Clinical Features and Outcomes of Very Elderly Patients with Non-Valvular Atrial Fibrillation Receiving Oral Anticoagulants

2022 ◽  
Author(s):  
U. FAN O ◽  
Tou Kun Chong ◽  
Yulin Wei ◽  
Bishow Paudel ◽  
Michael C. Giudici ◽  
...  
2021 ◽  
pp. 174749302110467
Author(s):  
Yutao Guo ◽  
Agnieszka Kotalczyk ◽  
Jacopo F Imberti ◽  
Yutang Wang ◽  
Gregory YH Lip ◽  
...  

Background Advancing age is a major risk factor for ischemic stroke in atrial fibrillation. We aimed to evaluate the predictors of all-cause death/any thromboembolism and the impact of oral anticoagulant on clinical outcomes in very elderly (≥85 years) Chinese atrial fibrillation patients. Methods The ChiOTEAF is a prospective registry proceeded in 44 sites from 20 provinces in China between October 2014 and December 2018. Outcomes of interest were all-cause mortality, any thromboembolism, major bleeding, and new onset/worsening heart failure. Results The eligible cohort for this analysis included 6416 patients and 1215 (18.9%) patients were aged ≥85 years. Only 320 (26.4%) very elderly patients were treated with oral anticoagulant, of whom 205 (64.1%) received non-vitamin K antagonist oral anticoagulants, while antiplatelet therapy was used among 642 (53.1%) very elderly patients. On multivariate analysis, the use of oral anticoagulant was an independent predictor of a lower risk of the composite outcome (OR: 0.46; 95% CI: 0.32–0.66) and all-cause death (OR: 0.47; 95% CI: 0.32–0.69) among these very elderly atrial fibrillation patients. Conclusions Advanced age should not be a reason to withhold oral anticoagulant, since the use of oral anticoagulants is safe and improves survival.


Author(s):  
Laurent Fauchier ◽  
Patrick Blin ◽  
Frédéric Sacher ◽  
Caroline Dureau-Pournin ◽  
Marie-Agnès Bernard ◽  
...  

Abstract Aims The real-life benefits and risks of the non-vitamin K antagonist oral anticoagulants for stroke prevention in very elderly patients with atrial fibrillation (AF) are still debated. Methods and results Cohorts of new users of rivaroxaban 15 mg, dabigatran 110 mg, or vitamin K antagonists (VKA) for AF ≥85 years old in 2013 or 2014 were identified in the nationwide French claims database and followed-up for 1 year. Cohorts were compared after 1:1 matching using high-dimensional propensity score. Compared to VKA use and considering 1-year cumulative incidences, risk of stroke, and systemic embolism was not different with rivaroxaban use [hazard ratio 1.14, 95% confidence interval (CI): 0.93–1.40] and lower with dabigatran use (0.77, 95% CI: 0.60–0.99), risk of major bleeding was not different with rivaroxaban use (0.91, 95% CI: 0.74–1.11) and with dabigatran use (0.81, 95% CI: 0.64–1.03), risk of all-cause death was borderline to significance lower with rivaroxaban use (0.91, 95% CI: 0.83–1.00), and lower with dabigatran use (0.87, 95% CI: 0.78–0.97). The risk for a composite of all events above was not different with rivaroxaban use (0.96, 95% CI: 0.88–1.04) and lower with dabigatran use (0.87, 95% CI: 0.79–0.96) as compared with VKA use. The risk for the composite of all events was not different with rivaroxaban use as compared with dabigatran use (1.09, 95% CI: 0.97–1.23). Conclusion This study shows for the first time in more than 25 000 new real-life anticoagulant users for AF aged ≥85 years a neutral overall benefit-risk of rivaroxaban 15 mg vs. VKA and a favourable overall benefit-risk of dabigatran 110 mg vs. VKA on relevant clinical events. Study registration European Medicines Agency EUPAS14567 (www.encepp.eu) and Clinicaltrials.gov id NCT02864758.


Author(s):  
Takeshi Yamashita ◽  
Shinya Suzuki ◽  
Hiroshi Inoue ◽  
Masaharu Akao ◽  
Hirotsugu Atarashi ◽  
...  

Abstract Aims To clarify the real-world clinical status and prognosis of elderly and very elderly non-valvular atrial fibrillation (NVAF) patients, more than 30 000 elderly patients with NVAF aged ≥75 years were enrolled in the ANAFIE Registry. Methods and Results This multicentre, prospective, observational study followed elderly NVAF patients in Japan for ∼2 years. Among 32 275 patients (mean age 81.5 years; men, 57.3%; mean CHA2DS2-VASc score 4.5), 2445 (7.6%) were not receiving oral anticoagulants (OACs) and 29 830 (92.4%) were given OACs. Of these, 21 585 (66.9%) were receiving direct OACs (DOACs) and 8233 (25.5%), warfarin (mean time in therapeutic range: ∼75%). In total, the 2-year incidence rate was 3.01% for stroke/systemic embolic events (SEE); 2.00%, major bleeding; and 6.95%, all-cause death. As compared with the warfarin group, the DOAC group had a lower hazard ratio (HR) for stroke/SEE, major bleeding, and all-cause death after adjusting for confounders. The group without OACs had a higher HR for stroke/SEE and all-cause death, with a lower HR for major bleeding. History of falls within 1 year at enrolment and of catheter ablation were positive and negative independent risk factors, respectively, for stroke/SEE, major bleeding and all-cause death. Conclusion In Japan, a large proportion of elderly and very elderly NVAF patients were receiving DOACs, which was significantly associated with lower rate of stroke/SEE, major bleeding, and all-cause death vs well-controlled warfarin. History of falls and of catheter ablation were independently associated with stroke/SEE, major bleeding, and all-cause death.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C C Wang ◽  
Y H Kim ◽  
B Brueggenjuergen ◽  
R De Caterina ◽  
P Kirchhof ◽  
...  

Abstract Background As populations age, prevalence of atrial fibrillation (AF) and ensuing need for oral anticoagulation increase. Benefits and risks of nonvitamin K antagonist oral anticoagulants such as edoxaban in the frail, elderly population with AF in regular clinical care is of special interest. Purpose Data from Global ETNA-AF capturing almost 2ehz745.1164 patients treated with edoxaban in Europe, Japan, and Korea/Taiwan, was analyzed to compare outcomes in patients <75 years, elderly (≥75 years), and very elderly (≥85 years) patients. Methods Global ETNA-AF is a multinational, multicentre, prospective, noninterventional program (EU: NCT02944019, Japan: UMINehz745.116417011, Korea/Taiwan: NCT02951039). Demographics, baseline characteristics, and 1-year outcome data were reported for 19416 patients classified into 3 age categories. Results At 1-year follow-up, rates of major bleeding (including intracranial haemorrhage [ICH]) and ischaemic stroke were generally low. All-cause and CV mortality increased with age; CV mortality was a minor proportion of all-cause mortality in all age groups. Rates of major bleeding and ischaemic stroke increased slightly with age, but to a lesser extent than all-cause and CV mortality. There was no increase in the rate of ICH with age. <75 yrs (N=9725) ≥75 yrs (N=9687) ≥85 yrs (N=2186) Age, median (IQR) 68.0 (63.0, 72.0) 80.0 (77.0, 84.0) 87.0 (86.0, 89.0) Gender, male % 65.8 51.5 41.4 BMI, median (IQR) 25.6 (22.9, 29.0) 24.5 (21.9, 27.5) 23.4 (20.8, 26.1) Weight, median (IQR) kg 71.0 (60.0, 84.5) 62.5 (52.9, 75.0) 55.4 (47.6, 67.0) CHA2DS2-VASc, mean (SD) 2.4 (1.28) 4.1 (1.27) 4.4 (1.34) CrCl [mL/min], median (IQR) 78.4 (63.6, 95.9) 52.0 (41.1, 64.5) 40.3 (32.2, 49.4) Edoxaban 60/30 mg, % 64.0/36.0 34.3/65.7 15.8/84.2 1-year outcome, n (%/year)   Major bleeding (ISTH) 57 (0.71) 93 (1.19) 25 (1.53)   Intracranial hemorrhage 22 (0.27) 22 (0.28) 3 (0.18)   Major GI* bleeding 18 (0.22) 36 (0.46) 16 (0.98)   CRNMB** 126 (1.57) 212 (2.73) 56 (3.45)   Ischaemic stroke 53 (0.66) 83 (1.06) 23 (1.41)   All-cause/CV mortality 95 (1.18)/25 (0.31) 224 (2.86)/55 (0.70) 89 (5.44)/23 (1.41) *Gastrointestinal. **Clinically relevant nonmajor bleeding. Conclusion Global data from this set of unselected patients support the use of edoxaban as a safe and effective treatment in elderly and very elderly patients with AF in regular clinical care. Acknowledgement/Funding Daiichi Sankyo


2021 ◽  
Vol 30 (1) ◽  
pp. 16-23
Author(s):  
S. Moiseev

Over the last decade, the number of people aged 80 years or over in Russia increased by 41% up to 5.7 mln. At least 10% of these individuals develop atrial fibrillation (AF). Treatment of rhythm disorders in the very elderly patients is challenging due to the high occurrence of comorbidities, including cognitive dysfunction, changes in the pharmacokinetics of drugs as a result of reduced kidney function, increased risk of interaction of drugs. The very elderly patients with AF have a higher risk of ischemic stroke and other cardiovasculat outcomes, including myocardial infarction, and should be treated with oral anticoagulants. The results of randomized controlled trials and prospective and retrospective observational studies suggest that in patients aged 80 years or older with non-valvular AF direct oral anticoagulants (DOAC) are at least as effective as vitamin K antagonists for prevention of ischemic stroke and are associated with a lower risk of intracerebral haemorrhage. The use of DOAC (once daily rivaroxaban in particular) impoves compliance to anticoagulation in the very elderly patients with non-valvular AF.


Author(s):  
Ghanshyam Palamaner Subash Shantha ◽  
Prashant D. Bhave ◽  
Saket Girotra ◽  
Denice Hodgson-Zingman ◽  
Alexander Mazur ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1162-1162
Author(s):  
Desirée Campoy ◽  
Gonzalo Artaza ◽  
César A Velasquez ◽  
Tania Canals ◽  
Erik A Johansson ◽  
...  

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.


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