Risk of Major Bleeding in Very Elderly Patients with Atrial Fibrillation- A Continuous Dilemma in the Real World Clinics. Evidence and Perspectives

2019 ◽  
Vol 07 (01) ◽  
Author(s):  
Rami Riziq Yousef Abumuaileq
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Real World ◽  
Very Elderly ◽  
The Real

Abstract 18465: Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20 mg QD

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shital Kamble ◽  
Xianying Pan ◽  
Hemant Phatak ◽  
Hugh Kawabata ◽  
Cristina Masseria ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Cox Proportional Hazards Model ◽  
Charlson Comorbidity Index Score ◽  
The Real

Aim: Limited data are available on the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). The study purpose was to compare the first major bleeding event risk among non valvular atrial fibrillation patients (NVAF) patients newly initiated on dose-adjusted warfarin versus apixaban 5mg BID, dabigatran 150mg BID, or rivaroxaban 20 mg QD. Methods: Retrospective cohort study was conducted using MarketScan® commercial & Medicare supplemental database from 01/2012 to 12/2013. NVAF patients 18+ years with ≥1 year baseline and newly prescribed oral anticoagulant from 01/01/2013 to 12/31/2013 were included. Major bleeding was defined as bleeding requiring hospitalization on the index drug during the supply duration or within 30 days after the last supply day of the last prescription. A Cox proportional hazards model was used to estimate the hazard ratios (HR) of major bleeding adjusted for age, sex, baseline comorbidities and comedications. Results: Among 26,604 patients, 2,057 (7.73%) were newly initiated on apixaban 5mg, 3,768 (14.16%) on dabigatran 150mg, 8,066 (30.32%) on rivaroxaban 20mg and 12,713 (47.79%) on warfarin. Patients initiating warfarin (72.5±11.9 yrs) and apixaban 5mg (67.0±11.4 yrs) were older as compared to rivaroxaban 20mg (65.2±11.4 yrs) and dabigatran 150mg (65.4±11.5 yrs). Patients initiating warfarin had higher CHA 2 DS 2- VASc score (3.22±1.65) and Charlson comorbidity index score (2.37±2.33) (P <0.0001 across all treatments) as compared to those initiating NOACs. After adjusting for baseline characteristics, patients newly initiated on apixaban 5mg BID had significantly lower risk of major bleeding (HR: 0.53, 95% CI: 0.29-0.97, P=0.0399) as compared to those initiated on warfarin (Table). Conclusion: Among newly anticoagulated NVAF patients in the real world setting, as compared to dose adjusted warfarin, only patients initiating on apixaban 5mg BID were associated with significantly lower risk of major bleeding.

Abstract 261: Applying Clinical Trial Data to Real-World: Apixaban, Dabigatran, and Rivaroxaban

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Michael Stokes ◽  
Ning Wu ◽  
Elyse Gatt ◽  
Dinara Makenbaeva ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Relative Risk ◽  
Clinical Outcome ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Absolute Risk ◽  
The Real

BACKGROUND: Data from randomized controlled trials and a real-world sample of non-valvular atrial fibrillation patients were combined to estimate the absolute effect of each new oral anticoagulant (NOAC, apixaban, dabigatran, and rivaroxaban) versus warfarin on stroke and major bleeding rates in real-world clinical practice. METHODS: Non-valvular atrial fibrillation patients were selected from Medco healthplans during 2007-2010. Reference rates for stroke and major bleeding excluding intracranial hemorrhage (to avoid double counting) were calculated for real-world Medco patients during warfarin use. Real-world event rates for NOACs were estimated by multiplying the corresponding relative risk from the randomized clinical trials by each reference rate. Absolute risk reductions and numbers needed to treat (NNT) or numbers needed to harm (NNH) for each NOAC vs. warfarin were then estimated. Reduction in net clinical outcome was calculated by summing the absolute risk reductions for stroke and major bleeding excluding intracranial hemorrhage for each NOAC versus warfarin. RESULTS: Each NOAC resulted in a reduction in stroke events compared with warfarin in the real-world (TABLE). Apixaban was the only NOAC to reduce the rate of major bleeding excluding intracranial hemorrhage compared with warfarin. The NNT to avoid one net clinical outcome (stroke plus major bleeding excluding intracranial hemorrhage) per year was 32 and 84 for apixaban and dabigatran, respectively. Rivaroxaban resulted in an increase in net clinical outcome (NNH=166). CONCLUSIONS: If relative risk reductions from randomized clinical trials persist in the real-world, apixaban would result in the greatest clinical benefit versus warfarin of all NOACs in terms of stroke and major bleeding excluding intracranial hemorrhage events avoided.

Net clinical benefit of anticoagulant treatments in elderly patients with nonvalvular atrial fibrillation: Experience from the real world

Heart Rhythm ◽  
2019 ◽  
Vol 16 (1) ◽  
pp. 31-37 ◽  
Author(s):  
Hilmi Alnsasra ◽  
Moti Haim ◽  
Adi Berliner Senderey ◽  
Orna Reges ◽  
Maya Leventer-Roberts ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Real World ◽  
Clinical Benefit ◽  
Nonvalvular Atrial Fibrillation ◽  
The Real ◽  
Net Clinical Benefit

scholarly journals Two-year outcomes of more than 30 000 elderly patients with atrial fibrillation: results from the All Nippon AF In the Elderly (ANAFIE) Registry

2021 ◽  
Author(s):  
Takeshi Yamashita ◽  
Shinya Suzuki ◽  
Hiroshi Inoue ◽  
Masaharu Akao ◽  
Hirotsugu Atarashi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Clinical Status ◽  
The Elderly ◽  
Very Elderly ◽  
History Of ◽  
Bleeding History

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.

Real-world effectiveness and the safety of anticoagulant treatment in elderly non-valvular atrial fibrillation in the ANAFIE registry, the largest real-world elderly AF registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Yamashita ◽  
H Inoue
Keyword(s):  
Elderly Patients ◽  
Major Bleeding ◽  
Real World ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Age Groups ◽  
Funding Source ◽  
Anticoagulant Treatment ◽  
Very Elderly ◽  
Private Company

Abstract Background The optimal anticoagulant regimen for elderly AF has not been well elucidated, because this population, especially the very elderly (≥85 years), have not been sufficiently represented in most randomized controlled clinical trials for stroke prevention in non-valvular AF (NVAF). Purpose The ANAFIE registry was designed to evaluate the real-world anticoagulant treatment status of elderly (≥75 years) NVAF patients including &gt;8,000 very elderly patients. In this main analysis of the ANAFIE, the incidence of stroke or systemic embolic events (stroke/SEE), and major bleeding were compared between warfarin (WF) and direct oral anticoagulants (DOACs). Methods A total of 33,018 NVAF patients aged ≥75 years was enrolled in the ANAFIE, and followed for 2 years. The incidence of stroke/SEE and major bleeding by type of anticoagulants (WF and all DOACs) was estimated using Kaplan-Meier method. Hazard ratio (HR) and 95% confidence interval (95% CI) were calculated by Cox proportional hazard model. Results In the analysis set of 32,099 patients, the mean age was 81.5 years. 23,738 (74%) were &lt;85 years and 8,361 (26.0%) were ≥85 years. 92.5% of the whole population used anticoagulants including WF (27.6%) or DOACs (72.3%). The ratio of each DOAC was dabigatran 7.8%, rivaroxaban 21.5%, apixaban 26.9% and edoxaban 16.1%. Stroke/SEE and major bleeding was observed in 396 patients (1.24/100 patient-years [py]) and 279 patients (0.87/100py). The time in therapeutic range for patients &lt;85 years and ≥85 years in the WF group was 76.7% and 72.2%, respectively. The incidence of stroke/SEE was numerically lower in patients taking any DOAC vs. WF regardless of age group (&lt;85 years [HR 0.83] and ≥85 years [HR 0.71]). Major bleeding was also lower vs. WF in both age groups (&lt;85 years [HR 0.60] and ≥85 years [HR 0.65]). Conclusion In elderly NVAF patients enrolled in the ANAFIE registry, the incidence of stroke/SEE and major bleeding was lower in patients taking a DOAC compared with WF for all patients ≥75 years, even for very elderly patients. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

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