Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials.

Background: Phase II trials of asundexian were underpowered to detect important differences in bleeding.

Objectives: The goal of this study was to obtain best estimates of effects of asundexian vs active control/placebo on major and clinically relevant nonmajor (CRNM) and all bleeding, describe most common sites of bleeding, and explore association between asundexian exposure and bleeding.

Methods: We performed a pooled analysis of 3 phase II trials of asundexian in patients with atrial fibrillation (AF), recent acute myocardial infarction (AMI), or stroke.

[Rivaroxaban for thrombosis prophylaxis in extensive hip and knee operations. Subanalysis of the German cohort (XAMOS-DE) of non-interventional study XAMOS].

Background: In global admission studies (RECORD I-IV) Rivaroxaban and enoxaparin as a standard prophylaxis were comparable in safety of treatment, but rivaroxaban appeared more effective in prevention of venous thromboembolism (VTE) when used in elective hip and knee replacement. The worldwide non-interventional cohort study XAMOS confirmed these results in the clinical routine compared to proven anticoagulants.

Method: Efficacy and safety of rivaroxaban was to be compared with the standard prophylaxis in the prevention of VTE after elective hip and knee replacement surgery in clinical practice in Germany.

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.

Background: Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin.

Methods: In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation.

The effects of timing of prophylaxis, type of anesthesia, and use of mechanical methods on outcome in major orthopedic surgery - subgroup analyses from 17,701 patients in the XAMOS study.

Purpose: Real-world data on the use of rivaroxaban in the perioperative period in patients undergoing major orthopedic surgery are limited. Subsets of data from the Phase IV, non-interventional XAMOS study were analyzed to explore the potential influence of timing of the first thrombo prophylactic dose, type of anesthesia, and concomitant mechanical prophylaxis on clinical outcomes in patients undergoing major orthopedic surgery in routine clinical practice.

Patients And Methods: In XAMOS, 8,778 patients received rivaroxaban (10 mg once daily) and 8,635 received standard-of-care (SOC) pharmacological prophylaxis (safety population).

Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

Aim: The aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non-interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study.

Methods: Concomitant drug use was at the discretion of the treating physician. Prespecified co-medications of interest were cytochrome P450 (CYP) 3A4/P-glycoprotein inhibitors/inducers, platelet aggregation inhibitors (PAIs) and nonsteroidal anti-inflammatory drugs (NSAIDs).

Rivaroxaban for Thromboprophylaxis After Fracture-Related Orthopedic Surgery in Routine Clinical Practice.

Background: The risk of venous thromboembolism is high in patients undergoing fracture-related major orthopedic surgery, but data on pharmacological thromboprophylaxis are limited. This analysis evaluated the effectiveness and safety of rivaroxaban after fracture-related orthopedic surgery in routine care compared with other pharmacological thromboprophylaxis (standard of care [SOC]).

Methods: The study population comprised a subset of patients with lower-limb fracture from XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee (XAMOS; a phase IV noninterventional study) and a XAMOS extension study (XAMOS-Extra).

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy.

Allogeneic blood transfusions and postoperative infections after total hip or knee arthroplasty.

Background: Up to 70% of patients who undergo total hip or total knee arthroplasty receive blood transfusions. Using data from more than 12,000 patients assessed in the Phase-III RECORD (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism) studies, we investigated whether allogeneic blood transfusion increases the risk of postoperative infection compared with autologous blood transfusion or no transfusion.

Methods: A post hoc analysis of the pooled RECORD data stratified patients into three groups according to the type of blood transfusion that they received: no transfusion (n = 6313), autologous blood transfusion (n = 1902), and allogeneic blood transfusion with or without autologous blood transfusion (n = 3962).

A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment.

Rivaroxaban demonstrated superior efficacy and a similar safety profile to enoxaparin for the prevention of venous thromboembolism in the phase III RECORD programme in patients undergoing elective hip or knee replacement surgery. The XAMOS study investigated adverse events, including bleeding and thromboembolic events, in patients receiving rivaroxaban for thromboprophylaxis in routine clinical practice. XAMOS was a non-interventional, open-label cohort study in patients undergoing major orthopaedic surgery of the hip or knee (predominantly elective arthroplasty), in which rivaroxaban was compared with other pharmacological thromboprophylaxis.