Use of new anticoagulants for the treatment of venous thromboembolism in the context of the results of the XALIA study — clinical trials and routine clinical practice

Abstract

The introduction of new non-vitamin K antagonist oral anticoagulants (NOAC) has had a significant impact on the treatment regimen of patients with venous thromboembolism. Phase 3 studies with the use of this group of drugs, including both direct factor II inhibitors and direct factor Xa inhibitors, have shown that the safety and effectiveness of this type of treatment are similar to vitamin K antagonists that have been used for a long time. Due to the eligibility of randomly selected patients that meet strict and specific inclusion criteria for pre-marketing studies, studies based on the assessment of the effectiveness and clinical safety of the above-mentioned drugs in the routine clinical practice are becoming extremely important. XALIA, the first international, multicenter, prospective clinical study on the use of the direct coagulation inhibitor — rivaroxaban in the routine clinical practice is an example of these types of studies. The aim of the study was to compare the results of the anticoagulant therapy in patients with deep vein thrombosis and patients with combined deep vein thrombosis and pulmonary embolism using rivaroxaban and standard anticoagulation regimen in the routine clinical practice. The results of the XALIA study confirm the findings of previous prospective, randomized studies in the population characterized by a broad spectrum of patients, indicating the safety and effectiveness of rivaroxaban in the treatment of venous thromboembolism in the routine clinical practice. The incidence of major bleeding complications in the group of patients receiving rivaroxaban was 0.7% compared to 0.8% of patients treated using standard anticoagulants. The proportion of recurrence of venous thromboembolism was low and similar to the results obtained in the EINSTEIN DVT study [XALIA — 1.4% vs. EINSTEIN DVT — 2.1%]. No cases of fatal bleeding were reported in the XALIA study and the calculated proportion of major bleeding complications in patients taking rivaroxaban was 1.2 per year, the proportion of recurrence and death from any cause was 2.4% and 0.8%, respectively. The obtained results confirm previous observations suggesting a low risk of recurrence as well as a high safety of the anticoagulant therapy in patients with deep vein thrombosis using rivaroxaban — this time in the study related to the routine clinical practice.