Real-world clinical outcomes and anticoagulant therapy in elderly non-valvular atrial fibrillation patients with heart failure: sub-analysis of the ANAFIE Registry

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are bidirectionally correlated; the more severe the NYHA classification, the higher the incidence rate of atrial fibrillation, and vice versa. HF is included in the items of CHA2DS2-VASc score used to calculate stroke risk in patients with AF, and is itself a risk factor for thromboembolism in such patients. Anticoagulant management in AF patients with HF is thus a key concern that remains to be sufficiently examined, especially in elderly patients aged ≥75 y. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry enrolled more than 30,000 elderly (≥75 y) patients with non-valvular AF (NVAF), aiming to produce real-world data on their clinical status and prognosis. This sub-analysis of the ANAFIE Registry assessed the 2-year outcomes and status of anticoagulant treatment in elderly NVAF patients with HF. Methods A total of 32,275 patients from the ANAFIE Registry were divided into two groups according to whether they had HF (HF group and reference group). The incidence rates and adjusted hazard ratios (HR) of clinical outcomes were determined using Kaplan-Meier analysis and the Cox proportional-hazards model, respectively. Results A total of 20,159 (62.5%) patients were included in the reference group, and 12,116 (37.5%) in the HF group. Compared with the reference group, the HF group had higher mean age (82.4 vs 80.9 y), female ratio (46.6% vs 40.4%), non-paroxysmal AF (69.8% vs 50.8%), and had lower mean CrCL (43.3 vs 51.6 mL/min). In the HF group, the rate control drugs were frequently used (50.1% vs 35.8%), and the rhythm control drugs were less used (14.2% vs 22.7%) than in the reference group. More patients in the HF group were using anticoagulants (93.9% vs 91.6%; warfarin (WF), 29.6% vs 23.0%; direct oral anticoagulants (DOAC), 64.2% vs 68.5%) than those in the reference group. The HF group had a numerically higher incidence of stroke or systemic embolic events (SEE) (3.28% vs 2.84%, HR 0.96, p=0.558) and major bleeding (2.35% vs 1.79%, HR 1.14, p=0.130) than the reference group, but the differences were not statistically significant. The HF group had a significantly higher incidence rate of HF requiring hospitalization (12.99% vs 4.59%, HR 1.94, p<0.001) and all-cause mortality (9.83% vs 5.21%, HR 1.32, p<0.001). In the HF group, patients receiving DOAC had significantly lower incidence rates for major bleeding, HF requiring hospitalization, and all-cause mortality than those receiving WF, while there was no difference for stroke/SEE between both groups. Conclusions Elderly NVAF patients with HF had higher risk of HF requiring hospitalization and mortality than those without. Differences were seen in the incidence rates of major bleeding, HF requiring hospitalization, and all-cause mortality between patients on DOAC and those on WF. This study will explore relevant factors affecting clinical outcomes in elderly NVAF patients with HF. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

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P1024Catheter ablation is associated with reduced all-cause mortality in a real-world cohort of patients with atrial fibrillation and heart failure

European Heart Journal ◽

10.1093/eurheartj/ehz747.0615 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

M Samuel ◽

M Abrahamowicz ◽

J Joza ◽

V Essebag ◽

L Pilote

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Major Bleeding ◽

Real World ◽

Population Based ◽

World Population ◽

Risk Of Death ◽

All Cause Mortality

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are common co-existing conditions. Randomized trial data suggests a reduction in all-cause mortality with catheter ablation (CA) in selected patients, however, whether these results are replicable in a real-world population and persist in the long-term remains to be shown. Purpose To evaluate the long-term effectiveness of CA in AF-HF patients in reducing the incidence of: a) all-cause mortality b) HF hospitalizations, and c) major morbidities (stroke/transient ischemic attack (TIA) and major bleeding). Methods A population-based administrative cohort was created of AF-HF patients with government prescription coverage in Quebec, Canada (1999–2015). Patients who underwent CA (cases) were matched 1:2 to controls using risk-set sampling. Cases were matched on time in the cohort and frequency of hospitalizations. Measured time-invariant confounders were controlled for using inverse probability of treatment weighting (IPTW) and included age, sex, clinical characteristics, presence of cardiac implantable electronic devices, and medication use. Multivariable Cox models adjusted the association of CA with the outcomes for the time varying confounders of the presence of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT), anticoagulation use (warfarin or direct oral anticoagulation), and any antiarrhythmic (AAD) use during follow-up. For non-fatal outcomes, the competing risk of death was accounted for using the Lunn-McNeil approach. Results Of the 87,676 AF-HF patients, 298 underwent CA and were matched to 591 controls. After IPTW, the distribution of covariates was balanced between cases and controls [age 65.6±11.0 vs 61.6±11.6; women 24% vs 20%; CHA2DS2-Vasc score 3.2±2.3 vs 2.9±2.1; CA vs non-CA, respectively; standardized mean differences <0.1 for all]. Over a median follow-up of 3.3 (IQR 1.1–6.4) years, 19 (7.3%) of CA patients died compared to 144 (24.6%) non-CA patients. After weighting and adjustment, CA was associated with a statistically significant reduction in the incidence of all-cause mortality [adjusted HR 0.5 (95% CI 0.3–0.9)]. In addition, there was no statistically significant difference in the incidence of HF hospitalizations over the follow-up [CA: 22.5% vs non-CA: 27.1%; adjusted HR 0.9 (95% CI 0.6–1.2)]. The incidences of stroke/TIA (1.7% vs 6.8%) and major bleeding (1.7% vs 4.9%) for CA vs non-CA were not statistically different. Conclusion In a matched population-based AF-HF cohort, CA was associated with a reduced risk of all-cause mortality compared to patients who did not undergo CA. Although no difference in the risk of HF hospitalizations, stroke/TIA, and major bleeding was detected between CA and non-CA patients, larger studies are warranted. Acknowledgement/Funding Canadian Institute of Health Research; Fonds de recherché du Quebec-Santé, Clinical Research Scholar Award (V. Essebag) and Doctoral Award (M. Samuel)

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Impact of polypharmacy on clinical outcomes in elderly patients with nonvalvular atrial fibrillation: sub-analysis of the ANAFIE Registry

European Heart Journal ◽

10.1093/eurheartj/ehab724.0467 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

T Yamashita ◽

Keyword(s):

Atrial Fibrillation ◽

Elderly Patients ◽

Clinical Outcomes ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Incidence Rates ◽

Cox Proportional Hazards Model ◽

Private Company ◽

All Cause Mortality ◽

The Mean

Abstract Background Elderly patients with AF often have multimorbidities leading to treated by polypharmacy, which has been reported to be associated with worse prognosis. Although stroke prevention is a cornerstone of optimal anticoagulation management, data on elderly NVAF patients aged ≥75 years with polypharmacy are lacking. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study that seeks to elucidate real-world data on the clinical status and prognosis of more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed 2-year outcomes and the status of anticoagulant management in elderly NVAF patients in view of polypharmacy. Methods A total of 32,275 patients from the ANAFIE Registry were divided into 3 groups by the number of concomitant medicines other than oral anticoagulants (OAC) (0 to 4, 5 to 8, ≥9 medicines). The annualized incidence rates of clinical outcomes were determined by Kaplan-Meier analysis. Hazard ratios (HR) for clinical outcomes were determined using the Cox proportional-hazards model. Results In the overall population, the mean age was 81.5 y; men accounted for 57.3%; the mean CHA2DS2-VASc score was 4.5; the mean HAS-BLED score was 1.9; the prevalence of paroxysmal AF was 42.1%; the mean follow-up period was 1.88 y; oral anticoagulants (OAC) were used by 92.4% of patients (WF, 25.5%; DOAC, 66.9%); the major concomitant medicines were antihypertensive drugs (70.9%), antiarrhythmic drugs (56.2%), dyslipidemia drugs (37.1%), and proton pump inhibitors (36.6%). The numbers of patients using 0 to 4, 5 to 8, and ≥9 concomitant medicines were 12,186 (37.8%), 13,597 (42.1%), and 5,636 (17.5%), respectively. As the number of concomitant medicines increased, the prevalence of comorbidities and renal dysfunction of creatinine clearance <50 mL/min increased. With an increase in concomitant medications, use of WF increased and that of DOAC decreased. Overall annualized incidence rates (% per patient-year) of clinical outcomes were 1.62 for stroke or systemic embolic events (SEE), 1.08 for major bleeding, 5.91 for cardiovascular (CV) events, 1.08 for CV death, and 3.71 for all-cause mortality. The annualized incidence rates and HR for each clinical outcome are shown in the table. As the number of concomitant medicines increased, the incidence for major bleeding, gastrointestinal bleeding, CV events, and all-cause death were significantly increased. Conclusions In elderly NVAF patients from the ANAFIE registry, polypharmacy was associated with increased risks of major bleeding, CV events, CV death, and all-cause mortality. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

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Long-term clinical outcomes after major bleeding in patients with atrial fibrillation: the Fushimi AF registry

European Heart Journal - Quality of Care and Clinical Outcomes ◽

10.1093/ehjqcco/qcaa082 ◽

2020 ◽

Author(s):

Hisashi Ogawa ◽

Yoshimori An ◽

Kenjiro Ishigami ◽

Syuhei Ikeda ◽

Kosuke Doi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischaemic Stroke ◽

Clinical Outcomes ◽

Major Bleeding ◽

Bleeding Event ◽

Community Based ◽

Increased Risk ◽

All Cause Mortality

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P < 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P < 0.01), history of major bleeding (7.7% vs. 4.0%; P < 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P < 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P < 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)

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Long-term effectiveness of catheter ablation in patients with atrial fibrillation and heart failure

EP Europace ◽

10.1093/europace/euaa036 ◽

2020 ◽

Vol 22 (5) ◽

pp. 739-747 ◽

Cited By ~ 1

Author(s):

Michelle Samuel ◽

Michal Abrahamowicz ◽

Jacqueline Joza ◽

Marie-Eve Beauchamp ◽

Vidal Essebag ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Catheter Ablation ◽

Major Bleeding ◽

World Population ◽

Cox Models ◽

Risk Of Death ◽

All Cause Mortality

Abstract Aims Randomized trials suggest reductions in all-cause mortality and heart failure (HF) rehospitalizations with catheter ablation (CA) in patients with atrial fibrillation (AF) and HF. Whether these results can be replicated in a real-world population with long-term follow-up or varies over time is unknown. We sought to evaluate the long-term effectiveness of CA in reducing the incidence of all-cause mortality, HF hospitalizations, stroke, and major bleeding in AF–HF patients. Methods and results In a cohort of patients newly diagnosed with AF–HF in Quebec, Canada (2000–2017), CA patients were matched 1:2 to controls on time and frequency of hospitalizations. Confounders were controlled for using inverse probability of treatment weighting. Multivariable Cox models adjusted for the presence of cardiac electronic implantable devices and medication use during follow-up, and the effect of time since CA was modelled with B-splines. For non-fatal outcomes, the Lunn–McNeil approach was used to account for the competing risk of death. Among 101 933 AF–HF patients, 451 underwent CA and were matched to 899 controls. Over a median follow-up of 3.8 years, CA was associated with a statistically significant reduction in all-cause mortality [hazard ratio 0.4 (95% confidence interval 0.2–0.7)], but no difference in stroke or major bleeding. The hazard of HF rehospitalization for CA patients, relative to non-CA patients, varied with time since CA (P = 0.01), with a reduction in HF rehospitalizations until approximately 3 years post-CA. Conclusion Compared with matched non-CA patients, CA was associated with a long-term reduction in all-cause mortality and a reduction in HF rehospitalizations until 3 years post-CA.

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P4758Label adherence of non-vitamin K antagonist oral anticoagulants and clinical outcomes in patients with atrial fibrillation: A nationwide study

European Heart Journal ◽

10.1093/eurheartj/ehz745.1134 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

H T Yu ◽

P S Yang ◽

E Jang ◽

T H Kim ◽

J S Uhm ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Clinical Outcomes ◽

Vitamin K ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Systemic Embolism ◽

Increased Risk ◽

All Cause Mortality

Abstract Background Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications. Purpose We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes in real-world clinical practice. Methods We evaluated 53,649 AF patients treated with a NOAC using Korean National Health Insurance Service database during the period from January 2013 to December 2016. NOAC doses were classified as either underdosed or overdosed, consistent with U.S. Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality. Results Overall, 16,757 NOAC-treated patients (31.2%) were underdosed, 4,492 were overdosed (8.4%), and 32,400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (71±8 and 75±7 years of age vs. 70±9 years of age, respectively; p<0.001), more likely female (39% and 53% vs. 38%, respectively; p<0.001), and had higher CHA2DS2-VASc scores (4.6±1.7 and 5.3±1.7 vs. 4.5±1.8, respectively; p<0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 vs. 4.03 events/100 patient-years, p<0.001), major bleeding (4.77 vs. 2.94 events/100 patient-years, p<0.001), and all-cause mortality (5.43 vs. 3.05 events/100 patient-years, p<0.001) compared with label-adherent use. Figure 1 Conclusion In routine clinical practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with increased risk for stroke or systemic embolism, major bleeding, and all-cause mortality in Asian patient with AF.

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Clinical outcomes of patients with newly diagnosed atrial fibrillation who refused anticoagulation: findings from the global GARFIELD-AF registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.0517 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

P Apenteng ◽

D.A Fitzmaurice ◽

S Virdone ◽

A.J Camm ◽

K.A.A Fox ◽

...

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Clinical Outcomes ◽

Major Bleeding ◽

Funding Source ◽

Newly Diagnosed ◽

All Cause Mortality ◽

Patient Refusal ◽

Event Rates

Abstract Introduction Atrial fibrillation (AF) remains a common cause of stroke and anticoagulation (AC) treatment reduces the risk of stroke. Reasons for patients with AF not receiving anticoagulation are generally attributed to the clinician decision, however in reality a proportion of patients refuse anticoagulation. The aim of our study was to investigate the clinical outcomes of patients with AF who refused anticoagulation. Methods The Global Anticoagulant Registry in the FIELD (GARFIELD-AF) was an international prospective observational study of patients ≥18 years with newly diagnosed AF and ≥1 investigator determined risk factor for stroke. We analysed two-year outcomes (unadjusted) of non-haemorrhagic stroke/systemic embolism (stroke/SE), major bleeding and all-cause mortality in patients at high risk of stroke (men with CHA2DS2VASc≥2 and women with CHA2DS2VASc≥3) who did not received anticoagulation due to patient refusal, patients at high risk of stroke who received anticoagulation, and patients who were not on anticoagulation due to reasons other than patient refusal. Results Out of 43,154 patients, 13,283 (30.8%) are at the higher risk of stroke and did not received anticoagulation at baseline. The reason for not receiving anticoagulation was unavailable for 38.7% (5146/13283); of the patients with a known reason for not receiving anticoagulation, 12.5% (1014/8137) refused anticoagulation. Overall the study participants had a mean (SD) age of 72.2 (9.9) years and 50% were female. The median (Q1; Q3) CHA2DS2VASc score was 3.0 (3.0; 5.0) in patients who refused anticoagulation and 4.0 (3.0; 4.0) in patients who received anticoagulation. The median (Q1; Q3) HAS-BLED score was 1.0 (1.0; 2.0) in both groups. Of the patients who received anticoagulants, 59.7% received VKA and 40.3% received non-VKA oral anticoagulants. 79.4% of patients who refused anticoagulation were on antiplatelets. At two-year follow up the rate of events per 100 person-years (AC refused vs AC received) were: stroke/SE 1.42 vs 0.95 (p=0.04), major bleeding 0.62 vs 1.20 (p=0.02), and all-cause mortality 2.28 vs 3.90 (p=0.0004) (Figure). The event rates in patients who were not on anticoagulation for reasons other than patient refusal were stroke/SE 1.56, major bleeding 0.91, and all-cause mortality 5.49. Conclusion In this global real-world prospective study of patients with newly diagnosed AF, patients who refused anticoagulation had a higher rate of stroke/SE but lower rates of all-cause mortality and major bleeding than patients who received anticoagulation. While patient refusal of anticoagulation is an acceptable outcome of shared decision-making, clinically it is a missed opportunity to prevent AF related stroke. Patients' beliefs about AF related stroke and anticoagulation need to be explored. The difference in all-cause mortality warrants further investigation; further analysis will include adjusted results. Event rates at two years of follow-up Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer AG.

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Comparison of clinical outcomes with edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonist in patients with atrial fibrillation in Germany: a real-world cohort study

European Heart Journal ◽

10.1093/ehjci/ehaa946.0401 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

X.L Marston ◽

R Wang ◽

Y.C Yeh ◽

L Zimmermann ◽

X Ye ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cohort Study ◽

Clinical Outcomes ◽

Vitamin K ◽

Major Bleeding ◽

Real World ◽

Lower Risk ◽

Sensitivity Analyses ◽

Funding Source ◽

Baseline Characteristics

Abstract Background Vitamin K antagonists (VKA) and non-VKA oral anticoagulants (NOACs) are used to prevent thromboembolic conditions in patients with atrial fibrillation (AF). Unlike VKA, NOACs have fixed dosage schemes, do not require regular laboratory tests, and have fewer drug and food interactions. The use of NOACs has increased substantially in recent years in Germany. However, there is limited evidence on the comparative effectiveness and safety between different NOACs and VKA in real-world settings. Purpose The objective of the study was to compare the clinical outcomes, including systemic embolism (SE), ischemic stroke (IS), and major bleeding, of edoxaban with other NOACs (apixaban, dabigatran, rivaroxaban) and VKA in AF patients in Germany. Methods Using an administrative database from our institution (Deutsche Analysedatenbank für Evaluation und Versorgungsforschung) between January 2013 and December 2017, a retrospective cohort study was conducted to compare the effectiveness (risk of SE or IS) and safety (risk of major bleeding) in NOAC-naïve AF patients who initiated anticoagulant therapy. Continuous enrolment for 12 months before anticoagulant initiation was required to assess baseline characteristics. Patients were followed up until (1) the first outcome event (SE, IS, or major bleeding), (2) disenrollment from health plans, or (3) discontinuation of the index NOAC or VKA or therapy switch, whichever occurred first. Inverse probability treatment weighting (IPTW) using propensity score was applied to control for differences in baseline characteristics. Cox proportional hazards models were used to estimate the hazard ratios (HR) for each outcome comparing edoxaban versus other NOACs and VKA. Sensitivity analyses were conducted with follow-up period cut-off at 1 year. Results A total of 1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA patients were included. Patient cohorts were well balanced after weighting. The adjusted risks of SE or IS were lower for edoxaban compared to apixaban (HR 0.83, 95% CI 0.69–0.99), dabigatran (HR 0.54, 95% CI 0.40–0.74), rivaroxaban (HR 0.72, 95% CI 0.60–0.87), and VKA (HR 0.65, 95% CI 0.53–0.78) (all p<0.05). Edoxaban was associated with a significantly lower risk of major bleeding compared to dabigatran (HR 0.73, 95% CI 0.55–0.98), rivaroxaban (HR 0.74, 95% CI 0.63–0.87), and VKA (HR 0.47, 95% CI 0.40–0.55) (all p<0.05). The risk of major bleeding was comparable between edoxaban and apixaban (HR 1.09, 95% CI 0.92–1.30, p=0.33). Results were consistent in the sensitivity analyses. Conclusions Edoxaban was associated with a significantly lower risk of SE or IS compared to other NOACs and VKA, indicating improved effectiveness. Edoxaban also had a favourable safety profile with a significantly lower risk of major bleeding compared to dabigatran, rivaroxaban, and VKA. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Daiichi Sankyo Inc.

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Atrial Fibrillation in Patients With Cardiomyopathy: Prevalence and Clinical Outcomes From Real‐World Data

Journal of the American Heart Association ◽

10.1161/jaha.121.021970 ◽

2021 ◽

Author(s):

Benjamin J. R. Buckley ◽

Stephanie L. Harrison ◽

Dhiraj Gupta ◽

Elnara Fazio‐Eynullayeva ◽

Paula Underhill ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Clinical Outcomes ◽

Restrictive Cardiomyopathy ◽

The United States ◽

Research Network ◽

Real World Data ◽

All Cause Mortality ◽

Incident Heart Failure ◽

The Impact

Background Cardiomyopathy is a common cause of atrial fibrillation (AF) and may also present as a complication of AF. However, there is a scarcity of evidence of clinical outcomes for people with cardiomyopathy and concomittant AF. The aim of the present study was therefore to characterize the prevalence of AF in major subtypes of cardiomyopathy and investigate the impact on important clinical outcomes. Methods and Results A retrospective cohort study was conducted using electronic medical records from a global federated health research network, with data primarily from the United States. The TriNetX network was searched on January 17, 2021, including records from 2002 to 2020, which included at least 1 year of follow‐up data. Patients were included based on a diagnosis of hypertrophic, dilated, or restrictive cardiomyopathy and concomitant AF. Patients with cardiomyopathy and AF were propensity‐score matched for age, sex, race, and comorbidities with patients who had a cardiomyopathy only. The outcomes were 1‐year mortality, hospitalization, incident heart failure, and incident stroke. Of 634 885 patients with cardiomyopathy, there were 14 675 (2.3%) patients with hypertrophic, 90 117 (7.0%) with restrictive, and 37 685 (5.9%) with dilated cardiomyopathy with concomitant AF. AF was associated with significantly higher odds of all‐cause mortality (odds ratio [95% CI]) for patients with hypertrophic (1.26 [1.13–1.40]) and dilated (1.36 [1.27–1.46]), but not restrictive (0.98 [0.94–1.02]), cardiomyopathy. Odds of hospitalization, incident heart failure, and incident stroke were significantly higher in all cardiomyopathy subtypes with concomitant AF. Among patients with AF, catheter ablation was associated with significantly lower odds of all‐cause mortality at 12 months across all cardiomyopathy subtypes. Conclusions Findings of the present study suggest AF may be highly prevalent in patients with cardiomyopathy and associated with worsened prognosis. Subsequent research is needed to determine the usefulness of screening and multisdisciplinary treatment of AF in this population.

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Predictors for major bleeding in elderly (75 years and over) patients with non-valvular atrial fibrillation at high risk of bleeding: sub-analysis of the ANAFIE Registry

European Heart Journal ◽

10.1093/eurheartj/ehab724.0555 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

K Okumura ◽

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Major Bleeding ◽

Risk Group ◽

Reference Group ◽

Bleeding Risk ◽

High Risk Group ◽

Bleeding Events ◽

All Cause Mortality ◽

High Bleeding Risk

Abstract Background In patients with atrial fibrillation (AF) receiving anticoagulant therapy, bleeding events are associated with reduced survival. Previous studies showed that bleeding events during anticoagulant therapy were more frequent in elderly AF patients than in younger patients. HAS-BLED score has been used to assess the risk of bleeding in AF patients. In patients at high bleeding risk (HAS-BLED score ≥3), we sought to identify other risk factors associated with major bleeding not included in HAS-BLED score in elderly non-valvular AF (NVAF) patients. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study to collect real-world data on clinical status and prognosis in more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed the 2-year outcomes and identified predictors for major bleeding in elderly NVAF patients with a high bleeding risk. Methods A total of 32,275 patients from the ANAFIE Registry were divided into 2 groups according to HAS-BLED score (≥3 [high-risk group] and ≤2 [reference group]). The annualized incidence rate, hazard ratio (HR) for clinical outcomes, and independent predictors for major bleeding were analyzed using Kaplan-Meier analysis and the Cox proportional-hazards model. Results A total of 6,826 patients constituted the high-risk group: mean age, 81.8 years old (75–80 years, 37.8%; 81–84 years, 33.9%; ≥85 years, 28.3%); male ratio, 72.2%; mean creatinine clearance (CrCL), 42.7 mL/min; history of major bleeding, 14.2%; presence of non-paroxysmal AF, 62.2%; mean total number of medicines used, 7.8. Anticoagulants were used in 91.2% (warfarin [WF], 29.9%; direct oral anticoagulants [DOACs], 61.2%). Proton-pump inhibitors (PPI) were administered in 46.5%. Compared to the reference group, the high-risk group had higher annualized incidence rates (/100 patient-year) of major bleeding (1.49 vs 0.97), intracranial hemorrhage (0.95 vs 0.70), gastrointestinal (GI) bleeding (2.63 vs 1.73), and all-cause mortality (5.50 vs 3.24). All-cause mortality more frequently occurred in patients aged ≥85 years compared to 75–79 years and those with CrCL <50 mL/min compared to CrCL ≥50 mL/min. In the high-risk group, DOAC subgroup had lower incidences of the above-mentioned outcomes other than GI bleeding than WF subgroup. The following relevant factors for major bleeding not included in HAS-BLED score were identified in the high-risk group: Body mass index (BMI) ≥25.0 kg/m2 (HR, 0.40), heart failure (HF) with reduced left ventricular ejection fraction (LVEF) (HR, 1.38), a fall within 1 year (HR, 2.29), and use of PPI (HR, 0.65). Conclusions Among elderly (≥75 years) Japanese NVAF patients in the high bleeding risk group (HAS-BLED score ≥3), HF with reduced LVEF, and a fall within 1 year were identified as independent predictors of major bleeding. BMI ≥25.0 kg/m2 and PPI use were protective for major bleeding. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

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Association of biomarkers of inflammation with hospitalization for heart failure and death in patients with atrial fibrillation

European Heart Journal ◽

10.1093/ehjci/ehaa946.0497 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

A.P Benz ◽

S Aeschbacher ◽

P Krisai ◽

S Blum ◽

P Meyre ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Plasma Levels ◽

Incidence Rates ◽

Adverse Outcomes ◽

Funding Source ◽

All Cause Mortality ◽

Hs Crp ◽

Multivariable Adjustment ◽

Inflammation Score

Abstract Background Hospitalization for heart failure and death are among the most common adverse clinical outcomes in patients with atrial fibrillation (AF). The underlying mechanisms are poorly understood. Purpose We hypothesised that inflammation, quantified by plasma levels of C-reactive protein (CRP) and interleukin 6 (IL-6), is independently associated with hospitalization for heart failure and death in a large, contemporary cohort of AF patients. Methods Patients with established AF and 65 years of age or older were enrolled in two large, prospective, multicentre cohort studies in Switzerland. Plasma levels of high-sensitivity (hs) CRP and IL-6 were measured from frozen EDTA plasma samples obtained at baseline. Using these two biomarkers, we calculated an inflammation score ranging from 0 to 4 (1 point for each biomarker between the 50th and 75th percentile, 2 points for each biomarker above the 75th percentile). We constructed multivariable Cox proportional hazards models to quantify the associations of hs-CRP, IL-6 and the inflammation score with time to first hospitalization for heart failure and time to all-cause mortality, respectively. Results A total of 3,784 patients with AF (median age 72 years, 28% women, 24% with a prior history of heart failure and 84% anticoagulation use at baseline) were followed for a median (interquartile range [IQR]) of 4.0 (2.9–5.1) years. The median (IQR) plasma levels of hs-CRP and IL-6 at baseline were 1.64 (0.81–3.69) mg/L and 3.42 (2.14–5.60) pg/mL, respectively. The incidence rates of hospitalization for heart failure and death were 3.04 and 2.80 per 100 person-years, respectively. After multivariable adjustment, both biomarkers were significantly associated with the risk of hospitalization for heart failure (per increase in 1 standard deviation [SD], adjusted hazard ratio [aHR] 1.22, 95% confidence interval [CI] 1.11–1.34 for log-transformed hs-CRP, and aHR 1.48, 95% CI 1.35–1.62 for log-transformed IL-6) and death (per increase in 1 SD, aHR 1.40, 95% CI 1.27–1.54 for log-transformed hs-CRP, and aHR 1.67, 95% CI 1.53–1.81 for log-transformed IL-6). Incidence rates of hospitalization for heart failure increased from 1.34 to 7.31 per 100 person-years across categories of the inflammation score (Figure 1). A strong relationship persisted after multivariable adjustment. Similar findings were observed for all-cause mortality. Conclusions Inflammation is a strong predictor of hospitalization for heart failure and death in patients with AF. Targeting inflammation may be a promising treatment strategy to improve outcomes in these patients at high risk for adverse outcomes. Figure 1 Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Swiss National Science Foundation

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