Anticoagulation therapy in the elderly with non-valvular atrial fibrillation: a double-edged sword (original) (raw)

Geriatric Conditions and Prescription of Vitamin K Antagonists vs. Direct Oral Anticoagulants Among Older Patients With Atrial Fibrillation: SAGE-AF

Frontiers in Cardiovascular Medicine, 2019

Background: Geriatric conditions are common among patients with atrial fibrillation (AF) and relate to complications of oral anticoagulation (OAC). Objective: To examine the prevalence of geriatric conditions among older patients with AF on OAC and relate type of OAC to geriatric conditions. Methods: Participants had a diagnosis of AF, were aged ≥65 years, CHA 2 DS 2 VASC ≥ 2, and had no OAC contraindications. Participants completed a 6-component geriatric assessment that included validated measures of frailty (CHS Frailty Scale), cognitive function (MoCA), social support (MOS), depressive symptoms (PHQ9), vision, and hearing. Type of OAC prescribed was documented in medical records. Results: 86% of participants were prescribed an OAC. These participants were on average aged 75.7 (SD: 7.1) years, 49% were women, two thirds were frail or pre-frail, and 44% received a DOAC. DOAC users were younger, had lower CHA 2 DS 2 VASC and HAS-BLED scores, and were less likely to be frail. In Massachusetts, pre-frailty was associated with a significantly lower odds of DOAC vs. VKA use (OR = 0.64, 95%CI 0.45, 0.91). Pre-frailty (OR = 0.33, 95%CI 0.18-0.59) and social isolation (OR = 0.38, 95%CI 0.14-0.99) were associated with lower odds of DOAC receipt in patients aged 75 years or older. Social isolation was associated with higher odds of DOAC use (OR = 2.13, 95%CI 1.05-4.29) in patients aged 65-74 years. McManus et al. Geriatric Conditions and Prescription of Oral Anticoagulants Conclusions: Geriatric conditions were common and related to type of OAC prescribed, differentially by age group. Research is needed to evaluate whether a geriatric examination can be used clinically to better inform OAC decision-making in older patients with AF.

Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical inpatients with atrial fibrillation

Geriatrics & Gerontology International, 2016

Aim The aim of the present study was to investigate the prevalence of geriatric syndromes among older medical inpatients with atrial fibrillation, and their association with use of vitamin K antagonists. Methods A retrospective study of patients aged ≥65 years discharged with a diagnosis of atrial fibrillation from the Acute Geriatric Ward was carried out. Stroke and bleeding risk were evaluated according to the CHA 2 DS 2-VASC and HAS-BLED scores. Comorbidity, cognitive status, functional autonomy and contraindications to vitamin K antagonists were also considered. Results Atrial fibrillation was documented in 1078 of 3650 patients (29.5%, mean age 83.4 ± 6.6 years, 60.3% women). Contraindications to vitamin K antagonists were documented in 24.9% of patients. Prescription of vitamin K antagonists at discharge was 37.8% and 47.9%, in the overall sample and in those without contraindications, respectively. In the overall sample, prescription of vitamin K antagonists was associated with younger age, permanent/persistent atrial fibrillation, home discharge, less comorbidity, higher hemoglobin levels, better functional independence, known atrial fibrillation at admission and lower HAS-BLED score. Among patients without contraindications to vitamin K antagonists, their use at discharge was independently associated with younger age, permanent/persistent atrial fibrillation, home discharge, higher hemoglobin levels and CHA2DS2-VASC score, better functional autonomy, and greater number of drugs. Conclusions We showed a high prevalence of atrial fibrillation among older medical inpatients, who have a poor health status and a high prevalence of geriatric syndromes. Vitamin K antagonists were prescribed in less than half of the patients; underuse was mainly accounted for by a high prevalence of comorbidities/contraindications, poor health status and limited functional autonomy.

Non-vitamin K oral anticoagulant use in the elderly: a prospective real-world study – data from the REGIstry of patients on Non-vitamin K oral Anticoagulants (REGINA)

Vascular Health and Risk Management

Purpose: Numerous studies on thromboembolic prevention for non-valvular atrial fibrillation (NVAF) have shown either equal or better efficacy and safety of non-vitamin K oral anticoagulants (NOACs) compared to warfarin, even for patients aged ≥75 years. Data on elderly patients, in particular, octogenarians, are lacking. Paradoxically, this population is the one with the highest risk of bleeding and stroke with a worse prognosis. This study aims to describe safety and effectiveness of NOACs in an elderly comorbid population. Patients and methods: REGIstry of patients on Non-vitamin K oral Anticoagulants (REGINA) is a prospective observational study enrolling consecutive NVAF patients started on NOACs and followed up to 1 year (at 1, 6, 12 months). The primary endpoint was the incidence rate of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB). The secondary endpoints were the incidence of 1) stroke or systemic embolism, 2) hospitalization, 3) death, and 4) drug-related adverse events. Results: We enrolled 227 patients aged 81.6±6.1 years (range 67-95 years; ≥80 years in 59.4%). The median CHA 2 DS 2-VASc was 5 (IQR 4-5) and HAS-BLED was 4 (IQR 3-5). The estimated glomerular filtration rate was 59.27±24.12 mL/min. During follow-up, only 10 MB and 23 CRNMB occurred, with a total incidence of 4.4% (95% CI: 1.7%-7.17%) and 5.7% (95% CI: 2.68%-8.72%), respectively. There were 2 cerebral ischemic events, with a total incidence of 0.88% (95% CI: 0.84%-0.92%), 23 NOAC-related hospitalizations, no NOAC-related deaths, and 4 minor drug-related adverse effects. Conclusion: In a population of aged and clinically complex patients, mainly octogenarians, NOACs were safe and effective.

Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a “Real-world” Nationwide Registry: Insights From the FANTASIIA Study

Journal of Cardiovascular Pharmacology and Therapeutics, 2020

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26....

Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients

Journal of the American Geriatrics Society

Older adult patients are underrepresented in clinical trials comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin. DESIGN: Retrospective observational study. SETTING: The Centers for Medicare & Medicaid Services and three US commercial claims databases. PARTICIPANTS: A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015. MEASUREMENTS: In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB. RESULTS: The patients in the six matched cohorts had a mean follow-up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49-.69), dabigatran (HR = .77; 95% CI = .60-.99), and rivaroxaban (HR = .74; 95% CI = .65-.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54-.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78-1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07-1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47-.89; MB: HR = .60; 95% CI = .49-.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59-.86; MB: HR = .50; 95% CI = .45-.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67-.90) compared with rivaroxaban. CONCLUSION: Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin.

Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and valvular heart disease

International journal of cardiology, 2016

Objective: To evaluate comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) and comorbid diabetes mellitus (DM). Methods: A retrospective cohort study using 2014-2016 5% national Medicare data was undertaken. NVAF patients with DM aged ≥65 years having at least one prescription for NOACs or warfarin between July, 2014 and December, 2015 were included in the study. Propensity score matching was used to balance demographic and baseline clinical characteristics of patients in two treatment groups. Cardiovascular outcomes including stroke/systemic embolism (SE), and myocardial infarction (MI) were evaluated to measure effectiveness. Assessment of safety outcomes included intracranial hemorrhage (ICH), major gastrointestinal bleeding (MGB), bleeding from other sites (OB), and all-cause mortality. Stratified Cox proportional hazards models were used to estimate hazard ratios for the outcomes in the matched cohort. Results: The matched sample consisted of 4,582 patients (2,291 pairs). Compared to warfarin, NOACs had a significantly lower risk of stroke/SE (Hazard Ratio (HR): 0.373, 95% confidence interval (CI): 0.247-0.564, p<0.001) and all-cause mortality (HR: 0.783, CI: 0.656-0.873, p=0.007). NOACs were found to significantly reduce the risk of ICH (HR: 0.500, CI: 0.300-0.834, p=0.008) and OB (HR: 0.608, CI: 0.424-0.870, p=0.007); but no difference was observed in the risk of MGB (HR: 0.862, CI: 0.640-1.160, p=0.326) between NOACs and warfarin. The composite outcome demonstrated superior overall effectiveness and safety of NOAC therapy to warfarin therapy (HR:0.685, CI: 0.587-0.801, p<0.001). Conclusion: Oral anticoagulation therapy with NOACs was found to be more effective than warfarin therapy among older adults with NVAF and comorbid DM.

Non-vitamin K antagonist oral anticoagulants in cardiovascular disease management: evidence and unanswered questions

Journal of Clinical Pharmacy and Therapeutics, 2014

Background: Elderly population is known to be associated with polymedication, comorbidities and altered drug pharmacokinetics. However, the most adequate oral anticoagulant, attending to its relative efficacy and safety, remains unclear. Methods: We searched for phase III randomized controlled trials (MEDLINE, Cochrane Library, SciELO collection and Web of Science) comparing novel non-vitamin K antagonist oral anticoagulants (NOACs) with Vitamin K antagonists (VKA) in the elderly population (≥75 years-old) in atrial fibrillation (AF). Risk ratios (RR) were calculated using a random effects model. Trial sequential analysis (TSA) was performed in statistically significant results to evaluate whether cumulative sample size was powered. Results: Four trials rendered data about elderly (≥75 years-old) and younger patients (< 75 years-old) with AF. NOACs demonstrated a 30% significant risk reduction (RR 0.70, 95% CI: 0.61 to 0.80) in elderly patients compared to VKA, without heterogeneity across studies (I 2 = 0%). The TSA showed that cumulative evidence of this subgroup exceeded the minimum information size required for the risk reduction. In younger patients, VKA and NOACs shared a similar risk of stroke and systemic embolism (RR 0.97, 95% CI: 0.79 to 1.18). Regarding major bleeding risk in the elderly, the overall comparative risk of NOACs was not different from VKA (RR 0.91, 95% CI: 0.72 to 1.16; I 2 = 86%). Conclusions: NOACs reduce significantly the risk of stroke and systemic embolism in elderly patients without increasing major bleeding events. The dimension of stroke risk reduction was significantly higher in the elderly than in younger adults.

Efficacy and safety of oral anticoagulant therapy in frail patients with atrial fibrillation

Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 2018

Antithrombotic treatment of frail patients with AF presents various challenges. The fear of bleeding often leds to a large underuse of anticoagulant agents in these patients, although more recent data indicate that oral anticoagulation (especially with the newer, direct anticoagulants) is increasingly used. While there is a need for more real world data, available evidence suggests that non-vitamin K antagonist oral anticoagulants (NOACs) are an effective alternative to warfarin in frail patients with AF for preventing thromboembolic events, with a better safety profile. Logical considerations and evidence-base data related to the reduced bleeding risk (also including major bleeding and intracranial bleeding) of NOACs make these drugs the anticoagulant agents of choice in frail patients; however, in this setting an individualised approach should be taken, taking into consideration the risk of thromboembolic and bleeding events, other comorbidities and patient-related factors, rathe...

Could some geriatric characteristics hinder the prescription of anticoagulants in atrial fibrillation in the elderly?

Journal of aging research, 2014

Several studies have reported underprescription of anticoagulants in atrial fibrillation (AF). We conducted an observational study on 142 out of a total of 995 consecutive ≥75 years old patients presenting AF (14%) when admitted in an emergency unit of a general hospital, in search of geriatric characteristics that might be associated with the underprescription of anticoagulation therapy (mostly antivitamin K at the time of the study). The following data was collected from patients presenting AF: medical history including treatment and comorbidities, CHADS2 score, ISAR scale (frailty), Lawton's scale (ADL), GDS scale (mood status), MUST (nutrition), and blood analysis (INR, kidney function, and albumin). Among those patients for who anticoagulation treatment was recommended (73%), only 61% were treated with it. In the group with anticoagulation therapy, the following characteristics were observed more often than in the group without such therapy: a recent (≤6 months) hospitaliza...