Trial Outcomes & Findings for Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism (NCT NCT03266783)

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

CRB events are defined as the composite of major bleeding (MB) events and clinically relevant non-major bleeding (CRNMB) events.

Major bleeding will be defined as fatal bleeding, and/or, Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin of ≥20 g/L, or leading to transfusion of ≥2 units of whole blood or red cells.

Clinically relevant non-major bleeding will be defined as any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the International Society on Thrombosis and Haemostasis (ISTH) definition of major bleeding but does meet at least one of the following criteria: * Requiring medical intervention by a healthcare professional * Leading to hospitalization or increased level of care * Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation

Recurrent VTE will be confirmed with investigational reports including clinic notes, D-dimer results and imaging as per standard of care. Recurrent Deep Vein Thrombosis (DVT) will be confirmed by compression ultrasound revealing a new (compared to baseline/index ultrasound) area of non-compressibility in the popliteal vein or more proximal vein, or venography demonstrating a constant intraluminal filling defect in the popliteal vein or more proximal veins. Recurrent Pulmonary Embolism (PE) will be diagnosed if the Ventilation-Perfusion (VQ) scan is non-normal and a new unmatched segmental or greater perfusion defect is documented, or an intraluminal filling defect is seen on Computed Tomography Pulmonary Angiogram (CTPA) in a segmental or greater vessel that was previously free of thrombus, or pulmonary angiography demonstrating a constant intraluminal filling defect or a cutoff of a vessel \>2.5 mm in diameter will be considered diagnostic for PE.

VTE-related death (fatal PE or unexplained deaths) will be confirmed using death certificates and/or autopsy findings.

Using a binary outcome of an event or no event (Individual rates of death related to VTE, bleeding or other causes).

Reported as the number of patients self-reporting full medication adherence.

We will measure health utility values using the EQ-5D-5L (EuroQoL-5 Dimension-5 Level) Questionnaire at baseline, 2 week (± 7 days), and 90 days (+14 days). We will model the prognosis of a cohort of patients receiving rivaroxaban as a baseline against the potential impact of apixaban. The results will be presented as incremental cost per QALY gained, incremental costs per one CRB cases prevented, and incremental cost per one life year saved.

Incremental cost-effectiveness ratios including cost per one CRB case prevented, cost per one life year saved, cost per one quality-adjusted life year (QALY) gained, which will be analyzed as part of the health economic analysis plan.

Impact of verbal consent on patient participation in comparison with participants from sites using written informed consent. Due to the qualitative nature of this outcome, it will be presented descriptively.