Extended thromboprophylaxis with betrixaban: a new standard for acute medically ill patients (original) (raw)

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Department of Haematological Medicine, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, Westminster Bridge Road, London, UK

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Alexander T Cohen, Extended thromboprophylaxis with betrixaban: a new standard for acute medically ill patients, European Heart Journal Supplements, Volume 20, Issue suppl_E, May 2018, Pages E1–E2, https://doi.org/10.1093/eurheartj/suy014
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The main advantage of understanding aetiological risks for any condition is that their recognition allows early targeted intervention in the form of preventive therapies, which ultimately reduce the burden of disease. This is particularly true for venous thromboembolism (VTE), the most significant preventable cause of morbidity and mortality in hospitalized patients.1,2

It has long been recognized that hospitalization for surgical and medical conditions is associated with ∼50% of the total burden of VTE, and half of this burden (23% of the total burden of VTE) occurs in the 3 months following admission to hospital for an acute medical illnesses.3 These figures are based on the presentation of symptomatic disease, and they significantly underestimate the attributable risk for VTE-related mortality. Studies have shown ∼70% of hospital-associated VTE-related mortality occurs in the acutely ill medical population.1,3

Prior to the APEX study with betrixaban, there were no United States Food and Drug Administration (FDA)-approved therapies for extended VTE prophylaxis in acute medically ill patients at risk of VTE. Betrixaban was recognized as having unique properties that would suit the prevention of VTE in acute medically ill patients,4 and hence, the APEX study was undertaken with this drug.5,6 The results are clinically significant with a 36% relative risk reduction in symptomatic VTE in the overall APEX study population (P =0.04), and therefore we the have the potential to reduce the overall burden of VTE by ∼10%.3 In the EU and USA, applying the APEX risk reductions to the epidemiological data means this has the potential to result in 30 000 fewer VTE-related deaths (18 000 and 12 000, respectively) and 50 000 fewer non-fatal symptomatic VTEs (30 000 and 20 000, respectively).1,6–8 In addition, based on the APEX data, extended-duration thromboprophylaxis with betrixaban may prevent one death for every 223 acute medically ill patients treated.9

In this supplement, we present the background of hospital-acquired thrombosis, the unmet need related to preventing VTE with extended thromboprophylaxis, and the pharmacology of betrixaban and its properties that suit the indication for extended VTE prophylaxis from hospitalization through post-discharge, as approved by the FDA. Finally, the primary results of the APEX study as well as post hoc analyses are reviewed.

Conflict of interest: A.T.C. received personal honoraria and research support from numerous pharmaceutical companies including Portola Pharmaceuticals, Bayer, BMS, Pfizer, Daiichi-Sankyo, Jannsen, Aspen, and Ono Pharmaceuticals.

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Author notes

Guest Editor

Published on behalf of the European Society of Cardiology. © The Author(s) 2018.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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