Evaluation of oral anticoagulants in atrial fibrillation patients over 80 years of age with nonsevere frailty

Shinohara, Mie; Wada, Ryou; Yao, Shintaro; Yano, Kensuke; Akitsu, Katsuya; Koike, Hideki; Kinoshita, Toshio; Yuzawa, Hitomi; Suzuki, Takeya; Fujino, Tadashi; Ikeda, Takanori

doi:10.1002/joa3.12231

Cited by 8 publications

(12 citation statements)

References 24 publications

(27 reference statements)

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“…Mortality rates in NOAC users were similar ( Nishida et al., 2019 ; Mitchell et al., 2019 ) to even significantly lower ( Deitelzweig et al., 2019 ; Kim et al., 2019 ; Poli et al., 2019 ; Russo et al., 2019 ; Alcusky et al., 2020 ; Chao et al., 2020 ) as compared to warfarin. In terms of safety, NOACs were associated with a similar ( Giustozzi et al., 2019 ; Mitchell et al., 2019 ; Nishida et al., 2019 ; Poli et al., 2019 ; Russo et al., 2019 ; Chao et al., 2020 ) to lower ( Kim et al., 2019 ; Shinohara et al., 2019 ; Nishida et al., 2019 ; Chao et al., 2020 ; Wong et al., 2020 ) major bleeding, a similar ( Hohmann et al., 2019 ; Kim et al., 2019 ) to significantly higher ( Mitchell et al., 2019 ; Wong et al., 2020 ) gastrointestinal bleeding and a lower ( Hohmann et al., 2019 ; Kim et al., 2019 ; Mitchell et al., 2019 ; Chao et al., 2020 ; Wong et al., 2020 ) intracranial bleeding risk (except for a similar risk in one study) ( Russo et al., 2019 ) as compared to VKAs in AF patients ≥75, ≥80, ≥85 and ≥90 years old ( Shinohara et al., 2019 ; Hohmann et al., 2019 ; Nishida et al., 2019 ; Mitchell et al., 2019 ; Giustozzi et al., 2019 ; Russo et al., 2019 ; Kim et al., 2019 ; Poli et al., 2019 ; Chao et al., 2020 ). Interestingly, in AF patients ≥90 years old, the use of NOACs as compared to no anticoagulation was associated with a significantly lower risk for the composite effectiveness endpoint (stroke/SE, pulmonary embolism and death), and a borderline similar risk for major bleeding and intracranial bleeding ( Raposeiras-Roubín et al., 2020 ).…”

Section: Resultsmentioning

confidence: 99%

“…In terms of effectiveness, NOACs had an equal stroke/SE risk as compared to VKAs in AF patients ≥75, ≥80, ≥85, and ≥90 years old ( Avgil-Tsadok et al., 2016 ; Lai et al., 2018 ; Giustozzi et al., 2019 ; Hohmann et al., 2019 ; Nishida et al., 2019 ; Mitchell et al., 2019 ; Russo et al., 2019 ; Shinohara et al., 2019 ; Alcusky et al., 2020 ). Some studies even described a significantly lower stroke/SE ( Deitelzweig et al., 2019 ; Kim et al., 2019 ) and ischemic stroke risk ( Mitchell et al., 2019 ; Deitelzweig et al., 2019 ; Chao et al., 2020 ), as opposed to a higher stroke/transient ischemic attack (TIA) risk in one small Italian study ( Poli et al., 2019 ) and a borderline increased ischemic stroke/TIA risk for apixaban in another study due to off-label underdosing ( Alcusky et al., 2020 ).…”

Section: Resultsmentioning

confidence: 99%

“…Studies including even older AF patients (e.g. ≥80, 85, or 90 years old) were not included in the meta-analysis, due to concerns of channelling bias ( Alcusky et al., 2020 ) in the introduction years and selective prescribing (of NOACs to more comorbid patients) later on, and more frequent inappropriate NOAC dosing in observational studies ( Shinohara et al., 2019 ; Raposeiras-Roubín et al., 2020 ) in the oldest AF patients. However, these results were included in an additional subgroup analysis.…”

Section: Methodsmentioning

confidence: 99%

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Effectiveness and Safety of Oral Anticoagulants in Older Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

et al. 2020

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Background and Objective: Atrial fibrillation (AF), the most common cardiac arrhythmia, typically increases with age. Oral anticoagulants (OACs) are the cornerstone of treatment to reduce the associated risk for systemic thromboembolism. Four large randomized controlled trials (RCTs) have shown that non-vitamin K antagonist oral anticoagulants (NOACs) are non-inferior to vitamin K antagonists (VKAs) in preventing stroke and systemic embolism, as well as regarding their risk for major bleeding. However, as vulnerable geriatric patients with AF were largely underrepresented in these trials, physicians are faced with the challenge of choosing the right anticoagulant for geriatric patients in real-life clinical practice. In this vulnerable patient group, NOACs tend to be underused or underdosed due to concerns of excessive fall-related intracranial bleeding, cognitive impairment, multiple drugdrug interactions, low body weight or impaired renal function. As life expectancy continues to rise worldwide, the number of geriatric patients substantially increases. Therefore, there is an urgent need for a critical appraisal of the added value of NOACs in geriatric patients with AF at high thromboembolic and bleeding risk. Methods and Results: This systematic review provides an overview of the literature on the impact of increased age (≥75 years), multimorbidity, polypharmacy, increased falling risk, frailty and dementia on the effectiveness and safety of NOACs as compared to VKAs, after searching the Medline database. Moreover, a meta-analysis on the impact of increased age ≥75 years old was performed after pooling results from 6 post hoc analyses of RCTs and 6 longitudinal observational cohort studies, highlighting the superior effectiveness (hazard ratio (HR) 0.83, 95% confidence interval (CI) [0.74-0.94] for stroke/SE; HR 0.77, 95%CI [0.65-0.92] for mortality) and non-inferior safety (HR 0.93, 95%CI [0.86-1.01] for major bleeding; HR 0.58, 95%CI [0.50-0.67] for intracranial bleeding; HR 1.17, 95%CI [0.99-1.38] for gastrointestinal bleeding) of NOACs versus VKAs in older AF patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Effectiveness and Safety of Oral Anticoagulants in Older Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

et al. 2020

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“…A large Asian study from the Taiwan National Health Insurance database found annual rates of thromboembolic events in patients with NVAF aged ≥ 90 years (mean CHA 2 DS 2 -VASc score 5.7) of 4.1 and 4.6/100 PY with DOACs and warfarin, respectively [ 16 ]. Single-center studies in Japan showed a much lower incidence rate of thromboembolic events (0.9 and 1.4/100 PY for DOACs and warfarin, respectively, in patients with NVAF aged ≥ 80 years [mean CHADS 2 score 2.7; mean CHA 2 DS 2 -VASc score 5.3]) [ 33 ] and a lower incidence rate of thromboembolic events (0 and 1.4% per year with DOACs and warfarin, respectively) in patients with NVAF aged ≥ 90 years (median CHADS 2 score 3; median CHA 2 DS 2 -VASc score 5) [ 34 ]. Different sample sizes and sampling methods (large national database vs. single-center medical chart) may have contributed to the different incidence rates for thromboembolic events.…”

Section: Discussionmentioning

confidence: 99%

“…We found no differences in the incidence rates of thromboembolic or bleeding events between patients treated with DOACs and those treated with warfarin. Recent studies suggested a greater benefit of DOACs over warfarin in very elderly patients with NVAF because DOACs were associated with a lower risk of major bleeding [ 13 – 17 , 33 ]. However, some studies suggested that the incidence of major bleeding was similar between elderly patients treated with DOACs and those treated with warfarin and that warfarin is still preferred over DOACs in patients aged ≥ 90 years who have a high thromboembolic and bleeding risk [ 32 , 34 , 38 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Direct Oral Anticoagulants and Warfarin in Japanese Patients with Atrial Fibrillation Aged ≥ 85 Years: A Single-Center Observational Study

Naganuma

Shiga

Hagiwara

2020

Drugs - Real World Outcomes

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Background Increasing age is associated with an increase in stroke in patients with nonvalvular atrial fibrillation (NVAF). Elderly patients have several comorbidities and increased bleeding risk. Objective The aim of this study was to evaluate the clinical outcomes of Japanese patients with NVAF aged ≥ 85 years who were treated with direct oral anticoagulants (DOACs) or warfarin. Methods We retrospectively studied the records of 358 patients with NVAF aged ≥ 85 years who had taken DOACs or warfarin between 2014 and 2018. The primary endpoints were the first occurrences of thromboembolic and bleeding events and death. The secondary endpoint was the discontinuation of oral anticoagulation (OAC) therapy. Results During a median follow-up period of 17 months, 24 patients died. The incidence (per 100 patient-years [PY]) of thromboembolic events was 1.8 in patients treated with DOACs and 2.2 in those treated with warfarin (adjusted subdistribution hazard ratio [SHR] 0.69; 95% confidence interval [CI] 0.23–2.12 in a competing model), and the incidence of major bleeding events was 3.1 and 4.2 in patients treated with DOACs and warfarin, respectively (adjusted SHR 0.95; 95% CI 0.32–2.86). The most common cause of bleeding events was gastrointestinal bleeding. A total of 33 patients permanently discontinued OAC therapy, at a median age of 89 years and with no differences between DOACs and warfarin. The most common reason for discontinuing OAC therapy was bleeding events. Conclusion Our results revealed that the incidences of thromboembolism and major bleeding among patients with NVAF aged ≥ 85 years were similar for those treated with DOACs and those treated with warfarin. Approximately 10% of patients permanently discontinued OAC therapy. Electronic supplementary material The online version of this article (10.1007/s40801-020-00209-4) contains supplementary material, which is available to authorized users.

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Impact of frailty models on the prescription of oral anticoagulants and on the incidence of stroke, bleeding, and mortality in older patients with atrial fibrillation: a systematic review

Presta

Brunetti

Polidori

et al. 2022

Ageing Research Reviews

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Evaluation of oral anticoagulants in atrial fibrillation patients over 80 years of age with nonsevere frailty

Cited by 8 publications

References 24 publications

Effectiveness and Safety of Oral Anticoagulants in Older Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

Effectiveness and Safety of Oral Anticoagulants in Older Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

Clinical Outcomes of Direct Oral Anticoagulants and Warfarin in Japanese Patients with Atrial Fibrillation Aged ≥ 85 Years: A Single-Center Observational Study

Impact of frailty models on the prescription of oral anticoagulants and on the incidence of stroke, bleeding, and mortality in older patients with atrial fibrillation: a systematic review

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