scholarly journals P3851Benefit-risk profile of dabigatran compared with vitamin-K antagonists in elderly patients with non-valvular atrial fibrillation: results from a cohort study in the French nationwide claims database

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
Y Cottin ◽  
P Blin ◽  
J Benichou ◽  
C Dureau-Pournin ◽  
A Abouelfath ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Elderly Patients ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Risk Profile ◽  
Claims Database

P3472Modifications of renal function in atrial fibrillation patients treated with different oral anticoagulants: a multicentre cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Pastori ◽  
G Y H Lip ◽  
A Sciacqua ◽  
F Perticone ◽  
F Melillo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Cohort Study ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Forest Plot ◽  
Multicentre Cohort Study ◽  
Egfr Decline ◽  
Multicentre Cohort

Abstract Background A decline of estimated glomerular filtration rate (eGFR) has been described in atrial fibrillation (AF) patients on Vitamin K antagonists (VKAs). Few real-world data on the modifications of eGFR in AF patients treated with non-vitamin K antagonist oral anticoagulants (NOACs) do exist. Purpose To evaluate changes of renal function in AF patients treated with VKAs or NOACs. Methods Multicentre prospective cohort study including 1,667 patients with non-valvular AF from 5 clinical centres of Internal Medicine and Cardiology in Italy. Renal endpoints were: 1) median annual decline of eGFR; 2) transition to eGFR <50 ml/min/1.73 m2; 3) eGFR class worsening according to KDIGO 2012 classification. The eGFR was assessed by the CKD-EPI formula at baseline and during follow-up. Results Median age was 73.7±9.1 years and 43.3% were women. 743 patients were on VKAs and 924 on NOACs (Dabigatran, Rivaroxaban e Apixaban). Median annual eGFR decline was −2,11 (Interquartile Range [IQR] −5,68/−0,62] in patients on VKAs, −0,27 [IQR −9,00/4,54] with Dabigatran (p<0.001 vs. VKAs), −1,21 [IQR −9,98/4,02] with Rivaroxaban (p=0.004 vs. VKAs) and −1,32 [IQR −8,7/3,99] with Apixaban (p=0.003, vs. VKAs). Use of Dabigatran and Apixaban was associated to a lower transition to eGFR <50 mL/min/1.73 m2, compared to VKAs: adjusted Odds Ratio (aOR) 0.492, 95% Confidence Interval (CI) 0.298–0.813, p=0.006 for Dabigatran; aOR 0.449, 95% CI 0.276–0.728, p=0.001 for Apixaban). Regarding the eGFR class worsening, Dabigatran (aOR 0.70, 95% CI 0.503–0.975, p=0.035), Rivaroxaban (aOR 0.591, 95% CI 0.423–0.825, p=0.002), and Apixaban (aOR 0.591, 95% CI 0.429–0.815, p=0.001) were all associated to a lower rate of eGFR class worsening compared to VKAs. Forest plot Conclusions In this prospective multicentre cohort study, NOACs use was associated with a lower decline of renal function compared to VKAs. Patients on Dabigatran showed the lowest annual rate of eGFR decline and those on Apixaban and Rivaroxaban a lower eGFR class worsening. Acknowledgement/Funding None

Safety and efficacy of non-vitamin K antagonist oral anticoagulants in elderly patients with atrial fibrillation: systematic review and meta-analysis of 22 studies and 440 281 patients

2019 ◽  
Author(s):  
Angelo Silverio ◽  
Marco Di Maio ◽  
Costantina Prota ◽  
Elena De Angelis ◽  
Ilaria Radano ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Indirect Comparison ◽  
Haemorrhagic Stroke ◽  
Intracranial Bleeding ◽  
Efficacy And Safety ◽  
Fatal Bleeding

Abstract Aims The aim of the present meta-analysis was to evaluate the efficacy and safety of non-vitamin K oral antagonists (NOACs) vs. vitamin K antagonists (VKAs) in elderly patients with atrial fibrillation (AF) and indirectly compare NOACs in this population. Methods and results MEDLINE, Cochrane, ISI Web of Sciences, and SCOPUS were searched for randomized or adjusted observational studies comparing NOACs vs. VKAs for stroke prevention in AF patients ≥75 years. The primary efficacy and safety outcomes of this meta-analysis were the composite of stroke and systemic embolism (SSE) and major bleedings, respectively. Other secondary outcomes were also analysed. The analysis included 22 studies enrolling 440 281 AF patients ≥ 75 years. The risk of SSE was significantly lower with NOACs vs. VKAs [hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.70–0.89], whereas no differences were found for major bleedings (HR 0.94; 95% CI 0.85–1.05). NOACs reduced the risk of intracranial bleeding (HR 0.46; 95% CI 0.38–0.58), haemorrhagic stroke (HR 0.61; 95% CI 0.48–0.79) and fatal bleeding (HR 0.46; 95% CI 0.30–0.72) but increased gastrointestinal (GI) bleedings (HR 1.46; 95% CI 1.30–1.65), compared to VKAs. The adjusted indirect comparison showed no significant differences in term of SSE between NOAC agents. Conversely, the risk of major bleeding was higher for rivaroxaban vs. apixaban (HR 1.69; 95% CI 1.39–2.08) and edoxaban (HR 1.37; 95% CI 1.14–1.67), and for dabigatran vs. apixaban (HR 1.47; 95% CI 1.18–1.85). Conclusion In elderly patients with AF, NOACs are associated to a lower risk of SSE, intracranial bleeding, haemorrhagic stroke and fatal bleeding than VKAs, but increase GI bleedings. In this analysis, the safety profile of individual NOAC agents was significantly different.

Reduced dose of rivaroxaban and dabigatran vs. vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study

EP Europace ◽  
2019 ◽  
Author(s):  
Laurent Fauchier ◽  
Patrick Blin ◽  
Frédéric Sacher ◽  
Caroline Dureau-Pournin ◽  
Marie-Agnès Bernard ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Real Life ◽  
European Medicines Agency ◽  
Very Elderly ◽  
Clinical Events ◽  
First Time

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.

scholarly journals Anticoagulation therapy in the elderly with non-valvular atrial fibrillation: a double-edged sword

2017 ◽  
Vol 3 (2) ◽  
Author(s):  
Francesco Vetta ◽  
Gabriella Locorotondo ◽  
Giampaolo Vetta
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Anticoagulant Therapy ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Treatment Strategies ◽  
The Elderly ◽  
Hemorrhagic Events

Prevalence of non-valvular atrial fibrillation is increasing over time. Particularly in elderly population, treatment strategies to reduce the rate of stroke are challenging and still represent an unsolved cultural question. Indeed, the risk of thromboembolism increases in the elderly in parallel with the risk of bleeding. The frequent coexistence of several morbidities, frailty syndrome, polypharmacy, chronic kidney disease and dementia strengthens the perception that risk-benefit ratio of anticoagulant therapy could be unfavorable, and explains why such treatment is underused in the elderly. Recently, the introduction of non-vitamin K oral anticoagulants (NOACs) has allowed us to overcome the large number of limitations imposed by the use of vitamin K antagonists. In this manuscript, the benefits of individual NOACs in comparison with warfarin in elderly patients are reviewed. Targeted studies on complex elderly patients are needed to test usefulness of a geriatric comprehensive assessment, besides the scores addressing risk of thromboembolic and hemorrhagic events. In the meantime, it is mandatory that use of anticoagulant therapy in most elderly people, currently excluded from randomized controlled trials, is prudent and responsible.

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