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A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J-ELD AF Registry).

ABSTRACT: BACKGROUND:A global, randomized clinical trial indicated the efficacy and safety of apixaban in stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, data in the elderly NVAF patients ?75?years, especially those on reduced dose, are limited. HYPOTHESIS:To confirm the current dose reduction criteria of apixaban in elderly NVAF patients. METHOD:With a large-scale, multicenter prospective observational study, one-year outcomes after administration of on-label doses of apixaban were analyzed in Japanese NVAF patients aged ?75?years. Endpoints were stroke or systemic embolism, bleeding requiring hospitalization, total death, and cardiovascular death. RESULTS:A total of 3031 patients (average age, 81.7?years; female, 48.2%) taking standard (5 mg bid) or reduced dose (2.5 mg bid) of apixaban were enrolled from 110 facilities. Standard and reduced apixaban doses were administered in 1284 (42.4%) and 1747 (57.6%) patients, respectively. Event rates (/100 person-years) in standard and reduced dose groups were 1.67 and 1.56, respectively, for stroke or systemic embolism, 1.42 and 2.25 for bleeding requiring hospitalization, 1.41 and 4.46 for total death, and 0.41 and 1.36 for cardiovascular death. Reduced apixaban dose was not significantly associated with stroke or systemic embolism and bleeding requiring hospitalization, but was independently associated with total and cardiovascular death. CONCLUSIONS:Incidences of stroke or systemic embolism and bleeding requiring hospitalization were similar between standard and reduced apixaban doses in the elderly NVAF patients. The incidences of total and cardiovascular death were significantly higher in the reduced dose group due to the coexisting higher risks in this group.

SUBMITTER: Okumura K

PROVIDER: S-EPMC7068106 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J-ELD AF Registry).

Okumura Ken K Yamashita Takeshi T Suzuki Shinya S Akao Masaharu M

Clinical cardiology 20191118 3

<h4>Background</h4>A global, randomized clinical trial indicated the efficacy and safety of apixaban in stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, data in the elderly NVAF patients ≥75 years, especially those on reduced dose, are limited.<h4>Hypothesis</h4>To confirm the current dose reduction criteria of apixaban in elderly NVAF patients.<h4>Method</h4>With a large-scale, multicenter prospective observational study, one-year outcomes after administration ...[more]

PMID: 31737921

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Project description:ObjectivesThe CArdioSurgEry Atrial Fibrillation (CASE-AF) registry is a prospective, multicentre study for collecting and analysing real-world data of surgical atrial fibrillation (AF) treatment. This study aimed to evaluate outcomes of surgery for long-standing persistent AF at 1 year.MethodsIn total, 17 centres consecutively include all eligible patients with continuous AF lasting for ≥1 year. Exclusion criteria are missing informed consent or age <18 years. For patient-reported outcomes measures, the European Heart Rhythm Association score was used. No presence of AF (based on ECG findings including Holter ECG and/or implanted devices), no re-ablation, no further cardioversion and no rehospitalization due to AF after a 3-month blanking period defined no AF recurrence at 1 year.ResultsFrom January 2017 to January 2020, a total of 1115 patients were enrolled in CASE-AF. Of them, 202 patients (mean age 69.7 ± 7.8 years, 27.2% female) underwent surgical ablation of long-standing persistent AF (study cohort), mostly accompanied by left atrial appendage closure (n = 180 [89%], resection n = 75 [42%]) and predominantly performed as concomitant (n = 174 [86%]) and left atrial only procedure (n = 144 [71%]). Early mortality (30 days) was 2.0% and morbidity was low. At follow-up (median 14.4 months, interquartile range, 12.7-17.6 months, 100% complete), 106 patients (56%) had no AF recurrence and 93% of them were asymptomatic. AF recurrence was accompanied by AF-related rehospitalization (n = 12, P = 0.003), direct current shock cardioversion (n = 23, P < 0.001), AF ablation (n = 7, P = 0.003) and stroke (n = 3, P = 0.059). Multivariable analysis identified cryoablation, predominantly performed endocardially including additional left atrial (74%) and biatrial (42%) lesions, as a significant factor for freedom from AF recurrence (odds ratio 2.7, 95% confidence interval 1.07-6.79, P = 0.035).ConclusionsAccording to CASE-AF, surgical ablation of long-standing persistent AF is most effective when concomitantly performed using endocardial cryoablation. Ongoing follow-up allows further elucidation of efficacious treatment strategies.

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.

Dataset Information

A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J-ELD AF Registry).

Publications

A multicenter prospective cohort study to investigate the effectiveness and safety of apixaban in Japanese elderly atrial fibrillation patients (J-ELD AF Registry).

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