Non-valvular atrial fibrillation: impact of apixaban on patient outcomes

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Abstract

Atrial fibrillation is the most common arrhythmia worldwide, and carries a significantly increased risk of thromboembolic stroke. Initially, vitamin K antagonists were used as stroke prophylaxis; but more recently, a group of drugs known as novel oral anticoagulants have been developed. Apixaban belongs to this group of drugs, and is a factor Xa inhibitor that has emerged as a popular pharmacological agent worldwide. In this review, we will provide an overview of the pivotal trials in the development of apixaban, while also critically evaluating the new emerging real-world data, and discussing the effectiveness, safety, economic viability and future prospects of apixaban and how it impacts on patient outcomes in those with non-valvular atrial fibrillation.

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Most cited references 40

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Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.

Stuart Connolly, Truman Milling, John W Eikelboom … (2016)

Background Andexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in healthy volunteers. Methods In this multicenter, prospective, open-label, single-group study, we evaluated 67 patients who had acute major bleeding within 18 hours after the administration of a factor Xa inhibitor. The patients all received a bolus of andexanet followed by a 2-hour infusion of the drug. Patients were evaluated for changes in measures of anti-factor Xa activity and were assessed for clinical hemostatic efficacy during a 12-hour period. All the patients were subsequently followed for 30 days. The efficacy population of 47 patients had a baseline value for anti-factor Xa activity of at least 75 ng per milliliter (or ≥0.5 IU per milliliter for those receiving enoxaparin) and had confirmed bleeding severity at adjudication. Results The mean age of the patients was 77 years; most of the patients had substantial cardiovascular disease. Bleeding was predominantly gastrointestinal or intracranial. The mean (±SD) time from emergency department presentation to the administration of the andexanet bolus was 4.8±1.8 hours. After the bolus administration, the median anti-factor Xa activity decreased by 89% (95% confidence interval [CI], 58 to 94) from baseline among patients receiving rivaroxaban and by 93% (95% CI, 87 to 94) among patients receiving apixaban. These levels remained similar during the 2-hour infusion. Four hours after the end of the infusion, there was a relative decrease from baseline of 39% in the measure of anti-factor Xa activity among patients receiving rivaroxaban and of 30% among those receiving apixaban. Twelve hours after the andexanet infusion, clinical hemostasis was adjudicated as excellent or good in 37 of 47 patients in the efficacy analysis (79%; 95% CI, 64 to 89). Thrombotic events occurred in 12 of 67 patients (18%) during the 30-day follow-up. Conclusions On the basis of a descriptive preliminary analysis, an initial bolus and subsequent 2-hour infusion of andexanet substantially reduced anti-factor Xa activity in patients with acute major bleeding associated with factor Xa inhibitors, with effective hemostasis occurring in 79%. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327 .).

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Non-Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction.

Xiaoxi Yao, Nilay Shah, Lindsey R. Sangaralingham … (2017)

Dose reduction of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in patients with atrial fibrillation (AF) with renal impairment. Failure to reduce the dose in patients with severe kidney disease may increase bleeding risk, whereas dose reductions without a firm indication may decrease the effectiveness of stroke prevention.

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The global burden of atrial fibrillation and stroke: a systematic review of the epidemiology of atrial fibrillation in regions outside North America and Europe.

Gregory Lip, Carolyn M Brechin, Deirdre Lane (2012)

Although atrial fibrillation (AF) is accepted as the most common sustained cardiac arrhythmia, most published epidemiologic studies focus on predominantly white populations in North America or Europe, and information on AF in nonwhite populations is scarce. The objective of this study was to undertake a systematic review of the published literature on the epidemiology of AF in other regions. Systematic literature searches (MEDLINE; 1990-2010) identified epidemiologic studies reporting on the prevalence or incidence of AF, stroke in AF, risk factors for AF, or the use of antithrombotic therapy in countries outside North America and Europe. This report presents a descriptive analysis of the data; no meta-analysis was planned. Many of the 38 articles identified were from the Far East, although Australia, New Zealand, the Middle East, and South America were also represented. The reported prevalence of AF varied among countries, with different ranges in community- and hospital-based studies (0.1%-4% and 2.8%-14%, respectively). The use of anticoagulant therapy varied widely among countries and studies, as did the reported prevalence of stroke in patients with AF (2.8%-24.2%). High-quality epidemiologic studies are clearly required to improve understanding of the worldwide burden of AF and stroke in AF. Major improvements in the provision of thromboprophylaxis are also needed in many countries, given the high proportion of untreated patients who are, hence, at risk of stroke.

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Journal

Journal ID (nlm-ta): Patient Relat Outcome Meas

Journal ID (iso-abbrev): Patient Relat Outcome Meas

Journal ID (publisher-id): Patient Related Outcome Measures

Title: Patient Related Outcome Measures

Publisher: Dove Medical Press

ISSN (Electronic): 1179-271X

Publication date Collection: 2017

Publication date (Electronic): 03 November 2017

Volume: 8

Pages: 121-131

Affiliations

[1 ]Cardiology Department, Royal Free NHS Foundation Trust, London, UK

[2 ]Cardiology Department, Medical School, University of Cyprus, Nicosia, Cyprus

[3 ]Cardiology Department, Frimley Health NHS Foundation Trust, London, UK

Author notes

Correspondence: Constantinos G Missouris, Frimley Health NHS Foundation Trust, Wexham Street, Slough SL2 4HL, UK, Tel +44 207 079 4217, Fax +44 207 580 0122, Email dinos.missouris@ 123456fhft.nhs.uk

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Publisher ID: prom-8-121

DOI: 10.2147/PROM.S117549

PMC ID: 5680948

SO-VID: 38e61182-667f-4d0a-b6c8-83bf4f7a9b09

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The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Non-valvular atrial fibrillation: impact of apixaban on patient outcomes

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Most cited references 40

Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.

Non-Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction.

The global burden of atrial fibrillation and stroke: a systematic review of the epidemiology of atrial fibrillation in regions outside North America and Europe.

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