Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in “real-world” clinical practice

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Summary

The ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA ₂ DS ₂ -VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59–0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54–0.65) than warfarin initiators. Different types of stroke/SE and major bleeding – including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding – were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA ₂ DS ₂ -VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest “real-world” study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard-and low-dose apixaban dose regimens.

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

Supplementary Material to this article is available online at www.thrombosis-online.com .

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Most cited references 15

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Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population.

Susan Colilla, Ann Crow, William Petkun … (2013)

Estimates and projections of diagnosed incidence and prevalence of atrial fibrillation (AF) in the United States have been highly inconsistent across published studies. Although it is generally acknowledged that AF incidence and prevalence are increasing due to growing numbers of older people in the U.S. population, estimates of the rate of expected growth have varied widely. Reasons for these variations include differences in study design, covered time period, birth cohort, and temporal effects, as well as improvements in AF diagnosis due to increased use of diagnostic tools and health care awareness. The objective of this study was to estimate and project the incidence and prevalence of diagnosed AF in the United States out to 2030. A large health insurance claims database for the years 2001 to 2008, representing a geographically diverse 5% of the U.S. population, was used in this study. The trend and growth rate in AF incidence and prevalence was projected by a dynamic age-period cohort simulation progression model that included all diagnosed AF cases in future prevalence projections regardless of follow-up treatment, as well as those cases expected to be chronic in nature. Results from the model showed that AF incidence will double, from 1.2 million cases in 2010 to 2.6 million cases in 2030. Given this increase in incidence, AF prevalence is projected to increase from 5.2 million in 2010 to 12.1 million cases in 2030. The effect of uncertainty in model parameters was explored in deterministic and probabilistic sensitivity analyses. Variability in future trends in AF incidence and recurrence rates has the greatest impact on the projected estimates of chronic AF prevalence. It can be concluded that both incidence and prevalence of AF are likely to rise from 2010 to 2030, but there exists a wide range of uncertainty around the magnitude of future trends.

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A systematic review of validated methods for identifying atrial fibrillation using administrative data.

S R Heckbert, Sascha Dublin, Chantel Jensen … (2011)

The objectives of this study were to characterize the validity of algorithms to identify AF from electronic health data through a systematic review of the literature and to identify gaps needing further research. Two reviewers examined publications during 1997-2008 that identified patients with atrial fibrillation (AF) from electronic health data and provided validation information. We abstracted information including algorithm sensitivity, specificity, and positive predictive value (PPV). We reviewed 544 abstracts and 281 full-text articles, of which 18 provided validation information from 16 unique studies. Most used data from before 2000, and 10 of 16 used only inpatient data. Three studies incorporated electronic ECG data for case identification or validation. A large proportion of prevalent AF cases identified by ICD-9 code 427.31 were valid (PPV 70%-96%, median 89%). Seven studies reported algorithm sensitivity (range, 57%-95%, median 79%). One study validated an algorithm for incident AF and reported a PPV of 77%. The ICD-9 code 427.31 performed relatively well, but conclusions about algorithm validity are hindered by few recent data, use of nonrepresentative populations, and a disproportionate focus on inpatient data. An optimal contemporary algorithm would likely draw on inpatient and outpatient codes and electronic ECG data. Additional research is needed in representative, contemporary populations regarding algorithms that identify incident AF and incorporate electronic ECG data. Copyright © 2012 John Wiley & Sons, Ltd.

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Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation

Xiaoxi Yao, Neena Abraham, Lindsey R. Sangaralingham … (2016)

Background The introduction of non–vitamin K antagonist oral anticoagulants has been a major advance for stroke prevention in atrial fibrillation; however, outcomes achieved in clinical trials may not translate to routine practice. We aimed to evaluate the effectiveness and safety of dabigatran, rivaroxaban, and apixaban by comparing each agent with warfarin. Methods and Results Using a large US insurance database, we identified privately insured and Medicare Advantage patients with nonvalvular atrial fibrillation who were users of apixaban, dabigatran, rivaroxaban, or warfarin between October 1, 2010, and June 30, 2015. We created 3 matched cohorts using 1:1 propensity score matching: apixaban versus warfarin (n=15 390), dabigatran versus warfarin (n=28 614), and rivaroxaban versus warfarin (n=32 350). Using Cox proportional hazards regression, we found that for stroke or systemic embolism, apixaban was associated with lower risk (hazard ratio [HR] 0.67, 95% CI 0.46–0.98, P=0.04), but dabigatran and rivaroxaban were associated with a similar risk (dabigatran: HR 0.98, 95% CI 0.76–1.26, P=0.98; rivaroxaban: HR 0.93, 95% CI 0.72–1.19, P=0.56). For major bleeding, apixaban and dabigatran were associated with lower risk (apixaban: HR 0.45, 95% CI 0.34–0.59, P<0.001; dabigatran: HR 0.79, 95% CI 0.67–0.94, P<0.01), and rivaroxaban was associated with a similar risk (HR 1.04, 95% CI 0.90–1.20], P=0.60). All non–vitamin K antagonist oral anticoagulants were associated with a lower risk of intracranial bleeding. Conclusions In patients with nonvalvular atrial fibrillation, apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin.

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Author and article information

Journal

Journal ID (nlm-ta): Thromb Haemost

Journal ID (iso-abbrev): Thromb. Haemost

Journal ID (doi): 10.1055/s-00035024

Title: Thrombosis and Haemostasis

Publisher: Schattauer GmbH

ISSN (Print): 0340-6245

ISSN (Electronic): 2567-689X

Publication date (Print): June 2017

Publication date (Electronic): 28 November 2017

Volume: 117

Issue: 6

Pages: 1072-1082

Affiliations

[1 ]Bristol-Myers Squibb Company, Lawrenceville, New Jersey, USA

[2 ]Ochsner Clinic Foundation, Department of Hospital Medicine, New Orleans, Louisianna, USA and The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, Louisianna, USA

[3 ]STATinMED Research, Ann Arbor, Michigan, USA

[4 ]Pfizer, Inc., New York, New York, USA

[5 ]Pfizer, Inc., Groton, Conneticut, USA

[6 ]Bristol-Myers Squibb Company, Wallingford, Conneticut, USA

[7 ]Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK

[8 ]Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

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Correspondence to: Xiaoyan Li Bristol-Myers Squibb3401 Princeton PikeLawrenceville, NJ 08648USA+1 609 302 4478 shawn.li@ 123456bms.com

Article

DOI: 10.1160/TH17-01-0068

PMC ID: 6291856

PubMed ID: 28300870

SO-VID: db5a3241-7183-42ab-9fc7-dece0831de1b

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This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.

History

Date received : 31 January 2017

Date accepted : 09 March 2017

Funding

Funded by: Bristol-Myers Squibb Company

Funded by: Pfizer, Inc.

Financial support: This study was funded by Bristol-Myers Squibb Company and Pfizer, Inc.

Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in “real-world” clinical practice : A propensity-matched analysis of 76,940 patients

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Most cited references 15

Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population.

A systematic review of validated methods for identifying atrial fibrillation using administrative data.

Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation

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