Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study

摘要: Summary Background The efficacy and safety of the anticoagulant rivaroxaban for treatment secondary prevention deep-vein thrombosis pulmonary embolism has been shown in phase 3 trials. However, data about use routine clinical practice are needed. Methods XA inhibition with Long-term Initial Anticoagulation venous thromboembolism (XALIA) was a multicentre, international, prospective, non-interventional study patients thrombosis, done hospitals community care centres 21 countries. investigated effectiveness compared standard anticoagulation therapy (initial unfractionated heparin, low-molecular-weight or fondaparinux, usually overlapping followed by vitamin K antagonist) at least months. Eligible were adults (aged ≥18 years) an objectively confirmed diagnosis indication to receive Following approval indication, concomitant also eligible; however, those isolated not included. Type, dose, duration each patient physician's discretion. primary outcomes major bleeding, recurrent thromboembolism, all-cause mortality. Propensity score-adjusted analyses account potential imbalances between groups. This is registered ClinicalTrials.gov, number NCT01619007. Findings Between June 26, 2012, March 31, 2014, 5142 enrolled. population (all who received one dose interest) comprised 2619 group 2149 group. Patients younger fewer had active cancer than In propensity population, frequency bleeding 0·8% (19/2505) 2·1% (43/2010) group, hazard ratio (HR) 0·77 (95% CI 0·40–1·50); p=0·44. 1·4% (36/2505) 2·3% (47/2010) (propensity HR 0·91 [95% 0·54–1·54], p=0·72). mortality 0·4% (11/2505) 3·4% (69/2010) 0·51 0·24–1·07], p=0·074). incidence treatment-emergent adverse events similar two groups (944 [36·0%] vs 805 [37·5%] group). Interpretation practice, rivaroxaban-treated lower risk profile baseline treated anticoagulation. results confirm that safe effective alternative broad range patients. Rates low consistent findings. Funding Bayer HealthCare Pharmaceuticals Janssen Research & Development, LLC.