Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor–associated major bleeds
Raza Alikhan a), May Nour b), Masahiro Yasaka c), Richard Ofori-Asenso d), Stina Axelsson-Chéramy e), Hungta Chen f), Vinay Seghal g), Shoji Yokobori h), Bruce Koch f), Andreas Tiede i), Brooks D. Cash j), Marc Maegele k), Adam J. Singer l)
a-University Hospital of Wales and Cardiff University School of Medicine, Cardiff, Wales, United Kingdom
b-University of California, Los Angeles, California, United States
c-Fukuoka Neurosurgical Hospital, Fukuoka, Japan
d-AstraZeneca, Cambridge, United Kingdom
e-AstraZeneca, Gothenburg, Sweden
f-AstraZeneca, Wilmington, Delaware, United States
g-University College London Hospital, London, United Kingdom
h-Nippon Medical School, Tokyo, Japan
i-Hannover Medical School, Hannover, Germany
j-University of Texas Health Science Center at Houston, Houston, Texas, United States
k-Cologne-Merheim Medical Center, Cologne, Germany
l-Stony Brook University, New York, New York, United States
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.