Elderly Atrial Fibrillation Patients Research Articles

Clinical implications of assessment of apixaban levels in elderly atrial fibrillation patients: J-ELD AF Registry sub-cohort analysis

Abstract Background Randomized clinical trials demonstrated the efficacy and safety of apixaban in preventing stroke in patients with atrial fibrillation (AF). However, data on distribution of apixaban levels and their relationships with clinical outcomes are limited. Purpose To evaluate the distribution of blood apixaban concentration and its relationship with clinical outcomes. Method The J-ELD AF Registry is a large-scale, multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75 years taking on-label dose (standard dose of 5 mg bid or reduced dose of 2.5 mg bid) of apixaban. Among the entire cohort (3,015 patients from 110 institutions), plasma apixaban levels at trough was measured by anti-Xa assay (Api-AXA) in 943 patients. The 943 patients were divided into 2 groups by the apixaban dose (standard dose [n=431] and reduced dose [n=512]) and each group was further divided into 2 groups with low and high Api-AXA levels compared with the median value. Results In patients with standard dose, the incidence rates (/100 person-years) of stroke or systemic embolism (1.48 and 1.99), bleeding requiring hospitalization (0.98 and 1.49), and total deaths (0.49 and 0.99) were comparable between low and high Api-AXA groups, respectively. In patients with reduced dose, although the incidence rates (/100 person-years) of stroke or systemic embolism (0.84 and 1.68) were comparable, bleeding requiring hospitalization (0.42 and 4.64), and total deaths (2.52 and 6.65) were significantly higher in high Api-AXA group than in low Api-AXA group. Multivariable Cox regression analysis revealed that in patients with reduced dose, high Api-AXA level was independently associated with bleeding requiring hospitalization (HR 12.12, 95% CI: 1.56–94.22, P=0.017) and insignificantly with total deaths (HR 2.15, 95% CI: 0.83–5.55, P=0.116). Conclusions High trough apixaban level in patients with standard dose was not associated with adverse events, while that in patients with reduced dose was associated with bleeding requiring hospitalization and total deaths. Measurement of apixaban levels may be informative in elderly patients indicated for reduced dose possibly with the intent of risk stratification and decision making. Funding Acknowledgement Type of funding source: Other. Main funding source(s): Bristol-Myers Squibb K.K.

Edoxaban treatment of elderly patients with atrial fibrillation in routine clinical practice: 1-year results of the non-interventional Global ETNA-AF program

Abstract Background The prevalence of atrial fibrillation (AF) and the need for appropriate anticoagulation increase with age. The benefit/risk profile of direct oral anticoagulants such as edoxaban in elderly population with AF in regular clinical practice is therefore of particular interest. Purpose Analyses of Global ETNA-AF data were performed to report patient characteristics, edoxaban treatment, and 1-year clinical events by age subgroups. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program conducted in Europe, Japan, Korea, Taiwan, and other Asian countries. Demographics, baseline characteristics, and 1-year clinical event data were analysed in four age subgroups. Results Of 26,823 patients included in this analysis, 50.4% were ≥75 years old and 11.6% were ≥85 years. Increase in age was generally associated with lower body weight, lower creatinine clearance, higher CHA2DS2-VASc and HAS-BLED scores, and a higher percentage of patients receiving the reduced dose of 30 mg daily edoxaban. At 1-year, rates of ISTH major bleeding and ischaemic stroke were generally low across all age subgroups. The proportion of intracranial haemorrhage within major bleeding events was similar across age groups. All-cause mortality increased with age more than cardiovascular mortality. Conclusion Data from Global ETNA-AF support the safety and effectiveness of edoxaban in elderly AF patients (including ≥85 years) in routine clinical care with only a small increase in intracranial haemorrhage. The higher all-cause mortality with increasing age is not driven by cardiovascular causes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo

Oral anticoagulants in extremely high risk very elderly (>90 years) patients with Atrial Fibrillation

Abstract Background The prevalence and incidence of atrial fibrillation (AF) increases with age, resulting in a high mortality and morbidity, especially from stroke and systemic thromboembolism (SSE). Nonetheless, the elderly are often denied oral anticoagulants (OACs), especially if they are “very elderly” (age ≥90 years) and perceived to be “high risk” of bleeding, for example, those with a history of intracranial haemorrhage (ICH), gastrointestinal bleeding or chronic kidney disease. We aimed to investigate the effectiveness and safety of OAC in this “high risk” very elderly group. Methods We used the Taiwan National Insurance Database to identify “high risk” very elderly subjects taking OACs, whether warfarin or non-vitamin K antagonist OACs (NOACs), who were compared to non-OAC users for the composite clinical endpoint of “ischemic stroke, ICH, major bleeding or mortality”. Propensity score matching was used for comparisons of the treatment groups. Results We studied 7,362 subjects (48.4% males; mean age 92.5 years, SD 2.78), of which 1737 were taking NOACs, 670 warfarin and 4955 were non-OAC users. Using non-OAC users as the reference group, warfarin use in “high risk” very elderly patients was associated with a higher risk of the composite endpoint (adjusted hazard ratio [aHR] 1.163, 95% CI 1.052–1.287), while NOACs were associated with a lower risk (aHR 0.763, 0.702–0.830). After propensity matching, NOACs were associated with a lower risk of events compared to “non-OAC use” or “warfarin”, while warfarin had a similar risk compared to non-OAC use (Figure). Conclusions Warfarin was associated with a similar (after propensity matching) or higher (Cox model before matching) risk of the composite clinical outcome compared to non-OAC use. NOACs were associated with a significantly lower risk of the composite clinical outcome compared to warfarin or non-OAC use. NOACs should be considered as the preferred OAC strategy in these “high risk” very elderly AF patients. Funding Acknowledgement Type of funding source: None

Risk factors associated with stroke/systemic embolic events in elderly non-valvular atrial fibrillation patients in the ANAFIE registry, the largest real-world elderly AF registry

Abstract Background Since prevalence of atrial fibrillation (AF) is increasing by aging, AF in elderly has been recognized as a big burden to keep long lasting healthy life worldwide. CHADS2 and CHA2DS2-VASc scores are commonly used for stroke risk assessment for AF, but predictors for elderly was not well elucidated, especially for very elderly (≥85 years old) patients. Purpose All Nippon AF In the Elderly (ANAFIE) registry was designed to evaluate a real-world treatment status of elderly (≥75 years old) non-valvular AF (NVAF) patients, including anticoagulant therapy and outcomes. The present analysis aimed to identify factors for stroke/systemic embolic events (SEE) of elderly NVAF patients using the dataset of ANAFIE registry, which was conducted in Japan. Methods Total of 32,099 patients aged ≥75 years with NVAF were enrolled in ANAFIE registry, and followed for 2 years. Incidence of stroke/SEE for total population, <85 years old group and ≥85 years old group was estimated using Kaplan-Meier method. Cox proportional hazards model was used to determine independent predictors of stroke/SEE. The factors included in the model were selected by backward elimination procedure. Results Mean age was 81.5 years. 23,738 (74%) was <85 years old and 8,361 (26%) was ≥85 years old. Women were more prevalent in ≥85 years old than in <85 years old group (53.2 vs 39.0%). Mean CHADS2 and CHA2DS2-VASc scores in the ≥85 years group were 3.0 and 4.7, and 2.8 and 4.4 in the <85 years group, respectively. 92.5% of whole population used anti-coagulants including warfarin (27.6%) or direct oral anticoagulants (DOACs) (72.3%). Stroke/SEE occurred in 396 patients at 12 month with 256 in <85 years old and 140 in ≥85 years old group. The cumulative incidence rate of stroke/SEE by Kaplan-Meier method at 12 months was 1.2% in the whole patients, and was higher in ≥85 years than in <85 years old group (1.7% vs 1.1%). In the multivariate analysis using the whole patients, age ≥85 years (hazard ratio [HR]: 1.27), history of major bleeding (HR: 1.93), persistent AF (HR: 1.64), longstanding persistent and permanent AF (HR: 1.61), high systolic blood pressure (130-<140 [HR: 1.43], ≥140 [HR: 1.44]), prior stroke (HR: 2.09), dementia (HR: 1.34), creatinine clearance <30 mL/min (HR: 1.82) emerged as independent predictors. Independent predictors for stroke/SEE were almost similar between <85 and ≥85 years old group except hypertension and diabetes. High blood pressure was associated with stroke/SEE only in patients aged <85 years, and high blood sugar was only associated in patients aged ≥85 years. Conclusion Among elderly NVAF patients in the era of DOACs, higher age (≥85 years), type of AF, prior major bleeding, high blood pressure, prior stroke, dementia, and low creatinine clearance were identified as independent predictors of stroke/SEE. The blood pressure and blood sugar control differently affected <85 years vs ≥85 years old group. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

Thromboembolic events and major bleeding in frail patients with incident atrial fibrillation: a nationwide cohort study

Abstract Background Growing evidence suggests that frail patients presenting with atrial fibrillation (AF) are less likely to receive adequate oral anticoagulant therapy (OAC) despite high thromboembolic risk. There is a paucity of evidence investigating clinical outcomes in different antithrombotic strategies. Purpose To assess thromboembolic events, bleeding, and all-cause mortality according to OAC treatment regimen in a Danish nationwide cohort of frail patients with AF Method We included all patients with non-valvular AF between 2011 and 2018 who were aged ≥64 years and had a frailty risk score >5 according to the ICD-10 based Hospital Frailty Risk Score. Patients with an OAC indication other than atrial fibrillation were excluded. The cohort was stratified by treatment regimen: warfarin, NOACs standard dose, NOACs reduced dose, or no OAC, determined by treatment status within 60 days before and 30 days after AF diagnosis. Patients were followed from 30 days after AF diagnosis (index date) for the occurrence of thromboembolic events and major bleeding. Cumulative incidence functions were used to depict development of outcome risk over time using on the Aalen–Johansen estimator assuming death as competing risk. Results We identified 31,745 frail AF patients (mean age 80.7 years, 53.8% female); 16540 (52.1%) received no OAC, 2993 (9.4%) received warfarin, 6181 (19.5%) received standard dose NOACs, and 6031 (19.0%) revived reduced dose NOACs. Risk of developing the outcomes over time is depicted in Figure 1. At 1-year follow-up, the absolute risk of thromboembolic events was 5.0% for patients with no OAC, 4.2% for reduced dose NOACs, 4.1% for warfarin, and 3.4% for standard dose NOACs. Bleeding risk was 6.1% for warfarin, 5.4% for reduced dose NOACs, 5.2% for No OAC, and 5.1% for standard dose NOACs. Conclusions Most patients in this nationwide cohort of elderly frail AF patients received no OAC, which was associated with a high risk of thromboembolism. The associated risk of thromboembolism was lower in patients receiving other studied treatment modalities, which might suggest a benefit of OAC across different antithrombotic strategies in frail AF patients. However, differences in risk profile and patient specific factors are likely to influence our observations, and studies investigating the comparative effectiveness and safety of NOACs including dosage regimens in frail AF patients are warranted. Figure 1. Cumulative risk of events Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer AG

Impact of creatinine clearance on clinical outcomes in elderly atrial fibrillation patients receiving apixaban: J-ELD AF Registry sub-analysis

Abstract Background Randomized clinical trials demonstrated the efficacy and safety of apixaban in preventing stroke in patients with atrial fibrillation (AF). However, data on patients with low creatinine clearance (CCr), especially CCr 15–29 mL/min, are limited. Methods The J-ELD AF Registry is a large-scale, multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75 years taking on-label dose (standard dose of 5 mg bid or reduced dose of 2.5 mg bid) of apixaban. The enrollment period was from September 2015 to August 2016, and the observation period for each patient was 1 year. The entire cohort (3,015 patients from 110 institutions) was divided into three CCr subgroups: CCr ≥50 mL/min (n=1,165, 38.6%), CCr 30–49 mL/min (n=1,395, 46.3%), and CCr 15–29 mL/min (n=455, 15.1%). Results Most patients (74.3%) in the CCr ≥50 group received the standard apixaban dose, and most (97.4%) in the CCr 15–29 group received the reduced apixaban dose. The average age was 79.2 years for the CCr ≥50 group, 82.5 years for the CCr 30–49 group, and 85.6 years for the CCr 15–29 group. The lower CCr value group included more female patients, had lower body weight, and less cases of paroxysmal AF, as well as more cases of heart failure, peripheral artery disease, and myocardial infarction as comorbidities. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.2 and 2.4±0.8 for the CCr ≥50 group, 4.5±1.2 and 2.4±0.8 for the CCr 30–49 group, and 4.9±1.2 and 2.4±0.7 for the CCr 15–29 group, respectively. Kaplan Meier curves for cumulative incidence of events are shown in Figure. The event incidence rates (/100 person-years) were 1.76, 1.39, and 1.67 for stroke or systemic embolism (log rank p=0.762), 1.39, 1.93, and 3.13 for bleeding requiring hospitalization (log rank p=0.159), 1.75, 2.76, and 7.87 for total deaths (log rank p<0.001), and 0.46, 0.84, and 2.62 for cardiovascular deaths (log rank p<0.001), in the CCr ≥50 group, CCr 30–49 group, and CCr 15–29 group, respectively. After adjusting for confounders by Cox regression analysis, CCr 15–29 was an independent risk for total death [hazard ratio (HR) 3.22, 95% confidence interval (CI) 1.68–6.17, with reference to the CCr ≥50 group] and cardiovascular death [HR 3.18, 95% CI 1.06–9.56], but not for stroke or systemic embolism [HR 0.94, 95% CI 0.40–2.24], or bleeding requiring hospitalization [HR 2.00, 95% CI 0.93–4.28]. Conclusions The incidence of events in each CCr value group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and significantly higher for total deaths and cardiovascular deaths only in the CCr 15–29 group, in Japanese non-valvular AF patients aged ≥75 years. Cumulative incidence rates of events Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bristol-Myers Squibb

Oral Anticoagulant Use in Elderly Japanese Patients With Non-Valvular Atrial Fibrillation - Subanalysis of the ANAFIE Registry.

Background: Oral anticoagulants (OACs) are effective in preventing stroke in patients with atrial fibrillation (AF), but are challenging for elderly patients because of the higher risk of bleeding complications.Methods and Results: The ANAFIE Registry is a prospective multicenter observational study of elderly (≥75 years) Japanese AF patients. This subanalysis evaluated the current use of OACs. Of 32,713 patients (mean age 81.5 years), 30,068 (91.9%) were receiving OACs, including 8,354 (25.5%) on warfarin and 21,714 (66.4%) on direct OACs (DOACs); 2,645 (8.1%) were not receiving OACs. The most common prescribed dose was a reduced dose for all DOACs. A substantial proportion of patients receiving the reduced dose did not fulfill dose reduction criteria (underdosing): apixaban, 25.1%; rivaroxaban, 26.3%; and edoxaban, 13.7%. Some patients received a lower off-label dose rather than the reduced dose: apixaban, 5.9%; rivaroxaban, 0.3%; edoxaban, 5.3%; and dabigatran, 13.6%. In multivariate analyses, advanced age, history of hemorrhage, paroxysmal AF, and antiplatelet drug use were significantly associated with no OAC. Advanced age, persistent or permanent AF, chronic kidney disease, and concomitant antiplatelet drugs were associated with warfarin rather than DOAC use.Conclusions: In the ANAFIE Registry, >90% of elderly Japanese AF patients received OAC therapy, mostly DOACs. Inappropriate low doses of DOACs that did not fulfill dose reduction criteria were prescribed in 20–30% of patients.

Cause of Death and Associated Factors in Elderly Patients With Atrial Fibrillation - Long-Term Retrospective Study.

Background: Oral anticoagulant (OAC) therapy reduces the risk of stroke in patients with atrial fibrillation (AF). This study elucidated the causes of death and related factors in elderly Japanese AF patients.Methods and Results: Over a median (interquartile range [IQR]) follow-up period of 46 (20–76) months, there were 171 all-cause deaths (28% cardiovascular, 46% non-cardiovascular, and 26% unknown causes) among 389 AF patients (median [IQR] age 80 [74–85] years; CHAD2DS2-VASc score 5 [4–6]). Cox regression analysis indicated that diabetes was associated with an increase in all-cause death (hazard ratio [HR] 1.48; 95% confidence interval [CI] 1.02–2.13), whereas hypercholesterolemia (HR 0.53; 95% CI 0.35–0.79), pre-existing heart failure (HR 0.67; 95% CI 0.48–0.95), and OAC use (HR 0.62; 95% CI 0.44–0.88) were associated with reductions in all-cause death. Pre-existing heart failure was associated with both cardiovascular (HR 3.03; 95% CI 1.33–8.20) and non-cardiovascular (HR 0.44; 95% CI 0.30–0.65) deaths, in opposite directions. OAC use was associated with a reduction in cardiovascular death (HR 0.34, 95% CI 0.17–0.69). The predominance of non-cardiovascular death and death-related factors were equivalent regardless of when observations started (before 2009 or in 2009 and later).Conclusions: The predominant cause of death in elderly Japanese AF patients was non-cardiovascular. Distinct clinical factors were associated with cardiovascular and non-cardiovascular death.

Screening of unknown atrial fibrillation through handheld device in the elderly.

ObjectiveTo estimate the prevalence of unknown atrial fibrillation (AF) in the elderly population of the Veneto Region, Italy.Methods1820 patients aged ≥ 65 years with no history of AF and not anticoagulated were enrolled in primary-care settings. They underwent an opportunistic electrocardiogram screening with a handheld device (MyDiagnostick) designed to specifically detect AF. The electrocardiogram recordings were reviewed by the researchers, who confirmed the presence of AF.ResultsThe device detected an arrhythmia in 143 patients, which was confirmed as AF in 101/143 (70.6%), with an overall prevalence of AF of 5.5% (101/1820). Prevalence of unknown AF resulted in 3.6% in patients aged 65–74 years, and 7.5% in patients age 75 or older, and increased according to CHA2DS2-VASc score: 3.5% in patients with a score of 1 or 2, 5.6% in patients with a score of 3, 7.0% in patients with a score of 4, and 7.2% in patients with a score ≥ 5. The detection rate was significantly higher in patients with mild symptoms compared to asymptomatic counterparts (24.1% vs. 4.0%, P < 0.0001). At multivariate analysis, congestive heart failure and age ≥ 75 years-old were independent predictors for screen-detected AF.ConclusionsAn opportunistic screening with handheld device revealed an unexpectedly high prevalence of unknown AF in elderly patients with mild symptoms. Prevalence increased with age and CHA2DS2-VASc score.

Novel oral anticoagulant vs. warfarin in elderly atrial fibrillation patients with normal, mid-range, and reduced left ventricular ejection fraction.

AimsPatients with concomitant atrial fibrillation (AF) and reduced left ventricular ejection fraction (LVEF) have poor prognosis. Outcomes of novel oral anticoagulant (NOAC) in elderly AF patients with normal, mid‐range, and reduced LVEF were investigated.Methods and resultsData were retrieved from Chang Gung Research Database during 2010–2017 for patients with AF. We excluded patients with venous thromboembolism within 6 months, total knee/hip replacement and heart valve replacement within 6 months, end‐stage renal disease, stroke/systemic embolism (SE)/death within 7 days, age <65 years old, or no records of LVEF. Primary outcomes were ischaemic stroke (IS)/SE, major bleeding, and death from any cause. There was a total of 50 035 elderly AF patients retrieved. After exclusion criteria, 9615 patients with normal LVEF ≥ 50%, 737 with mid‐range LVEF 41–49%, and 908 with reduced LVEF ≤ 40% were studied. At end of follow‐up, patients on NOAC had significantly reduced IS/SE compared with warfarin in LVEF ≥ 50% [adjusted hazard ration (aHR) 0.80, 95% confidence interval (CI) 0.71–0.89] and LVEF 41–49% (aHR 0.57, 95% CI 0.36–0.88) after adjusting for covariates, while there was no difference in LVEF ≤ 40%. Patients on NOAC had significantly reduced major bleeding in all LVEF groups. In addition, patients on NOAC had significantly reduced death compared with warfarin in LVEF ≥ 50% (aHR 0.81, 95% CI 0.67–0.98).ConclusionsIn elderly AF patients ≥65 years, using NOAC was associated with lower IS/SE compared with warfarin in normal and mid‐range LVEF but not in reduced LVEF. Using NOACs was associated with lower death compared with warfarin in normal LVEF.

Atrial fibrillation in elderly patients. Features of using rivaroxaban

The problem of anticoagulant treatment of elderly patients with atrial fibrillation (AF) is very topical for everyday medical practice because, on the one hand, the proportion of elderly patients among those who have AF is constantly increasing, and, on the other hand, there is no doubt that treatment of elderly patients involves many problems associated with a large number of complications. This material reviews the choice of optimal anticoagulant therapy for older AF patients and focuses on the use of rivaroxaban. Clinical research data show that rivaroxaban is one of the optimal drugs of choice for older patients. Thus, a comparative meta-analysis of the safety of various non-vitamin-K oral anticoagulants (NOAC) in patients of ≥75 years of age (in AF and deep vein thrombosis) showed that administration of rivaroxaban in comparison with warfarin was associated with an almost twofold significantly lower frequency of fatal bleedings (HR 0.53; 95% Cl 0.30-0.93; p = 0.03). According to the ROCKET-AF study, intake of rivaroxaban in elderly patients was comparable in efficiency and safety profile to warfarin. Since renal dysfunction is common in older patients with AF, safety issues are very important. In a ROCKET-AF study, the use of rivaroxaban in patients with moderate renal dysfunction was known to be associated with a lower frequency of fatal bleeding (0.28 vs. 0.74 per 100 patients/ year; HR 0.39; 95% CI 0.15-0.99; p = 0.047) than that of warfarin. Given the high probability of development of exacerbation of IHD in elderly patients with AF, they need an anticoagulant that maximally protects them from acute coronary complications. In the meta-analysis of 28 randomized trials with NOAC, only rivaroxaban was associated with a significant reduction by 22% in the risk of myocardial infarction and acute coronary syndrome compared to other control drugs. In conclusion, it can be stated that rivaroxaban may be a good choice for anticoagulant treatment specifically for elderly patients with AF, especially given its efficacy and safety profile and the adherence of patients to therapy.

P1006Cryo-balloon ablation in elderly; Outcome and prediction of recurrence

Abstract Background It is well known that prevalence of atrial fibrillation correlates with age, however the data on ablation of atrial fibrillation in elderly patients is poor. Aim of this study was analysis of outcome and prediction of recurrence after cryo-balloon ablation (CBA) in elderly patients based on available data in our registry. Methods The history of AF was assessed at admission. Additionally, all patients received echocardiographic examination and blood test. After a single trans-septal access and PV angiography PVI was performed using a 28-mm CBA. Mapping of PV signals before, during, and after each cryo application was performed with a 3F lasso catheter. The procedural endpoint after PVI was defined as complete elimination of all fragmented signals at the PV antrum with verification of entrance and exit block. Primary endpoint was first documented recurrence of AF, atrial tachycardia or atrial flutter (&amp;gt;30 sec.). All patients received a follow-up every 3 month within 1st year, once yearly thereafter and in case of symptoms. Seven days Holter ECG was recorded by every follow up. Results A total of 44 (39%) of enrolled patients were male, 48 (43%) suffered non- paroxysmal AF(nPAF), 93 (82%) had hypertension, CAD was diagnosed by 27 (24%), 28 (25%) had DM (Hb1AC &amp;gt; 6), Stroke/TIA was observed in 11 (10%). Median Age in elderly was 76 (75-78) y, BMI 25.77 (23.51-28.69), time since 1st diagnosis 40 (6-50) month, LA area index 11.36 (9.77-13.20), TAPSE 23 (19-26), GFR 74 (66-83) mL/min, LVEF 60 (57-62). A total of 44 patients (39%) reached endpoint within follow up of 20 (12-38) months. Univariate association with outcome was found by follows parameter: Time from 1st diagnosis &amp;gt; 3 y (HR = 3.22 (1.66-6.27), p=.001); LA area index (HR = 1.17 (1.03-1.32), p=.013); DM (HR = 1.89 (1.02-3.55), p=.042); nPAF (HR = 1.90 (1.04-3.47), p=.036). After multivariate analysis only time from 1st diagnosis &amp;gt; 3 y, (HR= 3.17 (1.62-6.16), p=.001 and nPAF (HR = 1.84 (1.01-3.36)), p=.048 were revealed to be predictive. The area under probability score calculated for these predictors was .731 (.638-8.25), p=.001. Follows complications were observed: 2 (2%) - pericard tamponades, 4 (4%) phrenicus nerve injury. Conclusion. PVI with cryo-balloon is effective for elderly patients providing freedom of arrhythmic events in 61% of patients. Longer history of AF over 3 years since 1st diagnosis was main predictor for post ablation recurrence. In elderly patients with shorter history of AF efficiency and safety of CBA is comparable with general population.

Clinical implications of assessment of apixaban levels in elderly atrial fibrillation patients: J-ELD AF registry sub-cohort analysis.

To investigate the distribution of plasma apixaban levels and their relationships with clinical outcomes in elderly patients with atrial fibrillation (AF). The J-ELD AF Registry is a multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75years taking an on-label dose of apixaban (3015 patients from 110 institutions). Among them, plasma apixaban levels at trough were estimated by anti-Xa assay (Api-AXA) in 943 patients. Patients with standard (5mg bid; n = 431) and reduced (2.5mg bid; n = 512) dose were further divided into two groups with low and high Api-AXA levels (boundary: median value). The incidence rates (per 100 person-years) of events in the low- and high-Api-AXA groups were as follows: 1.48 and 1.99 (log-rank test, P = 0.695) for stroke or systemic embolism, 0.98 and 1.49 (P = 0.652) for bleeding requiring hospitalization, and 0.49 and 0.99 (P = 0.565) for total deaths in patients with standard dose, versus 0.84 and 1.68 (P = 0.414), 0.42 and 4.64 (P = 0.004), and 2.52 and 6.65 (P = 0.035) in patients with a reduced dose, respectively. In multivariate Cox regression analysis among patients with a reduced dose, a high Api-AXA level was independently associated with bleeding requiring hospitalization (HR 12.12, 95% CI: 1.56-94.22) and nonsignificantly with total deaths. A high trough apixaban level in patients indicated for standard dose was not associated with adverse events, while a high apixaban level in patients indicated for a reduced dose was associated with bleeding requiring hospitalization.

Differences in treatment and prognosis by the experience of falls or bone fracture in elderly patients with atrial fibrillation.

Treatment and prognosis of elderly patients with atrial fibrillation (AF) may differ by the experience of fall or bone fracture. However, their current status is still unclear. From our institute database between 2010 and 2015, 674 AF patients with age ≥ 70years were selected and were divided into those who experienced fall or fracture during the observation period (F/F group; n = 49) and those who did not (non-F/F group; n = 625). We compared the treatment and prognosis between the 2 groups. Patients in the F/F group were older (79 vs 76years, P < 0.001) and had more comorbidities compared with those in the non-F/F group. The prescription rate of oral anticoagulant was similar between the two groups (77.6% vs 68.2%, P = 0.201), where warfarin was predominant. The F/F group was not associated with higher incidence of ischemic stroke. The F/F group was associated with a higher incidence of heart failure events (adjusted odds ratio (OR) 3.88; 95% confidence intervals (Cl) 1.70-8.85; P = 0.001), and cardiovascular events (OR 3.43; 95% Cl 1.71-6.85; P < 0.001). In elderly AF patients in a cardiovascular hospital, the experience of fall or fracture did not affect the prescription of oral anticoagulants and the incidence of ischemic stroke, but it was significantly associated with increase of heart failure.

Abstract P369: Polypharmacy, Adverse Outcomes, and Treatment Effectiveness in Elderly Patients With Atrial Fibrillation

Background: Polypharmacy is highly prevalent in elderly individuals with chronic conditions, including atrial fibrillation (AF). The impact of polypharmacy on adverse outcomes and on treatment effectiveness in elderly AF patients remains unaddressed. Methods: We studied 338,810 AF patients ≥75 years of age with 1,761,660 active prescriptions [mean (SD), 5.1 (3.8) per patient] enrolled in the MarketScan Medicare Supplemental database in 2007-2015. Polypharmacy was defined as ≥5 active prescriptions at AF diagnosis based on outpatient pharmacy claims. AF treatments (oral anticoagulation, rhythm and rate control) and cardiovascular endpoints (ischemic stroke, bleeding, heart failure) were defined based on inpatient, outpatient and pharmacy claims. Multivariable Cox models were used to estimate associations of polypharmacy with cardiovascular endpoints and the interaction between polypharmacy and AF treatments in relation to cardiovascular endpoints. Results: Prevalence of polypharmacy was 52% (176,007 of 338,810). Patients with polypharmacy had increased risk of major bleeding [hazard ratio (HR) 1.16, 95% confidence interval (CI) 1.12, 1.20] and heart failure (HR 1.33, 95%CI 1.29, 1.36), but not of ischemic stroke (HR 0.96, 95%CI 0.92, 1.00), compared to those not with polypharmacy (Table). Polypharmacy status did not consistently modify the effectiveness of oral anticoagulants. However, rhythm control (vs. rate control) was more effective in preventing heart failure hospitalization in patients not with polypharmacy (HR 0.87, 95%CI 0.76, 0.99) than among those with polypharmacy (HR 0.98, 95%CI 0.91, 1.07, p for interaction = 0.02). Conclusion: Polypharmacy is frequent among elderly patients with AF, associated with adverse outcomes, and potentially affecting the effectiveness of AF treatments. Optimizing management of polypharmacy in elderly AF patients may lead to improved outcomes.

Comparison of effectiveness and safety of direct oral anticoagulants versus vitamin-k antagonists in elderly patients with atrial fibrillation: a systematic review and cost-effectiveness analysis protocol.

BackgroundCurrent evidence regarding the effectiveness and safety of direct oral anticoagulants (DOACs) in the elderly with atrial fibrillation (AF) remains scarce. Based on the emerging evidence from real-world studies (RWSs) associated with DOACs, we will perform a systematic review and meta-analysis of data from RWSs and randomized controlled trials (RCTs) to compare the effectiveness, safety and cost of DOACs versus Vitamin K antagonists (VKAs) in elderly patients with AF.MethodsThe MEDLINE, EMBASE and Cochrane Library databases will be systematically searched until June 30, 2019 for eligible RWSs and RCTs that reported the clinical outcomes between DOACs and VKAs in elderly patients with AF. The effectiveness outcome is stroke or systemic embolism (SE), and the safety outcomes are major bleeding, intracranial haemorrhage (ICH), gastrointestinal bleeding (GIB), myocardial infarction (MI) and all-cause mortality. A random-effects model will be used to calculate adjusted hazard ratios (HRs) for RWSs and relative risks (RRs) for RCTs, separately. The interaction analysis and the ratio of HRs (RHRs) will be applied to compare the treatment effect difference between RWSs and RCTs. A Markov model will be constructed to evaluate the cost-effectiveness of DOACs versus VKAs in elderly AF patients in real-world setting.DiscussionThis study will summarize all available evidences from RWSs and RCTs for a comprehensive and rigorous systematic review on the effectiveness and safety associated with DOACs, as well as perform a cost-effectiveness analysis to evaluate the price performance of DOACs among elderly AF patients in real clinical setting.Trial registrationPROSPERO register platform (CRD42019142881, www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID =142881).

Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial.

AimsTo evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care.Methods and resultsThe ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72–83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37–0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27–0.82). For other adverse events, no statistically significant differences were observed.ConclusionIn this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

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Rhythm versus rate control strategies regarding anticoagulant use in elderly non-valvular atrial fibrillation patients: Subanalysis of the ANAFIE (All Nippon AF In the Elderly) Registry

BackgroundData on real-world antiarrhythmic and anticoagulant therapy use in elderly atrial fibrillation (AF) patients are lacking; thus, we performed a subanalysis of data from the ANAFIE registry to clarify the current management of Japanese patients aged ≥75 years with non-valvular AF. MethodsThe ANAFIE registry was a multicenter, prospective, observational study. Patients were stratified into three groups: rhythm control group, rate control group, and no antiarrhythmic group. The CHADS2, CHA2DS2-VASc, and HAS-BLED scores were used to estimate embolic and bleeding risk. ResultsAmong 32,490 patients, the overall frequencies of AF by type were 42.0 % (paroxysmal), 30.1 % (persistent and long-standing persistent), and 27.9 % (permanent). Significant differences (p < 0.0001, each) in age were observed among the three groups; more patients aged 75–79 years received rhythm control (44.2 %) vs rate control (38.8 %). Patients aged ≥85 years received either rate control therapy or no antiarrhythmic agent (∼20 %, each). In the overall population, 36.9 % and 19.6 % of patients were receiving rate and rhythm control therapy, respectively; 43.4 % were not receiving antiarrhythmic therapy. The rate control group consisted mainly of patients with persistent (16.3 %) and permanent AF (38.6 %), and the rhythm control group, of patients with paroxysmal AF (79.0 %). Significantly lower embolic and bleeding risk scores and significantly higher embolic risk scores were observed in patients in the rhythm and rate control groups, respectively. In total, 92.1 % of elderly Japanese patients with AF were receiving anticoagulant therapy. The frequency of direct-acting oral anticoagulant (DOAC) use was similar (∼66 %) among the three groups. Significantly more patients in the rate control group (28.6 %) were being treated with warfarin than in the rhythm control group (21.6 %) (p < 0.0001). ConclusionsUse versus non-use and antiarrhythmic therapy varied significantly by age, stroke risk scores, type of AF, and DOAC use between subgroups.

Impact of creatinine clearance on clinical outcomes in elderly atrial fibrillation patients receiving apixaban: J-ELD AF Registry subanalysis

Randomized clinical trials demonstrated the efficacy and safety of apixaban in preventing stroke in patients with atrial fibrillation (AF). However, data on patients with low creatinine clearance (CCr), especially CCr 15-29 mL/min, are limited. The J-ELD AF Registry is a large-scale, multicenter prospective observational study of Japanese nonvalvular AF patients aged ≥75 years taking on-label dose (standard dose of 5 mg bid or reduced dose of 2.5 mg bid) of apixaban. The entire cohort (3,015 patients from 110 institutions) was divided into 3 CCr subgroups: CCr ≥50 mL/min (n = 1,165, 38.6%), CCr 30-49 mL/min (n = 1,395, 46.3%), and CCr 15-29 mL/min (n = 455, 15.1%). The event incidence rates (/100 person-years) were 1.76, 1.39, and 1.67 for stroke or systemic embolism (log rank P = .762); 1.39, 1.93, and 3.13 for bleeding requiring hospitalization (log rank P = .159); 1.75, 2.76, and 7.87 for total deaths (log rank P < .001); and 0.46, 0.84, and 2.62 for cardiovascular deaths (log rank P < .001), respectively. After adjusting for confounders by Cox regression analysis, CCr 15-29 was an independent risk for total death and cardiovascular death but not for stroke or systemic embolism, or bleeding requiring hospitalization. The incidence of events in each CCr value group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and significantly higher for total deaths and cardiovascular deaths only in the CCr 15- to 29-mL/min group, in Japanese nonvalvular AF patients aged ≥75 years.