < 50 mL/min as compared to those with a CrCl ≥ 80 mL/min (adjusted HRs: 2.53 for death, 2.53 for cardiovascular [CV] events, 2.13 for strokes, and 1.83 for major bleeding). Risks of all adverse clinical events were statistically even between DOAC and warfarin users for each renal function level. Conclusion: Moderate–severe CKD was associated with a higher mortality, CV events, strokes, and major bleeding than normal renal function. The safety and effectiveness of DOACs over warfarin were similar for each renal function level. By a worsening renal function, the incidence of adverse clinical events increased, especially deaths and CV events as compared to strokes and major bleeding.

Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 502-502
Author(s):  
Vera Gelbricht ◽  
Sebastian Werth ◽  
Christina Koehler ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Safety Data ◽  
Real Life ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Daily Care ◽  
Short Period

Abstract Abstract 502 Background: In the RE-LY trial, dabigatran (DB) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF), which lead to approval in many countries. However, patients in RCT‘s present a selected population treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives: To evaluate the efficacy, safety and management issues of dabigatran anticoagulation in AF in daily care. Patients and methods: In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July31th 2012, 938 patients were registered. Of these, 201 received DB for AF (table 1). The population in our registry is older than in RELY (74.2 vs. 71.5 years) and has a higher CHADS2-Score (2.7 vs. 2.1). Interestingly, 110 mg BID was the preferred dosage in DB patients (55.7%) despite the fact that these patients had higher CHADS2-scores than patients receiving 150 mg BID (2.3 vs. 2.9). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications. Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 86.8 patient years. During FU, Three patients (1.5%) experienced major cardiovascular events (xyz) and another two patients (1.0%) minor cardiovascular events (syncope). Until now, no deaths occurred. Bleeding complications were frequent (14.9%) but major bleeding was rare (n=3; 1.5%) none of which was fatal. At 3 month, 93% of patients were still taking DB but switch to other anticoagulants increased between 3 and 6 month, mainly due to side effects or incompliance. Conclusion: In unselected patients in daily care, DB is effective and safe with low rates of cardiovascular or major bleeding events. However, within 6 month, about 20% of patients are switched to other anticoagulants. Long-term data will be reported. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

scholarly journals Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial

Circulation ◽  
2021 ◽  
Vol 143 (7) ◽  
pp. 673-684
Author(s):  
Thomas A. Zelniker ◽  
Maddalena Ardissino ◽  
Felicita Andreotti ◽  
Michelle L. O’Donoghue ◽  
Ophelia Yin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Hemorrhagic Stroke ◽  
Factor Xa ◽  
Efficacy And Safety ◽  
Similar Reduction ◽  
Similar Treatment ◽  
Endogenous Factor ◽  
Fatal Bleeding ◽  
Artery Disease

Background: Female sex is an independent risk factor for stroke and systemic embolic events in patients with atrial fibrillation. This study aimed to examine the efficacy and safety profile of edoxaban in women versus men. Methods: The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) randomly assigned 21 105 patients (8040 women) with atrial fibrillation and CHADS 2 score ≥2 either to a higher-dose edoxaban regimen, a lower-dose edoxaban regimen, or warfarin. The primary end points of the trial were the composite of stroke or systemic embolic events (efficacy), and International Society on Thrombosis and Haemostasis–defined major bleeding (safety). Results: In comparison with men, women were older, had lower body weight, were more likely to have hypertension and renal dysfunction, but less likely to smoke, drink alcohol, or have diabetes or coronary artery disease. Pretreatment endogenous factor Xa activity was significantly higher in women than in men (92.5% versus 86.1%, P <0.001). Treatment with edoxaban in women resulted in greater peak edoxaban concentration and inhibition of endogenous factor Xa in comparison with men, resulting in similar endogenous factor Xa activity between the sexes 2 to 4 hours after dose. Treatment with higher-dose edoxaban regimen (versus warfarin) resulted in similar reduction in the risk of stroke/systemic embolic events (women: hazard ratio [HR], 0.87 [0.69–1.11], men: HR, 0.87 [0.71–1.06]; P -interaction=0.97) and major bleeding (women: HR, 0.74 [0.59–0.92], men: HR, 0.84 [0.72–0.99]; P -interaction=0.34) in women and men. However, women assigned to higher-dose edoxaban regimen experienced greater reductions in hemorrhagic stroke (HR, 0.30 [95% CI, 0.15–0.59] versus HR, 0.70 [95% CI, 0.46–1.06]), intracranial bleeding (HR, 0.20 [95% CI, 0.10–0.39] versus HR, 0.63 [95% CI, 0.44–0.89]), and life-threatening or fatal bleeding (HR, 0.25 [95% CI, 0.15–0.42] versus HR, 0.72 [95% CI, 0.54–0.96]) than men (each P -interaction<0.05). Conclusions: Despite many differences in baseline characteristics between women and men and higher baseline endogenous factor Xa levels in women, the intensity of anticoagulation achieved with edoxaban between the sexes was similar. Treatment with higher-dose edoxaban regimen resulted in an even greater reduction in hemorrhagic stroke and several serious bleeding outcomes in women than in men, whereas the efficacy profile was similar between sexes.

Abstract P111: Sex Differences in Rate or Rhythm Control and Outcomes Among Elderly Patients With Atrial Fibrillation

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Vinita Subramanya ◽  
J'Neka S Claxton ◽  
Pamela L Lutsey ◽  
Richard MacLehose ◽  
Alanna M Chamberlain ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Rate Control ◽  
Treatment Strategy ◽  
Cox Regression ◽  
Rhythm Control ◽  
To Receive

Introduction: Women with atrial fibrillation (AF) experience greater symptomatology, worse quality of life, and have a higher risk of stroke as compared to men, but are less likely to receive rhythm control for the treatment of AF. Whether these differences exist in elderly patients with AF, and whether sex modifies the effectiveness of rhythm versus rate control therapy has not been assessed. Methods: We studied 135,850 men and 139,767 women 75 years or older diagnosed with AF in the MarketScan Medicare database between 2007-2015. Rate control was defined as use of rate control medication or atrioventricular node ablation. Rhythm control was defined by use of anti-arrhythmics, catheter ablation or cardioversion. Participants on both rate and rhythm were coded under rhythm control. We used multivariable logistic and Cox regression models to estimate 1) the association of sex and treatment strategy (within 30-day post AF diagnosis and entire follow-up) and, 2) the association of treatment strategy with incident heart failure, stroke and major bleeding. Results: Men were on average (SD) 82.5 (5.2) years old and women 83.8 (5.6) years, respectively. Women were less likely to receive rhythm control treatment as compared to men in the 30-day post AF diagnosis period (22% vs 27%), (OR 0.91, 95% CI 0.88, 0.94) and over the entire duration of follow-up (28% vs 32%) (HR 0.93, 95% CI 0.90, 0.96). Rhythm (vs. rate) control was associated with a higher risk of heart failure in women [HR 1.41, 95% CI 1.34, 1.49] than in men [HR, 1.21 95% CI 1.15, 1.28] (p for multiplicative interaction < 0.001, Table ). Sex did not modify associations between treatment and incident stroke or major bleeding events. Conclusion: Women aged 75 years and older were less likely to be prescribed rhythm control as compared to men, and experienced higher risk of heart failure than men when receiving rhythm (vs rate) control. Future studies will need to delve into the mechanisms underlying these differences.

Decline in renal function and oral anticoagulation dose reduction among patients with atrial fibrillation

Heart ◽  
2020 ◽  
Vol 106 (5) ◽  
pp. 358-364 ◽  
Author(s):  
Taku Inohara ◽  
DaJuanicia N Holmes ◽  
Karen Pieper ◽  
Rosalia G Blanco ◽  
Larry A Allen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Dose Reduction ◽  
Oral Anticoagulation ◽  
Oral Anticoagulants ◽  
Bleeding Complications ◽  
The Us ◽  
Informed Treatment ◽  
Over Time

ObjectiveNon-vitamin K oral anticoagulants (NOACs) require dose adjustment for renal function. We sought to investigate change in renal function over time in patients with atrial fibrillation (AF) and whether those on NOACs have appropriate dose adjustments according to its decline.MethodsWe included patients with AF enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry treated with oral anticoagulation. Worsening renal function (WRF) was defined as a decrease of >20% in creatinine clearance (CrCl) from baseline. The US Food and Drug Administration (FDA)-approved package inserts were used to define the reduction criteria of NOACs dosing.ResultsAmong 6682 patients with AF from 220 sites (median age (25th, 75th): 72.0 years (65.0, 79.0); 57.1% male; median CrCl at baseline: 80.1 mL/min (57.4, 108.5)), 1543 patients (23.1%) experienced WRF with mean decline in CrCl during 2 year follow-up of −6.63 mL/min for NOACs and −6.16 mL/min for warfarin. Among 4120 patients on NOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions. Of these, NOACs dosing was appropriately reduced in only 31 (20.1%) patients. Compared with patients with appropriately reduced NOACs, those without were more likely to experience bleeding complications (major bleeding: 1.7% vs 0%; bleeding hospitalisation: 2.6% vs 0%) at 1 year.ConclusionsIn the US practice, about one-fourth of patients with AF had >20% decline in CrCl over time during 2 year follow-up. As a result, about 3.7% of those treated with NOACs met guideline criteria for dose reduction, but of these, only 20.1% actually had a reduction.

P5708Balancing risk and benefit in patients with atrial fibrillation: the GARFIELD-AF risk score

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Fox ◽  
S Virdone ◽  
K Pieper
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Major Bleeding ◽  
Proportional Hazards Model ◽  
Haemorrhagic Stroke ◽  
Cox Proportional Hazards Model ◽  
Large Set ◽  
Risk Of Death ◽  
Major Bleed

Abstract Background The GARFIELD-AF risk tool was originally developed to predict future risk of adverse events in patients with atrial fibrillation (AF) using a range of baseline clinical variables. In the present work a new, improved risk tool was developed using data from all five GARFIELD cohorts gathered over 2 years' follow-up. Purpose To derive a new integrated risk tool for predicting mortality, stroke/systemic embolism (SE), and major bleeding in AF patients up to 2 years after enrolment and compare the risk tool versus CHA2DS2-VASc and HAS-BLED. Methods GARFIELD-AF is an international prospective registry of nonvalvular AF patients diagnosed within 6 weeks prior to enrolment and having at least one risk factor for stroke. In this study only the first occurrence of events was considered. Event rates were estimated using a Poisson model. Potential predictors of events including a large set of demographics, clinical characteristics, choice of treatment, and lifestyle factors were identified, and a Cox proportional hazards model chosen for each outcome by least absolute shrinkage and selection operator (LASSO). Indices were compared versus models of CHA2DS2-VASc and HAS-BLED. Results Among a total 52,080 patients enrolled 52,032 (male, 55.8%; median age, 71 years) had available follow-up data. At 2 years, 3702 patients had died (event rate, 3.82 [95% CI, 3.70–3.95] per 100 patient-years) whereas non-haemorrhagic stroke/SE was noted in 957 patients (rate, 1.00 [95% CI, 0.94–1.06] per 100 patient-years) and major bleed/haemorrhagic stroke in 673 patients (rate, 0.70 [95% CI, 0.65–0.75] per 100 patient-years). The GARFIELD risk tool outperformed CHA2DS2-VASc and HAS-BLED at predicting all adverse events in the overall population and pre-selected subpopulations over 2 years. Notably, the new model identified use of OAC therapy, which is not included in CHA2DS2-VASc, as one of the strongest predictors of risk of mortality and stroke, and unlike HAS-BLED, could discriminate a lower risk of bleeding in patients treated with NOACs versus VKAs. Population All-cause mortality Stroke/SE Major bleeding* GARFIELD CHA2DS2-VASc GARFIELD CHA2DS2-VASc GARFIELD CHA2DS2-VASc Overall 0.76 (0.75–0.76) 0.66 (0.65–0.67) 0.68 (0.67–0.70) 0.64 (0.62–0.66) – – AC treated 0.74 (0.73–0.75) 0.65 (0.64–0.66) 0.68 (0.66–0.70) 0.65 (0.62–0.67) 0.67 (0.64–0.69) 0.63 (0.61–0.65) *Model only considers AC-treated patients. Conclusions The GARFIELD-AF risk tool demonstrated good calibration and discrimination, outperforming CHA2DS2-VASc at predicting risk of death and non-haemorrhagic stroke and HAS-BLED for major bleed in AF patients over 2 years. Acknowledgement/Funding The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer AG.

scholarly journals Efficacy and safety of dronedarone vs placebo in patients with atrial fibrillation or atrial flutter across a spectrum of renal function: post hoc analyses of the EURIDIS-ADONIS trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Thind ◽  
W Zareba ◽  
D Atar ◽  
H Crijns ◽  
J Zhu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Adverse Events ◽  
Atrial Flutter ◽  
Cox Regression ◽  
Wide Spectrum ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Private Company ◽  
Post Hoc

Abstract Background/Introduction The use of antiarrhythmic drugs in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Since CKD commonly co-occurs with atrial fibrillation/atrial flutter (AF/AFL), it is important to establish efficacy and safety for such drugs when used in AF/AFL patients with CKD. Purpose To evaluate the efficacy and safety of dronedarone in patients with AF or AFL across different levels of renal function. Methods This post hoc analysis evaluated pooled data from two multicentre, double-blind, randomised (2:1) trials of rhythm control with dronedarone 400 mg twice daily vs placebo. Primary endpoint was time to first recurrence of AF or AFL. Renal function (estimated glomerular filtration rate [eGFR]) was assessed with the CKD-Epidemiology Collaboration equation. Patients were grouped by eGFR strata. Log-rank testing and Cox regression were used to compare time to events between treatment groups. Results Most (85%) patients had mild or mild-to-moderate decrease in eGFR (Table 1). Median time to first AF recurrence was significantly longer in the dronedarone vs placebo group for all eGFR subgroups except the 30–44 mL/min group (Figure 1), where the trend was consistent; however, the small population size may have precluded meaningful analyses in this subgroup. Serious adverse events, deaths, and treatment discontinuations did not differ notably between each group irrespective of eGFR strata. Conclusions This analysis confirms the efficacy and safety of dronedarone in patients with AF across a wide spectrum of renal function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi

scholarly journals Associations of Atrial Fibrillation Patterns With Mortality and Cardiovascular Events: Implications of the MISOAC-AF Trial

2022 ◽  
Vol 27 ◽  
pp. 107424842110694
Author(s):  
Amalia Baroutidou ◽  
Anastasios Kartas ◽  
Athanasios Samaras ◽  
Andreas S. Papazoglou ◽  
Eleni Vrana ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cox Regression ◽  
Bleeding Events ◽  
Mortality And Morbidity ◽  
Hospitalization Rates ◽  
Kaplan Meier ◽  
Prognostic Implications ◽  
Post Hoc

Aim: This retrospective cohort study aimed to evaluate the prognostic implications of the distinct atrial fibrillation (AF) temporal patterns: first diagnosed, paroxysmal, and persistent or permanent AF. Methods: In this post hoc analysis of the MISOAC-AF trial (NCT02941978), a total of 1052 patients with AF (median age 76 years), discharged from the cardiology ward between 2015 and 2018, were analyzed. Kaplan-Meier and Cox-regression analyses were performed to compare the primary outcome of all-cause mortality, the secondary outcomes of stroke, major bleeding and the composite outcome of cardiovascular (CV) mortality or hospitalization among AF patterns. Results: Of patients, 121 (11.2%) had first diagnosed, 356 (33%) paroxysmal, and 575 (53.2%) persistent or permanent AF. During a median follow-up of 31 months (interquartile range 10 to 52 months), 37.3% of patients died. Compared with paroxysmal AF, patients with persistent or permanent AF had higher mortality rates (adjusted hazard ratio (aHR), 1.37; 95% confidence interval [CI], 1.08-1.74, P = .009), but similar CV mortality or hospitalization rates (aHR, 1.09; 95% CI, 0.91-1.31, P = .35). Compared with first diagnosed AF, patients with persistent or permanent AF had similar mortality (aHR, 1.26; 95% CI, 0.87-1.82, P = .24), but higher CV mortality or hospitalization rates (aHR, 1.35; 95% CI, 1.01-1.8, P = .04). Stroke and major bleeding events did not differ across AF patterns (all P > .05). Conclusions: In conclusion, in recently hospitalized patients with comorbid AF, the presence of persistent or permanent AF was associated with a higher incidence of mortality and morbidity compared with paroxysmal and first diagnosed AF.

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