AI Article Synopsis
- The REVERXaL study investigates the characteristics and management of hospitalized patients who experience major bleeds related to factor Xa inhibitors (FXai), a new class of anticoagulants.
- It includes two cohorts: a historical cohort analyzing past patient data and a prospective cohort that evaluates current treatment and patient-reported outcomes over three months.
- The study aims to provide valuable information on treatment approaches and patient outcomes, potentially improving clinical practices for managing FXai-associated major bleeds.
Article 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.
Registration: URL: https://www.
Clinicaltrials: gov; unique identifier: NCT06147830.
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| http://dx.doi.org/10.1016/j.thromres.2024.109046 | DOI Listing |
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