Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds

Alikhan, Raza, Nour, May, Yasaka, Masahiro, Ofori-Asenso, Richard, Axelsson-Chéramy, Stina, Chen, Hungta, Seghal, Vinay, Yokobori, Shoji, Koch, Bruce, Tiede, Andreas, Cash, Brooks D., Maegele, Marc and Singer, Adam J. 2024. Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds. Thrombosis Research 240 , 109046. 10.1016/j.thromres.2024.109046

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Abstract

Background The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days. Methods REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months. Conclusions REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Elsevier
ISSN:	0049-3848
Date of First Compliant Deposit:	10 September 2024
Date of Acceptance:	28 May 2024
Last Modified:	19 Sep 2024 11:29
URI:	https://orca.cardiff.ac.uk/id/eprint/171968

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