Dataset Information

Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.

ABSTRACT: Background: The ELDERCARE-AF trial demonstrated that low-dose edoxaban prevented stroke or systemic embolism (SE) in very elderly Japanese patients with non-valvular atrial fibrillation (NVAF) in whom standard oral anticoagulant therapy was inappropriate because of high bleeding risk. The aim of this study was to elucidate the characteristics and outcomes of such patients in routine clinical practice. Methods and Results: Data were extracted from the Fushimi AF Registry for ELDERCARE-eligible NVAF patients aged ≥80 years, with a CHADS₂ score ≥2 and ≥1 bleeding risk factors, as shown in the ELDERCARE-AF trial. ELDERCARE-eligible patients (n=549; 12.8% of the entire cohort, 52.9% of those aged ≥80 years and with CHADS₂ score ≥2) were less often male, were older, had more comorbidity and higher risk scores than non-eligible patients from the entire cohort (n=3,734). The crude incidence (% per patient-year) of adverse events was significantly higher in ELDERCARE-eligible than non-eligible patients (stroke/SE, 4.8% vs. 2.0%; major bleeding, 3.6% vs. 1.9%; all-cause mortality, 15.5% vs. 3.9%; cardiovascular death, 2.7% vs. 0.6%; all log-rank P<0.001). Compared with non-eligible patients aged ≥80 years and with a CHADS₂ score ≥2 (n=488), the incidence of stroke/SE, all-cause mortality, and cardiovascular death remained significantly higher in ELDERCARE-eligible patients. Conclusions: Patients with NVAF who met the inclusion criteria of the ELDERCARE-AF trial were common in routine clinical practice, and had poor clinical outcomes.

SUBMITTER: Ide Y

PROVIDER: S-EPMC8578123 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.

Ide Yuya Y Ogawa Hisashi H Ishigami Kenjiro K Ikeda Syuhei S Doi Kosuke K Hamatani Yasuhiro Y Fujino Akiko A An Yoshimori Y Ishii Mitsuru M Iguchi Moritake M Masunaga Nobutoyo N Esato Masahiro M Tsuji Hikari H Wada Hiromichi H Hasegawa Koji K Abe Mitsuru M Lip Gregory Y H GYH Akao Masaharu M

Circulation reports 20211016 11

Background: The ELDERCARE-AF trial demonstrated that low-dose edoxaban prevented stroke or systemic embolism (SE) in very elderly Japanese patients with non-valvular atrial fibrillation (NVAF) in whom standard oral anticoagulant therapy was inappropriate because of high bleeding risk. The aim of this study was to elucidate the characteristics and outcomes of such patients in routine clinical practice. Methods and Results: Data were extracted from the Fushimi AF Regist ...[more]

PMID: 34805602

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Project description:Whereas insurance status has been previously associated with care patterns, little is currently known about the association between Medicaid insurance and the clinical characteristics, treatment, or outcomes of patients with atrial fibrillation (AF).We used data from adults with AF enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF), a national outpatient registry conducted at 176 community, multispecialty sites. The primary outcome of interest was the proportion of patients prescribed any oral anticoagulation (OAC; warfarin or novel oral anticoagulants [NOAC]). Secondary outcomes of interest included the proportion of patients prescribed NOACs (dabigatran or rivaroxaban); time in therapeutic range (TTR) for warfarin users, all-cause mortality, stroke/systemic embolism, and major bleed. Of 10 133 patients, N=470 (4.6%) had Medicaid insurance. Medicaid patients were similarly likely to receive OAC at baseline (72.8% vs 76.3%; unadjusted P=0.079), but less likely to receive NOAC at baseline or follow-up (12.1% vs 16.3%; unadjusted P=0.019). After risk adjustment, Medicaid status was associated with lower use of OAC at baseline among patients with high stroke risk (odds ratio [OR]=0.68; 95% CI=0.49, 0.94), but was not associated with OAC use overall (OR=0.82; 95% CI=0.61, 1.09). Among warfarin users, median TTR was lower among Medicaid patients (60% vs 68%; P<0.0001; adjusted TTR difference, -2.9; 95% CI=-5.7, -0.2; P=0.04). Use of an NOAC over 2 years of follow-up was not statistically different by insurance. Compared with non-Medicaid patients, Medicaid patients had higher unadjusted rates of mortality, stroke/systemic embolism, and major bleeding; however, these differences were attenuated following adjustment for clinical characteristics.In a contemporary AF cohort, use of OAC overall and use of NOACs were not significantly lower among Medicaid patients relative to others. However, among warfarin users, Medicaid patients spent less time in therapeutic range compared with those with other forms of insurance.

Project description:BackgroundPhysicians treating patients with atrial fibrillation (AF) must weigh the benefits of anticoagulation in preventing stroke versus the risk of bleeding. Although empirical models have been developed to predict such risks, the degree to which these coincide with clinicians' estimates is unclear.Methods and resultsWe examined 10 094 AF patients enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF) registry between June 2010 and August 2011. Empirical stroke and bleeding risks were assessed by using the congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and previous stroke or transient ischemic attack (CHADS2) and Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) scores, respectively. Separately, physicians were asked to categorize their patients' stroke and bleeding risks: low risk (<3%); intermediate risk (3%-6%); and high risk (>6%). Overall, 72% (n=7251) in ORBIT-AF had high-risk CHADS2 scores (≥2). However, only 16% were assessed as high stroke risk by physicians. Although 17% (n=1749) had high ATRIA bleeding risk (score ≥5), only 7% (n=719) were considered so by physicians. The associations between empirical and physician-estimated stroke and bleeding risks were low (weighted Kappa 0.1 and 0.11, respectively). Physicians weighed hypertension, heart failure, and diabetes mellitus less significantly than empirical models in estimating stroke risk; physicians weighted anemia and dialysis less significantly than empirical models when estimating bleeding risks. Anticoagulation use was highest among patients with high stroke risk, assessed by either empirical model or physician estimates. In contrast, physician and empirical estimates of bleeding had limited impact on treatment choice.ConclusionsThere is little agreement between provider-assessed risk and empirical scores in AF. These differences may explain, in part, the current divergence of anticoagulation treatment decisions from guideline recommendations.Clinical trial registration urlhttp://www.clinicaltrials.gov. Unique identifier: NCT01165710.

Dataset Information

Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.

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Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.

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Dataset Information

Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk - The Fushimi AF Registry.

Publications

Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk - The Fushimi AF Registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

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Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.

Clinical Characteristics and Outcomes of Very Elderly Patients With Atrial Fibrillation at High Bleeding Risk　- The Fushimi AF Registry.