Comparative clinical outcomes of dronedarone and sotalol in Asian patients with atrial fibrillation: a nationwide cohort study
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SUBMITTER: Lee S
PROVIDER: S-EPMC7527331 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:Background Atrial tachyarrhythmias are common after atrial fibrillation ablation, so adjunctive antiarrhythmic drug therapy is often used. Data on the effectiveness and safety of dronedarone and sotalol after AF ablation are limited. Here, we compared health outcomes of ablated patients treated with dronedarone versus sotalol. Methods and Results A comparative analysis of propensity score-matched retrospective cohorts was performed using IBM MarketScan Research Databases. Patients treated with dronedarone after atrial fibrillation ablation were matched 1:1 to patients treated with sotalol between January 1, 2013 and March 31, 2018. Outcomes of interest included cardiovascular hospitalization, proarrhythmia, repeat ablation, and cardioversion. This study was exempt from institutional review board review. Among 30 696 patients who underwent atrial fibrillation ablation, 2086 were treated with dronedarone and 3665 with sotalol after ablation. Propensity-score matching resulted in 1815 patients receiving dronedarone matched 1:1 to patients receiving sotalol. Risk of cardiovascular hospitalization was lower with dronedarone versus sotalol at 3 months (adjusted hazard ratio [aHR], 0.77 [95% CI, 0.61-0.97]), 6 months (aHR, 0.76 [95% CI, 0.63-0.93]), and 12 months after ablation (aHR, 0.70 [95% CI, 0.66-0.93]). Risk of repeat ablation and cardioversion generally did not differ between the 2 groups. A lower risk of proarrhythmia was associated with dronedarone versus sotalol at 3 months (aHR, 0.76 [95% CI, 0.64-0.90]), 6 months (aHR, 0.80 [95% CI, 0.70-0.93]), and 12 months (aHR, 0.83 [95% CI, 0.73-0.94]) after ablation. Conclusions These data suggest that dronedarone may be a more effective and safer alternative after ablation than sotalol.
| S-EPMC9238499 | biostudies-literature
Project description:BackgroundFurther studies are needed to expand the evidence for the association of rivaroxaban with a lower risk of adverse renal outcomes in patients with atrial fibrillation (AF) as compared with warfarin, especially in Asians.ObjectivesTo determine whether there are differences in adverse renal outcomes between rivaroxaban and warfarin-treated AF patients.MethodsUsing the Korean nationwide claims database partly linked to laboratory results, patients with AF who initiated warfarin or rivaroxaban from 1 January 2014 to 31 December 2017 were identified. Inverse probability of treatment weighting (IPTW) was used to balance the baseline characteristics of the two groups. The primary outcome (kidney failure) was defined as the need for maintenance dialysis or having kidney transplantation. For the exploratory analysis in a subset of patients with baseline and follow-up laboratory results, the composite of renal outcomes, including estimated glomerular filtration rate (eGFR) lower than 15 ml/min/1.73 m2 at follow-up measurement, starting dialysis, or having kidney transplantation, ≥ 30% decline in eGFR, doubling of serum creatinine level, and acute kidney injury (AKI) were evaluated. The two groups were compared using Cox proportional hazards regression in the weighted population.ResultsWe identified 30,933 warfarin users and 17,013 rivaroxaban users (51% of low dose rivaroxaban). After IPTW, the mean age was 70 years, and the mean CHA2DS2-VASc score was 3.9 in both groups. During a median follow-up of 0.93 (interquartile ranges 0.23-2.10) years, weighted incidence rates of kidney failure for warfarin and rivaroxaban were 0.83 and 0.32 per 100 person-years, respectively. Compared with the warfarin group, the rivaroxaban group was associated with a lower risk of kidney failure (hazard ratio [HR] 0.389, 95% confidence interval [CI] 0.300-0.499, p < 0.001). In patients with preexisting chronic kidney disease or eGFR ≤ 60 ml/min/1.73 m2, rivaroxaban was more beneficial than warfarin in reducing the risk of kidney failure. For the composite of five renal outcomes in the exploratory analysis, the rivaroxaban group showed a lower risk than warfarin (HR 0.798, 95% CI 0.713-0.892, p < 0.001).ConclusionRivaroxaban was associated with lower risks of renal adverse outcomes than warfarin in Korean patients with AF.
| S-EPMC9996329 | biostudies-literature
Project description:IntroductionThere exists variability in the administration of in-patient sotalol therapy for symptomatic atrial fibrillation (AF). The impact of this variability on patient in-hospital and 30-day posthospitalization costs and outcomes is not known. Also, the cost impact of intravenous sotalol, which can accelerate drug loading to therapeutic levels, is unknown.MethodsOne hundred and thirty-three AF patients admitted for oral sotalol initiation at an Intermountain Healthcare Hospital from January 2017 to December 2018 were included. Patient and dosing characteristics were described descriptively and the impact of dosing schedule was correlated with daily hospital costs/clinical outcomes during the index hospitalization and for 30 days. The Centers for Medicare and Medicaid Services reimbursement for 3-day sotalol initiation is $9263.51. Projections of cost savings were made considering a 1-day load using intravenous sotalol that costs $2500.00 to administer.ResultsThe average age was 70.3 ± 12.3 years and 60.2% were male with comorbidities of hypertension (83%), diabetes (36%), and coronary artery disease (53%). The mean ejection fraction was 59.9 ± 7.8% and the median corrected QT interval was 453.7 ± 37.6 ms before sotalol dosing. No ventricular arrhythmias developed, but bradycardia (<60 bpm) was observed in 37.6% of patients. The average length of stay was 3.9 ± 4.6 (median: 2.2) days. Postdischarge outcomes and rehospitalization rates stratified by length of stay were similar. The cost per day was estimated at $2931.55 (1. $2931.55, 2. $5863.10, 3. $8794.65, 4. $11 726.20).ConclusionsIn-patient oral sotalol dosing is markedly variable and results in the potential of both cost gain and loss to a hospital. In consideration of estimated costs, there is the potential for $871.55 cost savings compared to a 2-day oral load and $3803.10 compared to a 3-day oral load.
| S-EPMC9305518 | biostudies-literature
Project description:BackgroundWe examined all-cause mortality and long-term thromboembolic risk (ischemic stroke, transient ischemic attack, systemic thromboembolism) in patients with and without familial atrial fibrillation (AF).Methods and resultsUsing Danish nationwide registry data, we identified all patients diagnosed with AF (1995-2012) and divided them into those with familial AF (having a first-degree family member with a prior AF admission) and those with nonfamilial AF. We paired those with and without familial AF according to age, year of AF diagnosis, and sex in a 1:1 match. Using cumulative incidence and multivariable Cox models, we examined the risk of long-term outcomes. We identified 8658 AF patients (4329 matched pairs) with and without familial AF. The median age was 50 years (interquartile range 43-54 years), and 21.4% were women. Compared with nonfamilial AF patients, those with familial AF had slightly less comorbid illness but similar overall CHA2DS2-VASc score (P=0.155). Median follow-up was 3.4 years (interquartile range 1.5-6.5 years). Patients with familial AF had risk of death and thromboembolism similar to those with nonfamilial AF (adjusted hazard ratio 0.91 [95% CI 0.79-1.04] for death and 0.90 [95% CI 0.71-1.14] for thromboembolism).ConclusionsAlthough family history of AF is associated with increased likelihood for development of AF, once AF developed, long-term risks of death and thromboembolic complications were similar in familial and nonfamilial AF patients.
| S-EPMC5210350 | biostudies-literature
Project description:Background Patients with aortic stenosis (AS) have been underrepresented in the trials evaluating direct oral anticoagulants (DOACs) in atrial fibrillation (AF). We aimed to assess whether AS impacts outcomes in patients with AF and estimate the effects of DOACs versus warfarin in patients with AF and AS. Methods and Results The registry-based FinACAF (Finnish Anticoagulation in Atrial Fibrillation) study covered all patients with AF diagnosed during 2007 to 2018 in Finland. Hazard ratios (HRs) of first-ever gastrointestinal bleeding, intracranial bleeding, any bleeding, ischemic stroke, and death were estimated with cause-specific hazards regression adjusted for anticoagulant exposure variables. We identified 183 946 patients (50.5% women; mean age, 71.7 [SD, 13.5] years) with incident AF without prior bleeding or ischemic stroke, of whom 5231 (2.8%) had AS. The crude incidence rate of all outcomes was higher in patients with AS than in patients without AS. After propensity score matching, AS was associated with the hazard of any bleeding, gastrointestinal bleeding, and death but not with intracranial bleeding or ischemic stroke (adjusted HRs, 1.36 [95% CI, 1.25-1.48], 1.63 [95% CI, 1.43-1.86], 1.32 [95% CI, 1.26-1.38], 0.96 [95% CI, 0.78-1.17], and 1.11 [95% CI, 0.99-1.25], respectively). Among patients with AS, DOACs were associated with a lower risk of ischemic stroke when compared with warfarin, while bleeding and mortality did not differ between DOACs and warfarin. Conclusions AS is associated with substantially higher risk of gastrointestinal bleeding in patients with AF. DOACs may be more effective in preventing ischemic stroke than warfarin in patients with AF and AS. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04645537.
| S-EPMC10227229 | biostudies-literature
Project description:Atrial fibrillation (AF) is a supraventricular arrhythmia that leads to a decrease in cardiac output and impairs cardiac function and quality of life. Dronedarone has an atrial-selective property and has been used for management of AF in humans, but limited information is available in dogs. This study was designed to evaluate efficacy of dronedarone in attenuating the duration of AF in dog model of sustained AF. Six beagle dogs were anesthetized with isoflurane and instrumented to measure atrial action potential duration (aAPD) and atrial effective refractory period (AERP). Then AF was induced by rapid right atrial pacing (20 V, 40 Hz) simultaneously with infusion of phenylephrine (2 µg/kg/min, intravenously) for 20 min. The duration of sustained AF was recorded, and the animals were allowed to recover. Dronedarone was given at a dose of 20 mg/kg, BID, orally for 7 days. On the last day, the dogs were anesthetized again to record aAPD and AERP, and AF was induced with the same procedure as described above. The results showed that after dronedarone administration the aAPD was lengthened significantly from 76.4 ± 4.2 ms to 91.2 ± 3.9 ms (P<0.05) and AERP was prolonged significantly from 97.5 ± 2.8 ms to 120 ± 4.8 ms (P<0.05). The duration of sustained AF was also significantly attenuated after receipt of dronedarone (P<0.05). It can be suggested that oral dronedarone attenuates the duration of sustained AF in a dog model of AF by extending the AERP more than the aAPD, causing post-repolarization refractoriness. Hence, dronedarone may be useful for management of AF in dogs.
| S-EPMC5543246 | biostudies-other
Project description:BackgroundThe number of patients requiring dialysis is increasing worldwide, and the atrial fibrillation and atrial flutter (AF) prevalence among hemodialysis (HD) patients is higher than in the general population. There have been no studies of Korean AF patients undergoing HD that investigated how AF affects outcomes, such as all-cause mortality, hospitalization, and stroke events. We conducted a large-scale retrospective cohort study with data from the National Health Insurance System to determine how AF affects these outcomes.MethodsIn 2013, the Health Insurance Review and Assessment service, a Korean national health insurance scheme, collected data from 21,839 HD patients to evaluate the adequacy of dialysis centers. All-cause mortality, hospitalization, and stroke events were compared between patients with and without AF. Sub-analyses compared these outcomes between AF patients receiving warfarin and those not receiving warfarin.ResultsCox regression analysis found that AF was a significant risk factor for death from any cause (hazard ratio [HR], 1.356; 95% confidence interval [CI], 1.222-1.506; p < 0.001), hospitalization (HR, 1.323; 95% CI, 1.225-1.430; p < 0.001), and hemorrhagic stroke (HR, 1.500; 95% CI, 1.050-2.141; p = 0.026). AF was not significantly associated with an increased risk of ischemic stroke. The use of warfarin was significantly associated with hemorrhagic stroke incidence (HR, 1.593; 95% CI, 1.075-2.360; p = 0.020), while there was no significant correlation between warfarin treatment and all-cause mortality, hospitalization, and ischemic stroke.ConclusionThis cohort study of Korean dialysis patients showed that AF was a risk factor for multiple outcomes among HD patients.
| S-EPMC8041641 | biostudies-literature
Project description:Dronedarone is an amiodarone derivative that was approved in the US in July 2009 to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF), who are in sinus rhythm (SR), or who will be cardioverted.This article reviews the pharmacology, adverse effects, and clinical evidence available to date on the use of dronedarone in the management of AF and its potential role in the emergency department setting.In the EURIDIS and ADONIS studies evaluating the efficacy of dronedarone in maintaining SR, dronedarone significantly reduced the risk of recurrence of AF compared to placebo, by 22% and 27%, respectively. The ERATO study examined the ability of dronedarone to control ventricular rate in permanent AF. The DIONYSOS study demonstrated that recurrences of AF were more frequent with dronedarone. However, discontinuation of therapy due to intolerance was more frequent with amiodarone. Furthermore, the ATHENA study demonstrated that dronedarone reduced mortality and cardiovascular hospitalization by 24% (P < 0.05) in patients in SR but with other associated risks and a history of AF. However, the ANDROMEDA study, evaluating the use of dronedarone in patients with recent decompensated heart failure, and the PALLAS study, evaluating the use of dronedarone in patients with chronic AF, were both terminated prematurely due to a trend toward an increased risk of cardiovascular events.Dronedarone has been demonstrated to be effective in reducing the incidence of AF recurrence. It appears to be less effective but better tolerated than amiodarone. Dronedarone appears to have a low proarrhythmic risk and is the first anti-arrhythmic that has been demonstrated to reduce cardiovascular mortality and cardiovascular hospitalization in clinically stable patients with other risk factors for recurrent AF. Therefore, dronedarone can be recommended as an anti-arrhythmic of choice in clinically stable patients for maintaining SR. If dronedarone is to be used in a patient with chronic stable heart failure, the patient must be monitored closely for any worsening of heart failure symptoms. The drug must be discontinued should the heart failure symptoms worsen.
| S-EPMC4753968 | biostudies-other
Project description:OBJECTIVES:We compared long-term outcomes in patients with atrial fibrillation (AF) with and without a secondary precipitant. DESIGN AND SETTING:Retrospective cohort study based on Danish nationwide registries. PARTICIPANTS:Patients with AF with and without secondary precipitants (1996-2015) were matched 1:1 according to age, sex, calendar year, CHA2DS2-VASc score and oral anticoagulation therapy (OAC), resulting in a cohort of 39 723 patients with AF with a secondary precipitant and the same number of patients with AF without a secondary precipitant. Secondary precipitants included alcohol intoxication, thyrotoxicosis, myocardial infarction, surgery and infection in conjunction with AF. PRIMARY AND SECONDARY OUTCOMES:The primary outcome in this study was thromboembolic events. Secondary outcomes included AF rehospitalisation and death. Long-term risks of outcomes were examined by multivariable Cox regression analysis. RESULTS:The most common precipitants were infection (55.0%), surgery (13.2%) and myocardial infarction (12.0%). The 5-year absolute risk of thromboembolic events (taking death into account as a competing risk) in patients with AF grouped according to secondary precipitants were 8.3% (alcohol intoxication), 8.5% (thyrotoxicosis), 12.1% (myocardial infarction), 11.6% (surgery), 12.2% (infection), 10.1% (>1 precipitant) and 12.3% (no secondary precipitant). In the multivariable analyses, AF with a secondary precipitant was associated with the same or an even higher thromboembolic risk than AF without a secondary precipitant. One exception was patients with AF and thyrotoxicosis: those not initiated on OAC therapy carried a lower thromboembolic risk the first year of follow-up than matched patients with AF without a secondary precipitant and no OAC therapy. CONCLUSIONS:In general, AF with a secondary precipitant was associated with the same thromboembolic risk as AF without a secondary precipitant. Consequently, this study highlights the need for more research regarding the long-term management of patients with AF associated with a secondary precipitant.
| S-EPMC6756362 | biostudies-literature
Project description:BackgroundAtrial fibrillation (AF) recurrence after catheter ablation is associated with worse outcomes and quality of life. Left atrial (LA) structural remodeling provides the essential substrate for AF perpetuation. Baseline extent and the progression of LA fibrosis after ablation are strong predictors of postprocedural AF recurrence. Dronedarone is an antiarrhythmic drug proven to efficiently maintain sinus rhythm.ObjectiveWe sought to investigate the effect of the antiarrhythmic drug Dronedarone in decreasing LA fibrosis progression and AF recurrence after ablation of AF patients.MethodsEDORA (NCT04704050) is a multicenter, prospective, randomized controlled clinical trial. Patients with persistent or paroxysmal AF undergoing AF ablation will be randomized into Dronedarone versus placebo/standard of care. The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation. All patients will receive a late-gadolinium enhancement magnetic resonance imaging at baseline, 3- and 12-month follow-up for the quantification of LA fibrosis and ablation-related scarring. AA recurrence and burden will be assessed using a 30-day ECG patch every 3 months with daily ECG recordings in between. Quality of life improvement is assessed using the AFEQT and AFSS questionnaires.ConclusionEDORA will be the first trial to assess the progression of LA structural remodeling after ablation and its association with Dronedarone treatment and ablation success in a randomized controlled fashion. The trial will provide insight into the pathophysiology of AF recurrence after ablation and may provide potential therapeutic targets to optimize procedural outcomes.
| S-EPMC9298087 | biostudies-literature