scholarly journals Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients

Stroke ◽  
2018 ◽  
Vol 49 (12) ◽  
pp. 2933-2944 ◽  
Author(s):  
Gregory Y.H. Lip ◽  
Allison Keshishian ◽  
Xiaoyan Li ◽  
Melissa Hamilton ◽  
Cristina Masseria ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Observational Study ◽  
Oral Anticoagulants ◽  
Healthcare Providers ◽  
Pooled Analysis ◽  
Nonvalvular Atrial Fibrillation ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Cox Models ◽  
Multiple Data

Background and Purpose— This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non–vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods— A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results— A total of 434 046 patients were included in the 6 matched cohorts: 100 977 apixaban-warfarin, 36 990 dabigatran-warfarin, 125 068 rivaroxaban-warfarin, 37 314 apixaban-dabigatran, 107 236 apixaban-rivaroxaban, and 37 693 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.64; 95% CI, 0.58–0.70), dabigatran (HR, 0.82; 95% CI, 0.71–0.95), and rivaroxaban (HR, 0.79; 95% CI, 0.73–0.85) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.60; 95% CI, 0.56–0.63) and dabigatran (HR, 0.71; 95% CI, 0.65–0.78) had lower rates of MB, and rivaroxaban (HR, 1.06; 95% CI, 1.02–1.10) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions— In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration— URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.

P4794Comparative effectiveness and safety of non-VKA oral anticoagulants versus warfarin in non-valvular atrial fibrillation patients with differential treatment duration: an ARISTOPHANES study analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Dhamane ◽  
X Luo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Treatment Duration ◽  
Oral Anticoagulants ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Duration Of Treatment ◽  
Cox Models ◽  
Hazard Ratios

Abstract Background The ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS) study showed that non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of stroke/systemic embolism (S/SE) and variable comparative risks of major bleeding (MB) versus warfarin. Purpose To assess long-term use of non-VKA oral anticoagulants (NOACs) vs. warfarin in ARISTOPHANES by evaluating the risk of S/SE and MB among non-valvular atrial fibrillation (NVAF) patients by duration of treatment (<1 and ≥1 year). Methods In the ARISTOPHANES study, NVAF patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from 01/01/2013–09/30/2015 were identified from the CMS Medicare data and four US commercial claims databases, covering >180 million beneficiaries annually (∼56% of US population). After 1:1 propensity score matching (PSM) in each database between NOACs and warfarin (apixaban-warfarin, dabigatran-warfarin, and rivaroxaban-warfarin), the resulting patient records were pooled. Treatment duration was defined as time between the day after the treatment index date and discontinuation (30 days after a 30-day gap in the prescription), treatment switch, death, end of study period, or end of continuous medical and pharmacy enrollment, whichever occurred first. Matched patients with observed treatment duration <1 or ≥1 year were separately examined. Cox models were used to estimate hazard ratios of S/SE and MB (identified by inpatient claims) during observed treatment duration. Results The mean treatment duration for patients with shorter (<1 year) vs longer (≥1 year) duration was 4–5 months vs 18–21 months across the three matched cohorts. All the matched baseline variables remained balanced. The incidence rates of S/SE and MB and the proportion of patients with treatment discontinuation were higher in patients with shorter treatment duration. Regardless of treatment duration, apixaban patients had a lower risk of S/SE and MB versus warfarin; dabigatran patients had a lower risk of MB versus warfarin; and rivaroxaban patients had a lower risk of S/SE versus warfarin. Compared to warfarin patients, dabigatran patients with treatment duration <1 year had a similar risk of S/SE, while those with treatment duration ≥1 year had lower S/SE risk; rivaroxaban patients with treatment duration <1 year had a higher risk of MB, while those with treatment duration ≥1 year had similar MB risk. Conclusions Among NVAF patients with duration of treatment <1 and ≥1 year in the ARISTOPHANES study, apixaban and rivaroxaban were associated with lower risk of S/SE, while apixaban and dabigatran were associated with lower risk of MB, compared to warfarin. These findings indicate varying long-term effectiveness and safety outcomes between NOACs and warfarin. Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc.

scholarly journals Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme

EP Europace ◽  
2019 ◽  
Author(s):  
Michał Mazurek ◽  
Jonathan L Halperin ◽  
Menno V Huisman ◽  
Hans-Christoph Diener ◽  
Sergio J Dubner ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Newly Diagnosed ◽  
Antithrombotic Treatment ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Patient Age ◽  
Patient Âgé ◽  
Global Registry

Abstract Aims To assess antithrombotic therapy choices in relation to patient age in a large, global registry on atrial fibrillation (AF). Methods and results Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is an international programme involving patients with newly diagnosed AF and ≥1 risk factors for stroke. We used Phase II data (from November 2011 through December 2014), which commenced immediately following first non-vitamin K antagonist oral anticoagulants (NOACs) approval in participating countries. Of 15 092 patients (mean age 70.5 ± 11.0 years), enrolled at 982 centres, 26.9% were aged <65 years, 33.9% 65–74, 30.5% 75–84, and 8.6% ≥85 years old. Oral anticoagulant (OAC) use was 73.5%, 81.4%, 83.3%, and 82.3% (overall NOACs use was 44.4%, 49.7%, 48.7%, and 45.6%) for those aged <65, 65–74, 75–84 and ≥85 years, respectively. Corresponding proportions for antiplatelet monotherapy and no treatment were: 16.2% and 10.2%; 11.2% and 7.3%; 10.0% and 6.5%; 10.5% and 7.0%, respectively. Of those aged 65–74, 75–84, and ≥85 years, respectively, 83.7, 86.8 and 85.4% received OAC unless bleeding risk was high (HAS-BLED ≥3), whereby 64.1%, 63.5%, and 64.5% were anticoagulated, and 31.1%, 30.3%, and 31.3% received antiplatelets only. Of patients ≥85 years, OAC use was 88.1% in Europe (NOAC 45.1%), 79.5% in North America (NOAC 44.8%), and 54.1% in Asia (NOAC 40.2%). Conclusion Despite geographic differences in OAC use, neither OAC nor NOAC uptake was lower for patients ≥85 years old compared with younger patients. Although the majority of patients was prescribed OAC at all ages, nearly one-third received antiplatelet monotherapy when bleeding risk was increased. Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT01468701

P4768Comparative effectiveness and safety between non-VKA oral anticoagulants in non-valvular atrial fibrillation patients with differential duration of treatment: an analysis of the ARISTOPHANES study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Dhamane ◽  
X Luo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Treatment Duration ◽  
Oral Anticoagulants ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Duration Of Treatment ◽  
Cox Models ◽  
Similar Risk

Abstract Background The ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS) study showed that apixaban was associated with lower risks of stroke/systemic embolism (S/SE) and major bleeding (MB) versus dabigatran and rivaroxaban; dabigatran was associated with similar risk of S/SE and lower risk of MB compared to rivaroxaban. Purpose To assess long-term use of non-VKA oral anticoagulants (NOACs) in ARISTOPHANES by evaluating the risk of S/SE and MB among non-valvular atrial fibrillation (NVAF) patients receiving different NOACs by duration of treatment (<1 and ≥1 year). Methods In the ARISTOPHANES study, NVAF patients initiating apixaban, dabigatran, and rivaroxaban from 01/01/2013–09/30/2015 were identified from the CMS Medicare data and four US commercial claims databases, covering >180 million beneficiaries annually (∼56% of US population). After 1:1 propensity score matching (PSM) in each database between NOACs (apixaban-dabigatran, apixaban-dabigatran, and dabigatran-rivaroxaban), the resulting patient records were pooled. Treatment duration was defined as time between the day after the index treatment date and discontinuation (defined using a 30-day gap in the prescription), treatment switch, death, end of study period, or end of continuous medical and pharmacy enrollment, whichever occurred first. Matched patients with observed treatment duration <1 or ≥1 year were separately examined. Cox models were used to estimate hazard ratios of S/SE and MB (identified by inpatient claims) during observed treatment duration. S/SE included ischemic stroke, hemorrhagic stroke, and SE; MB included gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other MB. Results The mean treatment duration for patients with shorter (<1 year) vs longer (≥1 year) duration was ∼4 months vs 18–21 months across the three matched cohorts. All the matched baseline variables remained balanced. The incidence rates of S/SE and MB and the proportion of patients with treatment discontinuation were higher in patients with shorter treatment duration. Regardless of treatment duration, apixaban and dabigatran had a lower risk of MB versus rivaroxaban; and dabigatran had a similar risk of S/SE versus rivaroxaban. Compared to dabigatran patients, apixaban patients with treatment duration <1 year had a lower risk of S/SE and MB, while those with treatment duration ≥1 year had similar S/SE and MB risk. Compared to rivaroxaban patients, apixaban patients with treatment duration <1 year had a lower risk of S/SE, while those with treatment duration ≥1 year had similar S/SE risk. Conclusions Across NVAF patients with duration of treatment <1 and ≥1 year in the ARISTOPHANES study, both apixaban and dabigatran were associated with a lower risk of MB compared to rivaroxaban. These findings indicate varying long-term safety outcomes among different NOACs. Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc.

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